{"filings":[{"id":526681,"accession_number":"0001193125-26-230731","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2026-05-19T20:05:15+00:00","items":["5.07"],"status":"ready","headline":"Invivyd shareholders elect all six director nominees, ratify PwC as auditor","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["All six director nominees elected at May 19, 2026 annual meeting: Tamsin Berry, Paul B. Bolno, M.D., Marc Elia, Terrance McGuire, Kevin F. McLaughlin, Ajay Royan.","Each director received >173.5M votes For; broker non-votes totaled 29.7M shares.","Proposal 2: Ratification of PricewaterhouseCoopers LLP as FY2026 auditor passed 222.6M For, 80,390 Against, 44,315 Abstain."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.15,"calibrated_materiality_score":0.15,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":77521,"accession_number":"0001193125-26-222762","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2026-05-14T11:12:20+00:00","items":["2.02","8.01","9.01"],"status":"ready","headline":"Invivyd Q1 net product revenue $13.7M (+22% YoY); net loss $41.4M; VYD2311 data delayed to Q3 2026","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Q1 2026 PEMGARDA net product revenue $13.7M, up 22% YoY vs $11.3M.","Net loss $41.4M ($0.13/sh) vs $16.3M ($0.14/sh) in Q1 2025; R&D expense rose to $30.7M.","Cash $184.2M at Mar 31; raised ~$20M via ATM in Apr 2026, extending runway through VYD2311 launch.","DECLARATION trial upsized by ~500 subjects; top-line data now expected in Q3 2026 (shift from mid-year).","IDMC reduced VYD2311 post-dose monitoring from 2 hours to 30 min; in vitro neutralization vs BA.3.2.2 confirmed."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":95988,"accession_number":"0001193125-26-148865","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2026-04-09T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd announces Phase 3 DECLARATION upsizing; new measles antibody VMS063","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["DECLARATION Phase 3 COVID-19 prophylaxis study upsized by ~500 subjects; top-line results now expected in Q3 2026, shifted from mid-2026.","Pooled, blinded COVID-19 events at 1,500 subjects (Day 45) already support statistical power for high end of anticipated VYD2311 efficacy.","FDA alignment on initial Pediatric Study Plan for VYD2311 (DRUMMER study) for children aged 0-11 years, contingent on DECLARATION success.","New measles mAb candidate VMS063 targets F protein, shows potent in vitro neutralization (picogram/mL IC50s) across B3, D8, Edmonston lineages; IND-enablement started.","VMS063 is half-life extended, planned for treatment and prophylaxis in measles; U.S. measles incidence in 2026 on track to exceed 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":109467,"accession_number":"0001193125-26-092528","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2026-03-05T23:59:59+00:00","items":["2.02","8.01","9.01"],"status":"ready","headline":"Invivyd Q4 PEMGARDA revenue $17.2M (+31% QoQ); VYD2311 DECLARATION trial fully enrolled, top-line mid-2026","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Q4 2025 PEMGARDA net revenue $17.2M (up 25% YoY, 31% QoQ); FY2025 revenue $53.4M vs $25.4M in 2024.","Cash and equivalents $226.7M at Dec 31, 2025; raised over $200M in 2H 2025.","FY2025 net loss $52.5M ($0.30/share) vs $169.9M ($1.43/share) in 2024; R&D expenses fell to $38.3M.","DECLARATION Phase 3 trial for VYD2311 fully enrolled; IDMC allows pregnant/breastfeeding women; top-line data expected mid-2026.","Appointed Michael Mina, M.D., Ph.D., as CMO; Fast Track designation for VYD2311 granted Dec 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":109466,"accession_number":"0001193125-26-006997","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2026-01-08T23:59:59+00:00","items":["2.02","8.01","9.01"],"status":"ready","headline":"Invivyd reports preliminary Q4 2025 revenue $17.2M, VYD2311 Phase 3 trial initiated, top-line data mid-2026","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Preliminary Q4 2025 PEMGARDA net product revenue of $17.2M, up 25% YoY from $13.8M and 31% QoQ from $13.1M.","Ending 2025 cash and cash equivalents of $226.7M after raising over $200M in 2H 2025.","Initiated DECLARATION Phase 3 pivotal trial of VYD2311 for COVID prevention; top-line data expected mid-2026.","Fast Track designation for VYD2311 granted by FDA in December 2025.","Selected potential best-in-class RSV antibody candidate VBY329; IND readiness targeted for 2H 2026."],"consensus_eps_estimate":-0.0893,"consensus_eps_actual":-0.3,"consensus_revenue_estimate":null,"consensus_revenue_actual":53426000.0,"consensus_period":"2025-FY","consensus_source":"xbrl+finnhub","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":125980,"accession_number":"0001193125-25-329488","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-12-23T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd receives FDA Fast Track designation for COVID antibody VYD2311","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA Fast Track granted for VYD2311 to prevent COVID in individuals with risk factors for severe disease.","VYD2311 is an investigational vaccine-alternative monoclonal antibody candidate.","Phase 3 DECLARATION trial ongoing; top-line data expected mid-2026.","Fast Track enables priority review and rolling BLA submission if criteria met.","Total enrollment of 1770 participants in the placebo-controlled trial."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":125979,"accession_number":"0001193125-25-291992","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-11-24T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd selects RSV antibody candidate VBY329; 2H 2026 IND readiness targeted","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["VBY329 showed 1.5x greater potency vs nirsevimab, 1.2x vs clesrovimab against authentic RSV strains.","Up to ~500-fold enhanced neutralization vs nirsevimab-resistant variants in pseudovirus assays.","Half-life extension technology expected to expand protective window vs standard of care.","Pediatric RSV prophylaxis market estimated $3-4B annually globally by 2030.","Additional discovery efforts for ultra-long half-life RSV antibodies for elderly/immunocompromised."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":125978,"accession_number":"0001193125-25-288347","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-11-19T23:59:59+00:00","items":["1.01","8.01","9.01"],"status":"ready","headline":"Invivyd prices $125M stock and warrant offering; net proceeds ~$117.2M for pipeline funding","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Priced 44M shares at $2.50 and 6M pre-funded warrants at $2.4999; gross $125M, net ~$117.2M.","Offering closed Nov 19, 2025; underwriters have 30-day option for 7.5M additional shares.","Proceeds for VYD2311 commercial prep, RSV/measles R&D, SPEAR Long COVID study, and working capital.","Cantor Fitzgerald sole book-runner; H.C. Wainwright lead manager."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":125977,"accession_number":"0001193125-25-268057","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-11-06T23:59:59+00:00","items":["2.02","8.01","9.01"],"status":"ready","headline":"Invivyd Q3 revenue $13.1M (+41% YoY); net loss narrows; IND cleared for VYD2311","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["PEMGARDA net product revenue $13.1M in Q3 2025, up 41% YoY and 11% QoQ.","Net loss $10.5M ($0.06 diluted EPS) vs $60.7M ($0.51) in Q3 2024; R&D spend fell to $8.0M from $57.9M.","Cash $85.0M at Sep 30; >$100M after Oct ATM; $57.5M gross proceeds from Aug 2025 offering.","FDA cleared IND for VYD2311; pivotal REVOLUTION program (DECLARATION N=1770, LIBERTY N=210) starts near year-end 2025, data mid-2026.","Board adds Dr. Paul Bolno; Kristie Kuhl named CCO; pipeline expansion into RSV and measles."],"consensus_eps_estimate":-0.0816,"consensus_eps_actual":-0.3,"consensus_revenue_estimate":null,"consensus_revenue_actual":36219000.0,"consensus_period":"2025-Q3","consensus_source":"xbrl+finnhub","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":125976,"accession_number":"0001193125-25-258526","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-10-30T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd posts investor presentation on website; no substantive details provided in filing","summary_kind":"llm","event_type":"other_material","confidence":"low","bullets":["Filing states investor presentation posted on Oct 30, 2025 at www.invivyd.com.","Exhibit 99.1 contains only a title slide with a philosophical quote and date.","No financial results, guidance, or operational updates are disclosed in the 8-K or exhibit.","Investors must access the full presentation on the company's website for details."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.1,"calibrated_materiality_score":0.1,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":125975,"accession_number":"0001193125-25-230898","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-10-06T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd announces FDA IND clearance for VYD2311; Phase 3 and Phase 2 trials to start year-end 2025","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA cleared IND and aligned on pivotal clinical program for VYD2311, a vaccine-alternative monoclonal antibody to prevent COVID.","DECLARATION Phase 3 trial (N=~2,000) will evaluate single and monthly IM doses vs placebo for 3-month prevention of symptomatic COVID.","LIBERTY Phase 2 trial (N=~300) will compare safety/tolerability of VYD2311 vs mRNA vaccine and explore co-administration.","Trials to begin year-end 2025 with top-line data anticipated mid-2026; funded by recent capital raise and commercial launch quantities ready.","Details to be shared in public investor event later this month."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":142717,"accession_number":"0001193125-25-215541","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-09-24T23:59:59+00:00","items":["5.02","7.01","8.01","9.01"],"status":"ready","headline":"Invivyd appoints Paul B. Bolno, M.D. to board; regains Nasdaq compliance","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Dr. Bolno, President and CEO of Wave Life Sciences, appointed to Board and Compensation Committee effective September 22, 2025.","He receives $40,000 annual cash retainer, $5,000 for committee service, and 100,000 stock options vesting over three years.","Christine Akinc resigned from Board and all committees on September 22; departure not due to any disagreement.","Nasdaq notified Invivyd on September 22 that it regained compliance with the $1.00 minimum bid price requirement, closing the matter."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":142716,"accession_number":"0000950170-25-110952","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-08-22T23:59:59+00:00","items":["1.01","8.01","9.01"],"status":"ready","headline":"Invivyd closes $57.5M public offering; net proceeds ~$53.5M for pipeline development","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Raised ~$57.5M gross ($53.5M net) via 89.2M shares at $0.52/sh and 21.3M pre-funded warrants at $0.5199.","Underwriters' full option exercised; offering led by RA Capital Management and Janus Henderson.","Proceeds to fund VYD2311 clinical program, RSV/measles R&D, and Long COVID studies (SPEAR Study Group).","Dilution: total shares outstanding increases by ~110.6M (including pre-funded warrants exercisable)."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":142715,"accession_number":"0001193125-25-180890","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-08-14T23:59:59+00:00","items":["2.02","8.01","9.01"],"status":"ready","headline":"Invivyd aligns with FDA on rapid BLA pathway for VYD2311; Q2 revenue $11.8M, up 413% YoY","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Q2 2025 PEMGARDA net product revenue $11.8M, up 413% YoY; net loss $14.7M ($0.12/sh) vs $47.2M ($0.40/sh) in Q2 2024.","Cash and cash equivalents $34.9M as of June 30, 2025; near-term profitability target not met but possible with upcoming season.","FDA alignment on rapid BLA pathway for VYD2311; single Phase 2/3 trial with 12-week primary endpoint may support approval for COVID-19 prevention.","Pipeline expansion: RSV candidate identification expected Q3 2025, measles candidate by end of 2025.","VYD2311 safety data: 76-day half-life IM, attractive profile; quantities of commercial launch product available."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":142714,"accession_number":"0000950170-25-092528","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-07-02T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd forms SPEAR Study Group with top researchers to test mAbs for Long COVID","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["SPEAR Study Group includes Drs. Michael Peluso, Amy Proal, David Putrino; will evaluate PEMGARDA and VYD2311.","Up to 5% of Americans report Long COVID symptoms; no approved treatments exist for the condition.","PEMGARDA currently authorized only for COVID-19 prophylaxis; not approved for Long COVID treatment.","Invivyd plans FDA meeting early 3Q 2025 to discuss rapid approval pathways for COVID-19 mAbs.","Anecdotal reports suggest pemivibart may relieve Long COVID symptoms; rigorous clinical trials are planned."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":160787,"accession_number":"0000950170-25-090172","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-06-26T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd reports positive Phase 1/2 data for VYD2311 COVID-19 mAb; half-life up to 76 days","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["All adverse events mild to moderate; no serious or severe AEs observed across IV, SC, and IM routes.","VYD2311 half-life by cohort: IM 76 days, high-dose IV 61 days, vs pemivibart's 49 days.","Dose modeling indicates IM dosing every 3 months may provide robust efficacy for immunocompromised and non-IC.","Type C meeting with FDA scheduled for early Q3 2025 to discuss registration path for VYD2311.","VYD2311 is 99%+ structurally identical to adintrevimab and pemivibart, with improved potency."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":160786,"accession_number":"0000950170-25-075199","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-05-20T23:59:59+00:00","items":["5.07"],"status":"ready","headline":"Invivyd stockholders elect six directors, ratify PwC as auditor at 2025 annual meeting","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["All six director nominees elected; Marc Elia received ~3.3M withheld votes, others below 2.4M.","Ratification of PwC as independent auditor for FY2025 approved with 91.8M for, 97.7K against, 82.7K abstain.","Broker non-votes of 15.9M on director elections, none on auditor ratification.","Annual meeting held on May 20, 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.25,"calibrated_materiality_score":0.15,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":160785,"accession_number":"0001193125-25-120261","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-05-15T23:59:59+00:00","items":["2.02","8.01","9.01"],"status":"ready","headline":"Invivyd Q1 net revenue $11.3M; net loss narrows to $16.3M; targets 1H 2025 profitability","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["PEMGARDA net product revenue of $11.3M in Q1 2025, down from $13.8M in Q4 2024 due to sales force transition; re-acceleration seen in Q2 2025.","Net loss of $16.3M ($0.14 per share) vs $43.5M ($0.38) a year ago; R&D expenses fell to $10.6M from $31.2M.","Cash and equivalents $48.1M as of March 31 2025; secured $30M non-dilutive term loan facility with Silicon Valley Bank in April 2025.","FDA declined EUA expansion request for PEMGARDA as a treatment in Feb 2025 but provided potential near-term pathway for VYD2311.","VYD2311 Phase 1 data read-out (potency, half-life, safety) anticipated later in Q2 2025; pipeline expansion into RSV and measles underway."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.14,"consensus_revenue_estimate":null,"consensus_revenue_actual":11304000.0,"consensus_period":"2025-Q1","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":160784,"accession_number":"0000950170-25-068543","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-05-12T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd launches discovery program for measles monoclonal antibody; candidate target by 2025","summary_kind":"llm","event_type":"other_material","confidence":"medium","bullets":["Multiple healthcare providers have requested a monoclonal antibody for measles treatment and post-exposure prophylaxis from Invivyd.","Goal is to identify a preclinical measles mAb candidate in 2025; progress update expected by end of year.","Over 20 million Americans are unvaccinated; U.S. at risk of losing functional elimination as vaccination rates decline.","No approved therapies currently exist for measles; current options include high-dose Vitamin A and IVIG, both with limitations."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.35,"calibrated_materiality_score":0.35,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":160783,"accession_number":"0000950170-25-058705","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-04-25T23:59:59+00:00","items":["3.01"],"status":"ready","headline":"Invivyd receives Nasdaq bid price deficiency notice; compliance period ends Oct 20, 2025","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Received Nasdaq deficiency letter on April 21, 2025 for bid price closing below $1.00 for 30 consecutive business days.","Initial compliance period ends October 20, 2025; needs to close at or above $1.00 for at least ten consecutive business days.","If not compliant by Oct 20, may transfer to Nasdaq Capital Market for a second 180-day period to regain compliance.","No immediate effect on listing; stock continues trading on Nasdaq Global Market under IVVD."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":160782,"accession_number":"0000950170-25-056005","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-04-21T23:59:59+00:00","items":["1.01","2.03","7.01","9.01"],"status":"ready","headline":"Invivyd secures $30M non-dilutive term loan facility with Silicon Valley Bank","summary_kind":"llm","event_type":"debt","confidence":"high","bullets":["Up to $30M term loan facility split into three $10M tranches available upon meeting financial covenants and net product revenue milestones.","Interest rate at WSJ prime minus 0.25% (floor 6%, cap 9%), maturity March 1, 2029; prepayment premiums 3%-0% sliding over three years.","Loan secured by substantially all assets excluding IP; financial covenants include minimum net product revenue and minimum cash/EBITDA thresholds.","Proceeds for working capital; company highlights non-dilutive nature and potential FDA alignment on VYD2311 as catalyst."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":178987,"accession_number":"0000950170-25-045302","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-03-26T23:59:59+00:00","items":["5.02","7.01","9.01"],"status":"ready","headline":"Invivyd appoints Ajay Royan (Mithril Capital) to Board of Directors","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Royan appointed effective March 22, 2025; term expires at 2025 annual meeting.","Royan is founder of Mithril Capital, a significant long-term holder of IVVD stock.","He will receive $40,000 annual cash retainer and option for 100,000 shares vesting over 3 years.","Royan led the 2022 shareholder action that focused Invivyd on COVID-19 monoclonal antibodies.","Company plans to advance into higher-value medicines for vulnerable populations."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.3,"calibrated_materiality_score":0.3,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":178986,"accession_number":"0000950170-25-042331","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-03-20T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Invivyd Q4 2024 PEMGARDA revenue $13.8M (+48% QoQ); FY2024 net loss $169.9M; FDA rejects EUA expansion for treatment","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Q4 2024 net product revenue $13.8M, up 48% from Q3 $9.3M; full-year 2024 net product revenue $25.4M.","Cash and cash equivalents $69.3M at Dec 31, 2024; targeting near-term profitability by end of 1H 2025 with existing cash and expected revenue growth.","FDA declined request to expand PEMGARDA EUA for treatment of mild-to-moderate COVID-19 in immunocompromised; Invivyd submitted reconsideration request.","Phase 1 data for VYD2311 shows average 17-fold greater neutralization potency than pemivibart; commercial mfg substantially completed.","Net loss for 2024 $169.9M ($1.43 per share) vs $198.6M ($1.81 per share) in 2023."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":178985,"accession_number":"0000950170-25-033068","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-03-05T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd reports PEMGARDA neutralizes dominant SARS-CoV-2 variant LP.8.1","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["New in vitro data show PEMGARDA (pemivibart) neutralizes dominant LP.8.1 variant, consistent with prior variants.","CDC reports LP.8.1, XEC, and KP.3.1.1 make up majority of U.S. cases; all susceptible to PEMGARDA.","Pemivibart activity remains within expected assay variability range since Omicron BA.2.","Data provided to U.S. FDA; update to PEMGARDA Fact Sheet for Healthcare Providers anticipated.","VYD2311, next-gen mAb candidate, also demonstrates neutralizing activity against LP.8.1."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":178984,"accession_number":"0000950170-25-025227","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-02-24T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"FDA declines Invivyd's request to expand PEMGARDA EUA to COVID-19 treatment; prophylaxis EUA unchanged","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA declined expansion of PEMGARDA EUA for mild-to-moderate COVID-19 treatment in immunocompromised patients with no alternative options.","FDA reasoning: immunobridging must show superior antiviral activity, not just equivalence, to prior mAbs like adintrevimab.","Invivyd provided data showing comparable antiviral activity and predicted clinical efficacy above convalescent plasma.","Existing PEMGARDA EUA for pre-exposure prophylaxis remains in effect; treatment opportunity not in prior financial guidance."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":178983,"accession_number":"0000950170-25-012018","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-02-03T23:59:59+00:00","items":["2.02","8.01","9.01"],"status":"ready","headline":"Invivyd reports preliminary Q4 revenue of $13.8M; positive Phase 1/2 data for VYD2311","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Preliminary Q4 PEMGARDA net revenue $13.8M, 48% growth over Q3; total operating costs $32M, 55% reduction.","Cash and equivalents $69.3M; accounts receivable $10.9M; targets near-term profitability by end of 1H 2025.","Positive Phase 1/2 data for VYD2311: safety mild/moderate, serum concentrations high at Day 65, half-life not reached.","VYD2311 shows average 17-fold greater in vitro neutralization potency vs pemivibart across contemporary SARS-CoV-2 variants.","Potential clinical profile: 70-90% protection from symptomatic COVID-19 with once- or twice-annual dosing, also as treatment."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":178982,"accession_number":"0000950170-25-008995","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-01-27T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd submits XEC variant data to FDA supporting pemivibart treatment EUA amendment","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Updated immunobridging analysis with XEC variant shows pemivibart titers substantially exceed adintrevimab in Days 0-5.","Adintrevimab previously showed 66-74% risk reduction in hospitalization/death vs placebo in STAMP trial.","No additional anaphylaxis reports during post-authorization use of PEMGARDA for COVID-19 PrEP to date.","Submission consistent with prior analyses since July 2024; FDA review ongoing with no statutory deadline."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":178981,"accession_number":"0000950170-25-003781","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2025-01-10T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd announces PEMGARDA neutralizes dominant SARS-CoV-2 variant XEC in vitro","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["New data show PEMGARDA (pemivibart) maintains neutralizing activity against XEC, which with KP.3.1.1 accounts for 69% of U.S. variants per CDC.","Data submitted to FDA; update to PEMGARDA Fact Sheet for Healthcare Providers expected.","Pemivibart has shown consistent activity across 39 distinct SARS-CoV-2 variants over nearly three years.","Company does not anticipate meaningful change to neutralization if epitope remains intact as since Omicron BA.1."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":195668,"accession_number":"0000950170-24-140800","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-12-27T23:59:59+00:00","items":["3.01"],"status":"ready","headline":"Invivyd receives Nasdaq deficiency notice for bid price below $1.00 share","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Received deficiency letter on 12/27/2024; stock bid price <$1.00 for 30 consecutive business days.","Must regain compliance by June 25, 2025 via closing bid price >=$1.00 for 10 consecutive days.","May qualify for second 180-day period by transferring to Nasdaq Capital Market if eligible.","Company will monitor bid price and consider options but cannot assure regaining compliance."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":195667,"accession_number":"0000950170-24-132158","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-12-02T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"Director Sara Cotter resigns from Invivyd board effective November 27","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Sara Cotter notified her resignation from the Board of Directors and all committees, effective immediately on November 27, 2024.","No reason for the resignation was disclosed in the filing.","No replacement director has been named as of the filing date."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.3,"calibrated_materiality_score":0.3,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":195666,"accession_number":"0001193125-24-257993","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-11-14T23:59:59+00:00","items":["2.02","8.01","9.01"],"status":"ready","headline":"Invivyd Q3 2024 net product revenue $9.3M but net loss widens to $60.7M; cash $106.9M","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["PEMGARDA net product revenue $9.3M, up from $2.3M in Q2 2024; not at previously anticipated rates.","Net loss $60.7M ($0.51 EPS) vs $39.4M ($0.36 EPS) in Q3 2023; R&D spending rose to $57.9M.","Cash and equivalents $106.9M; year-end 2024 cash expected at least $65M, targeting near-term profitability.","NEJM published Invivyd letter on PEMGARDA immunobridging pathway; Ho Lab letter with conflicting in vitro data published same day.","VYD2311 Phase 1 dosing began August 2024; preliminary data readout expected late Q4 2024."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.28,"consensus_revenue_estimate":null,"consensus_revenue_actual":11564000.0,"consensus_period":"2024-Q3","consensus_source":"xbrl_only","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":195665,"accession_number":"0000950170-24-117934","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-10-29T23:59:59+00:00","items":["2.02","8.01","9.01"],"status":"ready","headline":"Invivyd reports preliminary Q3 2024 PEMGARDA revenue of $9.3M, withdraws 2024 guidance, targets 1H 2025 profitability","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Preliminary Q3 2024 PEMGARDA net product revenue of $9.3M; cash and equivalents ~$107M as of Sept 30.","Withdraws prior 2024 revenue guidance of $150-200M citing late-Q3 FDA Fact Sheet warning on pemivibart activity.","Targets near-term profitability in 1H 2025 using existing cash, anticipated revenue growth, and operational efficiencies.","Phase 3 CANOPY data: PEMGARDA provided 64% RRR vs placebo in months 7-12, total 12-month RRR 76% (nominal p<0.0001).","Expects to end 2024 with $65M+ cash; no new safety signals in months 7-12 follow-up."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.28,"consensus_revenue_estimate":null,"consensus_revenue_actual":11564000.0,"consensus_period":"2024-Q3","consensus_source":"xbrl_only","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211937,"accession_number":"0000950170-24-108624","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-09-23T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd provides virology data showing PEMGARDA neutralization potency stable against current SARS-CoV-2 variants","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["In vitro neutralization potency of PEMGARDA against KP.3.1.1 and LB.1 variants remains in-line with prior predominant variants dating to 2022.","Structural analysis shows 19-key-amino-acid pemivibart binding site has de minimis mutational change and 99%+ stability since Omicron BA.1.","Emerging variants XEC and LP.1 have mutations distal to binding site, not expected to meaningfully alter pemivibart activity; routine testing follows.","Data from independent LabCorp Monogram Biosciences lab; company expects sustained neutralization based on structural biology."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211936,"accession_number":"0001193125-24-214779","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-09-06T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd posts updated corporate presentation; no specific new details disclosed","summary_kind":"llm","event_type":"other_material","confidence":"low","bullets":["Corporate presentation dated September 6, 2024 posted on company website and furnished as Exhibit 99.1.","Presentation content not included in the filing; no financial or operational updates provided.","No earnings, guidance changes, or material events reported in this 8-K."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.1,"calibrated_materiality_score":0.1,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211935,"accession_number":"0000950170-24-103100","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-09-04T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd doses first participants in Phase 1 trial of COVID-19 mAb candidate VYD2311","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Phase 1 trial (NCT06523153) of VYD2311 dosed first healthy volunteers; placebo-controlled, randomized.","Trial in Australia evaluating multiple dose levels, including intramuscular administration.","Preliminary data readouts expected Q4 2024; additional clinical readouts anticipated in 2025.","VYD2311 discovered via affinity maturation against recent SARS-CoV-2 variants; high in vitro potency.","Program builds on PEMGARDA (pemivibart), which received FDA EUA for COVID-19 PrEP in immunocompromised."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211934,"accession_number":"0000950170-24-102552","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-09-03T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd announces PEMGARDA neutralizing activity against dominant variants KP.3.1.1 and LB.1","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["New in vitro data show PEMGARDA neutralizes KP.3.1.1 (42.2% of US cases) and LB.1 variants.","Pemivibart epitope intact across 99.59% of viral sequences since Omicron BA.1.","Data submitted to FDA for timely updates to PEMGARDA Fact Sheet.","Pipeline candidate VYD2311 also shows potent neutralization against contemporary variants.","Company notes 33 variants tested over two years; addresses preliminary non-peer-reviewed reports questioning activity."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211933,"accession_number":"0001193125-24-207466","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-08-27T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd's pemivibart shows 84% relative risk reduction in symptomatic COVID-19 in Phase 3 exploratory analysis","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["84% relative risk reduction vs placebo (1.9% vs 11.9% symptomatic COVID-19 rate, p=0.000061) over 180 days in immunocompetent cohort.","Immunocompromised cohort: 3% symptomatic COVID-19 rate; no COVID-19 hospitalizations or deaths over 180 days.","Safety: anaphylaxis in 0.6% of immunocompromised cohort (2 life-threatening); infusion reactions generally mild-moderate.","FDA updated PEMGARDA Fact Sheet for Healthcare Providers to include 180-day exploratory efficacy data.","Data collected during XBB/JN.1 variant waves; company to host conference call at 8:30AM EDT today."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":211932,"accession_number":"0001193125-24-200256","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-08-14T23:59:59+00:00","items":["2.02","8.01","9.01"],"status":"ready","headline":"Invivyd reports Q2 2024 net product revenue of $2.3M, expects 2024 revenue of $150-200M","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["PEMGARDA launched commercially in Q2 2024 with $2.3M net product revenue; early Q3 commercial acceleration noted.","Cash and cash equivalents were $147.9M as of June 30, 2024; projected year-end cash at least $75M.","EUA amendment request submitted to FDA for PEMGARDA for treatment of mild-to-moderate COVID-19 in immunocompromised patients.","Next-generation molecule VYD2311 first-in-human trial dosing scheduled to begin late August 2024.","Tim Lee joined as Chief Commercial Officer; board expanded with Srishti Gupta and Kevin F. McLaughlin."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.77,"consensus_revenue_estimate":null,"consensus_revenue_actual":2264000.0,"consensus_period":"2024-Q2","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":230729,"accession_number":"0000950170-24-073322","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-06-14T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd announces VYD222 shows neutralizing activity against KP.1.1 and KP.3 SARS-CoV-2 variants","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["VYD222 demonstrated in vitro neutralization of KP.1.1 FLiRT and KP.3 variants in pseudovirus assays.","Epitope at VYD222 binding interface is 99.8% conserved among 2024 GISAID sequences.","Next candidate VYD2311 also shows continued in vitro neutralization against these dominant strains.","FLiRT variants account for >50% of circulating SARS-CoV-2 sequences as of June 8, 2024.","CDC predicts KP.3 will become the most dominant lineage nationally in the near term."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":230728,"accession_number":"0001193125-24-151007","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-05-31T23:59:59+00:00","items":["5.02","8.01","9.01"],"status":"ready","headline":"Interim CEO departs, CFO takes PEO role, new CCO, FDA immunobridging path","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Jeremy Gowler ceases as interim CEO, COO, CCO effective May 30; employment ends June 29.","CFO William Duke Jr. appointed principal executive officer; continues as CFO and principal accounting officer.","Timothy Lee appointed Chief Commercial Officer; previously led Amylyx sales ($390M revenue in 14 months).","FDA alignment on repeatable immunobridging pathway for serial mAbs COVID-19 EUAs; Est. clinical cost $25-40M per mAb."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":230727,"accession_number":"0000950170-24-063279","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-05-22T23:59:59+00:00","items":["5.07","7.01","9.01"],"status":"ready","headline":"Invivyd elects two new independent directors at annual meeting","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Dr. Srishti Gupta and Kevin F. McLaughlin elected to board on May 21, 2024.","Gupta will chair Compensation Committee; McLaughlin chairs Audit Committee.","Board now consists of seven members after annual meeting.","Outgoing directors Thomas Heyman, Clive Meanwell, Michael Wyzga thanked."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":230726,"accession_number":"0001193125-24-135260","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-05-09T23:59:59+00:00","items":["2.02","8.01","9.01"],"status":"ready","headline":"Invivyd Q1 net loss $43.5M ($0.38/sh); launches PEMGARDA, guides 2024 rev $150-200M","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Launched PEMGARDA (pemivibart) for COVID-19 PrEP in immunocompromised; received CMS HCPCS Q and M codes.","Cash $189.4M at Q1 end; expects ≥$75M year-end cash on $150-200M net product revenue.","Net loss $43.5M vs $35.3M YoY; R&D $31.2M, SG&A $14.9M.","Plans to submit EUA for pemivibart as COVID-19 treatment in immunocompromised via rapid immunobridging.","Advancing VYD2311 mAb candidate optimized against BA.2.86/JN.1 lineages."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.38,"consensus_revenue_estimate":null,"consensus_revenue_actual":0.0,"consensus_period":"2024-Q1","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":230725,"accession_number":"0001193125-24-132585","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-05-07T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd to pursue EUA for pemivibart for COVID-19 treatment in immunocompromised","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Plans EUA submission for pemivibart to treat mild-to-moderate COVID-19 in moderately-to-severely immunocompromised people via immunobridging pathway.","Immunobridging relies on Phase 2/3 STAMP trial data with adintrevimab and ongoing CANOPY trial for pemivibart PrEP.","Manufacturing plan targets ~100,000 doses available through H2 2024 to serve both PrEP and potential treatment uses.","2024 net product revenue guidance remains $150-200M; year-end cash at least $75M, excluding potential treatment sales.","After EUA submission, plans to initiate confirmatory safety, PK, and clinical virology trial."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":230724,"accession_number":"0001193125-24-093929","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-04-12T23:59:59+00:00","items":["5.02","7.01","9.01"],"status":"ready","headline":"Invivyd CEO David Hering departs; Jeremy Gowler appointed Interim CEO","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Dave Hering ceased as CEO and director effective April 11, 2024; employment ends May 11, 2024; Board searching for permanent CEO.","COO/Commercial Officer Jeremy Gowler appointed Interim CEO effective immediately; will also retain COO/Commercial roles.","Gowler receives $5,000/month additional while serving as Interim CEO; 2024 bonus target increased to 55% on $525k annualized base for interim period.","Board reduced from 9 to 8 members upon Hering's resignation from board.","Press release highlights focus on PEMGARDA launch for COVID PrEP and strong balance sheet."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":230723,"accession_number":"0001193125-24-087408","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-04-04T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Invivyd announces PEMGARDA commercial launch, 2024 revenue guidance $150M-$200M","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["PEMGARDA now commercially available in the U.S. for COVID-19 PrEP in immunocompromised adults/adolescents.","2024 net product revenue guidance of $150M to $200M.","Expects to end 2024 with at least $55M in cash and cash equivalents.","Received FDA EUA on March 22, 2024; product available for order within two weeks."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":249118,"accession_number":"0001193125-24-079597","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-03-28T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Invivyd reports FY2023 net loss $198.6M; obtains EUA for PEMGARDA COVID-19 PrEP","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $198.6M ($1.81/share) vs $241.3M ($2.23/share) in 2022; R&D expenses $163.6M.","Cash & equivalents $200.6M as of Dec 31, 2023; expects runway into Q4 2024 (excl. PEMGARDA sales).","Received EUA on Mar 22, 2024 for PEMGARDA (pemivibart) for COVID-19 PrEP in immunocompromised patients.","Raised $40.5M in gross proceeds from ATM facility in Feb 2024 to strengthen balance sheet ahead of launch.","Nominated VYD2311 as next SARS-CoV-2 mAb candidate; expects streamlined FDA development pathway."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":249117,"accession_number":"0001193125-24-075582","cik":1832038,"company_name":"Invivyd, Inc.","ticker":"IVVD","form_type":"8-K","filed_at":"2024-03-25T23:59:59+00:00","items":["2.02","8.01","9.01"],"status":"ready","headline":"Invivyd gets FDA EUA for PEMGARDA as COVID-19 PrEP for immunocompromised; cash $200.6M","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA issued EUA for PEMGARDA (pemivibart) for pre-exposure prophylaxis of COVID-19 in adults/adolescents (≥12 yrs, ≥40 kg) with moderate-to-severe immune compromise.","Estimated cash and cash equivalents of $200.6M as of Dec 31, 2023 (preliminary, unaudited).","In Feb 2024, raised $40.5M gross proceeds from ATM share sales, strengthening balance sheet ahead of launch.","Immunobridging established: Day 28 calculated sVNA titer vs JN.1 was 7365 (90% CI: 7148–7589); ratio to reference 0.82 (0.80–0.85).","Anaphylaxis observed in 0.6% (4/623) of CANOPY participants; boxed warning and two-hour post-infusion monitoring required."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":332906420.00000006,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null}],"next_cursor":null}