{"filings":[{"id":649236,"accession_number":"0001104659-26-065992","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-05-26T11:15:41+00:00","items":["8.01","9.01"],"status":"ready","headline":"FDA grants Outlook Therapeutics appeal; BLA resubmission planned for June 2026","event_type":"regulatory","confidence":"high","bullets":["FDA concluded substantial evidence of effectiveness for LYTENAVA (bevacizumab-vikg) for nAMD after FDR appeal.","Company will resubmit BLA as Class 1 in June 2026; PDUFA decision expected within 60 days.","Appeal resolves December 30, 2025 Complete Response Letter; FDA directs final labeling discussions.","NORSE TWO trial results plus confirmatory data from NORSE EIGHT and other evidence supported effectiveness."],"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,"daily_digest_date":"2026-05-26","daily_digest_url":"/daily/2026-05-26","daily_digest_rank":2},{"id":481479,"accession_number":"0001104659-26-062865","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-05-15T23:55:16+00:00","items":["2.02","9.01"],"status":"ready","headline":"Outlook Therapeutics Q2 FY2026 net loss narrows to $4.5M; FDA decision on ONS-5010 expected May 2026","event_type":"earnings","confidence":"high","bullets":["Net loss of $4.5M ($0.05/sh) vs $46.4M ($1.50/sh) YoY; adjusted net loss $14.1M ($0.16/sh).","LYTENAVA unit sales in Europe down ~10% QoQ; cost reduction steps initiated to improve margins.","Cash $7.7M as of Mar 31; raised ~$4M in March offering and $4.2M net in April registered direct offering.","FDA formal dispute resolution meeting completed in April; written decision expected within May 2026.","Entered Swiss distribution agreement with Mediconsult AG; targeting 2027 launch pending marketing authorization."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.39,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2026-Q2","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.7,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":69281,"accession_number":"0001104659-26-060305","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-05-13T20:36:26+00:00","items":["1.01","1.02","2.02","9.01"],"status":"ready","headline":"Outlook Therapeutics enters new $100M ATM with H.C. Wainwright; cash at $7.7M","event_type":"other_material","confidence":"high","bullets":["Entered into $100M at-the-market offering agreement with H.C. Wainwright & Co. as sales agent.","Prior $100M ATM with BTIG terminated effective May 12, 2026.","Preliminary cash and cash equivalents of $7.7M as of March 31, 2026 (unaudited), plus $4.5M from April 2026 direct offering.","H.C. Wainwright will receive a 3% commission on gross proceeds from shares sold under the ATM."],"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,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":94395,"accession_number":"0001104659-26-047741","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-04-23T23:59:59+00:00","items":["3.02","8.01","9.01"],"status":"ready","headline":"Outlook Therapeutics raises ~$5M in registered direct offering and private placement at $0.31/unit","event_type":"other_material","confidence":"high","bullets":["Offering of 16,129,033 shares of common stock and accompanying Common Warrants at $0.31 per unit.","Gross proceeds approximately $5.0 million; net proceeds for working capital and general corporate purposes.","Common Warrants exercisable at $0.31 per share, subject to stockholder approval and increase in authorized shares.","Concurrent warrant amendment reduces exercise price of 2,142,854 existing warrants from $2.26 to $0.31.","H.C. Wainwright acted as placement agent with 7.0% cash fee and warrants for 1,129,032 shares."],"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,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":94394,"accession_number":"0001104659-26-046014","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-04-21T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Outlook Therapeutics completes FDA dispute resolution meeting for ONS-5010; decision expected May 2026","event_type":"regulatory","confidence":"high","bullets":["Completed Federal Dispute Resolution meeting with FDA Office of New Drugs to appeal Dec 30, 2025 Complete Response Letter for ONS-5010 BLA.","Meeting addressed regulatory pathway for ONS-5010/LYTENAVA (bevacizumab-vikg) for wet AMD.","Formal FDA decision expected in May 2026; company will update after receipt.","Follows Type A meeting with Division of Ophthalmology; CEO Bob Jahr cites constructive dialogue."],"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,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":94393,"accession_number":"0001104659-26-040387","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-04-07T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Outlook Therapeutics FDA accepts FDRR for ONS-5010; meeting set for April 2026","event_type":"regulatory","confidence":"high","bullets":["FDA accepted Formal Dispute Resolution Request for ONS-5010/LYTENAVA (bevacizumab) for wet AMD.","Meeting with deciding official scheduled for April 2026; follows Type A meeting on March 2, 2026.","Company cites NORSE TWO and NORSE EIGHT data supporting efficacy/safety; no safety concerns raised.","If approved, ONS-5010 would be first FDA-approved ophthalmic bevacizumab with standardized manufacturing."],"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":0.55,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":106754,"accession_number":"0001104659-26-034601","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-03-25T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Outlook Therapeutics closes $5.0M offering of common stock and warrants","event_type":"other_material","confidence":"high","bullets":["20M shares + 20M warrants sold at $0.25/unit; gross proceeds ~$5.0M, net ~$4.0M.","Warrants exercisable immediately at $0.25, expire in 5 years; includes 4.99%/9.99% beneficial ownership limitation.","H.C. Wainwright placement agent, receiving 7% cash fee and 1.4M warrants at $0.3125.","Company agreed to one-year ban on variable rate transactions and lock-up agreements.","Offering closed March 25, 2026; net proceeds ~$4.0M for general corporate purposes."],"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,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":106753,"accession_number":"0001104659-26-028103","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-03-16T23:59:59+00:00","items":["1.01","2.03","8.01","9.01"],"status":"ready","headline":"Outlook Therapeutics raises $17M via Atlas note to partially repay Avondale debt; going concern warning","event_type":"debt","confidence":"high","bullets":["Issued $18.36M unsecured note (net $17M after OID) to Atlas Sciences; proceeds used to repay $17M of $33.1M Avondale Note.","Remaining Avondale Note balance of ~$10.8M; maturity extended to Dec 31, 2026 via amendment.","Atlas note: interest prime+3% (floor 9.5%), matures 15 months from March 16, 2026; quarterly redemption up to $3M; 7.5% exit fee.","Supplemental risk factors state substantial doubt about going concern; cash insufficient for next 12 months.","FDA issued third Complete Response Letter for ONS-5010 in Dec 2025; Type A meeting held March 2026 with no clear path."],"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":0.85,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":106752,"accession_number":"0001104659-26-026465","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-03-11T23:59:59+00:00","items":["5.02","9.01"],"status":"ready","headline":"Director Julia Haller resigns from Outlook Therapeutics board, effective March 11, 2026","event_type":"leadership","confidence":"high","bullets":["Dr. Julia Haller resigned as Class II director, also serving on Nominating and Corporate Governance Committee.","Board accepted resignation on March 6, 2026, effective March 11, with board size reduced to nine.","Resignation not due to any dispute with company; she cited new CEO duties at Wills Eye Hospital.","Company thanked Dr. Haller for her contributions during her tenure."],"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":0.4,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":106751,"accession_number":"0001104659-26-025893","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-03-10T23:59:59+00:00","items":["5.07","9.01"],"status":"ready","headline":"Outlook Therapeutics annual meeting elects three Class I directors, ratifies KPMG, approves say-on-pay","event_type":"other_material","confidence":"high","bullets":["Yezan Haddadin, Faisal G. Sukhtian, Kurt J. Hilzinger elected as Class I directors with votes for >12M each.","KPMG LLP ratified as independent auditor for FY2026 with 35.6M votes for, 0.8M against, 0.9M abstain.","Non-binding advisory vote on exec compensation approved: 13.9M for, 1.5M against, 0.4M abstain.","Approximately 50.7% of outstanding shares (37.3M of 73.5M) represented at meeting."],"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":0.2,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":106750,"accession_number":"0001104659-26-024189","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-03-05T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Outlook Therapeutics updates on Type A meeting with FDA for ONS-5010; no definitive resolution","event_type":"regulatory","confidence":"high","bullets":["Type A meeting held with FDA to discuss December 30, 2025 Complete Response Letter for ONS-5010 BLA.","FDA had requested confirmatory evidence of effectiveness; no safety concerns identified by FDA.","Company expects continued discussions to clarify agency views on confirmatory evidence.","ONS-5010 met primary endpoints in Phase 3 NORSE TWO trial; NORSE EIGHT provided confirmatory efficacy/safety data.","If approved, ONS-5010 would be first FDA-approved ophthalmic bevacizumab with US manufacturing supply chain."],"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":0.55,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":106749,"accession_number":"0001104659-26-017118","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-02-18T23:59:59+00:00","items":["3.01"],"status":"ready","headline":"Outlook Therapeutics receives Nasdaq minimum bid price deficiency notice; 180-day cure period","event_type":"regulatory","confidence":"high","bullets":["Received Nasdaq letter on Feb 18, 2026, for closing bid price below $1.00 for 30 consecutive business days.","Has 180 calendar days, until August 17, 2026, to regain compliance.","To regain compliance, bid price must close at $1.00+ for at least 10 consecutive business days.","If not compliant by Aug 17, may be eligible for additional 180-day period if it meets other standards.","Company will monitor bid price and evaluate options including reverse stock split."],"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,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":106748,"accession_number":"0001104659-26-015887","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-02-17T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Outlook Therapeutics Q1 FY2026 net loss $23.1M; unit sales of LYTENAVA double in Europe","event_type":"earnings","confidence":"high","bullets":["Net loss of $23.1M ($0.38/share) vs net income of $17.4M ($0.72/share) in prior-year quarter.","Adjusted net loss $13.5M ($0.22/share) vs adjusted net loss $21.6M ($0.89/share) a year ago.","Revenue negatively impacted by returns reserve for short-dated product from UK distributor; unit sales more than doubled QoQ.","Cash and equivalents $8.7M as of Dec 31, 2025 (excluding $2.4M ATM proceeds post-quarter).","Submitted Type A meeting request to FDA to discuss ONS-5010 CRL for wet AMD; additional EU launches planned."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.38,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2026-Q1","consensus_source":"xbrl_only","sentiment":"negative","materiality_score":0.7,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":106747,"accession_number":"0001104659-26-013470","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-02-11T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Outlook Therapeutics requests Type A FDA meeting after CRL for wet AMD drug ONS-5010","event_type":"regulatory","confidence":"high","bullets":["CRL dated Dec 30, 2025 cited lack of substantial evidence; company believes it contradicts alignment from Sept 2025 meeting.","Phase 3 NORSE TWO met primary endpoint (15-letter gain at 12 months); NORSE EIGHT missed primary at 8 weeks.","ONS-5010/LYTENAVA is already approved and commercially available in EU and UK for wet AMD.","FDA has not raised safety concerns; company plans to pursue resolution via Type A meeting."],"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":0.85,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":106746,"accession_number":"0001104659-26-000066","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2026-01-02T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"FDA issues Complete Response Letter for Outlook Therapeutics' ONS-5010 BLA for wet AMD","event_type":"regulatory","confidence":"high","bullets":["FDA CRL states additional mechanistic/natural history data does not alter prior conclusion; confirmatory efficacy evidence needed but not defined.","Outlook Therapeutics disagrees with decision and is exploring all available U.S. approval pathways.","ONS-5010 (LYTENAVA) already approved in EU and UK; commercially available in Germany and UK since June 2025.","CEO Bob Jahr reaffirms commitment to bringing first FDA-approved on-label bevacizumab for wet AMD to U.S. patients.","Company continues to expand European presence and seek commercial partners outside Europe."],"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":0.85,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":123063,"accession_number":"0001104659-25-122786","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-12-19T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Outlook Therapeutics FY2025 net loss $62.4M; $1.4M revenue from LYTENAVA launch in Europe","event_type":"earnings","confidence":"high","bullets":["Net loss $62.4M ($1.79/share) vs $75.4M ($4.06/share) prior year; revenue $1.4M from initial EU sales.","Cash $8.1M at Sept 30, 2025; $14.9M net from ATM after quarter-end; no debt mentioned.","Expenses fell $4.6M YoY due to lower R&D, partly offset by higher SG&A for European launch.","FDA PDUFA goal date for ONS-5010 is Dec 31, 2025; awaiting U.S. approval decision.","LYTENAVA accepted into UK tender framework in Dec 2025; launch expanding to Austria and Netherlands."],"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,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":123062,"accession_number":"0001104659-25-111316","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-11-13T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"FDA accepts Outlook Therapeutics' BLA resubmission for ONS-5010; PDUFA date Dec 31, 2025","event_type":"regulatory","confidence":"high","bullets":["FDA acknowledged receipt of BLA resubmission for ONS-5010 (bevacizumab-vikg) and assigned Class 1 review.","Class 1 review results in a two-month review period from resubmission date.","PDUFA goal date set for December 31, 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":0.8,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":123061,"accession_number":"0001104659-25-105633","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-11-03T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Outlook Therapeutics resubmits BLA for ONS-5010 (wet AMD) to FDA after Sept 2025 Type A meeting","event_type":"other_material","confidence":"high","bullets":["Resubmitted BLA on Nov 3, 2025 for ONS-5010 (LYTENAVA) to treat wet AMD.","Resubmission follows FDA Type A meeting in Sept 2025; aims to resolve CRL issued Aug 2025.","CEO Bob Jahr says resubmission marks 'important step forward' for potential near-term U.S. approval.","Company accelerating commercial efforts in Europe while positioning for U.S. approval."],"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,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":139763,"accession_number":"0001104659-25-094558","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-09-29T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Outlook Therapeutics completes FDA Type A meeting for ONS-5010 BLA; plans resubmission in 2025","event_type":"regulatory","confidence":"high","bullets":["Type A meeting with FDA discussed August 27, 2025 CRL for ONS-5010 BLA (bevacizumab for wet AMD).","Company expects to resubmit BLA before end of calendar year 2025 after reviewing FDA feedback.","CEO Bob Jahr stated productive discussion; written minutes still pending."],"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,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":139762,"accession_number":"0001104659-25-087886","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-09-05T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"Chief Commercial Officer Jeff Evanson departs Outlook Therapeutics effective immediately","event_type":"leadership","confidence":"high","bullets":["Jeff Evanson stepped down as Chief Commercial Officer on September 5, 2025.","Departure is without 'cause'; eligible for severance benefits per employment agreement.","No replacement named; interim CEO Lawrence Kenyon continues in role.","Company is a biopharmaceutical firm focused on ophthalmic therapies."],"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,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":139761,"accession_number":"0001104659-25-086428","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-09-02T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"FDA issues Complete Response Letter to Outlook Therapeutics for ONS-5010 BLA; lacks efficacy evidence","event_type":"regulatory","confidence":"high","bullets":["CRL cites lack of substantial evidence of effectiveness; ONS-5010 did not meet primary endpoint in NORSE EIGHT trial.","FDA recommends confirmatory evidence; NORSE TWO met primary endpoint but is not sufficient alone.","No other deficiencies in BLA; company plans to meet with FDA to discuss possible path to approval.","ONS-5010/LYTENAVA already approved in EU and UK; commercial launch in Germany and UK began June 2025."],"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":0.85,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":139760,"accession_number":"0001104659-25-078622","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-08-14T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Outlook Therapeutics reports first LYTENAVA sales, $20.2M net loss for Q3 FY2025","event_type":"earnings","confidence":"high","bullets":["First commercial sales of LYTENAVA (bevacizumab gamma) in Germany and UK; $1.5M revenue recognized.","Net loss of $20.2M ($0.55 per share), compared to net loss of $0.89 per share in prior-year quarter.","Adjusted net loss of $15.8M ($0.44 per share), excluding $2.3M change in promissory notes and $2.0M warrant liability.","Cash and cash equivalents of $8.9M as of June 30, 2025.","FDA PDUFA goal date for ONS-5010 (bevacizumab-vikg) set for August 27, 2025."],"consensus_eps_estimate":-0.2584,"consensus_eps_actual":-1.6,"consensus_revenue_estimate":null,"consensus_revenue_actual":1505322.0,"consensus_period":"2025-Q3","consensus_source":"xbrl+finnhub","sentiment":"neutral","materiality_score":0.7,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":139759,"accession_number":"0001104659-25-064755","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-07-01T23:59:59+00:00","items":["5.02","9.01"],"status":"ready","headline":"Outlook Therapeutics appoints Robert C. Jahr as President and CEO, replacing interim CEO","event_type":"leadership","confidence":"high","bullets":["Robert C. Jahr appointed President & CEO effective July 1, 2025; replaces interim CEO Lawrence Kenyon, who remains CFO and board member.","Base salary $600,000; target annual bonus 70% of base; inducement option for 800,000 shares vesting over 4 years.","Jahr previously Chief Commercial Officer at Sobi NA (2021-2025); held leadership roles at UCB Pharma and Amgen.","Severance: 12 months base salary + target bonus on qualifying termination; 18 months base + 150% bonus on termination in connection with change in control."],"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":0.7,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":157329,"accession_number":"0001104659-25-055521","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-06-02T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"Outlook Therapeutics launches LYTENAVA (bevacizumab gamma) in Germany and UK for wet AMD","event_type":"other_material","confidence":"high","bullets":["Commercial launch of LYTENAVA (bevacizumab gamma) in Germany and UK announced on June 2, 2025.","Indication: treatment of wet age-related macular degeneration (wet AMD).","First approved bevacizumab gamma product for wet AMD in these two markets."],"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,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":157328,"accession_number":"0001104659-25-052452","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-05-23T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Outlook Therapeutics raises $13M in public offering of common stock and warrants","event_type":"other_material","confidence":"high","bullets":["Offering of 9,285,714 shares and warrants to purchase 18,571,428 shares at combined price $1.40 per unit.","Gross proceeds of ~$13M; closing expected May 27, 2025.","Warrants exercisable immediately at $1.40/share, expire in 5 years, with beneficial ownership cap.","GMS Ventures (affiliated with directors) committed $6M of the offering.","Underwriting agreement entered with BTIG, LLC."],"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":0.55,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":157327,"accession_number":"0001104659-25-049411","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-05-15T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Outlook Therapeutics Q2 FY2025 net loss $46.4M; cash $7.6M; PDUFA Aug 27","event_type":"earnings","confidence":"high","bullets":["Net loss $46.4M ($1.50/share) vs $114.3M ($8.01) YoY; adjusted net loss $12.5M ($0.40) vs $22.1M ($1.55).","Cash and equivalents $7.6M as of March 31, 2025; no revenue (pre-commercial stage).","LYTENAVA commercial launch in Germany and UK planned for Q2 CY2025.","FDA PDUFA goal date August 27, 2025 for ONS-5010 (bevacizumab-vikg) BLA resubmission.","Warrant inducement expenses $33.9M and other non-cash items drove adjusted loss items."],"consensus_eps_estimate":-0.4012,"consensus_eps_actual":-1.05,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q2","consensus_source":"xbrl+finnhub","sentiment":"negative","materiality_score":0.6,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":157326,"accession_number":"0001558370-25-004726","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-04-11T23:59:59+00:00","items":["5.02","9.01"],"status":"ready","headline":"Outlook Therapeutics awards $237,500 retention bonus to CFO/Interim CEO Kenyon","event_type":"leadership","confidence":"high","bullets":["Cash retention bonus of $237,500 approved by Compensation Committee on April 9, 2025.","Bonus payable December 31, 2025, contingent on Kenyon's continuous employment through that date.","Kenyon declined option to receive stock options in lieu of cash; no election made.","Upon a qualifying termination before Dec 31, 2025, bonus accelerated subject to release of claims.","Retention bonus letter filed as Exhibit 10.1 with the 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":0.5,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":157325,"accession_number":"0001558370-25-004606","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-04-08T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"FDA accepts resubmission of OTLK's BLA for ONS-5010; PDUFA date set for August 27, 2025","event_type":"regulatory","confidence":"high","bullets":["FDA acknowledged receipt of resubmission of BLA for ONS-5010 (bevacizumab-vikg).","FDA designated the BLA as a Class 2 review with a six-month review period.","PDUFA goal date for the BLA is August 27, 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":0.6,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":175704,"accession_number":"0001558370-25-003013","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-03-14T23:59:59+00:00","items":["1.02","5.03","5.07","9.01"],"status":"ready","headline":"Outlook Therapeutics closes $33.1M convertible note, increases authorized shares to 260M","event_type":"other_material","confidence":"high","bullets":["Issued $33.1M convertible note to Avondale Capital on March 13, 2025; proceeds used to repay $32.91M Streeterville note.","Stockholders approved increase in authorized common shares from 60M to 260M, effective March 11.","Annual Meeting elected directors: Julian Gangolli, Ralph Thurman, Lawrence Kenyon to Class III.","Stockholders approved potential issuance of >19.99% of outstanding common stock upon note conversion.","Ratified KPMG as auditor for FY2025; advisory say-on-pay passed."],"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,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":175703,"accession_number":"0001104659-25-018717","cik":1649989,"company_name":"Outlook Therapeutics, Inc.","ticker":"OTLK","form_type":"8-K","filed_at":"2025-02-28T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"Outlook Therapeutics resubmits BLA for ONS-5010 to FDA","event_type":"regulatory","confidence":"high","bullets":["Resubmitted Biologics License Application for ONS-5010 to FDA on February 28, 2025.","No details on resubmission content, prior FDA actions, or expected review timeline provided.","Resubmission marks a key regulatory step for the company's sole pipeline candidate."],"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":0.85,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null}],"next_cursor":null}