{"filings":[{"id":536277,"accession_number":"0001493152-26-024510","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K/A","filed_at":"2026-05-20T11:30:22+00:00","items":["5.02"],"status":"ready","headline":"Celcuity appoints Charles R. Romp to board; board expands from 7 to 8","event_type":"leadership","confidence":"high","bullets":["Board expanded from 7 to 8 members; Charles R. Romp appointed as director effective Feb 11, 2026.","Mr. Romp qualifies as an independent director under Nasdaq and SEC rules.","On May 14, 2026, appointed to Compensation Committee and Nominating & Corporate Governance Committee.","Compensation: $70k annual cash retainer, $135k annual equity award, initial 215 restricted shares vesting Apr 30, 2026."],"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,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":499043,"accession_number":"0001493152-26-024175","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2026-05-18T20:05:38+00:00","items":["5.02","5.07","9.01"],"status":"ready","headline":"Celcuity stockholders approve 2026 equity plan (3M shares) and amended ESPP at annual meeting","event_type":"other_material","confidence":"high","bullets":["Stockholders approved the 2026 Stock Incentive Plan authorizing 3,000,000 shares of common stock for equity awards.","Stockholders approved the Amended and Restated ESPP, increasing share reserve by 289,199 shares and extending expiration ten years.","All eight director nominees elected; Richard Nigon and Charles Romp each received over 37.6M 'for' votes.","Ratified Boulay PLLP as independent auditor for FY2026 with 40.9M 'for' votes; advisory 'say-on-pay' approved with 35.8M 'for'."],"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":442519,"accession_number":"0001493152-26-023065","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2026-05-14T20:05:21+00:00","items":["2.02","9.01"],"status":"ready","headline":"Celcuity reports Q1 net loss $52.8M; VIKTORIA-1 hits primary endpoint in PIK3CA mutant","event_type":"earnings","confidence":"high","bullets":["Net loss $52.8M ($0.97/share) vs $37.0M ($0.86/share) in Q1 2025; non-GAAP adjusted net loss $46.8M ($0.86).","VIKTORIA-1 PIK3CA mutant cohort: gedatolisib triplet and doublet both achieved statistically significant PFS improvement vs alpelisib+fulvestrant.","Detailed VIKTORIA-1 data to be presented at ASCO LBA oral session on June 2, 2026; sNDA submission planned for Q3 2026.","NDA for gedatolisib in PIK3CA wild-type accepted with Priority Review; PDUFA date July 17, 2026.","VIKTORIA-2 expanded: Study 2 (~740 patients) evaluating gedatolisib as first-line in endocrine-sensitive HR+/HER2- advanced breast cancer."],"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":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":94013,"accession_number":"0001493152-26-020918","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2026-05-01T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Celcuity Phase 3 VIKTORIA-1 PIK3CA mutant cohort meets primary endpoint with significant PFS improvement","event_type":"other_material","confidence":"high","bullets":["Gedatolisib triplet (plus fulvestrant and palbociclib) showed statistically significant PFS improvement vs alpelisib+fulvestrant.","Gedatolisib doublet (plus fulvestrant) also achieved statistically significant PFS improvement as secondary endpoint.","Both regimens were generally well tolerated with manageable safety profiles and no new safety signals.","Celcuity plans sNDA submission to FDA; detailed results will be presented at ASCO 2026 on June 2.","FDA previously granted Priority Review for NDA in PIK3CA wild-type cohort with PDUFA date July 17, 2026."],"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":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":106066,"accession_number":"0001493152-26-012668","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2026-03-25T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Celcuity reports Q4 loss $0.97/share; FDA grants Priority Review for gedatolisib, PDUFA July 17, 2026","event_type":"earnings","confidence":"high","bullets":["Net loss Q4 $51.0M ($0.97), FY $177.0M ($3.79); adjusted net loss Q4 $38.4M ($0.73), FY $150.8M ($3.22).","FDA accepted NDA for gedatolisib in HR+/HER2-/PIK3CA WT advanced breast cancer, granted Priority Review; PDUFA goal date July 17, 2026.","Topline results from PIK3CA mutant cohort of Phase 3 VIKTORIA-1 expected in Q2 2026.","Updated efficacy/safety results from PIK3CA WT cohort published in Journal of Clinical Oncology in March 2026."],"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":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":106065,"accession_number":"0001493152-26-006444","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2026-02-12T23:59:59+00:00","items":["5.02","7.01","9.01"],"status":"ready","headline":"Celcuity appoints Charles Romp to board of directors; brings commercial oncology expertise","event_type":"leadership","confidence":"high","bullets":["Charles (Chip) R. Romp appointed to board, effective Feb 11, 2026; board size increased from 7 to 8.","Romp is CEO of Secura Bio, previously EVP Commercial at Seagen (sold to Pfizer), with 25+ years oncology experience.","He will receive $50k annual cash retainer, $100k annual equity award, and pro-rated grant of 215 restricted shares vesting by 2026 annual meeting or April 30.","Company notes preparation for potential approval and launch of gedatolisib later this year (HR+/HER2- advanced breast cancer).","Romp qualifies as independent under Nasdaq and SEC rules; no committee assignments yet."],"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":0.4,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":122364,"accession_number":"0001493152-25-023897","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2025-11-17T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Celcuity completes NDA submission to FDA for gedatolisib in HR+/HER2- advanced breast cancer under RTOR program","event_type":"regulatory","confidence":"high","bullets":["NDA submitted for gedatolisib in HR+/HER2-, PIK3CA wild-type advanced breast cancer.","Submitted under FDA's RTOR program; drug previously received Breakthrough Therapy and Fast Track designations.","Phase 3 VIKTORIA-1: triplet reduced risk of progression/death by 76% (HR 0.24); median PFS 9.3 mo vs 2.0 mo.","Doublet (gedatolisib + fulvestrant) reduced risk by 67% (HR 0.33); median PFS 7.4 mo vs 2.0 mo.","CEO Sullivan: 'unprecedented efficacy results and overall safety profile are potentially practice changing.'"],"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":0.9,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":122363,"accession_number":"0001493152-25-021903","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2025-11-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Celcuity Q3 net loss $43.8M; gedatolisib NDA on track for Q4 2025","event_type":"earnings","confidence":"high","bullets":["Q3 net loss $43.8M ($0.92 loss per share) vs $29.8M ($0.70 loss) in prior year.","Operating expenses $42.8M (R&D $34.9M, G&A $7.9M), up from $30.1M.","PIK3CA WT cohort: gedatolisib triplet reduced risk of progression/death by 76% (HR 0.24); median PFS 9.3 vs 2.0 months.","FDA accepted NDA under RTOR program; submission for gedatolisib on track for Q4 2025.","PIK3CA mutant cohort fully enrolled; topline data expected late Q1 2026 or Q2 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":-2.81,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q3","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.65,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":122362,"accession_number":"0001493152-25-018565","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2025-10-20T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Phase 3 VIKTORIA-1 data: gedatolisib triplet reduces progression risk by 76% in HR+/HER2- ABC","event_type":"other_material","confidence":"high","bullets":["Median PFS 9.3mo for gedatolisib triplet vs 2.0mo for fulvestrant (HR=0.24); incremental 7.3mo improvement.","ORR 31.5% for triplet vs 1% for fulvestrant; median DOR 17.5mo.","Rolling NDA submission started under FDA RTOR; completion targeted Q4 2025.","PIK3CA mutant cohort fully enrolled; topline expected late Q1 2026 or Q2 2026.","Phase 1b data: median PFS 14.6mo in PIK3CA mutant patients overall, 19.7mo with intermittent dose."],"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":0.9,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":139063,"accession_number":"0001641172-25-027025","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2025-09-10T23:59:59+00:00","items":["1.01","2.03","3.02","7.01","9.01"],"status":"ready","headline":"Celcuity upsizes senior secured facility to $500M, receives $30M immediate funding","event_type":"debt","confidence":"high","bullets":["Total facility increased to $500M ($350M committed + $150M discretionary); $30M funded, total outstanding $130M.","Adds $100M upon FDA approval of gedatolisib in 2L wild-type advanced breast cancer; $120M upon commercial milestones.","Maturity extended to Nov 1, 2029; interest-only period extended by 14 months, with possible 7-month FDA-approval extension.","Issued warrants for 50,537 shares to lenders; cashless exercise through tenth anniversary of Term D funding.","Funds will support NDA rolling submission via FDA's RTOR program, commercial launch prep, and strategic initiatives."],"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":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":139062,"accession_number":"0001641172-25-024007","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2025-08-14T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Celcuity reports Phase 3 gedatolisib milestone; NDA filing on track for Q4 2025","event_type":"earnings","confidence":"high","bullets":["Phase 3 VIKTORIA-1: gedatolisib triplet reduced risk of progression/death by 76% (HR=0.24); median PFS 9.3 mo vs 2.0 mo.","NDA for gedatolisib based on PIK3CA wild-type cohort expected Q4 2025; PIK3CA mutant topline data also in Q4 2025.","Q2 2025 net loss $45.3M ($1.04/sh) vs $23.7M ($0.62/sh) in Q2 2024; operating expenses $44.0M.","Completed concurrent offerings of notes, stock, warrants with net proceeds $286.5M; proforma cash $455M funding through 2027.","New patent extends gedatolisib dosing regimen exclusivity into 2042; first patient dosed in Phase 3 VIKTORIA-2 first-line trial."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.9,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q2","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.85,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":139061,"accession_number":"0001641172-25-021894","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2025-08-01T23:59:59+00:00","items":["1.01","2.03","8.01","9.01"],"status":"ready","headline":"Celcuity issues $201.25M of 2.750% convertible notes due 2031; net proceeds ~$194.5M","event_type":"debt","confidence":"high","bullets":["Issued $201.25M aggregate principal of 2.750% Convertible Senior Notes due 2031; initial conversion price ~$51.30/share.","Net proceeds of ~$194.5M after underwriting discounts and expenses; over-allotment option exercised in full.","Notes mature Aug 1, 2031; interest payable semiannually; redeemable at company's option after Aug 6, 2029 under conditions.","Company elected physical settlement for any conversions; notes are unsecured senior obligations.","Proceeds intended for working capital, R&D, clinical trials, and commercial launch expenditures."],"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,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":139060,"accession_number":"0001641172-25-021739","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2025-07-31T23:59:59+00:00","items":["1.01","8.01","9.01"],"status":"ready","headline":"Celcuity prices $175M convertible notes and stock offering; net proceeds ~$248.7M","event_type":"other_material","confidence":"high","bullets":["$175M of 2.750% convertible senior notes due 2031 priced; initial conversion price ~$51.30/share (35% premium to stock offering).","Common stock offering: 1,836,842 shares at $38.00/share + pre-funded warrants for 400,000 shares at $37.999/warrant.","Combined net proceeds ~$248.7M after underwriting discounts; use for working capital and general corporate purposes.","Company will not enter previously contemplated capped call transactions; investors may hedge via derivative transactions or selling shares.","Underwriters have 30-day options: up to $26.25M additional notes and up to 335,526 additional shares of common stock."],"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":139059,"accession_number":"0001641172-25-021274","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2025-07-29T23:59:59+00:00","items":["1.01","8.01","9.01"],"status":"ready","headline":"Celcuity launches $150M convertible notes + $75M common stock offerings; also to draw $30M loan","event_type":"other_material","confidence":"high","bullets":["Concurrent underwritten offerings: $150M convertible notes due 2031 and $75M common stock; 30-day over-allotment options for additional $22.5M notes and $11.25M stock.","Proceeds to fund capped call transactions (reduce dilution on note conversion) and for working capital, clinical trials, R&D.","Intends to draw $30M Term D Loan in late August 2025 after achieving clinical milestone under existing loan agreement.","Amended loan with Innovatus/Oxford: $25k fee, extended conversion right on Term A loan to $10/share through May 9, 2026.","Preliminary cash at June 30, 2025: ~$168.4M (down from $283.1M a year ago)."],"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},{"id":139058,"accession_number":"0001641172-25-021095","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2025-07-28T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Celcuity Phase 3 VIKTORIA-1 PIK3CA wild-type: gedatolisib triplet cuts progression/death risk by 76% (HR 0.24)","event_type":"other_material","confidence":"high","bullets":["Gedatolisib triplet (plus palbociclib/fulvestrant) mPFS 9.3 mo vs 2.0 mo for fulvestrant, incremental gain 7.3 mo.","Gedatolisib doublet (plus fulvestrant) mPFS 7.4 mo vs 2.0 mo, reducing risk by 67% (HR 0.33; p<0.0001).","Treatment discontinuation due to AEs lower than prior Phase 1b; fewer hyperglycemia/stomatitis events.","Celcuity expects to submit NDA to FDA for gedatolisib in Q4 2025; mutation cohort topline by end of 2025.","Efficacy milestones: best HR and mPFS improvement ever reported in any Phase 3 for HR+/HER2- ABC."],"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":0.95,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":156581,"accession_number":"0001641172-25-017043","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2025-06-30T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Celcuity reports 66% six-month rPFS in mCRPC Phase 1, 43% ORR in HER2+ mBC Phase 2","event_type":"other_material","confidence":"high","bullets":["Phase 1 mCRPC (gedatolisib + darolutamide): 66% six-month rPFS; no treatment-related discontinuations or Grade 3 hyperglycemia; Grade 2-3 stomatitis in 10.5% of patients.","Phase 2 HER2+ mBC (gedatolisib + trastuzumab-pkrb): ORR 43%, median PFS 6.0 months, median OS 24.7 months; no discontinuations due to treatment-related AEs; 2.3% Grade 3 hyperglycemia.","Protocol amended to explore additional gedatolisib doses in mCRPC Phase 1/1b; up to six patients per arm in three arms, then Phase 1b with up to 40 patients to determine RP2D.","No prophylaxis for stomatitis used in the mBC trial; data cut-off Feb 10, 2025; results presented at ASCO 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":"positive","materiality_score":0.75,"daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":156580,"accession_number":"0001641172-25-011273","cik":1603454,"company_name":"Celcuity Inc.","ticker":"CELC","form_type":"8-K","filed_at":"2025-05-16T23:59:59+00:00","items":["5.02","5.07","9.01"],"status":"ready","headline":"Celcuity shareholders approve 3M-share increase under 2017 stock plan","event_type":"other_material","confidence":"high","bullets":["Approved 3M share increase under 2017 Stock Incentive Plan (2.5M for ISOs).","All seven director nominees elected, including CEO Brian Sullivan.","Boulay PLLP ratified as independent auditor for FY2025.","Advisory say-on-pay approved with 25.4M For vs 0.8M Against.","Broker non-votes of 6.9M on director and say-on-pay matters."],"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}],"next_cursor":null}