Every 8-K that Celcuity Inc. (CELC) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow CELC and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full CELC filings page.
Celcuity Inc. appointed David W. Gryska as a director effective October 1, 2026, increasing its board from eight members to nine. The board also appointed him to its Audit and Compensation Committees and determined that he qualifies as an independent director under Nasdaq listing standards and SEC rules. His term extends through the 2027 Annual Meeting and election of his successor, or his earlier death, resignation or removal.
Celcuity’s non-employee director compensation program provides an annual cash retainer of $70,000, payable quarterly, and an annual equity award with a fair market value of $100,000, payable in restricted stock units, stock options or a combination at the director’s election. Celcuity granted Gryska a prorated annual award of 893 restricted stock units under its 2026 Stock Incentive Plan; all shares vest upon the earlier of the 2027 Annual Meeting or April 30, 2027. The company’s announcement says Gryska has over 35 years of strategic and financial leadership experience in the life sciences industry.
Celcuity Inc. (CELC) announced that REVTORPYK (gedatolisib) became commercially available in the United States on September 30, 2026, for eligible adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation after progression following at least one line of endocrine therapy in the metastatic setting. The FDA approved REVTORPYK on July 14, 2026, with fulvestrant, with or without palbociclib.
In the PIK3CA wild-type cohort of Phase 3 VIKTORIA-1, the triplet and doublet reduced the risk of disease progression or death by 76% and 67%, respectively, compared with fulvestrant. Stomatitis occurred in 72% of patients receiving the triplet, including Grade 3 events in 22%, and in 58% receiving the doublet, including Grade 3 events in 12%. Celcuity submitted a supplemental New Drug Application in August for the PIK3CA-mutated group; if approved, physicians could prescribe REVTORPYK regardless of tumor PIK3CA status. The company also launched patient services for insurance, reimbursement and financial assistance.
Celcuity Inc. (CELC) reported the submission of a supplemental New Drug Application (sNDA) to the U.S. FDA for REVTORPYK (gedatolisib) to treat adults with HR+/HER2-, PIK3CA-mutated locally advanced or metastatic breast cancer after at least one prior endocrine therapy. The sNDA is supported by the PIK3CA-mutant cohort of the Phase 3 VIKTORIA-1 trial, where the REVTORPYK-triplet (with fulvestrant and palbociclib) reduced risk of disease progression or death by 50% versus alpelisib plus fulvestrant and achieved median progression-free survival of 11.1 months versus 5.6 months. The REVTORPYK-doublet (with fulvestrant) reduced risk by 49% and achieved median progression-free survival of 11.3 months versus 5.6 months, with robust objective response rates and durable responses. REVTORPYK is already FDA-approved for HR+/HER2- advanced breast cancer without a PIK3CA mutation, and this filing seeks to expand its labeled population.
Celcuity Inc. reported second quarter 2026 results alongside major clinical, regulatory and financing milestones. The U.S. FDA approved REVTORPYK (gedatolisib) on July 14, 2026 for HR+/HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer after endocrine therapy, with commercial launch activities underway and shipments expected late in the third quarter of 2026. REVTORPYK in combination with fulvestrant, with or without palbociclib, was added to NCCN Guidelines as a preferred Category 1 second-line option.
In the PIK3CA-mutant cohort of the Phase 3 VIKTORIA-1 trial, gedatolisib regimens roughly doubled progression-free survival versus alpelisib plus fulvestrant, with hazard ratios of 0.50 and 0.51 and median PFS of 11.1 and 11.3 months versus 5.6 months. Objective response rates reached 49% for the triplet and 36% for the doublet, with lower discontinuation rates due to adverse events than alpelisib.
Net loss for the quarter widened to $78.9 million or $1.44 per share from $45.3 million or $1.04. Total operating expenses rose to $66.1 million, driven by a jump in SG&A to support commercialization, while R&D declined as VIKTORIA-1 costs eased. Celcuity completed a $575.0 million 0.250% convertible note offering, using $137.0 million to prepay term debt, and ended the quarter with $754.0 million in cash, cash equivalents and investments, which it expects will fund operations at least into 2029.
Celcuity Inc. reports that the U.S. FDA has approved REVTORPYK (gedatolisib), a pan-PI3K and mTORC1/2 inhibitor, for treatment of adult patients with HR+/HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer after progression on at least one line of endocrine therapy in the metastatic setting.
The approval is based on the Phase 3 VIKTORIA-1 trial, where REVTORPYK plus palbociclib and fulvestrant achieved median progression-free survival of 9.3 months vs 2.0 months with fulvestrant alone and substantially higher response rates. Celcuity anticipates commercial launch in late Q3 2026 and plans to submit a supplemental NDA in Q3 2026 for PIK3CA-mutated disease. The current amendment primarily corrects an omitted presentation slide and related webcast description.
Celcuity Inc. received U.S. Food and Drug Administration approval for REVTORPYK™ (gedatolisib), its first FDA-approved product, for adult patients with hormone receptor positive, HER2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected after progression on at least one line of endocrine therapy in the metastatic setting, in combination with fulvestrant with or without palbociclib.
The approval is based on the Phase 3 VIKTORIA-1 trial, where the REVTORPYK triplet achieved median progression free survival of 9.3 months versus 2.0 months with fulvestrant, with an objective response rate of 32% vs 1%. Celcuity anticipates commercial launch in late Q3 2026 and plans to submit a supplemental New Drug Application in Q3 2026 for PIK3CA-mutated HR+/HER2- disease, while continuing additional Phase 3 and Phase 1/2 studies in breast and prostate cancers.
Celcuity Inc. completed an upsized convertible debt financing by issuing $575,000,000 aggregate principal amount of 0.250% Convertible Senior Notes due 2032, generating approximately $557.0 million in net proceeds. The company used part of this cash to voluntarily prepay and terminate its existing loan agreement, making a payoff of approximately $137.5 million including principal, interest, fees and expenses. The notes pay 0.250% interest semi-annually, mature on August 1, 2032, and are convertible at an initial rate of 8.0302 shares per $1,000 principal, implying an initial conversion price of about $124.53 per share. Celcuity may redeem the notes on or after August 6, 2029 if its stock price conditions are met, and holders have put rights upon certain fundamental changes. Remaining proceeds are earmarked for working capital, clinical and commercialization spending, and potential business or technology acquisitions.
Celcuity Inc. reported detailed Phase 3 VIKTORIA-1 results showing its investigational PAM pathway inhibitor gedatolisib improved outcomes for patients with HR+/HER2-, PIK3CA-mutant advanced breast cancer after CDK4/6 therapy. In the PIK3CA mutant cohort, the gedatolisib-triplet doubled the likelihood of remaining free from disease progression or death versus alpelisib plus fulvestrant, with median progression free survival of 11.1 months versus 5.6 months (hazard ratio 0.50; p<0.0001). Objective response rate was 48.9% versus 26.0%, and median duration of response 15.7 months versus 7.5 months. A gedatolisib-doublet also showed longer median progression free survival of 11.3 months with an objective response rate of 35.7% and 24.2‑month median duration of response. Gedatolisib regimens were generally well tolerated, with relatively low discontinuation rates and a safety profile that differed from alpelisib, including lower rates of hyperglycemia and rash but higher neutropenia with the triplet. Overall survival data are immature but trending positively. Celcuity plans to file a supplemental NDA based on these data and is preparing for a potential commercial launch in the third quarter of 2026, alongside an ongoing Priority Review NDA in the PIK3CA wild-type population with a PDUFA date of July 17, 2026.
Celcuity Inc. expanded its Board of Directors from seven to eight members and appointed Charles (Chip) R. Romp as a new independent director, effective February 11, 2026. His term runs through the Company’s 2026 Annual Meeting of Stockholders and the election of his successor, or earlier departure.
On May 14, 2026, Mr. Romp was also appointed to the Board’s Compensation Committee and Nominating and Corporate Governance Committee. As a non-employee director, he is eligible for an annual cash retainer of $70,000 and an annual equity award with a fair market value of $135,000. Upon joining the Board, he received a pro-rated grant of 215 shares of restricted stock that vested in full on April 30, 2026.
The Board determined that Mr. Romp is an independent director under Nasdaq and SEC rules, and the Company states there are no related-party relationships or arrangements that must be disclosed for his appointment.
Celcuity Inc. held its 2026 Annual Meeting of Stockholders, where stockholders approved a new 2026 Stock Incentive Plan and an amended employee stock purchase plan. The 2026 plan authorizes up to 3,000,000 shares of common stock for equity awards to employees, consultants, and non-employee directors, replacing the prior 2017 plan for new grants.
Stockholders also approved the Amended and Restated 2017 Employee Stock Purchase Plan, increasing available shares by 289,199 and extending the plan for ten additional years. Eight directors were elected, the company’s executive compensation was approved on an advisory basis, and Boulay PLLP was ratified as independent registered public accounting firm for the fiscal year ending December 31, 2026.
Celcuity Inc. reported first quarter 2026 results alongside major clinical advances for its lead drug, gedatolisib. The pivotal Phase 3 VIKTORIA-1 trial met its primary endpoint, with both triplet and doublet regimens showing statistically significant and clinically meaningful improvements in progression-free survival versus an alpelisib-based regimen and generally manageable safety. The FDA has accepted Celcuity’s New Drug Application for gedatolisib in HR+/HER2- PIK3CA wild-type breast cancer, granted Priority Review, and set a PDUFA goal date of July 17, 2026, while an sNDA based on VIKTORIA-1 is planned for the third quarter. Celcuity posted a GAAP net loss of $52.8 million, or $0.97 per share, compared with a $37.0 million loss, as operating expenses rose to $50.5 million on higher R&D and commercialization spending. Non-GAAP adjusted net loss was $46.8 million, or $0.86 per share. Cash, cash equivalents and investments totaled $387.1 million, and the company expects available cash and debt facilities to fund operations through 2027 while it prepares for a potential U.S. launch in the third quarter of 2026.
Celcuity Inc. reported positive topline Phase 3 results from the PIK3CA mutant cohort of its VIKTORIA-1 trial in HR+/HER2- advanced breast cancer. Gedatolisib plus fulvestrant, with or without palbociclib, showed a statistically significant and clinically meaningful improvement in progression-free survival versus alpelisib plus fulvestrant and was generally well tolerated.
The company plans to submit these data as a supplemental New Drug Application to the FDA and then to other regulators, and to present detailed results in a late-breaking oral session at the 2026 ASCO Annual Meeting. An existing NDA for gedatolisib in PIK3CA wild-type disease is already under FDA Priority Review with a PDUFA goal date of July 17, 2026.
Celcuity Inc. reported fourth quarter and full year 2025 results alongside major regulatory and clinical milestones for its lead drug candidate, gedatolisib.
The FDA accepted Celcuity’s New Drug Application for gedatolisib in HR+/HER2- PIK3CA wild-type advanced breast cancer, granted Priority Review, and set a PDUFA goal date of July 17, 2026. Published Phase 3 VIKTORIA-1 cohort data showed the gedatolisib triplet improved median time to definitive deterioration in patient-reported well-being to 23.7 months versus 4.0 months on fulvestrant, with a hazard ratio of 0.39.
Total operating expenses rose to $49.2 million in the fourth quarter and $172.2 million for 2025, driving a GAAP net loss of $51.0 million for the quarter and $177.0 million for the year. Non-GAAP adjusted net loss was $38.4 million for the quarter and $150.8 million for 2025. Cash, cash equivalents and short-term investments were $441.5 million at year-end 2025, which the company expects will fund operations through 2027.
Celcuity Inc. has expanded its Board of Directors from seven to eight members and appointed Charles (Chip) R. Romp as a new independent director, effective immediately, to serve through the 2026 Annual Meeting of Stockholders and until his successor is elected or he departs earlier.
Romp will be compensated under Celcuity’s standard non-employee director program, including a $50,000 annual cash retainer and an annual equity award valued at $100,000. Upon joining, he received a pro-rated grant of 215 restricted shares that vest at the earlier of the 2026 Annual Meeting or April 30, 2026.
Romp is currently CEO of Secura Bio and brings over 25 years of oncology-focused pharmaceutical experience, including senior commercial roles at Seagen and Genentech. Celcuity highlights his expertise as it advances its lead candidate gedatolisib through multiple Phase 3 and Phase 1/2 trials in breast and prostate cancer.
Celcuity Inc. (CELC) reported that it has submitted a New Drug Application to the U.S. Food and Drug Administration for gedatolisib as a treatment for hormone receptor positive, HER2-negative, PIK3CA wild-type advanced breast cancer. This step means the company is formally asking the FDA to review gedatolisib for potential approval in this breast cancer setting. The submission focuses on patients whose tumors are HR+/HER2- and PIK3CA wild-type, a defined subset of advanced breast cancer. Celcuity disclosed this news through a press release that is furnished as an exhibit to the report.
Celcuity Inc. (CELC) furnished an 8-K announcing its third-quarter 2025 results press release. The company reported that a press release covering financial results for the quarter ended September 30, 2025 was made available as Exhibit 99.1.
The Item 2.02 information, including Exhibit 99.1, is being furnished and not filed under the Exchange Act, and will not be incorporated by reference into other filings. Celcuity’s common stock trades on Nasdaq under the symbol CELC.
Celcuity Inc. (CELC) reported positive Phase 3 results from the VIKTORIA-1 PIK3CA wild-type cohort in HR+/HER2- advanced breast cancer. Median progression-free survival with the gedatolisib triplet (gedatolisib + palbociclib + fulvestrant) was 9.3 months versus 2.0 months with fulvestrant (HR=0.24; p<0.0001). The gedatolisib doublet (gedatolisib + fulvestrant) achieved 7.4 months versus 2.0 months (HR=0.33; p<0.0001). Objective response rates were 31.5% for the triplet and 28.3% for the doublet, compared to 1% with fulvestrant.
Celcuity initiated a rolling NDA under the FDA’s Real-Time Oncology Review, targeting completion in Q4 2025. The company plans topline data for the PIK3CA mutant cohort in late Q1 2026 or during Q2 2026. Safety was generally manageable: common grade 3 events with the triplet included neutropenia (52.3%), stomatitis (19.2%), rash (4.6%), and hyperglycemia (2.3%); grade 4 neutropenia occurred in 10.0%. Discontinuations due to treatment-related adverse events were 2.3% (triplet) and 3.1% (doublet). Overall survival trends were described as promising but immature.
Celcuity Inc. amended its existing loan and security agreement to expand and extend its debt facilities. The company confirmed achievement of the Term D milestone, triggering immediate disbursement of a $30.0 million Term D Loan. It increased the potential Term E Loan from $50.0 million to up to $100.0 million, available only upon U.S. Food and Drug Administration approval of gedatolisib in second line wild-type advanced breast cancer patients after CDK4/6 inhibitor therapy. Celcuity also added three new $40.0 million Term F Loans tied to future trailing three-month product revenue thresholds and replaced a prior $45.0 million Term F Loan with a discretionary $150.0 million Term G Loan available solely at the lenders’ discretion. The amendment adds an amendment fee of $50,000, updates non‑utilization fees to 3.0% of unfunded commitments for certain tranches, and extends the term loan maturity to November 1, 2029. In connection with the amendment, Celcuity issued warrants to purchase 50,537 shares of common stock to Oxford, Innovatus and affiliates, exercisable on a cashless basis for ten years from the Term D funding date.
Celcuity Inc. (CELC) filed an 8-K detailing several capital-raising and financing actions dated 28 Jul 2025.
Loan amendment: The company executed a Second Amendment to its Amended & Restated Loan and Security Agreement with Innovatus and Oxford Finance. Key changes: (i) allows issuance of $150 m aggregate principal Convertible Senior Notes due 2031 and related capped-call transactions; (ii) permits equity conversion of the notes solely into common shares (cash only for fractional shares); (iii) requires a one-time $25 k amendment fee paid to Oxford; and (iv) extends to 9 May 2026 Innovatus’ option to convert up to 20 % of Term A principal into CELC stock at $10.00 per share.
Capital markets activity: Celcuity launched a concurrent offering for $150 m of the Notes plus $75 m of common stock. Proceeds would strengthen liquidity and fund operations.
Additional debt capacity: Management believes the Phase 3 VIKTORIA-1 data achieve the “Term D Milestone,” enabling a $30 m Term D Loan draw by 31 Aug 2025.
Preliminary cash position: Cash, equivalents and short-term investments are expected at ~<$168.4 m> on 30 Jun 2025 versus $283.1 m a year earlier (-41 %). Figures are unaudited and subject to change.
Forward-looking statements caution that the offerings may not close, the Term D draw might not occur, and final June-quarter financials could differ.
Celcuity’s Form 8-K furnishes topline data from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 trial in HR-positive/HER2-negative metastatic breast cancer. Adding gedatolisib to fulvestrant plus palbociclib cut risk of progression or death by 76 % (HR 0.24; p<0.0001) and extended blinded-review median PFS to 9.3 months vs. 2.0 months. The gedatolisib+fulvestrant doublet reduced risk by 67 % (HR 0.33) with mPFS of 7.4 months. Both hazard ratios and incremental PFS gains are the best reported for second-line HR+/HER2- ABC in any Phase 3 study. Discontinuations and class-related AEs (hyperglycemia, stomatitis) were lower than prior Phase 1b data and other approved regimens, indicating an improved tolerability profile.
Celcuity plans to file a New Drug Application with the FDA in Q4 2025; full data will be presented at a medical meeting in 2025. Topline results from the separate PIK3CA-mutant cohort are expected by year-end 2025.