Celcuity Inc. filings document formal disclosures for a clinical-stage biotechnology company developing targeted oncology therapies. Recent 8-K reports cover gedatolisib and VIKTORIA-1 clinical-trial results in HR+/HER2- advanced breast cancer, FDA-related regulatory updates, financial results, Regulation FD materials, and amendments to a loan and security agreement.
Proxy materials describe annual meeting matters, director elections, auditor ratification, executive compensation votes, stock incentive plans, and employee stock purchase plan amendments. Governance filings also record board composition changes and director compensation arrangements.
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. (symbol: CELC) is the issuer of record for a Form 4 filing submitted to the SEC.
Celcuity Inc. (symbol: CELC) is the issuer of record for a Form 4 filing submitted to the SEC.
Celcuity Inc. (CELC) reported that its Chief Financial Officer, Vicky Hahne, acquired equity-based awards on August 14, 2026. She received a grant of 10,000 Performance Stock Units, each representing a contingent right to receive one share of Celcuity common stock, which vest only if the common stock reaches specified trailing average per-share price thresholds. She also received 16,000 shares of common stock in the form of time-based restricted stock units, of which 25% vest on the first day of the month following each of the first four anniversaries of the grant date. Following these awards, Hahne directly holds 37,808 shares of common stock, which include 2,948 shares acquired through Celcuity’s employee stock purchase plan.
Celcuity Inc. reported a larger loss as it transitions from development toward commercialization of REVTORPYK (gedatolisib). For the quarter ended June 30, 2026, net loss was $78.9 million versus $45.3 million a year earlier, driven by sharply higher selling, general and administrative expenses of $35.0 million as the company built out its commercial infrastructure. Research and development expense declined to $31.1 million from $36.4 million.
Total assets rose to $828.2 million, including $754.0 million of cash, cash equivalents and short-term investments, after issuing $575.0 million of 0.250% convertible notes due 2032 and repaying its prior term loan. Convertible notes outstanding increased to $753.2 million, and stockholders’ equity moved to a deficit of $12.8 million, reflecting accumulated deficit of $580.6 million and new debt.
Subsequent to quarter-end, the FDA approved REVTORPYK for HR+/HER2- advanced breast cancer without a PIK3CA mutation, triggering a $50.0 million milestone payment to Pfizer that was recognized as an intangible asset and liability at June 30, 2026. Celcuity had used $110.5 million of cash in operating activities in the first half and believes its $754.0 million liquidity will fund operations for at least one year.
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.
Bank of America Corporation, through several wholly owned subsidiaries, reports beneficial ownership of Celcuity Inc. common stock. The filing states beneficial ownership of 3,170,198 shares of Celcuity common stock, representing 6.5% of the class, based on 48,766,288 shares outstanding as reported by Celcuity as of May 7, 2026.
Bank of America and its subsidiaries report no sole voting or dispositive power, but shared voting power over 3,143,687 shares and shared dispositive power over 3,144,064 shares
Baker Bros. Advisors LP, its general partner and principals Julian and Felix Baker report beneficial ownership of 4,877,963 Celcuity Inc. common shares, equal to 9.99% of the class. This includes 4,815,792 shares held by affiliated funds and 62,171 shares issuable from $0.001 prefunded warrants.
The prefunded warrants are only exercisable up to a 9.99% “Maximum Percentage” ownership cap, adjustable up to 19.99% with a 61‑day delay. The group also holds 2.75% Convertible Notes convertible at 19.4932 shares per $1,000, but these cannot currently be converted due to a separate 4.99% Beneficial Ownership Limitation. All 4,877,963 shares are subject to sole voting and dispositive power by the reporting group.
The reporting persons previously reported on Schedule 13D but now report on Schedule 13G after confirming they own under 10%, are not affiliates of Celcuity, and hold the securities for investment purposes without an intent to change or influence control.