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.
Baker Bros. Advisors and related reporting persons filed Amendment No. 2 to their Schedule 13D for Celcuity Inc., reporting beneficial ownership of 4,877,963 shares of common stock, representing 9.99% of the class. The percentage is based on 48,766,288 shares outstanding as of May 7, 2026 plus 62,171 shares underlying prefunded warrants exercisable within 60 days.
The change reflects sales of Celcuity common stock and a written notice setting a 9.99% Maximum Percentage beneficial ownership cap on 481,437 and 5,666,350 $0.001 prefunded warrants held by the Funds. The Funds also hold 2.75% Convertible Notes, convertible into 19.4932 shares per $1,000 principal but currently restricted by a 4.99% Beneficial Ownership Limitation. The reporting persons state they now own less than 10%, are not affiliates, hold the securities for investment purposes, and plan to report future holdings on Schedule 13G, subject to Rule 13d-1.
Entities associated with Baker Bros. Advisors LP, described as former 10% owners of Celcuity Inc., reported open-market sales of a combined 3,100,000 shares of Celcuity common stock at $102.50 per share on July 14, 2026.
Following these transactions, two Baker Bros.-advised funds hold 4,372,852 and 442,940 Celcuity shares, respectively. Julian and Felix Baker and related advisory entities disclaim beneficial ownership except to the extent of any indirect pecuniary interest.
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.
A holder of Celcuity (CELC) common stock plans to sell 261,368 shares through Goldman Sachs & Co. LLC, with an aggregate market value of $26,790,220.00, associated with NASDAQ trading and noting 48,766,288 shares outstanding and an approximate sale date of 07/14/2026. Another section describes purchases of common stock in open-market transactions in May 2025 totaling 261,368 shares for cash.
A holder of CELC common stock filed a notice of proposed sale of up to 2,838,632 shares through Goldman Sachs & Co. LLC on NASDAQ, with an approximate sale date of 07/14/2026. The aggregate market value of the planned sale is $290,959,780.00. These shares were acquired via open market purchases on 05/16/2025, paid for in cash on 05/19/2025. Shares outstanding were 48,766,288; this is a baseline figure, not the amount being sold.
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. director Polly A. Murphy reported gifting stock options linked to Celcuity common stock. On 2026-06-10, she made bona fide gift transfers totaling 28,096 stock options, each with an exercise price of $10.69 per share and an expiration date of May 19, 2035.
One transaction involved 14,048 options held indirectly through a trust, which continued to hold 14,048 options after the gift. A separate gift of 14,048 directly held options left her with zero directly held options from this grant, while she and her spouse remain trustees and beneficiaries of the trust that holds the indirect position.
Celcuity Inc. director Richard E. Buller reported a gift transfer of stock options. On the reported date, he disposed of derivative securities representing 25,006 underlying shares of common stock through bona fide gifts. After the transactions, 12,503 options are held indirectly in a trust where he and his spouse are trustees and beneficiaries, and he continues to beneficially own those securities.
Murphy Polly A. reported acquisition or exercise transactions in this Form 4 filing.
Celcuity Inc. director Polly A. Murphy received a grant of 1,530 shares of common stock in the form of restricted stock units. These RSUs vest upon the earlier of the company’s 2027 annual meeting of stockholders or April 30, 2027. Following this award, Murphy directly holds 6,530 shares of Celcuity common stock.
Dalvey David reported acquisition or exercise transactions in this Form 4 filing.
Celcuity Inc. director David Dalvey reported an equity award and updated holdings. He received a grant of 1,530 shares of common stock in the form of restricted stock units at $0.0000 per share. These units will vest upon the earlier of the 2027 annual meeting of stockholders or April 30, 2027.
After this grant, Dalvey holds 1,530 shares directly. Separately, 65,000 shares of common stock are held indirectly through Brightstone Venture Capital Fund, LP, where he is the General Partner, reflecting his associated interest in that investment vehicle.