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. Schedule 13G shows RTW Investments, LP and Roderick Wong, M.D. reporting beneficial ownership of 3,039,621 shares, equal to 6.3% of the class. The filing states 48,336,675 shares outstanding as of March 17, 2026. The shares are held by the RTW Funds and reported with shared voting and dispositive power.
Celcuity Inc. reported a larger net loss as it ramps up late-stage development of its lead cancer drug gedatolisib. For the three months ended March 31, 2026, net loss was $52.8 million, compared with $37.0 million a year earlier, driven by higher research and development and commercial launch preparation costs.
Research and development expense rose to $33.1 million from $29.8 million, while selling, general and administrative expense increased to $17.4 million from $6.4 million as the company invested in marketing, market access and support functions ahead of potential commercialization. Celcuity ended the quarter with $387.1 million in cash, cash equivalents and short-term investments and stated this should fund operations for at least one year.
Strategically, the company highlighted strong Phase 3 VIKTORIA-1 results for gedatolisib in HR+/HER2- advanced breast cancer, including both PIK3CA wild-type and mutant cohorts, and ongoing Phase 3 VIKTORIA-2 and Phase 1b/2 CELC-G-201 trials. The FDA accepted Celcuity’s New Drug Application for gedatolisib in PIK3CA wild-type disease, granted Priority Review, and set a PDUFA goal date of July 17, 2026, positioning the company for a potential first product approval.
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. director-associated fund sells shares under trading plan
Brightstone Venture Capital Fund, LP, an entity associated with Celcuity director David Dalvey, executed an open-market sale of 25,000 shares of Celcuity common stock on May 4, 2026 at an average price of $140.68 per share.
After this transaction, Brightstone remained the indirect owner of 65,000 Celcuity shares. The sale was carried out pursuant to a pre-arranged Rule 10b5-1 trading plan adopted by Brightstone, indicating the trades were scheduled in advance rather than timed discretionarily by the manager.
Celcuity Inc. director Richard E. Buller exercised stock options for 9,000 shares of common stock at $5.10 per share through a trust, then sold 9,000 shares in multiple open-market trades around $137–$143. These transactions were executed under a pre-arranged Rule 10b5-1 trading plan adopted on December 8, 2025. Following the transactions, he holds 1,029 shares directly, 15,760 shares indirectly through the trust, and 654 remaining stock options at a $5.10 exercise price expiring on May 14, 2030.
CELC filed a Form 144 notice reporting an intended sale of 6,000 shares of Common Stock tied to an option exercise, with the transaction dated 05/04/2026. The filing also states 3,000 shares were sold during the past three months on 03/31/2026 for $330,804. The plan is labeled as equity compensation and the broker listed is Stifel Nicolaus & Company Inc.
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. director Richard Nigon reported a bona fide gift of 10,000 shares of Common Stock on April 9, 2026. The transfer was recorded at no cash consideration, reflecting a charitable or personal gift rather than a market sale. After the transaction, he directly holds 79,035 Celcuity shares.
Celcuity Inc. is asking stockholders at its May 14, 2026 annual meeting to elect eight directors, ratify Boulay PLLP as independent auditor, approve executive compensation on an advisory basis, and adopt two updated equity plans.
The company seeks approval of a new 2026 Stock Incentive Plan covering 3,000,000 shares, which will replace the existing 2017 stock plan for new grants and includes an annual share “evergreen” increase of up to 1.0% of common stock from 2027 through 2036. It also discloses an average three-year equity grant burn rate of 4.4% and a fully diluted overhang of 18.2% as of March 17, 2026.
Celcuity further proposes an amended and restated 2017 Employee Stock Purchase Plan, increasing the share pool by 289,199 to a total authorization of 1,229,370 shares and extending the ESPP term by ten years, with a standard Section 423 structure and a 15% purchase discount. As of March 17, 2026, there were 48,336,675 common shares outstanding, each entitled to one vote on these proposals.