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. 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. 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 reported an exercise-and-sale on May 4, 2026. He exercised stock options for 9,000 shares at $5.10 per share, then a trust sold 9,000 Celcuity shares in multiple trades at weighted-average prices between $137.00 and $143.2378, pursuant to a Rule 10b5-1 plan adopted December 8, 2025. After these transactions, the trust holds 6,760 shares, and he also directly owns 1,029 shares.
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.