Positive Phase III Results Justify Buy Rating for Celcuity's Geda Triplet Therapy

Celcuity's geda triplet therapy has shown promising Phase III results, with a hazard ratio of 0.24, indicating a significant improvement in progression-free survival for patients with WT. The company plans to submit a New Drug Application in Q4 and expand its commercial operations. This has led to a Buy rating from TD Cowen and a $70.00 price target from Needham.

Celcuity (NASDAQ: CELC) reported its second quarter 2025 results on August 14, 2025, highlighting top-line Phase III data for gedatolisib in second-line HR-positive, HER2-negative advanced breast cancer. The company ended the quarter with $455 million in pro forma cash after raising $286.5 million in new financing, and plans to file a New Drug Application (NDA) with the FDA in 2025. Key milestones and strategic updates position Celcuity for a potential solo commercial launch pending regulatory approval.

Gedatolisib, a PIK3CA inhibitor, demonstrated a median progression-free survival (PFS) of 9.3 months for the triplet regimen and 7.4 months for the doublet in the PIK3CA wild-type cohort of the VICTORIA-1 trial, compared to 2 months for fulvestrant alone. The hazard ratio for the triplet was 0.24, indicating a 4.2 times higher likelihood of survival without disease progression compared to fulvestrant. For the gedatolisib doublet, the median PFS was 7.4 months, with a hazard ratio of 0.33, translating to a 3 times higher likelihood of survival without disease progression. These results establish several new milestones in the history of drug development for this patient population.

Celcuity also secured long-term exclusivity and funding. In July and August, the company raised $286.5 million in net proceeds from offerings of convertible notes, common stock, and prefunded warrants, increasing pro forma cash reserves to $455 million at quarter-end. Additionally, the company gained a new U.S. patent on gedatolisib's clinical dosing regimen, extending exclusivity until at least 2042.

With extended patent protection and a robust cash position, Celcuity is equipped to independently execute clinical, regulatory, and commercial strategies without near-term reliance on partners or dilutive capital raises. The company began building its commercial organization in 2024, hiring key leadership in marketing, market access, and operations, and has continued to expand these teams in preparation for a 2026 launch.

Looking ahead, Celcuity plans to submit a U.S. NDA for gedatolisib in 2025, present full PIK3CA wild-type Phase III data at a medical conference later this year, and release top-line PIK3CA-mutant cohort data by year-end 2025. Management expects current resources to fund operations through 2027, supporting solo launch preparations.

The company's progress has garnered attention from financial analysts. TD Cowen has issued a Buy rating for Celcuity, while Needham has set a $70.00 price target for the stock.

References:
[1] https://www.nasdaq.com/articles/celcuity-q2-results-highlight-cash-surge
[2] https://www.ainvest.com/news/celcuity-reports-q2-2025-results-expects-q4-nda-submission-gedatolisib-2508/