CELC news

Celcuity Inc. announced the appointment of David W. Gryska to its Board of Directors to support the commercial launch of its product REVTORPYK and advance clinical development programs.

Celcuity Inc. announced that REVTORPYK (gedatolisib), an FDA-approved breast cancer therapy, is commercially available in the US. The launch follows recent regulatory approvals and positions the company in the advanced breast cancer market.

Celcuity submitted a supplemental New Drug Application to the FDA for REVTORPYK targeting breast cancer patients with a PIK3CA mutation. Market relevance: If approved, it could become the first therapy to inhibit all class I PI3K isoforms in advanced breast cancer.

Celcuity announced FDA approval for the REVTORPYK targeted therapy to treat HR+/HER2- breast cancer without a PIK3CA mutation. The drug reduced the risk of disease progression or death by up to 76% in clinical trials.

CEL-SCI Corporation has entered into a placement agency agreement with ThinkEquity LLC to act as exclusive placement agent for an offering of up to 2,500,000 shares of common stock at $1.00 per share. The offering will be conducted on a reasonable best efforts basis with closing at Sichenzia Ross Fe…

Celcuity announced positive Phase 3 VIKTORIA-1 trial results showing gedatolisib combination regimens reduced disease progression risk by 50% compared to alpelisib in PIK3CA mutant HR+/HER2- breast cancer patients. The results represent a potential major advancement for the company's lead candidate …