Tag: approval

SAN CARLOS, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced the appointment of Marc. R Theoret, M.D. to assume the newly created position of Senior Vice President, Regulatory Strategy, where he will focus on clinical regulatory strategy for Iovance’s pipeline. Effective immediately, Dr. Theoret will report to Dr. Raj K. Puri, M.D., Ph.D., Chief Regulatory Officer.

DENVER, July 10, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, today announced it has entered into a definitive agreement for the issuance and sale of an aggregate of 5,242,464 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $0.763 per share of common stock (or per common stock equivalent in lieu thereof), in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, SeaStar Medical will issue and sell unregistered warrants to purchase up to 5,242,464 shares of common stock. The warrants will have an exercise price of $0.638 per share, will be exercisable immediately upon issuance and will expire five years following the effective date of the resale registration statement registering the shares of common stock issuable upon exercise of the warrants.

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Company expects to submit deucrictibant IR capsule NDA to the U.S. FDA for the on-demand treatment of HAE attacks in 1H2026

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