Tag: FDA

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In PepGen To Contact Him Directly To Discuss Their Options

– Absence of neurotoxicity of any grade in low-volume disease to-date –

MONTREAL and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone^® Pharmaceuticals Inc. (“Milestone”) (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the pricing of its previously announced underwritten public offering (the “Offering”) of (i) 31,500,000 of its common shares (the “Shares”), accompanying Series A common warrants (the “Series A Common Warrants”) to purchase an aggregate of 31,500,000 common shares and accompanying Series B common warrants (the “Series B Common Warrants”) to purchase an aggregate of 31,500,000 common shares , at a combined public offering price of $1.50 per share and accompanying Series A Common Warrant and Series B Common Warrant and (ii) in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase 3,502,335 common shares, accompanying Series A Common Warrants to purchase an aggregate of 3,502,335 common shares and accompanying Series B Common Warrants to purchase an aggregate of 3,502,335 common shares, at a combined public offering price of $1.499 per pre-funded warrant and accompanying Series A Common Warrant and Series B Common Warrant, which represents the combined public offering price for the Shares and accompanying common warrants less the $0.001 per share exercise price for each such pre-funded warrant. The proceeds to Milestone from the Offering, before deducting underwriting commissions and offering expenses payable by Milestone, are expected to be approximately $52.5 million. The Offering is expected to close on or about July 14, 2025, subject to satisfaction of customary closing conditions.

New York City, NY, July 11, 2025 (GLOBE NEWSWIRE) --  CrazyBulk, a leading provider of legal steroid alternatives, is excited to announce its expanded line of top-rated, natural supplements designed to help athletes and fitness enthusiasts build muscle, enhance strength, and lose fat. These cutting-edge products are formulated to provide safe, effective results, mimicking the effects of anabolic steroids without the associated side effects and legal risks.

MONTREAL, Quebec and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone^® Pharmaceuticals Inc. (“Milestone”) (Nasdaq: MIST) today announced that it has commenced an underwritten public offering (the “Offering”) of its common shares, accompanying Series A warrants to purchase common shares (the “Series A Warrants”) and accompanying Series B warrants to purchase common shares (the “Series B Warrants”), and, in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase common shares, accompanying Series A Warrants and accompanying Series B warrants. All securities to be sold in the Offering will be sold by Milestone. The Offering is subject to market and other conditions and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

SANTA ANA, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced the administration of the first dose of troculeucel, an expanded autologous NK cell therapy, under a single compassionate use, Investigational New Drug (“IND”) authorization cleared by the U.S. Food and Drug Administration (“FDA”), to a patient with mild-stage Alzheimer’s disease who exhibited continued cognitive decline despite ongoing treatment with lecanemab, an amyloid targeting therapy. This exploratory work is being conducted in collaboration with Anita Fletcher, M.D., a board-certified neurologist with specialized training in neuroimmunology, who also serves as Director of Neuroscience Clinical Research at AdventHealth Neuroscience Institute in Orlando, Florida.

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.

"Comprehensive Analysis of FDA Approved CAR T-Cell Therapies: Market Trends, Business Strategies, Competitive Intelligence, Clinical Trials, and Patent Trends Driving Growth from 2024 to 2029"