Strategic Signals Weekly

Capricor Therapeutics announced that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will convene a meeting on July 29, 2026, to discuss the company's Biologics License Application (BLA) for Deramiocel. The investigational cell therapy is seeking approval for the treatment of Duchenne muscular dystrophy. The BLA maintains a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026.

Drug: Deramiocel · Indication: Duchenne muscular dystrophy

Genprex announced that the Canadian Intellectual Property Office has issued a Notice of Allowance for a patent covering Reqorsa® Gene Therapy (quaratusugene ozeplasmid) in combination with PD-1 or PD-L1 antibodies for non-small cell and small cell lung cancer. This patent strengthens the company's intellectual property portfolio, providing crucial protection for therapeutic combinations currently being evaluated in the Acclaim-3 clinical trial. This expands on previously granted patents for REQORSA in other major markets.

Aytu BioPharma and Lannett Company mutually agreed to terminate their exclusive license agreement for Metadate CD®, effective June 23, 2026. Aytu retains the right to sell existing inventory and will continue to pay royalties on these sales. For the quarter ended March 31, 2026, Metadate CD® generated $49,000 in net revenue.

Drug: Metadate CD® · Partner: Lannett Company, Inc.

MoonLake Immunotherapeutics entered into an underwriting agreement with Leerink Partners LLC for a public offering. The company will issue and sell 9,000,000 Class A ordinary shares and up to 1,000,000 pre-funded warrants, with an option for underwriters to purchase an additional 1,500,000 shares. The gross proceeds from this offering are expected to be $200 million before deducting underwriting discounts and offering expenses.

Taysha Gene Therapies, Inc. entered into an underwriting agreement to issue and sell 32,500,001 shares of common stock and pre-funded warrants in a public offering. The company expects to raise approximately $187.4 million in net proceeds, or up to $215.6 million if underwriters fully exercise their option. These funds, combined with existing cash, are anticipated to cover operating expenses and capital expenditures into the second half of 2028.

Serina Therapeutics, Inc. held its 2026 Annual Meeting, where stockholders approved several key proposals. These included increasing the authorized common stock from 40 million to 125 million shares and approving the issuance of common stock related to the exercise of existing Private Placement Securities. Additionally, stockholders ratified the election of three directors and an amendment to the 2024 Equity Incentive Plan.

Passage Bio, Inc. has entered into a definitive merger agreement with Remix Therapeutics, Inc., under which Remix will become a wholly-owned subsidiary of Passage Bio. Immediately prior to the merger, Remix will complete a concurrent private financing of at least $100 million. Upon closing, Remix's CEO will lead the combined company, with Remix's equity valued at $226 million compared to Passage Bio's approximately $20 million.

Absci Corporation entered into an underwriting agreement for a public offering of 13,495,277 shares of common stock at $7.41 per share, expecting to raise approximately $93.5 million in net proceeds. The company intends to use these funds to advance ABS-201, its AI-designed anti-PRLR antibody product candidate, for androgenetic alopecia and endometriosis, in addition to general corporate purposes. The offering is anticipated to close on June 25, 2026.