Just a month after laying off 147 employees and announcing plans to mull “strategic alternatives,” Vor Biopharma Inc. reported raising $175 million in private placement in public equity financing and inking a new $4.23 billion license deal for Yantai Rongchang Biotechnologies (Remegen) Co. Ltd.’s telitacicept, a dual-target fusion protein drug approved in China for three autoimmune indications.

Merck’s pediatric RSV prophylactic gets ACIP thumbs up

Picking up where it left off yesterday, the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) voted 5-2 today to recommend that infants younger than 8 months who are not protected by maternal vaccination get one dose of a monoclonal as they head into their first respiratory syncytial virus (RSV) season. That was followed with a unanimous vote to add those monoclonals, including Merck & Co. Inc.’s newly approved long-acting Enflonsia (clesrovimab), to the Vaccines for Children program, which ensures coverage of the vaccines. Despite all the public scrutiny of the meeting in the wake of a complete shakeup of the ACIP two weeks earlier, the committee’s discussions had been fairly uneventful until today’s presentation, by the Children’s Defense Fund, recommending the removal of thimerosal as a preservative in multidose vials of influenza vaccines. “I’m not quite sure how to respond to this presentation,” said ACIP member Cody Meissner. “This is an old issue that has been addressed in the past. . . . Of all the issues I think that ACIP needs to focus on, this is not a big issue.” The committee is scheduled to vote on removing thimerosal before adjourning today.

Altimmune’s phase IIb in MASH hits and misses, stock halves

Top-line results from Altimmune Inc.’s phase IIb Impact study of pemvidutide in treating metabolic dysfunction-associated steatohepatitis showed the peptide-based GLP-1/glucagon dual receptor agonist hit one primary endpoint while not hitting statistical significance in another. That dampened enthusiasm for company’s stock (NASDAQ:ALT) at midday, with shares down 54.6% at $3.50 each. In hitting a primary endpoint, the percentage of patients achieving MASH resolution without worsened fibrosis at 24 weeks were 59.1% at the 1.2 mg dose level and 52.1% for those receiving 1.8 mg doses vs. 19.1% for those in both dosage groups getting a placebo (p< 0.0001). In the other primary endpoint, no significant difference was found in fibrosis improvement without worsening of MASH in 31.8% and 34.5% of participants receiving pemvidutide 1.2 mg and 1.8 mg doses vs. 25.9% of those receiving placebo.

Edgewise offers FDA update on sevasemten in muscular dystrophies

Shares of Edgewise Therapeutics Inc. (NASDAQ:EWTX) dipped $1.31, or 9%, to trade at $13.02 on news regarding sevasemten in Becker (BMD) and Duchenne muscular dystrophies (DMD). Edgewise learned from the U.S. FDA that phase II Canyon data with the drug, a small molecule designed to prevent contraction-induced muscle damage, are not sufficient for an accelerated approval in BMD, but the agency provided a “clear” path for the future, Edgewise said. Work continues in DMD as well.

Innovent raises HKD$4.3B to advance R&D pipeline, global expansion

Innovent Biologics Inc. announced a HKD$4.3 billion (US$547 million) placement on the Hong Kong Stock Exchange to advance its R&D projects and to fund its global expansion. The funds raised will allow the company to expand its global pipeline and provide flexibility to unlock potential assets, Innovent said, adding that 90% of the funds would go directly to its global R&D programs. News of the capital raise comes a day after Innovent presented data at the American Diabetes Association meeting in San Francisco from its phase III Dreams-1 study of its dual glucagon/glucagon-like peptide-1 receptor agonist mazdutide in Chinese adults with type 2 diabetes.

Newco news: Abvance secures seed funding to limit glucose lows

Abvance Therapeutics Inc. secured an undisclosed amount of capital in a seed round led by Zubi Capital to support development of insulin and glucagon combination products. The company was spun out of work from Alan Cherrington and colleagues at Vanderbilt University that showed co-administration of the two drugs, which have opposite effects on glucose levels when dosed separately, can keep glucose levels in check after a meal and also moderate the low glucose levels that follow, potentially reducing the risk of hypoglycemia.

Also in the news

Abvance, Alvotech, Amicus, Aprea, Arbor, Arbutus, Ascidian, Assembly, Aytu, Beone, Biogen, Bio-Thera, Blue Earth, Calcimedica, Cidara, Crossject, Engene, Ernexa, Essential, Evaxion, Formycon, Forte, Grace, Hemab, Hoth, Immedica, Indivior, Inmed, Innovent, Ionis, JCR, Kashiv, Klinge, Medipal, Novartis, Ovid, Phio, Precision, PTC, Q32, Qbiotics, Qilu, Regulus, Sanofi, Silo, Soleno, Steincares, Syndax, Vistagen, Zyversa