Pfizer Inc. is taking over Metsera Inc., paying $47.50 each for all of Metsera’s outstanding shares. The obesity-centered deal has an enterprise value of $4.9 billion, but included in the terms is a non-transferable contingent value right that pushes the value even higher. Metsera stock (NASDAQ:MTSR) was trading at $53.99, up $20.67, or 62%.

MBX stock nearly doubles on phase II data

MBX Biosciences Inc. posted positive top-line phase II study data in treating chronic hypoparathyroidism, positioning itself to take on a U.S. FDA-approved therapy for the rare endocrine disease. MBX’s Avail study of canvuparatide hit its primary endpoint in treating adults, demonstrating statistical significance at week 12 and positive 6-month results from the open-label extension study. MBX said it is poised to begin a phase III study of once-weekly canvuparatide next year. The company’s stock (NASDAQ:MBX) was up 99% at midday, with shares going for $19.88 each. Ascendis Pharma A/S’ hormone replacement therapy Yorvipath (palopegteriparatide) is the first and only treatment for adults with the disease.

US FDA clears ‘one-minute’ Keytruda SC injection for solid tumors

The U.S. FDA approved Merck & Co. Inc.’s Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection on Sept. 19, making it the first and only subcutaneously (SC) administered immune checkpoint inhibitor that can be administered in about a minute. Keytruda, first cleared in intravenous (IV) form in 2014, is Rahway, N.J.-based Merck’s blockbuster anti-PD-1 cancer therapy that generated $29.5 billion in sales in 2024. Compared to the 30-minute infusion time required for the original IV formulation, Keytruda Qlex can be administered in either a one-minute SC injection every three weeks or a two-minute SC injection every six weeks.

Ionis hits goals with zilganersen in first Alexander disease trial

As the first – and so far only – drug to enter clinical testing for the rare neurogenetic disorder Alexander disease, there were some unknowns heading into the readout of the pivotal study testing Ionis Pharmaceuticals Inc.’s zilganersen in children and adults. But the top-line data yielded a clear win for the antisense oligonucleotide candidate, which demonstrated a disease-modifying impact, including statistical significance on the primary endpoint of gait speed as assessed by the 10-Meter Walk Test vs. control at week 61. Ionis said an NDA submission is planned for the first quarter of 2026.

Genentech $569M deal lifts Starpharma stock 73%

Starpharma Holdings Ltd.’s stock shot up 73% on the news that it is outlicensing its dendrimer enhanced product (DEP) drug delivery technology to Roche Holding AG subsidiary Genentech Inc. in a deal worth more than $569 million. Under terms of the deal, Starpharma will receive an up-front payment of $5.5 million and is eligible for development, commercial and sales-based milestones of up to $564 million, plus royalties on sales. In exchange, Starpharma will employ its DEP platform technology to develop dendrimer-drug conjugates that incorporate Genentech drugs for certain undisclosed oncology targets.

Stealth wins US FDA approval of first Barth syndrome drug

After a long regulatory road that included a complete response letter in May, Stealth Biotherapeutics Inc. finally got its Barth syndrome drug across the finish line, with the U.S. FDA granting accelerated approval to Forzinity (elamipretide HCl) to improve muscle strength in the roughly 150 Americans that have the ultra-rare pediatric mitochondrial cardioskeletal disease. The approval is for both adults and children weighing at least 30 kg (66 lbs.), while the company works to provide expanded access for those under the approved weight limit. It is privately held Stealth’s first approved drug.

UK college offers guidance, clarity for psychedelic research

The Royal College of Psychiatrists in the U.K. has published its first-ever guidance to support research into psychedelic drugs as therapies for conditions including treatment-resistant depression, substance abuse disorders and posttraumatic stress, saying that in a fast-moving field there is a risk of jumping ahead of the evidence. “We are only just starting to see large, rigorous clinical trials being carried out and additional high-quality research is needed,” said Oliver Howes, chair of the psychopharmacology committee of the Royal College and co-author of the report. “We hope to provide some much needed clarity on the known benefits and risks associated with the medical use of these substances – and the gaps that need to be addressed in future research,” Howes said.

Also in the news

Achieve, Alera, Alexion, Alvotech, ARS, Astrazeneca, Axcelead, Carisma, Celltrion, Clearmind Medicine, Enveric, Esperion, Evommune, Faron, Formation, Henlius, Iaso, Idorsia, Incyte, Innovent, Ipsen, Jasper, Johnson & Johnson, Kalvista, Kuros, Merck, NS, Nuvation, Organon, Orthocellix, Otsuka, Polyrizon, Reviva, Roche, Skye, Sobi, Syndax, Verrica, Xforest