An effort two decades in the making, Vertex Pharmaceuticals Inc.’s suzetrigine gained U.S. FDA approval as the first drug targeting the NaV1.8 pain signal. Branded Journavx, the oral small molecule is cleared for use as a non-opioid option for treating moderate to severe acute pain. The announcement, which Vertex has anticipated will open up another multibillion-dollar franchise alongside its cystic fibrosis portfolio, came after market close on its Jan. 30 PDUFA date. The suzetrigine NDA submission was assessed under priority review. It previously gained fast track and breakthrough therapy designations.

Symbravo combo from Axsome wins FDA nod in migraine

Axsome Therapeutics Inc. won U.S. FDA approval of Symbravo to treat migraine with or without aura in adults. Symbravo combines meloxicam, a non-steroidal anti-inflammatory drug from Baudax Bio Inc. first approved for pain as Anjeso by the FDA in 2020, and rizatriptan, a serotonin (5HT) 1B/1D receptor agonist from Intelgenx Corp. that, branded Rizafilm, gained its initial clearance in 2023 for acute treatment of migraine. Shares of Axsome (NASDAQ:AXSM) were trading at $108.35, down 50 cents.

Leqembi review stalls again at European regulator

EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but asked it to examine new safety data that has recently become available. In addition to asking if the EMA’s opinion on Leqembi needs to be “updated,” the commission asked the Committee for Medicinal Products for Human Use to look at whether the wording of the risk minimization measures is “clear enough to ensure correct implementation.” Leqembi’s joint owners, Biogen Inc. and Eisai Co. Ltd. said the safety profile reported in clinical practice in the U.S., Japan and other countries after launch is consistent with that in the approved labels, and no new safety signals are identified. 

Novo Nordisk to appeals court: Hurry up, please, on IRA challenge

Now that Novo Nordisk A/S’ blockbuster semaglutide franchise has been selected as one drug for the next round of the CMS price negotiation, the Bagsværd, Denmark-based company is asking a U.S. appellate court to expedite its consideration of Novo’s challenge to the negotiations and the way CMS is implementing the program.

Metsera and Maze IPOs look to bring $415M to Nasdaq

A week after the first IPO of the year was priced, Metsera Inc. and Maze Therapeutics Inc. have begun trading on Nasdaq. Metsera entered the market at an upsized $18 a share in hopes of raising $275 million. The company said it plans to use the net proceeds to continue developing its obesity treatments. Maze plans to further develop its small-molecule kidney disease treatments with a $140 million offering at $16 per share. At midday, both stocks (NASDAQ:MAZE and NASDAQ:MTSR) had barely moved up or down from their opening prices. The IPOs follow Jan. 24’s pricing by Ascentage Pharma Group Corp. Ltd., the year’s first in the U.S.

2024 nonprofit deals plummet from pandemic peak

Biopharma nonprofit deals remained low in 2024, compared to the pandemic and pre-pandemic years, while grants saw a slight decline from the previous year. In 2024, biopharma grants totaled $5.17 billion, down 15% from $6.11 billion in 2023 but still 41% higher than $3.66 billion in 2022. The industry recorded 529 grants, matching the 2023 total. The Biomedical Advanced Research and Development Authority led biopharma grant funding over the year with 24 awards, followed by the National Institute of Allergy and Infectious Diseases with 19.

Also in the news

Agenus, Allarity, Alterity, Amgen, Cargo, Cognition, Comanche, Creative Medical Technology, Elicio, Ethris, Evaxion, Genfit, Immunome, Ironwood, Karolinska, Lundbeck, March, Merck, Outlook, Pepgen, Revance, Silexion, Tectonic, Teoxane, Tubulis, Uniqure, Ypsilon