Pemvidutide

The biggest news of the last week was easily the expanded approval of Sarepta’s Duchenne muscular dystrophy gene therapy, Elevidys. CBER Director Peter Marks again overruled FDA staff members and review teams to grant the therapy full approval and a broad label expansion despite its missing the primary endpoint in a Phase III confirmatory study. This approval has us thinking about other big FDA decisions to watch this year, first and foremost, Eli Lilly’s anti-amyloid antibody donanemab. If given the green light, donanemab will be a direct competitor to Biogen and Eisai’s Leqembi, also a disease-modifying anti-amyloid antibody. Beyond that, Verona Pharma is expecting a decision Wednesday on ensifentrine, which could be the first novel mechanism for chronic obstructive pulmonary disease in over a decade, and in August, the FDA is set to decide on Lykos’ MDMA-assisted PTSD therapy, which an advisory committee voted against earlier this month. Then this week, Alnylam scored big with a Phase III win in transthyretin amyloidosis with cardiomyopathy (ATTR-CM). In what Alnylam CMO Pushkal Garg called “overwhelmingly positive data,” Amuvttra significantly lowered the risk of death and recurrent cardiovascular events in patients with ATTR-CM. Meanwhile, biopharma conference season continues with the American Diabetes Association’s annual conference held this past weekend. Eli Lilly’s blockbuster drug Zepbound “significantly improved” disease severity in patients with obesity and sleep apnea, and Altimmune racked up a Phase II victory for pemvidutide, which was effective at helping patients lose weight while retaining lean muscle. Greg Slabodkin is the news editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.  Heather McKenzie is a senior editor at BioSpace. You can reach her at heather.mckenzie@biospace.com. Follow her on LinkedIn. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn. > Listen on Spotify > Listen on Apple Podcasts > Listen on Amazon Music > Listen on iHeart

Today, a brief rundown of news from Altimmune, Jiangsu Hengrui,Eli Lilly and others that you might have missed from over the weekend, when the American Diabetes Association held its annual meeting.After an early setback for Altimmunes obesity shot pemvidutide, the biotechnology company appears to be back on track with additional data. The dual-acting drug, which stimulates the hormones GLP-1 and glucagon, helped participants in the Momentum trial lose an average of 16% of their body weight at the highest dose given, according to full trial results presented at ADA. That weight loss at 48 weeks is in line with what Novo Nordisks Wegovy produced at 68 weeks. The company also pointed to pemvidutides preservation of lean body mass, which could help differentiate it if approved. Trial investigators described the shot as well-tolerated, although early data cuts had revealed that nearly one-quarter of patients dropped out due to side effects. Jonathan GardnerAn obesity drug Jiangsu Hengrui Pharmaceuticalsrecently licensed to a new startup company showed weight loss in a Phase 2 trialthat appears very competitive to other drugs in development, wrote Cantor Fitzgerald analyst Prakhar Agrawal in a Sunday note to clients. Treatment with the dual agonist drug, code-named HRS9531,led to weight loss at 24 weeks of up to 17% among participants given the highest dose. The startup now developing it is backed by $400 million raised from investors Bain Capital Life Sciences, RTW Investments, Atlas Venture and Lyra Capital. Ned PagliaruloBack in April, Eli Lillyreleased summary data on studies of weight loss medicine Zepbound in people with obesity and sleep apnea. A fuller presentation of results at the ADA meeting, also published in The New England Journal of Medicine Friday, revealed data on secondary measures. Among them was a finding that 42% of trial volunteers taking Zepbound alone and half of those taking it while using a breathing machine saw resolution of their condition when measured by sleep apnea events and daytime sleepiness scores. Lilly also said it has submitted the data to the Food and Drug Administration. An approval could allow for Medicare coverage of Zepbound for people with obesity and sleep apnea. Jonathan GardnerThree people with Type 1 diabetes achieved independence from insulin one year following treatment with a stem cell-derived cell therapy being developed by Vertex Pharmaceuticals, according to data presented at the ADA meetingon Friday. Researchers also reported the elimination of severe hypoglycemic events in these three individuals, who all had HbA1C levels below the recommended 7%. Nine other study participants with shorter follow-up also appear to be benefiting from treatment, showing blood sugar control and endogenous insulin secretion. Ned PagliaruloAmylyx Pharmaceuticals is buying an experimental, blood sugar-regulating medicine from Eiger Biopharmaceuticals, which is currently selling assets as part of its Chapter 11 bankruptcy proceedings. Eiger's medicine acts on a protein tied to GLP-1 the hormone at the center of a revolution in obesity and diabetes care. On Friday, Amylyx agreed to acquire all the rights to the drug for $35 million, plus some other, smaller costs. Earlier this year, the company pulled its closely watched treatment for ALS from the market, and has been trying to recover. Jacob Bell '