The ability of obesity medications to impact co-morbidities, reducing the symptoms and costs associated with down-the-road disease, has attracted significant attention throughout the biopharma industry.
The multibillion-dollar market potential for obesity medications that analysts expect in the next decade signifies change is afoot for a patient population historically plagued with unsafe options and generally dismissed by investors and insurers. While glucagon-like peptide 1 receptor agonists have paved the way – offering hope-filled patients the first significant non-surgical weight loss benefit upwards of 15% – only a small portion of the obesity population and certain overweight patients are treated with medication, and even a smaller percentage receive insurance reimbursement.
Three years after Alnylam Pharmaceuticals Inc. gained U.S. FDA approval of the first treatment for rare disease primary hyperoxaluria type 1 (PH1), Novo Nordisk A/S solidified its own marketing clearance for RNAi therapy Rivfloza (nedosiran).
The multibillion-dollar market potential for obesity medications that analysts expect in the next decade signifies change is afoot for a patient population historically plagued with unsafe options and generally dismissed by investors and insurers. While glucagon-like peptide 1 receptor agonists have paved the way – offering hope-filled patients the first significant non-surgical weight loss benefit upwards of 15% – only a small portion of the obesity population and certain overweight patients are treated with medication, and even a smaller percentage receive insurance reimbursement.
Structure Therapeutics Inc.’s stock climbed 34.6% following a readout of what analysts call “competitive” and “exceptional” phase Ib data at 28 days of oral small-molecule glucagon-like peptide 1 (GLP-1) receptor agonist GSBR-1290 in healthy overweight or obese individuals. Shares (NASDAQ:GPCR) rose $12.95 to close Sept. 29 at $50.42. At the same time as the data readout, the San Francisco-based company agreed to a $300 million private placement with several large health care institutional and mutual fund investors, extending Structure’s runway through the end of 2026.
It has been a long time coming, but Fabre-Kramer Pharmaceuticals Inc. finally received U.S. FDA approval for its major depressive disorder candidate, Exxua (gepirone hydrochloride extended-release tablets). The approval comes three months after the June 23 PDUFA date (as a result of amendments filed by the company in April and May), but 24 years after the original NDA was filed in 1999.
Three months after Intercept Pharmaceuticals Inc. received its second complete response letter for obeticholic acid to treat fibrosis due to nonalcoholic steatohepatitis, causing a mass layoff and the decision to drop development for the indication, Bologna, Italy-based Alfasigma SpA agreed to acquire the company for $19 per share in cash, or about $793.8 million.
Shares of ARS Pharmaceuticals Inc. (NASDAQ:SPRY) plummeted 55.8% Sept. 20 on word that the U.S. FDA issued a complete response letter (CRL) for Neffy, despite receiving a recommendation for approval in May from the agency’s advisory committee (adcom) and following a three-month delay in action.
With one program in the clinic and another not far behind, Generate Biomedicines Inc. raised $273 million in a series C financing to advance its generative biology platform. It is one of the largest venture capital (VC) rounds for a U.S. company in 2023. Funds will go toward advancing the Somerville, Mass.-based company’s 17 pipeline programs, including the filing of multiple IND applications in 2024.
Shares of Corvus Pharmaceuticals Inc. (NASDAQ:CRVS) sank 21.5% on Sept. 7, even though the company confirmed a phase III plan with the U.S. FDA for its ITK inhibitor, soquelitinib, to treat relapsed peripheral T-cell lymphoma (PTCL).
