Ipsen SA picked up U.S. FDA accelerated approval for its Genfit SA-licensed elafibranor, making it the first new drug in eight years for treating primary biliary cholangitis, though a potential competitor lurks just around the corner.
Moderna Inc. is gearing up to meet with regulators on the next steps for mRNA-1083, the first combination vaccine for influenza and COVID-19 to succeed in phase III testing, not only demonstrating noninferiority to individually licensed competitor vaccines but also eliciting statistically significant higher immune responses.
Geron Corp., a company founded more than three decades ago, is finally celebrating its first U.S. FDA approval. The agency cleared imetelstat, branded Rytelo, for use in transfusion-dependent anemia in adults with low- to intermediate-risk myelodysplastic syndromes, specifically those requiring four or more red blood cell units over eight weeks who have failed or no longer respond to erythropoiesis-stimulating agents (ESA) or who are not eligible for ESA treatment.
Amgen Inc. is looking to position inebilizumab as the first therapeutic specifically for treating immunoglobulin G4-related disease (IgG4-RD), a rare, immune-mediated condition that can affect multiple organs, after yielding what Leerink Partners analyst David Risinger called “exceptional” phase III results.
Shares of Structure Therapeutics Inc. (NASDAQ:GPCR) were trading up more than 54%, gaining $18.54 to close June 3 at $52.74, on the back of data for GSBR-1290, an oral, GLP-1 receptor agonist it hopes to position in the highly competitive obesity market. The latest readout sees the company regaining ground lost late in 2023 when earlier phase IIa data prompted unflattering comparisons to more advanced oral GLP-1 candidates.
Ultragenyx Pharmaceutical Inc. anticipates a meeting later this year with the U.S. FDA to discuss a BLA filing for gene therapy DTX-401 as the first potential medical treatment for glycogen storage disease type 1a (GSD1a) after the phase III study hit its primary endpoint and two key secondary endpoints.
Merck & Co. Inc. is shelling out $1.3 billion in cash up front to acquire privately held Eyebiotech Ltd., gaining rights to the latter’s pivotal trial-ready diabetic macular edema drug and a pipeline of earlier-stage candidates targeting vision loss. An additional $1.7 billion could follow in development, regulatory and commercial milestones, raising the deal total to $3 billion.
Gilgamesh Pharmaceuticals Inc. is getting $65 million up front in an early stage deal with Abbvie Inc. to discover neuroplastogens targeting psychiatric disorders, with the chance to receive up to $1.95 billion in options fees and milestones, plus tiered royalties in the mid-single to low-double digits from any products emerging from the collaboration.
As Poseida Therapeutics Inc. anticipates reporting further data this year from allogeneic CAR T-cell therapy P-MUC1C-ALLO1, for which Astellas Pharma Inc. has nabbed first negotiation rights, the two companies inked a second deal aimed at combining their respective cell therapy platforms in an early stage collaboration targeting solid tumors.
Less than a week ago, executives at Lyra Therapeutics Inc. were looking ahead to “imminent” data from its first phase III study in chronic rhinosinusitis (CRS), testing drug-device candidate LYR-210, a drug-device candidate largely expected to fill a much-needed gap in CRS treatment. On Monday, May 6, they were announcing plans to preserve cash in the wake of the failed Enlighten 1 study, which raised doubts as to the feasibility of the company’s CRS programs, which also include the similarly designed candidate LYR-220.
