The U.S. FDA approved Corcept Therapeutics Inc.’s oral, selective glucocorticoid receptor antagonist, Lifyorli (relacorilant), nearly four months ahead of schedule for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. A short time after the agency approved Lifyorli, it cleared Denali Therapeutics Inc.’s Avlayah (tividenofusp alfa) under the accelerated approval pathway for mucopolysaccharidosis II, also called Hunter syndrome, ahead of the April 5 PDUFA date.
For a company founded only four years ago, Quotient Therapeutics Inc. entered its third major deal, this time with Merck & Co. Inc. to find novel drug targets for inflammatory bowel disease (IBD) using its somatic genomics platform technology.
T-cell engager company Kali Therapeutics Inc. licensed its lead product, CD19/BCMA/CD3 trispecific antibody KT-501, to Sanofi SA in a global deal that could be worth more than $1.2 billion. The San Mateo, Calif.-based biotech first emerged in 2024 and moved KT-501 into a phase Ia trial last week to treat adults with rheumatoid arthritis.
With the U.S. FDA’s approval of GSK plc’s ileal bile acid transporter (IBAT) inhibitor, Lynavoy (linerixibat), patients with primary biliary cholangitis no longer need off-label treatments for a debilitating internal itch symptom called cholestatic pruritus.
As AI continues to storm into global life, biopharma companies are figuring out ways to incorporate it into their operations, all with the goal of bringing better therapies to patients faster. At Pharma USA, a Reuters Events meeting in Philadelphia March 16-17, numerous AI companies presented their offerings to attendees, driving interest and partnerships.
Rare disease drug development companies battle with economic challenges and small patient populations, but new technology alongside a human connection are helping researchers and marketers identify patients, educate physicians and build networks. At Pharma USA, a Reuters Events meeting in Philadelphia March 16-17, executives from Astrazeneca plc and UCB SA discussed their successes with rare disease launches, presenting their playbooks for building trust and driving adoption among patients.
The disjointed health care system that patients face today blocks a significant proportion of them from accessing life-changing, innovative drugs, prompting many in the biopharma industry to explore more direct-to-consumer (DTC) pathways. During Pharma USA, a Reuters Events meeting held in Philadelphia March 16-17, executives from Eli Lilly and Co., Roche Holding AG’s Genentech unit, Amgen Inc. and consulting firm ZS Associates, among others, offered glimpses into a future where R&D is no longer enough.
Vertex Pharmaceuticals Inc. is on track to complete a BLA by the end of March seeking potential U.S. accelerated approval for povetacicept, its dual inhibitor of the BAFF and APRIL cytokines, to treat immunoglobulin A nephropathy (IgAN), following a successful phase III Rainier trial.
The failure of the Persevera study, sponsored by Roche Holding AG’s Genentech unit, disrupts advancement of giredestrant in combination with palbociclib (Ibrance, Pfizer Inc.) as a first-line treatment for ER-positive, HER2-negative, locally advanced or metastatic breast cancer. For competitor Olema Pharmaceuticals Inc., which has palazestrant for the same indication, missing the phase III Persevera primary endpoint of progression-free survival translated to a 25.8% stock slide (NASDAQ:OLMA) to a $16 close on March 9.
Pricing shares at $20 each, below the intended price range, insulin delivery company Minimed Group Inc. debuted with an IPO on Nasdaq March 6, raising $560 million. The company offered a total of 28 million shares, which would have brought the Northridge, Calif.-based company $742 million in gross proceeds if the IPO had priced at the midpoint of the $25-to-$28 price range disclosed in February.
