Privately held F-star Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. have completed their third license agreement, one that could bring F-star about $1 billion. The new collaboration is focused on R&D against undisclosed cancer targets.
The U.S. FDA has removed the partial clinical hold it placed in April 2022, prompted by a patient’s death, on Curis Inc.’s phase I/IIa study of emavusertib in treating leukemia. The company also said it just raised $15 million to keep everything going.
Privately held F-star Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. have completed their third license agreement, one that could bring F-star about $1 billion. The new collaboration is focused on R&D against undisclosed cancer targets.
Cyteir Therapeutics Inc. is leading a pack of companies that have taken a hard look at their future and don’t care for what they see. According to BioWorld data, at least 100 biopharma companies have announced restructurings and layoffs this year, resulting in more than 8,400 jobs lost. Other companies either packing it in, restructuring from within or considering new paths include Aurinia Pharmaceuticals Inc., Bellerophon Therapeutics Inc., Calithera Biosciences Inc. and Spexis AG.
Two years after a U.S. FDA advisory committee agreed that Celltrans Inc.’s pancreatic islet cellular therapy had a favorable risk-benefit profile, the agency has finally approved Lantidra (donislecel) for treating adults with type 1 diabetes.
The dose-escalation portion of Black Diamond Therapeutics Inc.’s phase I study of BDTX-1535 for treating non-small-cell lung cancer (NSCLC) produced strong data that moved the market in a big way.
A tough spring has settled into a cruel summer for Fibrogen Inc. as the company has stumbled for the third time in two months. The newest problem is top-line results showing the phase III Zephyrus-1 study of pamrevlumab, a monoclonal antibody, missed its primary endpoint for treating idiopathic pulmonary fibrosis.
Sarepta Therapeutics Inc. has set the wholesale acquisition cost of the first gene transfer therapy for ambulatory patients with Duchenne muscular dystrophy at $3.2 million, making it one of the most expensive gene therapies. The company said the gross-to-net price for Elevidys (delandistrogene moxeparvovec) will be in the mid-20% range, which, suggests Mizuho Group analyst Uy Ear, would put the price at about $2.4 million.
In its newly issued complete response letter (CRL) to Aldeyra Therapeutics Inc., the U.S. FDA said there’s just not enough evidence of efficacy right now to approve ADX-2191, an injectable vitreous-compatible formulation of methotrexate to treat primary vitreoretinal lymphoma (PVRL).
What could be the first newly approved antifungal in nearly 20 years based on a novel mechanism hit a bump as F2G Ltd. has received a complete response letter from the U.S. FDA.
