Eli Lilly and Co., through its Loxo@Lilly oncology unit, secured its second accelerated approval for non-covalent Bruton’s tyrosine kinase (BTK) inhibitor Jaypirca (pirtobrutinib), this time to treat adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. The U.S. FDA approval of 100-mg and 50-mg tablets is for patients who have received two prior lines of therapy, including another BTK inhibitor and a BCL-2 inhibitor. It is based on phase I/II data from a subset of 108 patients participating in the open-label, single-arm, multi-cohort Bruin trial.
Redhill Biopharma Ltd.’s stock (NASDAQ:RDHL) has soared in recent days following news that the U.S. FDA granted five years of market exclusivity for Talicia, a first-line therapy for eradication of Helicobacter pylori infection, which affects about 35% of the U.S. adult population.
The U.S. FDA put out a safety warning Nov. 28 that antiseizure drugs levetiracetam and clobazam can cause a rare but serious hypersensitivity drug reaction that may start as a rash but can progress to injure internal organs. In addition, U.K. health care providers are being told to get a plan in place now to implement the first phase of the Medicines and Healthcare products Regulatory Agency’s new regulatory measures to reduce the risks of valproate, a treatment for epilepsy and bipolar disorder.
In a deal that could bring Avidity Biosciences Inc. $2.3 billion if all milestones are met, Bristol Myers Squibb Co. gained global rights to Avidity’s antibody oligonucleotide conjugates platform to advance up to five genetic cardiovascular targets. Avidity’s technology, which combines the specificity of monoclonal antibodies with the precision of oligonucleotide therapies, aims to address the root cause of diseases that are untreatable with current RNA therapeutics. Its lead internal programs are based on the targeted delivery of RNA into muscle.
Two-year-old Ensem Therapeutics Inc. landed a deal potentially worth $1.33 billion, if all milestones are met, with Beigene Ltd. to advance its lead IND-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor. Beigene, which has a presence in Basel, Switzerland, Beijing, and Cambridge, Mass., plans to fold the inhibitor into its breast cancer efforts, which includes its internally discovered phase I CDK4 inhibitor. Rights to the Ensem product are exclusive and global.
More than a week earlier than its PDUFA date, Bristol Myers Squibb Co. received U.S. FDA approval of its next-generation ROS1 tyrosine kinase inhibitor repotrectinib for adults with ROS1-positive locally advanced or metastatic non-small-cell lung cancer.
A year after Alkermes plc announced it would divide its oncology and neuroscience efforts into two separate businesses, the Dublin-based company spun out Mural Oncology plc with $275 million in funding and the lead solid tumor candidate nemvaleukin alfa. Shares of Mural (NASDAQ:MURA) will begin trading Nov. 16. “We’re very excited,” Mural’s CEO Caroline Loew told BioWorld. “We’ve got two major clinical datapoints in the next 18 months.”
In a global deal worth up to $770.5 million in up-front and milestone payments, Stevenage, U.K.-based Autifony Therapeutics Ltd. signed with Dublin-based Jazz Pharmaceuticals plc for two ion channel-targeting programs aimed at finding and developing new drugs for neurological disorders. Autifony will take selected candidates through preclinical development, while Jazz will cover clinical development, manufacturing, regulatory activities and commercialization.
In one of the larger biopharma IPOs in 2023, Cargo Therapeutics Inc. pulled in $281.3 million on Nov. 10, selling 18.75 million shares at $15 each, the low end of its price range. The market debut comes just eight months after the San Mateo, Calif.-based company raised $200 million in an oversubscribed series A round.
A year-and-a-half after Eli Lilly and Co.’s Mounjaro (tirzepatide) gained U.S. FDA approval for adults with type 2 diabetes, the GLP-1 and GIP dual agonist was cleared for chronic weight management in adults who are obese or overweight and who also have one related condition.
