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Despite getting a renewed green light from the FDA, Homology Medicines is putting the brakes on its phase 2 trial of a gene therapy for phenylketonuria (PKU) and shifting resources to a potentially more profitable path. Read More
Blueprint Medicines has enough pivotal data in hand to seek a new indication for Ayvakit (avapritinib) as a treatment for nonadvanced systemic mastocytosis and plans to file a supplemental new drug application later this year. Read More
With the announcement of a failed phase 3 breast cancer trial hot on the heels of a negative phase 2, Sanofi has decided to pull the plug on amcenestrant, an investigational oral selective estrogen receptor degrader (SERD). Read More
Merck and Orna Therapeutics announced that they are joining in a new partnership to advance development of the Cambridge, Mass., startup company’s RNA and lipid nanoparticle delivery platform to treat cancer, genetic disorders and infectious diseases. Read More
Novartis has a third strike-out in a series of trials pitting its anti-inflammatory drug Ilaris (canakinumab) against nonmetastatic non-small cell lung cancer (NSCLC). Read More
Partners Daiichi Sankyo and AstraZeneca said a phase 3 trial of Enhertu (trastuzumab deruxtecan) to treat HER2-positive metastatic breast cancer met its primary and secondary endpoints, with the expected blockbuster drug showing a significant improvement in progression-free survival and overall survival. Read More
Brainstorm Cell Therapeutics is counting on a corrected subanalysis of a phase 3 trial to change the FDA’s mind about NurOwn, an unusual investigational treatment for amyotrophic lateral sclerosis (ALS). Read More
BeiGene’s anti-PD-1 monoclonal antibody tislelizumab has racked up more positive phase 3 numbers, proving itself just as good as sorafenib in extending the lives of patients with unresectable hepatocellular carcinoma. Read More
Abecma (idecabtagene vicleucel), a first-in-class CAR-T cell treatment codeveloped by Bristol Myers Squibb and 2seventybio, significantly improved progression-free survival relative to standard therapy in patients with relapsed multiple myeloma, the companies reported. Read More
Nebulized ensifentrine, an investigational inhaled anti-inflammatory, reduced exacerbations of chronic obstructive pulmonary disease (COPD) by 42 percent over 24 weeks — a significant benefit that could propel Verona Pharma to submit regulatory documents for a first-in-class treatment. Read More
Karuna Therapeutics’ investigational schizophrenia drug KarXT (xanomeline-trospium) reduced symptoms of the disorder in a late-stage study, with clinically meaningful changes seen within two weeks of beginning treatment. Read More