Mirati Therapeutics Inc.’s cancer treatment Krazati (adagrasib) is having a tough time outside the U.S. The EMA’s Committee for Medicinal Products for Human Use (CHMP) came out with a negative opinion on an MAA for treating KRAS G12C-mutated advanced non-small-cell lung cancer (NSCLC). The ruling came with a flurry of positive CHMP opinions for companies, including Abbvie Inc., Beigene Ltd. and the Janssen Pharmaceutical Cos., plus a mixed result for Ipsen SA after a stumble earlier this week.
Dismissed as undruggable in the early 2000s, Src homology 2 domains are now viable and at the heart of Recludix Pharma Inc.’s new deal with Sanofi SA’s U.S. unit. The two will collaborate on developing and commercializing treatments for immunological and inflammatory diseases. In the near term, Recludix will get $125 million, but long term it could add up to $1.2 billion in milestones. Recludix could also bring in up to double-digit royalties on possible future product sales.
Strong and complete phase III results for Eli Lilly and Co.’s donanemab for treating early Alzheimer's disease (AD) will no doubt inspire more comparisons with recently approved Leqembi (lecanemab). The newly released data for donanemab show it significantly slowed cognitive and functional decline for those with amyloid-positive early symptomatic AD, which lowered the disease-progression risk.
Novartis AG just added muscle to its siRNA development effort by buying Dtx Pharma Inc. in an M&A deal that could total $1 billion. Novartis is getting a preclinical asset, DTx-1252, which just received the U.S. FDA’s orphan drug designation on June 8. Dtx is developing the siRNA candidate for treating the neuromuscular disease Charcot-Marie-Tooth disease type 1A (CMT1A). Basel, Switzerland-based Novartis will pay Dtx $500 million up front and make payments of up to $500 million in milestones completions.
To bolster its obesity treatment pipeline, Eli Lilly and Co. is buying Versanis Bio Inc. in a massive cash deal that could reach $1.92 billion. The total amount of the deal includes an up-front payment and development and sales milestone payments. Privately held Versanis, of Boston, brings to Lilly its lead asset bimagrumab, a monoclonal antibody that’s enjoying a resurgence since a failure in treating sarcopenia.
First Wave Biopharma Inc. is taking apart the top-line data from its phase II study of adrulipase for treating nutrition deficiencies in cystic fibrosis patients and seems unsure exactly what it found. The company said that while the initial data found the enhanced enteric microgranule delivery formulation of adrulipase was safe, well-tolerated and was an improvement over other formulations, the preliminary data also indicate that “it is likely the primary efficacy endpoint was not achieved.”
The counterintuitive side of preventing a health crisis prompted by antimicrobial resistance showed itself at a July 11 U.S. Senate hearing, with witnesses saying that antibiotics exist to treat current infections but they often don’t have staying power in the market.
Seven deaths and five respiratory-related, treatment-emergent adverse events in a group of 40 aged and very unwell cancer patients rang alarm bells for ADC Therapeutics SA. The company has voluntarily paused enrollment in its phase II Lotis-9 study of Zynlonta (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) for treating previously untreated diffuse large B-cell lymphoma in those who are considered frail or unfit.
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.
