Cancer
The nod brings Bayer face-to-face in the market with Boehringer Ingelheim and AstraZeneca, each of which has its own HER2 blocker for non-small cell lung cancer.
With positive data from the Phase III HERIZON-GEA-01 study, Zymeworks and Jazz Pharmaceuticals will file an approval application for Ziihera in the first half of 2026 for the treatment of gastroesophageal adenocarcinoma.
Halda Therapeutics is developing oral assets for prostate and lung cancer. The deal comes after Johnson & Johnson set an ambitious goal for its oncology sales by 2030.
Artios Pharma is working on a pipeline of oncology assets, led by alnodesertib, currently being tested for second-line pancreatic cancer and third-line colorectal cancer.
Aside from announcing layoffs, Sensei has decided to terminate its R&D work. The biotech has $25 million on hand, and continues to evaluate its strategic alternatives.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
Cogent Biosciences expects to file a new drug application for bezuclastinib in gastrointestinal stromal tumors early next year after what Leerink said was “the first positive trial in this disease in over a decade.”
Darzalex Faspro’s approval for smoldering multiple myeloma could allow for earlier intervention and reduce the risk of progression to active disease.
The discontinued CAR T therapy bbT369 came to Regeneron when the pharma bought all of 2seventy bio’s pipeline assets for $5 million upfront in January 2024.
The antibody-drug conjugate, withdrawn from the market by GSK in 2022 after failing a confirmatory study, was approved Thursday by the FDA for previously treated patients with multiple myeloma. This is despite a negative advisory committee vote in July.
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