Cancer
With the latest round, Roche’s Genentech will have racked up nearly 450 layoffs in California over the last year amid ongoing restructuring. At the same time, the biotech is joining forces with Astex Pharmaceuticals in a deal that could surpass $490 million.
The centerpiece of the acquisition is Myricx Bio’s novel N-myristoyltransferase inhibitor payload platform, which could help Novartis develop antibody-drug conjugates that can overcome the limitations of existing therapies.
Many of the FDA’s decisions this quarter involve applications that have previously been delayed, declined or outright rejected, including one for an mRNA vaccine that became the center of controversy earlier this year.
The approval of Tregzi—the first regulatory greenlight for Orca Bio—was based on a Phase 3 study in which patients on the therapy were twice as likely to survive without cancer relapse and without chronic GVHD compared with conventional allogeneic transplant.
The star of Ipsen’s acquisition is an MDM2 blocker being proposed as an add-on therapy to ruxolitinib for myelofibrosis. The drug could be available to patients “as early as 2028,” according to Ipsen CEO David Loew.
Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
Replimune’s resubmission for RP1 for melanoma comes after the departures of FDA leaders in place at the time of the drug’s first two rejections. The FDA expects to hold an advisory committee meeting in late July.
Encouraging data for combination regimens of Revolution Medicines’ zoldonrasib “reinforce the path to leadership in PDAC” for the biotech, according to Truist Securities.
Gilead’s Trodelvy can now be used as a monotherapy and in combination with Merck’s Keytruda to treat certain patients with triple-negative breast cancer.
Novartis and Antares Therapeutics are shooting for the stars, launching a joint mission to develop small molecule oncology therapies.
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