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What’s in Today’s Brief? (July 2nd Preview)
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KRAS G12C lung cancer competition heats up
Roche pushed its KRAS G12C program forward with new Phase 3 results that beat existing therapies in previously treated non-small cell lung cancer. The divarasib study, Krascendo-1, reported improvements in both overall survival and progression-free survival versus Amgen’s Lumakra and Bristol Myers Squibb’s Krazati for KRAS G12C patients after prior therapy. Roche did not disclose detailed efficacy or safety tables ahead of planned medical meeting presentations. The company said no new safety signals of concern emerged and that most treatment-related side effects were manageable and reversible. The headline implication is direct competitive pressure in an already established KRAS G12C setting, with Roche also testing a potentially larger market opportunity in earlier-line disease via Krascendo-2—divarasib plus Merck’s Keytruda versus Keytruda plus chemotherapy.
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IPF biotech Celea raises for next-generation pirfenidone follow-on
Celea Therapeutics raised $180 million to advance deupirfenidone, its next-generation idiopathic pulmonary fibrosis (IPF) therapy. The PureTech spinout, launched in 2025, positions the program as a retooled version of pirfenidone (Roche’s Esbriet), aiming to move into late-stage testing. Celea said the funds will support launching deupirfenidone into late-stage studies in the third quarter of 2026. Early Phase 2 data released in late 2024 showed slower lung function decline versus placebo over six months, with Leerink Partners describing improved efficacy and similar-to-slightly-better tolerability relative to pirfenidone. Investors backing the round include RA Capital Management, Leaps by Bayer, and PureTech, along with two unnamed funds. The financing lands as IPF remains an area of limited approved options and multiple companies are competing for label expansions and new mechanisms.
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Orca Bio gets FDA approval for Tregzi in HSCT
The FDA approved Orca Bio’s Tregzi, a personalized regulatory T-cell (Treg) therapy designed to reduce graft-versus-host disease complications after matched-donor allogeneic HSCT. The approval makes Tregzi the first cell therapy based on regulatory T cells. Orca said clinical results from its Phase III Precision-T trial showed reduced risk of chronic GVHD-related outcomes and related complications, supporting broader use in hematologic malignancies undergoing transplant. The therapy is intended to improve chronic GVHD-free survival while supporting immunologic and hematopoietic reconstitution. The approval is set to expand the cell-therapy category beyond conventional approaches used in HSCT and underscores regulators’ growing comfort with personalized, manufacturing-intensive cellular products.
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Regulatory fight: Colorado court blocks Amgen Enbrel price cap
A U.S. District Court in Colorado halted a 70% price cap on Amgen’s Enbrel after granting the company a preliminary injunction. The decision came from Judge Daniel Domenico, who said the cap could cause “economic injury” to Amgen. The ruling interrupts state-level implementation of the pricing policy and adds to the legal friction around drug affordability mechanisms. It also signals that courts may scrutinize the economic impact claims underpinning price controls. For manufacturers and payers, the immediate practical effect is continued pricing freedom for Enbrel while the legal process proceeds—potentially shaping how other states draft or defend similar measures.
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Otsuka readouts aim to convert accelerated kidney approval to full
Otsuka reported long-term Phase 3 data for Voyxact (now branded by the company for kidney disease indication), aiming to convert an accelerated approval into full approval. The company said the trial showed stabilization of kidney function when compared with placebo across the extended dataset. The update is intended to strengthen the evidence package for regulators by providing longer follow-up in IgA nephropathy, where durable clinical outcomes and renal function trajectory are central to conversion from accelerated pathways. If the data hold up in the final regulatory review, Otsuka’s move could tighten competition in chronic kidney disease categories that depend on sustained renal benefits rather than short-term surrogate endpoints.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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