CANCER
AstraZeneca set high ambitions in a harsh climate
As AstraZeneca rolls out key ASCO data on its cancer drugs Imfinzi, camizestrant, and Enhertu, CEO Pascal Soriot is both bullish and wary — touting progress in gastric breast cancers while warning that U.S. drug pricing reforms could kneecap future innovation, STAT's Matt Herper writes.
While Imfinzi continues to carve out niches overlooked by competitors like Merck's Keytruda, and camizestrant shows promise in ESR1-mutated breast cancer, Soriot stressed that "most-favored nation" pricing could derail U.S. biopharma and shift momentum to China.
If it was enacted "on existing products, the impact on the industry would be substantial," he said. "I mean, honestly, substantial is an understatement. Dramatic. And I think it would really undermine the leadership the U.S. has in biosciences, biopharmaceuticals."
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Policy
Despite all its promise, mRNA is in peril
Once hailed a pandemic-era miracle, mRNA is now under fire as federal health leaders, including HHS Secretary Robert F. Kennedy Jr., roll back vaccine recommendations and funding while embracing rhetoric rooted in Covid-era backlash, STAT's Lizzy Lawrence and Isabella Cueto write.
The Trump administration's cancellation of more than $700 million in Moderna flu vaccine contracts, coupled with new FDA restrictions and sidelining of mRNA by NIH, signals a stark retreat from a platform that saved millions.
"This is the only place in the world where this is happening," said Clay Alspach, executive director for the Alliance for mRNA Medicines. "Other countries are rolling out the red carpet for this technology."
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BIOTECH
Kymera reports early-stage success for drug meant to rival Sanofi and Regeneron's Dupixent
Kymera Therapeutics this morning reported that an experimental drug designed to rival Sanofi and Regeneron's blockbuster therapy Dupixent succeeded in a closely watched early-stage trial, STAT's Jonathan Wosen reports.
The Phase 1 trial, which enrolled 118 healthy volunteers, tested the safety and tolerability of KT-621, a small molecule drug that targets STAT6, a signaling protein that plays a key role in driving immune activation. The study found that the experimental therapy was as safe as the placebo, with no severe adverse events and no treatment-related adverse events that caused participants to stop taking the drug.
The announcement, shared in a company press release, falls somewhere between what market analysts had expected and what they had described as a best-case scenario.
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psychedelics
Atai, Beckley merge amid psychedelic policy shift
Atai Life Sciences is merging with Beckley Psytech in a $370 million deal that consolidates two major players in psychedelic drug development, forming a new entity called Atai Beckley.
The combined company, STAT's Jason Mast writes, will house a portfolio including BPL-003, Beckley's intranasal syntehtic 5-MeO-DMT — an ultra-short-acting psychedelic derived from toad venom that has gained cultural notoriety and regulatory attention.
With randomized depression data expected midyear, the deal comes amid a volatile policy landscape: newly appointed FDA chief Marty Makary has pledged swift reviews of psychedelic data, even as the agency last year rejected MDMA therapy over trial concerns.
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