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What’s in Today’s Brief? (February 15th Preview)
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Exact Sciences Posts Strong Quarter – Shareholders Set to Vote on $23B Abbott Deal
Exact Sciences reported a 23% year-over-year revenue increase in Q4 2025 and is moving toward shareholder approval of Abbott Laboratories’ proposed $23 billion acquisition. The company posted $878.4 million in Q4 revenue, driven by a 26% rise in screening revenue and a 14% increase in precision oncology testing, the company said. Exact’s net loss narrowed versus the prior year but adjusted EPS missed some analyst expectations. CEO Kevin Conroy signaled continued momentum as the company prepares a special meeting on Feb. 20 to vote on Abbott’s offer. The vote will determine whether Abbott’s planned integration proceeds and could reshape market dynamics in cancer diagnostics and screening services.
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FDA Rejects Disc’s Rare-Disease Drug: Voucher Program Faces First Test
The FDA rejected Disc Medicine’s bitopertin for a rare blood disorder, citing uncertainties about whether the trial biomarker correlates with clinical benefit, according to STAT. Bitopertin was the first experimental drug reviewed under the FDA commissioner’s new expedited-voucher program; the agency posted a complete response letter that sent Disc shares sharply lower. BioCentury’s reporting adds that the rejection follows a broader pattern of regulators pushing back on biomarker-only endpoints, intensifying debate over accelerated pathways and the value of new priority review vouchers. The decisions raise questions about the reliability of surrogate endpoints and the predictability of the agency’s expedited review programs for companies pursuing rare-disease approvals.
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BridgeBio’s Oral Infigratinib Matches Voxzogo on Height – Adds Patient‑Friendly Option
BridgeBio reported data showing its FGFR3 inhibitor infigratinib produced height gains comparable to Voxzogo (vosoritide) in patients with achondroplasia while offering an oral dosing option, BioCentury reported. The company is preparing regulatory submissions that could position infigratinib as an alternative treatment with different administration characteristics. FGFR3-targeted therapies address the genetic driver of achondroplasia. An oral agent could change prescribing patterns and patient preference versus an injectable option; BridgeBio’s next steps will include regulatory filings and discussions on labeling and long‑term safety monitoring.
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Vertex Sees Casgevy Uptick – Gene‑Edited Therapy Bolsters Results
Vertex reported a rebound in sales for Casgevy, the gene‑edited therapy developed with CRISPR Therapeutics, with quarterly sales more than tripling versus the prior quarter. Management cited the therapy as a bright spot in the company’s financials and a contributor to commercial momentum. Casgevy is a CRISPR‑based, ex vivo gene‑editing product authorized for a rare genetic indication; rising uptake highlights commercial viability for gene‑edited medicines and signals strengthening demand as manufacturing and distribution scale. Analysts view the growth as validation for gene‑editing commercialization strategies.
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PTC Withdraws Translarna FDA Bid – Data Gaps Cited
PTC Therapeutics said it will stop pursuing FDA approval for Translarna (ataluren) after regulators indicated the submitted data are unlikely to meet the agency’s threshold for substantial evidence of effectiveness. The company’s decision follows a prior negative decision in Europe and reflects unresolved differences with the FDA over trial interpretation. Translarna has been under development for nonsense‑mutation Duchenne muscular dystrophy for nearly two decades. PTC’s withdrawal underscores regulatory challenges for long‑running rare‑disease programs when new analyses or regulator expectations shift; the move will reshape the company’s regulatory strategy and investor expectations.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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