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What’s in Today’s Brief? (February 12th Preview)
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FDA refuses to review Moderna flu shot — agency cites trial design
The U.S. Food and Drug Administration issued a rare refusal-to-file for Moderna’s mRNA influenza vaccine (mRNA-1010), citing deficiencies in the pivotal trial’s comparator and overall study design. The letter, signed by Vinay Prasad, director of the FDA’s biologics office, said the trial did not meet the agency’s standard for an "adequate and well-controlled" study. Moderna disputed the decision and said the refusal is inconsistent with prior pre‑BLA communications and guidance; the company has requested a Type A meeting to clarify next steps. Moderna notes its Phase 3 met endpoints and that regulators in the EU, Canada and Australia accepted the submission for review. The action has immediate market and policy implications: Moderna shares fell on the announcement, industry groups raised concerns about shifting FDA standards, and observers flagged potential spillover effects for vaccine developers working with mRNA platforms. The dispute centers on what constitutes an appropriate active comparator in vaccine trials—a technical but pivotal regulatory question that could reshape future flu and respiratory vaccine development.
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BridgeBio's oral dwarfism drug clears pivotal test — FDA filing planned
BridgeBio reported positive top-line results from Propel 3, a global Phase 3 trial of oral infigratinib in children with achondroplasia, meeting the primary endpoint for annualized height velocity (AHV). The trial showed statistically significant gains in AHV versus placebo, with treatment differences ranging from roughly +1.74 cm/year to +2.10 cm/year depending on analysis. Company statements indicate plans to meet regulators and prepare filings later this year. BridgeBio said the drug was well tolerated; reported adverse events included transient hyperphosphatemia that did not require dose changes. The result adds to a recent string of late‑stage wins for BridgeBio and positions oral infigratinib as a potential competitor to injectable therapies. Analysts and clinicians will watch how regulators size up the benefit versus established options from BioMarin and Ascendis. If approved, an oral FGFR‑targeting therapy could change the competitive dynamics for achondroplasia treatment and broaden patient choices.
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Madrigal bets big on siRNA — $60M upfront, $4.4B potential deal with Ribo
Madrigal Pharmaceuticals struck a licensing and development agreement with Suzhou Ribo Life Science (Ribocure) to license six preclinical siRNA programs targeting metabolic dysfunction-associated steatohepatitis (MASH). The pact includes a $60 million upfront payment and up to $4.4 billion in biobucks tied to development, regulatory and commercial milestones, plus royalties. Ribo will provide programs built on its GalSTAR siRNA delivery and chemical modification platforms; Madrigal intends to integrate the RNAi assets with its approved THR‑β agonist Rezdiffra and other pipeline programs. The deal underscores a strategic move by Madrigal to expand beyond a single‑product company and to capture multi‑mechanistic approaches for MASH. The transaction follows a flurry of MASH acquisitions and alliances across the industry and signals continued investor appetite for liver‑targeted RNA therapeutics. The structure heavily backloads potential payments, aligning incentives for clinical success while limiting near‑term cash outlay.
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CareDx’s AlloHeme flags relapse weeks early — high sensitivity and specificity
CareDx presented validation data from the observational ACROBAT study showing its AlloHeme cell‑free DNA assay for allogeneic hematopoietic cell transplant (HCT) surveillance achieved 85% sensitivity and 92% specificity versus clinical relapse, with a median 41‑day lead time to detect relapse. The study enrolled 285 transplant recipients across 11 U.S. sites; 198 were analyzable and 118 completed two‑year follow‑up. Investigators reported a 95% negative predictive value and 79% positive predictive value, outperforming traditional bone marrow biopsy sensitivity estimates cited by experts. CareDx plans commercial groundwork for AlloHeme ahead of a planned launch next year, contingent on publication of ACROBAT results. Company executives and academic co‑investigators highlighted the assay’s potential to shift monitoring paradigms in post‑HCT care by enabling earlier therapeutic intervention and reducing invasive testing.
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Seres pauses lead program and trims workforce — microbiome strategy shifts
Microbiome specialist Seres Therapeutics announced a strategic reboot that pauses its flagship program and cuts about 30% of staff, refocusing resources toward earlier-stage immunology research. The move follows prior rounds of restructuring as the company seeks a sustainable development path. Seres cited the need to concentrate on programs with clearer scientific paths and to extend runway. The pause affects ongoing clinical priorities and will force reprioritization of pipeline assets and external partnerships. Investors and industry watchers view the move as reflective of wider pressures in the live biotherapeutics field, where translational challenges and commercial uncertainty have prompted companies to narrow programs and preserve capital.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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