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What’s in Today’s Brief? (February 19th Preview)
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Novartis bets $1.8B on macrocycles: Unnatural Products deal
Novartis signed a multi-element discovery and licensing collaboration with Unnatural Products (UNP) to apply UNP’s AI‑guided macrocyclic peptide platform to cardiovascular targets. The agreement includes roughly $100 million in upfront and pre‑IND payments and up to ~$1.8 billion in development, regulatory, and commercial milestones, with tiered royalties on sales. Novartis will lead IND‑enabling studies, clinical development and commercialization while UNP supplies discovery output and platform expertise. The deal pairs UNP’s integrated discovery stack — AI design, parallel synthesis and direct-to-biology screening — with Novartis’ global development footprint. Cameron Pye, UNP’s CEO, and Muneto Mogi, Novartis’ head of discovery chemistry, framed the partnership as a route to “undruggable” targets using macrocycles’ hybrid properties between small molecules and biologics. Macrocyclic peptides are cyclic compounds sized to reach difficult protein surfaces while retaining drug-like properties. The transaction follows a wave of platform-driven alliances and underscores Big Pharma’s appetite for nontraditional modalities to address target classes that have resisted conventional approaches.
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FDA pivots: single pivotal trial becomes new default
Top FDA officials authored a New England Journal of Medicine perspective establishing a single well‑controlled clinical trial as the agency’s new default for approvals, while urging sponsors to provide “confirmative evidence” (mechanistic data, related‑indication findings, animal models or real‑world evidence) when appropriate. Commissioner Marty Makary and CBER Director Vinay Prasad argued the two‑trial dogma is outdated and that integrated evidence can substitute for a second trial. The move formalizes a major regulatory shift that could lower late‑stage costs and speed product approvals, but the change has stirred debate inside and outside the agency about statistical robustness and exceptions for unclear mechanisms or surrogate endpoints. Analysts flagged that the policy retains FDA discretion to require additional studies when warranted. Stakeholders are assessing potential impacts on development timelines, statistical planning, and investment in confirmatory mechanistic work.
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FDA reverses: will review Moderna’s mRNA flu shot
The FDA reversed a prior refusal and agreed to review Moderna’s mRNA seasonal influenza vaccine mRNA‑1010, assigning a PDUFA date of Aug. 5, 2026. Regulators and Moderna negotiated an amended filing that proposes traditional approval for adults 50–64 and accelerated approval for those 65 and older, with a post‑marketing study required in the older cohort. The reversal follows a Type A meeting after agency staff initially raised concerns about the trial comparator and design. The episode exposed internal agency tensions and heightened scrutiny of vaccine review standards; company CEO Stéphane Bancel said Moderna appreciates the FDA’s engagement. If approved, mRNA‑1010 would be positioned for the 2026–27 flu season in selected age groups and marks an important test of mRNA vaccines beyond COVID‑19.
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Altesa raises $75M to revive rhinovirus antiviral for COPD
Altesa BioSciences closed a $75 million Series B to advance vapendavir, a once‑failed antiviral that targets rhinovirus, into a planned Phase 2b trial for chronic obstructive pulmonary disease (COPD). The raise was led by Forbion and included strategic backing from Sanofi and other investors. Brett Giroir, Altesa CEO and former acting FDA commissioner, framed the program as targeting patients at high risk for hospitalizations driven by rhinovirus exacerbations. Vapendavir previously failed a Phase 2 asthma study but showed symptom and duration benefits in a Phase 2a challenge trial in COPD patients. Altesa expects to start the larger, placebo‑controlled mid‑stage study in Q2 to enroll roughly 900 COPD patients randomized at the time of rhinovirus infection. Sanofi’s participation and the hire of experienced clinical leadership signal industry interest in antivirals that prevent exacerbations in chronic lung disease.
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Liquid biopsy for kids: M‑PACT classifies brain tumors from CSF
An international team led by St. Jude Children’s Research Hospital and the Hopp Children’s Cancer Center developed M‑PACT, a methylation‑based predictive algorithm that classifies difficult pediatric brain tumors using tiny amounts of circulating tumor DNA (ctDNA) from cerebrospinal fluid (CSF). Published in Nature Cancer, M‑PACT achieved 92% identification in a 79‑sample benchmark and 88% in a 58‑sample validation set. The workflow uses low‑input enzymatic methyl sequencing (EM‑Seq), imputation to recover sparse CpG coverage, and tumor fraction deconvolution to separate malignant from nonmalignant signals. CSF offers a higher brain‑specific ctDNA signal versus blood but is more technically challenging to assay. Investigators propose M‑PACT as a tool to subtype tumors, guide treatment strategies, and accelerate trial enrollment for pediatric CNS cancers where tissue biopsies may be limited.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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