Onyx @ Jefferies: David Hung, CEO, Nuvation Bio
Nuvation is gaining real momentum after its first FDA approval, with IBTROZI now treating a growing number of patients with ROS1-positive lung cancer.
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Onyx @ Jefferies: Jon Rees, CEO, MitoRx
The British biotech recently secured a £5.5 million pre-Series A round to advance their lead asset, Myo-004, toward clinical candidate selection.
Perspective Therapeutics Announces Acceptance of VMT-α-NET Data for Presentation at the ASCO Gastrointestinal Cancers Symposium
✨ Onyx Summary Perspective Therapeutics announced that updated safety and preliminary efficacy data from its [212Pb]VMT-α-NET program in advanced SSTR2-expressing neuroendocrine tumors have been accepted for presentation at the ASCO Gastrointestinal Cancers Symposium 2026. The accepted abstract builds on previously reported interim results showing a favorable safety profile and early
“Speed is survival”: inside 4D Molecular Therapeutics’ bid to scale genetic medicine
Driven by the precision of viral biology, 4D Molecular Therapeutics is redefining gene therapy’s reach - scaling a once ultra-rare field into broad, sustainable markets.
VeriSIM Life Wins Prestigious AI in Action Award at Reuters Global Pharma Awards
✨ Onyx Summary VeriSIM Life was named the winner of the AI in Action Award at the Reuters Global Pharma Awards 2025 for its BIOiSIM platform, which applies explainable, mechanistic AI to predict human safety, efficacy, and translational outcomes earlier in drug development. The recognition highlights VeriSIM Life’s growing role
Onyx @ Jefferies: Warner Biddle, CEO, Kyverna Therapeutics
Fresh momentum from Jefferies and a new $150 million non-dilutive financing has extended its runway into 2027.
FDA Approvals - November 2025
Mitochondrial disease and mutant leukemias signal where specialty pharma is placing its biggest bets.
MassBio and SCbio launch Drive application for spring cohort
✨ Onyx Summary MassBio and SCbio opened applications for the Spring 2026 cohort of Drive, a national accelerator for early-stage biotech and biomarker/diagnostic startups, with programs running March 23–May 15, 2026 and an application deadline of January 16, 2026. The announcement reflects continued investment in early scientific founders, building
enGene’s Detalimogene Selected for FDA Manufacturing Pilot Program to Support Manufacturing Readiness
✨ Onyx Summary enGene Holdings Inc. announced that the U.S. Food and Drug Administration has selected its investigational non-viral gene therapy detalimogene voraplasmid for participation in the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program. The selection supports enGene’s commercial-scale manufacturing strategy and regulatory preparation as
Alzheon Announces Peer-Reviewed Publication Providing Evidence for Hippocampal Volume as Surrogate Marker for Clinical Benefit and Neurodegeneration in Early Alzheimer’s Disease
✨ Onyx Summary Alzheon, Inc. announced a peer-reviewed publication in CNS Drugs synthesizing evidence that hippocampal volume on MRI tracks cognitive decline and therapeutic response in early symptomatic Alzheimer’s disease, supporting its use as a surrogate marker in clinical development. The review proposes a hippocampal volume preservation threshold (≥40 mm³
Belite Bio Announces Pricing of $350.0 Million Underwritten Public Offering of American Depositary Shares
✨ Onyx Summary Belite Bio priced an underwritten public offering of 2,272,727 ADSs at $154.00 per ADS, with a 30-day option for underwriters to purchase up to an additional 340,909 ADSs, for expected gross proceeds of about $350 million before fees and expenses, with closing anticipated around
Belite Bio Announces Proposed Underwritten Public Offering of American Depositary Shares
✨ Onyx Summary Belite Bio commenced an underwritten public offering of ADSs, with all shares sold by the company and an additional 30-day underwriter option for extra ADSs, subject to market conditions. Proceeds are earmarked for commercialization buildout, pipeline development and expansion, and general corporate purposes, with Morgan Stanley, Leerink, BofA
New Hope for People Living with a Disease Once Deemed Untreatable: Belite Bio Announces Positive Topline Results from the Pivotal Global, Phase 3 DRAGON Trial of Tinlarebant in Adolescents with Stargardt Disease
✨ Onyx Summary Belite Bio reported positive topline Phase 3 DRAGON results showing its oral therapy tinlarebant met the primary endpoint in Stargardt disease type 1, delivering a statistically significant 35.7% reduction in retinal lesion growth versus placebo over 24 months in 104 adolescent patients. The company said the safety
Recursion Announces Webinar For Upcoming Clinical Data Readout on the TUPELO Phase 1b/2 Trial of REC-4881 in Familial Adenomatous Polyposis on December 8, 2025
✨ Onyx Summary Recursion announced it will host a December 8, 2025 company webinar to present an updated clinical readout from the ongoing TUPELO Phase 1b/2 trial evaluating REC-4881 monotherapy in patients with familial adenomatous polyposis, including new safety and efficacy data. Salt Lake City, Dec. 01, 2025 – Recursion (Nasdaq:
Cellares Appoints Former MaxCyte Commercial Chief Ali Soleymannezhad as Chief Commercial Officer to Lead Global IDMO Expansion, Catalyze Next Wave of Partnerships, Prepare for IPO
✨ Onyx Summary Cellares appointed Ali Soleymannezhad as Chief Commercial Officer to lead global commercial strategy as it scales its IDMO Smart Factory network across the U.S., Europe, and Japan, positioning the company for commercial expansion ahead of a potential IPO. The hire underscores Cellares’ strategy to address global cell
Nature Genetics Study Validates Seer’s Proteograph Platform as Essential for Turning Genetic Signals Into Reliable Drug Targets and Biomarkers
✨ Onyx Summary Seer, Inc. announced publication in Nature Genetics of a large-scale GWAS demonstrating that its Proteograph platform’s peptide-level mass spectrometry is critical for accurately validating protein–gene associations and reducing false signals common in affinity-based proteomics. The study, spanning ~1,600 multi-ethnic samples, shows that up to one-third