Nuvation Bio's Safusidenib Posts Durable Responses in IDH1 Glioma
Nuvation Bio reported updated Phase 2 data for safusidenib in IDH1-mutant glioma, with a 51.9% response rate and a 79.1% three-year progression-free rate.
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Daily commentary on the catalysts moving small-cap biotech — FDA decisions, clinical readouts, financings and deals.
REGENXBIO's Gene Therapy Shows Five-Year Durability in Retinal Disease
REGENXBIO reported long-term data showing its AbbVie-partnered gene therapy sura-vec preserved vision and cut injection burden through five years in wet AMD.
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4DMT's One-Shot Eye Therapy Holds Up at Two Years in Wet AMD
4DMT presented two-year Phase 2b PRISM data showing its gene therapy 4D-150 cut anti-VEGF treatment burden by 78% while maintaining vision in wet AMD.
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Trevi Therapeutics Jumps as GSK Exits the Chronic Cough Race
Trevi Therapeutics shares climbed nearly 10% after GSK abandoned its chronic cough candidate camlipixant, removing a leading competitor to Trevi's Haduvio.
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Jasper Therapeutics Reinvents Itself With Kira Merger and $132M Raise
Jasper Therapeutics announced an all-stock merger with Kira Pharmaceuticals alongside a roughly $132 million private placement, reshaping its pipeline and balance sheet.
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Intensity Therapeutics Restarts Its INVINCIBLE-4 Breast Cancer Trial
Intensity Therapeutics resumed dosing of INT230-6 in its Phase 2 presurgical triple-negative breast cancer trial under an amended, lower-dose protocol.
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Celcuity Lands Its First FDA Approval With REVTORPYK
Celcuity won FDA approval for REVTORPYK in HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, marking the company's first commercial product.
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Q32 Bio's Bempikibart Regrows Hair in Tough Alopecia Cases
Q32 Bio reported 36-week Phase 2a data showing its antibody bempikibart drove meaningful hair regrowth in patients with severe alopecia areata.
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Cue Biopharma Lines Up $50M Private Placement Led by Cormorant
Cue Biopharma announced a $50 million private placement led by Cormorant Asset Management to fund clinical development, expected to close on or about July 13, 2026.
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Forte Biosciences Posts Positive Phase 1b Vitiligo Data for FB102
Forte Biosciences reported that its FB102 candidate met the primary endpoint in a Phase 1b vitiligo study, showing a statistically significant improvement over placebo at week 24.
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Arcutis Biotherapeutics: FDA Accepts ZORYVE Filing for Infant Eczema
The FDA accepted Arcutis Biotherapeutics' supplemental application to expand ZORYVE cream into infants with atopic dermatitis, with a decision targeted for February 2027.
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MeiraGTx Secures Up to $400M From Oberland to Fund Gene Therapies
MeiraGTx entered a largely non-dilutive financing of up to $400 million with Oberland Capital to support its late-stage retinitis pigmentosa and xerostomia gene therapy programs.
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Aligos Therapeutics Banks $25M Upfront in Greater China Hepatitis B Deal
Aligos Therapeutics received a $25 million upfront payment and could earn up to $420 million in milestones from an exclusive Greater China license for its hepatitis B candidate.
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Can-Fite's Namodenoson Clears the Safety Bar in Phase 2a Pancreatic Cancer Study
Can-Fite said its Phase 2a study of namodenoson in advanced pancreatic cancer met the primary safety endpoint and showed durable survival in heavily pretreated patients.
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Arcutis Wins Expanded FDA Approval for ZORYVE in Young Children
The FDA approved Arcutis' supplemental application to expand ZORYVE cream 0.3% for plaque psoriasis to children as young as age 2, broadening the product's eligible patient population.
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NeuroSense Hits Its Primary Endpoint in Phase 2b ALS Trial
NeuroSense reported that its Phase 2b PARADIGM study of PrimeC in ALS met its primary endpoint on a TDP-43 biomarker, with the company already cleared to start Phase 3.
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Capricor Therapeutics Gets an FDA Panel Date for Duchenne Cell Therapy Deramiocel
Capricor Therapeutics said the FDA will convene an advisory committee on July 29 to review its Duchenne muscular dystrophy cell therapy deramiocel ahead of an August 22 decision date.
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Viridian Therapeutics Lands Its First FDA Approval With Lumvoa for Thyroid Eye Disease
The FDA approved Viridian Therapeutics' Lumvoa for thyroid eye disease across active and chronic stages, marking the company's first commercial product following its pivotal THRIVE Phase 3 program.
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ProQR Therapeutics Posts a First Clinical Win for Its Axiomer RNA-Editing Platform
ProQR Therapeutics reported Phase 1 target-engagement data that it says provides the first clinical validation of its Axiomer RNA-editing platform, and priced a $50 million financing the same day.
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Zevra Therapeutics Adds Infant Data to Its Niemann-Pick Drug MIPLYFFA
Zevra Therapeutics published positive Phase 2/3 pediatric substudy data for its Niemann-Pick type C therapy MIPLYFFA in infants under two, adding to the approved rare-disease drug's safety profile.
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Achieve Life Sciences Draws an FDA Complete Response Letter on Cytisinicline
Achieve Life Sciences received an FDA complete response letter for cytisinicline tied to third-party manufacturing, not efficacy or safety, and plans to resubmit the smoking-cessation drug in late 2026.
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REGENXBIO Wins an FDA Reset on NAVSUNLI Gene Therapy for Hunter Syndrome
REGENXBIO reached alignment with the FDA on an accelerated approval path for its MPS II gene therapy NAVSUNLI, reversing a February complete response letter and enabling a third-quarter resubmission.
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