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FDA
REGENXBIO to resubmit application for Hunter gene therapy after FDA’s most recent pivot
The resubmission for RGX-121, expected in the third quarter, comes as the FDA has deemed REGENXBIO’s existing data “sufficient” to support an accelerated filing. It immediately follows a similar reversal of position regarding uniQure’s embattled Huntington’s disease gene therapy.
June 22, 2026
·
3 min read
·
Heather McKenzie
Psychedelics
Definium’s LSD-based therapy elicits ‘profound’ efficacy in Phase 3 depression trial
Results for Definium Therapeutics psychedelic candidate for major depressive disorder “exceeded expectations,” according to Stifel, while Jefferies called the efficacy data “profound.”
June 22, 2026
·
2 min read
·
Michael Gibney
Funding
Sofinnova, Sanofi alum unveil Bionyra with $165M and next-gen immunology assets
Formed by Sofinnova Partners and former Sanofi executive Frédéric Marrache, Bionyra Pharma emerged from stealth Monday with an initial focus in inflammatory bowel disease and atopic dermatitis.
June 22, 2026
·
2 min read
·
Gabrielle Masson
Press Releases
TrueLab Biopharmaceutical Announces License Agreement with Bionyra Pharma for Two Next-Generation Monoclonal and Bispecific Antibodies for Immune-Mediated Inflammatory Diseases Valued up to $985 Million
June 22, 2026
·
6 min read
Press Releases
Catheter Precision, Inc. Announces Allowance of Key Intellectual Property
June 22, 2026
·
3 min read
Press Releases
Prolium Bioscience Announces First Patient Dosed in its Multinational, Phase 1/2 Study of PRO-203 in Systemic Sclerosis, and Last Patient, Last Visit in an Investigator-Led Study of PRO-203 in Refractory Lupus Nephritis
June 22, 2026
·
3 min read
Press Releases
Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation for Elsunersen for the Treatment of Seizures Associated with SCN2A Developmental and Epileptic Encephalopathy Caused by Gain of Function Variants
June 22, 2026
·
7 min read
Press Releases
Taysha Gene Therapies Announces Completion of Dosing in REVEAL Pivotal Trial and Reports Longer-Term Clinical Data from Part A of REVEAL Phase 1/2 Trials Evaluating TSHA-102 for Rett Syndrome
June 22, 2026
·
12 min read
Business
Sanofi’s R&D head exits, with AI biotech Xaira’s exec stepping in
About two months into CEO Belén Garijo’s new tenure, Sanofi’s R&D chief has departed, with Xaira’s chief medical officer set to take charge of the pharma’s pipeline.
June 22, 2026
·
1 min read
·
Gabrielle Masson
Press Releases
Prime Medicine Receives U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for PM359 for the Treatment of Chronic Granulomatous Disease (CGD)
June 22, 2026
·
8 min read
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