Related coverage linked through entity extraction aliases.
Aug 07, 2026
Biotech companies posted Q2 2026 results: REGENXBIO's Duchenne trial met its primary endpoint, Compass Pathways' COMP360 NDA submission is on track for Q4, Puma raised full-year guidance on NERLYNX demand, and Evotec cut its 2026 outlook.
Jul 17, 2026
A securities class action lawsuit alleges REGENXBIO misled investors about the safety of its gene therapy RGX-111. Following an FDA clinical hold due to a patient tumor, the stock fell 17.8% in one day. Affected shareholders have until April 14, 2026 to seek lead plaintiff status.
Jun 15, 2026
The FDA has granted accelerated approval to Denali Therapeutics' Avlayah (tividenofusp alfa-eknm), the first therapy targeting neurological symptoms of Hunter syndrome. The approval was based on a surrogate endpoint measuring heparan sulfate reduction in cerebrospinal fluid, with confirmatory study results required for full approval. The global Hunter syndrome treatment market is projected to reach $2.6 billion by 2033.
Mar 20, 2026
A class action lawsuit was filed against REGENXBIO covering the period from February 9, 2022 to January 27, 2026, following FDA clinical holds on gene therapies RGX-111 and RGX-121 after a CNS tumor was discovered in a trial participant.
Feb 17, 2026
The provided source articles lack sufficient accessible factual content for synthesis. One article is inaccessible, another covers unrelated stock performance topics, and the third concerns a different company entirely.
Jan 29, 2026
The FDA placed clinical holds on Regenxbio's RGX-111 and RGX-121 gene therapies following a tumor case in an MPS I patient. The company's stock fell nearly 18% on the news.
