TSHA News & Events

Dr. Marty Makary, the commissioner of the Food and Drug Administration, resigned on Tuesday, according to multiple media reports citing administration officials. Makary ultimately resigned over concerns about the administration's decision to authorize fruit-flavored e-cigarettes, which he opposed, four people familiar with the matter told The New York Times. Kyle Diamantas, the F.D.A.'s top food regulator, was named the acting commissioner, according to The Times and Politico, which was first to report of Makary's resignation. Publicly traded large-cap drugmakers include AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Biotech stocks that could be impacted by the news include Replimune (REPL), Moderna (MRNA), Sarepta (SRPT), Xencor (XNCR), PTC Therapeutics (PTCT), Biohaven (BHVN), Edgewise Therapeutics (EWTX), Design Therapeutics (DSGN), Ultragenyx (RARE), Dyne Therapeutics (DYN), Wave Life Sciences (WVE), MeiraGTx (MGTX), uniQure (QURE), Regenxbio (RGNX), Novavax (NVAX) and Lexeo Therapeutics (LXEO).

"We continued to execute our clinical development strategy for TSHA-102 and recently reaffirmed alignment with the FDA on our pathway to a BLA filing, including trial design, endpoints and the potential to submit for approval based on the six-month interim analysis from the REVEAL pivotal trial," said Sean P. Nolan, Chairman and Chief Executive Officer of Taysha. "We further advanced dosing in the REVEAL pivotal trial, with enrollment in the ASPIRE trial ongoing across multiple sites, and we remain on track to complete dosing in both trials this quarter. In parallel, we plan to report longer-term safety and efficacy data from Part A of our REVEAL Phase 1/2 trials in the second quarter of this year."