Welcome to Fierce Pharma's regulatory tracker for the second half of 2026. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Be sure to come back regularly for the latest updates.
UPDATED: Wednesday, July 1 at 2:00 p.m. ET
The FDA has assigned a target decision date of Feb. 28, 2027, for Sarepta Therapeutics’ applications that seek to convert the accelerated approvals of Amondys 45 and Vyondys 53 to full approvals.
Sarepta filed the two exon-skipping drugs for the treatment of Duchenne muscular dystrophy (DMD) despite missing the primary endpoint of a confirmatory trial called Essence. The company has pointed to an average 0.05 steps/second difference in favor of the therapies on a 4-step ascend velocity test designed to measure DMD patient mobility, as well as real-world evidence, to support its case. It has also suggested that the COVID-19 pandemic confounded the Essence readout.
“In populations this small and in a disease where damage unfolds over years, real-world experience is essential to understanding how these therapies impact the disease course,” Louise Rodino‑Klapac, Ph.D., Sarepta’s president of research & development and technical operations, said in a June 30 statement. “We look forward to working with the FDA throughout the review.”
In a Tuesday note, Jefferies analysts estimated that investors are assuming a 50%-plus probability of approval. The analysts suggested that the FDA may allow the two drugs to remain in the market even if the agency declined to convert the accelerated approvals.