Revolution Medicines, Disc Medicine, Regeneron Stocks Jump After-Hours As FDA Fast-Tracks 9 Drugs Under New Review Program

Shares of Revolution Medicines, Disc Medicine, and Regeneron Pharmaceuticals rose in after-hours trading on Thursday after the U.S. Food and Drug Administration (FDA) announced the first group of drugs selected for expedited review under its new National Priority Voucher pilot program.

In after-hours trading on Thursday, Revolution Medicines jumped 9%, Disc Medicine surged 17%, and Regeneron Pharmaceuticals edged up 0.1%.

FDA Names 9 Drugs For Accelerated Review

The FDA said nine products have been chosen for the fast-track review process, which shortens decision timelines from the usual 10–12 months to just one or two months once a complete application is filed.

The selected drugs include Merck KGaA’s fertility treatment Pergoveris, Sanofi’s Type 1 diabetes therapy teplizumab, Regeneron’s gene therapy DB-OTO for congenital deafness, and ketamine for domestic manufacturing of a general anesthetic. 

Also on the list are Revolution Medicines’ RMC-6236 for pancreatic cancer, Disc Medicine’s bitopertin for porphyria, Achieve Life Sciences’ cytisinicline for nicotine vaping addiction, Dompe’s cenegermin-bkbj for blindness, and Augmentin XR for domestic manufacturing of a common antibiotic.

FDA Commissioner Highlights Expedited Review Effort

FDA Commissioner Marty Makary said the initiative could shorten FDA decision times from a year to "a matter of weeks” by moving promising or high-impact therapies to the front of the review line.

Makary said some of the drugs selected for vouchers, including one that uses ketamine as a general anesthetic, will be manufactured in the United States. He described Regeneron’s DB-OTO, a gene therapy for congenital deafness, as “an exciting treatment,” noting that “some of these kids got normal hearing from this amazing treatment.”

He added that this is just the first round of vouchers, with additional selections expected in the coming weeks.

How Stocktwits Traders Reacted To FDA’s Fast-Track List

On Stocktwits, retail sentiment toward Revolution Medicines was ‘extremely bullish’ with ‘extremely high’ message volume, while Disc Medicine saw ‘neutral’ sentiment amid similarly ‘extremely high’ activity, and Regeneron registered ‘neutral’ sentiment with ‘normal’ engagement levels.

One  user said they expect Regeneron shares to climb steadily, projecting the stock could reach the $800-$900 range within two years. 

Another bullish trader suggested Revolution Medicines could be an attractive takeover candidate, potentially fetching twice its current value.

So far this year, Revolution Medicines shares have gained 14%, Disc Medicine is up 17%, while Regeneron has declined 20%.

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