NEW YORK, January 1, 2026, 10:07 ET — Market closed
Disc Medicine, Inc. shares rose 3.3% to $79.41 in the last U.S. trading session of 2025, before Wall Street shut on Thursday for the New Year’s Day holiday.
Investors are focused on a U.S. Food and Drug Administration decision expected by the end of January on Disc’s lead drug candidate bitopertin for erythropoietic protoporphyria, or EPP, a rare genetic disease in which light exposure can trigger severe pain. Investing.com Australia
The ruling is being watched beyond Disc because bitopertin is among the early drugs tapped for the FDA’s Commissioner’s National Priority Voucher pilot, a program meant to compress reviews to as little as one to two months for selected applications. U.S. Food and Drug Administration
Disc submitted a New Drug Application, or NDA, in September seeking accelerated approval for bitopertin in EPP, the company said. Accelerated approval allows a drug to be cleared using a surrogate marker — a stand-in measurement — while requiring a confirmatory study to prove patients benefit. Disc Medicine Inc.
There was no fresh company announcement in the past day, and Disc’s investor site lists its most recent press release in early December.
The stock has been volatile since mid-December after STAT reported that FDA biologics center director Vinay Prasad had become personally involved in the review and was skeptical about efficacy, BioSpace reported. BioSpace said Disc later held a call with analysts after the report, which sent the shares sharply lower.
BMO Capital Markets analyst Evan David Seigerman reiterated an “outperform” rating and a $120 price target on Disc in a December note, StreetInsider reported. Streetinsider
Biotech traded mixed into the year-end close: the SPDR S&P Biotech ETF rose about 0.2% while the iShares Nasdaq Biotechnology ETF slipped about 0.1%. Broader markets fell, with SPY down about 0.7% and QQQ off about 0.8%.
In EPP, Disc’s bid would compete in a market where Clinuvel Pharmaceuticals’ Scenesse is approved in the United States to increase pain-free light exposure in adults with EPP, according to the FDA label. FDA Access Data
“Sunny days ahead for bitopertin,” Leerink Partners analyst Thomas J. Smith wrote in a research note cited by Chemical & Engineering News.
For Disc holders, the next catalyst is any signal on whether the FDA is comfortable leaning on the surrogate endpoint and whether the accelerated timetable stays intact under the voucher process. Disc has also pointed investors to ongoing enrollment in its APOLLO trial, which it has described as a confirmatory study. Disc Medicine Inc.
Before U.S. markets reopen on Friday, traders will be watching whether the stock holds above Wednesday’s intraday low near $76.80; the last session’s high around $80.32 is the nearest overhead level, based on historical price data. StockAnalysis
Macro data could also influence risk appetite for small-cap biotech early in the year. ISM said its December 2025 manufacturing report is due on Monday, Jan. 5, and the Bureau of Labor Statistics calendar shows the December jobs report scheduled for Friday, Jan. 9.
