Disc Medicine Stock Slides After FDA Fast-Track Approval Doubts Surface — Wall Street Calls It An ‘Overreaction’

• Disc Medicine management said earlier this month that its application seeking approval for Bitopertin has officially been accepted for review on schedule. 
• Wall Street analysts dismissed the media report hinting at approval delays and termed the share drop as overblown. 
• Disc Medicine is hopeful for an approval of the drug by the end of January 2026.

Shares of Disc Medicine (IRON) plunged 12% on Friday after a report flagged concerns pertaining to the U.S. Food and Drug Administration’s speedy approval of the company’s blood disorder drug Bitopertin.

Disk Medicine’s Biopertin for the treatment of Erythropoietic Protoporphyria (EPP) is one of the 18 drugs to currently have been tapped for fast review by the FDA under its Commissioner's National Priority Voucher program. The Commissioner's National Priority Voucher program, announced in June, aims to reduce FDA assessment times to one to two months from the standard 10 to 12 months.

However, Stat News reported on Friday, citing government officials, that high-level FDA officials have been involved in every part of the new program involving the vouchers. The political pressure is creating “uncomfortable situations” for career scientists at the FDA, the report said.

The report dragged down investor sentiment and hopes for an expedited approval of Bitopertin as the report also noted that FDA senior official Vinay Prasad raised doubts about the drug’s effectiveness.

Wall Street Dismisses Concerns

Jefferies analyst Roger Song, however, termed the share drop a “stock overreaction”. Song said that while the priority voucher program's timeline may be under pressure with increasing demand, the firm remains confident on Bitopertin's approval in EPP under the program, based on robust efficacy and safety data and to-date review experience.

TD Cowen also maintained its ‘Buy’ rating on the shares and said the firm believes skepticism on the program’s path is overblown. Disc's management remains confident, it noted, and added that the firm's confidence in accelerated approval remains high.

BMO Capital said that it had discussions with Disc Medicine’s management which highlighted a lack of interactions with senior official Prasad but robust active dialogue with the FDA. While Prasad may have speculated efficacy concerns related to Bitopertin, these have not been communicated to Disc, and no clear concerning questions around efficacy have been raised, BMO added. Some procedural questions have been asked by FDA in trying to understand the Bitopertin data package and how it may translate to clinical benefit, it said. The firm has an ‘Outperform’ rating on the shares with a price target of $120.

Management Takeaway

Disc Medicine management said earlier this month that its application seeking approval for Bitopertin has officially been accepted for review on schedule and expressed hopes for potential launch by the end of January 2026, consistent with the 1-2 month timeline for drugs which receive the priority voucher.

“Our commercialization efforts have been accelerated significantly and we are well on our way to launch readiness,” the company said.

The company submitted its application for approval in patients aged 12 years and older with EPP on September 29. Erythropoietic Protoporphyria (EPP) is a rare, inherited metabolic disorder causing extreme sensitivity to sunlight (phototoxicity), leading to immediate, painful skin reactions like burning, tingling, redness, and swelling, due to the buildup of protoporphyrin in red blood cells from an enzyme deficiency.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around IRON stayed within the ‘bearish’ territory while message volume rose from ‘low’ to ‘high’ levels.

IRON stock has gained about 26% this year.

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