Disc Medicine Inc.'s (IRON:NASDAQ) bitopertin is likely to receive U.S. Food and Drug Administration (FDA) approval in the near term despite the recent news report alleging a delay, reported H.C. Wainwright & Co. (HCW) Analyst Douglas Tsao in a Jan. 16 research note.
"Another leak belies internal controversies within [the] FDA; we still remain confident that approval will occur," Tsao wrote.
Bitopertin is under review for approval as a treatment of erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP). Protoporphyria is a rare, inherited metabolic disorder that manifests as severe, painful, burning and itchy skin when exposed to sunlight or certain artificial lights.
66% Upside Implied
HCW maintained its US$118 per share (US$118/share) price target on the Massachusetts-based biopharmaceutical company, trading at the time of Tsao's report at US$71.04/share, the analyst noted. From there, the return to target is 66%.
Disc Medicine remains a Buy. Its market cap is US$2.7 billion.
Approval Delay Alleged
Reuters reported in a Jan. 15 article that the FDA delayed its decisions on bitopertin and a second drug being reviewed under its Commissioner's National Priority Voucher (CNPV) program, Tsao explained. As for bitopertin, which received the CNPV designation in October 2025, the article said the FDA's decision on it will be postponed two weeks due to concerns about the drug's efficacy and potential for abuse. The article gave the new decision date for bitopertin as Feb. 10, implying the original decision date was Jan. 27.
However, Disc Medicine's management stated they did not know about any scheduled action date in January or February. Management did say that the date of Jan. 27 is consistent with the original FDA guidance provided on the CNPV program. The date also aligns with the biopharma's expectation of a late January-early February approval.
Management said that its interactions with the FDA have been regular and typical, but more frequent than usual, given the accelerated timeline.
Previous News Report
A December 2025 STAT News article about the CNPV program stated that Vinay Prasad, the head of the FDA's Center for Biologics Evaluation and Research, had "expressed skepticism" about bitopertin's efficacy.
Given that a different FDA division, the Center for Drug Evaluation and Research, is reviewing bitopertin, it is not known if Prasad has a role or any influence in the approval process, Tsao wrote.
CNPV Program the Target
The analyst wrote that the intention of the Reuters article was likely to shed light on the CNPV program rather than on bitopertin's approval prospects, given that the news report mentioned more than one drug under review.
In 2025, the FDA awarded nine traditional priority review vouchers, a number consistent with the 7–11 awarded annually in each of the past five years, noted Tsao. These vouchers take about six months to review. Also, last year the agency awarded 18 CNPVs, which generally take one to two months to review. This greater amount of CNPVs led to more expedited reviews, signaling a material increase in the FDA's workload.
"It poses a considerable challenge for the agency to complete reviews on time, especially in light of staff shortages caused by layoffs earlier in 2025," Tsao wrote.
On Question of Efficacy
Tsao reiterated that bitopertin is under review for accelerated approval based on a surrogate endpoint, which is one that predicts a true clinical outcome. The surrogate endpoint for bitopertin is Protoporphyrin IX (PPIX) reduction, which the FDA considers valid for EPP or XLP treatment. Because results of the current clinical trial show this reduction occurs, bitopertin meets the criteria for accelerated approval.
The clinical efficacy required for full approval will be based on the results of the ongoing confirmatory Apollo study. Topline Apollo data are expected in late 2026-early 2027.
"Even in the case of a complete response letter [from the FDA], an outcome we continue to see as unlikely, the [approval] delay would be relatively modest," Tsao wrote.
On Abuse Potential Claim
As for the suggestion bitopertin has abuse potential, Disc Medicine's management stated that evaluating this is a standard part of the FDA's drug review process, reported Tsao. In addition, in its new drug application package, the life sciences company provided all relevant information to the agency.
Further, the analyst noted, when Roche was developing bitopertin, it studied abuse potential and determined it was not an issue.
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Disclosures for H.C. Wainwright & Co. Disc Medicine Inc., January 16, 2026
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H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Douglas Tsao and Lucy Lai, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Disc Medicine, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of December 31, 2025 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Disc Medicine, Inc..
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