The U.S. Food and Drug Administration (FDA) reviewers on Thursday postponed their decision on an experimental treatment from Disc Medicine Inc. (NASDAQ:IRON) by about two weeks to Feb.10.

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The drug, bitopertin, is being developed for erythropoietic protoporphyria, a rare blood disorder that causes extreme sensitivity to sunlight.

Regulators questioned whether "pain-free time in the sun," a secondary endpoint in trials, was a statistically reliable measure of effectiveness or whether biomarker data could instead support approval.

Citing internal documents, the Reuters report on Thursday added that FDA staff responsible for evaluating drugs with abuse potential were asked to examine whether bitopertin posed any risk of misuse or addiction, adding another layer to the review process.

H.C. Wainwright on Friday said, “…We continue to think it is likely noise.”

Analyst Douglas Tsao said the company was not aware of a specific FDA action date before the article was published, though the implied Jan. 27 timing is consistent with prior FDA guidance for the CNPV program and management's expectation of an end-January or early-February decision. Disc received CNPV designation in October.

In December, STAT News reported the FDA’s Center for Biologics Evaluation and Research head Vinay Prasad expressed skepticism about bitopertin's efficacy under the CNPV program.

However, because bitopertin is under review by CBER, management said it is unclear what role, if any, Prasad has in the review or decision-making process.

Disc added that its interactions with the FDA have followed a "regular" review process, though they have been more frequent due to the accelerated timeline.

“Another leak belies internal controversies within the FDA; we still remain confident that approval will occur,” Tsao said on Friday.

“Even in the case of a CRL — an outcome we continue to see as unlikely — the delay would be relatively modest,” Tsao wrote in an investor note.

HC Wainwright reiterates the Buy rating, with a price forecast of $118.

IRON Price Action: Disc Medicine stock is up 2.59% at $72.88 at publication on Friday.

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