Disc Medicine: Bitopertin’s Accelerated Approval Path and FDA Timing Support Buy Rating and $118 Target

Disc Medicine, the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Douglas Tsao from H.C. Wainwright reiterated a Buy rating on the stock and has a $118.00 price target.

Douglas Tsao has given his Buy rating due to a combination of factors related to Disc Medicine’s lead asset, bitopertin, and the overall regulatory backdrop. He views the recent Reuters report about a possible short delay in the FDA’s decision as largely a reflection of internal FDA dynamics and workload pressure under the new CNPV program, rather than a negative reassessment of bitopertin itself. In his view, the leak appears aimed at highlighting strain within the priority review system, not signaling an adverse shift specific to Disc’s application. Management’s description of its FDA interactions as standard for an expedited review, combined with a compressed but orderly timeline, reinforces his confidence that a near-term approval remains likely.

Tsao also emphasizes that bitopertin is being evaluated under the accelerated approval pathway using a surrogate endpoint—reduction in PPIX—which the FDA already accepts as predictive of clinical benefit in EPP/XLP, and which the pivotal trial has clearly demonstrated. He notes that longer-term clinical outcomes needed for full approval are being addressed in the ongoing confirmatory Apollo study, with data expected in 2026–2027, limiting downside even if additional work were requested. Concerns about abuse potential appear manageable, as abuse liability has been thoroughly assessed, including prior work by Roche, with no significant issues identified. Based on these regulatory and clinical considerations, Tsao’s financial model, which risk-adjusts pipeline assets, supports his $118 price target and underpins his continued Buy rating on Disc Medicine shares.

In another report released yesterday, LifeSci Capital also maintained a Buy rating on the stock with a $110.00 price target.