Wedbush analyst David Nierengarten has reiterated an Outperform rating for Disc Medicine (NASDAQ: IRON), maintaining a price target of $88. The reaffirmation signals continued confidence in the company's performance potential.

The rating and price target remain unchanged following the review. Disc Medicine is listed on the NASDAQ under the ticker symbol IRON.

Disc Medicine, Inc. has completed a Type A meeting with the US Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) regarding the New Drug Application (NDA) for bitopertin in erythropoietic protoporphyria (EPP). The company aligned with the FDA that the ongoing Phase 3 APOLLO study, if successful, can serve as the basis for a response to the CRL and could potentially support a traditional approval. This alignment provides a regulatory path forward for the treatment of patients suffering from serious hematologic diseases.

The APOLLO study is a double-blind, placebo-controlled Phase 3 trial evaluating bitopertin in patients ages 12 and above with EPP and X-linked protoporphyria (XLP). The study includes sites in the US, Canada, Europe, and Australia. The co-primary endpoints are the average monthly total time in sunlight without pain between 10:00 and 18:00 during the last month of the 6-month treatment period and the percent change from baseline in whole blood metal-free PPIX after 6 months of treatment.

John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine, stated that the discussion with the FDA provided valuable clarity on the path forward for the bitopertin NDA. The company remains committed to advancing bitopertin as a potential treatment option for patients with EPP.

Data from the APOLLO study is expected in Q4 2026. Following the data release, Disc Medicine plans to submit a response to the CRL. An FDA decision is expected by mid-2027.