Promising Developments at Disc Medicine: NDA Filing and Phase III Trial for Bitopertin in EPP

TD Cowen analyst Tara Bancroft has maintained their bullish stance on IRON stock, giving a Buy rating today.

Tara Bancroft’s rating is based on several promising developments at Disc Medicine. The company is preparing for a significant second half of the year, with plans to file a New Drug Application (NDA) for bitopertin in Erythropoietic Protoporphyria (EPP) and the initiation of a confirmatory Phase III trial. These steps are crucial as they could lead to accelerated approval, given the FDA’s recognition of the high unmet need in EPP and support for using PPIX as a surrogate endpoint.
Bancroft also highlights the company’s successful meetings with the FDA, which have aligned on the regulatory path and manufacturing aspects of the NDA. The initiation of the APOLLO study, a post-marketing trial, further strengthens the company’s position, with plans to enroll 150 patients across multiple regions. The trial’s design, including the selection of a higher dose and inclusion of adolescents, aligns with FDA guidance and addresses gaps in current treatments, enhancing the likelihood of a successful outcome.

In another report released today, LifeSci Capital also maintained a Buy rating on the stock with a $85.00 price target.