Disc Medicine (IRON) faces a delayed timeline for bitopertin after receiving a complete response letter from the US Food and Drug Administration, but the company has enough runway and multiple upcoming pipeline catalysts, Morgan Stanley said in a Monday note.
The firm said the regulator requested data from a confirmatory phase 3 trial to support traditional approval of bitopertin, with data readout now expected in Q4 and a potential updated FDA decision by mid-2027.
Morgan Stanley noted the company ended 2025 with about $791 million in cash and cash equivalents, providing runway into 2029, and is well-capitalized even without near-term bitopertin revenue.
The firm highlighted multiple upcoming catalysts, including phase 3 topline data on bitopertin, regulatory interactions with the FDA, and multiple pipeline readouts, including updated data for DISC-0974 in anemia of myelofibrosis as well as data for DISC-3405 in polycythemia vera and sickle cell disease.
Morgan Stanley maintained its overweight rating on Disc Medicine and cut its price target to $75 from $120.
Shares of Disc Medicine were up over 12% in recent Tuesday trading.
Price: 62.99, Change: +7.04, Percent Change: +12.57