Disc Medicine's MWTX-003 Gets FDA Fast Track Designation For Polycythemia Vera Treatment; Stock Up

(RTTNews) - Disc Medicine Inc. (IRON) said that the United States Food and Drug Administration has granted Fast Track Designation to MWTX-003 for the treatment of patients with polycythemia vera or PV.

IRON closed Wednesday's regular trading at $48.98 down $1.87 or 3.68%. But in the after-hours trading the stock gained $5.59 or 11.41%.

Fast Track is a process designed by the FDA to facilitate the development and expedite the review of investigational drugs intended to treat serious conditions and for which nonclinical or clinical data demonstrate the potential to address unmet medical need.

A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan. Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data.

Polycythemia vera is a chronic and rare myeloproliferative neoplasm characterized by the abnormal proliferation of red blood cells. PV affects about 150,000 patients in the U.S. and has a similar prevalence in Europe. The overproduction of red blood cells alters the viscosity of blood, causing it to thicken and placing patients at an elevated risk of cardiovascular and thromboembolic events, such as heart attack and stroke.

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