Journey Medical Corp. (DERM) Monday announced FDA's acceptance of its New Drug Application for DFD-29 or Minocycline Hydrochloride Modified Release Capsules, 40 mg for the treatment of inflammatory lesions and erythema of rosacea in adults. The Prescription Drug User Fee Act goal will be November 4, 2024.
Rosacea is an inflammatory skin condition that causes small, red, pus-filled bumps, redness and visible blood vessels in the face.
In the pre-market session, the shares are at $3.71, up 9.12 percent from the previous close of $3.40.
The commercial-stage pharmaceutical company said, if approved, DFD-29 will be the only oral medication to address both inflammatory lesions and erythema from rosacea.
The company said the NDA submission was supported by positive data from its two DFD-29 Phase 3 clinical trials. The Phase 3 clinical trials achieved all co-primary and secondary endpoints. While evaluating erythema or redness associated with rosacea, one of the secondary endpoint, DFD-29 showed a statistically significant reduction in Clinician's Erythema Assessment compared to placebo.
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