2023-04-20 06:57:55 ET
Shares of medical dermatology company Dermata Therapeutics ( NASDAQ: DRMA ) jumped ~28% in the pre-market trading Thursday after issuing updates on its late-stage clinical program for acne candidate DMT310.
Aiming to discuss a Phase 3 trial for DMT310 in moderate-to-severe acne, Dermata ( DRMA ) said it filed an end-of-Phase 2 meeting package to the FDA, and the company expects to receive the agency's response by the end of June 2023.
Depending on FDA feedback, Dermata ( DRMA ) expects to launch a Phase 3 program for the candidate in acne in H2 2023. Subject to positive data, it also intends to submit a new drug application for DMT310 targeting moderate-to-severe acne.
Dermata ( DRMA ) also said it received a positive response from the FDA regarding the company's Type C Chemistry, Manufacturing, and Controls (CMC) meeting request. The agency has noted the CMC procedures and controls, as cited in the documentation, were enough to support the start of Phase 3 studies.
While Dermata ( DRMA ) is a favorite on Wall Street with an average rating of Buy from analysts, Seeking Alpha's Quant System, which consistently beats the market, rates DRMA as a Hold.
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Dermata climbs ~28% after update on acne candidate