Journey Medical

DFD-29, a modified-release minocycline hydrochloride capsule (40 mg), shows higher dermal concentration than doxycycline from Day 1, potentially offering better rosacea treatment. Its New Drug Application is under FDA review, with a decision expected by November 4, 2024. Both drugs were well tolerated in healthy subjects.

Highly anticipated FDA approvals by year-end include acoramidis for ATTR-CM, olezarsen for FCS, sotagliflozin for type 1 diabetes, oral sulopenem for uUTI, and DFD-29 for rosacea.

Lake Street Capital Markets initiated coverage on Journey Medical Corp. with a Buy rating and a $9.00 price target, highlighting DFD-29's potential. The analyst anticipates DFD-29 will dominate its category and turn AEBITDA positive in 2025. Journey Medical reported Q2 net product revenue of $14.9 million, exceeding expectations, and DFD-29's PDUFA date is set for November 4, 2024. The company plans to discontinue Amino and reduce sales territories, aiming for portfolio expansion.

Emrosi, a low-dose minocycline hydrochloride extended-release capsule, was FDA approved on November 1, 2024, for treating rosacea's inflammatory lesions in adults. Supported by Phase 3 trials, it showed superiority over standard treatments. Warnings include skin reactions, tooth discoloration, and CNS side effects. Common adverse reaction is dyspepsia.

The FDA has accepted Journey Medical’s new drug application for DFD-29, a minocycline hydrochloride modified release capsule for rosacea treatment, setting a PDUFA date of Nov. 4. Supported by positive phase 3 trial data, DFD-29 aims to address both inflammatory lesions and erythema, potentially becoming a preferred treatment option.

Journal Medical's DFD-29, a new oral treatment for rosacea, has been accepted by the FDA with a PDUFA date of November 4, 2024. Positive phase 3 trial results show significant improvement in treating inflammatory lesions and erythema compared to doxycycline and placebo, with no major safety concerns.

Journey Medical Corporation announced FDA acceptance of its NDA for DFD-29, targeting rosacea treatment, with a PDUFA goal date of November 4, 2024. DFD-29, supported by positive Phase 3 trial data, aims to treat both inflammatory lesions and erythema, potentially becoming a preferred oral medication for rosacea.

Journey Medical Corporation announced FDA acceptance of its NDA for DFD-29, targeting rosacea treatment, with a PDUFA goal date of November 4, 2024. DFD-29 showed superiority in Phase 3 trials over current treatments, aiming to address both inflammatory lesions and erythema in rosacea patients.

The FDA accepted Journey Medical's NDA for DFD-29, targeting rosacea treatment, with a PDUFA goal date of November 4, 2024. DFD-29, supported by positive Phase 3 trial data, aims to treat both inflammatory lesions and erythema, potentially becoming the preferred oral medication for rosacea.

Journey Medical submitted a new drug application to the FDA for DFD-29, an oral treatment for rosacea, after two phase 3 trials showed significant efficacy and safety improvements over placebo and doxycycline in treating inflammatory lesions and erythema.