Journey Medical

In November 2024, the FDA approved 40-mg minocycline hydrochloride (Emrosi) for rosacea, marking a significant advancement as the first oral therapy targeting both erythema and inflammatory lesions. Supported by MVOR-1 and MVOR-2 trials, DFD-29 showed superior efficacy and safety over doxycycline, offering a novel, extended-release treatment option with potential to simplify rosacea management.

UCB’s Bimzelx approved for hidradenitis suppurativa; FDA approves Emrosi for rosacea, Danziten for CML without fasting, Aucatzyl for ALL, Kebilidi for AADC deficiency, Revuforj for acute leukemia, Ziihera for HER2-positive BTC, Attruby for ATTR-CM, Imkeldi for leukemia, and Rapiblyk for SVT, marking significant advancements in treatment options.

Emrosi, a minocycline hydrochloride extended-release capsule, was FDA approved on November 1, 2024, for treating rosacea's inflammatory lesions in adults. It's a low-dose, modified-release formulation, not for infections, to prevent drug resistance. Supported by Phase 3 trials, it's superior to Oracea® and placebo. Administered orally once daily, with warnings including skin reactions and CNS side effects.

The FDA approved Emrosi (minocycline hydrochloride) for treating inflammatory rosacea in adults, based on positive phase 3 trial results showing superiority over current treatments. Available in 2025, it aims to become a leading oral medication for rosacea.

Journey Medical Corporation announced Q2 2024 financial results with $14.9M revenue, a 14% increase from Q1. DFD-29, a rosacea treatment, is under FDA review with a PDUFA goal date of November 4, 2024. A conference call is scheduled for today at 4:30 p.m. ET to discuss updates.

Sentynl Therapeutics' NDA for CUTX-101, a Menkes disease treatment, received FDA Priority Review. Fortress Biotech and Cyprium Therapeutics also announced FDA acceptance for CUTX-101, with a PDUFA date of June 30, 2025. Checkpoint Therapeutics' UNLOXCYT™, an anti-PD-L1 treatment for cSCC, was FDA approved. Fortress Biotech reported Q3 2024 results, including FDA approval of Emrosi for rosacea. Avenue Therapeutics anticipates Phase 1b/2a trial data for AJ201 by end of 2024. Checkpoint Therapeutics awaits FDA decision on cosibelimab. Journey Medical Corporation's Emrosi™ for rosacea was FDA approved. Mustang Bio received Nasdaq listing extension and FDA Orphan Drug Designation for MB-108. Highbridge Capital acquired Fortress Biotech shares. Journey Medical presented DFD-29 data. Mustang Bio exercised warrants for $4M. Avenue Therapeutics to participate in Maxim Group’s 2024 Healthcare Virtual Summit.

FDA approved various treatments including Berdazimer Gel for Molluscum Contagiosum, Dupilumab for Atopic Dermatitis, Lifileucel for Melanoma, and others for conditions like Psoriasis, Rosacea, and Alopecia. Studies highlighted advancements in dermatology treatments and safety concerns over benzene in acne products.

2024 saw FDA approvals for treatments targeting conditions like atopic dermatitis, psoriasis, and prurigo nodularis. Notable approvals included Biofrontera's RhodoLED XL lamp, Arcutis Biotherapeutics' roflumilast cream, Sun Pharma's deuruxolitinib, Citius Pharmaceuticals' denileukindiftitox, Galderma's nemolizumab, Eli Lilly's lebrikizumab, UCB's bimekizumab, and Journey Medical's minocycline hydrochloride, enhancing therapeutic options across various dermatological conditions.

Zelsuvmi's approval for molluscum contagiosum tops Healio's most-read FDA approvals in dermatology for 2024, with other notable approvals including Xeomin, Klisyri, Zoryve, and more.