Journey Medical
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 58
- Market Cap
- $109.6M
- Introduction
Journey Medical Corp. is a commercial-stage pharmaceutical company, which focuses on the development and commercialization of pharmaceutical products for the treatment of dermatological conditions. Its brands include QBREXZA, Accutane, Targadox, AMZEEQ, Ximino, ZILXI, Exelderm, and Luxamend. The company was founded by Claude Maraoui in October 2014 and is headquartered in Scottsdale, AZ.
Fortress Biotech Reports Strong 2024 Results with Two FDA Approvals and Strategic Acquisition Deal
• Fortress Biotech secured FDA approvals for two key products in Q4 2024: Emrosi for inflammatory lesions of rosacea and UNLOXCYT for advanced cutaneous squamous cell carcinoma, with commercial launch of Emrosi already underway.
• Subsidiary Checkpoint Therapeutics is being acquired by Sun Pharma in a deal valued at $4.10 per share plus potential CVR of $0.70, expected to generate approximately $28 million for Fortress plus a 2.5% royalty on UNLOXCYT sales.
• FDA accepted New Drug Application for CUTX-101 for priority review with PDUFA date of September 30, 2025, potentially qualifying for a valuable Priority Review Voucher upon approval.
Eirion Therapeutics' ET-02 Shows Promise in Phase 1 Trial for Androgenic Alopecia
• Eirion Therapeutics announced positive results from its first-in-man clinical trial of topical ET-02 for androgenic alopecia.
• The Phase 1 trial demonstrated that ET-02 was safe and well-tolerated among participants.
• Early results indicated that improvements were observed as early as 5 weeks into the treatment.
• The 5% dosage of ET-02 showed a significant increase in non-vellus hair count, marking a potential breakthrough in hair loss treatment.
FDA Approves Emrosi (Minocycline Hydrochloride) for Rosacea Treatment in Adults
• The FDA has approved Emrosi (minocycline hydrochloride) as a 40mg extended-release capsule for treating inflammatory lesions of rosacea in adults.
• Emrosi demonstrated statistically significant superiority over Oracea and placebo in Phase 3 trials, showing success in Investigator’s Global Assessment and lesion reduction.
• Journey Medical anticipates launching Emrosi in early 2025, positioning it as a potential best-in-class oral medication for rosacea with a favorable safety profile.
• Emrosi's extended-release formulation delivers minocycline steadily, mitigating drug level fluctuations and improving tolerability for patients with rosacea.
FDA Grants Priority Review to CUTX-101 for Menkes Disease, Offering Hope for Rare Pediatric Condition
• The FDA has accepted Sentynl Therapeutics' NDA for CUTX-101, granting priority review for the treatment of Menkes disease, a rare genetic disorder.
• Clinical trials of CUTX-101 demonstrated an almost 80% reduction in mortality risk compared to untreated patients, significantly improving overall survival.
• CUTX-101 has been granted multiple designations, including Breakthrough Therapy and Orphan Drug, highlighting its potential to address a critical unmet need.
• Cyprium Therapeutics is eligible to receive up to $129 million in milestone payments and royalties, retaining ownership of a potential Priority Review Voucher.
FDA Approves Journey Medical's Emrosiâ„¢ for Rosacea Treatment
• The FDA has approved Emrosi™ (minocycline hydrochloride extended-release capsules, 40 mg) for treating inflammatory lesions of rosacea in adults.
• Journey Medical anticipates launching Emrosi™ in late Q1 or early Q2 of 2025, expanding their dermatology-focused product portfolio.
• Clinical data presented at the 44th Fall Clinical Dermatology Conference highlighted Emrosi's higher dermal concentration compared to doxycycline.
• The approval marks a significant advancement in rosacea treatment, addressing a prevalent dermatological condition.
FDA Wraps Up 2024 with Key Approvals for Drugs Targeting Various Conditions
• The FDA approved Vertex's Alyftrek for cystic fibrosis, offering improved dosing and potential market exclusivity.
• Novo Nordisk's Alhemo was approved for hemophilia A and B, providing a new option for patients with inhibitors.
• Bristol Myers Squibb's Opdivo Qvantig gained approval as a subcutaneous formulation, offering faster administration for various solid tumors.
• Eli Lilly's Zepbound secured approval for obstructive sleep apnea in obese adults, marking the first prescription medicine for this condition.
FDA Approves UCB's Bimzelx (bimekizumab-bkzx) for Hidradenitis Suppurativa
• The FDA has approved Bimzelx (bimekizumab-bkzx) as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa (HS).
• Approval was based on Phase 3 trials (BE HEARD I and BE HEARD II) demonstrating significant improvement in HS signs and symptoms at Week 16 and sustained responses at Week 48.
• Bimekizumab-bkzx showed a higher proportion of patients achieving HiSCR50 (50% improvement) compared to placebo, along with clinically meaningful improvements in HiSCR75.
• This approval marks the fifth patient population in the U.S. that may benefit from Bimzelx, addressing a substantial unmet need in HS treatment.
Fortress Biotech's Emrosi Receives FDA Approval for Rosacea Treatment
• The FDA approved Emrosi (minocycline hydrochloride extended-release capsules, 40mg) for treating inflammatory lesions of rosacea in adults, marking Fortress Biotech's first FDA approval.
• Clinical data presented at the Fall Clinical Dermatology Conference showed Emrosi provides higher dermal concentration than doxycycline, potentially leading to clinically meaningful impact.
• Fortress Biotech anticipates a PDUFA goal date of December 28, 2024, for cosibelimab, an anti-PD-L1 antibody, for treating metastatic or locally advanced cutaneous squamous cell carcinoma.
• Journey Medical will launch Emrosi in late Q1 or early Q2 2025, offering a potential new treatment paradigm for millions suffering from rosacea.
Fortress Biotech Highlights FDA Approval of Emrosi and Cosibelimab's Upcoming PDUFA Date
• Fortress Biotech announced FDA approval for Emrosi (minocycline hydrochloride) for treating inflammatory lesions of rosacea in adults, marking their first FDA approval.
• The PDUFA goal date for cosibelimab, an anti-PD-L1 antibody, is set for December 28, 2024, targeting metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC).
• Clinical data presented at the Fall Clinical Dermatology Conference showed Emrosi has higher dermal concentration than oral doxycycline for rosacea treatment.
• Longer-term data from the pivotal trial of cosibelimab in cSCC demonstrated deepening responses over time, with higher objective and complete response rates.
Journey Medical's Emrosi Receives FDA Approval for Rosacea Treatment
• Journey Medical's Emrosi (Minocycline Hydrochloride Extended Release Capsules, 40 mg) has been approved by the FDA for treating inflammatory lesions of rosacea in adults.
• The launch of Emrosi is anticipated in late Q1 or early Q2 of 2025, following the completion of manufacturing activities and deployment of the dermatology sales force.
• Clinical data presented at a recent conference highlighted Emrosi's higher dermal concentration compared to oral Doxycycline, potentially leading to clinically meaningful impact.
• Journey Medical reported $14.6 million in total revenues for Q3 2024, with a focus on commercializing core dermatology products and preparing for the launch of Emrosi.
FDA Approves Emrosi for Rosacea, Proposes Removal of Oral Phenylephrine
• The FDA has approved Journey Medical's Emrosi (minocycline hydrochloride extended-release capsules) for treating inflammatory lesions of rosacea in adults, based on positive Phase 3 trial data.
• Clinical trials demonstrated that Emrosi was more effective than both placebo and the current standard treatment, Oracea, in reducing inflammatory lesions associated with rosacea.
• The FDA is proposing to remove oral phenylephrine from the list of active ingredients allowed in over-the-counter (OTC) nasal decongestants due to its lack of proven effectiveness.
• Starting March 31, 2025, the FDA will require companies participating in the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) program to provide mail-back envelopes for opioid analgesics.
FDA Approves Emrosi (Minocycline) for Rosacea Treatment
• The FDA has approved Emrosi, an oral minocycline capsule, for treating rosacea in adults, offering a new option to manage the pimple-like bumps by reducing inflammation.
• Emrosi's formulation includes immediate and extended-release minocycline, designed for once-daily dosing to maintain steady drug levels and potentially reduce side effects.
• Clinical trials demonstrated Emrosi's effectiveness in improving rosacea symptoms compared to placebo and a standard treatment, with availability expected in late 2024 or early 2025.
• Common side effects include indigestion, and warnings advise against use during later pregnancy and early childhood due to potential tooth staining and bone growth effects.
FDA Approves Journey Medical's Emrosi for Inflammatory Lesions of Rosacea
• The FDA has approved Journey Medical's Emrosi (minocycline hydrochloride) for treating inflammatory lesions of rosacea in adults.
• Phase 3 trials demonstrated Emrosi's superiority over Oracea and placebo in Investigator's Global Assessment treatment success and lesion reduction.
• Emrosi is expected to be available in late Q1 or early Q2 2025, with Journey Medical preparing for a successful launch.
• Rosacea affects over 16 million people in the US, significantly impacting self-esteem and professional interactions.
Beam Therapeutics Reports Patient Death in BEAM-101 Sickle Cell Disease Trial
• Beam Therapeutics reported a patient death in their Phase I/II trial of BEAM-101 for sickle cell disease, attributed to busulfan conditioning, not the therapy.
• Sana Biotechnology is refocusing on autoimmune assets, leading to workforce reductions and program cuts to extend its cash runway into 2026.
• OSE Therapeutics announced positive Phase II data for lusvertikimab in ulcerative colitis, marking a significant step for the anti-IL-7 therapy.
• Ring Therapeutics is partnering with Singaporean institutions to advance a new class of viral vectors based on commensal anelloviruses.
FDA Approves Journey Medical's Emrosi (Minocycline) for Rosacea Treatment
• The FDA has approved Journey Medical's Emrosi (minocycline hydrochloride extended-release capsules, 40 mg) for treating inflammatory lesions of rosacea in adults.
• Emrosi demonstrated statistically significant superiority over placebo and Oracea 40 mg capsules in Phase 3 trials, meeting all co-primary and secondary endpoints.
• Journey Medical anticipates Emrosi will be available in the US market by late Q1 or early Q2 of 2025, with commercialization through its dermatology-focused sales team.
• Emrosi has the potential to become the best-in-class oral medication for rosacea, offering a new standard of care for millions of rosacea patients in the US.
FDA Approves Journey Medical's Emrosi (Minocycline HCl) for Rosacea
• The FDA has approved Journey Medical's Emrosi (minocycline hydrochloride extended-release capsules, 40 mg) for treating inflammatory lesions of rosacea in adults.
• Emrosi's approval is based on positive Phase 3 trial data (MVOR-1 and MVOR-2) demonstrating efficacy and tolerability compared to placebo and Oracea (doxycycline 40mg).
• Journey Medical anticipates Emrosi will be available in the US market in late Q1 or early Q2 2024, offering a new oral standard of care.
• Rosacea affects over 16 million Americans, and Emrosi aims to address the condition's impact on self-esteem and social interactions.
FDA Approves Journey Medical's Emrosi for Rosacea Treatment
• The FDA has approved Journey Medical's Emrosi (minocycline hydrochloride extended-release capsules) for treating rosacea, a chronic inflammatory skin condition.
• Phase III clinical trials demonstrated Emrosi's statistically significant superiority over placebo and the current standard of care, Oracea, in reducing rosacea symptoms.
• Journey Medical anticipates Emrosi will be available to U.S. patients in the first half of 2025, aiming to establish it as a new standard of care.
• Emrosi's approval marks a potential shift in the rosacea treatment market, where Journey Medical seeks to become a leading player.
FDA Approves Emrosi (DFD-29) for Rosacea-Related Inflammatory Lesions in Adults
• The FDA has approved Emrosi (minocycline hydrochloride extended-release capsules, 40 mg) for treating inflammatory lesions caused by rosacea in adults.
• Approval was based on positive results from two Phase 3 clinical trials (MVOR-1 and MVOR-2) that demonstrated statistically significant superiority over placebo and doxycycline.
• DFD-29 showed greater Investigator's Global Assessment (IGA) treatment success and reduction in total inflammatory lesion count compared to both placebo and doxycycline.
• A pharmacokinetic study showed DFD-29 provides higher dermal concentrations of minocycline compared to doxycycline from Day 1, suggesting a clinically meaningful impact.
FDA Approves Emrosi (Minocycline) for Rosacea Treatment
• The FDA has approved Emrosi (minocycline hydrochloride extended-release capsules 40 mg) for treating rosacea in adults, offering a new therapeutic option.
• Phase 3 trials demonstrated Emrosi's superiority over placebo and Oracea (doxycycline) in improving IGA scores and reducing inflammatory lesions after 16 weeks.
• Developed by Journey Medical in collaboration with Dr. Reddy’s Laboratories, Emrosi is expected to be available in the U.S. market in early 2025.
• Emrosi's narrow spectrum of antibiotic activity may appeal to patients concerned about antibiotic resistance, according to the National Rosacea Society.
FDA Approves Minocycline Hydrochloride (Emrosi) for Rosacea
• The FDA has approved minocycline hydrochloride extended-release capsules (Emrosi) for treating inflammatory lesions of rosacea in adults.
• Phase III trials (MVOR-1 and MVOR-2) demonstrated that minocycline hydrochloride achieved significantly greater treatment success compared to doxycycline and placebo.
• Minocycline hydrochloride showed superior mean reductions in inflammatory lesion counts compared to doxycycline and placebo in clinical trials.
• Journey Medical anticipates Emrosi will be available in the first half of 2025, offering a new treatment option for rosacea patients.
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