Fortress Biotech Inc Stock Price, News & Analysis

Journey Medical (NASDAQ: DERM) announced the publication of Phase 3 clinical trial results for Emrosi™ (DFD-29) in JAMA Dermatology. The trials demonstrated superior efficacy of DFD-29 (40 mg Minocycline Hydrochloride Modified-Release Capsules) compared to both Oracea® and placebo in treating rosacea.

Key findings from the MVOR-1 and MVOR-2 trials showed:

• DFD-29 achieved 65.0% and 60.1% IGA treatment success rates respectively
• Significant reduction in inflammatory lesions compared to alternatives
• Superior reduction in erythema versus placebo
• No major safety issues reported

The FDA approved Emrosi™ in November 2024 for treating inflammatory lesions of rosacea in adults, with launch expected in early spring 2025.

Journey Medical (Nasdaq: DERM) announced its participation in the 2025 American Academy of Dermatology Annual Meeting in Orlando, Florida, from March 7-11, 2025. The company will showcase Emrosi™, their newly FDA-approved treatment for inflammatory lesions of rosacea in adults, approved in November 2024.

Emrosi™, featuring 40 mg Minocycline Hydrochloride Modified-Release Capsules (10 mg immediate release and 30 mg extended release), is positioned as the lowest-dose oral minocycline available. According to the company, it demonstrates superior clinical outcomes for rosacea compared to placebo and Oracea® while maintaining a comparable safety profile.

The AAD annual meeting, with over 350 exhibitors and nearly 20,000 attendees, including 10,000+ medical personnel, will provide Journey Medical an opportunity to present their dermatology product portfolio at booth 2181.

Fortress Biotech (FBIO) has initiated dosing in a Phase 2 clinical trial evaluating Triplex, a cytomegalovirus (CMV) vaccine, in stem cell donors. The trial aims to reduce CMV events in patients undergoing hematopoietic stem cell transplantation (HSCT).

The multicenter, placebo-controlled study is funded by the National Cancer Institute and builds upon encouraging pilot study results. Triplex works by inducing CMV-specific immune responses in donors, which is then transferred to transplant recipients through adoptive immunity.

CMV reactivation affects 60-70% of CMV-seropositive HSCT recipients, with primary infection occurring in 20-30% of CMV-seronegative recipients. The trial is being conducted across three major transplant centers in the United States. A second NCI-funded trial is planned for higher-risk transplant recipients with partial HLA matches.

Journey Medical (Nasdaq: DERM) has announced a conference call and webcast scheduled for February 5, 2025, at 4:30 p.m. ET to discuss the commercial launch plan for Emrosi™, their newly FDA-approved treatment for inflammatory lesions of rosacea in adults.

The medication, which contains 40 mg Minocycline Hydrochloride in extended-release capsules, was developed in collaboration with Dr. Reddy's Laboratories and received FDA approval in November 2024. The company is currently completing manufacturing of launch quantities for the U.S. market and preparing their dermatology-focused sales force for the product rollout.

The conference call will be accessible via phone (1-866-777-2509 domestic, 1-412-317-5413 international) and webcast through Journey Medical's website. The most common adverse reaction reported in clinical trials was dyspepsia, occurring in ≥1% of subjects treated with Emrosi compared to placebo.

Fortress Biotech and its subsidiary Cyprium Therapeutics announced that the U.S. FDA has accepted the New Drug Application (NDA) for CUTX-101 (Copper Histidinate) for the treatment of Menkes disease, a rare pediatric condition. The NDA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2025.

In December 2023, Sentynl Therapeutics assumed responsibility for the development and commercialization of CUTX-101. Cyprium will receive royalties and up to $129 million in aggregate development and sales milestones, and retains ownership of any Priority Review Voucher issued upon NDA approval.

The NDA submission is supported by positive clinical efficacy results, showing a nearly 80% reduction in the risk of death for early-treated Menkes disease patients compared to untreated controls. Median overall survival was 177.1 months for the treated cohort versus 16.1 months for the control group. CUTX-101 has previously received multiple FDA designations, including Breakthrough Therapy and Orphan Drug.

If approved, CUTX-101 could become the first FDA-approved treatment for Menkes disease.

Sentynl Therapeutics has announced that the FDA has accepted and granted Priority Review to its New Drug Application (NDA) for CUTX-101, intended for the treatment of Menkes disease, a rare and fatal pediatric disorder.

The FDA has set a six-month review period with a target action date of June 30, 2025. If approved, CUTX-101 would be the first FDA-approved treatment for Menkes disease, which is caused by mutations in the ATP7A gene affecting copper transport in the body. Current estimates suggest a prevalence of 1 in 34,810 to 1 in 8,664 live male births.

Topline clinical efficacy results show that early treatment with CUTX-101 significantly improves overall survival in Menkes disease patients, reducing the risk of death by nearly 80% compared to an untreated historical control cohort. Median overall survival was 177.1 months for the early treatment cohort versus 16.1 months for the historical control.

Sentynl has taken over the development and commercialization of CUTX-101 from Cyprium Therapeutics, a subsidiary of Fortress Biotech. The drug has received multiple designations from the FDA, including Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug Designations, as well as Orphan Designation from the EMA.

Checkpoint Therapeutics (CKPT) has received FDA approval for UNLOXCYT™ (cosibelimab-ipdl), marking its first-ever marketing approval. The drug is the first FDA-approved PD-L1 blocking antibody for treating adults with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who aren't candidates for curative surgery or radiation.

The approval targets a U.S. market estimated to exceed $1 billion annually. UNLOXCYT is administered as a 1,200 mg intravenous infusion over 60 minutes every three weeks. The drug's unique features include binding to PD-L1 rather than PD-1 and the ability to induce antibody-dependent cell-mediated cytotoxicity (ADCC), differentiating it from existing therapies.

Fortress Biotech reported Q3 2024 financial results and highlights, including FDA approval of Emrosi for adult rosacea treatment. The company has an upcoming PDUFA date of December 28, 2024, for cosibelimab in treating advanced skin cancer. Q3 net revenue was $14.6 million from dermatology products, compared to $34.8 million in Q3 2023. Cash position stood at $58.9 million as of September 30, 2024. The company reported a net loss of $(15.0) million or $(0.76) per share. The board paused preferred stock dividends to maintain financial flexibility.

Checkpoint Therapeutics reported Q3 2024 financial results and updates. The FDA set a PDUFA goal date of December 28, 2024 for their cosibelimab BLA review. The company received $9.2 million from warrant exercises in November, extending cash runway into 2025. Q3 financials show cash position of $4.7 million, R&D expenses of $6.4 million (up from $5.5M YoY), and G&A expenses of $3.4 million (up from $2.2M YoY). Net loss was $9.7 million ($0.23 per share) compared to $5.7 million ($0.29 per share) in Q3 2023. The company presented promising longer-term data for cosibelimab in cSCC at ESMO Congress 2024.