Fortress Biotech, Inc. - FBIO STOCK NEWS

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.

Journey Medical (DERM) reported Q3 2024 financial results with total revenues of $14.6 million, marking a 4% decrease from Q3 2023. The company received FDA approval for Emrosi™, a treatment for inflammatory lesions of rosacea in adults, with launch expected in late Q1 or early Q2 2025. Q3 2024 showed a net loss of $2.4 million ($0.12 per share), compared to net income of $16.8 million in Q3 2023. Gross margin improved to 63.9% from 57.9% year-over-year. The company ended the quarter with $22.5 million in cash and cash equivalents.

Journey Medical (Nasdaq: DERM) has received FDA approval for Emrosi™, a 40 mg minocycline hydrochloride extended-release capsule for treating inflammatory lesions of rosacea in adults. The approval is backed by successful Phase 3 clinical trials where Emrosi demonstrated superior efficacy compared to both Oracea® 40 mg capsules and placebo. The trials met all co-primary and secondary endpoints with no significant safety concerns. Journey Medical plans to launch Emrosi in the U.S. market through its dermatology-focused sales force, with initial supply expected late Q1 or early Q2 2025.

Journey Medical (Nasdaq: DERM) presented data on DFD-29, a minocycline-based treatment for rosacea, at the 44th Fall Clinical Dermatology Conference. The study compared DFD-29 (40mg) with doxycycline (40mg) over 21 days, showing DFD-29 achieved higher dermal concentrations from Day 1. The company's New Drug Application is under FDA review with a PDUFA date of November 4, 2024. The randomized study demonstrated that DFD-29's modified-release formulation maintained consistent plasma levels while providing superior skin penetration compared to doxycycline, with both treatments showing good tolerability.

Journey Medical (Nasdaq: DERM), a commercial-stage pharmaceutical company specializing in FDA-approved prescription drugs for dermatological conditions, has announced its participation in the 3rd Annual ROTH Healthcare Opportunities Conference. The event is set to take place on Wednesday, October 9, 2024, in New York City.

Members of Journey Medical's management team will be attending one-on-one meetings during the conference. This participation highlights the company's commitment to engaging with investors and industry professionals in the healthcare sector.

The conference provides an opportunity for Journey Medical to showcase its focus on selling and marketing dermatological treatments, potentially attracting investor interest and fostering business relationships within the pharmaceutical industry.