Fortress Biotech, Inc. - FBIO STOCK NEWS

Fortress Biotech subsidiary, Aevitas Therapeutics, has entered into an asset purchase agreement with 4D Molecular Therapeutics (4DMT) for Aevitas' short-form human complement factor H (sCFH) asset, targeting complement-mediated diseases. The agreement could yield up to $140 million in milestone payments and royalties for Aevitas. 4DMT plans to develop product candidate 4D-175 to treat Geographic Atrophy (GA) linked to age-related macular degeneration (AMD). This innovative therapy combines Aevitas' sCFH with 4DMT's proprietary vector, enhancing treatment efficacy. Fortress' CEO, Lindsay A. Rosenwald, emphasized the partnership’s potential to generate shareholder value by expediting the development of this promising therapy. The technology aims to restore normal complement regulation and reduce retinal injury.

Fortress Biotech, Inc. (Nasdaq: FBIO) reported consolidated net revenues of $75.7 million for the full-year 2022, a significant growth from $68.8 million in 2021. The company is gearing up to file three new drug applications in 2023, including the Biologics License Application for cosibelimab for cSCC and NDA submissions for CUTX-101 and DFD-29. Cosibelimab's FDA filing was accepted with a PDUFA date set for January 3, 2024. The company aims to enhance its clinical pipeline and diversify with new acquisitions while maintaining a strong growth trajectory amidst escalating R&D expenditures.

Journey Medical Corporation (Nasdaq: DERM) reported total revenues of $73.7 million for the full year 2022, reflecting a 17% increase from 2021. The company experienced a 9% decline in Q4 revenue, primarily due to generic competition affecting Targadox. Despite this, SG&A expenses increased due to expanded sales efforts, reaching $59.5 million. The net loss decreased to $29.6 million, or $1.69 per share from $44.0 million in 2021. Journey Medical completed enrollment for its Phase 3 clinical trials for DFD-29 in January 2023, with topline data expected soon. The company plans to file a New Drug Application in the second half of 2023.

Journey Medical Corporation (Nasdaq: DERM) has announced plans to release its year-end 2022 financial results on March 29, 2023, after U.S. market close. The Company will host a conference call at 4:30 p.m. ET to discuss the results and provide a corporate update. Interested parties can join the call by dialing 1-866-777-2509 (U.S.) or 1-412-317-5413 (international) approximately 10 minutes prior to start time. A live audio webcast and replays will be available on the Company’s website. Journey Medical focuses on dermatological pharmaceutical products and is based in Scottsdale, Arizona.

Journey Medical Corporation (Nasdaq: DERM) has completed treatment in its Phase 1 clinical trial of DFD-29, aimed at treating papulopustular rosacea. The trial involved 60 healthy adults and assessed both safety and tolerability, with no significant safety issues reported. Topline results from this trial are expected in the first half of 2023. Additionally, the Phase 3 trials for DFD-29 have been fully enrolled, with data anticipated in the same timeframe, leading to a potential New Drug Application filing later in 2023. Rosacea affects over 16 million Americans, emphasizing the market need for effective treatments.

Journey Medical Corporation (Nasdaq: DERM), a biopharmaceutical company focused on dermatological treatments, will participate in the 35th Annual ROTH Conference from March 12-14, 2023. CEO Claude Maraoui will host a fireside chat on March 14 at 9:30 a.m. PT and will be available for one-on-one meetings. A webcast of the chat will be accessible on Journey Medical's website for 30 days post-event. The company is committed to innovative dermatology products and currently markets eight treatments for common skin conditions. Founded by Fortress Biotech (Nasdaq: FBIO), Journey Medical is headquartered in Scottsdale, Arizona.

Fortress Biotech, Inc. (NASDAQ: FBIO) announced that Dr. Lindsay A. Rosenwald will participate in two investor conferences in March 2023. The 35th Annual ROTH Conference will include a fireside chat on March 13, 2023, at 9:00 a.m. PT, with a subsequent webcast available for 30 days. The Oppenheimer 33rd Annual Virtual Healthcare Conference will feature a presentation on March 15, 2023, at 12:40 p.m. ET, also followed by a 30-day webcast. Fortress Biotech focuses on acquiring, developing, and commercializing innovative therapeutic products, maintaining a diversified pipeline across various medical sectors.

Helocyte, a subsidiary of Fortress Biotech (Nasdaq: FBIO), announced the presentation of Phase 1 trial results for its CMV vaccine, Triplex, at the 2023 Tandem Meetings in Orlando. The trial highlighted that donor vaccination with Triplex significantly enhanced CMV-specific immunity in recipients of allogeneic hematopoietic cell transplants (HCT). Key findings showed an 18% rate of CMV events requiring antiviral intervention in recipients with vaccinated donors, compared to 37% in control cohorts. The promising results suggest potential for Triplex to reduce antiviral therapy needs and improve outcomes in immunocompromised transplant patients.

Helocyte, a subsidiary of Fortress Biotech (FBIO), announced a Phase 2 clinical trial to evaluate the efficacy of its Triplex vaccine in enhancing CMV-specific T cell immunity in stem cell transplant recipients. A Phase 1 pilot study demonstrated Triplex's feasibility, safety, and potential efficacy with significant increases in CMV-specific T cells in vaccinated donors. The trial revealed that only 18% of recipients with Triplex-vaccinated donors experienced CMV reactivation, compared to 37% in control groups. Helocyte's Triplex vaccine aims to improve post-transplant outcomes and decrease reliance on toxic antivirals.