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Rare Pediatric Disease Priority Review Voucher (PRV) granted by FDA at approval to be transferred from Sentynl Therapeutics to Cyprium
MIAMI, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the resubmission of the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class 1 resubmission and as a result, the new Prescription Drug User Fee Act (PDUFA) target action date for the NDA is January 14, 2026.
Clinical trial achieved all three primary objectives with no significant safety issues being reported Results indicate that Emrosi can be safely used for up to 16 weeks with no detectable impact on skin, GI tract or vaginal microbiota FDA-approved Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) is available in the United States for the treatment of inflammatory lesions of rosacea in adults SCOTTSDALE, Ariz., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company primarily focused on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that results from the Phase 1 clinical trial (DFD-29-CD-006) assessing the impact of low-dose oral minocycline (“DFD-29” or commercially known as “Emrosi™) on skin, gastrointestinal (“GI”) and vaginal microflora in healthy adults were published in the Journal of Drugs in Dermatology, a leading peer-reviewed publication in clinical dermatology.
Fortress Biotech (FBIO) came out with quarterly earnings of $0.11 per share, beating the Zacks Consensus Estimate of a loss of $0.43 per share. This compares to a loss of $0.76 per share a year ago.
Total net revenue increased 20.5% to $17.6 million for third quarter of 2025 compared to the third quarter of 2024 Fortress subsidiary Checkpoint Therapeutics acquired by Sun Pharma; Fortress received ~$28 million at closing and is eligible to receive up to an additional $4.8 million under a contingent value right (CVR), plus a 2.5% royalty on future net sales of UNLOXCYT™ (cosibelimab-ipdl) Dotinurad, a next-generation URAT1 inhibitor, is advancing in two Phase 3 clinical trials with potential for best-in-class safety and efficacy following Crystalys Therapeutics' $205 million Series A financing MIAMI, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2025. Lindsay A.
Fortress Biotech, Inc. ( FBIO ) Q3 2025 Earnings Call November 12, 2025 4:30 PM EST Company Participants Jaclyn Jaffe - Senior Director of Corporate Operations Claude Maraoui - Founder, President, CEO & Director Joseph Benesch - CFO & Corporate Controller Ramsey Alloush - COO, General Counsel & Company Secretary Conference Call Participants Brandon Folkes - H.C. Wainwright & Co, LLC, Research Division Scott Henry - Alliance Global Partners, Research Division Thomas Flaten - Lake Street Capital Markets, LLC, Research Division Mayank Mamtani - B.
Third quarter 2025 net revenues were $17.6 million Emrosi™ total prescriptions increased 146% over the second quarter of 2025 Emrosi net revenues were $4.9 million Company to hold conference call today at 4:30 p.m. ET to discuss the financial results and provide a business update SCOTTSDALE, Ariz.
MIAMI, Nov. 06, 2025 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (OTC: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, and its majority-owned subsidiary, Baergic Bio, Inc. (“Baergic”), today announced that Avenue has entered into an agreement for Baergic to be acquired by Axsome Therapeutics, Inc. (NASDAQ: AXSM) (“Axsome”), including the global rights to BAER-101 (also known as AZD7325), a novel oral GABAA α2,3 subtype-selective receptor positive allosteric modulator (PAM). BAER-101 was originally licensed by Baergic from AstraZeneca AB (“AstraZeneca”) and will be referred to as AXS-17 by Axsome going forward.
Company to host conference call to discuss financial results and provide a corporate update on November 12, 2025 at 4:30 p.m. ET Company to host conference call to discuss financial results and provide a corporate update on November 12, 2025 at 4:30 p.m. ET
Fortress Biotech, Inc. (NASDAQ: FBIOP - Get Free Report)'s share price was down 1.9% during mid-day trading on Monday. The stock traded as low as $6.80 and last traded at $6.87. Approximately 7,918 shares changed hands during mid-day trading, a decline of 46% from the average daily volume of 14,778 shares. The stock had previously
NEW YORK , Oct. 28, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Fortress Biotech Inc. ("Fortress" or the "Company") (NASDAQ: FBIO). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
FDA-approved Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) is available in the United States for the treatment of inflammatory lesions of rosacea in adults
NEW YORK , Oct. 23, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Fortress Biotech Inc. ("Fortress" or the "Company") (NASDAQ: FBIO). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
MIAMI, Oct. 21, 2025 (GLOBE NEWSWIRE) -- Urica Therapeutics, Inc. (“Urica” or the “Company”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary, today announced that Crystalys Therapeutics, Inc. (“Crystalys”), in which Urica maintains an equity position, dosed first patients in its two randomized, double-blind, multicenter global Phase 3 trials, the RUBY study (NCT07089875) and the TOPAZ study (NCT07089888), evaluating dotinurad, a next-generation, once daily oral, URAT1 inhibitor with potential for best-in-class safety and efficacy for the treatment of gout.
NEW YORK , Oct. 18, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Fortress Biotech Inc. ("Fortress" or the "Company") (NASDAQ: FBIO). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
NEW YORK , Oct. 13, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Fortress Biotech Inc. ("Fortress" or the "Company") (NASDAQ: FBIO). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
NEW YORK , Oct. 8, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Fortress Biotech Inc. ("Fortress" or the "Company") (NASDAQ: FBIO). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.
SCOTTSDALE, Ariz., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (“Journey Medical” or “the Company”) (Nasdaq: DERM), a commercial-stage pharmaceutical company primarily focused on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that members of Journey Medical's management team will participate in two October 2025 investor conferences.
LOS ANGELES, Oct. 01, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Fortress Biotech Inc., ("Slide" or the "Company") (NASDAQ: FBIO) investors that the firm has initiated an investigation into possible securities fraud, and may file a class action on behalf of investors.
ATLANTA, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Fortress Biotech, Inc. (“Fortress” or the “Company”) (NASDAQ: FBIO) complied with federal securities laws. On October 1, 2025, Fortress and its subsidiary, Cyprium Therapeutics, Inc., announced that the FDA issued a Complete Response Letter (“CRL”) relating to the New Drug Application (“NDA”) for CUTX-101 and that the “CRL noted cGMP deficiencies had been observed at the facility where CUTX-101 is manufactured.” Following this news, the price of the Company's stock dropped.