Total net revenue was $17.4 million in the second quarter of 2023, a 40% increase from $12.4 million in the first quarter of 2023 Positive topline results from two Phase 3 clinical trials evaluating DFD-29 demonstrated achievement of co-primary and all secondary endpoints versus placebo and Oracea® (doxycycline) with no significant safety issues Fortress is advancing several late-stage clinical assets with two NDA submissions anticipated in the second half of 2023 for DFD-29 and CUTX-101 Cosibelimab longer-term results demonstrated substantial increases in complete response rates in advanced cutaneous squamous cell carcinoma PDUFA goal date of January 3, 2024, set by FDA for cosi

Study met primary endpoint with 47.4% objective response rateSafety and tolerability profile consistent with previously reported dataPlanned BLA submission on track for later this yearConference call to be held today, Tuesday, January 25, 2022, at 8:30 AM ET WALTHAM, Mass., Jan. 25, 2022 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced positive topline results from its registration-enabling clinical trial evaluating the safety and efficacy of its anti-PD-L1 antibody, cosibelimab, administered as a fixed dose of 800 mg every two weeks in patients with metastatic cutaneous squamous c

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Cosibelimab is its anti-programmed death ligand-1 ("PD-L1") antibody, as a potential new treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation. The resubmission has been accepted as a complete response to the FDA's December 2023 complete response letter ("CRL") and the FDA has set a Prescription Drug User Fee Act ("PDUFA") goal date of December 28, 2024.

HC Wainwright & Co. analyst Joseph Pantginis reiterates Checkpoint Therapeutics (NASDAQ:CKPT) with a Buy and maintains $34 price target.

Collaboration explores the potential synergistic effects of Checkpoint's anti-PD-L1, cosibelimab, in combination with the autologous T cell therapy, Immuncell-LC

Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced it has entered into a definitive agreement with a single healthcare-dedicated institutional investor for the issuance and sale of an aggregate of 5,853,659 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $2.05 per share of common stock (or per common stock equivalent in lieu thereof), in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, Checkpoint will issue and sell unregistered warrants to purchase up to 5,853,659 shares of common stock. Th

Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced it has completed the resubmission of its Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation.   The BLA resubmission follows Checkpoint recently reaching alignment with the FDA on its BLA resubmission strategy to potentially address all approvability deficiencies out

HC Wainwright & Co. analyst Joseph Pantginis reiterates Checkpoint Therapeutics (NASDAQ:CKPT) with a Buy and maintains $34 price target.

HC Wainwright & Co. analyst Joseph Pantginis reiterates Checkpoint Therapeutics (NASDAQ:CKPT) with a Buy and maintains $34 price target.

Checkpoint Therapeutics (NASDAQ:CKPT) reported quarterly losses of $(0.33) per share which missed the analyst consensus estimate of $(0.27) by 22.22 percent. This is a 62.92 percent increase over losses of $(0.89) per share from the same period last year.

Emrosi approved by FDA on November 4 for the treatment of inflammatory lesions of rosacea in adults Cosibelimab PDUFA goal date of December 28 for potential approval to treat metastatic or locally advanced cutaneous squamous cell carcinoma MIAMI, Nov. 14, 2024 (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 revenue, today announced financial results and recent corporate highlights for the third quarter ended September 30, 2024. Lindsay A. Rosenwald, M.D., Fortress' Chairman,

Biologics License Application for cosibelimab under review by U.S. FDA PDUFA goal date of December 28, 2024 WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the third quarter ended September 30, 2024, and recent corporate updates. "With the Prescription Drug User Fee Act ("PDUFA") goal date set for next month, we await the decision by the U.S. Food and Drug Administration ("FDA") on our Biologics License Application ("BLA") resubmission for cosibelimab, our anti-programmed death ligand-1 ("PD-L1") antibody," said James Oliviero

WALTHAM, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the presentation of longer-term data from its pivotal trial of cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, in locally advanced and metastatic cutaneous squamous cell carcinoma ("cSCC") during the European Society for Medical Oncology ("ESMO") Congress 2024, which is taking place in Barcelona, Spain, from September 13 to 17, 2024. Poster Presentation Title: Cosibelimab in Advanced Cutaneous Squamous Cell Carcinoma (CSCC): Longer-term Efficacy and Safety Results from Pivotal Study

WALTHAM, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that James Oliviero, President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 26th Annual Global Investment Conference on Tuesday, September 10, 2024, at 10:00 a.m. ET. The Company will also attend in-person and virtual one-on-one meetings during the conference. A webcast of the presentation will be available on the News & Events page, located within the Investors section of Checkpoint's website, https://ir.checkpointtx.com/event-calendar/default.aspx, for approxim

PDUFA goal date of November 4, 2024 for DFD-29 for the treatment of inflammatory lesions and erythema of rosacea in adults FDA accepted Biologics License Application resubmission for cosibelimab to treat metastatic or locally advanced cutaneous squamous cell carcinoma; PDUFA goal date of December 28, 2024 MIAMI, Aug. 13, 2024 (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 revenue, today announced financial results and recent corporate highlights for the second quarter ended J

WALTHAM, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced financial results for the second quarter ended June 30, 2024, and recent corporate updates. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "We've made significant recent progress as we seek approval of cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (‘'cSCC'') who are not candidates for curative surgery or curative radiation. We are pleased to have reached alignment with the U.S. Food and Drug Admin

WALTHAM, Mass., July 25, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that the U.S. Food and Drug Administration ("FDA") has accepted for review Checkpoint's resubmission of its Biologics License Application ("BLA") for cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, as a potential new treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation. The resubmission has been accepted as a complete response to the FDA's December 2023 complete response let

Collaboration explores the potential synergistic effects of Checkpoint's anti-PD-L1, cosibelimab, in combination with the autologous T cell therapy, Immuncell-LC YONGIN, South Korea and WALTHAM, Mass., July 15, 2024 (GLOBE NEWSWIRE) -- GC Cell (KRX: 144510.KS) and Checkpoint Therapeutics ("Checkpoint") (NASDAQ:CKPT) have announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint's anti-PD-L1 antibody with dual mechanism of action, with GC Cell's Immuncell-LC, an innovative autologous Cytokine Induced Killer ("CIK") T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells. This collaboration will initially focus on conducting in

WALTHAM, Mass., July 02, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced it has entered into a definitive agreement with a single healthcare-dedicated institutional investor for the issuance and sale of an aggregate of 5,853,659 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $2.05 per share of common stock (or per common stock equivalent in lieu thereof), in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, Checkpoint will issue and sell unregistered warrants to

WALTHAM, Mass., July 02, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ:CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced it has completed the resubmission of its Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for cosibelimab, its anti-programmed death ligand-1 ("PD-L1") antibody, as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation. The BLA resubmission follows Checkpoint recently reaching alignment with the FDA on its BLA resubmission strategy to pote