Day: March 28, 2024

Announced Phase 2a study of SLS009 in r/r AML Showing 50% Response Rate in the Selected Optimal Dose of 30 mg BIW Exceeding the Targeted 20% and 100% Response Rate in Patients with Identified Biomarkers – Completed Enrollment in Phase 3 REGAL Study of Galinpepimut-S in Patients with Acute Myeloid Leukemia; Steering Committee Guided Interim Analysis May Be Imminent; IDMC Scheduled in Late April- Phase 1b/2 Study of SLS009 in Relapsed/Refractory Peripheral T-cell Lymphoma Patients Ongoing with Top-line Data Expected in First Half 2024 First Patient Dosed in Phase 1b/2 Study of SLS009 in Combination with Brukinsa® (Zanubrutinib, BTK Inhibitor) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)NEW YORK, March 28, 2024 (GLOBE NEWSWIRE) —  SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”),...

Four candidates planned to be in clinical development in 2024 with interim data from two studies anticipated by year end Clinical development timelines accelerated for ABI-5366; now anticipating interim data from Phase 1a available in 3Q2024, initiation of Phase 1b in individuals with recurrent genital herpes by end of 2024 and interim Phase 1b data available in 1H2025 Gilead Sciences, Inc. partnership supports advancement and strengthening of antiviral pipeline targeting serious viral diseasesSOUTH SAN FRANCISCO, Calif., March 28, 2024 (GLOBE NEWSWIRE) — Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today reported financial results and recent highlights for the fourth quarter and year ended December 31, 2023. “Our progress in 2023 demonstrated...

— Company to host call at 4:30pm today — NEWTOWN, Pa., March 28, 2024 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced results for the quarter and full year ended December 31, 2023. Fourth Quarter and Recent Business UpdatesSecured Healthcare Common Procedure Coding System (“HCPCS”) Level II codes for the Portable Neuromodulation Stimulator (“PoNS®”) mouthpiece and controller from the Centers for Medicare & Medicaid Services (“CMS”), representing a significant step toward reimbursement. Further expanded the registrational program in stroke by adding a second site and initiating an open-label study; reached alignment with the U.S. Food...

FORT WORTH, Texas, March 28, 2024 (GLOBE NEWSWIRE) — TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the fourth quarter and full year 2023. “Over the last several months, we have made significant progress showing that our Thin Film Freezing technology can be successfully applied, with both TFF TAC and TFF VORI demonstrating the potential to significantly improve the product profiles for two FDA-approved therapies,” said Harlan Weisman, M.D., Chief Executive Officer of TFF Pharmaceuticals. “As recently announced, we made the decision to prioritize the clinical development of TFF TAC, and we look forward to continuing...

SAN DIEGO, March 28, 2024 (GLOBE NEWSWIRE) — Telesis Bio Inc. (NASDAQ: TBIO), a leading provider of RNA and DNA solutions enabling researchers to accelerate therapeutic discovery through advanced, flexible, and rapid automated synthesis in their own lab, today announced financial results for the fourth quarter and year ended December 31, 2023. Results highlight strong BioXp® kit sales, expanding gross margin and reduced operating expense. In discussing the results, Todd R. Nelson Ph.D., Founder and CEO of Telesis Bio said, “I’m pleased with our operating execution in a challenging macro environment during 2023. Our company experienced record BioXp kits sales and expanding gross margin against the backdrop of significant cost cutting initiatives undertaken to align our operating structure with our strategic vision for growth. We...

Company progresses the development of furmonertinib with a data readout planned for 2024 Furmonertinib granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration Completed $201 million initial public offering (“IPO”) in January 2024NEWTOWN SQUARE, Pa., March 28, 2024 (GLOBE NEWSWIRE) — ArriVent BioPharma, Inc. (“Company” or “ArriVent”) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today reported financial results for the full year ended December 31, 2023, and highlighted recent company progress. “The fourth quarter was transformational for ArriVent, as we positioned our company for the successful IPO that we executed in January of this year and continued our strong progress with furmonertinib, which received Breakthrough...

Positive Business Momentum and Sales Pipeline Growth Following FDA 510(k) Clearance of Vivos’ Proprietary Oral Medical Devices to Treat Severe Obstructive Sleep Apnea Annual Operating Expenses Declined 27% Due to Success of Cost Cutting Initiatives Management to Host Conference Call Today at 5:00 pm ET LITTLETON, Colo., March 28, 2024 (GLOBE NEWSWIRE) — Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders (including all severities of obstructive sleep apnea (OSA in adults)), today reported financial results and operating highlights for the fourth quarter and full year ended December 31, 2023. Fourth Quarter and Full Year 2023 Financial...

ATLANTA, March 28, 2024 (GLOBE NEWSWIRE) — Sharecare (Nasdaq: SHCR), the digital health company that helps people manage all their health in one place, today announced financial results for the quarter and year ended December 31, 2023. “In my first three months as CEO, I have been increasingly impressed by Sharecare’s ability to innovate, and I believe that the breadth and depth of assets that the company has assembled over the years gives us everything we need to be successful,” said Brent Layton, CEO of Sharecare. “In addition to the strength of our core business that serves self-insured employers and health plans as well as health systems and life sciences companies, I am particularly encouraged by the momentum we are experiencing in Medicaid, Medicare, and the Exchange, value-based care, and reinsurance as our team...

Following FDA Clearance of FemaSeed®, Company Secures Capital to Support Commercial Initiatives; Cash Expected to Fund Operations Into 2H 2025 ATLANTA, March 28, 2024 (GLOBE NEWSWIRE) — Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, announces financial results for the year ended December 31, 2023 and provides a corporate update. Corporate Highlights from 4Q 2023 to dateCompany announced positive topline data from pivotal trial for FDA-cleared FemaSeed® for the treatment of infertility Following FDA clearance of FemaSeed, the Company’s revolutionary approach to artificial insemination, Femasys announced completion of enrollment in pivotal trial in support...

Reported positive Phase 1/2 proof-of-concept data for lonigutamab, first subcutaneous anti-IGF-1R to demonstrate clinical responses in thyroid eye disease patients Achieved primary endpoint with high statistical significance in global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis with robust clinical responses also achieved for higher hurdle endpoints Announced differentiated long-term 32-week data from global Phase 2b clinical trial of izokibep in hidradenitis suppurativa – ongoing Phase 3 trial is enrolling faster than previously expected and topline data now expected in second half of 2024 Cash, cash equivalents and short-term marketable securities of $721.3 million provides runway to support key late-stage data milestones including registrational studies for multiple indications LOS ANGELES, March 28, 2024 (GLOBE...