Day: August 12, 2024

Company continues to make significant progress towards disrupting the existing cochlear implant industry with its investigational, breakthrough fully implanted Acclaim® cochlear implant; Maintains goal of starting Pivotal Clinical Trial by end of the year WHITE BEAR LAKE, Minn., Aug. 12, 2024 (GLOBE NEWSWIRE) — Envoy Medical®, Inc. (“Envoy Medical”) (Nasdaq: COCH), a revolutionary hearing health company focused on fully implanted hearing devices, today announces its corporate and financial results for the second quarter ended June 30, 2024. “We are pleased with the steady progress that Envoy Medical has made this quarter and year-to-date in advancing our goal of becoming a leading cochlear implant company,” commented Brent T. Lucas, Envoy Medical’s Chief Executive Officer. “We believe the results of our Early Feasibility Study...

– Completed enrollment in its RewinD-LB Phase 2b clinical trial evaluating neflamapimod in patients with early-stage dementia with Lewy bodies (DLB) in June 2024; topline data expected in December 2024 – – Hosted a virtual key opinion leader event in July 2024 highlighting neflamapimod’s potential for patients with early-stage DLB – – Completed private placement for up to $149.4 million of potential proceeds with leading institutional healthcare investors in April 2024 – – Added to the Russell 2000® and Russell 3000® Indexes effective July 1, 2024, as part of the 2024 Russell U.S. Indexes annual reconstitution – BOSTON, Aug. 12, 2024 (GLOBE NEWSWIRE) — CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today reported its...

Single, Well-Tolerated Infusion of ANX005 Significantly Accelerated Recovery of GBS Patients vs. Placebo in Pivotal Phase 3 Trial; Potential to be First Targeted Therapy for GBS; Topline Real-World Evidence (RWE) Comparability Data Now Expected by Year-End 2024 Dosing Initiated in ARCHER II Registrational Trial for ANX007; Only Program to Demonstrate Significant Vision Protection and Structural Protection in Regions of the Eye Important for Vision Acuity in GA; Phase 3 Data Expected Second Half 2026 First-in-Kind Oral C1s Inhibitor ANX1502 Successfully Completed Bridging Study to Twice-Daily Tablet; Proof-of-Concept Data in Autoimmune Disease Expected Q4 2024 Robust Balance Sheet with Cash, Cash Equivalents, and Short-term Investments of Approximately $368.7 Million as of June 30, 2024, and Anticipated Runway into Second Half 2026 BRISBANE,...

Completed enrollment of the 150 patients in the COMPANION-002 Study, a Phase 2/3 trial of CTX-009 (DLL4 and VEGF-A bispecific antibody) plus paclitaxel versus paclitaxel monotherapy in patients with previously treated, unresectable advanced metastatic or recurrent biliary tract cancers (BTC); top-line data expected in the first quarter of 2025. Approved an Investigator Sponsored Trial (IST) of CTX-009 in patients with BTC in the first-line setting. Completed review of encouraging preliminary data from Stage 1 of COMPANION-003, a Phase 2 trial of CTX-009 in patients with advanced colorectal cancer (CRC) treated in the third- and fourth-line settings. Based on the data, designs of a Phase 2 study in the second-line setting combining CTX-009 with chemotherapy in patients with DLL4-positive CRC are being evaluated. Planning a Phase 2 monotherapy...

NEW YORK, Aug. 12, 2024 (GLOBE NEWSWIRE) — Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announced financial results for the second quarter ended June 30, 2024, and provided a corporate update. Jeffrey Meckler, Indaptus Therapeutics’ Chief Executive Officer, commented, “During the second quarter we had multiple opportunities to share our findings regarding our Phase 1 clinical trial to date, and to demonstrate the unique approach that our Decoy platform offers. These included impactful conferences such as the American Association for Cancer Research (AACR) annual meeting and the American Society of Clinical Oncology (ASCO) annual meeting, which are considered among the top annual oncology...