Mainz Biomed Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm for Integration into Pivotal FDA PMA Clinical Trial for Next Generation Colorectal Cancer Diagnostic


Excerpt from the Press Release: BERKELEY, Calif. and MAINZ, Germany, April 25, 2024 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today groundbreaking topline results from a pooled clinical study which included new patients and subjects from Mainz…

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Freedom Biosciences Announces FDA Approval of IND Application for FREE001 in Patients with Treatment-Resistant Depression


Excerpt from the Press Release: SAN FRANCISCO, April 25, 2024 /PRNewswire/ — Freedom Biosciences, Inc. (“Freedom Bio” or the “Company”), a clinical-stage biotechnology platform focused on developing next-generation neuropsychiatric therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it may proceed with its FREE001-TRD-201 study for its lead program, FREE001,…

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Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR™-310 in Relapsed/Refractory B-cell NHL


Company advances towards their second clinical trial for SynKIR™ platform treating patients with Diffuse Large B Cell Lymphoma and other B-cell Non-Hodgkin Lymphoma subtypes who are relapsed or refractory after standard of care, including CAR T therapies Excerpt from the Press Release: PHILADELPHIA, April 3, 2024 /PRNewswire/ — Verismo Therapeutics, a clinical-stage CAR T company developing…

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eGenesis Announces World’s First Successful Transplant of Genetically Engineered Porcine Kidney in a Living Patient


– Marks historic milestone and opens new frontier in transplantation to address kidney shortage affecting millions of patients globally – Transplant was conducted at Massachusetts General Hospital and authorized by the U.S. FDA under a single Expanded Access protocol Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–eGenesis, a biotechnology company developing human-compatible engineered organs to…

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Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma


Company will initiate Phase 1 study of CLN-619 for relapsed or refractory multiple myeloma, first MICA/B antibody clinical study in hematologic malignancies Follows ongoing clinical study of CLN-619 alone and in combination with pembrolizumab in solid tumors, with anticipated updated clinical data in Q2 2024 Excerpt from the Press Release: CAMBRIDGE, Mass., March 01, 2024…

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NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity


Preclinical Studies Show DA-1726 Elicits Superior Weight Loss Compared to Semaglutide (Wegovy™) and Similar Weight Loss Compared to Tirzepatide (Mounjaro™), While Consuming More Food Initiation of Phase 1 Clinical Trial Expected to Occur in the First Half of 2024 Excerpt from the Press Release: CAMBRIDGE, Mass., Feb. 1, 2024 /PRNewswire/ — NeuroBo Pharmaceuticals, Inc. (Nasdaq:…

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Strand Therapeutics Receives IND Clearance for Programmable mRNA Therapy STX-001 to Treat Solid Tumors


Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Strand Therapeutics, the programmable mRNA company developing breakthrough therapies for cancer and other diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1, first-in-human trial of STX-001, a multi-mechanistic synthetic self-replicating mRNA technology that expresses an…

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Puma Biotechnology Announces Phase II Clinical Trial Design for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer


Excerpt from the Press Release: LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201). Based on the Company’s interactions with the U.S. Food and Drug Administration (FDA), the Company…

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Caribou Biosciences Provides Regulatory Update on CB-010 Pivotal Plan with Phase 3 Trial Initiation Expected by YE 2024


— Caribou met with the FDA and reached alignment on a pivotal trial in 2L LBCL with CB-010 versus a comparator arm of immunochemotherapy followed by HDCT and ASCT — — ANTLER Phase 1 trial continues dose expansion enrollment; initial dose expansion data and RP2D expected Q2 2024 — — Caribou plans to initiate Phase…

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Lighthouse Pharmaceuticals Announces FDA Approval To Proceed With Phase 2 Spring Trial Of LHP588, A Next-Generation Treatment For P. Gingivalis-positive Alzheimer’s Disease


Phase 1 single ascending and multiple ascending dose studies previously completed demonstrate safety, tolerability and dosing to reach optimal target engagement Excerpt from the Press Release: SAN FRANCISCO, Nov. 16, 2023 /PRNewswire/ — Lighthouse Pharmaceuticals, a clinical-stage biopharmaceutical company pioneering precision medicine for the treatment of Alzheimer’s and other diseases of aging, today announced clearance by…

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