Announcements

Naveris Announces Expansion of the NavDx® Test in Anal Cancer Molecular Residual Disease Surveillance

01/20/2025

The NavDx test demonstrates high performance in detecting recurrent disease, providing an enhanced and widely accessible surveillance tool for HPV+ anal squamous cell carcinoma patients Excerpt from the Press Release: WALTHAM, Mass.–(BUSINESS WIRE)–Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, today announced the expanded commercial availability of the NavDx test for Molecular…

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Mersana Therapeutics Announces Positive Initial Clinical Data from Phase 1 Clinical Trial of Emiltatug Ledadotin (XMT-1660); Initiation of Expansion in Triple Negative Breast Cancer

01/17/2025

– Emiltatug ledadotin observed to be generally well tolerated with differentiated safety and tolerability profile– Promising clinical activity observed in patients with triple-negative breast cancer (TNBC) previously treated with topoisomerase-1 inhibitor (topo-1) ADCs; confirmed responses observed across all enrolled tumor types– First expansion cohort initiated in patients with TNBC previously treated with at least one…

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Tyra Biosciences Receives IND Clearance from FDA to Proceed with Phase 2 Study of TYRA-300 in Non-Muscle Invasive Bladder Cancer (SURF302)

01/16/2025

-TYRA appoints urologic oncologist, Erik Goluboff, M.D., as SVP, Clinical Development to lead NMIBC- Excerpt from the Press Release: CARLSBAD, Calif., Jan. 10, 2025 /PRNewswire/ — Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced today that…

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Totus Medicines Announces Successful Completion of a Phase 1 Dose-Escalation Study and Initiation of an Expansion Trial Evaluating TOS-358, a Covalent PI3Ka Selective Therapy for the Treatment of Select Solid Tumors and Appoints Zelanna Goldberg as Chief Medical Officer

01/15/2025

Successfully completed a Phase 1 dose-escalation study demonstrating pan-mutant clinical activity, 95% target engagement and no grade 3 or 4 toxicities at doses as low as 5 mg BID Initiating an expansion trial in breast, endometrial, urothelial and head and neck cancers at 5 & 8 mg BID Appoints Zelanna Goldberg, M.D., M.A.S. as Chief…

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Marea Therapeutics Provides Update on Corporate Progress Including Positive Topline Results from Phase 2a Clinical Trial of MAR001 for Cardiovascular Disease and Disclosure of Second Lead Pipeline Program for the Treatment of Acromegaly

01/14/2025

Positive topline results from Phase 2a study of MAR001 demonstrate clinically meaningful reductions in remnant cholesterol and triglycerides; Phase 2b study expected to initiate in First Half 2025 Second Lead Program announced, MAR002, a growth hormone receptor (GHR) antagonist for the treatment of acromegaly; Phase 1 study expected to initiate in Second Half 2025 Marea…

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Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

01/13/2025

PDUFA target action date is June 30, 2025 If approved, avutometinib in combination with defactinib would be the first-ever FDA-approved treatment specifically for adults with recurrent KRAS mutant LGSOC cerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that the…

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Aclarity Graduated from Mansfield Bio-Incubator

01/10/2025

Excerpt from the Press Release: MANSFIELD, MA – Last month, Aclarity, a leader in PFAS removal, officially completed the move from Mansfield Bio-Incubator to their new headquarters in Medway. September 2022, the time when Aclarity became Mansfield Bio-Incubator’s member with less than five lab-based employees and taking up a bench in the shared space, seems…

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NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Initial Section of U.S. New Drug Application to the FDA for NRX-100 (IV Ketamine) for the Treatment of Suicidal Depression

01/09/2025

Excerpt from the Press Release: WILMINGTON, Del., Dec. 30, 2024 /PRNewswire/ — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”, the “Company”), a clinical-stage biopharmaceutical company, today announced the transmission of first section of its New Drug Application (NDA) for NRX-100 (ketamine) for electronic filing with the U.S. Food & Drug Administration (FDA). NRX-100 was initially granted…

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Children’s Hospital of Philadelphia Researchers Develop New Tool with Potential to Advance Precision Medicine Treatment for Cancer

01/08/2025

Technology Discovers Antigen-Reactive T Cell Receptors with High Efficiency Excerpt from the Press Release: PHILADELPHIA, Jan. 3, 2025 /PRNewswire/ — Researchers at Children’s Hospital of Philadelphia (CHOP) and the Perelman School of Medicine at the University of Pennsylvania developed a new screening technology, Aptamer-based T Lymphocyte Activity Screening and SEQuencing (ATLAS-seq), to better identify antigen-reactive T…

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First of Its Kind Gene Therapy Model Offers Hope for X-Linked Sideroblastic Anemia Treatment

01/07/2025

New model and vector could be instrumental in transforming the lives of XLSA patients and those with a broad spectrum of other diseases Excerpt from the Press Release: PHILADELPHIA, Jan. 2, 2025 /PRNewswire/ — Researchers at Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania Perelman School of Medicine pioneered a first of its kind…

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