Biopharmaceutical

Mirati Announces IND Clearance by U.S. FDA Enabling Phase 1 Initiation for First-in-Class Oral KRASG12D Selective Inhibitor, MRTX1133

01/23/2023

IND demonstrates Mirati’s leadership in KRAS, representing the Company’s third KRAS or KRAS-signaling program to enter clinical development Excerpt from the Press Release: SAN DIEGO, Jan. 19, 2023 /PRNewswire/ — Mirati Therapeutics, Inc. (NASDAQ: MRTX), announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of MRTX1133, a potential…

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Vial Announces Enrollment of First Patient in Phase II Clinical Trial TLL018-205 for the Treatment of Plaque Psoriasis Sponsored by Highlightll Pharmaceutical

01/23/2023

Excerpt from the Press Release: SAN FRANCISCO, Jan. 19, 2023 /PRNewswire/ — Vial, a global tech-enabled CRO providing next-generation clinical trial management services, announced that the first patient has been enrolled in the clinical trial TLL018-205, a Phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of TLL-018 in human subjects with moderate…

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Aitia and G3 Therapeutics Publish Results Identifying New Causal Biomarkers of Atherosclerotic Coronary Artery Disease (ASCAD), the Leading Cause of Morbidity and Mortality Worldwide

01/18/2023

Excerpt from the Press Release: ATLANTA and SOMERVILLE, Mass., Jan. 12, 2023 /PRNewswire/ — G3 Therapeutics, a life sciences company that leverages large-scale multi-omic biological big data to develop life-changing therapeutics and diagnostics, and Aitia, the leader in the application of Causal AI and “Digital Twins” to discover and develop new drugs, today announced results…

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MediciNova Announces Completion of Enrollment in the Phase 2 Clinical Trial Evaluating MN-166 (ibudilast) for Treatment of Recurrent and Newly Diagnosed Glioblastoma

01/18/2023

Preliminary results will be presented at the 20th Annual World Congress of the Society for Brain Mapping and Therapeutics Excerpt from the Press Release: LA JOLLA, Calif., Jan. 12, 2023 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange…

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Frontier Medicines Advances First Development Candidate, FMC-376, a Uniquely Differentiated Inhibitor of Both Active and Inactive KRASG12C, into IND-Enabling Studies

01/17/2023

FMC-376 directly, rapidly, and completely blocks both active and inactive forms of KRASG12C to overcome non-response and resistance seen with prior generation KRASG12C inhibitors The company has also advanced two additional precision oncology programs against historically undruggable disease-causing targets into lead optimization Pamela Klein, M.D., seasoned oncology drug developer, elected to board of directors Excerpt…

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FDA Approves IND Submission Allowing ABVC BioPharma to Proceed With Clinical Study of ABV-1519 for Treatment of Non-Small Cell Lung Cancer

01/13/2023

Excerpt from the Press Release: FREMONT, CA, Jan. 05, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology today announced that the US Food & Drug Administration notified the company that the IND application for the proposed clinical investigation…

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Phio Pharmaceuticals Announces New Clinical Program to Study PH-762 for the Treatment of Cutaneous Squamous Cell Carcinoma

01/10/2023

Excerpt from the Press Release: MARLBOROUGH, Mass., Dec. 21, 2022 /PRNewswire/ — Phio Pharmaceuticals Corp., today announced it expects to file an IND in the US in the first half of 2023 for a Phase 1b clinical trial of its INTASYL™ compound, PH-762. Phio is a clinical stage biotechnology company whose proprietary INTASYL self-delivering RNAi…

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Kala Pharmaceuticals Announces FDA Acceptance of IND Application for KPI-012 for the Treatment of PCED

01/09/2023

— On-track to initiate Phase 2b trial in 1Q 2023; Topline data expected in 1Q 2024 — — Received remaining $25 million investment under previously announced private placement financing — Excerpt from the Press Release: ARLINGTON, Mass., Dec. 27, 2022 (GLOBE NEWSWIRE) — Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development…

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Janux Therapeutics Announces Submission of Investigational New Drug Application for JANX008, an EGFR-TRACTr for Solid Tumors

01/09/2023

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today announced that the Company has submitted the investigational new drug (IND)…

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Imago BioSciences Announces First Participant Dosed in Investigator-Sponsored Phase 2 Study of Bomedemstat in Combination with Ruxolitinib in Myelofibrosis

01/06/2023

Excerpt from the Press Release: REDWOOD CITY, Calif., Dec. 20, 2022 (GLOBE NEWSWIRE) — Imago BioSciences, Inc. (“Imago” or the “Company”) (Nasdaq: IMGO), a clinical-stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, today announced that the first participant has been dosed in an investigator-sponsored Phase…

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