NDA
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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Excerpt from the Press Release: CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Jan. 12, 2023 /PRNewswire/ — Harbour BioMed (the”Company”, HKEX: 02142) announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence clinical trials of its globally first-in-class fully human monoclonal antibody HBM1020 targeting B7H7 (also known…
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– Spin-off of technology platform to newly-formed Kimia Therapeutics intended to maximize the full potential of Carmot’s metabolic portfolio while enabling Kimia to pursue a broad range of opportunities across oncology, immunology and inflammation – – Encouraging clinical data from CT-388 and CT-868, Carmot’s dual GLP-1/GIP receptor modulators, represent significant opportunity for Carmot to advance…
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As previously reported, resmetirom demonstrated improvements in NASH and liver fibrosis on liver biopsies, the primary endpoints of the MAESTRO-NASH trialA supportive analysis using consensus reads of digitized biopsy images by the central pathologists replicated the positive primary endpoint resultsThese data will be presented at the NASH-TAG Conference on Friday January 6th, 2023 Excerpt from…
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Excerpt from the Press Release: BOSTON, Dec. 29, 2022 (GLOBE NEWSWIRE) — TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA Oncology Company™ committed to more effectively treating cancer using RNA therapeutics, announced today that it has received written authorization from the U.S. Food and Drug Administration (FDA) that it may proceed with its First-in-Human (FIH) Phase…
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— 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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Excerpt from the Press Release: PALO ALTO, Calif.–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today positive results from ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Episode), an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer (CRC) in average-risk…
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– Topline data for pivotal Phase 3 RECOVER trial evaluating brilaroxazine for schizophrenia expected in mid-2023 – Brilaroxazine is a serotonin/dopamine modulator with a differentiated pharmacological and safety profile Excerpt from the Press Release: CUPERTINO, Calif., Dec. 15, 2022 (GLOBE NEWSWIRE) — Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a clinical-stage pharmaceutical…
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Excerpt from the Press Release: BOSTON, Nov. 30, 2022 (GLOBE NEWSWIRE) — TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, announced today that it has submitted an exploratory Investigational New Drug (eIND) application to the U.S. Food and Drug Administration (FDA) for a planned First-in-Human…
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KING OF PRUSSIA, PA, USA This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion. Excerpt from the Press Release: This historic approval provides a new treatment option…
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