Month: December 2022

Astria Therapeutics Announces Positive Preliminary Results from the Phase 1a Clinical Trial of STAR-0215 in Healthy Subjects

12/20/2022

— Shown Early Proof of Concept of STAR-0215’s Profile as a Long-Acting Plasma Kallikrein Inhibitor with Estimated Half-Life of Up to 110 Days — — Plans to Initiate ALPHA-STAR Phase 1b/2 Trial in Hereditary Angioedema Patients in Q1 2023 — Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215…

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Frequency Therapeutics Announces First Patient Dosed in Phase 1b Study of FX-345, the Company’s Second Therapeutic Candidate for Sensorineural Hearing Loss

12/20/2022

Regenerative Treatment Designed to Increase Drug Exposure Through the Cochlea; Study Results Expected in H2 2023 Frequency’s Lead Hearing Program, FX-322, on Track for Phase 2b Topline Results in Q1 2023 Excerpt from the Press Release: LEXINGTON, Mass.–(BUSINESS WIRE)–Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage regenerative medicine company focused on developing therapeutics to activate a…

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IMV Inc. Announces Initial Data from the Ongoing Phase 2B VITALIZE Trial in Patients with r/r DLBCL

12/19/2022

Complete responses were observed in patients who received at least three previous lines of treatment (including CAR-T’s) Recent clinical data add to the growing enthusiasm for the therapeutic potential of cancer vaccines in combination with checkpoint inhibitors Oral presentation of the clinical data at the Immuno-Oncology 360° conference in February 2023 Excerpt from the Press…

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Reviva Pharmaceuticals Announces Positive Safety Data from Drug-Drug Interaction Clinical Study of Brilaroxazine

12/19/2022

– 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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Rezolute Announces Initiation of a Phase 2 Study of RZ402 in Patients with Diabetic Macular Edema

12/19/2022

RZ402 is an oral therapy being developed as a potential alternative to invasive and suboptimal injections into the eye Excerpt from the Press Release: REDWOOD CITY, Calif., Dec. 15, 2022 (GLOBE NEWSWIRE) — Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company dedicated to developing transformative therapies with the potential to shift the treatment paradigms of…

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Moderna and Merck Announce mRNA-4157/V940, an Investigational Personalized mRNA Cancer Vaccine, in Combination with KEYTRUDA(R) (pembrolizumab), Met Primary Efficacy Endpoint in Phase 2b KEYNOTE-942 Trial

12/16/2022

mRNA-4157/V940, in combination with KEYTRUDA, demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death compared to KEYTRUDA monotherapy in stage III/IV melanoma patients with high risk of recurrence following complete resection Results are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical…

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Ambrx Announces Encouraging Preliminary Safety and Efficacy Data Evaluating ARX788 in HER2 Positive Metastatic Breast Cancer Patients Who Progressed Following T-DM1 Treatment

12/16/2022

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–​Ambrx Biopharma Inc., or Ambrx, (NYSE: AMAM), a clinical stage biopharmaceutical company using its proprietary Engineered Precision Biologics (EPBs) platform to create antibody drug conjugates (ADCs), today announced preliminary safety and efficacy data from its Phase 2 ACE‑Breast-03 study during a Spotlight Poster Presentation at the 2022 San…

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Harpoon Therapeutics Presents Updated Interim Results at ASH 2022 for Novel T Cell Engager HPN217 in Relapsed/Refractory Multiple Myeloma

12/15/2022

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Dec. 11, 2022 (GLOBE NEWSWIRE) — Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immuno-oncology company developing novel T cell engagers, today presented updated interim data from its Phase 1 clinical trial evaluating single-agent HPN217 in relapsed/refractory multiple myeloma (RRMM) in a poster presentation at the 64th American Society…

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Geron Reports Oral Presentation at ASH Annual Meeting Highlighting Continuous Long-Term Transfusion Independence with Imetelstat Treatment in Lower Risk MDS Patients

12/15/2022

Excerpt from the Press Release: FOSTER CITY, Calif.–(BUSINESS WIRE)–Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced results from an oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting on longer follow-up data from the IMerge Phase 2 clinical trial of imetelstat, the Company’s first-in-class telomerase inhibitor, in lower risk…

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FREENOME PRESENTS RESEARCH HIGHLIGHTING THE PROMISE OF IDENTIFYING DRUG-RESPONSE BIOMARKERS FOR DLBCL PATIENTS

12/15/2022

– Freenome’s comprehensive multiomics and multi-feature computational approach provides insights for therapy development and patient efficacy Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Dec. 12, 2022 /PRNewswire/ — Freenome, a privately held biotech company, presented research on Saturday at the American Society of Hematology (ASH) Annual Meeting in New Orleans. Freenome’s multiomics platform allows…

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