Galera Therapeutics, LLC

88 articles with Galera Therapeutics, LLC

• Galera Announces Presentation of Supplemental Analysis of Phase 3 ROMAN Trial at European Congress on Head and Neck Oncology

  3/10/2023

  Galera Therapeutics, Inc. today announced the presentation of a net treatment benefit analysis of Phase 3 ROMAN results at the 10th European Congress on Head and Neck Oncology (ECHNO), taking place March 8-11, 2023, in Lisbon, Portugal.

• Galera Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate Updates

  3/8/2023

  Galera Therapeutics, Inc. today announced financial results for the fourth quarter and year ended December 31, 2022 and provided recent corporate updates.

• Galera Therapeutics Announces Pricing of Registered Direct Offering of $30 Million of Common Stock and Warrants

  2/15/2023

  Galera Therapeutics, Inc. announced that it has agreed to sell 14,320,000 shares of common stock and warrants to purchase up to 14,320,000 shares of common stock in a registered direct offering at a combined offering price of $2.095 per share and accompanying warrant.

• Galera Announces FDA Acceptance and Priority Review of Avasopasem NDA for Radiotherapy-Induced Severe Oral Mucositis

  2/15/2023

  Galera Therapeutics, Inc. (Nasdaq: GRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted priority review to the New Drug Application (NDA) for avasopasem manganese for radiotherapy (RT)-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC) undergoing standard-of-care treatment.

• Galera Submits New Drug Application for Avasopasem for Severe Oral Mucositis

  12/12/2022

  Galera Therapeutics, Inc. (Nasdaq: GRTX) today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avasopasem for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer (HNC) undergoing standard-of-care treatment.

• Galera to Present at Piper Sandler Annual Healthcare Conference

  11/22/2022

  Galera Therapeutics, Inc. today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at the Piper Sandler 34th Annual Healthcare Conference on Tuesday, November 29, 2022 at 11:10 a.m. E.T.

• Galera Reports Third Quarter 2022 Financial Results and Recent Corporate Updates

  11/9/2022

  Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the third quarter ended September 30, 2022 and provided recent corporate updates.

• Galera Announces Presentation of Phase 3 ROMAN Long-term Follow-up Data at 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting

  10/26/2022

  Galera Therapeutics, Inc. (Nasdaq: GRTX) today announced the presentation of one-year tumor and renal function outcomes data from its Phase 3 ROMAN trial of avasopasem manganese 90 mg for radiotherapy-induced severe oral mucositis (SOM), as well as topline results from a recently completed meta-analysis of the ROMAN and GT-201 SOM trial results, at the 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting.

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  Movers & Shakers: Galera, Verily, Avid and More Tap New Execs

  9/2/2022

  Biopharma and life sciences companies, such as Seraxis, Verily and Vaxart, tap new members to bolster their leadership teams in roles like CMO, CTO, CCO, and more.

• Galera Announces Results from Phase 1 Stage of GRECO-1 Trial of Rucosopasem with SBRT for NSCLC

  6/29/2022

  Galera Therapeutics, Inc. today announced results from the open-label Phase 1 stage of the GRECO-1 trial of rucosopasem in combination with stereotactic body radiation therapy (SBRT) in patients with centrally located or large non-small cell lung cancer (NSCLC).

• Galera to Present at Jefferies Healthcare Conference

  6/2/2022

  Galera Therapeutics, Inc. announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at the 2022 Jefferies Healthcare Conference on Thursday, June 9, 2022 at 2:00 p.m. E.T.

• Galera Announces Oral Presentation at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting Detailing Results from Phase 3 ROMAN Trial of Avasopasem

  5/26/2022

  Galera Therapeutics, Inc. (Nasdaq: GRTX), today announced data from its Phase 3 ROMAN trial of avasopasem for severe oral mucositis will be highlighted in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

• Galera Reports First Quarter 2022 Financial Results and Recent Corporate Updates

  5/16/2022

  Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the first quarter ended March 31, 2022 and provided recent corporate updates.

• Galera Announces Plan to Submit Avasopasem NDA by Year End After discussions with FDA, Company is on track to file an NDA for avasopasem for the treatment of radiotherapy-induced severe oral mucositis by end of 2022

  5/16/2022

  Galera Therapeutics, Inc. announced its intent to file a New Drug Application for avasopasem manganese for the treatment of radiotherapy-induced severe oral mucositis in patients with locally advanced head and neck cancer with the U.S. Food and Drug Administration by the end of 2022.

• Galera Announces Topline Results from Phase 2a AESOP Trial of Avasopasem for Chemoradiotherapy-Induced Esophagitis

  5/2/2022

  Galera Therapeutics, Inc. (Nasdaq: GRTX), today announced topline results from the six-week, Phase 2a, open-label, single-arm AESOP trial of avasopasem evaluating its ability to reduce the incidence of severe acute radiation-induced esophagitis in patients with lung cancer receiving concurrent chemoradiotherapy.

• Galera to Present at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

  4/27/2022

  Galera Therapeutics, Inc. announced that clinical data from its Phase 3 ROMAN trial of avasopasem for severe oral mucositis will be presented in an oral presentation at the upcoming 2022 American Society of Clinical Oncology Annual Meeting, taking place June 3-7, 2022 in Chicago, Illinois.

• Galera Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Corporate Updates

  3/10/2022

  Galera Therapeutics, Inc. announced financial results for the fourth quarter and year ended December 31, 2021 and provided recent corporate updates.

• Galera to Present at H.C. Wainwright BioConnect Conference

  1/6/2022

  Galera Therapeutics, Inc. announced that Mel Sorensen, M.D., President and Chief Executive Officer, will present at the H.C. Wainwright BioConnect Conference, taking place January 10-13, 2022.

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  Clinical Catch-Up: December 11-17

  12/20/2021

  It was an enormously busy week with plenty of announcements from the American Society of Hematology meeting and numerous companies working to get the news out ahead of the holidays and year-end. Here’s a look.

• Galera Announces Primary Endpoint Met Statistical Significance in Corrected Topline Efficacy Data of Phase 3 ROMAN Trial of Avasopasem

  12/14/2021

  Galera Therapeutics, Inc. (Nasdaq: GRTX), today announced that corrected results from its Phase 3 ROMAN trial of avasopasem for the treatment of RT-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) achieved statistical significance on the primary endpoint of reduction in the incidence of SOM.