Galera Therapeutics, Inc., a clinical stage biopharmaceutical company, focuses on the development and commercialization of therapeutics for the transformation of radiotherapy in cancer. The company's lead product candidate is avasopasem manganese (GC4419), a small molecule superoxide dismutase mimetic, which is in Phase III clinical trial for the treatment of radiation-induced severe oral mucositis in patients with head and neck cancer (HNC); and in Phase IIa clinical trial for the treatment of radiotherapy-induced esophagitis in patients with lung cancer; in phase IIa clinical trial for patients with HNC undergoing standard-of-care radiotherapy; and has completed pilot placebo-controlled Phase I/II clinical trial in combination with stereotactic body radiation therapy (SBRT) for patients with locally advanced pancreatic cancer, as well as in Phase II clinical trial for hospitalized patients with COVID-19 disease. It is also involved in developing GC4711, a superoxide dismutase mimetic product candidate, which is in Phase I/II clinical trial in combination with SBRT in patients with non-small cell lung cancer. The company was incorporated in 2012 and is headquartered in Malvern, Pennsylvania.
IPO Year: 2019
Exchange: NASDAQ
Website: galeratx.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 8/10/2023 | $6.00 → $0.50 | Overweight → Neutral | Piper Sandler |
| 12/20/2021 | $11.00 → $20.00 | Buy | Citigroup |
| 12/15/2021 | $10.00 | Neutral → Buy | HC Wainwright & Co. |
| 12/15/2021 | $15.00 | Neutral → Buy | BTIG |
| 10/20/2021 | Buy → Neutral | HC Wainwright & Co. | |
| 10/19/2021 | $17.00 → $2.00 | Buy → Underperform | BofA Securities |
| 10/19/2021 | Buy → Neutral | BTIG Research |
4 - Galera Therapeutics, Inc. (0001563577) (Issuer)
4 - Galera Therapeutics, Inc. (0001563577) (Issuer)
4 - Galera Therapeutics, Inc. (0001563577) (Issuer)
4 - Galera Therapeutics, Inc. (0001563577) (Issuer)
4 - Galera Therapeutics, Inc. (0001563577) (Issuer)
4 - Galera Therapeutics, Inc. (0001563577) (Issuer)
4 - Galera Therapeutics, Inc. (0001563577) (Issuer)
3 - Galera Therapeutics, Inc. (0001563577) (Issuer)
4 - Galera Therapeutics, Inc. (0001563577) (Issuer)
3 - Galera Therapeutics, Inc. (0001563577) (Issuer)
Company appoints leading sales, market access and operations executives with decades of experience successfully launching and commercializing new oncology products New Drug Application (NDA) for avasopasem is currently under priority review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee (PDUFA) target date of August 9, 2023 MALVERN, Pa., May 01, 2023 (GLOBE NEWSWIRE) -- 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 the appointment of accomplished pharmace
MALVERN, Pa., Sept. 01, 2022 (GLOBE NEWSWIRE) -- 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 the appointment of Eugene P. Kennedy, M.D., F.A.C.S., as Chief Medical Officer (CMO). Dr. Kennedy is a renowned Johns Hopkins-trained surgical oncologist and former Chief of Pancreatic and Hepatobiliary Surgery at Thomas Jefferson University with over 15 years' experience in clinical development and biopharma leadership. He will succeed Jon T. Holmlund, M.D., who will retire at the end of this yea
MALVERN, Pa., Oct. 12, 2021 (GLOBE NEWSWIRE) -- 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 the appointment of Mark J. Bachleda, Pharm.D., M.B.A., as Chief Commercial Officer (CCO) and Jennifer Evans Stacey, Esq., as Chief Legal and Compliance Officer (CLCO) and Secretary. Both executives join Galera with over 25 years of leadership experience within the biopharmaceutical industry. "We are thrilled to welcome Mark and Jennifer to Galera at this critical point in the Company's growth," sa
4 - Galera Therapeutics, Inc. (0001563577) (Issuer)
4/A - Galera Therapeutics, Inc. (0001563577) (Issuer)
4 - Galera Therapeutics, Inc. (0001563577) (Issuer)
Galera's development strategy shifts from toxicity reduction to anti-cancer therapeutics, with three trials in patients with highly resistant subsets of advanced breast cancer. Lead program is Phase 1/2 trial of Nova Pharmaceutical's Clinical Stage Nitric Oxide Synthase (NOS) Inhibitor on top of standard-of-care nab-paclitaxel and alpelisib in metaplastic breast cancer. Concurrent financing when added to Galera's existing cash balance, is anticipated to fund operations through data readout of its lead program and into 2026. Galera intends to leverage NCI grants, academic partnerships and the I-SPY 2 network for efficient and cost-effective clinical dataset expansion. MALVERN, Pa.
MALVERN, Pa., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company historically focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that its Board of Directors has approved a Plan of Liquidation and Dissolution (Plan of Dissolution), which provides for the dissolution of the Company under Delaware law, and plans to seek stockholder approval of the Plan of Dissolution at a special meeting of stockholders to be held on or around October 17, 2024. If the Plan of Dissolution is approved by the Company's stockholders, the Company intends t
MALVERN, Pa., May 13, 2024 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing 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, 2024, and provided recent corporate updates. "Our review of strategic options continues, as we strive to maximize value for our stockholders," said Mel Sorensen, M.D., Galera's President and CEO. "Potential options may include mergers, asset sales, divestiture, licensing arrangements, or other strategic transactions and may encompass a potential development path
MALVERN, Pa., May 03, 2024 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that its Board of Directors (the "Board") has unanimously resolved to adopt a limited duration stockholder rights agreement (the "Rights Agreement") to protect stockholder interests. The Board resolved to adopt the Rights Agreement in response to recent accumulations of the Company's common stock and the Rights Agreement is intended to enable all Galera stockholders to realize the full potential value of their investment in the comp
MALVERN, Pa., March 28, 2024 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the fourth quarter and year ended December 31, 2023 and provided recent corporate updates. "As a result of last year's FDA request for a second Phase 3 trial to support the avasopasem NDA, we have implemented key measures to extend our cash runway and assess strategic alternatives," said Mel Sorensen, M.D., Galera's President and CEO. "Among these measures, we recognize that the decision to discontinu
FDA confirms need for new trial for avasopasem; GRECO trials with rucosopasem to be discontinued Company evaluating potential strategic options to optimize shareholder value MALVERN, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing 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, 2023 and provided recent corporate updates. "Given the considerable time and investment required for additional clinical trials, we find it prudent to explore strategic options," said
FDA confirms need for new trial for avasopasem for severe oral mucositis (SOM) GRECO-2 trial did not pass futility analysis; Company will discontinue both GRECO trials Company reviewing potential strategic alternatives to maximize shareholder value MALVERN, Pa., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that it has received official meeting minutes from the Type A meeting with the United States Food and Drug Administration (FDA) held September 28, 2023 in which the FDA
MALVERN, Pa., Sept. 18, 2023 (GLOBE NEWSWIRE) -- 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 that a Type A Meeting has been scheduled for September 28, 2023 with the U.S. Food and Drug Administration (FDA) regarding the Complete Response Letter (CRL) received for the Company's New Drug Application (NDA) for avasopasem manganese (avasopasem). The FDA is expected to issue written meeting minutes approximately 30 days following the meeting. "We look forward to further understanding the FD
MALVERN, Pa., Sept. 05, 2023 (GLOBE NEWSWIRE) -- 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 that Mel Sorensen, M.D., President and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 25th Annual Global Investment Conference on Monday, September 11, 2023, at 4:30 p.m. E.T. A live webcast of the event will be accessible from the Investors page of Galera's website, investors.galeratx.com. An archived version of the webcast will be available in the Events & P
Company received Complete Response Letter from FDA for avasopasem and intends to request Type A meeting with FDA to discuss potential next steps Cash runway extended into Q2 2024 in connection with reduction in workforce FDA granted orphan drug designation to rucosopasem for the treatment of pancreatic cancer Enrollment in GRECO trials with rucosopasem remains ongoing MALVERN, Pa., Aug. 14, 2023 (GLOBE NEWSWIRE) -- 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
8-K - Galera Therapeutics, Inc. (0001563577) (Filer)
10-K - Galera Therapeutics, Inc. (0001563577) (Filer)
8-K/A - Galera Therapeutics, Inc. (0001563577) (Filer)
8-K - Galera Therapeutics, Inc. (0001563577) (Filer)
DEF 14A - Galera Therapeutics, Inc. (0001563577) (Filer)
D - Galera Therapeutics, Inc. (0001563577) (Filer)
D - Galera Therapeutics, Inc. (0001563577) (Filer)
8-K - Galera Therapeutics, Inc. (0001563577) (Filer)
8-K - Galera Therapeutics, Inc. (0001563577) (Filer)
10-Q - Galera Therapeutics, Inc. (0001563577) (Filer)
SC 13G/A - Galera Therapeutics, Inc. (0001563577) (Subject)
SC 13G - Galera Therapeutics, Inc. (0001563577) (Subject)
SC 13G/A - Galera Therapeutics, Inc. (0001563577) (Subject)
SC 13G - Galera Therapeutics, Inc. (0001563577) (Subject)
SC 13G/A - Galera Therapeutics, Inc. (0001563577) (Subject)
SC 13D/A - Galera Therapeutics, Inc. (0001563577) (Subject)
SC 13G/A - Galera Therapeutics, Inc. (0001563577) (Subject)
SC 13G - Galera Therapeutics, Inc. (0001563577) (Subject)
SC 13D/A - Galera Therapeutics, Inc. (0001563577) (Subject)
SC 13G - Galera Therapeutics, Inc. (0001563577) (Subject)
Piper Sandler downgraded Galera from Overweight to Neutral and set a new price target of $0.50 from $6.00 previously
Citigroup reiterated coverage of Galera Therapeutics with a rating of Buy and set a new price target of $20.00 from $11.00 previously
HC Wainwright & Co. upgraded Galera Therapeutics from Neutral to Buy and set a new price target of $10.00
BTIG upgraded Galera Therapeutics from Neutral to Buy and set a new price target of $15.00
HC Wainwright & Co. downgraded Galera Therapeutics from Buy to Neutral
BofA Securities downgraded Galera from Buy to Underperform and set a new price target of $2.00 from $17.00 previously
BTIG Research downgraded Galera from Buy to Neutral
Credit Suisse resumed coverage of Galera with a rating of Outperform and set a new price target of $15.00
Galera's development strategy shifts from toxicity reduction to anti-cancer therapeutics, with three trials in patients with highly resistant subsets of advanced breast cancer. Lead program is Phase 1/2 trial of Nova Pharmaceutical's Clinical Stage Nitric Oxide Synthase (NOS) Inhibitor on top of standard-of-care nab-paclitaxel and alpelisib in metaplastic breast cancer. Concurrent financing when added to Galera's existing cash balance, is anticipated to fund operations through data readout of its lead program and into 2026. Galera intends to leverage NCI grants, academic partnerships and the I-SPY 2 network for efficient and cost-effective clinical dataset expansion. MALVERN, Pa.
MALVERN, Pa., May 03, 2024 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (NASDAQ:GRTX), a biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that its Board of Directors (the "Board") has unanimously resolved to adopt a limited duration stockholder rights agreement (the "Rights Agreement") to protect stockholder interests. The Board resolved to adopt the Rights Agreement in response to recent accumulations of the Company's common stock and the Rights Agreement is intended to enable all Galera stockholders to realize the full potential value of their investment in the comp
The Company remains committed to its goal of bringing avasopasem to patients and intends to meet with FDA as soon as possible to discuss potential next steps Galera will take actions to extend its cash runway and continue enrolling its rucosopasem clinical trials Conference call tomorrow, August 10, 2023 at 8:30 a.m. ET MALVERN, Pa., Aug. 09, 2023 (GLOBE NEWSWIRE) -- 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 that it has received a Complete Response Letter (CRL) from the U.S. Food an
Corrected topline Phase 3 ROMAN data demonstrate primary endpoint achieved statistical significance in reducing the incidence of radiotherapy-induced severe oral mucositis (p=0.045) Topline results from single-arm Phase 2a trial of avasopasem in Europe in line with the ROMAN trial results Company plans to discuss avasopasem data with the FDA in 2022 Company to host conference call and live audio webcast on Tuesday, December 14 at 8:30 a.m. ET MALVERN, Pa., Dec. 14, 2021 (GLOBE NEWSWIRE) -- 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