Galera Therapeutics, Inc. (GRTX)

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1.6200

-0.1200

(-6.90%)

At close: 04:00PM EDT

1.7000

+0.08

(+4.94%)

After hours:

04:51PM EDT

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Don't sell cheap!
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B of A SOLD OUT 66% TRYING TO CREATE A SELL OFF!
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So it looks like the FDA didn't think another trial was necessary and they can go ahead with a NDA by the end of 2022. Should only go up from here.
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Up 12% on 45K shares after hours.
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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

MALVERN, Pa., May 16, 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 its intent to file a New Drug Application (NDA) for avasopasem manganese (avasopasem) for the treatment of radiotherapy-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer with the U.S. Food and Drug Administration (FDA) by the end of 2022.
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Financials came out and ending cash $60.9 millions. Market cap - $40millions.
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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
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why end of the year? all data is ready so just submit ASAP
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I was chasing shares and nobody was selling
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deep silence about FDA meeting is concerning 😟....
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At $35M market cap great buyout candidate!
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Is the corrected data not significant? At this rate it will touch 52 week low, similarly to identifying data interpretation problem timeline! Been watching since Citi et al rated buy's in Dec 2021. Tried to catch a falling knife and have been cut...ouch! Any thoughts on why today's significant drop, can't find anything yet...this is not simply market driven!
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News came out. It is going to be great today.
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dudes, 6 months is more than enough for NDA... they have time since beginning of this year. I expect the NDA filed in the Fall..
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Incidence of Grade 3 esophagitis substantially reduced in patients treated with avasopasem compared to literature

No Grade 4 or 5 esophagitis in patients treated with avasopasem

MALVERN, Pa, May 02, 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 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.

The multicenter Phase 2a trial enrolled 39 patients (62 screened) with unresectable Stage 3A/3B or post-operative Stage 2B non-small cell (NSCLC) or limited-stage small cell (SCLC) lung cancers. Thirty-five patients completed treatment with 60 gray of intensity-modulated radiation therapy (IMRT) plus chemotherapy over six weeks. Of these 35 patients, 29 received at least five weeks of 90 mg of avasopasem on the days they underwent IMRT. These 29 patients were evaluated as the pre-specified per protocol population. Patients enrolled in this trial were considered at high risk for developing esophagitis due to the amount of radiation planned to be delivered to the esophagus.1 Patients were assessed and classified according to NCI-CTCAE criteria.2
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Why is keep going down everyday? Any knows what is going on?
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define by end of the year....now until 31 Dec 22.
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so far no reaction to positive news... hope it will change once market open
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Avasopasem produced clinically meaningful, statistically significant reduction of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer receiving radiotherapy

Company on track to submit NDA to U.S. FDA for avasopasem by end of 2022

MALVERN, Pa., May 26, 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 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 on Friday, June 3, 2022 from 2:45 p.m. – 5:45 p.m. CDT during the Head and Neck Cancer session. Topline data was announced in December 2021. Abstracts are currently available in the ASCO digital program.
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Meeting with FDA is coming!!