Galera Therapeutics Inc (GRTX)

[WARHAMMER]

I exited when I saw your posting partner lmao, I’ll take a position upon good news.

[Triple nickle]

Well positioned now
Big hit or ??????

[WARHAMMER]

what the heck is all that about, lol

[TrendTrade2016]

circus clowns are everywhere

[Triple nickle]

Go back to happy place

[TrendTrade2016]

bid side....lol...cough cough...bull shit!!

[WARHAMMER]

Ty u2

[Triple nickle]

Bid side pal

[TrendTrade2016]

thought you were out....fake T

[Triple nickle]

Good to see you here

[WARHAMMER]

Bidding. Waiting for .15’s

[Triple nickle]

In and out I’m good

[hondaboost]

How about your 80k GRTX shares/?

[Triple nickle]

I’m confident that meeting will go well

[Triple nickle]

Loaded 80k just in case

[hondaboost]

GRTX, might break through back to $2 with this inspiring meeting with FDA on Sep 28.

Galera Schedules Type A Meeting with FDA to Discuss Next Steps for Avasopasem

2023-09-18 07:00 ET - News Release


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 FDA’s review of our NDA for avasopasem and the data from our two randomized placebo-controlled clinical trials,” said Mel Sorensen, M.D., Galera’s President and CEO. “We believe in avasopasem’s potential to bring meaningful benefit to patients with head and neck cancer suffering from severe oral mucositis. With clarity on the perspective of the FDA reviewers from the meeting and subsequent minutes, we hope to identify necessary steps to bring avasopasem to these patients.”

The Company intends to gain an understanding from the FDA of its evaluation of avasopasem for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment and next steps to support an NDA resubmission. The Type A Meeting is the highest priority classification of meeting that the FDA grants to NDA sponsors.

[Triple nickle]

Two bucks in no time

[subslover]

Galera Schedules Type A Meeting with FDA to Discuss Next Steps for Avasopasem
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 FDA’s review of our NDA for avasopasem and the data from our two randomized placebo-controlled clinical trials,” said Mel Sorensen, M.D., Galera’s President and CEO. “We believe in avasopasem’s potential to bring meaningful benefit to patients with head and neck cancer suffering from severe oral mucositis. With clarity on the perspective of the FDA reviewers from the meeting and subsequent minutes, we hope to identify necessary steps to bring avasopasem to these patients.”

The Company intends to gain an understanding from the FDA of its evaluation of avasopasem for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment and next steps to support an NDA resubmission. The Type A Meeting is the highest priority classification of meeting that the FDA grants to NDA sponsors.

About Galera Therapeutics

[Zardiw]

Everything bounces................

Z

[willlbone]

Mortally wounded.

[Hungry_Ghost]

When is the NEXT reverse split scheduled. They should be due for another R/S once again.

[57_2001]

Galera Presents Additional Chronic Kidney Disease Data from ROMAN Trial at 2023 ASCO Annual Meeting

https://investors.galeratx.com/news-releases/news-release-details/galera-presents-additional-chronic-kidney-disease-data-roman
HIGHLIGHTS.
Avasopasem was associated with significant improvements in preservation of kidney function compared to placebo based on mean change in estimated Glomerular Filtration Rate (eGFR) compared to baseline, beginning by 3 months through the one-year end of follow-up
Avasopasem was associated with a significant reduction in incidence of grade 3+ CKD according to KDIGO1 criteria (eGFR <60 mL/min/1.73m2)
10% of patients treated with avasopasem had grade 3+ CKD, compared to 20% of patients in the placebo arm at one-year follow-up (relative risk 0.55, p=0.0043)
Reductions in CKD were consistent across cisplatin dosing schedules
Avasopasem was associated with reduced incidence of cisplatin-related renal adverse events during treatment

[57_2001]

galera files lawsuit.

https://www.otcmarkets.com/filing/html?id=16691759&guid=2XT-kF378EFYB3h

[57_2001]

now they do. have ODS


https://investors.galeratx.com/news-releases/news-release-details/galera-announces-fda-orphan-drug-designation-granted-rucosopasem

Anti-Cancer Programs:
Locally Advanced Pancreatic Cancer (LAPC)
Enrollment is ongoing in the randomized, placebo-controlled Phase 2b GRECO-2 trial of rucosopasem in combination with
stereotactic body radiation therapy (SBRT) in patients with LAPC. The primary endpoint of the trial is overall survival. The
trial is enrolling well. As a result, the Company plans to expand the target enrollment from 160 to 220 patients in order to
accrue the necessary events (number of deaths) for data analysis sooner. Completion of enrollment is now anticipated in 2024.

is a p2, possible with increase in number
of patients, to become a p2-3. IMO.

the first half of 2024, and topline data readout is expected by the end of 2024.

[57_2001]

ODS


https://www.goodrx.com/healthcare-access/medication-education/orphan-drug-status

As a result, compared to clinical trials for more common conditions, there usually aren’t phase 1 safety studies on healthy volunteers. Instead, because there are fewer people, manufacturers often combine phase 2 and phase 3 studies to determine an OD’s safety and effectiveness in people who have the condition.

would be nice if they got ODS. as of now, have not heard that they have.

[57_2001]

first gt. results.


https://investors.galeratx.com/node/8486/pdf

On May 1, 2023, the Company expanded its commercial leadership team with the appointment of accomplished
pharmaceutical sales, market access, and commercial operations executives, including Patrick Campbell as Vice President
of Sales & Account Management, Elizabeth Turner as Vice President of Market Access, and Henning Thorsen as Vice
President of Commercial Operations. The new executives joined Lorraine Walker, Pharm.D., the Company’s Vice President
of Marketing. Under the direction of the Company’s Chief Commercial Officer, Mark Bachleda, Pharm.D., MBA, the team is
responsible for building out commercial operations, strategy development, and execution in preparation for the potential
U.S. commercial launch of avasopasem in 2023.

if things go well, time will tell.

[turning stone]

I will certainly attend unless my schedule changes to have to miss it.

[57_2001]

welcome to the board.
seems i am the only regular, annual meeting is june 14, perhaps you will have a
chance to attend.
i don't post often. best regards.

[turning stone]

I am a holder of a lot of shares of GMDA. I just noticed GRTX and started to dabble in this company also. What I didn't notice till now is that I live 6.5 miles from GRTX front door. Next step will be to take a run over there and try to meet some of the folks there. My major win so far was when PFE bought ARENA Pharm and I was holding 2500 shares of ARNA at $4/share after they did a reverse split way back when. PFE bought them for $100/share and I all most fell off the chair when I actually saw it completed.

[57_2001]

march 10/23 PR.


https://investors.galeratx.com/news-releases/news-release-details/galera-announces-presentation-supplemental-analysis-phase-3

[57_2001]

march 8/23 PR.


https://investors.galeratx.com/news-releases/news-release-details/galera-reports-fourth-quarter-and-full-year-2022-financial

[57_2001]

upgrade B of A . from 2 to 7.

https://seekingalpha.com/news/3937343-grtx-stock-raised-buy-bofa-fda-priority-review-lead-asset?utm_source=otcmarkets&utm_medium=referral

[57_2001]

corporate page update.


https://investors.galeratx.com/static-files/dcfc4907-65f7-4ca9-915c-d37eb17339ff

[57_2001]

prs


https://investors.galeratx.com/news-releases/news-release-details/galera-therapeutics-announces-pricing-registered-direct-offering


https://investors.galeratx.com/news-releases/news-release-details/galera-announces-fda-acceptance-and-priority-review-avasopasem

[57_2001]

feb 13. new 13g.



https://investors.galeratx.com/node/8316/html

[57_2001]

the company should have a reply

from the FDA by now, however as a material event i believe they have four days to respond to
the general public and shareholders, so sometime this week. IMO.

[57_2001]

for more

information on 13d s, see post no. 245462 on the biotech values board.

[57_2001]

sc13/d info.


https://www.investopedia.com/ask/answers/09/schedule-13d.asp

https://www.prosek.com/unboxed-thoughts/another-difference-between-d-and-g-is-more-than-just-the-obvious/

[57_2001]

Compliance complete. 8-k 1/25/23



on January 24, 2023, Galera Therapeutics, Inc. (the “Company”) received a letter from The Nasdaq Stock Market LLC (“Nasdaq”) stating that (i) the Nasdaq Listing Qualifications staff had determined that the Company had regained compliance with the minimum Market Value of Listed Securities (“MVLS”) of $50,000,000 required for continued listing on The Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5450(b)(2)(A) (the “MVLS Requirement”), (ii) the Company is therefore in compliance with all Nasdaq Global Market listing requirements, (iii) the hearing before the Nasdaq Hearings Panel (“Panel”) scheduled for January 26, 2023 has been cancelled, and (iv) as a result, the Company’s securities will continue to be listed and traded on The Nasdaq Global Market.

[57_2001]

the FDA has sixty days to

accept or reject the NDA. Rejection may just mean they need more information. if they accept, then the review process begins.

more information here.
https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-continued

[57_2001]

NDA


https://finance.yahoo.com/news/galera-submits-drug-application-avasopasem-120000449.html

[57_2001]

third gt. results.


https://investors.galeratx.com/news-releases/news-release-details/galera-reports-third-quarter-2022-financial-results-and-recent

[57_2001]

10/26 new PR.


https://investors.galeratx.com/news-releases/news-release-details/galera-announces-presentation-phase-3-roman-long-term-follow

[57_2001]

info. asco




https://investors.galeratx.com/news-releases/news-release-details/galera-announces-oral-presentation-2022-american-society

[57_2001]

rucosopasem is in early testing,

dealing with pancreatic cancer, could be the real gem here, if successful. IMO.

https://www.bizjournals.com/philadelphia/news/2022/05/16/galera-therapeutics-malvern-nda-cancer-mucostitis.html?ana=yahoo

more info june 3 at asco.

[57_2001]

PR info.



https://investors.galeratx.com/news-releases/news-release-details/galera-announces-plan-submit-avasopasem-nda-year-end.


https://investors.galeratx.com/news-releases/news-release-details/galera-reports-first-quarter-2022-financial-results-and-recent

[57_2001]

asco info.


https://investors.galeratx.com/news-releases/news-release-details/galera-present-2022-american-society-clinical-oncology-asco

[57_2001]

info.



https://investors.galeratx.com/static-files/dcfc4907-65f7-4ca9-915c-d37eb17339ff


https://www.galeratx.com/

[Amrsto1000]

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U.S. Severe Oral Mucositis Market to Surpass US$ 267.7 Million by 2028, Says Coherent Market Insights (CMI)

August 12, 2021 09:20 ET| Source: CMI

SEATTLE, Aug. 12, 2021 (GLOBE NEWSWIRE) -- According to Coherent Market Insights, the U.S. Severe Oral Mucositis Market is estimated to be valued at US$ 78.5 million in 2021 and is expected to exhibit a CAGR of 19.2% during the forecast period (2021-2028).

Key Trends and Analysis of the U.S. Severe Oral Mucositis Market:

Key players operating in the market are focusing on the development of treatments for severe oral mucositis, which is expected to offer lucrative opportunities for the market players to launch novel products in the market. For instance, in June 2020, Soligenix, Inc. announced that it completed patient enrolment in its Phase 3 DOM-INNATE study for SGX942 (dusquetide) in the treatment of oral mucositis (OM) in head and neck cancer (HNC) patients.

For instance, in February 2020, Galera Therapeutics, Inc. announced full tumor results of the two year follow up of patients with head and neck cancer treated with avasopasem manganese (GC4419), which is Galera’s lead product candidate for severe oral mucositis (SOM) and is curently in a Phase 2b clinical trial.

Key Market Takeaways:

The U.S. severe oral mucositis market is expected to exhibit a CAGR of 19.2% during the forecast period due to increasing prevalence of head and neck cancer in the U.S., which is expected to boost the U.S. severe oral mucositis market in 2028. For instance, according to the Centers for Disease Control and Prevention report, around 650,000 cancer patients receive chemotherapy in an outpatient setting each year in the U.S. and according to a consensus about 500,000 cases of OM occur in the U.S. every year.

[da_stock_analyst]

4 Swing Trade Ideas #LGVN ?? #CRTX ?? #GRTX ?? #QLGN ?? Technical analysis with entry and exit!