Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
how does this compare to the others.
https://ir.sagimet.com/news-releases/news-release-details/sagimet-biosciences-presents-data-itt-and-f3-patient-population
sagimet moving up.
institutional buying is increasing. (fintel)
do your own research, dd.
https://sagimet.com/fasn/
gpcr.info.
GSBR-1290 demonstrated an encouraging safety and tolerability profile following once-daily dosing. No participants discontinued the study drug due to adverse events. The majority of adverse events reported were mild, with no severe or serious adverse events observed. As expected for this class, leading adverse events were gastrointestinal-related, with the two most common adverse events being nausea and vomiting, with higher incidences observed in the 60 and 90 mg dose cohorts compared to placebo. There were no clinically meaningful changes in liver function tests.
https://www.sec.gov/Archives/edgar/data/1888886/000110465923105027/tm2327162d2_ex99-1.htm
seems to me to have a very high MC, but it is oral.
if i was to guess at a percent,
perhaps it would be 25% protection for the person wearing the mask, and 75% for the general public.
much the same reason a surgeon wears a mask. again just a opinion.
being covid does not
seem to be a big concern, for most people, perhaps the thinking is that people coming in
for a shot at this time, may not be feeling the best. IMO.
yes, bummer.
will hold my shares, see what comes, more interested in the Pancreatic drug,
see what the p2 results are, if they don't bk before that.
for the most part, believe i am done with bio
grtx, news today or tomorrow.
drug approval or not. perhaps in a few minutes.
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
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.
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.
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.
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.
you had it right,
and from the start. thought they had something, with a oral pill, even if it was
only 50-60% effective.
time has proven they did not. best.
sivb interesting on analyst view.
ya hoo..... 6 strong buys....9 buys........4 holds. no sells.
one major player went to overweight on 3/9.
GRTX.
Acceptance and Priority Review for nda. along with a offering.
feb 13. new 13g.
https://investors.galeratx.com/node/8316/html
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.
for more
information on 13d s, see post no. 245462 on the biotech values board.
thanks dew. EOM
couple sc13/d s filed on grtx.
any thoughts by the board, good news, bad news, for investors.
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.
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
couple different opinions.
the comment at the bottom, nat. debt-interest rate. perhaps a big factor.
https://news.yahoo.com/larry-summers-along-inflation-ominous-193034057.html
https://www.msn.com/en-us/money/markets/cathie-wood-takes-on-larry-summers-over-inflation/ar-AA120NhA
see what the morning brings.
after hgen, not much faith in any of these trials.
did pick up some
vtgn at .15.