Thinking through this more- aren’t most CRC tumors CDK 4/6 dependent, vs SCLC and TNBC? Why did they think this wouldn’t be a major risk to efficacy? Because they thought they could offset the toxicity of the 5FU and allow for greater exposure?
Makes me slightly more optimistic on TNBC
Agreed! Let’s see how much cash they have left when Balance sheet is observed(minus any debt/liabilities from legacy trial(s)..hopefully the readouts in other ongoing trials will prove to be Statistically Sig!!!!
I hope they survive. Drug has real potential in the right settings
October 01 2021 - 07:45AM
G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the permanent J-code for COSELA™ (trilaciclib) that was issued in July 2021 by the Centers for Medicare & Medicaid Services (CMS) is now effective for provider billing for all sites of care. The permanent J-code for COSELA, J1448 (Injection, trilaciclib, 1mg.), published online on the CMS website here (page 5).
J-codes are permanent, product specific reimbursement codes assigned to outpatient and physician administered “buy and bill” products under Medicare Part B and are used by commercial insurers and government payers to facilitate and standardize claims submissions and reimbursements for medications like COSELA. With the permanent J-code now in effect, all hospital outpatient departments, ambulatory surgery centers and physician offices in the United States will have one consistent Healthcare Common Procedure Coding System (HCPCS) code to standardize the submission and payment of COSELA insurance claims across Medicare, Medicare Advantage, Medicaid and commercial plans.
“Given the emergent presentation of extensive-stage small cell lung cancer, and the clinical benefits of COSELA as a proactive multilineage myeloprotection drug when give prior to chemotherapy, it is absolutely essential that patients have timely access to it,” said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "We are pleased to receive this new permanent J-code for all sites of care as it will enable a more efficient billing process, which will ultimately help facilitate patient access to COSELA.”
G1’s new technology add-on payment (NTAP) for COSELA which provides additional payment to inpatient hospitals above the standard Medicare Severity Diagnosis-Related Group (MS-DRG) payment amount also became effective for provider billing today, October 1, 2021.
About COSELA™ (trilaciclib) for Injection
COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.
No one gives a chit about this SCAM! lolzzzzzzzzzzzzzzzzz
$GTHX JPMorgan cautions that G1's lead asset Cosela--aimed at treating low blood cell counts from chemotherapy- -may face a downward revision of estimates near-term. The investment bank bases that on the fact that a recent physician survey indicated Cosela tracking to a 3Q miss relative to street consensus. Coupled with "no game-changing clinical catalysts for the next 9-12 months," JPMorgan cuts G1 to neutral from overweight, and lowers the price target to $20 from $24. "While, in our view, the long-term fundamental value of Cosela is intact, we would look to get constructive on GTHX shares if Cosela sales begin to inflect upward relative to Street consensus," JPMorgan says. Shares are down nearly 9%. (firstname.lastname@example.org)
I’m long on GTHX, this stock is going to play out just like IMMU in my opinion, did any of you have a position in IMMU?
It's funny with biopharmas - I've seen them run up to an event and then drop after the news, but I think this is different. With this one I honestly think that this is the beginning of the development of an extremely profitable company that might end up with it being acquired by a bigger fish, so I'm not going to play any games with it like selling into momentum and then buying on the dip - I'm just holding. I'd be happy with $40 by the end of the day on Tuesday, but I really believe it will be $80 a year from now. In the back of my mind I think Jack Bailey might want to take this company back home to SmithKlineGlaxo after a while.
price target avg $50 & max $82 as per wsj https://www.wsj.com/market-data/quotes/GTHX/research-ratings
GTHX Webcast and Conference Call
The management team will host a webcast and conference call at 8:00 a.m. ET on Tuesday, February 16, 2021 to discuss the FDA approval of COSELA (trilaciclib). The live call may be accessed by dialing 866-763-6020 (domestic) or (210) 874-7713 (international) and entering the conference code: 6195528. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.
text copied from news
congrats(: what's your price target expectation on Tuesday? ihub shows incorrect today's close price, it is 30.89$
min $39 to 42 range and on nutcase 46.70 to 55$ on Tuesday AM if company drops official updates one hr before.
gthx option implied Volatility(IV) is around 27%, with this positive outcome, stock could move 30.89*27%+close price=39ish and some market bull momentum.
YESSSSS!! I made a big bet on this one thinking Jack Bailey wouldn't easily make the decision to give up his career at SmithGlaxoKline to come here unless it was very promising, and I was right! I can hardly wait until Tuesday morning's open!
GTHX FDA APPROVAL - Today After Hrs(:-LINK
trading side it filled the gap, sold off in later days profit taking before PDUFA date due on 15th feb. Afterhours @35(: if fda update positive, could
we see 45-55+?
I found an interesting comment from poster Alex on the Yahoo board. GTHX was co-founded by Norman Sharpless in 2008. Mr. Sharpless is the current director of the National Cancer institute (NCI) and was recently the acting Commissioner of the Food and Drug Administration (FDA). This bode well for GTHX.
Steadily up goes the share price, probably at least until PDUFA day in less than two weeks. I can't decide what to do, but my tendency is to want to hold through and after the date because I like the long-term prospects of the company so much, even though the share price may retreat after the FDA's decision.
My plan is to sell half in week after approval (as I am pretty confident). Then hold half. I'd like to hold all but I need some liquidity to trade the next one.
I am too - I don't think Jack Bailey would have given up his career at SmithGlaxoKline to run this company if he hadn't been pretty confident that it would be approved. The only question I have is do I hold until just before the PDUFA date and sell then, as I have almost inevitably seen biopharmas run up to a significant date such as this and then fall back. I like this company's prospects so much for the long-term, however, that I am reluctant to do that.
I added significantly more today. I don't see much risk that the PDUFA in mid-February will have a bad result, as Jack Bailey wouldn't have given up his career at SmithGlaxoKline to come here if he didn't know that their key drug would be successful.
I agree, but once GTHX's PDUFA date comes it will be too late to get in at these levels. The time to buy is now before that date arrives, and I'm surprised more people don't see that.
PDUFA day is about a month away. I don't think we will ever see this trade below $20 again. I'm buying more tomorrow morning.
It does seem odd to me. I put another $1,200 to work here this morning. I just have to believe that someone of the new CEO's caliber knows far more than I do, and he came here having given up an extremely high-level role at SGK to so. I'm trusting his judgement here.
what is causing it to stay so low when its only a month away from approval
This is a screaming double from here and maybe a four-bagger within a year. All of my available incoming capital is going here for the foreseeable future. All we have to do is wait for people to put the pieces together, and I have a feeling it won't be long now.
Not liking this price action. Looks like this might fill that gap from $14 to $16.
Will see what happens this week on Wednesday, if we get any extra news.
That's good to know - I think my available investment capital will be directed here for some time to come.
I agree he's a heavy hitter, and it's just not him a few other big name pharma people are on board. I do believe a buyout will be in the works after the 1st approval.
The fact that an executive of Jack Bailey's caliber came to this company to lead it is primarily what led me to take a position. He wouldn't waste his time that way if he didn't see tremendous potential in the pipeline and the people. I'll be adding to my position as long as the price stays as low as it is.
RESEARCH TRIANGLE PARK, N.C., Nov. 24, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that incoming Chief Executive Officer Jack Bailey and Chief Medical Officer and Senior Vice President, R&D Raj Malik, M.D. will present a company update at the Evercore ISI 3rd Annual HealthCONx Conference on December 3, 2020 at 1:00 p.m. ET.
To access the live and archived webcast of the presentation, please visit the Events & Presentations page of the G1 website.
About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer. The company is developing and advancing two novel therapies: trilaciclib is a first-in-class therapy designed to improve outcomes for patients being treated with chemotherapy; rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. In 2020, the company out-licensed global development and commercialization rights to its differentiated oral CDK4/6 inhibitor, lerociclib.
Jack Baily Head of GSK USA including their oncology department to run GTHX in January. GSK looking to expand their oncology pipeline? GTHX has three new oncology therapies with potential lead oncology therapy and candidate Trilaciclib FDA approval very near term: Feb 15, 2021 or sooner. This is a very interesting takeover candidate for big pharma if approved ESPECIALLY at these low stock and enterprise numbers by big pharma?? $65/share x 38 million shares o/s= $2.47 billion= average price to price a drug to market?
Commenting on his time at GSK, Jack Bailey said:
“After more than a decade at GSK and nearly three decades in the life sciences industry, I look forward to the chance to explore my next professional chapter. I am enormously proud of every GSK US colleague who has worked so hard to both navigate an exceptionally dynamic operating environment while returning the US Affiliate to double digit revenue growth these past several years. I am confident the company will build upon the talent, culture and performance success of the US Affiliate as it now expands its portfolio into oncology.”
Looks like this will be a perfect candidate for a buy out. Dropped it so the experts could pick up cheaper shares. This will be at $50 before you know it. Keep shorting love the short squeezes.
Looks like the twitter pump failed and is now being dumped.........sorry