Please ensure Javascript is enabled for purposes of website accessibility

Why G1 Therapeutics Is Soaring 16% Today

By Todd Campbell - Apr 30, 2019 at 3:21PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The clinical-stage biopharmaceutical company is on track to file for FDA approval of its first drug, trilaciclib.

What happened

After the closing bell on Monday, G1 Therapeutics (GTHX -1.68%) announced that it plans to file for regulatory approval of trilaciclib, an agent to protect bone marrow from the damage caused by chemotherapy. In response, the company's shares skyrocketed, and were up 16% as of 3:15 p.m. EDT Tuesday.

So what

Trilaciclib aims to reduce the risks to bone marrow production of white blood and red blood cells and platelets, which are important to preventing infection and maintaining energy levels.

Pills spill out of a prescription bottle into the shape of a dollar sign.


In December, G1 Therapeutics reported results from a mid-stage study showing an overall response rate of 13.3% in second-line and third-line small cell lung cancer patients given trilaciclib and topotecan, a chemotherapy. The response rate was lower than chemotherapy alone, but the doublet did reduce the rate of severe (grade 4) neutropenia, a depletion of white blood cells. 

In November, it delivered results from a study pairing trilaciclib with Roche Holdings' (RHHBY 2.31%) Tecentriq and chemotherapy in first-line small cell lung cancer, showing that the combination outperformed Tecentriq and chemotherapy alone. The trilaciclib arm had lower rates of neutropenia, anemia, and thrombocytopenia while producing similar overall response and progression-free survival rates to Tecentriq and chemoptherapy alone.

These findings were good enough for the company to emerge from its post-phase 2 meeting with the FDA encouraged. It plans to have a new drug application (NDA) pre-meeting with the FDA regarding trilaciclib's use in small cell lung cancer cases later this year, with an official NDA filing thereafter. After that, it also plans to file for European approval.

Now what

Chemotherapy damage to bone marrow can require doctors to change dosing and delay treatment in ways that can reduce the odds of positive outcomes. Therefore, trilaciclib's ability to protect bone marrow could make it a favored therapy for patients with small cell lung cancer -- a particularly tough cancer with historical five-year survival rates of 30% or less.

However, we're still a while away from an actual NDA filing, and even if the FDA grants a priority review, it will be six months or longer after that before the agency weighs in with its decision. Furthermore, there's no guarantee that doctors will incorporate trilaciclib into standard care if it is approved. A lot of questions remain for this company, so investors might want to wait and see what G1 Therapeutics says later this year about its pre-NDA meeting. 

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

G1 Therapeutics Stock Quote
G1 Therapeutics
$4.96 (-1.68%) $0.09
Roche Holding AG Stock Quote
Roche Holding AG
$42.06 (2.31%) $0.95

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning service.

Stock Advisor Returns
S&P 500 Returns

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 05/23/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.