Better Therapeutics (NASDAQ:BTTX) stock is rocketing higher on Thursday as investors react to results from a Phase 2 clinical trial.
This Phase 2 study saw Better Therapeutics using BT-001 to treat type 2 diabetes. BT-001 is a prescription digital therapeutic that uses nutritional cognitive behavioral therapy (nCBT) to meet its goal.
Better Therapeutics notes that the Phase 2 clinical trial saw a decrease in baseline A1c meeting its primary endpoint. That includes a statistically significant drop when compared to patients taking a placebo.
Frank Karbe, president and CEO of Better Therapeutics, said the following about the clinical trial results.
“We believe the data from this trial is remarkable, given we enrolled a diverse patient population with advanced disease already on rigorous blood sugar lowering regimens and who could self-select their dose of BT-001, unlike in traditional new drug pivotal trials. The positive data from this trial serves as an important stepping stone towards our goal of bringing BT-001 to patients and physicians in need of new therapies, and entering the next phase of our growth as a commercial-stage company.”
BTTX Stock: Better Therapeutics Wants Marketing Approval for BT-001
With those positive results in hand, Better Therapeutics intends to submit a de novo classification request to the U.S. Food and Drug Administration (FDA). It’s aiming to do so in the third quarter of 2022. This has it applying for marketing authorization for BT-001 to treat type 2 diabetes.
The news brings heavy trading to BTTX stock today with some 32 million shares on the move as of this writing. That’s well above its daily average trading volume of around 6.9 million shares.
BTTX stock is up 27.5% as of Thursday morning.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.