Better Therapeutics Submits De Novo Request to U.S. FDA for BT-001 Investigational Prescription Digital Therapy for Type 2 Diabetes
Better Therapeutics, Inc. (BTTX)
Company Research
Source: Business Wire
Submission follows completion of first-in-class trial demonstrating significant improvements in A1c reduction with investigational therapy targeting the root causes of type 2 diabetes. SAN FRANCISCO--(BUSINESS WIRE)--Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy (CBT) to address the root causes of cardiometabolic diseases, today announced that it has submitted a de novo classification request to the U.S. Food and Drug Administration (FDA) seeking marketing authorization for BT-001, its potentially first-in-class digital therapeutic designed to use CBT to treat Type 2 Diabetes (T2D) in patients 18 years and older.“Submitting this de novo request is not just a major milestone for our company but an important moment for patients, providers and payers. As the first digital therapeutic submitted to the FDA for the treatment of type 2 diabetes, BT-001 marks a new kind of treatment paradi
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News
- Better Therapeutics Announces an Innovative Partnership with the American College of Lifestyle Medicine to Expand Access to AspyreRx Across 1,400 Federally Qualified Health Centers [Yahoo! Finance]Yahoo! Finance
- Better Therapeutics Announces an Innovative Partnership with the American College of Lifestyle Medicine to Expand Access to AspyreRx Across 1,400 Federally Qualified Health CentersBusiness Wire
- Better Therapeutics Announces Acceptance of Late Breaking Abstract for Its AspyreRx Pivotal Trial 180 Day Outcomes and Participation at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) [Yahoo! Finance]Yahoo! Finance
- Better Therapeutics Announces Acceptance of Late Breaking Abstract for Its AspyreRx Pivotal Trial 180 Day Outcomes and Participation at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD)Business Wire
- Better Therapeutics and Biotricity Interviews to Air on the RedChip Small Stocks, Big Money(TM) Show on Bloomberg TVAccesswire
BTTX
Earnings
- 8/9/23 - Beat
BTTX
Sec Filings
- 3/21/24 - Form 424B3
- 3/21/24 - Form 8-K
- 3/15/24 - Form 424B3
- BTTX's page on the SEC website