hapabapa
Bicycle Therapeutics (NASDAQ:BCYC) traded ~9% higher on Monday after the oncology-focused biotech said that the U.S. FDA agreed on plans for a Phase 2/3 registrational trial for its bladder cancer therapy BT8009.
The trial named Duravelo-2 is designed to support a potential accelerated approval for BT8009 in metastatic bladder cancer as a first-line and second-line option, the company said, adding that the global trial will begin in Q1 2024.
The decision to focus on untreated patients is in line with the FDA’s Project FrontRunner, an initiative to encourage developers to seek approval for new cancer drugs in earlier-line settings rather than as late-line options.
Discussions between Bicycle (BCYC) and the FDA are already underway over the design of a confirmatory trial to test BT8009 for previously treated metastatic bladder cancer.
After the announcement, B. Riley upgraded BCYC to Buy from Neutral, noting that “Bicycle has not only found an accelerated pathway but will directly target the frontline market, the largest potential opportunity, from the get-go.”
However, the firm notes that the company is years away from a potential approval, “but we believe that the regulatory barriers keeping a lid on shares have now been lifted.”
