What happened
Shares of Bicycle Therapeutics (BCYC 0.93%) were up 9% as of 1:30 p.m. ET on Monday after the healthcare stock climbed as high as 10.4% earlier in the day. The company's shares are still down more than 8% so far this year.
So what
The clinical-stage biotech company focuses on short amino acid sequences that form stable loops called bicyclic peptides, or bicycles, to treat diseases that the company says are underserved by existing therapies. Many of the company's therapies are being looked at to treat solid tumors. These bicyclic peptides bind with molecules with high affinity and selection, making them good drug candidates for a variety of conditions.
On Monday, the company's shares rose when it said that, after discussions with the Food and Drug Administration (FDA), it is planning on a phase 2/3 investigational trial for BT8009 to treat metastatic bladder cancer. The trial is now expected to begin in the first quarter of 2024. The trial will have two cohorts; the first looks at the therapy in untreated bladder cancer and the second is for patients with previously treated bladder cancer.
"We are pleased to have reached alignment with the FDA on the registrational trial design, dose selection and clinical trial endpoints that could support potential accelerated approval in a broad metastatic bladder cancer population," said Santiago Arroyo, the chief development officer at Bicycle Therapeutics.
Now what
Bicycle already has a development deal that could be worth $1.7 billion with Roche Ag. The company also has several other ongoing collaborations, including ones with Novartis, Ionis Pharmaceuticals and Bayer. In the second quarter, the company reported that it had $340.4 million in cash, not counting a $45 upfront payment from Bayer in July, or the $215.5 million it received from a public stock sale in July. The company reported a net loss of $42.6 million in the quarter, but with its strong cash position, it has plenty of time to develop its pipeline, which includes 13 other assets besides BT8009.
