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Bicycle (BCYC) to Begin Pivotal Bladder Cancer Study, Stock Up

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Bicycle Therapeutics (BCYC - Free Report) , a clinical-stage company, announced moving forward with its decision to expedite the development of BT8009 for metastatic bladder (urothelial) cancer after recent discussions with the FDA.

Per the press release, the company has aligned with the FDA on the design of a phase II/III registrational study called Duravelo-2, which can provide the basis for an accelerated approval in untreated (first-line) and previously treated (second-line plus) metastatic bladder cancer. 

Bicycle anticipates initiating the Duravelo-2 registrational study in the first quarter of 2024. Currently, the company is evaluating BT8009 in a phase I/II study, enrolling patients with Nectin-4 expressing advanced solid tumors.

Per management, the company reached alignment with the FDA in terms of the design of the registrational study, dose selection and study endpoints. The planned late-stage study could potentially support BT8009’s accelerated approval in a broad metastatic bladder cancer population.

BCYC’s stock swiftly climbed about 9% in the last trading session, in response to the encouraging update regarding the development plan of BT8009 in metastatic bladder cancer. Year to date, shares of the company have plunged 22.9% compared with the industry’s 13.4% fall.

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Bicycle reported that the registrational phase II/III Duravelo-2 study will evaluate the safety and efficacy of BT8009 in untreated metastatic bladder cancer (Cohort 1) and previously treated metastatic bladder cancer (Cohort 2).

Cohort 1 of the study will initially assess two doses of BT8009 in combination with Merck’s (MRK - Free Report) Keytruda (pembrolizumab) to determine the optimal dose. Upon selection of the optimal dose, the BT8009/Keytruda combo will be evaluated against chemotherapy. The objective response rate (ORR) in this cohort will form the basis for potential accelerated approval, while the clinical benefit of the combo regimen is expected to be confirmed by the progression-free survival data.

Cohort 2, on the other hand, will evaluate BT8009 both as a monotherapy and in combination with Merck’s Keytruda in the second-line treatment of metastatic bladder cancer. A potential accelerated approval of BT8009 in the second-line setting, both as a monotherapy and in combination with Keytruda, will be determined by ORR compared with historical control data.

Currently, Bicycle is conducting discussions with the FDA to determine the design of the confirmatory study for previously treated metastatic bladder cancer.

BCYC expects to provide additional updates from the BT8009 program as well as updates on other candidates in its pipeline, such as BT5528 and BT7480, which are currently being developed for other oncology indications later this year.

Zacks Rank and Stocks to Consider

Bicycle Therapeutics currently has a Zacks Rank #3 (Hold).

A few better-ranked stocks in the same industry are Dynavax Technologies (DVAX - Free Report) and Better Therapeutics (BTTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has remained constant at 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of DVAX have risen by 26%.

DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.

In the past 30 days, the Zacks Consensus Estimate for Better Therapeutics’ 2023 loss per share has remained constant at 98 cents. During the same period, Better Therapeutics’ 2024 loss per share has remained constant at 80 cents. Year to date, shares of BTTX have lost 44.8%.

BTTX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 24.22%.

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