February 2, 2016 / 6:48 PM / in 2 years

Telesta Therapeutics Inc: FDA rejects bladder cancer therapy

** Canadian drug developer’s U.S.-listed shares slump about 80 pct to 51 cents

** The U.S. FDA rejected the company’s bladder cancer therapy, MCNA, saying Telesta should conduct another late-stage study to establish its safety and efficacy

** MCNA is a biologic therapy under development for invasive bladder cancer patients who are refractory to or relapsing from first-line therapy

** This is disappointing outcome, though not unexpected based on the feedback received from the advisory committee (to the FDA)”, Roth Capital Partners said, as it downgraded the stock to “neutral” from “buy” and slashed its PT to 10 cents from 50 cents

** If the drug had been approved, it would have been the first new bladder cancer therapeutic to reach the U.S. market since 1998

** Up to Monday’s close, the stock had fallen about 20 pct this year (Reuters Messaging:; natalie.grover.thomsonreuters.com@reuters.net)

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