Telesta Therapeutics (TSX:TST) received news today from the FDA that was a clear negative even if the reasoning behind it may be puzzling, says Euro Pacific Canada analyst Doug Loe.
This morning, Telesta announced a negative result in its biologics licence application (BLA) for MCNA. The FDA voted 18 “no’s” to six “yes’s” to the question “”Does MCNA have an overall favorable benefit-risk profile for the treatment of non-muscle invasive bladder cancer at high risk of recurrence or progression in adult patients who failed prior BCG immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing?”
“While we are disappointed by the Advisory Committee’s vote, we remain hopeful that the FDA will recognize the value of providing a new treatment option to adult patients with high risk non-muscle invasive bladder cancer who are refractory to or relapsing from front-line BCG therapy,” said CEO Dr. Michael Berendt. “We were also encouraged that the majority of practicing urologists on the Advisory Panel voted yes in support of MCNA.”
Loe says there were a number of aspects of the vote he thinks were simply “baffling”.
“No denying that the No vote was decisive, but frequently with positive commentary on its prospects,” says the analyst. “We are quite prepared to take our lumps on negative clinical and/or regulatory events for technology developers in our coverage universe (and we have!), but to be blunt, some of the criticisms of MCNA by the No voters were just baffling to us, and with impractical consequences. First of all, the post-vote explanations from the No voters were frequently quite positive on MCNA’s medical utility (huh?), and there was clearly no guidance from Panel administrators on the incongruity of these two lines of thought. We heard the phrase that MCNA ‘sure would be nice to have’ more than once during the day. Secondly, more than one panelist effectively criticized MCNA for having a benign safety profile (again, huh?), citing this as a reason why MCNA could discourage other new therapies from being tested in BCG-refractory disease, maybe on the concern that future drugs would be compared more to MCNA’s safety than to its efficacy. We have just never heard of this as a concern for any developmental therapy we have reviewed.”
In a research update to clients today, Loe downgraded Telesta Therapeutics from “Speculative Buy” to “Hold” and cut his one-year price target from $1.70 to $0.30, implying a return of 24.1 per cent at the time of publication.