In order to conserve cash as it assesses its strategic options, Telesta Therapeutics (OTCPK:BNHLF) cuts 15% of its workforce, most coming from its Montreal manufacturing site. It has also reduced its internal and consulting expenses after the FDA rejected its BLA last month seeking clearance for lead product candidate MCNA for the treatment of bladder cancer. In its Complete Response Letter (CRL), the agency cited the need to conduct a new Phase 3 study to demonstrate efficacy.
The company has requested a meeting with the regulator to clarify an approval path for MCNA for the second-line treatment of high-risk non-muscle bladder cancer. It expects the meeting to take place within 30 days.
Previously: FDA rejects Telesta's BLA for lead product candidate; shares plummet 66% (Feb. 2)
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