2023-04-17 13:53:25 ET
Clinical-stage biotech Candel Therapeutics ( NASDAQ: CADL ) added ~18% Monday after announcing that the FDA granted fast-track designation for its lead asset CAN-2409 in a combination regimen for certain patients with lung cancer.
Specifically, the designation covers the use of the viral immunotherapy plus valacyclovir in combination with pembrolizumab as a late-line option for certain patients with non-small cell lung cancer (NSCLC) who don't respond to first-line PD-( L )1 inhibitors.
Candel ( CADL ) is currently advancing an open-label Phase 2 clinical trial for the therapeutic combination in patients with late-stage NSCLC.
The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. It allows developers to communicate frequently with the regulator on plans for clinical studies.
If certain criteria are met, such programs will also be able to win Accelerated Approval and Priority Review, enabling patients to access those treatments sooner.
Wall Street has remained bullish on CADL stock, with an average rating of Buy from analysts , while Seeking Alpha's Quant System, which consistently beats the market, rates CADL as a Strong Sell.
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Candel rallies 18% on FDA Fast Track tag for lead asset