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Shares of Candel Therapeutics (CADL) jumped 9% on Tuesday after the biotech company launched a pivotal Phase 3 trial of its lead cancer therapy in advanced non-small cell lung cancer (NSCLC), expanding its clinical ambitions beyond its promising late-stage success in prostate cancer.
CADL shares, which climbed to their highest levels in 16 months, are also on track to record their biggest monthly gains since December 2024.
On Tuesday, Candel launched its global Phase 3 Aurora trial to evaluate its investigational therapy, Aglatimagene Besadenovec (CAN-2409), in patients with NSCLC whose disease has progressed despite treatment with Pembrolizumab and platinum-based chemotherapy.
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The open-label study will compare CAN-2409 plus Valacyclovir, alongside continued Pembrolizumab, with the current standard-of-care chemotherapy, Docetaxel. The first trial site has already opened for patient enrollment, with the study expected to recruit participants across more than 150 sites worldwide.
The primary goal of the trial is to assess overall survival, while secondary endpoints include safety and quality of life. The investigational therapy has received Fast Track designation from the U.S. Food and Drug Administration (FDA).
The launch comes weeks after The Lancet Oncology published positive Phase 3 data for CAN-2409 in localized prostate cancer. The study showed a 30% improvement in disease-free survival when the therapy was added to standard radiotherapy, supporting Candel’s planned Biologics License Application submission in the fourth quarter of 2026.
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Last month, Candel announced cash and cash equivalents totaling $194.8 million, which are expected to fund operations into the first quarter of 2028.
Retail sentiment on Stocktwits turned ‘extremely bullish’ from ‘bullish’ a day earlier, amid ‘high’ message volumes.
One user said, “Our SLS days are coming,” potentially referring to Sellas’s smashing 236% gains in 2026, driven by bullish sentiment surrounding the highly anticipated data from its trial evaluating Galinpepimut-S therapy for Acute Myeloid Leukemia.
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Another user called the latest update “unequivocally good news” as it removes “execution uncertainty.”
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CADL stock has soared more than 100% so far this year.
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