CYAD - Celyad stock soars 35% as FDA lifts hold on colorectal cancer trial of CYAD-101/Keytruda

• Celyad Oncology ( NASDAQ: CYAD ) said the the U.S. Food and Drug Administration (FDA) a lifted a clinical hold on a phase 1b trial of its CAR T cell therapy CYAD-101, after the company made changes to the eligibility criteria for the trial.
• In March, the FDA placed a clinical hold on the study — dubbed CYAD-101-002, also called (KEYNOTE-B79) undertaken with a collaboration with Merck ( NYSE: MRK ) — in colorectal cancer to investigate reports of two fatalities in the trial.
• Celyad had said in February that it voluntarily paused the trial to investigate reports of the two deaths.
• The study will evaluate CYAD-101 with Keytruda (pembrolizumab) in patients with refractory metastatic colorectal cancer with microsatellite stable/ mismatch-repair proficient disease.
• "We remain confident in the potential development of not only the candidate itself, but the continued development with our proprietary TIM technology. CYAD-101 is currently our only clinical candidate co-expressing NKG2D and TIM, and we hope to continue to showcase our expertise with our non-gene edited technologies and explore additional opportunities to utilize NKG2D in allogeneic CAR T," said Celyad's Chief Medical Officer Charles Morris.
• CYAD +35.06% to $2.35 premarket Aug. 1

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