Welcome to our dedicated page for Alx Oncology Holdings news (Ticker: ALXO), a resource for investors and traders seeking the latest updates and insights on Alx Oncology Holdings stock.
ALX Oncology Holdings Inc. reports company news around a clinical-stage oncology pipeline led by evorpacept, an investigational CD47 inhibitor designed to address a cancer immune-evasion signal. Updates commonly cover clinical data presentations, biomarker analyses involving CD47 expression, and studies of evorpacept combinations in HER2-positive cancers, including breast and gastric cancer settings.
The company also reports development activity for ALX2004, an EGFR-targeted antibody-drug conjugate for EGFR-expressing solid tumors. Other recurring updates include quarterly financial results, research and development spending, cash runway commentary, registered offerings of common stock and pre-funded warrants, leadership appointments, investor conference participation, and Nasdaq inducement equity grants.
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ALX Oncology Holdings Inc. (Nasdaq: ALXO) announced that its next-generation CD47 blocker, evorpacept, has received orphan drug designation (ODD) from the European Commission for treating gastric cancer patients. This designation covers both gastric cancer and gastroesophageal junction adenocarcinoma. The U.S. FDA had previously granted ODD to evorpacept for the same indication in January 2022.
Dr. Sophia Randolph, Chief Medical Officer at ALX Oncology, highlighted the significance of this regulatory achievement and the growing recognition of evorpacept's potential in improving clinical outcomes for gastric cancer patients. The company plans to present data from ASPEN-06, a randomized Phase 2 trial of evorpacept in combination with other drugs for HER2-positive gastric cancer, in the second half of 2023.
The EC grants orphan drug designation to medicines treating rare conditions affecting no more than five in 10,000 people in the EU. This status provides financial and regulatory incentives, including ten years of market exclusivity if approved for marketing.
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