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. (Nasdaq: ALXO) is a clinical-stage biotechnology company whose news flow centers on the development of investigational cancer therapies. The company regularly issues updates on its lead CD47 inhibitor, evorpacept, and its EGFR-targeted antibody-drug conjugate, ALX2004, as these programs advance through clinical and preclinical milestones.
News about ALX Oncology often covers clinical trial progress for evorpacept in HER2-positive gastric and gastroesophageal cancers, HER2-positive metastatic breast cancer and indolent B-cell non-Hodgkin lymphoma. Press releases detail study designs, enrollment status, biomarker findings such as CD47 overexpression as a potential predictive biomarker, and data presented at major oncology and immunotherapy conferences, including meetings of the Society for Immunotherapy of Cancer (SITC), the American Society of Hematology (ASH) and the European Society for Medical Oncology (ESMO).
For ALX2004, company announcements highlight preclinical data, poster presentations at scientific conferences such as the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, and updates from the ongoing Phase 1 first-in-human trial in EGFR-expressing solid tumors. These items typically describe dose-escalation progress, safety observations and the rationale for further clinical evaluation.
ALX Oncology also reports quarterly financial results and corporate updates via press releases and related conference calls, which are referenced in Current Reports on Form 8-K. Additional news may include participation in investor conferences, webcasts, and changes in leadership or board composition. Readers who follow ALXO news can use this page to track clinical milestones, data disclosures and corporate developments over time.
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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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ALX Oncology (Nasdaq: ALXO) recently announced a collaboration with Sanofi to evaluate the combination of evorpacept, a CD47 blocker, and SARCLISA (isatuximab-irfc) in treating patients with relapsed or refractory multiple myeloma (RRMM). This collaboration involves a Phase 1/2 study focused on assessing the safety, efficacy, and pharmacokinetics of the combination therapy. The study aims to identify the optimal dosing and evaluate its efficacy in a broader patient population. ALX will supply evorpacept while Sanofi will provide SARCLISA. This partnership represents a significant step in developing combination therapies for multiple myeloma, which currently lacks a definitive cure.
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