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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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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.
ALX Oncology Holdings Inc. (Nasdaq: ALXO) announced dosing of the first patient in the I-SPY-P1-TRIAL, sponsored by Quantum Leap Healthcare Collaborative, for treating unresectable or metastatic HER2-positive and HER2-low breast cancer. This Phase 1 study evaluates evorpacept, a CD47 blocker, combined with ENHERTU® (fam-trastuzumab deruxtecan-nxki) to assess safety, tolerability, and efficacy. Dr. Laura Esserman highlighted that this treatment may be transformative for patients resistant to other therapies. The I-SPY TRIAL aims to rapidly screen and test novel therapies tailored to specific patient subgroups.
ALX Oncology Holdings reported its financial results for Q4 and the full year 2022, highlighting significant progress in clinical trials for its lead product, evorpacept. The company experienced a GAAP net loss of $30.7 million for Q4 2022, up from $28.4 million in Q4 2021, and a full-year GAAP net loss of $123.5 million, compared to $83.5 million in 2021. R&D expenses rose to $25.2 million for Q4 and $98.4 million for the year, reflecting ongoing development efforts. ALX has sufficient cash reserves of $282.9 million, expected to fund operations through mid-2025. The company anticipates key trial data presentations and IND filings in 2023.