Welcome to our dedicated page for Pyxis Oncology news (Ticker: PYXS), a resource for investors and traders seeking the latest updates and insights on Pyxis Oncology stock.
Pyxis Oncology, Inc. (PYXS) is a clinical-stage biopharmaceutical company pioneering antibody-drug conjugates (ADCs) targeting components of the tumor microenvironment to address challenging cancers. This page provides investors and researchers with a comprehensive repository of official announcements, clinical trial updates, and strategic developments.
Access timely updates on PYX-201 progress, partnership agreements, and regulatory milestones. Our curated collection includes earnings reports, preclinical data disclosures, and management commentary – all essential for evaluating the company’s position in oncology innovation.
Key content categories include ADC platform advancements, clinical trial phase transitions, and scientific collaborations. Users will find verified information on therapeutic mechanisms targeting extracellular matrix proteins like EDB+FN, a focus area distinguishing Pyxis in immuno-oncology.
Bookmark this page for streamlined access to material events affecting Pyxis Oncology’s trajectory. Check regularly for new developments in their pipeline programs and evidence-based analysis of therapeutic candidates.
Pyxis Oncology (NASDAQ: PYXS) announced new preclinical data for micvotabart pelidotin (MICVO), their first-in-concept antibody-drug conjugate targeting EDB+FN in the tumor microenvironment. The data will be presented at AACR 2025 in Chicago.
Key highlights include:
- Patient-derived xenograft mouse models showed gene signatures associated with MICVO efficacy
- Combination of MICVO analog with anti-PD-1 therapy demonstrated enhanced tumor regression
- Phase 1 studies showed significant tumor regression across multiple tumor types
The company is advancing MICVO in clinical trials:
- Phase 1 monotherapy expansion for recurrent/metastatic head and neck cancer with preliminary data expected in 2H2025 and 1H2026
- Phase 1/2 combination study with Keytruda® with preliminary data expected in 2H2025
MICVO has received Fast Track Designation from the FDA for treating adult patients with recurrent/metastatic head and neck squamous cell carcinoma after platinum-based chemotherapy and anti-PD-(L)1 therapy.
Pyxis Oncology (NASDAQ: PYXS) has reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical programs. The company's lead candidate, micvotabart pelidotin (MICVO), showed promising results with a 50% objective response rate in head and neck cancer patients during Phase 1 trials. MICVO received FDA Fast Track Designation for treating recurrent/metastatic head and neck squamous cell carcinoma.
The company has initiated multiple expansion cohorts and combination studies, with preliminary data expected throughout 2025-2026. To optimize resources, Pyxis implemented a 20% workforce reduction and suspended PYX-106 development.
Financial highlights include:
- Cash position of $128.4M as of December 31, 2024
- Expected runway into 2H 2026
- R&D expenses increased to $58.7M from $49.6M in 2023
- G&A expenses decreased to $25.4M from $32.6M in 2023
- Net loss of $77.3M ($1.32 per share) compared to $73.8M ($1.85 per share) in 2023
Pyxis Oncology (Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics for difficult-to-treat cancers, has announced its participation in the Leerink Partners Global Healthcare Conference in Miami, Florida.
The company's President and CEO, Dr. Lara S. Sullivan, will engage in a fireside chat scheduled for March 10, 2025, at 2:20 PM EST. Investors and interested parties can access both the live webcast and replay of the presentation through the Events & Presentations page in the Investor Relations section of Pyxis Oncology's website at ir.pyxisoncology.com.
Pyxis Oncology (PYXS) has received FDA Fast Track Designation for PYX-201, targeting the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). This designation applies specifically to patients whose disease has progressed after treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody.
PYX-201 is a pioneering antibody-drug conjugate (ADC) that targets Extradomain-B Fibronectin (EDB+FN), a structural component within the tumor extracellular matrix highly expressed in various tumor types. The Fast Track status is designed to expedite the development and review process of new drugs addressing serious or life-threatening conditions with unmet medical needs.
Pyxis Oncology (NASDAQ: PYXS) has announced significant progress in its clinical program for PYX-201, a first-in-concept antibody-drug conjugate targeting Extradomain-B Fibronectin. The company has initiated two major developments:
1. A Phase 1/2 combination trial of PYX-201 with Merck's KEYTRUDA® in multiple solid tumors, set to begin dosing in Q1 2025. The trial will target first-line and second-line+ recurrent/metastatic head and neck squamous cell carcinoma, hormone receptor-positive and HER2-negative breast cancer, and advanced triple-negative breast cancer.
2. The expansion of its ongoing Phase 1 monotherapy trial to include cohorts for second and third-line recurrent/metastatic head and neck squamous cell carcinoma patients who have received prior treatments.
Pyxis Oncology (NASDAQ: PYXS) announced a strategic portfolio prioritization to focus resources on PYX-201, its lead clinical program. PYX-201, a first-in-concept antibody-drug conjugate targeting Extradomain-B Fibronectin, showed promising results in Phase 1 trials with a 50% objective response rate in head and neck squamous cell carcinoma patients and 26% ORR across six solid tumor types.
The company will suspend investment in PYX-106, its second clinical program, to concentrate on PYX-201's development. Multiple expansion studies are planned for early 2025, including monotherapy and combination trials with pembrolizumab. The company's current cash position is expected to fund operations into the second half of 2026.
Pyxis Oncology (NASDAQ: PYXS) announced positive preliminary data from its Phase 1 clinical trial of PYX-201, a novel antibody-drug conjugate targeting Extradomain-B Fibronectin. The drug achieved a 50% objective response rate including one complete response in head and neck cancer patients, and 26% overall response rate across six solid tumor types. PYX-201 demonstrated a favorable safety profile and dose-dependent responses. The company also announced a new clinical trial collaboration with Merck to evaluate PYX-201 in combination with KEYTRUDA®, with dosing expected to begin in Q1 2025.
Pyxis Oncology (NASDAQ: PYXS) reported Q3 2024 financial results and provided updates on its clinical programs. The company ended Q3 with $146.3 million in cash and investments, expecting runway into 2H 2026. The company has enrolled 80 patients in the PYX-201 Phase 1 trial and 45 patients in the PYX-106 trial. Q3 net loss was $21.2 million ($0.35 per share), compared to $23.0 million ($0.56 per share) in Q3 2023. R&D expenses increased to $17.7 million from $14.7 million, while G&A expenses decreased to $6.0 million from $10.7 million year-over-year.
Pyxis Oncology (Nasdaq: PYXS) announced an upcoming investor event on November 20, 2024, to present preliminary data from their Phase 1 clinical trial of PYX-201. The event will be held both in-person in New York City and virtually. The presentation will cover data from approximately 80 patients, including safety, preliminary efficacy, and pharmacokinetics results for PYX-201, a first-in-concept antibody-drug conjugate targeting Extradomain-B Fibronectin in solid tumors. Executive management will be joined by physician thought leaders Dr. Anthony Tolcher and Dr. Glenn Hanna to discuss the findings and future development plans.
Pyxis Oncology (Nasdaq: PYXS), a clinical-stage company developing next-generation cancer therapeutics, has announced its participation in two upcoming investor conferences. CEO Lara S. Sullivan will engage in fireside chats at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 6 at 12:20 PM ET and the H.C. Wainwright 26th Annual Global Investment Conference on September 9 at 2:00 PM ET, both in New York.
Management will also participate in one-on-one meetings during these events. Investors can access live webcasts and replays of the presentations through the Events & Presentations page in the Investor Relations section of Pyxis Oncology's website at ir.pyxisoncology.com.
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