Pyxis Oncology pins hope on lead cancer drug following FDA fast track nod

Pyxis Oncology (NASDAQ: PYXS) has narrowed its pipeline to a single cancer drug, micvotabart pelidotin (PYX-201), as it races to capitalize on rising investor interest in antibody-drug conjugates (ADCs).

The US biotech earlier this year secured fast track designation from the FDA for PYX-201 in adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This regulatory status is designed to speed up the review process for treatments addressing serious medical needs and could lead to accelerated approval pathways.

PYX-201 is the first ADC to target a protein known as Extradomain-B Fibronectin (EDB+FN), found in the tumor microenvironment of many aggressive cancers. The drug delivers a microtubule inhibitor payload directly to tumor sites, aiming to increase precision and reduce systemic side effects.

According to Visible Alpha consensus, analysts assign a 25% probability of success for PYX-201 in this indication. Should the drug win approval, sales are projected to reach $24 million by 2030.

The ADC category is one of the fastest-growing segments in oncology, with Big Pharma—including Pfizer (NYSE: PFE), AstraZeneca (LSE: AZN), and Gilead (NASDAQ: GILD), among others—pouring capital into the space through acquisitions, partnerships and in-house R&D.

Pyxis is currently running two Phase 1 trials for PYX-201: one as a standalone therapy, and another in combination with Merck’s immunotherapy blockbuster Keytruda. Preliminary clinical data are expected through 2025 and 2026.

To streamline operations and conserve cash, Pyxis recently cut 20% of its workforce and shelved its other main program, PYX-106, signaling an all-in commitment to PYX-201.

The company reports first-quarter 2025 earnings on May 12. Analysts expect costs to rise sharply from 2026 onwards as PYX-201’s clinical development accelerates.