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Pyxis gains on FDA nod to start two Phase 1 trials for cancer drugs

  • Development-stage biotech Pyxis Oncology (NASDAQ:PYXS) announced Thursday that the FDA cleared two of its Investigational New Drug (IND) applications permitting the company to start Phase 1 trials for cancer candidates PYX-201 and PYX-106.
  • Pyxis (PYXS) shares added ~16% pre-market in reaction to the news.
  • Accordingly, antibody-drug conjugate PYX-201 will enter a clinical study designed to evaluate its effect as a potential treatment for several solid tumors, including breast, head and neck, lung, and thyroid cancer.
  • Meanwhile, immunotherapy PYX-106 will be studied for solid tumors, including bladder, cholangiocarcinoma, colorectal, and kidney cancer.
  • Additionally, Pyxis (PYXS) management disclosed that the company’s cash runway extended into H1 2025, and both studies are expected to start in early 2023.
  • In early November, along with its Q3 financials, the company reported $200M in cash (including restricted cash) as of Sep. 30.