Gold prices dip as hawkish Fed minutes weigh ahead of Jackson Hole
BOSTON - Pyxis Oncology , Inc. (NASDAQ:PYXS), a clinical-stage biopharmaceutical company with a market capitalization of $71 million, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for its investigational drug PYX-201. This designation is for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who have experienced disease progression after platinum-based chemotherapy and anti-PD-(L)1 antibody therapy. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 7.33, holding more cash than debt on its balance sheet.
PYX-201 is a first-in-concept antibody-drug conjugate (ADC) targeting Extradomain-B Fibronectin (EDB+FN), a component within the tumor extracellular matrix, which is highly expressed in various tumor types. The Fast Track Designation aims to expedite the development and review of new drugs that treat serious conditions and fill unmet medical needs.
Head and neck squamous cell carcinoma (HNSCC) represents a significant health concern worldwide as the sixth most common cancer, with a high rate of recurrence and metastasis post-initial treatment. The median overall survival for these patients is less than one year, underscoring the urgent need for new therapeutic options. While Pyxis Oncology’s stock has faced challenges, trading near its 52-week low of $1.19, InvestingPro analysis suggests the company is currently undervalued. Discover more insights about undervalued opportunities at Most Undervalued Stocks.
Pyxis Oncology is conducting two clinical trials for PYX-201. The first, PYX-201-101, evaluates the drug as a monotherapy in patients with R/M HNSCC. The second, PYX-201-102, is testing PYX-201 in combination with Merck (NSE:PROR)’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors. This combination trial stems from a Clinical Trial Collaboration Agreement with Merck.
Lara S. Sullivan, M.D., President and CEO of Pyxis Oncology, noted the Fast Track Designation as a significant milestone for the company and for patients with R/M HNSCC. The company is actively recruiting patients for the trials and is committed to working with the FDA to advance this therapy efficiently.
The information in this article is based on a press release statement from Pyxis Oncology, Inc.
In other recent news, Pyxis Oncology has made a strategic decision to prioritize its lead clinical program, PYX-201, following promising preliminary data from a Phase 1 trial. The trial showed a 50% objective response rate in head and neck squamous cell carcinoma (HNSCC) patients, with a 100% disease control rate among six evaluable patients. As a result, the company will suspend investment in another program, PYX-106, to focus resources on PYX-201. Analysts at H.C. Wainwright have adjusted their price target for Pyxis Oncology to $5.00 while maintaining a Buy rating, reflecting this strategic shift. RBC Capital also revised its price target to $8.00, keeping an Outperform rating due to the early indications of PYX-201’s effectiveness. The strategic focus on PYX-201 is seen as a way to optimize resource allocation and prepare for additional study results expected in 2025. Pyxis Oncology’s financial position is anticipated to support the planned trials of PYX-201 into the second half of 2026. These developments reflect the company’s commitment to advancing its pipeline and addressing unmet needs in cancer treatment.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.