NuvOx Therapeutics Receives FDA Fast Track Designation to NanO₂™ for the Treatment of Acute Ischemic Stroke
- 8 hours ago
- 5 min read
TUCSON, AZ, July 15, 2026 — NuvOx Therapeutics, Inc. (“NuvOx Therapeutics”, “NuvOx”, or the “Company”) today announces that its wholly owned subsidiary, NuvOx Pharma LLC, has been granted Fast Track designation for NanO₂™ by the U.S. Food and Drug Administration (“FDA”) for the treatment of adult patients presenting with acute ischemic stroke (“AIS”).
Acute ischemic stroke remains a leading cause of death and long-term disability worldwide. Despite advances in mechanical thrombectomy and thrombolytic therapy, many patients experience irreversible brain injury due to inadequate oxygen delivery to ischemic tissue before blood flow can be restored.
Fast Track designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and fill an unmet medical need. The designation provides opportunities for more frequent interactions with the FDA, eligibility for rolling review of marketing applications, and the potential for Priority Review if relevant criteria are met. The Fast Track designation further strengthens NuvOx Therapeutics’ regulatory strategy as the Company advances its clinical development program. NanO₂ is currently being evaluated in clinical studies designed to assess its ability to improve neurological outcomes when administered alongside standard stroke therapies.
"We are honored that the FDA has recognized the potential of NanO₂ to address one of the greatest unmet needs in acute stroke care," said Rong Wang, President and Chief Executive Officer of NuvOx Therapeutics. "Fast Track designation is an important milestone. We believe it validates the goal of our oxygen therapeutic platform and supports our commitment to accelerating the clinical development of NanO₂ for patients who urgently need new treatment options. We look forward to working closely with the FDA as we advance our stroke program."
"This designation represents an important recognition of the potential for the scientific rationale underlying NanO₂," said Evan C. Unger, M.D., Executive Chairman of the Board of Directors and Co-founder of NuvOx Therapeutics. "For many years, our team has worked to develop a therapy capable of delivering oxygen to tissues that remain viable but critically oxygen deprived. We believe this technology has the potential to fundamentally change the treatment paradigm for ischemic diseases, beginning with acute stroke."
"Receiving Fast Track designation is the culmination of years of research, formulation development, manufacturing, and clinical collaboration," said Jennifer Johnson, Ph.D., Chief Operating Officer and Co-founder of NuvOx Therapeutics. "Our team has focused on developing a robust, scalable product candidate while generating the scientific and clinical evidence needed to support regulatory advancement. This designation provides an important opportunity to work more closely with the FDA and accelerate the development of NanO₂ for stroke patients."
In addition to its stroke program, NuvOx Therapeutics is evaluating NanO₂ across multiple therapeutic areas where tissue hypoxia plays a critical role, including oncology and acute respiratory failure.
About NuvOx:
NuvOx is a privately held clinical stage biopharmaceutical company developing a novel platform of oxygen therapeutics for the treatment of diseases where hypoxia plays a role. Hypoxia, or low oxygen, is responsible for resistance to cancer treatment, brain damage in stroke, and the death of patients with acute respiratory distress syndrome.
NuvOx’s product candidate, NanO2, is a platform technology designed to address multiple unmet needs, with two completed Phase Ib/II studies: one in glioblastoma as a radiosensitizer and the other in stroke as a neuroprotectant. It has safety and efficacy data in 7+ indications in various preclinical and clinical stages and Orphan Drug Designation for both glioblastoma and sickle cell anemia.
NanO2 is designed to be synergistic, rather than competitive, with standard of care. The company also has a strong IP portfolio: 10 Patent Families; 11 issued US patents and 31 foreign equivalents.
NuvOx has completed enrollment in a randomized, placebo-controlled Phase IIb clinical trial as a radiosensitizer in treatment of primary glioblastoma. In this study, the drug was well tolerated. A Phase IIb clinical trial for NanO2 in treatment of acute ischemic stroke has also started, funded by the UK government. In addition, NuvOx is conducting a Phase Ib clinical trial for NanO2 in treatment of respiratory distress in Canada, partially funded by BARDA.
Forward-looking statement:
This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing.
The forward-looking statements include statements regarding: We believe it validates the goal of our oxygen therapeutic platform and supports our commitment to accelerating the clinical development of NanO₂ for patients who urgently need new treatment options ; This designation represents an important recognition of the potential for the scientific rationale underlying NanO2; We believe this technology has the potential to fundamentally change the treatment paradigm for ischemic diseases, beginning with acute stroke.
Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to derive the potential benefits associated with the FDA’s Fast Track Designation for the treatment of adult patients presenting with acute ischemic stroke, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees. These risks should not be construed as exhaustive. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
Investor Relations
Hanover International, Inc.
For more, visit Innovative Oxygen Therapeutics | NuvOx Pharma | Arizona.