In a strategic regulatory move that could accelerate its path to market, NanoViricides, Inc. (NYSE American: NNVC) announced that it has filed for Orphan Drug Designation with the FDA for NV-387, its experimental measles treatment—a timely development as the country grapples with a dramatic resurgence of the once-rare disease.
The filing comes at a critical moment for public health. After reporting just 59 measles cases in 2023, the United States saw cases jump to 285 in 2024, then explode to 2,251 in 2025, including three deaths. Even more alarming: as of February 5, 2026, the CDC has already confirmed 727 cases this year, putting the country on pace for its worst measles outbreak in decades.
Why Orphan Drug Status Matters
If granted, the Orphan Drug Designation would provide NanoViricides with substantial development incentives, including tax credits for clinical trials, exemption from certain FDA user fees, and potentially seven years of market exclusivity following approval. These benefits are reserved for drugs treating rare diseases affecting fewer than 200,000 Americans annually—a threshold measles still falls beneath despite its recent surge.
“NV-387, as an effective drug would be an important tool to fight Measles resurgence in the USA and worldwide, when approved,” said Anil R. Diwan, PhD. “Treating a patient and providing the drug prophylactically to contacts would eliminate the need for quarantine and loss of valuable school time. An Orphan Drug Designation would help us tremendously in the mission of regulatory development and approval of NV-387 to treat Measles.”
Filling a Critical Gap in Measles Management
Here’s the sobering reality: while an effective measles vaccine exists, there is currently no approved treatment for active measles infection. Once someone contracts the virus, medical care is limited to supportive measures—managing symptoms and hoping the patient’s immune system prevails.
The current public health playbook relies heavily on prevention through vaccination and quarantine protocols. When a measles case is identified, all contacts must be quarantined for at least 14 days. Vaccination can be administered but takes 2-3 weeks to become effective and requires two doses for full protection. For children, this means significant lost school time. For communities, it means substantial economic disruption.
NV-387 could fundamentally change this equation. According to NanoViricides, NV-387 is the only drug candidate to their knowledge that has demonstrated strong in vivo activity against lethal measles infection in a humanized animal model study. If approved, it could be used both therapeutically for infected patients and prophylactically for contacts, potentially eliminating quarantine requirements entirely.
The Vaccine Hesitancy Factor
The measles resurgence isn’t occurring in a vacuum. Vaccination rates have been declining worldwide, primarily driven by vaccine hesitancy. Public health experts estimate that vaccination rates above 95% are needed to achieve herd immunity and prevent measles spread. As those rates slip, outbreaks become increasingly likely.
The standard measles vaccine is generally given as a combination of 3 or 4 vaccines (MMR or MMRV) at one year of age, providing lifelong immunity. However, 6-7% of recent U.S. measles cases occurred in vaccinated individuals—so-called “breakthrough” cases—with the remainder affecting unvaccinated persons or those with unknown vaccination status.
Only an effective treatment can help patients and avoid potential severe disease scenarios such as encephalitis, neurological disabilities, and potential fatalities. A preventive NV-387 treatment of contacts would eliminate the need for quarantining, with significant positive impact for children as well as economically.
Beyond Measles: A Broad-Spectrum Platform
NV-387 represents more than just a potential measles drug. NanoViricides describes it as “an unusually broad-spectrum antiviral” that has demonstrated strong effectiveness in relevant animal models against multiple human viral infections, including RSV, COVID-19, influenza, mpox, smallpox, and measles.
This breadth reflects the company’s core technology platform: what NanoViricides calls “host-mimetic nanomedicine technology that viruses cannot escape.” The company is a clinical-stage pioneer in developing broad-spectrum antivirals based on this proprietary nanoviricide™ technology.
Expert Guidance on Regulatory Strategy
For its Orphan Drug Designation application, NanoViricides enlisted Only Orphans Cote, LLC, a regulatory consultancy founded by Dr. Timothy Cote, former Director of the FDA’s Office of Orphan Products Development. Dr. Cote has intimate knowledge of the laws, rules, and regulations governing orphan drugs and the potential benefits to drug sponsors.
Global Implications
While measles remains rare in the U.S. by orphan disease standards, the disease continues to be endemic in developing and less developed nations. Measles cases are rising across the Western world, including several European countries and the UK, as well as the USA and Canada. Additionally, Mexico and several other Central and South American countries have been suffering from rising measles outbreaks.
A drug for measles is sorely needed for combating the disease worldwide, according to the company.
What Comes Next
The FDA’s Office of Orphan Products Development will now review NanoViricides’ application. If granted, the designation would mark a significant milestone for the clinical-stage company and provide valuable incentives as NV-387 moves through the regulatory approval process.
For investors, the orphan drug pathway represents a potentially faster and less expensive route to market approval compared to traditional drug development. For public health officials watching measles cases climb, an effective treatment option would address a critical unmet medical need.
NanoViricides trades on the NYSE American under the ticker symbol NNVC. The company is a clinical-stage developer creating special purpose nanomaterials for antiviral therapy based on its proprietary nanoviricide™ technology platform, licensed from TheraCour Pharma, Inc.
NanoViricides’ orphan drug filing comes amid heightened investor interest in the biotech sector. Other biotech stocks drawing attention recently include Quince Therapeutics Inc (NASDAQ: QNCX), Moderna Inc. (NASDAQ: MRNA), BioNTech SE (NASDAQ: BNTX) and Novavax Inc. (NASDAQ: NVAX). Meanwhile, clinical-stage players like Cassava Sciences Inc. (NASDAQ: SAVA) in Alzheimer’s treatment and Ocugen Inc. (NASDAQ: OCGN) in gene therapy are seeing trading volume as investors hunt for the next breakthrough. NNVC’s focus on addressing current public health challenges with its broad-spectrum antiviral platform positions it within a competitive landscape where regulatory milestones like orphan drug designation can significantly impact valuations and development timelines.
Source:
https://finance.yahoo.com/news/nanoviricides-president-dr-diwan-interviewed-133000134.html
https://finance.yahoo.com/news/measles-orphan-drug-designation-application-133000267.html
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