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NRx Pharmaceuticals’ KETAFREE ANDA Acceptance: A Milestone for Market Position and Revenue Growth

NRx Pharmaceuticals’ KETAFREE ANDA Acceptance: A Milestone for Market Position and Revenue Growth

Analyst Patrick Trucchio from H.C. Wainwright reiterated a Buy rating on NRX Pharmaceuticals and keeping the price target at $40.00.

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Patrick Trucchio’s rating is based on the recent acceptance of NRx Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for KETAFREE, their preservative-free intravenous ketamine. This acceptance by the FDA is seen as a significant milestone that reduces risk and provides a clear regulatory timeline, with a goal date set for July 2026. The acceptance not only validates the company’s manufacturing and regulatory strategy but also offers a non-dilutive funding bridge to support the development of its higher-value branded pipeline assets.
Furthermore, KETAFREE’s unique preservative-free formulation, which excludes the potentially harmful benzethonium chloride, positions it well in the market, especially as the FDA does not recognize this preservative as safe. A pending Citizen Petition could further strengthen NRx’s market position by potentially removing competitors until they reformulate. This, combined with the company’s readiness to scale manufacturing, sets the stage for significant revenue growth, which is crucial for funding the development of their branded products, NRX-100 and NRX-101, representing a potential multi-billion dollar opportunity.

In another report released on December 8, BTIG also maintained a Buy rating on the stock with a $25.00 price target.

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