Nrx Pharmaceuticals Inc Stock Price, News & Analysis

NRx Pharmaceuticals has submitted an Abbreviated New Drug Application (ANDA) to the FDA for NRX-100, a preservative-free IV ketamine formulation. The company aims to address the current US ketamine shortage in a market valued at $750 million, projected to reach $3.35 billion globally by 2034. NRX-100 eliminates benzethonium chloride, a neurotoxic preservative, and will be marketed for all approved uses including anesthesia and pain management. The company plans to file a citizen's petition to remove this toxic preservative from all IV ketamine products. This ANDA complements NRx's ongoing NDA submission for ketamine use in suicidal depression, with PDUFA anticipated in late 2025. The product has received Fast Track Designation and a PDUFA fee waiver, with patent protection sought through 2045.

NRx Pharmaceuticals (NASDAQ:NRXP), a clinical-stage biopharmaceutical company, announced its selection to present at the Wall Street Conference on May 21, 2025 in Palm Beach, Florida. Dr. Jonathan Javitt, Founder, Chairman and CEO of NRx and Co-CEO of HOPE Therapeutics, will provide a company update focusing on progress towards FDA approval of NRX-100 (preservative-free ketamine) and upcoming acquisitions of HOPE clinics specializing in treatment of suicidal depression, PTSD, and related disorders.

The conference, which will host six presenting companies, is expected to attract over 1,000 attendees representing more than $1 trillion in investment capital.

NRx Pharmaceuticals (NASDAQ:NRXP) reported Q1 2025 financial results and provided significant updates on its drug development pipeline. The company is advancing two key drugs: NRX-100 (preservative-free IV ketamine) and NRX-101 for suicidal depression, with NDAs expected in 2025. Notable achievements include a $4.3M FDA fee waiver for NRX-100 and a new patent filing potentially providing exclusivity until 2045. Through its HOPE Therapeutics subsidiary, NRXP is expanding into clinical operations with planned acquisitions of three clinics representing ~$15M in pro-forma revenues, with additional targets identified for ~$20M more. The company raised $8.9M in January 2025 and secured $10.3M in non-dilutive acquisition capital. Q1 2025 showed improved financials with net loss of $5.5M versus $6.5M in Q1 2024. Cash position stands at $5.5M, expected to support operations through 2025.

HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals (NASDAQ:NRXP), has secured a term sheet with Universal Capital for $7.8 million in debt financing. Combined with a previously announced strategic investment, HOPE is set to receive $10.3 million in total acquisition capital.

The funding will support HOPE's national expansion strategy through the acquisition of interventional psychiatry clinics, starting with Dura Medical, Kadima, and NeuroSpa. These clinics specialize in neuroplastic treatments, including ketamine and transcranial magnetic stimulation (TMS), for treating severe depression, PTSD, and related conditions. The clinics currently serve veterans through Veterans Health Administration contracts and the general public.

Universal Capital shares HOPE's vision of establishing a nationwide network of mental health clinics and plans to participate in future funding as additional acquisitions are identified.

HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals (NASDAQ:NRXP), has signed a definitive agreement to acquire Kadima Neuropsychiatry Institute in La Jolla, CA. Kadima, a profitable clinic specializing in interventional psychiatry, will serve as the clinical model for HOPE's nationwide treatment network. The institute is a leading research site for CNS and psychedelic therapies, offering treatments including ketamine, Spravato, and TMS for conditions like suicidal depression and PTSD.

Dr. David Feifel, Kadima's founder and a recognized expert in interventional psychiatry, will join HOPE as Chief Medical Innovation Officer post-acquisition. The acquisition is expected to be accretive to revenue and EBITDA for both NRx and HOPE, subject to closing conditions and financing finalization.

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has scheduled its first quarter 2025 financial results announcement for May 15, 2025, after market close. The company will release results through a press release available on their investor relations website, followed by a conference call at 4:30 PM ET.

Interested parties can access the conference call via webcast on the company's website or by telephone using the following dial-in numbers: +1-800-717-1738 (domestic) or +1-646-307-1865 (international).

NRx Pharmaceuticals (NASDAQ:NRXP) and its subsidiary HOPE Therapeutics announced an upcoming investor event at Mar-A-Lago Club on May 8, 2025. The event will discuss strategic initiatives including HOPE's interventional psychiatry clinic expansion and NRx's clinical pipeline progress.

Key discussion topics include: HOPE's recent clinic acquisitions, integration of digital health solutions, status of NRX-100 (preservative-free IV Ketamine) NDA following a $4.3M FDA filing fee waiver, a new patent filing for NRX-100 that could provide market exclusivity until 2045, and the Breakthrough Therapy Designation of NRX-101 for bipolar depression treatment. Dr. Jonathan Javitt, Chairman and CEO of NRx and Co-CEO of HOPE Therapeutics, will lead the discussion.

NRx Pharmaceuticals (NASDAQ:NRXP) has filed a patent application for NRX-100, its preservative-free intravenous ketamine formulation designed to treat suicidal depression. The patent, if granted, would provide exclusivity until 2045 and could be listed in the FDA Orange Book. NRX-100's key innovation is its formulation without benzethonium chloride or other preservatives, which have been linked to cytotoxic or neurotoxic effects.

The company has already initiated an NDA filing for NRX-100 and received Fast Track Designation with NRX-101 from the FDA. With a recent FDA fee waiver in place, NRx plans to complete its NDA submission in the current quarter. The patent application includes twenty claims covering pharmaceutical compositions, treatment methods, and manufacturing processes.

NRx Pharmaceuticals (NASDAQ: NRXP) has received an FDA waiver for the $4.3 million filing fee for its New Drug Application for NRX-100, a preservative-free ketamine treatment for suicidal depression. The company plans to complete the NDA filing by Q2 2025.

The drug's key innovation is its preservative-free formulation, avoiding benzethonium chloride, which has potential neurotoxic effects. NRX-100 has demonstrated two-year shelf life stability and could receive long-term exclusivity upon FDA approval.

Clinical trials have shown ketamine's superiority over placebo and active comparators in treating depression and suicidal ideation. The FDA's fee waiver, granted to Small Business Entities and drugs deemed necessary for Public Health, enables NRx to proceed with its application using existing resources. The company aims to make this potentially life-saving therapy accessible through insurance coverage, as current ketamine treatments for depression are not FDA-approved and require out-of-pocket payment.