NRX Pharmaceuticals(US:NRXP)2025-12-02 15:02Summary of NRx Pharmaceuticals Update Call Company Overview - Company: NRx Pharmaceuticals (NasdaqCM:NRXP) - Date of Call: December 02, 2025 Key Points Regulatory Updates - NRx Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) for a preservative-free formulation of ketamine named Ketaphree to the FDA, which has accepted the filing for review with a goal date of July 29, 2026 for completion [4][9][10] - Ketaphree is the first preservative-free ketamine formulation, eliminating benzethonium chloride (BZT), which is not recognized as safe by the FDA [5][9] - The company has filed a citizens' petition to remove BZT from all commercial presentations of ketamine, citing toxicity concerns [5][9] Market Potential - The global market for ketamine is approximately $750 million annually, with compounded ketamine sales in the U.S. due to a shortage of manufactured products [7][11] - If the ANDA is approved and the citizens' petition is successful, NRx expects to capture a substantial market share, potentially increasing revenue significantly in the second half of 2026 [8][9][10] Manufacturing Capabilities - NRx has manufactured three commercial lots of Ketaphree and aims to produce one million doses per month using modern blow-fill-seal technology [10][11] - The company has sufficient active pharmaceutical ingredient (API) supply for five years, allowing for scalability in manufacturing [20] Pipeline Developments - NRx is developing NRx-101, a combination of D-cycloserine and lurasidone for treating suicidal bipolar depression, which has received Breakthrough Therapy Designation from the FDA [12][14] - Recent studies show that low-dose D-cycloserine combined with transcranial magnetic stimulation (TMS) resulted in an 87% clinical response and 72% remission from depression and suicidality [12][14][25] - The market estimate for NRx-101, if approved, exceeds $1 billion [14] Clinical Trials and Future Plans - A confirmatory phase three trial for NRx-101 is planned for early 2026, focusing on its efficacy in augmenting TMS effects [22][28] - The trial will utilize both objective and subjective measures of depression, enhancing the reliability of results [29] Industry Context - The psychiatry field is moving away from SSRIs, which have low efficacy (around 30%) and significant side effects, towards innovative treatments like TMS and NRx-101 [23][24] - TMS is gaining recognition as a viable treatment option, with reported response rates of 50-60% without D-cycloserine [24] Closing Remarks - NRx Pharmaceuticals is optimistic about the ANDA filing and the expansion of its pipeline, aiming to deliver safer treatment options for patients and value for shareholders [32] Additional Important Information - The FDA's recognition of ketamine as a national priority drug emphasizes the importance of U.S. manufacturing of this critical medicine [10][21] - NRx has launched a nationwide expanded access program for NRx-101, allowing physicians to provide the medication at no charge to patients [14]