Remaining $5.4 million debt was repaid through strategic equity conversion in common stock with no additional warrants or adjustment provisionsCompany anticipates that Dec 31 balance sheet will reflect no outstanding convertible debtDebt-free balance sheet sets the stage for accelerated growth in 2026 with potential drug approvals and clinic expansions WILMINGTON, Del., Dec. 18, 2025 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced tha ...

Core Insights - NRx Pharmaceuticals has amended its Investigational New Drug filing for NRX-101 to include its use in conjunction with Transcranial Magnetic Stimulation (TMS) for treating depression, including suicidal depression [1][8] Group 1: Clinical Findings - NRX-101 has shown a promising new indication that may expedite its commercialization as a Breakthrough Therapy-designated drug, with evidence indicating a more than two-fold benefit in symptom reduction when combined with TMS [2] - Clinical trials reported a 75% clinical response and a 40% remission rate in patients treated with D-cycloserine (DCS) alongside TMS [2] - A recent study using a modern TMS device and a one-day protocol combined with DCS showed an 87% clinical response and a 72% remission rate at six weeks [3] Group 2: Mechanism and Efficacy - Nonclinical evidence suggests that D-cycloserine enhances neuroplasticity when used with TMS, potentially leading to a response rate exceeding 80%, which is significantly higher than the 30% success rate associated with traditional SSRI antidepressants [4] - NRX-101 combines D-cycloserine with a low dose of lurasidone, which is already approved for depression treatment and has anti-hallucinatory properties, addressing the contraindication of DCS in depression patients [5] Group 3: Future Prospects - The company plans to conduct well-controlled trials with approximately 120 participants to further validate the clinical benefits observed in earlier studies [6] - NRx anticipates that over 1 million Americans may be treated with TMS annually by 2030, creating a substantial market opportunity for NRX-101 [7] - The company has published an Expanded Access policy for NRX-101, allowing physicians to request information for patients who may benefit from the treatment [7]

Core Points - NRx Pharmaceuticals, Inc. is conducting a corporate update call to discuss recent developments and future plans [1] - The call includes forward-looking statements that are subject to risks and uncertainties, which may lead to actual results differing from expectations [2][3] - Dr. Jonathan Javitt, the Founder, Chairman, and CEO, will provide a regulatory update and discuss a significant addition to the company's development pipeline [4]

Summary 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]

Core Viewpoint - NRx Pharmaceuticals has received acknowledgment from the FDA for its Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free intravenous ketamine formulation, with a goal date for final review set for July 29, 2026 [1][8]. Company Developments - The FDA has determined that the ANDA for KETAFREE™ is "substantially complete," marking a significant milestone for the company [1][8]. - KETAFREE™ aims to provide a single-patient, preservative-free ketamine option, addressing safety concerns associated with the current multi-dose vials containing Benzethonium Chloride (BZT), which is not recognized as safe by the FDA [2][3]. - The company has manufactured initial registration lots of KETAFREE™ and is prepared to scale production to 1 million vials per month [8]. Market Context - The global generic ketamine market is estimated to be worth $750 million annually, indicating a substantial market opportunity for KETAFREE™ upon approval [8]. - The current healthcare initiatives are focused on the review and removal of toxic substances from drugs, aligning KETAFREE™ with these priorities [4]. Future Outlook - The next key milestone for NRx Pharmaceuticals is the completion of the FDA review under the Generic Drug User Fee Amendments framework, with the GDUFA goal date also set for July 29, 2026 [5][8]. - The company is also advancing its pipeline, including the development of NRX-100 for suicidal depression, which has received Fast Track designation from the FDA [5][7].

Core Viewpoint - NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, is set to provide a corporate update on December 2, 2025, focusing on recent clinical, regulatory, and operational developments [1]. Company Overview - NRx Pharmaceuticals specializes in Neuroplastic Therapies aimed at treating central nervous system disorders, including suicidal depression, PTSD, anxiety, and Autism [3]. - The company is developing two key products: NRX-100, a preservative-free intravenous ketamine, and NRX-101, an oral D-cycloserine/lurasidone [3]. - NRX-100 has received Fast Track Designation for treating suicidal ideation in depression, while NRX-101 has been granted Breakthrough Therapy Designation for suicidal bipolar depression [3]. - An Abbreviated New Drug Application for NRX-100 has been filed, with a launch anticipated in July 2026 [3]. Subsidiary Information - HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals, is focused on creating a network of interventional psychiatry clinics that provide various therapies, including ketamine and transcranial magnetic stimulation [4]. - HOPE Therapeutics is the first network in Florida to offer the AMPA One Day (ONE-D) treatment, which combines TMS, physician-prescribed D-cycloserine, and lisdexamfetamine for treatment-resistant depression [4].

Core Insights - Several biotechnology and pharmaceutical companies experienced significant gains in after-hours trading due to corporate updates and upcoming event announcements [1] Company Updates - Jasper Therapeutics, Inc. (JSPR) saw a 21.51% increase to $2.09 after hours, following the announcement of a webinar on December 2 to present findings from the BEACON study and preliminary data from the ETESIAN study [2] - NRx Pharmaceuticals, Inc. (NRXP) rose 13.39% to $2.71 after hours, with the CEO scheduled to present at NobleCon21 on December 3, discussing the company's expanded focus and clinical revenue progress [3] - Unicycive Therapeutics, Inc. (UNCY) increased by 5.42% to $6.33, with the CEO participating in two upcoming events, although no new announcements were made on Monday [4] - Spruce Biosciences, Inc. (SPRB) shares rose 4.68% to $87.00 after reporting a net loss of $8.2 million for the quarter ending September 30, 2025, an improvement from a net loss of $8.7 million in the previous year [5] - Evaxion A/S (EVAX) added 3.96% to $5.65, announcing progress in its CMV vaccine program with new protective data and ongoing preclinical development [6] - Solana Company (HSDT) gained 3.48% to $3.87, reporting a net loss of $352.8 million for the third quarter, a significant increase from a net loss of $3.7 million in the prior-year period, with revenue totaling $697,000 [7] - Protara Therapeutics, Inc. (TARA) rose 5.04% to $7.08, planning a conference call on December 3 to review interim data from its Phase 2 trial of TARA-002 in bladder cancer patients [8]

Core Points - NRx Pharmaceuticals, Inc. will present at NobleCon21 on December 3rd, 2025, focusing on its expanded initiatives in investigational drugs and therapies for mental health conditions [1][2] - The company has begun generating clinical revenue and has made significant advancements in drug development since its last appearance at NobleCon in 2024 [2] Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company specializing in Neuroplastic Therapies for central nervous system disorders, including suicidal depression, PTSD, anxiety, and Autism [5] - The company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101 (oral D-cycloserine/lurasidone), with NRX-100 receiving Fast Track Designation for treating suicidal ideation in depression and NRX-101 receiving Breakthrough Therapy Designation for suicidal bipolar depression [5] - NRx has filed an Abbreviated New Drug Application for its ketamine formulation, anticipating a launch in July 2026 [5] HOPE Therapeutics Overview - HOPE Therapeutics, a subsidiary of NRx, is establishing a network of interventional psychiatry clinics offering various therapies, including ketamine and transcranial magnetic stimulation [6] - The network is the first in Florida to provide the AMPA One Day (ONE-D) treatment, which combines TMS, physician-prescribed D-cycloserine, and lisdexamfetamine for treatment-resistant depression [6] Conference Details - Interested investors can attend the presentation at a discounted rate using a specific discount code [3] - A high-definition video webcast of the presentation will be available on the company's website and other platforms for 90 days following the event [4]

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Financial Data and Key Metrics Changes - For Q3 2025, the company reported a loss from operations of $4 million, compared to a loss of $3 million in Q3 2024, primarily due to increased R&D expenses of $800,000 and additional administrative expenses of $400,000 [30][31] - The company reported revenue for the first time in its history, approximately $240,000, reflecting only 22 days of revenue from a single clinic [31][32] - As of September 30, 2025, the company had approximately $7.1 million in cash and cash equivalents, which would have been $10.3 million if not for a subscription receivable [31][32] Business Line Data and Key Metrics Changes - The company has advanced its drug approval applications for Ketaphree, NRx 100, and NRx 101, and has expanded its NRx 101 pipeline [3][4] - The acquisition of Durra Medical has initiated revenue generation, with plans to grow from two clinics to six or more by year-end [12][32] - The company anticipates significant revenue growth from short-term multimodality treatments that are already reimbursed at higher levels [13] Market Data and Key Metrics Changes - The market for ketamine is projected at approximately $750 million, with the company aiming to provide a preservative-free option [23] - The estimated market for NRx 101, targeting suicidal bipolar depression, is in excess of $1 billion [28] Company Strategy and Development Direction - The company aims to transform the treatment of severe depression and PTSD through innovative therapies combining D-cycloserine and TMS [4][11] - The strategy includes expanding the network of interventional psychiatry clinics and engaging with the payer community to adapt to changing treatment paradigms [12][15] - The company is focused on advancing drug development initiatives and planned clinic acquisitions to build long-term shareholder value [33] Management's Comments on Operating Environment and Future Outlook - Management views the recent quarter as a watershed moment in the treatment of severe depression and PTSD, with promising data supporting their therapies [4][11] - The leadership team is optimistic about the potential for accelerated drug approvals and the impact on addressing the national crisis of suicide [30][46] - The company believes it is better positioned than ever to build shareholder value and address mental health challenges [30] Other Important Information - The company holds rights to over 70 patents related to the use of D-cycloserine in treating depression and PTSD [7] - The FDA has granted breakthrough therapy designation for NRx 101, and the company is pursuing two approval pathways for its ketamine product [18][24] Q&A Session Summary Question: Can you clarify the DCS results with TMS and its unique position? - The company explained that DCS is a mixed agonist-antagonist and has shown to enhance neuroplasticity, which is critical for its effectiveness in combination with TMS [34][35] Question: What feedback have you received on the accelerated approval strategy for NRx 100? - The company indicated that they expect to hear about the CMPV this year and are preparing to file for accelerated approval with substantial real-world data [39][40] Question: How will you position Hope to become an early adopter of the 1D protocol? - The company has partnered with AMPA and is the first site in Florida to implement the 1D protocol, which is readily deployable [42][43] Question: What is your commercialization strategy for NRx 100 and 101? - The company plans to utilize medical science liaison functions for NRx 100 and anticipates building a sales force for NRx 101, with potential partnerships with larger commercial entities [44][45]