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1 week ago

NRx Pharmaceuticals (Nasdaq:NRXP) Reports Full-Year 2025 Results and Highlights Key Regulatory and Commercial Progress NRx Pharmaceuticals (Nasdaq: NRXP) reported full-year 2025 results and operational progress including $7.8 million cash at year-end, conversion of all previously issued convertible debt to common stock, and reduced loss from operations to $16.2 million. The company cited a favorable FDA bioequivalence signal for preservative-free ketamine and anticipates at least one ANDA approval in Q3 2026.NRx also reported first clinic revenue from five HOPE Therapeutics sites, a nationwide partnership with neurocare AG for TMS clinics, a Type C FDA meeting on NRX-100, and filing of an IND for NRX-101.

#NRXP NRx Pharmaceuticals (Nasdaq:NRXP) Reports Full-Year 2025 Results and Highlights Key Regulatory and Commercial Progress

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2 weeks ago

NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Bioequivalence Determination by Office of Generic Drugs for NRx’s Preservative-Free Ketamine Application NRx Pharmaceuticals (Nasdaq: NRXP) said the FDA Office of Generic Drugs told the company it has not identified bioequivalence deficiencies for NRx’s preservative-free ketamine ANDA; the communication is preliminary pending final supervisory review. NRx expects an FDA GDUFA decision in Summer 2026.NRx aims to offer the first ketamine formulation free of benzethonium chloride, anticipates three years room-temperature stability, has filed patents, and plans U.S. manufacturing to support domestic supply resilience.

#NRXP NRx Pharmaceuticals (Nasdaq:NRXP) Announces FDA Bioequivalence Determination by Office of Generic Drugs for NRx’s Preservative-Free Ketamine Application

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3 weeks ago

HOPE Therapeutics, an NRx Subsidiary (Nasdaq:NRXP) Announces opening of Palm Beach, FL Clinic offering One Day treatment for Depression and PTSD HOPE Therapeutics (Nasdaq: NRXP) opened a Palm Beach, FL clinic on March 9, 2026, offering one‑day interventional psychiatry treatments for depression and PTSD that combine ketamine and other neuroplastic drugs, transcranial magnetic stimulation (TMS), hyperbaric oxygen, and physician‑led psychotherapy.Peer‑reviewed publications cited an 87% clinical response rate for a short‑term TMS plus neuroplastic medication protocol; pilot programs with added hyperbaric oxygen reported a 90% return to full function rate. HOPE cites a nationwide partnership with neurocare AG and is now accepting patients by phone.

#NRXP HOPE Therapeutics, an NRx Subsidiary (Nasdaq:NRXP) Announces opening of Palm Beach, FL Clinic offering One Day treatment for Depression and PTSD

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2 months ago

NRx Pharmaceuticals (Nasdaq:NRXP) Announces 2025 Annual Meeting Date and Record Date NRx Pharmaceuticals (Nasdaq: NRXP) will hold its 2025 annual meeting of stockholders on March 23, 2026 at 10:00 a.m. ET in a virtual-only format at https://www.cstproxy.com/nrxpharma/2026. The Board set a record date of February 12, 2026 for stockholders entitled to notice and to vote. The company said its proxy statement, to be filed with the SEC prior to the meeting, will describe meeting matters and voting procedures.Because the meeting date is more than 60 days after the prior meeting anniversary, the advance-notice deadline under the bylaws for stockholder proposals and director nominations (other than Rule 14a-8 submissions) is the close of business on January 26, 2026. Submissions must follow the bylaws and be delivered by hand, overnight courier, or certified/registered mail to the company’s principal executive offices.

#NRXP NRx Pharmaceuticals (Nasdaq:NRXP) Announces 2025 Annual Meeting Date and Record Date

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3 months ago

NRx Pharmaceuticals (Nasdaq:NRXP) announces elimination of all balance sheet debt following equity conversion NRx Pharmaceuticals (Nasdaq: NRXP) said it eliminated its remaining balance sheet debt after converting the final $5.4 million owed to Anson Funds into common stock with no warrants or repricing provisions.The company noted Anson originally lent $16.2 million to fund prior loans and operating expenses and that it expects to end Dec 31, 2025 with a debt-free balance sheet. Management said the debt-free capital structure positions the company for potential drug approvals and clinic expansions in 2026.

#NRXP NRx Pharmaceuticals (Nasdaq:NRXP) announces elimination of all balance sheet debt following equity conversion

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4 months ago

NRx Pharmaceuticals to discuss new NRX-101 pipeline indication for augmentation of Transcranial Magnetic Stimulation As previously announced, low dose D-cycloserine has been associated with augmentation of the antidepressant and antisuicidal response achieved by Transcranial Magnetic Stimulation (TMS). NRx has amended its Investigational New Drug filing for NRX-101 (D-cycloserine/lurasidone) to include its use in

#NRXP NRx Pharmaceuticals to discuss new NRX-101 pipeline indication for augmentation of Transcranial Magnetic Stimulation

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4 months ago

NRx Pharmaceuticals Announces US Food and Drug Administration (FDA) Receipt of ANDA for KETAFREE™, a Preservative-Free IV Ketamine NRx Pharmaceuticals (NASDAQ: NRXP) announced the FDA has received and deemed substantially complete its Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free IV ketamine. The FDA assigned a GDUFA goal date of July 29, 2026 for final review. NRx manufactured initial registration lots, can scale to 1 million vials per month, and seeks KETAFREE™ as a proprietary name. The company estimates the current worldwide generic ketamine market at $750 million per year and is awaiting an FDA response to an August citizen petition about Benzethonium Chloride removal. KETAFREE™ is separate from NRx’s NRX-100 program.

#NRXP NRx Pharmaceuticals Announces US Food and Drug Administration (FDA) Receipt of ANDA for KETAFREE™, a Preservative-Free IV Ketamine

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4 months ago

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Third Quarter 2025 Financial Results and Provides Corporate Update NRx has refiled its Abbreviated New Drug Application for KETAFREE™ (preservative free ketamine), received supportive correspondence from FDA, and expects Q2 2026 GDUFA date. HOPE Therapeutics is now operating three revenue-generating facilities in Florida and expects six or more by year-end

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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StockTitan

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4 months ago

HOPE Therapeutics, Inc., an NRx Pharmaceuticals Subsidiary, Announces First-in-Florida Initiation of One Day (ONE-D) Depression Treatment in Partnership with Ampa Health HOPE Therapeutics (NASDAQ: NRXP) began offering the Ampa ONE-D protocol for treatment‑resistant depression in Florida on Nov 10, 2025, deploying the FDA‑cleared Ampa device at clinics in Sarasota, Naples and Fort Myers with six Florida locations planned by year‑end 2025.The ONE‑D protocol reports 87% response and 72% remission at 6 weeks in nonrandomized results when single‑day TMS is combined with physician‑prescribed D‑cycloserine and lisdexamfetamine; D‑cycloserine is also a component of investigational NRX‑101, which has Breakthrough Therapy designation and expanded access availability.

#NRXP HOPE Therapeutics, Inc., an NRx Pharmaceuticals Subsidiary, Announces First-in-Florida Initiation of One Day (ONE-D) Depression Treatment in Partnership with Ampa Health

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6 months ago

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Re-Files Abbreviated New Drug Application (ANDA) for KETAFREE™, Preservative-Free IV Ketamine KETAFREE™ to provide innovative, preservative-free IV ketamine formulation, eliminating toxic preservatives, in keeping with current HHS priorities to eliminate toxic preservatives from foods and drugs Filing is based on FDA interaction and approval of Suitability Petition for NRx’s proposed

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Re-Files Abbreviated New Drug Application (ANDA) for KETAFREE™, Preservative-Free IV Ketamine

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StockTitan

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7 months ago

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Expanded Access Policy for NRX-100 (preservative-free ketamine) NRx Pharmaceuticals (NASDAQ:NRXP) has announced its expanded access policy for NRX-100 (preservative-free ketamine) following FDA's Fast Track designation for treating suicidal ideation in patients with depression, including bipolar depression.The company will make NRX-100 available through expanded access for patients with serious or life-threatening suicidal depression who haven't responded to current treatments. According to CDC data, approximately 13 million adults consider suicide annually, with one American dying from suicide every 11 minutes.Eligible patients must meet specific criteria, including having a serious condition unresponsive to approved treatments, and physicians can request access via expandedaccess@nrxpharma.com.

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Expanded Access Policy for NRX-100 (preservative-free ketamine)

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7 months ago

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Second Quarter 2025 Financial Results and Provides Corporate Update NRx Pharmaceuticals (NASDAQ:NRXP) reported Q2 2025 financial results and significant developments across its drug portfolio. The company received an expanded Fast Track Designation for NRX-100 from the FDA for all depression indications, increasing its addressable market to 13 million Americans. A $6.5 million investment was secured from B Group Capital for approximately 3.9 million shares with a one-year lockup.Key developments include filing an ANDA for NRX-100, submitting an NDA for NRX-101, and expanding HOPE Therapeutics through strategic acquisitions. The company reported a Q2 2025 net loss of $17.6 million, compared to $7.9 million in Q2 2024, with $2.9 million in cash as of June 30, 2025. HOPE Therapeutics is targeting $100 million in pro-forma revenue by year-end 2025 through clinic acquisitions.

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Second Quarter 2025 Financial Results and Provides Corporate Update

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7 months ago

NRx Pharmaceuticals Reschedules Q2 Earnings Call, Cites Need for Additional Financial Data Review Clinical-stage biotech NRx Pharmaceuticals moves Q2 2025 results release to August 19, with investor call on August 20. Company needs extra time for Form 10-Q preparation. Get details.

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reschedules Second Quarter 2025 Financial Results Release to August 19, 2025

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StockTitan

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7 months ago

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Granted FDA Fast Track Designation for NRX-100 for Suicidal Ideation in Patients with Depression, including Bipolar Depression NRx Pharmaceuticals (NASDAQ:NRXP) has received FDA Fast Track designation for NRX-100, its intravenous ketamine treatment for suicidal ideation in patients with depression, including bipolar depression. This expanded designation represents a 10-fold increase in the addressable population compared to its 2017 designation.Clinical trials demonstrated significant efficacy, with 55% response rate in suicidal patients compared to 30% for active comparator, and 63% achieving full remission from suicidal ideation within three days versus 31% for placebo. The company targets a $3+ billion market opportunity, addressing approximately 13 million Americans who consider suicide annually.NRX-100 is the first preservative-free ketamine formulation filed with FDA, offering potential three-year room temperature shelf life. The company has completed CMC information filing and is pursuing a Commissioner's National Priority Voucher to expedite review.

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Granted FDA Fast Track Designation for NRX-100 for Suicidal Ideation in Patients with Depression, including Bipolar Depression

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8 months ago

NRx Pharmaceuticals Teams with Yale Expert to Reveal Latest CNS Treatment Innovations at BTIG Conference Join NRx and Yale experts discussing breakthrough neuroplasticity treatments for CNS disorders, including ketamine therapy advances. Get exclusive insights.

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) to Join Fireside Chat at BTIG Virtual Biotech Conference July 29 - 30, 2025

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9 months ago

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Filing of Commissioner's National Priority Voucher Application for Intravenous Ketamine (NRX-100) NRx Pharmaceuticals (NASDAQ:NRXP) has filed for the FDA's new Commissioner's National Priority Voucher (CNPV) program for NRX-100, its preservative-free ketamine formulation. The CNPV program could reduce FDA review time from 10-12 months to 1-2 months. The company's application aligns with all required criteria, including addressing the US health crisis of suicidal depression and PTSD. NRx has already submitted CMC information and received FDA feedback, maintaining its timeline for potential approval by end of 2025. The company is targeting the current $750 million ketamine market, projected to reach $3-5 billion by 2033. NRx is also filing a citizen petition to withdraw preservative-containing ketamine forms and has filed a patent for its preservative-free manufacturing process.

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces Filing of Commissioner's National Priority Voucher Application for Intravenous Ketamine (NRX-100)

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9 months ago

NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) and HOPE Therapeutics, Inc. Announce Strategic Investor Relations Partnership with astr partners NRx Pharmaceuticals (NASDAQ: NRXP) and its subsidiary HOPE Therapeutics announced a strategic investor relations partnership with astr partners, a boutique IR firm specializing in life sciences. The partnership comes at a crucial time as NRx has filed an ANDA and is approaching completion of two NDA filings, while actively acquiring profitable interventional psychiatry clinics. astr partners, founded by former The Trout Group veterans Jonathan Fassberg and Brian Korb, will provide comprehensive IR services including investor targeting, message development, earnings preparation, and investor engagement. The firm brings extensive experience in biotech investor relations and healthcare capital markets, having previously held senior positions at Solebury Trout and Oppenheimer & Co.

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) and HOPE Therapeutics, Inc. Announce Strategic Investor Relations Partnership with astr partners

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StockTitan

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9 months ago

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Abbreviated New Drug Application (ANDA) for Preservative-Free IV Ketamine 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.

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Abbreviated New Drug Application (ANDA) for Preservative-Free IV Ketamine

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Small Cap Strategist

@smcapstrategist.bsky.social

10 months ago

Small-cap stocks with strong volume declines, Wed May 21st - #XAGE #WRAP #URGN #SBC #RILY #QIPT #NRXP #KOSS #CXAI #ALMS #WOLF #HYLN #CRTI - More: crystalequityresearch.com/SmCpStr/ - #smallcap

StockTitan

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10 months ago

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports First Quarter 2025 Financial Results and Provides Corporate Update 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.

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports First Quarter 2025 Financial Results and Provides Corporate Update

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10 months ago

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Patent Application for NRX-100, its Proprietary, Preservative Free Formulation of IV Ketamine Patent expected to be Orange Book listable, if granted NRX-100, preservative free, IV ketamine, is designed to avoid potential toxicity concerns linked to benzethonium chloride, used in currently available formulations of ketamine Filing strengthens NRx's leadership in advancing safe and effective treatments for suicidal depression WILMINGTON, Del., May...

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Patent Application for NRX-100, its Proprietary, Preservative Free Formulation of IV Ketamine

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ORTEX

@ortex.com

1 year ago

HeatMaps - ORTEX

📢 Morning Earnings Are In!

#DEC, #TSQ, #NRXP, #SAIQ, #INSE, #QFIN, and more have reported.

See how the market is reacting with ORTEX’s Earnings HeatMap. 🔍

app.ortex.com/earnings/hea...

#ORTEX #Earnings #Heatmap #Investing

StockTitan

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1 year ago

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update NRx Pharmaceuticals (NASDAQ:NRXP) reported significant developments in Q4 2024 and FY2024. The company initiated NDA filings for two key products: NRX-100 (IV Ketamine) for Suicidal Depression and NRX-101 for bipolar depression, both with anticipated PDUFA dates before December 31, 2025.Key financial highlights include:Reduced operating loss by 33.5% to $18.5M in 2024 from $27.8M in 2023R&D expenses decreased by 53.6% to $6.2MG&A expenses reduced to $13.5M from $14.2MCash position of $1.4M as of December 31, 2024, with additional $8.5M raised in January 2025Strategic developments include:Received non-binding terms for NRX-100 licensing worth over $300M in milestones plus double-digit royaltiesHOPE Therapeutics signed LOIs to acquire three precision psychiatry centersRegained NASDAQ complianceManagement forecasts profitability by year-end 2025

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

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1 year ago

Mental Health Revolution: HOPE's $27M Backed Ketamine Clinic Network Takes Shape With BTIG Partnership HOPE Therapeutics partners with BTIG to accelerate expansion of innovative psychiatric clinics, combining ketamine therapy and advanced treatments, backed by $27M funding.

#NRXP HOPE Therapeutics™, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Engage BTIG as Financial Advisor

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StockTitan

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1 year ago

Revolutionary Mental Health Company Plans 100M Revenue Push with Ketamine Clinics HOPE Therapeutics lands $27M investment to build nationwide chain of advanced psychiatric clinics, targeting $100M revenue through innovative depression treatments.

#NRXP HOPE Therapeutics™, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Execute Agreement for $27 Million Funding Transaction for HOPE Clinic Acquisition

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StockTitan

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1 year ago

NRx Pharma's $8.9M Deal Unlocks Path to FDA Approval for Revolutionary Depression Treatments NRx Pharmaceuticals raises $8.9M through strategic financing with Anson Funds, supporting NRX-100 and NRX-101 drug applications and operations through 2026. Above-market equity priced at $2.88.

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Advances Relationship with Anson Funds with $8.9 Million Financing, Including Above the Market Equity and Senior Secured Debt

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StockTitan

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1 year ago

NRx Pharmaceuticals Pursues NASDAQ Global Market Uplisting to Boost Institutional Access NRx Pharmaceuticals seeks uplisting from NASDAQ Capital Market to Global Market, targeting $75M market value requirement with 15.7M outstanding shares.

#NRXP NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Announces it has Filed an Application with NASDAQ to Uplist to the NASDAQ Global Market from the NASDAQ Capital Market

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Market Wire News

@marketwirenews.com

1 year ago

JUST IN: ( NASDAQ: #NRXP ) HOPE Therapeutics(TM), Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Conduct Investor Workshop at the Mar-A-Lago Club

StockTitan

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1 year ago

NRx Pharmaceuticals Secures $25M Backing for Massive Mental Health Clinic Expansion NRx's HOPE subsidiary receives major funding commitment, targets $100M revenue stream through ambitious rollout of 150 interventional psychiatry clinics by 2027.

#NRXP HOPE Therapeutics™, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Conduct Investor Workshop at the Mar-A-Lago Club

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