Tonix Pharmaceuticals, Set To File An NDA For Tonmya For The Management Of Fibromyalgia, Assuming Approval By The FDA In 2H 2025

7/17/24 8:04:54 AM ET

Biotechnology: Pharmaceutical Preparations

Health Care

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With the completion of its final pre-NDA meeting with the FDA, Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced it is filing an NDA submission in 2H 2024 and laying plans for the commercial launch of Tonmya™* for the management of fibromyalgia, assuming approval by the FDA in 2H 2025.

The fibromyalgia market has not seen a new FDA-approved drug in over 15 years. And now with two drugs making their way through the FDA - Tonix's Tonmya and one from another U.S. company - there could be the prospect of a two-drug rivalry reminiscent of the 2010s when two blockbuster fibromyalgia drugs together created $10 billion in peak sales.

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Date	Price Target	Rating	Analyst
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CHATHAM, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully integrated commercial-stage biotechnology company today announced the appointment of Irina Ishak as General Counsel, effective December 8, 2025. Ms. Ishak will lead Tonix's legal, corporate governance, and compliance functions. "Irina is a highly accomplished corporate and commercial attorney whose experience spans public and private life sciences companies, as well as advising life sciences investors," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. "Her deep background in complex transactions, public company matters, and governa

12/9/25 7:00:00 AM ET

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Biotechnology: Pharmaceutical Preparations

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Tonix Pharmaceuticals Reports Third Quarter 2025 Financial Results and Operational Highlights

Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia set to launch in November Tonmya is the first new FDA-approved medicine for fibromyalgia in more than 15 years Cash and cash equivalents of $190.1 million reported as of September 30, 2025; current cash runway expected to fund operations into the first quarter of 2027 CHATHAM, N.J., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully-integrated commercial biotechnology company today announced financial results for the third quarter ended September 30, 2025, and provided an overview of recent operational highlights. "Following U.S. Food a

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Biotechnology: Pharmaceutical Preparations

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Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Ganesh Kamath as Head of Market Access

Mr. Kamath brings more than 25 years of market access, pricing, and commercial operations experience to Tonix On August 15, 2025, the U.S. Food and Drug Administration approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, the first new fibromyalgia therapy in more than 15 years US Launch of Tonmya expected in the fourth quarter of 2025 CHATHAM, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the appointment of Ganesh Kamath as Head of Market Access

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Breakthrough Therapies Advance as Rare Disease Burden Intensifies Across Aging Populations

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Tonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive Disorder

Tonix plans to initiate potential pivotal Phase 2 HORIZON study of TNX-102 SL in adults with major depressive disorder in mid-2026 More than 21 million US adults experience a major depressive episode each year CHATHAM, N.J., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) ("Tonix" or the "Company"), a fully-integrated commercial biotechnology company, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support clinical development of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the treatment of major depressive disorder (MDD) in adults. "There is a clear need for

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Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

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Tonix Pharmaceuticals Completes Acquisition of Two FDA-Approved, Marketed Migraine Products

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Tonix Pharmaceuticals Reports Third Quarter 2022 Financial Results and Operational Highlights

Five Potentially Pivotal Phase 2 or 3 Studies for CNS Programs Expected to be in the Clinic by First Quarter 2023 Data from Planned Interim Analyses of TNX-102 SL in Phase 3 Fibromyalgia Study and Phase 2 Long COVID Study Expected Second Quarter 2023 Advanced Development Center in Dartmouth, Mass. and Infectious Disease Research and Development Facility in Frederick, Md. Operational Cash and Cash Equivalents Totaled Approximately $140 Million at September 30, 2022 CHATHAM, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the

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Tonix Pharmaceuticals, Set To File An NDA For Tonmya For The Management Of Fibromyalgia, Assuming Approval By The FDA In 2H 2025

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Recent Analyst Ratings for
$TNXP

Tonix Pharmaceuticals, Set To File An NDA For Tonmya For The Management Of Fibromyalgia, Assuming Approval By The FDA In 2H 2025

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Recent Analyst Ratings for
$TNXP

$TNXP
Insider Trading

Director Taylor Carolyn E. bought $15,061 worth of shares (418 units at $36.03) (SEC Form 4)

Director Treco James bought $9,000 worth of shares (250 units at $36.00) (SEC Form 4)

SEC Form 4 filed by Director Hunter James Randolph Jr

$TNXP
Insider Purchases

Director Taylor Carolyn E. bought $15,061 worth of shares (418 units at $36.03) (SEC Form 4)

Director Treco James bought $9,000 worth of shares (250 units at $36.00) (SEC Form 4)

Chief Executive Officer Lederman Seth bought $86,200 worth of shares (4,000 units at $21.55), increasing direct ownership by 80,000% to 4,005 units (SEC Form 4)

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SEC Filings

Tonix Pharmaceuticals Holding Corp. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits

SEC Form 424B5 filed by Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals Holding Corp. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits

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Analyst Ratings

Noble Capital Markets initiated coverage on Tonix Pharma

Alliance Global Partners resumed coverage on Tonix Pharmaceuticals with a new price target

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Leadership Updates

Tonix Pharmaceuticals Appoints Irina Ishak as General Counsel

Tonix Pharmaceuticals Reports Third Quarter 2025 Financial Results and Operational Highlights

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Press Releases

Tonix Pharmaceuticals Appoints Irina Ishak as General Counsel

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Tonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive Disorder

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Financials

Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

Tonix Pharmaceuticals Completes Acquisition of Two FDA-Approved, Marketed Migraine Products

Tonix Pharmaceuticals Reports Third Quarter 2022 Financial Results and Operational Highlights

$TNXP
Large Ownership Changes

Amendment: SEC Form SC 13G/A filed by Tonix Pharmaceuticals Holding Corp.

Amendment: SEC Form SC 13G/A filed by Tonix Pharmaceuticals Holding Corp.

Amendment: SEC Form SC 13G/A filed by Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals, Set To File An NDA For Tonmya For The Management Of Fibromyalgia, Assuming Approval By The FDA In 2H 2025

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Recent Analyst Ratings for $TNXP

Tonix Pharmaceuticals, Set To File An NDA For Tonmya For The Management Of Fibromyalgia, Assuming Approval By The FDA In 2H 2025

Crush Q1 2026 with the Best AI Superconnector

Recent Analyst Ratings for $TNXP

$TNXP Insider Trading

Director Taylor Carolyn E. bought $15,061 worth of shares (418 units at $36.03) (SEC Form 4)

Director Treco James bought $9,000 worth of shares (250 units at $36.00) (SEC Form 4)

SEC Form 4 filed by Director Hunter James Randolph Jr

$TNXP Insider Purchases

Director Taylor Carolyn E. bought $15,061 worth of shares (418 units at $36.03) (SEC Form 4)

Director Treco James bought $9,000 worth of shares (250 units at $36.00) (SEC Form 4)

Chief Executive Officer Lederman Seth bought $86,200 worth of shares (4,000 units at $21.55), increasing direct ownership by 80,000% to 4,005 units (SEC Form 4)

$TNXP SEC Filings

Tonix Pharmaceuticals Holding Corp. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits

SEC Form 424B5 filed by Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals Holding Corp. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits

$TNXP Analyst Ratings

Noble Capital Markets initiated coverage on Tonix Pharma

Alliance Global Partners resumed coverage on Tonix Pharmaceuticals with a new price target

$TNXP Leadership Updates

Tonix Pharmaceuticals Appoints Irina Ishak as General Counsel

Tonix Pharmaceuticals Reports Third Quarter 2025 Financial Results and Operational Highlights

Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Ganesh Kamath as Head of Market Access

$TNXP Press Releases

Tonix Pharmaceuticals Appoints Irina Ishak as General Counsel

Breakthrough Therapies Advance as Rare Disease Burden Intensifies Across Aging Populations

Tonix Pharmaceuticals Announces FDA IND Clearance for Phase 2 Study of TNX-102 SL for the Treatment of Major Depressive Disorder

$TNXP Financials

Tonix Pharmaceuticals Announces FDA Approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the Treatment of Fibromyalgia

Tonix Pharmaceuticals Completes Acquisition of Two FDA-Approved, Marketed Migraine Products

Tonix Pharmaceuticals Reports Third Quarter 2022 Financial Results and Operational Highlights

$TNXP Large Ownership Changes

Amendment: SEC Form SC 13G/A filed by Tonix Pharmaceuticals Holding Corp.

Amendment: SEC Form SC 13G/A filed by Tonix Pharmaceuticals Holding Corp.

Amendment: SEC Form SC 13G/A filed by Tonix Pharmaceuticals Holding Corp.

Recent Analyst Ratings for
$TNXP

Recent Analyst Ratings for
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Insider Trading

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SEC Filings

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Large Ownership Changes