Tonix Pharmaceuticals Announces PDUFA Goal Date of

TONIX PHARMACEUTICALS HOLDING CORP. 8-K

Tonix Pharmaceuticals Announces PDUFA

Goal Date of August 15, 2025,

for FDA Decision on U.S. Marketing Approval for TNX-102 SL for Fibromyalgia

Tonix received FDA's Day 74 Letter

granting TNX-102 SL a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025

TNX-102 SL is a non-opioid, centrally acting

analgesic, granted Fast Track designation by FDA

Fibromyalgia affects more than 10 million

adults in the U.S., who are mostly women

TNX-102 SL has the potential to be the first

member of a new class of analgesic drugs for fibromyalgia and first new drug for its treatment in more than 15 years

NDA based on two statistically significant

Phase 3 studies of TNX-102 SL for the management of fibromyalgia, in which TNX-102 SL was generally well tolerated

CHATHAM, N.J., December 23, 2024 (GLOBE NEWSWIRE)

- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company) today announced that the

U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision

on marketing approval for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia. TNX-102 SL is a non-opioid, centrally-acting

analgesic. Fibromyalgia is a common chronic pain condition that affects mostly women.

"We look forward to working closely with

the FDA throughout the review period in advance of the August 15, 2025, PDUFA goal date," said Seth Lederman, M.D., Chief Executive

Officer of Tonix Pharmaceuticals. "We believe that TNX-102 SL has the potential to be the first member of a new class of medicines

for the management of fibromyalgia, a debilitating condition affecting over 10 million adults in the U.S. Data from our pivotal Phase

3 trials support that TNX-102 SL can provide fibromyalgia patients with significant reduction in pain with favorable tolerability, helping

to address the significant unmet need in this community."

Dr. Lederman continued, "TNX-102 SL was

previously granted Fast Track designation for fibromyalgia by the FDA in July of 2024. Fast Track is designed to expedite FDA review of

important new drugs to treat serious conditions and fill an unmet medical need. This recognition from FDA confirms that the Agency recognizes

the significant unmet needs of the fibromyalgia community, who have been waiting for a new drug for over 15 years."

The accepted NDA is supported by data from

two 14-week double-blind, randomized, placebo-controlled Phase 3 clinical trials evaluating the safety and efficacy of TNX-102 SL as a

bedtime treatment for fibromyalgia. The first Phase 3 trial, RELIEF, of TNX-102 SL 5.6 mg in fibromyalgia, completed in December 2020,

met its pre-specified primary endpoint of significantly reducing daily pain compared to placebo (p=0.010). In the confirmatory Phase 3

RESILIENT study in fibromyalgia, completed in December 2023, TNX-102 SL again met the pre-specified primary endpoint of significantly

reducing daily pain compared to placebo (p =0.00005). In both trials, TNX-102 SL was generally well tolerated with an adverse event profile

comparable to prior studies and with no new safety signals observed. In both pivotal studies, the most common treatment-emergent adverse

event was tongue or mouth numbness at the administration site, which was temporally related to dosing, self-limited, never rated as severe,

and rarely led to study discontinuation (one participant in each study). Excluding COVID-19, rates of systemic adverse events in each

of the two studies were all below 4.0%. Tonix believes the submitted dossier contains the requisite safety and efficacy data from two

adequate and well-controlled studies to support NDA approval.

Fibromyalgia is a common chronic pain disorder

that is understood to result from amplified sensory and pain signaling within the central nervous system, called central sensitization.

Brain imaging studies have localized the functional disorder to the brain's insula and anterior cingulate cortex. Fibromyalgia afflicts

more than 10 million adults in the U.S., the majority of whom are women. Symptoms of fibromyalgia include chronic widespread pain, non-restorative

sleep, fatigue, and brain fog (or cognitive dysfunction). Other associated symptoms include mood disturbances, including depression, anxiety,

headaches and abdominal pain or cramps. Individuals suffering from fibromyalgia often struggle with their daily activities, have impaired

quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.

Fibromyalgia is now recognized as the prototypic nociplastic syndrome. Nociplastic pain is the third primary type of pain in addition

to nociceptive pain and neuropathic pain. Many patients present with pain syndromes that are mixtures of the three primary types of pain.

Nociplastic syndromes are associated with central and peripheral sensitization. Fibromyalgia can occur without any identifiable precipitating

event. However, many fibromyalgia cases follow one or more precipitating event(s) including: post-operative pain, acute or chronic nociceptive

or neuropathic pain states; recovery from an infectious illness; a cancer diagnosis or cancer treatment; a metabolic or endocrine stress;

or a traumatic event. In the cases of recovery from an infectious illness, fibromyalgia is considered an Infection-Associated Chronic

Condition. In addition to fibromyalgia cases associated with other conditions or stressors, the U.S. National Academies of Sciences, Engineering,

and Medicine, has concluded that fibromyalgia is a diagnosable condition that can occur after recovery from COVID-19 in the context of

Long COVID. Fibromyalgia is also recognized as a Chronic Overlapping Pain Condition, which is a group of related conditions that include

chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), irritable bowel syndrome, endometriosis, low back pain, post-concussive syndrome

(also known as mild traumatic brain injury), chronic Lyme Disease, chronic diabetic neuropathy and chronic post-herpetic neuralgia.

TNX-102 SL is a centrally acting, non-opioid

investigational drug, designed for chronic use. The tablet is a patented sublingual formulation of cyclobenzaprine hydrochloride developed

for bedtime dosing for the management of fibromyalgia. Cyclobenzaprine potently binds and acts as an antagonist at four different post-synaptic

neuroreceptor subtypes: serotonergic-5-HT2A, adrenergic- 1, histaminergic-H1, and muscarinic-M1-cholinergic

receptors. Together, these interactions are believed to target the non-restorative sleep characteristic of fibromyalgia identified by

Professor Harvey Moldofsky in 1975. Cyclobenzaprine is not associated with risk of addiction or dependence. The TNX-102 SL tablet is based

on a eutectic formulation of cyclobenzaprine HCl and mannitol that provides a stable product which dissolves rapidly and delivers cyclobenzaprine

by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying

agent that is also part of the formulation and required for efficient transmucosal absorption. Patents based on TNX-102 SL's eutectic

composition and its properties have issued in the U.S., E.U., Japan, China and many other jurisdictions around the world and provide market

protection into 2034. The European Patent Office's Opposition Division maintained Tonix's European Patent EP 2 968 992 in

unamended form after an Opposition was filed against it by a Sandoz subsidiary, Hexal AG. Hexal AG did not appeal that decision. The formulation

of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed

sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that relative to oral cyclobenzaprine,

TNX-102 SL results in higher levels of exposure during the first 2 hours after dosing and in deceased levels of the long-lived active

metabolite, norcyclobenzaprine in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism.

At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine.

In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background

level of norcyclobenzaprine.

Tonix Pharmaceuticals Holding Corp.*

Tonix is a fully integrated biopharmaceutical company

focused on transforming therapies for pain management and vaccines for public health challenges. Tonix's development portfolio is

focused on central nervous system (CNS) disorders. Tonix's priority is to advance TNX-102 SL, a product candidate for the management

of fibromyalgia. The FDA has accepted the NDA filing for TNX-102 SL for fibromyalgia and assigned a PDUFA goal date of August 15, 2025.

TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University

of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix's CNS portfolio includes TNX-1300 (cocaine

esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and

its development is supported by a grant from the U.S. National Institute of Drug Abuse and Addiction. Tonix's immunology development

portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified

humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for

the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease, including TNX-2900

for Prader-Willi syndrome, and infectious disease, including a vaccine for mpox, TNX-801. In July 2024, Tonix announced a contract with

the U.S. DoD's Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule

broad-spectrum antiviral agents targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military

personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick,

Md. Tonix Medicines, our commercial subsidiary, markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan

nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.

* Tonix's product development candidates are

investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks

of Tonix Medicines. All other marks are property of their respective owners.

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