TNXP Tonix Pharmaceuticals Holding Corp.

CIK 0001430306 50 ready 8-Ks latest June 29, 2026, 7:05 AM ET RSS · JSON

Activity: NORMAL 1 filings / 30d vs 3 baseline Risk accumulating: auditor change (2)

Ready 8-Ks 50

Latest filing June 29, 2026, 7:05 AM ET

Top materiality 0.95

Event mix other_material ×32 · earnings ×8 · regulatory ×5

Sentiment 27 pos · 1 neg · 22 neu

Latest earnings ▼ miss 2026-Q1

Executive change recent →

SHENANIGAN SCORE 2 / 7 see the board

Recent 8-K filings for TNXP

Highest-materiality recent filing

Tonix receives FDA approval of Tonmya (cyclobenzaprine HCl) for fibromyalgia in adults

August 18, 2025, 7:59 PM ET regulatory materiality 0.95 positive item 7.01 item 8.01 item 9.01

FDA approved Tonmya (cyclobenzaprine HCl sublingual tablets) for treatment of fibromyalgia in adults.
Product launch and commercialization strategy underway; commercial team led by Thomas Englese.

Read filing →

June 29, 2026, 7:05 AM ET other material materiality 0.60 neutral item 7.01 item 8.01 item 9.01

Tonix enrolls first patient in Phase 2 MDD study of TNX-102 SL (TONMYA)

First patient enrolled in HORIZON, a potentially pivotal Phase 2 study of TNX-102 SL 5.6 mg as first-line monotherapy for major depressive disorder.
June 8, 2026, 7:05 AM ET other material materiality 0.55 positive item 7.01 item 8.01 item 9.01

Tonix secures second GPO agreement for TONMYA, expanding commercial coverage to ~52M lives

Second GPO agreement effective June 1, 2026 adds ~17M US commercial lives (~10% of total).
May 27, 2026, 7:05 AM ET other material materiality 0.75 positive item 7.01 item 8.01 item 9.01

Tonix publishes Phase 1 data for TNX-1500; shows TDAR blockade, favorable safety

TNX-1500 Phase 1 data in Journal of Clinical Immunology; blocked primary TDAR at all doses (3,10,30 mg/kg).
May 15, 2026, 9:25 AM ET other material materiality 0.70 positive item 7.01 item 8.01 item 9.01

Tonix reports Phase 1 PK data for TNX-4800 Lyme antibody; two-dose regimen supports 6-month protection

TNX-4800 Phase 1 PK data presented at Global Lyme Alliance; two-dose 350 mg SC regimen (Day 1, Day 56) modeled.
May 11, 2026, 5:17 PM ET earnings materiality 0.80 positive item 2.02 item 9.01 ◈ Earnings Releases

Tonix Q1 net loss $40.2M; TONMYA launch generates $3.7M revenue with 2,145 prescribers

Net product revenue $6.9M (TONMYA $3.7M, legacy products $3.2M); net loss $40.2M ($2.93/share).
May 7, 2026, 7:59 PM ET other material materiality 0.60 neutral item 5.02 item 5.07 item 9.01 ◈ Shareholder Votes ×4

Tonix shareholders approve reverse stock split authorization and 2026 equity plan at annual meeting

Reverse stock split authorized up to 1:250 ratio; 4,400,765 votes for, 2,826,586 against.
May 6, 2026, 7:59 PM ET other material materiality 0.75 positive item 7.01 item 8.01 item 9.01

Tonix secures GPO coverage for TONMYA, expanding commercial access to ~35M patients

Agreement effective May 1, 2026 with leading GPO provides coverage for ~35M U.S. commercial lives (20% of ~177M total).
May 1, 2026, 7:59 PM ET earnings materiality 0.65 negative item 2.02 item 8.01 ◈ Earnings Releases

Tonix reports preliminary Q1 net loss $40.8M, cash $185.5M, revenue $6.9M

Net loss for Q1 2026 was ~$40.8M, up from $16.8M in Q1 2025; revenue rose to $6.9M from $2.4M, led by TONMYA ($3.7M).
April 29, 2026, 7:59 PM ET other material materiality 0.55 positive item 7.01 item 8.01 item 9.01

Tonix presents TNX-4800 Phase 1 data; plans adaptive Phase 2 field study for Lyme disease prevention in H1 2027

Phase 1 data of TNX-4800 (anti-OspA mAb) for Lyme disease presented at Ticks and Tickborne Diseases Symposium.
April 23, 2026, 7:59 PM ET other material materiality 0.35 neutral item 7.01 item 8.01 item 9.01

Tonix reports preclinical data for TNX-1700 and TNX-4700 at AACR 2026

TNX-1700 reversed aging-associated gastric inflammation and attenuated tumor progression in aged mouse model.
March 31, 2026, 7:59 PM ET other material materiality 0.75 positive item 7.01 item 8.01 item 9.01

Tonix reports Phase 1 data for Lyme prophylactic TNX-4800; Phase 2 field study planned for H1 2027

Phase 1 data (N=44) showed no significant safety signals; mean half-life 62-69 days; serum levels at 5 mg/kg ~10 μg/ml at 4 months, ~2x in vitro MEC.
March 26, 2026, 7:59 PM ET other material materiality 0.55 neutral item 7.01 item 8.01 item 9.01

Tonix doses first participant in Phase 1 study of TNX-1900 for migraine and craniofacial pain

First participant dosed in Phase 1 investigator-initiated study of TNX-1900 (intranasal potentiated oxytocin).
March 18, 2026, 7:59 PM ET other material materiality 0.70 neutral item 4.01 item 9.01 ◈ Auditor Changes ×2

Tonix Pharmaceuticals dismisses EisnerAmper, appoints PwC as new auditor

Dismissed EisnerAmper on March 16, 2026; no disagreements on accounting principles or practices.
March 13, 2026, 7:59 PM ET earnings materiality 0.65 neutral item 2.02 item 9.01 ◈ Earnings Releases

Tonix reports Q4 2025 net loss $46.9M; TONMYA launch shows ~4,200 prescriptions

Net loss available to common stockholders for Q4 2025 was $46.9M ($3.98/share) vs $22.1M ($9.77/share) in Q4 2024.
March 10, 2026, 7:59 PM ET other material materiality 0.65 positive item 7.01 item 8.01 item 9.01

Tonix unveils post hoc data: TONMYA pain relief from Day 2; NNT=7, NNH=26

Post hoc analysis of Phase 3 RESILIENT trial (n=457) shows TONMYA pain improvement vs placebo from Day 2, significant through Week 14 (p<0.001).
March 3, 2026, 6:59 PM ET other materiality 0.30 positive item 7.01 item 8.01 item 9.01

Tonix Pharmaceuticals uplists from Nasdaq Capital Market to Global Select Market

Nasdaq approved transfer of TNXP common stock, effective March 3, 2026, ticker unchanged.
February 3, 2026, 6:59 PM ET earnings materiality 0.60 positive item 2.02 item 8.01

Tonix prelim 2025: net loss $118.9M vs $130.0M; cash $207.6M funds ops into Q1 2027

Cash & equivalents $207.6M at Dec 31, 2025; 12.79M shares outstanding as of Jan 30, 2026.
December 29, 2025, 6:59 PM ET other material materiality 0.70 positive item 7.01 item 8.01 item 9.01

Tonix announces TNX-4800 Phase 1 data, plans 2026 FDA meeting for Phase 2/3 Lyme disease prevention

Phase 1 study of TNX-4800 in 44 subjects showed mean half-life of 62-69 days; detectable up to 12 months.
December 29, 2025, 6:59 PM ET other material materiality 0.65 neutral item 1.01 item 8.01 item 9.01 ◈ Material Agreements ×2

Tonix Pharmaceuticals prices $20M registered direct offering with Point72; shares and pre-funded warrants

Sold 615,025 shares at $16.26 and pre-funded warrants for 615,025 shares at $16.259 to Point72; gross proceeds ~$20M.
December 16, 2025, 6:59 PM ET other material materiality 0.55 positive item 7.01 item 8.01 item 9.01

Tonix licenses exclusive worldwide rights to TNX-4900 for neuropathic pain from Rutgers University

Licensed exclusive worldwide rights to TNX-4900 (S1R antagonist) from Rutgers University for chronic neuropathic pain.
December 9, 2025, 6:59 PM ET leadership materiality 0.30 neutral item 7.01 item 8.01 item 9.01

Tonix Pharmaceuticals appoints Irina Ishak as General Counsel effective Dec 8, 2025

Irina Ishak joins from Lowenstein Sandler LLP where she was Senior Counsel since 2013.
November 24, 2025, 6:59 PM ET regulatory materiality 0.85 positive item 7.01 item 8.01 item 9.01

Tonix Pharma receives FDA IND clearance for TNX-102 SL Phase 2 MDD study

FDA cleared IND for TNX-102 SL (cyclobenzaprine HCl) 5.6 mg sublingual tablets to treat major depressive disorder in adults.
November 21, 2025, 6:59 PM ET other material materiality 0.70 neutral item 1.01 item 8.01 item 9.01 ◈ Material Agreements

Tonix Pharmaceuticals increases ATM equity offering capacity from $150M to $400M

Sales Agreement with A.G.P./Alliance Global Partners amended to raise maximum aggregate offering price to $400M from $150M.
November 18, 2025, 6:59 PM ET other material materiality 0.65 positive item 8.01

Tonix Pharma expands share repurchase program by $25M to $35M total authorized

Board approved an additional $25.0 million for share repurchases, raising total authorized to $35.0 million.
November 17, 2025, 6:59 PM ET other material materiality 0.85 positive item 7.01 item 8.01 item 9.01

Tonix launches TONMYA as first new fibromyalgia treatment in 15 years

TONMYA (cyclobenzaprine HCl sublingual tablets) now available by prescription nationwide.
November 10, 2025, 6:59 PM ET earnings materiality 0.75 neutral item 2.02 item 9.01

Tonix Q3 2025 net loss widens to $32M; cash $190.1M; Tonmya launch in November

Net product revenue $3.3M (up from $2.8M YoY) from Zembrace/Tosymra sales.
October 27, 2025, 7:59 PM ET other material materiality 0.80 neutral item 2.02 item 8.01

Tonix reports preliminary Q3 net loss $32M, plans Tonmya launch by Nov 2025

Preliminary Q3 2025 net loss ~$32.0M vs $14.2M YoY; net revenue $3.3M vs $2.8M.
October 22, 2025, 7:59 PM ET other material materiality 0.55 neutral item 7.01 item 8.01 item 9.01

Tonix doses first patient in FOCUS study of intranasal oxytocin for AVP-D at MGH

First patient dosed in FOCUS study at Massachusetts General Hospital for arginine-vasopressin deficiency (AVP-D).
October 7, 2025, 7:59 PM ET other material materiality 0.45 neutral item 7.01 item 8.01 item 9.01

Tonix Pharmaceuticals plans Phase 2 trial of TNX-102 SL for MDD in 2026, Phase 2/3 of TNX-4800 for Lyme in 2027

Phase 2 trial of TNX-102 SL for major depressive disorder expected to start in 2026.
September 30, 2025, 7:59 PM ET other material materiality 0.75 positive item 7.01 item 8.01 item 9.01

Tonix sets Tonmya WAC at $1,860/month; appoints Ganesh Kamath as Head of Market Access

Tonmya (cyclobenzaprine HCl sublingual tablets) approved Aug 15, 2025 for fibromyalgia; launch expected Q4 2025.
September 29, 2025, 7:59 PM ET other material materiality 0.70 positive item 7.01 item 8.01 item 9.01

Tonix plans Phase 2 trial of TNX-2900 for Prader-Willi syndrome in 2026

TNX-2900 (intranasal magnesium-potentiated oxytocin) to enter Phase 2 in children ages 8-17.5 with PWS, starting 2026.
September 18, 2025, 7:59 PM ET regulatory materiality 0.60 positive item 7.01 item 8.01 item 9.01

Tonix completes positive Pre-IND meeting with FDA for TNX-102 SL in MDD; IND filing Q4 2025

FDA found proposed long-term safety data collection plan generally reasonable, potentially streamlining development.
September 17, 2025, 7:59 PM ET M&A materiality 0.60 positive item 7.01 item 8.01 item 9.01

Tonix in-licenses Phase 2/3-ready Lyme disease antibody TNX-4800

In-licensed worldwide rights to TNX-4800, a fully human monoclonal antibody targeting OspA of Borrelia burgdorferi.
August 18, 2025, 7:59 PM ET regulatory materiality 0.95 positive item 7.01 item 8.01 item 9.01

Tonix receives FDA approval of Tonmya (cyclobenzaprine HCl) for fibromyalgia in adults

FDA approved Tonmya (cyclobenzaprine HCl sublingual tablets) for treatment of fibromyalgia in adults.
August 15, 2025, 7:59 PM ET regulatory materiality 0.90 positive item 7.01 item 8.01 item 9.01

FDA approves Tonix's Tonmya for fibromyalgia; first new therapy in over 15 years

Tonmya (cyclobenzaprine HCl sublingual tablets) approved for adults with fibromyalgia; Q4 2025 commercial launch expected.
August 11, 2025, 7:59 PM ET earnings materiality 0.70 neutral item 2.02 item 9.01

Tonix Q2 net loss $28.3M; cash $125.3M; FDA PDUFA Aug 15 for TNX-102 SL

Net product revenue $2.0M (down from $2.2M YoY); SG&A surged to $16.2M from $7.5M on pre-launch spend.
July 25, 2025, 7:59 PM ET earnings materiality 0.60 neutral item 2.02 item 8.01

Tonix reports preliminary Q2 net operating loss of $26.3M, cash $125.3M, runway to Q3 2026

Net operating loss of $26.3M in Q2 2025, improved from $78.8M in Q2 2024.
July 21, 2025, 7:59 PM ET other material materiality 0.25 neutral item 7.01 item 8.01 item 9.01

Tonix launches 'Move Fibro Forward' awareness campaign for fibromyalgia patients

Tonix Medicines subsidiary launched campaign to support individuals with fibromyalgia.
July 16, 2025, 7:59 PM ET other material materiality 0.50 neutral item 7.01 item 8.01 item 9.01

Tonix plans 70-90 sales reps for TNX-102 SL if FDA approves fibromyalgia NDA

Company plans to hire 70-90 sales representatives for TNX-102 SL conditional on FDA approval of NDA for fibromyalgia.
July 10, 2025, 7:59 PM ET other material materiality 0.65 positive item 7.01 item 8.01 item 9.01

Tonix TNX-801 vaccine data: 100,000-fold less virulent, s.c. route protective

TNX-801 is up to 100,000-fold less virulent than licensed vaccinia in interferon receptor knockout mice.
July 9, 2025, 7:59 PM ET regulatory materiality 0.90 positive item 7.01 item 8.01 item 9.01

Tonix Pharmaceuticals Announces Publication of Phase 3 RESILIENT Trial Data for TNX-102 SL

Full results from confirmatory Phase 3 RESILIENT trial of TNX-102 SL published online in Pain Medicine on July 9, 2025.
July 2, 2025, 7:59 PM ET other material materiality 0.70 positive item 7.01 item 8.01 item 9.01

Tonix announces preclinical data for TNX-1700 in gastric cancer models published in Cancer Cell

mTNX-1700 plus anti-PD-1 increased survival and decreased metastases in gastric cancer animal models vs anti-PD-1 alone.
June 16, 2025, 7:59 PM ET other material materiality 0.65 positive item 7.01 item 8.01 item 9.01

Tonix presents positive Phase 3 TNX-102 SL data at EULAR; PDUFA Aug 15, 2025

TNX-102 SL (sublingual cyclobenzaprine) showed statistically significant pain reduction in Phase 3 RESILIENT study at 14 weeks.
June 13, 2025, 7:59 PM ET leadership materiality 0.50 neutral item 5.02 item 8.01 item 9.01 ◈ executive_change

Tonix appoints former EVP James Hunter to Board; 7,740 option grant at $34.54

Appointment effective June 12, 2025; Hunter served as EVP Commercial from June 2023 to Dec 2024.
June 11, 2025, 7:59 PM ET other material materiality 0.70 neutral item 1.01 item 9.01

Tonix enters $150M ATM equity facility and $75M Lincoln Park purchase agreement

ATM facility with A.G.P. allows sale of up to $150M in common stock at 3% commission.
May 21, 2025, 7:59 PM ET other material materiality 0.40 neutral item 7.01 item 8.01 item 9.01

Tonix doses first patient in Phase 2 OASIS trial of TNX-102 SL for acute stress reaction

Phase 2 OASIS trial evaluating TNX-102 SL in reducing severity of acute stress reaction and frequency of acute stress disorder.
May 14, 2025, 7:59 PM ET leadership materiality 0.55 neutral item 7.01 item 8.01 item 9.01

Tonix Pharmaceuticals appoints Joseph Hand as General Counsel and EVP of Operations

Joseph Hand appointed General Counsel and EVP of Operations, effective May 14, 2025.
May 12, 2025, 7:59 PM ET earnings materiality 0.65 neutral item 2.02 item 9.01

Tonix Q1 net loss $16.8M; cash $131.7M; PDUFA date Aug 15 for TNX-102 SL

Net loss $16.8M ($2.84/share) vs $14.9M ($535.72/share) in Q1 2024; product revenue $2.4M.
May 8, 2025, 7:59 PM ET other material materiality 0.65 positive item 5.07

Tonix shareholders approve reverse stock split authorization and stock plan amendments at annual meeting

Reverse stock split authorized at ratio between 1:2 and 1:250, with 1,764,316 for, 1,203,561 against.
April 29, 2025, 7:59 PM ET other material materiality 0.40 positive item 7.01 item 8.01 item 9.01

Tonix Pharmaceuticals Presents Positive Preclinical Data on TNX-1700 for Gastric Cancer at AACR 2025

At AACR 2025, Tonix showed TFF2-MSA (murine TNX-1700) plus anti-PD1 inhibited gastric tumor growth by 78.29% in mouse models.