Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Gary Ainsworth as Vice President of Market Access Mr. Ainsworth brings over two decades of industry and market access experience to Tonix U.S. Food and Drug Administration (FDA) recently assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for U.S. marketing authorization of TNX-102 SL for the management of fibromyalgia CHATHAM, N.J., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceu...
Tonix Pharmaceuticals to Present at Two Upcoming January Investor Conferences CHATHAM, N.J., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Tonix management will present and host investor meetings at the following January investor conferences: 8th Annual Neuroscience Innovation Forum by Sachs Associates Company PresentationPresenter:Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals...
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...
Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia FDA is expected to assign a Prescription Drug User Fee Act (PDUFA) target action date and announce whether Priority Review has been granted in the Day 74 Letter 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 the first new drug for treating fibr...
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Two Directors at Snap Inc sold 32,303 shares at between 12.421USD and 12.500USD. The significance rating of the trade was 54/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last tw...
BROOKFIELD, Wis.--(BUSINESS WIRE)-- REV Group, Inc. (NYSE: REVG) today reported results for the three months ended October 31, 2024 (“fourth quarter 2024”). Consolidated net sales in the fourth quarter 2024 were $597.9 million, compared to $693.3 million for the three months ended October 31, 2023 (“fourth quarter 2023”). Net sales for the fourth quarter 2023 included $54.2 million attributable to Collins Bus Corporation (“Collins”) which was divested on January 26, 2024. Excluding the impact of the Collins divestiture, net sales decreased $41.2 million, or 6.4% compared to the prior year quar...
Tonix Pharmaceuticals Announces Expansion of Leadership Team with Two Strategic Hires Tonix appoints two executives with decades of experience successfully launching and commercializing new CNS products Bradley Raudabaugh, MBA, joins as Vice President, Marketing, bringing over 25 years of marketing, sales and product planning experience to Tonix Errol Gould, Ph.D., joins Tonix as Vice President, Medical Affairs, with over 25 years of experience in R&D and medical affairs across a wide range of therapeutic areas, including fibromyalgia New Drug Application (NDA) for TNX-102 SL for the man...
Tonix Pharmaceuticals to Participate in the NobleCon20 Investor Conference CHATHAM, N.J., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present and conduct investor meetings at NobleCon20, Noble Capital Markets’ Twentieth Annual Emerging Growth Equity Conference, being held December 3-4 in Boca Raton, Fla. Investors int...
BROOKFIELD, Wis.--(BUSINESS WIRE)-- REV Group, Inc. (NYSE: REVG) announced that it will release its fourth-quarter fiscal 2024 financial results on Wednesday, December 11, 2024, prior to the market opening. The results will be discussed during a live webcast later that morning, beginning at 10:00 a.m. ET. During the webcast, members of REV Group’s leadership team will also provide an overview of the company’s business segments, recent transformation efforts, and strategic priorities along with updated three-year financial targets. The event will include a detailed presentation and a Q&A sessio...
Tonix Pharmaceuticals to Present at the Winter 2024 Investor Summit Virtual CHATHAM, N.J., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the Winter 2024 Investor Summit Virtual on Thursday, November 21, 2024, at 10:00 a.m. ET. Investors interested in arranging a meeting with the Company’s management virtually during ...
Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting Poster presentation highlighted results from confirmatory Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine HCl) treatment demonstrating statistically significant improvement in primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality New Drug Application (NDA) submitted to FDA in October 2024; Fast Track designation previously granted by ...
Tonix Pharmaceuticals Announces Poster Presentation at the American College of Rheumatology (ACR) Convergence 2024 Annual Meeting CHATHAM, N.J., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will deliver a poster presentation at the ACR Convergence 2024 Annual Meeting, which will be held in Washington, D.C., November 14-19, 2024...
Tonix Pharmaceuticals Announces Peer-Reviewed Publication in mSphere Journal Highlighting the Tolerability of Company’s Single-Dose Mpox and Smallpox Vaccine Candidate TNX-801, in Immune-Compromised Animals The World Health Organization (WHO) declared the spread of new Clade Ib Mpox a public health emergency of international concern (PHEIC): Second Mpox-related WHO PHEIC declaration in two years Clade Ib Mpox cases detected in 16 African countries and outside of Africa, in Sweden, Thailand, Singapore, India, Germany and England Single-dose mpox vaccines with durable protection may be...
Tonix Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operational Highlights Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studies Granted Fast Track Designation by FDA in July 2024 for TNX-102 SL, a centrally-acting, non-opioid analgesic; Fibromyalgia is a common chronic pain condition that affects mostly women Expect FDA decision in December 2024 on TNX-102 SL NDA acceptance for review and 2025 PDUFA date; If FDA-approved in 2025, TNX-102 SL would be the first new drug for fibro...
Tonix Pharmaceuticals Announces Research Agreement with Kenya Medical Research Institute (KEMRI) to Design, Plan and Seek Regulatory Approval for a Phase I Clinical Study of TNX-801 for Mpox in Kenya Proposed clinical study in Kenya intended to test the safety, tolerability, and immunogenicity of TNX-801, a vaccine being developed to prevent mpox (formerly called monkeypox) The World Health Organization (WHO) declared mpox a public health emergency of international concern (PHEIC) 1-4: cases of the new Clade Ib mpox detected in Sweden, Thailand, Singapore, India, Germany and England ...
Tonix Pharmaceuticals Presented Data on Potential Mpox Vaccine TNX-801 at World Vaccine Congress-Europe 2024 New data show tolerability and no evidence of spreading to blood or tissues even at high doses of Tonix’s attenuated live-virus, minimally replicating vaccine candidate TNX-801 in immunocompromised animals TNX-801, has characteristics that align closely with the World Health Organization’s (WHO) preferred target product profile (TPP) criteria for mpox vaccines WHO-declared public health emergency of international concern (PHEIC)1-4: Mpox cases of the new clade Ib mpox detected in S...
What's New: In this first take following tonight’s results, we focus on: 1. Solid, not yet spectacular advertising trends, with DR and advertiser growth leading 2. Very careful rollout of Simple Snapchat progressing 3. Very early days for Promoted Places and Sponsored Snaps
Tonix Pharmaceuticals to Present at BIO-Europe® 2024 CHATHAM, N.J., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at BIO-Europe®, being held November 4-6, 2024, in Stockholm, Sweden. The presentation will take place on Monday, November 4, 2024, at 1:00 p.m. CET. To schedule a meeting with the Company’s management a...
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