Smallpox

Tonix Pharmaceuticals Announces Poster Presentation at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

Retrieved on: 
Thursday, May 25, 2023

Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023.

Key Points: 
  • Enrollment in a Phase 2 study has been completed, and topline results are expected in the third quarter of 2023.
  • TNX-1900 (intranasal potentiated oxytocin), in development for chronic migraine, is currently enrolling with topline data expected in the fourth quarter of 2023.
  • TNX-4300 (estianeptine) is a small molecule oral therapeutic in preclinical development to treat MDD, Alzheimer’s disease and Parkinson’s disease.
  • A Phase 2 study of TNX-1300 is expected to be initiated in the third quarter of 2023.

Tonix Pharmaceuticals to Present at the June 1st Virtual Investor Summit

Retrieved on: 
Wednesday, May 24, 2023

CHATHAM, N.J., May 24, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the June 1st Virtual Investor Summit on Thursday, June 1, 2023, at 10:30 a.m.

Key Points: 
  • CHATHAM, N.J., May 24, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that Jessica Morris, Chief Operating Officer of Tonix Pharmaceuticals, will present at the June 1st Virtual Investor Summit on Thursday, June 1, 2023, at 10:30 a.m.
  • Investors interested in arranging a meeting with the Company’s management during the conference should contact the Investor Summit conference coordinator.
  • A webcast of the presentation can be found here and will be available under the IR Events tab of the Tonix website at www.tonixpharma.com .
  • Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering.

Tonix Pharmaceuticals to Participate in the A.G.P. Virtual Healthcare Conference

Retrieved on: 
Thursday, May 18, 2023

CHATHAM, N.J., May 18, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that management will participate in the A.G.P.

Key Points: 
  • CHATHAM, N.J., May 18, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced today that management will participate in the A.G.P.
  • Virtual Healthcare Conference and host investor meetings.
  • In addition, Seth Lederman, M.D., Chief Executive Officer of Tonix, will participate in a panel discussion titled, “New Approaches to Depression,” scheduled from 12:00 p.m. – 1:00 p.m.
  • Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering.

KaliVir Immunotherapeutics Appoints Viral Immunotherapy Researcher Grant McFadden, Ph.D., to its Board of Directors

Retrieved on: 
Wednesday, May 10, 2023

PITTSBURGH, May 10, 2023 /PRNewswire/ -- KaliVir Immunotherapeutics, Inc. , a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, today announced the appointment of Grant McFadden, Ph.D., to its Board of Directors.

Key Points: 
  • PITTSBURGH, May 10, 2023 /PRNewswire/ -- KaliVir Immunotherapeutics, Inc. , a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, today announced the appointment of Grant McFadden, Ph.D., to its Board of Directors.
  • McFadden is the director of the Biodesign Center for Immunotherapy, Vaccines and Virotherapy and a Professor at Arizona State University.
  • He was co-founder and Board member of OncoMyx Therapeutics and has served on advisory boards for numerous companies including Jennerex, DNAtrix and IMV.
  • "KaliVir has exciting technology and a stellar team and I am honored to join its Board of Directors as the company progresses its first candidate into the clinic," said McFadden.

Emergent BioSolutions Reports Financial Results For First Quarter 2023

Retrieved on: 
Tuesday, May 9, 2023

OVERALL — Reflects the impact of the previously announced sale of the Travel Health business to Bavarian Nordic, which is anticipated to close in the second quarter.

Key Points: 
  • OVERALL — Reflects the impact of the previously announced sale of the Travel Health business to Bavarian Nordic, which is anticipated to close in the second quarter.
  • Anthrax MCM — Unchanged, reflecting assumptions that have remained constant regarding procurement and delivery of the Company's related products to the U.S. and allied governments.
  • (2) See "Reconciliation of Non-GAAP Measures" and the reconciliation tables for the definitions and reconciliations of these non-GAAP financial measures to the most closely related GAAP financial measures.
  • Company management will host a conference call at 5:00 pm eastern time today, May 9, 2023, to discuss these financial results.

Tonix Pharmaceuticals Announces 1-for-6.25 Reverse Stock Split

Retrieved on: 
Tuesday, May 9, 2023

CHATHAM, N.J., May 09, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it will effect a 1-for-6.25 reverse stock split of its outstanding common stock.

Key Points: 
  • CHATHAM, N.J., May 09, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it will effect a 1-for-6.25 reverse stock split of its outstanding common stock.
  • As a result of the reverse stock split, every six and one-quarter pre-split shares of common stock outstanding will become one share of common stock.
  • The reverse stock split will also proportionately reduce the number of shares of authorized common stock from 1 billion to 160 million shares.
  • The reverse split will also apply to common stock issuable upon the exercise of Tonix’s outstanding warrants and stock options.

GeoVax Announces Expansion of Next-Generation COVID-19 Vaccine Rights to Include Omicron Variants and Use Against Orthopoxviruses

Retrieved on: 
Monday, April 17, 2023

ATLANTA, GA, April 17, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the expansion of its rights under its exclusive license agreement with City of Hope (COH), a world-renowned cancer research and treatment organization, to include development and commercialization rights against orthopoxviruses in addition to SARS-CoV-2.

Key Points: 
  • Orthopoxviruses include Mpox (monkeypox), smallpox, and other viruses that cause disease in humans.
  • GeoVax previously demonstrated that an experimental HIV vaccine, utilizing MVA as the vaccine vector, protected non-human primates challenged with a lethal dose of the Mpox virus (publication accessible here ).
  • Such a vaccine may offer a simplified vaccine regimen for protection against diseases associated with SARS-CoV-2 and orthopoxviruses.
  • GeoVax is focusing on the clinical development of this vaccine for use in patients with special medical limitations or needs, specifically the immunocompromised populations.

Tonix Pharmaceuticals Expedites Fibromyalgia and Chronic Migraine Programs

Retrieved on: 
Thursday, April 13, 2023

CHATHAM, N.J., April 13, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that it is eliminating the interim analyses in its registration-enabling, confirmatory Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia and its Phase 2 PREVENTION study of TNX-1900 for chronic migraine. The modifications to the RESILIENT and PREVENTION studies are designed to streamline the trials and to provide topline data for both programs in 2023. Target enrollment for the core TNX-102 SL fibromyalgia study remains approximately 470 participants while target enrollment for the TNX-1900 chronic migraine study will be reduced from approximately 300 participants to approximately 150 participants, to accommodate the new topline timing.

Key Points: 
  • “In an effort to expedite and deliver on clinical timelines, we are modifying the designs of our confirmatory, registration-enabling Phase 3 trial in fibromyalgia and our Phase 2 trial in chronic migraine,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
  • Fibromyalgia and migraine each affect millions of people, and we remain committed to aligning our operational and scientific efforts on these core CNS programs.
  • Eliminating interim analysis of Phase 2 PREVENTION study of TNX-1900 (intranasal potentiated oxytocin) for chronic migraine; topline results now expected in the fourth quarter of 2023.
  • Topline results of Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine tablets) for fibromyalgia in the fourth quarter of 2023.

Veru Announces Preclinical Study Results that Demonstrate Sabizabulin Inhibits Poxviruses

Retrieved on: 
Tuesday, April 11, 2023

MIAMI, FL, April 11, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced results from a preclinical in vitro study evaluating the effects of sabizabulin against prototypical poxvirus, vaccinia virus, which demonstrated that sabizabulin prevented both the release of poxvirus from infected cells and the spread of poxvirus to healthy cells. These preclinical study results support the expansion of sabizabulin’s program into additional indications to potentially treat the lethal smallpox virus infection or other related infections if a worldwide emergency outbreak occurs.

Key Points: 
  • These preclinical study results support the expansion of sabizabulin’s program into additional indications to potentially treat the lethal smallpox virus infection or other related infections if a worldwide emergency outbreak occurs.
  • The purpose of the study was to evaluate the mechanism of antiviral efficacy of sabizabulin, a novel microtubule disruptor, against the prototypical poxvirus vaccinia in cell culture.
  • To assess the ability of sabizabulin to slow or stop vaccinia virus cell-to-cell spread, BSC40 cells were treated with different concentrations of sabizabulin before inoculation with vaccinia virus at a low multiplicity of infection.
  • In this study, sabizabulin, by disrupting microtubules, was able to prevent the export and release of infectious vaccinia virus.

Tonix Pharmaceuticals Presents Data from its Vaccine Development Program at the World Vaccine Congress

Retrieved on: 
Thursday, April 6, 2023

CHATHAM, N.J., April 06, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, presented data from its live virus vaccine platform development program in two oral presentations at the World Vaccine Congress being held in Washington D.C., April 3-6, 2023. Copies of the Company’s presentations are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

Key Points: 
  • CHATHAM, N.J., April 06, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, presented data from its live virus vaccine platform development program in two oral presentations at the World Vaccine Congress being held in Washington D.C., April 3-6, 2023.
  • Copies of the Company’s presentations are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com .
  • “Our lead vaccine candidate, TNX-801, is a live virus vaccine in development to protect against monkeypox (‘mpox’) and smallpox.
  • TNX-1800 is an example of the ability of Tonix’s adaptable vaccine platform to protect against emerging threats and future pandemics.