Zuclomifene

Veru to Report Fiscal 2022 Fourth Quarter and Full Year Financial Results on December 5, 2022

Retrieved on: 
Monday, November 28, 2022
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ET to discuss its fiscal 2022 fourth quarter and full year ended September 30, 2022 financial results and provide a business update.

Key Points: 
  • ET to discuss its fiscal 2022 fourth quarter and full year ended September 30, 2022 financial results and provide a business update.
  • To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call.
  • An archived version of the audio webcast will be available for replay on the Companys website for approximately three months.
  • Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and oncology.

Veru Announces Late-Breaker Oral Presentation of Sabizabulin Treatment for Hospitalized Adults with COVID-19 on Supplemental Oxygen at Infectious Disease Week 2022

Retrieved on: 
Monday, October 24, 2022
Efficiency, The New England Journal of Medicine, NASDAQ, Acute respiratory distress syndrome, Medicine, Mortality, Zuclomifene, TGA, U.S. Securities and Exchange Commission, Tadalafil, Telehealth, Comorbidity, Infection, AR, Eli Lilly and Company, Private Securities Litigation Reform Act, WHO, Company, GLOBE, Odds ratio, FDA, Government, Hospital, MHRA, Review, Lilly, Vaccine, Security (finance), Collection, Trial of the century, Prostate cancer, Death, Flash, Form 10-Q, CDK, Insurance, Medicines and Healthcare products Regulatory Agency, Disease, Patient, Man, European Medicines Agency, Finasteride, Safety, Fast Track, Gonadotropin-releasing hormone, Forward-looking statement, Pregnancy, COVID-19, Capsule, Pharmaceutical industry, Birth control, Medical imaging, D.C, ICU, Verus Pharmaceuticals

Utilizing sabizabulin in WHO Class 4 patients may help prevent progression of disease, filling a gap in care in our hospitalized patients, said Paula Skarda, M.D.

Key Points: 
  • Utilizing sabizabulin in WHO Class 4 patients may help prevent progression of disease, filling a gap in care in our hospitalized patients, said Paula Skarda, M.D.
  • Internal Medicine/Pediatrics Regions Hospital, St. Paul, Minnesota, a lead investigator in Verus Phase 2 and Phase 3 clinical trials of sabizabulin.
  • Patients were randomized (2:1) to sabizabulin 9 mg or placebo oral daily dose (up to 21 days or discharge from hospital).
  • Randomization was stratified by oxygen requirement at baseline (WHO 4 = supplemental oxygen, WHO 5 = NIV/forced oxygen, WHO 6 = mechanical ventilation).

Veru to Present Late-Breaker Oral Presentation of Sabizabulin Treatment for Hospitalized Adults with COVID-19 on Supplemental Oxygen at Infectious Disease Week 2022

Retrieved on: 
Thursday, October 13, 2022
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Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and oncology.

Key Points: 
  • Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and oncology.
  • The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin in hospitalized moderate to severe COVID-19 patients who are at high risk for ARDS.
  • On July 27, 2022, The European Medicines Agencys Emergency Task Force initiated the review of sabizabulin treatment for hospitalized COVID-19 patients for emergency use in European Union countries.
  • Verus late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.

Veru Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Tuesday, October 4, 2022
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In accordance with NASDAQ Listing Rule 5635(c)(4), the awards were made as a material inducement to the seven employees entry into employment with the Company.

Key Points: 
  • In accordance with NASDAQ Listing Rule 5635(c)(4), the awards were made as a material inducement to the seven employees entry into employment with the Company.
  • Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and oncology.
  • The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.
  • A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in 204 hospitalized COVID-19 patients with moderate to severe COVID at high risk for ARDS and death.

Veru to Participate in the Cantor Oncology, Hematology & HemeOnc Conference on September 28th, 2022

Retrieved on: 
Wednesday, September 21, 2022
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Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.

Key Points: 
  • Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.
  • The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.
  • A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in 204 hospitalized COVID-19 patients with moderate to severe COVID at high risk for ARDS and death.
  • Verus late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.

Veru Announces FDA has Updated the Meeting Date for the Advisory Committee Meeting to Review Emergency Use Authorization for Sabizabulin for Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

Retrieved on: 
Monday, September 19, 2022
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The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.

Key Points: 
  • The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.
  • A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in 204 hospitalized COVID-19 patients with moderate to severe COVID at high risk for ARDS and death.
  • In June, the Company submitted a request for emergency use authorization to FDA.
  • On July 27, 2022, The European Medicines Agencys Emergency Task Force initiated the review of sabizabulin treatment for hospitalized COVID-19 patients for emergency use in European Union countries.

Veru to Present at the H.C. Wainwright 24th Annual Global Investment Conference on September 12th, 2022

Retrieved on: 
Tuesday, September 6, 2022
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MIAMI, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that the Company will present at the H.C. Wainwright 24th Annual Global Investment Conference.

Key Points: 
  • MIAMI, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that the Company will present at the H.C. Wainwright 24th Annual Global Investment Conference.
  • The presentation will be available through the Conference on September 12, 2022, starting at 7:00 AM (Eastern Daylight Time).
  • Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.
  • The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.

Veru Granted Expedited Provisional Registration Regulatory Pathway for Sabizabulin Treatment in Hospitalized COVID-19 Patients by Australia’s Therapeutic Goods Administration

Retrieved on: 
Monday, August 22, 2022
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A provisional registration determination by TGA is an expedited review of a provisional registration application, whose application, if authorized, would allow the drug to be prescribed in Australia earlier than the standard registration process.

Key Points: 
  • A provisional registration determination by TGA is an expedited review of a provisional registration application, whose application, if authorized, would allow the drug to be prescribed in Australia earlier than the standard registration process.
  • Verus regulatory agent in Australia is Adjutor Healthcare Pty Ltd.
    We are pleased that another tier 1 regulatory agency, Australias Therapeutics Goods Administration, has determined that sabizabulin qualifies for an expedited regulatory review pathway for the treatment of hospitalized COVID-19 patients at high risk for ARDS, said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru.
  • By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19 infections.
  • The Company has completed a positive Phase 3 COVID-19 study in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.

Veru Announces Appointment of Jason Davies to Lead EMEA, LATAM and APAC Infectious Disease Franchise for Veru International Focused on Hospitalized COVID-19 Patients

Retrieved on: 
Friday, August 19, 2022
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Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.

Key Points: 
  • Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.
  • The Company has completed a positive Phase 3 COVID-19 study in hospitalized moderate to severe COVID-19 patients at substantial risk for ARDS.
  • The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study.
  • Verus late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.

Veru Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Friday, August 12, 2022
FDA, Death, U.S. Securities and Exchange Commission, Tadalafil, The New England Journal of Medicine, Prostate cancer, Medicines and Healthcare products Regulatory Agency, Forward-looking statement, Trial of the century, GLOBE, Finasteride, Breast, Private Securities Litigation Reform Act, Telehealth, COVID, Pregnancy, Medicine, CDK, Management of prostate cancer, Gonadotropin-releasing hormone, Security (finance), Flash, Eli Lilly and Company, Government, Zuclomifene, Man, Patient, Review, COVID-19, Company, Lilly, Vaccine, European Medicines Agency, Safety, Capsule, Infection, NASDAQ, Form 10-Q, MHRA, WHO, Employment, Insurance, Fast Track, Collection, Efficiency, AR, Pharmaceutical industry, Birth control, Medical imaging, Verus Pharmaceuticals

In accordance with NASDAQ Listing Rule 5635(c)(4), the award was made as a material inducement to the five employees entry into employment with the Company.

Key Points: 
  • In accordance with NASDAQ Listing Rule 5635(c)(4), the award was made as a material inducement to the five employees entry into employment with the Company.
  • In connection with the commencement of employment, five employees received stock options on August 8, 2022 to purchase an aggregate 128,450 shares of Veru common stock under the Companys recently adopted 2022 Employment Inducement Equity Incentive Plan.
  • Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers.
  • The Company has completed a positive Phase 3 COVID-19 study in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.