Management of prostate cancer

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

Retrieved on: 
Friday, August 12, 2022
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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.

Veru to Report Fiscal 2022 Third Quarter Financial Results, Host Conference Call on August 11th

Retrieved on: 
Thursday, July 28, 2022
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Verus management will host a conference call that same day at 8 a.m.

Key Points: 
  • Verus management will host a conference call that same day at 8 a.m.
  • Interested parties may access the call by dialing 1-800-341-1602 from the U.S. or 1-412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call.
  • The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com .
  • A playback of the call will be archived and accessible on the same website for at least three months.

European Medicines Agency’s Emergency Task Force Has Initiated the Review of Veru's Sabizabulin Treatment for Hospitalized COVID-19 Patients for Emergency Use in European Union Countries

Retrieved on: 
Wednesday, July 27, 2022
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The results of this study would indicate that sabizabulin treatment reduces the number of deaths in these patients compared with placebo (a dummy treatment).

Key Points: 
  • The results of this study would indicate that sabizabulin treatment reduces the number of deaths in these patients compared with placebo (a dummy treatment).
  • .The review will assist EU Member States who may consider allowing use of the medicine before a possible authorisation.
  • The ETF will conduct this review and send recommendations to the Agencys human medicines committee (CHMP), which will issue the Agencys opinion.
  • By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19 in the EU.

Veru Submits Emergency Use Authorization (EUA) Application to U.S. FDA for Sabizabulin, its Novel, Oral Antiviral and Anti-Inflammatory Drug Candidate for Hospitalized COVID-19 Patients at High Risk for ARDS

Retrieved on: 
Tuesday, June 7, 2022
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MIAMI, June 07, 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 is has submitted an emergency use authorization (EUA) application to the U.S. Food and Drug Administration for its sabizabulin oral 9mg treatment of moderate to severe hospitalized COVID-19 patients at high risk for developing Acute Respiratory Distress Syndrome (ARDS).

Key Points: 
  • COVID-19 new cases and hospitalizations are on the rise again with a summer and fall-winter peaks expected.
  • By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19.
  • We are moving as quickly as possible to get this potential treatment to patients by expeditiously submitting this request for EUA application.
  • We look forward to working with the FDA during its review of our request for EUA application.

Veru Announces Presentation of Final Positive Phase 1b/2 Clinical Trial Results for Sabizabulin in Metastatic Castration Resistant Prostate Cancer at the 2022 American Society of Clinical Oncology Annual Meeting

Retrieved on: 
Monday, June 6, 2022
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Efficacy- Sabizabulin administration resulted in both cytotoxic and cytostatic anticancer activity with PSA declines and objective and durable tumor responses.

Key Points: 
  • Efficacy- Sabizabulin administration resulted in both cytotoxic and cytostatic anticancer activity with PSA declines and objective and durable tumor responses.
  • A Phase Ib/II study of sabizabulin, a novel oral cytoskeleton disruptor, in men with metastatic castration resistant prostate cancer with progression on an androgen receptor targeting agent.
  • Verus late-stage prostate cancer portfolio comprises sabizabulin, VERU-100, a long-acting GnRH antagonist, and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.
  • Current studies on these drugs include:
    Enrolling Phase 3 VERACITY study in metastatic castration and androgen receptor targeting agent resistant prostate cancer prior to IV chemotherapy.

Leap Therapeutics to Present Initial Data from the Investigator-Sponsored Study of DKN-01 Plus Docetaxel in Patients with Prostate Cancer at the 2022 ASCO Annual Meeting

Retrieved on: 
Thursday, May 26, 2022
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"As the initial data show, DKN-01 in combination with docetaxel is a promising therapy option for prostate cancer patients, particularly for those with aggressive variant prostate cancer," said David Wise, MD, PhD, Medical Oncologist at Perlmutter Cancer Center, NYU Langone Health and principal investigator on the study.

Key Points: 
  • "As the initial data show, DKN-01 in combination with docetaxel is a promising therapy option for prostate cancer patients, particularly for those with aggressive variant prostate cancer," said David Wise, MD, PhD, Medical Oncologist at Perlmutter Cancer Center, NYU Langone Health and principal investigator on the study.
  • Key Initial Findings from the Investigator-Sponsored Phase 1b/2a Clinical Trial:
    Data that will be presented at ASCO is from the completed Phase 1 portion of the study.
  • Thirteen patients were enrolled, with 7 patients in the DKN-01 monotherapy cohort and 6 patients in the DKN-01 plus docetaxel combination cohort.
  • The study also aims to study correlations between DKK1 expression and tumor genetics, histology and anti-tumor activity.

NanOlogy Publishes Results from a Phase 1/2 Clinical Trial of its Topical Investigational Drug in the Treatment of Cutaneous Metastases of Breast Cancer

Retrieved on: 
Tuesday, May 3, 2022
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NanOlogy LLC , a clinical-stage interventional oncology drug company, announced today that results from a clinical trial of topical submicron particle paclitaxel (SOR007) in cutaneous metastases of breast cancer (CMBOC) have been published in Breast Cancer Research and Treatment .

Key Points: 
  • NanOlogy LLC , a clinical-stage interventional oncology drug company, announced today that results from a clinical trial of topical submicron particle paclitaxel (SOR007) in cutaneous metastases of breast cancer (CMBOC) have been published in Breast Cancer Research and Treatment .
  • The research article entitled Phase 1/2 Study of Topical Submicron Particle Paclitaxel for Cutaneous Metastases of Breast Cancer presents final safety and response data from the multi-site study ( NCT03101358 ).
  • SOR007 was well tolerated at all concentrations allowing the 2.0% concentration to continue to the dose expansion phase of the trial.
  • In addition to SOR0007, NanOlogy clinical programs have advanced tumor-directed investigational drugs in pancreas, lung, bladder, peritoneal, ovarian, and prostate cancers.