Zidovudine

Global Antiretroviral Therapy Market (NRTI, NNRTI, Protease Inhibitors & Integrase Inhibitors): Insights & Forecast with Potential Impact of COVID-19 (2020-2024)

Saturday, May 23, 2020 - 12:20am

The global antiretroviral therapy market is also prone to certain challenges like increasing voluntary male circumcisions and huge cost of treatment.

Key Points: 
  • The global antiretroviral therapy market is also prone to certain challenges like increasing voluntary male circumcisions and huge cost of treatment.
  • The global antiretroviral therapy market by drug type can be segmented into the following: NRTI, NNRTI, protease inhibitors and integrase inhibitors.
  • The global antiretroviral therapy market by region can be segmented into the following regions: North America, Europe and Asia Pacific.
  • The report provides a comprehensive analysis of the global antiretroviral therapy market with potential impact of COVID-19.

CytoDyn to Prepare a Phase 3 Protocol to Submit to the FDA for a Three-Arm Comparative and Combination Trial of Leronlimab and Remdesivir

Monday, May 18, 2020 - 11:00am

Leronlimab was administered to more than sixty patients with COVID-19 under emergency Investigational New Drug (eINDs) authorizations granted by the FDA.

Key Points: 
  • Leronlimab was administered to more than sixty patients with COVID-19 under emergency Investigational New Drug (eINDs) authorizations granted by the FDA.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.
  • CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.

CytoDyn Completed Submission of All Remaining Parts of Biologics License Application (“BLA”) on May 11, 2020

Wednesday, May 13, 2020 - 11:00am

After the BLA submission is deemed completed, the FDA assigns a Prescription Drug User Fee Act (PDUFA) goal date.

Key Points: 
  • After the BLA submission is deemed completed, the FDA assigns a Prescription Drug User Fee Act (PDUFA) goal date.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.
  • After the BLA submission is considered completed, the FDA will make a filing decision and set a PDUFA goal date.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

CytoDyn Clarifies Status of Biologics License Application

Saturday, May 9, 2020 - 12:59am

The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.

Key Points: 
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.
  • CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.

Novant Health Initiates Phase 2b/3 Trial with CytoDyn’s Leronlimab for Severely and Critically Ill COVID-19 Patients

Thursday, May 7, 2020 - 11:19pm

Leronlimab has been administered to 54 severely and critically ill COVID-19 patients thus far under Emergency Investigational New Drug (EINDs) authorizations granted by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • Leronlimab has been administered to 54 severely and critically ill COVID-19 patients thus far under Emergency Investigational New Drug (EINDs) authorizations granted by the U.S. Food and Drug Administration (FDA).
  • Since initiating the leronlimab mild/moderate last month, Novant Health has screened nearly 400 patients for eligibility.
  • Expanding treatment options for our more critically ill patients is a vital step in our fight against COVID-19.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

CytoDyn Announces Vyrologix as Proprietary Name for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients in the United States

Monday, April 27, 2020 - 2:20pm

Food and Drug Administration(FDA) of the proprietary name Vyrologix (pronounced - vie-ro-loj-iks) for leronlimab as a combination therapy for highly treatment experienced HIV patients in the United States.

Key Points: 
  • Food and Drug Administration(FDA) of the proprietary name Vyrologix (pronounced - vie-ro-loj-iks) for leronlimab as a combination therapy for highly treatment experienced HIV patients in the United States.
  • We are pleased to receive the FDAs conditional acceptance of Vyrologix as the proprietary name for leronlimabs combination therapy treatment of HIV, said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients.

CytoDyn Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients

Monday, April 27, 2020 - 2:12pm

The FDA previously granted both Fast Track designation for leronlimab and rolling review for the Companys BLA in HIV indication.

Key Points: 
  • The FDA previously granted both Fast Track designation for leronlimab and rolling review for the Companys BLA in HIV indication.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients.

First Patient Treated with Leronlimab in Phase 2b/3 Trial for COVID-19

Wednesday, April 15, 2020 - 11:15am

Concurrently, the Company has about 15 patients enrolled in its Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S.

Key Points: 
  • Concurrently, the Company has about 15 patients enrolled in its Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S.
  • Thus far, over 30 COVID-19 patients have been treated with leronlimab in hospitals and clinics throughout the country.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.

CytoDyn Collaborating with U.K.’s Department of Health to Provide Emergency Access to Leronlimab for Severe and Critically Ill COVID-19 Patients

Tuesday, April 7, 2020 - 11:00am

The FDA recently cleared the Company to initiate a Phase 2b/3 clinical trial for severe and critically ill COVID-19 patients for which enrollment is now underway.

Key Points: 
  • The FDA recently cleared the Company to initiate a Phase 2b/3 clinical trial for severe and critically ill COVID-19 patients for which enrollment is now underway.
  • The Phase 2b/3 trial for severe and critically ill COVID-19 patients is for 390 patients, double blinded with 2:1 ratio (active drug to placebo ratio).
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.

Treatment with CytoDyn's Leronlimab Indicates Significant Trend Toward Immunological Restoration in Severely Ill COVID-19 Patients

Thursday, April 2, 2020 - 11:00am

Patient test data reveals improvement in cytokines, IL-6, and a trend toward the normalization of the CD4/CD8 ratio.

Key Points: 
  • Patient test data reveals improvement in cytokines, IL-6, and a trend toward the normalization of the CD4/CD8 ratio.
  • The current data suggests a trend toward the restoration of immune function and mitigation of the cytokine storm.
  • This is consistent with prior laboratory results in the first four patients treated for COVID-19 with leronlimab.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.