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Conference/Events
CytoDyn to hold a pharmaceutical update conference call » 15:55
07/22/21
07/22
15:55
07/22/21
15:55
CYDY

CytoDyn

$1.85 /

-0.0435 (-2.30%)

President & CEO…

President & CEO Pourhassan, Chairman & Chief Medical Officer and Chief Operating Officer Recknow discuss the results from the recently reported data from the mTNBC trials, along with updates on cancer, COVID-19, and NASH trials, and the status of the resubmission to the FDA of the BLA for HIV on a conference call to be held on July 22 at 4 pm. Webcast Link

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CYDY CytoDyn
$1.85 /

-0.0435 (-2.30%)

CYDY CytoDyn
$1.85 /

-0.0435 (-2.30%)

04/06/21
CytoDyn to host conference call
Conference/Events
CytoDyn to hold a pharmaceutical update conference call » 04:55
07/22/21
07/22
04:55
07/22/21
04:55
CYDY

CytoDyn

$1.85 /

-0.0435 (-2.30%)

President & CEO…

President & CEO Pourhassan, Chairman & Chief Medical Officer and Chief Operating Officer Recknow discuss the results from the recently reported data from the mTNBC trials, along with updates on cancer, COVID-19, and NASH trials, and the status of the resubmission to the FDA of the BLA for HIV on a conference call to be held on July 22 at 4 pm. Webcast Link

ShowHide Related Items >><<
CYDY CytoDyn
$1.85 /

-0.0435 (-2.30%)

CYDY CytoDyn
$1.85 /

-0.0435 (-2.30%)

04/06/21
CytoDyn to host conference call
Conference/Events
CytoDyn to hold a pharmaceutical update conference call » 09:30
07/20/21
07/20
09:30
07/20/21
09:30
CYDY

CytoDyn

$1.66 /

+0.24 (+16.90%)

President & CEO…

President & CEO Pourhassan, Chairman & Chief Medical Officer and Chief Operating Officer Recknow discuss the results from the recently reported data from the mTNBC trials, along with updates on cancer, COVID-19, and NASH trials, and the status of the resubmission to the FDA of the BLA for HIV on a conference call to be held on July 22 at 4 pm. Webcast Link

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CYDY CytoDyn
$1.66 /

+0.24 (+16.90%)

CYDY CytoDyn
$1.66 /

+0.24 (+16.90%)

04/06/21
CytoDyn to host conference call
Hot Stocks
CytoDyn's leronlimab shows survival efficacy in Phase 1b/2 breast cancer trials » 06:06
07/19/21
07/19
06:06
07/19/21
06:06
CYDY

CytoDyn

$1.42 /

+0.053 (+3.88%)

CytoDyn announced…

CytoDyn announced "strong" preliminary results from its Phase 1b/2 trials and compassionate use with a total of 30 metastatic triple-negative breast cancer - mTNBC - patients. Patients in Phase 1b/2 were treated with leronlimab in combination with carboplatin. 72% of patients had a decrease in cancer-associated macrophage-like cells, or CAMLs, ~30 days after induction of leronlimab. The decrease in CAMLs was associated with: a ~300% increase in mean progression-free survival, or mPFS; aAsignificant ~450% increase in overall survival at 12 months; high CCR5 in tumor tissue biopsies may help to stratify patients likely to progress on leronlimab; decreases in CAMLs and CTCs (circulating tumor cells) appear to be related to slower progression and lower mortality; CAMLs appear to identify populations that are responding to leronlimab. CytoDyn will seek FDA guidance on proceeding with an expedited regulatory plan for approval of leronlimab with existing FDA Fast Track designation for mTNBC.

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CYDY CytoDyn
$1.42 /

+0.053 (+3.88%)

CYDY CytoDyn
$1.42 /

+0.053 (+3.88%)

04/06/21
CytoDyn to host conference call
Hot Stocks
CytoDyn trial for metastatic triple-negative breast cancer demonstrates safety » 06:02
07/12/21
07/12
06:02
07/12/21
06:02
CYDY

CytoDyn

$1.54 /

+0.1 (+6.94%)

CytoDyn announced its…

CytoDyn announced its clinical trial with leronlimab in combination with carboplatin for the treatment of metastatic triple-negative breast cancer has advanced from Phase 1b to a Phase 2 trial. The positive advancement confirms leronlimab will be administered with a 700 mg dosage for patients in the mTNBC trial and Basket trial for 22 solid tumor cancers, as well as compassionate use, eIND and "right-to-try" patients.

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CYDY CytoDyn
$1.54 /

+0.1 (+6.94%)

CYDY CytoDyn
$1.54 /

+0.1 (+6.94%)

04/06/21
CytoDyn to host conference call
Hot Stocks
CytoDyn receives patent for leronlimab from USPTO » 06:04
07/06/21
07/06
06:04
07/06/21
06:04
CYDY

CytoDyn

$1.70 /

+ (+0.00%)

CytoDyn announced its…

CytoDyn announced its drug candidate, leronlimab, has been granted U.S. Patent No. 11,045,546 by the U.S. Patent and Trademark Office, or USPTO, for methods of treating coronavirus infection. The Patent is owned by CytoDyn and its term of protection is expected to extend at least until June 15, 2040. The USPTO prioritized examination of CytoDyn's patent application, resulting in the grant of this Patent under the USPTO's COVID-19 Prioritized Examination Pilot Program in just about one year. The Patent discloses methods of treating hyperinflammation-a common complication of COVID-19 caused by SARS-CoV-2 coronavirus infection.

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CYDY CytoDyn
$1.70 /

+ (+0.00%)

CYDY CytoDyn
$1.70 /

+ (+0.00%)

04/06/21
CytoDyn to host conference call
07/06/20 H.C. Wainwright
CytoDyn downgraded to Neutral from Buy at H.C. Wainwright
Over a month ago
Hot Stocks
CytoDyn submits dose justification report to FDA over BLA for HIV » 18:08
07/01/21
07/01
18:08
07/01/21
18:08
CYDY

CytoDyn

$1.70 /

+ (+0.00%)

CytoDyn announced it has…

CytoDyn announced it has submitted a dose justification report to the U.S. Food and Drug Administration, which will be followed by an official submission to CytoDyn's IND. This is an integral step in the resubmission process for the Biologics License Application for HIV patients with multiple resistance to current standard of care. The dose justification report is a key component for the BLA and includes receptor occupancy analysis, among other factors, to determine the optimal marketed dose for leronlimab. Following FDA feedback on this critical step, CytoDyn will begin submission of BLA modules by specified timelines in accordance with FDA guidance and approval. Chris Recknor, M.D., CytoDyn's Chief Operating Officer and Head of Clinical Development, commented, "Our team has done a great job and remains focused on the goal of a BLA for HIV. We have a great molecule with many opportunities being evaluated in parallel to the BLA, including COVID, NASH and Oncology. We are on track for the top line report for the COVID-19 long-haulers symptoms/biomarker trial and will soon start two COVID-19 trials in Brazil. Our Phase 2 NASH trial has enrolled the 60th patient on schedule. We are working on our CCR5 solid tumor cancers basket trial and our triple-negative breast cancer dose escalation portion is completed with the main trial beginning in July. We are very excited about all we have ahead of us this year."

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CYDY CytoDyn
$1.70 /

+ (+0.00%)

CYDY CytoDyn
$1.70 /

+ (+0.00%)

04/06/21
CytoDyn to host conference call
07/06/20 H.C. Wainwright
CytoDyn downgraded to Neutral from Buy at H.C. Wainwright
Conference/Events
CytoDyn to hold a pharmaceutical update conference call » 15:55
06/21/21
06/21
15:55
06/21/21
15:55
CYDY

CytoDyn

$1.89 /

+0.09 (+5.00%)

President & CEO…

President & CEO Pourhassan, Chairman & CMO Kelly and COO Recknor discuss the results from the unblinded data from COVID-19 long-haulers trial and other regulatory advancements on a conference call to be held on June 21 at 4 pm. Webcast Link

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CYDY CytoDyn
$1.89 /

+0.09 (+5.00%)

CYDY CytoDyn
$1.89 /

+0.09 (+5.00%)

04/06/21
CytoDyn to host conference call
07/06/20 H.C. Wainwright
CytoDyn downgraded to Neutral from Buy at H.C. Wainwright
Hot Stocks
CytoDyn announces preliminary results of data from long-haulers trial » 08:54
06/21/21
06/21
08:54
06/21/21
08:54
CYDY

CytoDyn

$1.89 /

+0.09 (+5.00%)

CytoDyn announced…

CytoDyn announced preliminary results after unblinding the data from its COVID-19 long-haulers clinical trial The purpose of this clinical trial was to assess the safety and efficacy of leronlimab administered as weekly subcutaneous injection in subjects experiencing prolonged symptoms of COVID-19. The primary outcome was change from baseline in daily COVID-19-related symptom severity score through Day 56. Secondary outcomes included progression of COVID-19-associated symptoms through Day 56 compared to baseline. Patient symptoms were self-reported daily throughout the 56-day evaluation period and reported electronically. The symptom scores were rated as severe, moderate, mild, and none. Chris Recknor, M.D., CytoDyn's Chief Operating Officer and Head of Clinical Development, commented, "We are very pleased with the preliminary results from our long-haulers trial, which showed a greater improvement in the leronlimab patient group over placebo in 18 of 24 COVID-19 symptoms. Although the study was not designed to show statistically significant differences due to the small sample size of 56 patients, clinically meaningful improvements in leronlimab over placebo were observed for cough, stuffy/runny nose, shortness of breath, tightness of chest, feeling of fast heartbeat, fatigue, muscle aches/cramps, muscle weakness, joint pain/swelling, chills/shivering, feeling hot or feverish, difficulty in concentration, sleep disturbance/insomnia, headache, dizziness, tingling/numbness, sense of taste, and sense of smell. Of the remaining 6 symptoms, sore throat, exertional malaise, anxiety, nausea, and vomiting had no clinically meaningful change. Diarrhea was worse in leronlimab treated compared to placebo. Biomarkers at multiple timepoints are being analyzed to help determine reasons for response and to provide better insight into the mechanism of action of leronlimab. As in other previous trials with leronlimab, no adverse safety signals were noted. Once our final analysis is performed, we will seek to hold discussions with the FDA regarding next steps."

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CYDY CytoDyn
$1.89 /

+0.09 (+5.00%)

CYDY CytoDyn
$1.89 /

+0.09 (+5.00%)

04/06/21
CytoDyn to host conference call
07/06/20 H.C. Wainwright
CytoDyn downgraded to Neutral from Buy at H.C. Wainwright
Conference/Events
CytoDyn to hold a pharmaceutical update conference call » 04:55
06/21/21
06/21
04:55
06/21/21
04:55
CYDY

CytoDyn

$1.89 /

+0.09 (+5.00%)

President & CEO…

President & CEO Pourhassan, Chairman & CMO Kelly and COO Recknor discuss the results from the unblinded data from COVID-19 long-haulers trial and other regulatory advancements on a conference call to be held on June 21 at 4 pm. Webcast Link

ShowHide Related Items >><<
CYDY CytoDyn
$1.89 /

+0.09 (+5.00%)

CYDY CytoDyn
$1.89 /

+0.09 (+5.00%)

04/06/21
CytoDyn to host conference call
07/06/20 H.C. Wainwright
CytoDyn downgraded to Neutral from Buy at H.C. Wainwright

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