CytoDyn Inc. (OTCMKTS:CYDY) is down 8% in week. The company has submitted a Breakthrough Therapy Designation application to the FDA for leronlomab as a possible mTNBC treatment.
Trading Data
On Monday, CYDY stock slid 0.87% at $1.14 with more than 3.04 million shares, compared to its average volume of 2.35 million shares. The stock has moved within a range of $1.1250 – 1.1900 after opening the trade at $1.16.
Major FDA News
The analysis the data company reported on November 3, 2021, supports the BTD application. In addition, the company’s CMO Scott Kelly shared preliminary studyfindings with scientific and medical communities during the Tripe-Negative Breast cancer Drug Development Digital Summit in April 2021. The Breakthrough Therapy Designation efforts have been led by CytoDyn’s CTO and COO,Nitya Ray, in partnership with Oncology, Regulatory affairs, and Biostatistics affairs.
The findings represented data analysis from 28 pool subjects from the Compassionate Use Study, Basket Study, and Phase 1b /2 Study. The subjects received aleronlimabdose subcutaneously in combination with SOC systemic chemotherapy. CEO Nader Pourhassan said the findings offer strong support for the company’s move to submit the BTD for leronlimab in mTNBC treatment.CYDY is worth watching in the coming days.
Key Quote
The Company’s Chief Medical Officer, Scott Kelly, M.D., shared early findings from this study with the medical and scientific communities at the Triple-Negative Breast Cancer Drug Development Digital Summit in April 2021. Dr. Nitya Ray, CytoDyn’s COO and CTO, has led the BTD effort in collaboration with experts in Oncology, Biostatistics, and Regulatory affairs.
Technical Data
CYDY stock is trading above the 20-Day and 50-Day Moving averages of $1.36 and $1.60 respectively. However, the stock is trading below 200-Day moving average of $2.45. The stock is down 13% in the past 3-month.
