Shares of Lipocine Inc (NASDAQ:LPCN) closed higher last week after releasing key FDA updates.
Trading Data
On Friday, LPCN stock moved down 5.08% at $1.1200 with more than 775.21K shares, compared to its average volume of 878.01K shares. The stock has moved within a range of $1.0900 – 1.1800 after opening the trade at $1.1800.
FDA Grants Fast Track Designation to LPCN 1144 for Treatment of Non-Cirrhotic NASH
Clinical-stage biopharmaceutical company focusing on metabolic and endocrine disorders, Lipocine Inc ( NASDAQ:LPCN), on November 4, 2021, announced that the US FDA has approved Fast Track Designation to LPCN 1144.
LPCN 1144, an oral prodrug of bioidentical testosterone, will be used for treating non-cirrhotic non-alcoholic steatohepatitis. It was recently part of Liver Fat intervention with oral Testosterone Phase 2 paired biopsy clinical study in patients.
Treatment with LPCN 1144 resulted in significant liver fat reduction, assessed by magnetic resonance imaging as well as proton density fat fraction demonstrating improvement of liver injury markers.
Furthermore, a key secondary endpoint after 36 weeks showed that treatment with LPCN 1144 met the NASH resolution regulatory endpoint.
Based out of Salt Lake City, Utah, Lipocine said that LPCN 1144 demonstrated improvement in liver injury markers in a Phase 2 study. The fast-tracking makes it easy for developing and expediting the review of treatments for potentially life-threatening illnesses.
The company feels that the designation will allow the firm to work closely on the development program including the design of Phase 3.
Dr. Mahesh Patel, Chairman, President, and Chief Executive Officer of Lipocine, said that the Fast Track Designation shows that LPCN 1144 has the potential to address tremendous unmet needs in treating NASH.
Key Quote
“The granting of Fast Track Designation represents an important recognition by the FDA of LPCN 1144’s potential to address a significant unmet need in the treatment of NASH,” said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. “We believe the Fast Track Designation will enable us to work closely with the FDA on our development program for NASH, including the design of the Phase 3 program.”
Technical Data
LPCN stock is trading below the 200-Day and 50-Day Moving averages of $1.39 and $1.13 respectively. However, the stock is trading above 200-Day moving average of $1.10. The stock is down 15% in the past 3-month.
