Biotech Stocks Facing FDA Decision in January 2018


A panel of outside experts convened by the FDA is scheduled to review Lipocine Inc.’s (LPCN) New Drug Application for TLANDO on January 10, 2018.

TLANDO, formerly known as LPCN 1021, is a twice-a-day oral testosterone product candidate that is designed to help restore normal testosterone levels in hypogonadal men.

This is TLANDO’s second go-around with the FDA.
The regulatory agency had turned down the oral testosterone product candidate in June 2016, citing deficiencies related to the dosing algorithm for the proposed label.

Addressing the concerns raised by the FDA, the Company resubmitted the NDA for TLANDO in August of this year which was deemed a complete response.

The final decision on TLANDO is expected on May 8, 2018. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

If approved, TLANDO will be the first oral TRT option to patients in the U.S. Oral TRT product is available in Canada, Mexico and Europe but it has many drawbacks like short half-life, requiring very frequent (impractical) dosing, and liver safety issues. TLANDO is believed to overcome all these issues associated with oral TRT.

LPCN closed Tuesday’s (Dec.26) trading at $3.50, unchanged from the previous day’s close.