Lipocine Inc. (NASDAQ: LPCN) shares absolutely plummeted on Monday after the firm announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Tlando.
Tlando is an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
The CRL identified one deficiency, stating the efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations.
Also, the CRL did not identify any specific issues relating to the chemistry, manufacturing and controls of Tlando.
Even after this setback, Lipocine is continuing actively to enroll in its ongoing LPCN 1144 Lift Phase 2 clinical study in confirmed pre-cirrhotic non-alcoholic steatohepatitis (NASH) subjects.
Dr. Mahesh Patel, chair, president and chief executive of Lipocine, commented:
We are disappointed by the FDA’s decision and intend to request a meeting with the FDA as soon as possible to discuss a potential path forward for the approval of Tlando.
Shares of Lipocine traded down about 70% on Monday, at $0.82 in a 52-week range of $0.62 to $3.45. The consensus price target is $5.67.