Is This FDA Update the Death of Lipocine?
Lipocine shares absolutely plummeted on Monday after the firm announced that it received a Complete Response Letter from the FDA regarding its New Drug Application for Tlando.
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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.
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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.
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Chris Lange is a financial and geopolitical writer with more than a decade of experience covering a myriad of topics. He has published thousands of articles for 24/7 Wall St., with past coverage focused heavily on stocks, IPOs, healthcare, defense, global affairs, and technology.
His work has been quoted, or referenced by a number of outlets including Business Insider, USA Today, Yahoo Finance, MSN, The Motley Fool, and many other publications. A graduate of Southwestern University, he studied business with a focus on investments and has previous experience in banking and startups.
When not reading or writing the news, he is following his passion for Lacrosse, playing chess, or building solar projects with his dad.
