It's always risky playing biotech small caps. The stock could collapse at any minute or skyrocket the next. $LPCN looks quite interesting after dropping 70% yesterday. What caught our attention is that the stock opened on the lows and rallied from there. Some bottom feeders were in the stock and that's a good sign for those that are looking for new stocks to trade. Here's what happened:
Lipocine (NASDAQ:LPCN) has received a third Complete Response Letter (CRL) from the FDA regarding its refiled marketing application for testosterone replacement therapy candidate Tlando.
This time the agency cited one issue (instead of four the first time): the efficacy trial failed to meet the three secondary endpoints for maximal testosterone concentrations (Cmax).
The company intends to request a meeting with the agency to clarify a path forward.
The company received the first CRL in June 2016 and the second in May 2018.
Lipocine Inc., a specialty pharmaceutical company, focuses on the development of pharmaceutical products in the area of men’s and women’s health. Its primary development programs are based on oral delivery solutions for poorly bioavailable drugs. The company has a portfolio of product candidates designed to produce pharmacokinetic characteristics and facilitate lower dosing requirements, bypass first-pass metabolism in certain cases, reduce side effects, and eliminate gastrointestinal interactions that limit bioavailability. Its lead product candidate is TLANDO, an oral testosterone replacement therapy. The company’s pipeline candidates also include LPCN 1111, an oral testosterone therapy product for once daily dosing that completed Phase II testing; LPCN 1107, an oral hydroxyprogesterone caproate product for the prevention of recurrent preterm birth and has completed an end-of-Phase II meeting with the Food and Drug Administration; and LPCN 1144, an oral prodrug of bioidentical testosterone that is in Phase I Clinical trial for the treatment of non-alcoholic steatohepatitis. Lipocine Inc. is headquartered in Salt Lake City, Utah.
As always, trade with caution and use protective stops.
Good luck to all!
Lipocine (NASDAQ:LPCN) has received a third Complete Response Letter (CRL) from the FDA regarding its refiled marketing application for testosterone replacement therapy candidate Tlando.
This time the agency cited one issue (instead of four the first time): the efficacy trial failed to meet the three secondary endpoints for maximal testosterone concentrations (Cmax).
The company intends to request a meeting with the agency to clarify a path forward.
The company received the first CRL in June 2016 and the second in May 2018.
Lipocine Inc., a specialty pharmaceutical company, focuses on the development of pharmaceutical products in the area of men’s and women’s health. Its primary development programs are based on oral delivery solutions for poorly bioavailable drugs. The company has a portfolio of product candidates designed to produce pharmacokinetic characteristics and facilitate lower dosing requirements, bypass first-pass metabolism in certain cases, reduce side effects, and eliminate gastrointestinal interactions that limit bioavailability. Its lead product candidate is TLANDO, an oral testosterone replacement therapy. The company’s pipeline candidates also include LPCN 1111, an oral testosterone therapy product for once daily dosing that completed Phase II testing; LPCN 1107, an oral hydroxyprogesterone caproate product for the prevention of recurrent preterm birth and has completed an end-of-Phase II meeting with the Food and Drug Administration; and LPCN 1144, an oral prodrug of bioidentical testosterone that is in Phase I Clinical trial for the treatment of non-alcoholic steatohepatitis. Lipocine Inc. is headquartered in Salt Lake City, Utah.
As always, trade with caution and use protective stops.
Good luck to all!
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We are not financial advisors. Always conduct your own research and read our full disclaimer at insiderfinancial.com/disclaimer/