Lipocine Inc (NASDAQ:LPCN) continued its ascent in the stock market, adding another 2.4% during yesterday’s trading session and having a trade volume of 2.22 million, following the dismissal of patent infringement litigation, on October 7. The company had been accused of patent litigation, by Clarus Therapeutics Inc, a few months ago. The litigation targeted a late stage drug from Lipocine, LPCN1021, developed as a testosterone replacement therapy, for the treatment of hypogonadism.
The lawsuit had also attracted a number of other litigations from several law firms, which claimed that in light of current events, Lipocine made false or misleading statements about LPCN1021. It should be noted here that this was when the company had filed a New Drug Application, with the FDA, which the agency had returned with notes of deficiencies. The law firms had asked investors, who had bought the stock between June 30, 2015 and June 28, 2016, to come forth as a lead plaintiff in the proceedings.
Currently, Lipocine is working on meeting the FDA requirements, with respect to its NDA. Dr. Mahesh Patel, the CEO of LPCN, expressed his pleasure at the dismissal of the lawsuit and voiced his belief that the drug has the potential to improve the ease of use, as compared to other treatments. He claimed that LPCN1021 would even overcome the terstosterone transference risk, to children and partners, as is the case with topical gels.
However, with its lead drug facing patent infringement litigation, Lipocine had made significant progress with other drug candidates on its portfolio. Recently, the company revealed top of the line results from a phase-2b trial of LPCN1111, TRT to be taken once per day. Moreover, the company stated that it plans to meet with the FDA in 4Q2016, which should clear the path for the phase-3 clinical trials to begin. The study was an open-label randomized trial, carried out for a period of 2-weeks and found a good relationship between dose and response, meeting its primary and secondary endpoints. Lipocine Inc (NASDAQ:LPCN) closed at a share price of $5.54, at the end of the October 10 trading session.
