LIPOCINE INC. (NASDAQ:LPCN) Files An 8-K Other Events
Item 8.01 Other Events
On April 17, 2020, the Company issued a press release announcing the U.S. Food and Drug Administration denies Clarus Therapeutic Inc.’s Citizen Petition. The press release is filed as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
Lipocine Inc. Exhibit
EX-99.1 2 tm2016199d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 U.S. FDA Denies Clarus’s Oral Testosterone Ester Citizen Petition SALT LAKE CITY,…
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About LIPOCINE INC. (NASDAQ:LPCN)
Lipocine Inc. is a specialty pharmaceutical company. The Company is focused on applying its oral drug delivery technology for 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 bioavailable drugs. Its lead product candidate, LPCN 1021, is an oral testosterone replacement therapy (TRT), designed for twice-a-day dosing and is in Phase III testing. The Company’s additional pipeline candidates include LPCN 1111, an oral testosterone therapy product targeted for once daily dosing, which is in Phase II testing, and LPCN 1107, an oral therapy for the prevention of preterm birth, which is in Phase I testing. These products are based on its Lip’ral promicellar drug delivery technology platform. Lip’ral promicellar technology is a technology based on lipidic compositions, which form an optimal dispersed phase in the gastrointestinal environment for improved absorption of insoluble drugs.