Is this the news why Lipocine Inc. (NASDAQ: LPCN) shares took a hike in the After-hours?

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Lipocine Inc. (NASDAQ: LPCN), shares jumped 22.62% in the after-hours after the announcement by the clinical-stage biotech firm focusing on metabolic and endocrine diseases, recently confirmed that the U.S. TLANDO, the oral testosterone medication for testosterone replacement therapy in adult males, has been tentatively approved by the Food and Drug Administration for disorders associated with lack or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

In granting preliminary approval, the FDA determined that TLANDO meets all the consistency, protection, and effectiveness requirements needed for approval, but that TLANDO did not obtain final approval and that it is not available for final approval and marketing in the United States until the expiry of the exclusivity term previously given to Clarus Therapeutics, Inc. in respect of Jatenzo, which expires in March.

Lipocine is actively evaluating the preliminary approval of TLANDO by the FDA and remains committed to taking adequate steps to gain full approval to allow TLANDO to be released. The FDA has also required Lipocine to perform some post-marketing trials to assess patient awareness of the critical risks associated with TLANDO and (ii) evaluate adrenal insufficiency production with chronic TLANDO treatment.

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