Lipocine Inc. (LPCN) stock plummeted 19.24% in the current-market trading session at the price of $1.46 following the FDA approval of TLANDO.
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LPCN, works on proprietary drug delivery technology, is a clinical-stage biopharma firm. The company has centered to treat metabolic and neuroendocrine disorders.
FDA Approved TLANDO
On 29th March 2022, LPCN announced that Antares Pharma published a press release revealing the FDA approval of TLANDO. The drug is an oral medicine for testosterone replacement therapy in patients with disorders related to hypogonadism. Additionally, LPCN authorized Antares Pharma exclusive commercialization rights for TLANDO.
Dr. Patel commented that the FDA approval of TLANDO is a notable landmark for them. He thanked all participants, employees, researchers, opinion leaders, and advisors who made approval achievable. The patients are closer to accessing a great testosterone replacement alternative with TLANDO.
LPCN Year 2021 Financial Highlights
On 9th March 2022, LPCN reported its financial results for the quarter and year ended 31st December 2021. The company has also delivered its corporate updates. For the year 2021, revenues totaled US$16.1M, compared to zero revenue in 2020. Net loss was US$0.63M, or per share of ($0.01), for 2021, compared to the loss of US$21M, or per share of ($0.38), last year.
LPCN has R&D expenses of US$7.7M for the year 2021, compared to US$9.7M prior year. G&A costs totaled US$5.3M for 2021, compared to US$8.2M for the year 2020. On 31st December 2021, Lipocine had cash and cash equivalents of roughly US$44.6M. Cash totaled US$19.7M on 31st December 2020.
Regulatory Guidance Regarding LPCN
Earlier on 1st March 2022, LPCN delivered updates from the guidance meeting with the FDA about the development phase of LPCN 1144. The drug had devised to treat nonalcoholic steatohepatitis in non-cirrhotic men. The company received an FDA response acknowledging that the NDA submission of the drug would be through the 505(b)2 regulatory pathway.