Lipocine stock surges 30% on Health Canada drug approval

Lipocine Inc (NASDAQ:LPCN) shares rose 30% in premarket trading Wednesday after Health Canada approved the company's oral testosterone drug TLANDO.

The approval, announced through Lipocine's licensing partner Verity Pharmaceuticals Inc., allows TLANDO (testosterone undecanoate) capsules to be marketed for testosterone replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone. Verity Pharma holds exclusive commercial rights to TLANDO in North America and plans to launch the drug in the Canadian market by the end of 2026.

TLANDO is designed as an oral alternative to existing testosterone replacement therapies, which are primarily delivered through injections and topical gels. The drug features a fixed dosing regimen that does not require dose titration.

More than 700,000 prescriptions are written annually in Canada for testosterone replacement therapy, with approximately 50% of patients covered through private insurance, according to the company. Intramuscular injections currently hold the largest share of prescriptions in the market.

Lipocine and Verity Pharma entered into an exclusive license agreement in January 2024, under which Verity Pharma gained commercial rights to TLANDO in the United States and Canada. Verity Pharma is responsible for regulatory and commercialization obligations in both markets.

TLANDO is already approved by the FDA in the United States for conditions associated with hypogonadism in adult males. The drug was developed using Lipocine's proprietary drug-delivery technology platform.