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Shares of Lipocine (LPCN) surged more than 30% in pre-market trading on Wednesday after Health Canada approved its oral testosterone replacement therapy, expanding its commercial footprint into a market where more than 700,000 testosterone-replacement prescriptions are written each year.
If the pre-market levels hold after the opening bell, LPCN shares would record their best single-day gains since May 2023. The stock surged more than 70% before paring most of the gains.
Lipocine said the Canadian approval of Tlando gives men with low testosterone a different option to injections and gels. Tlando is licensed to Verity Pharmaceuticals, which holds commercial rights in the U.S. and Canada and plans to launch the drug in Canada by the end of 2026.
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The drug is already approved by the U.S. Food and Drug Administration (FDA) for adult men with conditions linked to low or absent natural testosterone production. Its fixed oral dose does not require titration, meaning patients can stay on the same prescribed dose.
Lipocine reported $190,000 in Tlando royalty revenue in the second quarter (Q2) of 2026, up from $123,000 a year earlier.
Lipocine is currently developing LPCN 1154, or Brlizio, an oral treatment for postpartum depression. The company started its Phase 3 trial last month after incorporating feedback from a meeting with the FDA. The 120-patient study is intended to support a future New Drug Application.
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Its broader pipeline also includes therapies for major depressive disorder, tremor, epilepsy, obesity management, liver cirrhosis and prevention of preterm birth. Most therapies are currently in development.
Lipocine had $23.3 million in unrestricted cash, cash equivalents and marketable securities as of June 30, versus $14.9 million at the end of 2025. The company said its existing resources should be sufficient to execute the Phase 3 study for Brlizio.
Retail sentiment surrounding LPCN on Stocktwits flipped to ‘extremely bullish’ from ‘neutral’ a day earlier, amid ‘extremely high’ message volumes.
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One user said that despite the dip, the stock will skyrocket when the market opens.
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Another user said the news is worth the stock ripping 400%
Despite the strong pre-market gains, the stock has been under heavy selling pressure this year, crashing more than 66%
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