Lipella Pharmaceuticals (NASDAQ: LIPO) has secured FDA approval for an Expanded Access Program (EAP) for its investigational oral rinse, LP-310, designed to treat Oral Lichen Planus (OLP). This decision opens up a crucial treatment option for patients suffering from this chronic inflammatory condition, which affects nearly 6 million Americans.
What This Means for Patients
The EAP approval allows patients with serious cases of OLP to access LP-310 before it receives full FDA approval. Currently, there are no FDA-approved treatments for OLP, making this a significant milestone in addressing an unmet medical need. In addition to providing relief for patients, the expanded access program could also generate critical safety data and clinical evidence, potentially expediting LP-310’s journey toward full FDA approval.
LIPO Stock Surges on Positive News
Following this major development, Lipella Pharmaceuticals’ stock has seen an extraordinary rally. As of the latest market update:
- LIPO shares surged by 93.93%, reaching $5.08.
- The stock opened at $6.65, significantly up from its previous closing price of $2.62.
- During pre-market trading, LIPO shares skyrocketed by 140.0%, hitting $6.21.
This sharp stock movement reflects growing investor confidence in Lipella’s future prospects, fueled by the potential impact of LP-310 in the OLP treatment market. With no existing FDA-approved therapies for this condition, Lipella Pharmaceuticals (NASDAQ: LIPO) could be on the brink of a breakthrough that reshapes the landscape of oral disease treatment.
