FDA Approves Expanded Access Program For Lipella Pharma's LP-310 In Oral Lichen Planus; Stock Up

(RTTNews) - Lipella Pharmaceuticals Inc. (LIPO), a clinical-stage biotechnology company, Wednesday said that the U.S. Food and Drug Administration (FDA) has granted approval for an Expanded Access Program (EAP) for LP-310 for the treatment of oral lichen planus (OLP). The company's shares were more than 90 percent up in pre-market.

Oral lichen planus is a chronic inflammatory condition that affects the mucous membranes inside the mouth, often causing burning pain, white patches, swollen tissue and open sores.

A phase 2a study of LP-310 is underway.

An expanded access program allows patients with serious or life-threatening illnesses to access treatments outside of clinical trials that are not yet approved by the FDA.

"The FDA's approval for expanded use reinforces LP-310's potential as a new therapeutic option for OLP and supports ongoing clinical development efforts," the company said in a statement.

Lipella stock had closed at $2.58, up 1.18 percent on Wednesday. It has traded in the range of $2.21 - 12.00 in the last 1 year.