October 13, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Three biotech companies will have information this week that could spark their stocks. Sometimes it’s trial data, sometimes it’s a decision by the U.S. Food and Drug Administration (FDA). The three companies are Opexa Therapeutics , Egalet Corporation, and Windtree Therapeutics .
Opexa Therapeutics , headquartered in The Woodlands, Texas, focuses on personalized immunotherapies to treat diseases such as multiple sclerosis (MS), and other autoimmune diseases. The company has a proprietary T-cell technology, ImmPath.
Opexa is presenting topline data from its Phase IIb clinical trial of Tcelna (imilecleucel-T) tomorrow. Tcelna, formerly known as Tovaxin, is a personalized T-cell immunotherapy to treat Secondary Progressive Multiple Sclerosis. It was granted Fast Track status by the FDA. The company and the FDA completed formal End of Phase II meetings and plans to move ahead with its pivotal Phase III clinical trials.
The company says, “Tcelna possesses a unique mechanism of action that combats the demyelination of the nerve fibers in the central nervous system, the underlying cause of MS. Five clinical trials have been completed with Tcelna in 356 patients, many with multiple years of treatment.”
Opexa is currently trading for $3.70.
2. Egalet
Egalet Corporation (EGLT), located in Buffalo Grove, Illinois, focuses on developing drugs to treat acute and chronic pain. The company’s ARYMO ER (morphine sulfate) to treat pain severe enough to require daily long-term opioid treatment, has a PDUFA date of October 14.
The company submitted its New Drug Application (NDA) to the FDA in December 15, 2015. Morphine suflate is an opioid agonist and a Schedule II controlled substance that is acknowledged for its ease of abuse. Egalet’s Guardian Technology is a polymer matrix tablet technology that results in tablets with controlled-release properties in addition to features that make them resistant to manipulation.
An FDA advisory committee voted 18 to 1 to recommend approval of the drug on August 4.
Egalet is currently trading for $7.70.
Windtree Therapeutics , headquartered in Warrington, Pennsylvania, is working to develop novel KL4 surfactant therapies for respiratory diseases and other applications. Its proprietary technology platform includes a synthetic, peptide-containing surfactant that is similar to human pulmonary surfactant. It also has novel drug-delivery technologies that allow for noninvasive aerosolized administration.
Windtree began enrollment in an AEROSURF Phase IIa clinical trial for its KL4 surfactant. It was expected to be completed in September with top-line results by early October 2016.
On September 19, the FDA granted AEROSURF Fast Track designation. “This Fast Track designation for AEROSURF underscores the significant need to reduce the use of invasive intubation and mechanical ventilation, which are required to administer surfactant therapy, but may result in serious complications and increase the risk for other respiratory conditions,” said Craig Fraser, the company’s president and chief executive officer, in a statement. “By enabling non-invasive delivery of our aerosolized KL4 surfactant, we believe that AEROSURF will address a serious unmet medical need and potentially provide transformative clinical and pharmacoeconomic benefits.”
Windtree is currently trading for $2.58.
