One of the biggest winners on Wednesday was a little-known biotech company which tripled in value after a major announcement from the U.S. Food and Drug Administration (FDA).
Melinta Therapeutics Inc (NASDAQ: MLNT) skyrocketed today after the FDA accepted a supplemental new drug application for one of Melinta’s drugs for priority review.
The application is for their BAXDELA drug, which is meant for adult patients suffering from community-acquired bacterial pneumonia (CABP), which means pneumonia that’s contracted by a person with little contact with the overall health care system. CAPB is the most common type of pneumonia as well as a leading cause of death among patients.
“Due to the rise of antibiotic resistance and an aging population, community-acquired bacterial pneumonia, remains a challenge for healthcare professionals and has led to a need for new treatment options,” said Sue Cammarata, chief medical officer at Melinta Therapeutics. “We look forward to working with the FDA to help evaluate bringing this potential option to people with CABP as soon as possible.”
The application was approved mainly because of positive results from a Phase III, randomized, double-blind study that compared the safety and potency of BAXDELA to another compound for the treatment of CABP.
The study wound up demonstrating that BAXDELA was comparable to the drug in question, moxifloxacin, in it’s early clinical response as well as being generally safe and well-tolerated by the patients.
Previously, BAXDELA was approved in the form of tablets and injections by the FDA in 2017 for treating acute bacterial skin infections. However, it appears that the drug shows more promise, as treating pneumonia is a much more significant use of the drug then helping skin infections.
Shares of Melinta Therapeutics shot up 223.8 percent on Wednesday in response to the news, making the stock the second highest gainer on public markets.
While investors who have held onto the stock for the past while are now enthusiastic at the announcement, the reality of the situation for Melinta is that it has been on a steady decline throughout the past few months. After doubling in February, shares of Melinta have been falling from $9.25 to less than $2 a few days ago.
The history of the stock is much more interesting the longer back you look at it, however, as one year ago the stock was trading around $100 per share. Even farther back in 2016, Melinta was trading around $500 per share, and in mid-2015 peaked at over $1,100 per share.
In comparison to these previous highs, today’s significant jump is almost insignificant. Whether Melinta is now a good investment seems rather unlikely overall, but it could be a decent, if not speculative, buying opportunity at present.
Melinta Therapeutics Company Profile
Melinta Therapeutics Inc is a clinical-stage biotechnology company that develops differentiated antibiotics for acute care and community settings.
The company’s goal is to develop treatments for bacterial infectious diseases, particularly respiratory tract infections and staphylococcal infections. The company is particularly focused on treating community-acquired bacterial pneumonia, as well as gonorrhea and other indications. – Warrior Trading News