Melinta Therapeutics Inc (NASDAQ: MLNT) is rocketing with gains in multiples in the market today after announcing that it has received FDA acceptance. The acceptance surrounds a supplemental New Drug Application for its flagship treatment BAXDELA.
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MLNT Stock Gains On FDA Approval Of BAXDELA NDA
In a press release issued early this morning, Melinta Therapeutics announced that the FDA has accepted its supplemental New Drug Application (sNDA) for BAXDELA for priority review. Ultimately, the company is hoping that the FDA will allow it to expand its indication for the treatment to include adult patients with community-acquired bacterial pneumonia.
In the release, MLNT said that the priority review comes as a result of the company’s previous Qualified Infectious Disease Product designation. This designation was created to incentivise the development of antibacterial and antifungal treatments for serious or life-threatening infections. As a result of the priority review, the FDA will be providing a decision with regard to label expansion by no later than October 24, 2019.
In a statement, Sue Cammarata, M.D., CMO at MLNT, had the following to offer:
Due to the rise of antibiotic resistance and an aging population, community-acquired bacterial pneumonia, or CABP, remains a challenge for healthcare professionals and has led to a need for new treatment options.
BAXDELA’s potency and activity against the most common bacterial pathogens seen in CABP indicate it could play a significant role in the treatment of this life-threatening illness, if approved. We look forward to working with the FDA to help evaluate bringing this potential option to people with CABP as soon as possible.
Why This Is So Exciting
There are multiple reasons that investors are excited about today’s announcement. These include:
- Priority Review – Priority review means that the company will receive a decision from the FDA relatively soon. Also, with the treatment under priority review, the FDA sees a clear medical need for the treatment, which will likely weigh into its decision.
- BAXDELA Is Already Approved – BAXDELA was approved by the FDA to treat skin and skin structure infections. Historically, drugs that have already received approval have a higher potential of achieving approval for new indications. So, there’s a strong chance that BAXDELA will be approved.
- Market Opportunity – Finally, should BAXDELA be approved, it comes with tremendous market opportunity. Should the treatment be approved, it will become an option in a market that experts expect to grow to be worth $22.9 billion annually by the year 2025. Considering the company’s current market cap of just over $50 million, tapping into a small percentage of this large market would be a meaningful win for Melinta Therapeutics and its investors.
Final Thoughts
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At the end of the day, the news from MLNT proved to be incredibly positive. With the FDA’s acceptance of the NDA, the company is one step closer to breaking into a market that comes with incredible potential. Should the treatment be approved, it could push the company to the next level. So, if you’re not watching this one closely, you could be missing out!
What Do You Think?
Where do you think MLNT is headed moving forward? Join the discussion in the comments below!
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