Melinta stock doubles on FDA approval of a supplemental new drug application for BAXDELA to treat pneumonia
Melinta Therapeutics Inc (NASDAQ:MLNT) stock rocketed Wednesday after it revealed the US Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for BAXDELA (delafloxacin) for priority review.
The sNDA filing seeks to expand the current indication for BAXDELA to include adult patients with community-acquired bacterial pneumonia (CABP), which refers to pneumonia contracted by a person with little contact with the health care system.
CAPB is the most common type of pneumonia, and a leading cause of illness and death.
Shares in the New Haven, Connecticut, pharma company more than doubled to $4.43.
READ: Melinta Therapeutics stock climbs after it highlights positive 4Q sales momentum
The FDA granted priority review status to BAXDELA based on the previous Qualified Infectious Disease Product designation the drug enjoys, which offers incentives to drug makers to develop antibacterial and antifungal treatments for life threatening infections.
Through this process, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of October 24, 2019.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date, or proposed review deadline date of October 24.
“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.
Cammarata said BAXDELA’s potency against the most common bacterial pathogens seen in CABP show it could play a “significant role” in the treatment of this 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,” said Cammarata.
The sNDA application is based on positive results from a Phase III, randomized, double-blind, study that compared the potency and safety of BAXDELA to moxifloxacin for the treatment of CABP.
The study results showed that BAXDELA had comparable efficacy to moxifloxacin for early clinical response. Additionally, BAXDELA was generally safe and well-tolerated. The company said results from this study will be submitted for presentation at an upcoming medical conference.
BAXDELA (delafloxacin) tablets and intravenous injection were approved by the FDA in 2017 for treating acute bacterial skin and skin structure infections.
Contact Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive
Story by ProactiveInvestors
Source: https://www.proactiveinvestors.com/companies/news/222428/melinta-stock-doubles-on-fda-approval-of-a-supplemental-new-drug-application-for-baxdela-to-treat-pneumonia-222428.html
Anyone can join.
Anyone can contribute.
Anyone can become informed about their world.
"United We Stand" Click Here To Create Your Personal Citizen Journalist Account Today, Be Sure To Invite Your Friends.
Lion’s Mane Mushroom
Mushrooms are having a moment. One fabulous fungus in particular, lion’s mane, may help improve memory, depression and anxiety symptoms. They are also an excellent source of nutrients that show promise as a therapy for dementia, and other neurodegenerative diseases. If you’re living with anxiety or depression, you may be curious about all the therapy options out there — including the natural ones.Our Lion’s Mane WHOLE MIND Nootropic Blend has been formulated to utilize the potency of Lion’s mane but also include the benefits of four other Highly Beneficial Mushrooms. Synergistically, they work together to Build your health through improving cognitive function and immunity regardless of your age. Our Nootropic not only improves your Cognitive Function and Activates your Immune System, But it benefits growth of Essential Gut Flora, further enhancing your Vitality.
Our Formula includes:
Lion’s Mane Mushrooms which Increase Brain Power through nerve growth, lessen anxiety, reduce depression, and improve concentration. Its an excellent adaptogen, promotes sleep and improves immunity.
Shiitake Mushrooms which Fight cancer cells and infectious disease, boost the immune system, promotes brain function, and serves as a source of B vitamins.
Maitake Mushrooms which regulate blood sugar levels of diabetics, reduce hypertension and boosts the immune system.
Reishi Mushrooms which Fight inflammation, liver disease, fatigue, tumor growth and cancer. They Improve skin disorders and soothes digestive problems, stomach ulcers and leaky gut syndrome.
Chaga Mushrooms which have anti-aging effects, boost immune function, improve stamina and athletic performance, even act as a natural aphrodisiac, fighting diabetes and improving liver function.
Try Our Lion’s Mane WHOLE MIND Nootropic Blend 60 Capsules. Today Be 100% Satisfied Or Receive A Full Money Back Guarantee Order Yours Today By Following This Link.