Aradigm Corporation (NASDAQ:ARDM)
Aradigm Corporation (NASDAQ:ARDM) skyrocketed more than 32.8% yesterday following news that the U.S. Food and Drug Administration (FDA) agreed to accelerate the approval review of its lead drug candidate.
The stock rose 32.81% in regular trading hours to $3.36 and jumped an additional 2.38% in trading after-hours to end at $3.44. The day was characterized by modest volume of shares changing hands. The gains left Aradigm up 110% for the year and cut its losses over the last 12 months to 48.3%. In the last 12 months, Aradigm has declined to a low of $0.78 and risen to a high of $7.19.
Aradigm Corporation (NASDAQ:ARDM) is engaged in the development and commercialization of treatment and prevention therapies of severe respiratory diseases.
Linhaliq gets accelerated review
On September 25, Aradigm Corporation (NASDAQ:ARDM) released an announcement stating that the FDA accepted to grant priority review to new drug application (NDA) for Linhaliq. Priority Review status implies a faster a FDA review of a drug application compared to regular review process. As such, Priority Review should shorten the time of bringing a new drug to market if the application is approved.
In light of the Priority Review, Aradigm Corporation (NASDAQ:ARDM) is expecting to hear from the FDA regarding the outcome of Linhaliq review by January 26, 2018.
Aradigm developed Linhaliq as a treatment for NCFBE (non-cystic fibrosis bronchiectasis) in patients with chronic infections with Pseudomonas aeruginosa (P. aeruginosa). The company said it will continue working with the FDA during the review period to support approval of Linhaliq so that the drug can provide much-needed treatment for the targeted patients.
Unmet medical need
NCFBE is a severe, chronic, and rare disease frequently associated with chronic lung infections. More than 150,000 people in the U.S. are victims of NCFBE, while more than 200,000 people in Europe suffer from the disease. NCFBE represents an unmet medical need, and there is currently no drug approved for treatment of NCFBE patients with chronic infections with P. aeruginosa. This category of NCFBE patients has three times higher mortality and a worse quality of life compared to the group of NCFBE patients without P. aeruginosa infections.
Aradigm Corporation (NASDAQ:ARDM)’s Linhaliq has obtained several favorable regulatory labels, implying that it could come to market with a strong profile. For example, the FDA granted Linhaliq Orphan Drug Designation for the management of bronchiectasis. The candidate also carries Fast Track Designation and Qualified Infectious Disease Product (QIDP) Designation for the treatment of NCFBE patients who also have chronic lung infections with P. aeruginosa.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.