Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and finally, a response from the regulatory agency regarding the approval status.
An update on the regulatory front was provided earlier this week by Actelion Ltd. ALIOF. Actelion announced that the FDA has accepted its new drug application (NDA) for Uptravi for the treatment of pulmonary arterial hypertension (PAH).
The NDA will be assessed under the standard review process, with an action from the agency expected within 12 months from the date of submission (Dec 22, 2014).
Actelion said that it will present detailed data from the phase III GRIPHON study on Uptravi at the upcoming American College of Cardiology congress to be held on Mar 15, 2015 at San Diego, CA.
Meanwhile, Actelion is in the process of submitting the registration dossier for Uptravi to the regulatory authorities of different countries. In Dec 2014, the company filed for the candidate with the European Medicines Agency (EMA) for the treatment of patients suffering from PAH. Uptravi is also under review in New Zealand, Switzerland and Canada.
Our Take
Actelion holds a lead position in the market for PAH treatments with products like Tracleer, Ventavis, Veletri and Opsumit. With generic competition and pricing pressure expected to intensify for Tracleer and Ventavis in 2015, potential approval for a new candidate will be a highly awaited event for investors. Upon approval, it should help the company maintain top-line growth.
Well-placed stocks in the same industry include Sucampo Pharmaceuticals, Inc. SCMP, Lannett Company, Inc. LCI and Salix Pharmaceuticals Ltd. SLXP.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment