Pfizer's (PFE) Trumenba Accepted For Review In The EU

Pfizer Inc. (NYSE:PFE) announced that the European Medicines Agency has accepted for review the marketing authorization application for Trumenba (meningococcal group B vaccine). The acceptance marks the initiation of the EMA’s review process for the vaccine.

Pfizer is looking to get Trumenba approved for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10 years and older.

We note that Trumenba gained accelerated approval in the U.S. for active immunization for the prevention of invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years of age. The company is currently looking to convert accelerated approval to traditional approval.

Pfizer, Spark Therapeutics Report New Hemophilia B Data

Also, Pfizer and Spark Therapeutics (NASDAQ:ONCE) announced encouraging new data from initial patients dosed in the phase I/II study on SPK-9001, which is being evaluated for the treatment of hemophilia B. Spark Therapeutics' shares jumped 14.4% on the news. Overall, the shares gained 23.3% on the news.

Data showed that the first three patients enrolled in the study witnessed adeno-associated virus -mediated factor IX activity levels following one administration of SPK-9001 at the initial low dose level. Additionally, none of the three patients received regular infusions of factor IX concentrates to prevent bleeding events found over the combined 28 weeks of observation. On the safety front, SPK-9001 was found to be well-tolerated and none of the patients required or received immunosuppression.

Both companies intend to present an expanded dataset on the first cohort at the meeting of the European Hematology Association next month.

We note that Pfizer and Spark Therapeutics entered into a collaboration in 2014 under which Spark Therapeutics will be responsible for conducting all phase I/II studies for any candidate that may be developed under its SPK-FIX program. On the other hand, Pfizer will be accountable for pivotal studies, any regulatory activity and global commercialization of any product that may result from the collaboration.

Pfizer is a Zacks Rank #1 (Strong Buy) stock. A couple of other top-ranked stocks in the health care sector are Bristol-Myers Squibb Company (NYSE:BMY) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) , each sporting the same Zacks Rank as Pfizer.