We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Roche's (RHHBY) Xolair Gets Breakthrough Therapy Status
Read MoreHide Full Article
Roche (RHHBY - Free Report) announced that the FDA has granted Breakthrough Therapy designation to Xolair (omalizumab). The designation was granted for the prevention of severe allergic reactions, following accidental exposure to one or more foods in people with allergies, based on data from seven clinical studies evaluating the drug. The studies evaluated Xolair as monotherapy or in combination with oral immunotherapy.
We note that the breakthrough therapy designation from the FDA is expected to speed up the development and review of drugs intended to treat serious or life-threatening diseases.
Shares of Roche have decreased 5% so far this year compared with the industry's decline of 2.4%.
Xolair is currently approved for the treatment of moderate-to-severe persistent allergic asthma and chronic idiopathic urticarial (chronic hives without a known cause) in the United States.
This is the 23rd breakthrough therapy designation for Genentech’s portfolio of medicines.
We note that Xolair is co-developed by Genentech and Novartis Pharmaceuticals Corporation, subsidiaries of Roche and Novartis (NVS - Free Report) , respectively. The companies are planning to initiate a pivotal study to evaluate the drug for treatment of multiple food allergies.
Per the press release, approximately 200,000 patients with food allergies have to visit emergency room at hospitals annually. Moreover, it also states that 8% and 4% of children and adults, respectively, are affected by food allergies and the rate of incidence is on the rise.
With no approved treatment available for food allergies, the Breakthrough Therapy status will boost the potential of the drug to become an early-bird treatment for these patients. This may help the drug to gain a significant market share.
However, there are several other pharma/biotech companies developing treatments for food allergies. These include Aimmune Therapeutics, Inc. , which is evaluating its pipeline candidate, AR101, in a phase III study for treating peanut allergy while Sanofi (SNY - Free Report) initiated an early stage study in September 2016 to evaluate SAR439794 for this indication.
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Image: Bigstock
Roche's (RHHBY) Xolair Gets Breakthrough Therapy Status
Roche (RHHBY - Free Report) announced that the FDA has granted Breakthrough Therapy designation to Xolair (omalizumab). The designation was granted for the prevention of severe allergic reactions, following accidental exposure to one or more foods in people with allergies, based on data from seven clinical studies evaluating the drug. The studies evaluated Xolair as monotherapy or in combination with oral immunotherapy.
We note that the breakthrough therapy designation from the FDA is expected to speed up the development and review of drugs intended to treat serious or life-threatening diseases.
Shares of Roche have decreased 5% so far this year compared with the industry's decline of 2.4%.
Xolair is currently approved for the treatment of moderate-to-severe persistent allergic asthma and chronic idiopathic urticarial (chronic hives without a known cause) in the United States.
This is the 23rd breakthrough therapy designation for Genentech’s portfolio of medicines.
We note that Xolair is co-developed by Genentech and Novartis Pharmaceuticals Corporation, subsidiaries of Roche and Novartis (NVS - Free Report) , respectively. The companies are planning to initiate a pivotal study to evaluate the drug for treatment of multiple food allergies.
Per the press release, approximately 200,000 patients with food allergies have to visit emergency room at hospitals annually. Moreover, it also states that 8% and 4% of children and adults, respectively, are affected by food allergies and the rate of incidence is on the rise.
With no approved treatment available for food allergies, the Breakthrough Therapy status will boost the potential of the drug to become an early-bird treatment for these patients. This may help the drug to gain a significant market share.
However, there are several other pharma/biotech companies developing treatments for food allergies. These include Aimmune Therapeutics, Inc. , which is evaluating its pipeline candidate, AR101, in a phase III study for treating peanut allergy while Sanofi (SNY - Free Report) initiated an early stage study in September 2016 to evaluate SAR439794 for this indication.
Roche Holding AG Price
Roche Holding AG Price | Roche Holding AG Quote
Zacks Rank
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Click for details >>