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 Rituxan Gets 'Breakthrough Therapy' Designation by FDA
Read MoreHide Full Article
Roche Holding AG’s (RHHBY - Free Report) member, Genentech announced that the FDA has granted Breakthrough Therapy Designation status to Rituxan (rituximab) for the treatment of pemphigus vulgaris.
Rituxan is approved to treat rheumatoid arthritis (RA) in combination with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well enough. Rituxan is marketed under the trade name MabThera in the European Union.
MabThera, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s, GPA) and microscopic polyangiitis (MPA).
Roche’s share price shows that the company has outperformed the Zacks classified Medical - Biomedical and Genetics industry year to date. The stock gained 11.2% compared to the Large Cap Pharmaceuticals industry’s gain of 6.5%.
Coming back to the release, the Breakthrough Therapy Designation status was granted based on encouraging data from a Roche-supported randomized trial conducted in France, which assessed Rituxan plus oral corticosteroid (CS) treatment compared to CS as a first-line treatment in patients with moderate to severe pemphigus. The results showed that Rituxan may provide substantial improvement in pemphigus vulgaris remission rates and successful tapering and/or cessation of CS therapy.
Also, Genentech is currently enrolling in a phase III study in pemphigus vulgaris (PEMPHIX, NCT02383589), to assess the efficacy and safety of Rituxan compared with mycophenolate mofetil (MMF) in patients with moderate to severe active pemphigus vulgaris requiring 60-120 mg/day oral prednisone (or equivalent), We note that the FDA also granted Orphan Drug Designation to Rituxan for the treatment of pemphigus vulgaris in 2015.
Rituxan, however also faces stiff competition. The biosimilar versions of Rituxan are expected to enter Europe in the second half of 2017.
We expect investors to focus on new drug approvals at Roche, as the company’s top line could be marred by the entry of biosimilars for its key drugs like MabThera and Herceptin.
Roche currently carries a Zacks Rank #3 (Hold). Some other better-ranked stocks in the health care sector include Heska Corp. , Retrophin, Inc. and Addus HomeCare Corp. (ADUS - Free Report) . While Heska and Retrophin carry a Zacks Rank #1 (Strong Buy), Addus HomeCare carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%. Its share price increased 37.2% year to date.
Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018, over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.
Addus HomeCare earnings estimates increased from $1.38 to $1.41 for 2017, over the last 30 days. The company posted a positive earnings surprise in two of the four trailing quarters with an average beat of 10.14%.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market. Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020. Click here for the 6 trades >>
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Roche's Rituxan Gets 'Breakthrough Therapy' Designation by FDA
Roche Holding AG’s (RHHBY - Free Report) member, Genentech announced that the FDA has granted Breakthrough Therapy Designation status to Rituxan (rituximab) for the treatment of pemphigus vulgaris.
Rituxan is approved to treat rheumatoid arthritis (RA) in combination with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well enough. Rituxan is marketed under the trade name MabThera in the European Union.
MabThera, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s, GPA) and microscopic polyangiitis (MPA).
Roche’s share price shows that the company has outperformed the Zacks classified Medical - Biomedical and Genetics industry year to date. The stock gained 11.2% compared to the Large Cap Pharmaceuticals industry’s gain of 6.5%.
Coming back to the release, the Breakthrough Therapy Designation status was granted based on encouraging data from a Roche-supported randomized trial conducted in France, which assessed Rituxan plus oral corticosteroid (CS) treatment compared to CS as a first-line treatment in patients with moderate to severe pemphigus. The results showed that Rituxan may provide substantial improvement in pemphigus vulgaris remission rates and successful tapering and/or cessation of CS therapy.
Also, Genentech is currently enrolling in a phase III study in pemphigus vulgaris (PEMPHIX, NCT02383589), to assess the efficacy and safety of Rituxan compared with mycophenolate mofetil (MMF) in patients with moderate to severe active pemphigus vulgaris requiring 60-120 mg/day oral prednisone (or equivalent), We note that the FDA also granted Orphan Drug Designation to Rituxan for the treatment of pemphigus vulgaris in 2015.
Rituxan, however also faces stiff competition. The biosimilar versions of Rituxan are expected to enter Europe in the second half of 2017.
We expect investors to focus on new drug approvals at Roche, as the company’s top line could be marred by the entry of biosimilars for its key drugs like MabThera and Herceptin.
Roche Holding AG Price
Roche Holding AG Price | Roche Holding AG Quote
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold). Some other better-ranked stocks in the health care sector include Heska Corp. , Retrophin, Inc. and Addus HomeCare Corp. (ADUS - Free Report) . While Heska and Retrophin carry a Zacks Rank #1 (Strong Buy), Addus HomeCare carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%. Its share price increased 37.2% year to date.
Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018, over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.
Addus HomeCare earnings estimates increased from $1.38 to $1.41 for 2017, over the last 30 days. The company posted a positive earnings surprise in two of the four trailing quarters with an average beat of 10.14%.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market. Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020. Click here for the 6 trades >>