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 (RHHBY) MS Drug FDA Review Date Extended in U.S.
Read MoreHide Full Article
Roche Holding AG (RHHBY - Free Report) announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for the review of the company’s Biologics License Application (BLA) for Ocrevus to Mar 28, 2017.
We note that Roche has underperformed the Zacks classified Large Cap Pharmaceuticals industry in the year-to-date period. In fact, the stock has lost 17.9% during this period, compared with a drop of 5.4% for the industry.
Coming back to the latest news, the review date was extended to accommodate the submission of additional data by Genentech on the commercial manufacturing process of Ocrevus. Consequently, the FDA has asked for additional time to review the application. The company has also clarified that the extension is not related to the efficacy and safety of Ocrevus.
We remind investors that in Jun 2016, the FDA had accepted Roche’s BLA for Ocrevus for the treatment of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) and granted Priority Review designation to the application, with a targeted action date of Dec 28, 2016.
Ocrevus is being evaluated for the treatment of relapsing forms of RMS and PPMS.
The extension comes as a disappointment for investors. Note that Biogen BIIB holds a strong position in the MS market backed by a wide range of products including Avonex, Tysabri, Tecfidera and Plegridy.
Nevertheless, Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space on robust demand for its HER2 franchise drugs. The company is also making efforts to develop its portfolio beyond oncology into immunology. We remind investors that neuroscience is a major area of focus of research and development at Roche. The company currently has more than a dozen experimental candidates in clinical development for diseases like MS, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease and autism.
Roche currently carries a Zacks Rank #4 (Sell).
Key Picks in the Sector
A couple of better-ranked stocks in the health care sector include Heska Corp. (HSKA), and Vanda Pharmaceuticals (VNDA). Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 94.1% year to date.
Vanda’s loss estimates for 2016 narrowed from 62 cents to 52 cents, while its earnings estimates for 2017 increased from 13 cents to 22 cents over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 83% year to date.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Roche (RHHBY) MS Drug FDA Review Date Extended in U.S.
Roche Holding AG (RHHBY - Free Report) announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) date for the review of the company’s Biologics License Application (BLA) for Ocrevus to Mar 28, 2017.
We note that Roche has underperformed the Zacks classified Large Cap Pharmaceuticals industry in the year-to-date period. In fact, the stock has lost 17.9% during this period, compared with a drop of 5.4% for the industry.
Coming back to the latest news, the review date was extended to accommodate the submission of additional data by Genentech on the commercial manufacturing process of Ocrevus. Consequently, the FDA has asked for additional time to review the application. The company has also clarified that the extension is not related to the efficacy and safety of Ocrevus.
We remind investors that in Jun 2016, the FDA had accepted Roche’s BLA for Ocrevus for the treatment of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) and granted Priority Review designation to the application, with a targeted action date of Dec 28, 2016.
Ocrevus is being evaluated for the treatment of relapsing forms of RMS and PPMS.
The extension comes as a disappointment for investors. Note that Biogen BIIB holds a strong position in the MS market backed by a wide range of products including Avonex, Tysabri, Tecfidera and Plegridy.
Nevertheless, Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space on robust demand for its HER2 franchise drugs. The company is also making efforts to develop its portfolio beyond oncology into immunology. We remind investors that neuroscience is a major area of focus of research and development at Roche. The company currently has more than a dozen experimental candidates in clinical development for diseases like MS, Alzheimer’s disease, spinal muscular atrophy, Parkinson’s disease and autism.
Roche currently carries a Zacks Rank #4 (Sell).
Key Picks in the Sector
A couple of better-ranked stocks in the health care sector include Heska Corp. (HSKA), and Vanda Pharmaceuticals (VNDA). Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 94.1% year to date.
Vanda’s loss estimates for 2016 narrowed from 62 cents to 52 cents, while its earnings estimates for 2017 increased from 13 cents to 22 cents over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 83% year to date.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>