J&J Files for FDA Approval of Simponi Aria Label Expansion
Johnson & Johnson’s JNJ subsidiary, Janssen Biotech, Inc. announced that it has submitted two Supplemental Biologics License Applications (sBLAs) in the U.S., seeking approval of Simponi Aria for the treatment of adults with active psoriatic arthritis and active ankylosing spondylitis.
A look at J&J’s year-to-date share price movement shows that the company has outperformed the Zacks classified Large Cap Pharmaceutical industry. Specifically, the stock gained 12.6% so far this year, compared with the 5.5% drop for the industry.
Coming back to the latest news, the sBLA was supported by data from the two phase III studies – GO-VIBRANT for active psoriatic arthritis and GO-ALIVE for active ankylosing spondylitis. Both the studies evaluated the safety and efficacy of Simponi Aria (2 mg/kg) as an intravenous infusion every eight weeks after two starter doses at weeks 0 and 4.
According to the company’s press release, more than two million people in the U.S. suffer from the combined effect of psoriatic arthritis and ankylosing spondylitis. Thus, if approved for these indications, the drug can address a significantly large market.
Simponi Aria is currently approved in the U.S., in combination with methotrexate, as a 30-minute intravenous infusion for the treatment of adult patients with moderate-to-severely active rheumatoid arthritis (RA).
We note that J&J is working actively on expanding the label of its marketed products. Last week, the company filed an sBLA in the U.S. for approval of Stelara for the treatment of adolescents between 12 and 17 years of age with moderate-to-severe plaque psoriasis. In addition, Stelara is being evaluated in the phase III CADMUS Jr study for the treatment of pediatric patients aged 6 to 11 years of age.
A potential label expansion these drugs should contribute significantly to the company’s top line, going forward.
JOHNSON & JOHNS Price and Consensus
JOHNSON & JOHNS Price and Consensus | JOHNSON & JOHNS Quote
J&J carries a Zacks Rank #3 (Hold).
Key Picks in the Sector
Some better-ranked stocks in the health care sector include Vanda Pharmaceuticals Inc. VNDA Heska Corp. HSKA and Cambrex Corp. CBM. 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.
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 77% year to date.
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 surged almost 86% year to date.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has surged almost 15% year to date.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>
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
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
CAMBREX CORP (CBM): Free Stock Analysis Report
HESKA CORP (HSKA): Free Stock Analysis Report
VANDA PHARMACT (VNDA): Free Stock Analysis Report
To read this article on Zacks.com click here.
