Johnson & Johnson’s (JNJ - Free Report) subsidiary, Janssen announced the submission of a Biologics License Application (BLA) to the FDA for its pipeline candidate guselkumab for the treatment of adults with moderate to severe plaque psoriasis.
The application is served on the basis of four studies – phase III VOYAGE 1, VOYAGE 2 and NAVIGATE, and phase II X-PLORE – evaluating the efficacy and safety of guselkumab administered by subcutaneous injection for the treatment of adults with moderate to severe plaque psoriasis.
Results of the VOYAGE 1 study were recently presented at the European Academy of Dermatology and Venereology congress in Austria, while VOYAGE 2 and NAVIGATE data are expected to be presented at upcoming scientific congresses.
Data from the VOYAGE 1 trial (n=837) showed that significantly higher proportions of patients with moderate-to-severe plaque psoriasis treated with guselkumab achieved high rates of skin clearance compared to those receiving placebo. 73% of the patients receiving guselkumab achieved near complete skin clearance versus 2.9% on placebo.
The active comparator arm of the VOYAGE trial evaluated guselkumab in comparison with AbbVie Inc.’s (ABBV - Free Report) top-selling product, Humira. The study demonstrated statistically significant efficacy of guselkumab compared to Humira after week 16, which was maintained through 48 weeks of treatment. Almost 50% of the patients treated with Humira achieved near-complete skin clearance compared with 73% receiving guselkumab.
A phase II trial evaluating guselkumab in moderate-to-severely active psoriatic arthritis is also ongoing. Per the company’s press release, around 125 million people worldwide suffer from psoriasis, including 7.5 million Americans with their disease ranging from mild to severe and disabling. Hence, an approval of guselkumab would give the company access to a wide patient population in the U.S.
Zacks Rank & Key Picks
Johnson & Johnson currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Cambrex Corp. (CBM - Free Report) and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . 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.
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 increased 9.7% year to date.
Vanda’s loss estimates narrowed from 68 cents to 56 cents for 2016, while its earnings estimates have increased from 16 cents to 17 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average positive surprise of 56.65%. Its share price has surged 83.1% year to date.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>