After a nice jump in the first half of 2017, Johnson & Johnson (NYSE:JNJ) stock has largely tread water over the last few months. Wouldn't it be nice if the healthcare giant had a catalyst or two to generate more enthusiasm among investors?
As it turns out, the company just might get some good news in the coming weeks. Mark your calendars, because October could be a big month for Johnson & Johnson.
A potential younger market for Stelara
The U.S. Food and Drug Administration (FDA) is scheduled to make an approval decision by Oct. 15, 2017, for Stelara for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. J&J submitted a supplemental New Drug Application (sNDA) for the additional indication last December based on positive results from its Cadmus late-stage study.
Approval for treating adolescents with plaque psoriasis should be significant for Johnson & Johnson. Stelara is the company's second best-selling drug after Remicade, and, unlike Remicade, it can claim solid sales growth. Around one-third of the 7.5 million Americans with psoriasis are first affected by the disease prior to the age of 20. Approval for treating adolescents, therefore, presents a sizable market opportunity for J&J.
Chances for approval appear to be pretty good. The efficacy and safety profile from the Cadmus study in adolescents was similar to the profile of the drug in treating adults. Stelara first won approval for treating adults with plaque psoriasis in 2009.
Two opportunities for Simponi Aria
Johnson & Johnson has another blockbuster autoimmune disease drug for which sales are growing, albeit slowly -- Simponi Aria. The company hopes to kick that sales growth up a notch by winning approval in October for two additional indications for Simponi Aria in treating adults with active psoriatic arthritis and in treating adults with active ankylosing spondylitis.
Simponi Aria is an intravenous form of golimumab. The subcutaneous injection form of the drug, branded as Simponi, already won approval for treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis back in 2009, and won approval for treating ulcerative colitis in 2013. Simponi Aria's only approval thus far came in 2013 for treating rheumatoid arthritis.
Although anything can happen with the approval process, J&J should be in good shape to get a thumbs-up from the FDA for the two additional indications for Simponi Aria. The company reported solid results from the two late-stage studies on which the basis of the regulatory submissions were made.
Another dose for Xarelto
On June 28, 2017, the FDA granted priority review of J&J's sNDA for Xarelto to include a 10 mg once-daily dose for reducing the risk of venous thromboembolism (VTE) after at least six months of standard anticoagulant therapy. Because drugs receiving priority review enjoy a shorter review process, a decision from the FDA is expected by Oct. 28, 2017.
A 20 mg dose of Xarelto is already approved for reducing the risk of VTE, which occurs when a blood clot breaks loose and travels in the blood stream. However, the lower dose of the drug, if approved, would offer physicians more flexibility to tailor treatment plans based on patient needs.
J&J's Einstein Choice late-stage study found both 10 mg and 20 mg doses of Xarelto to be more effective than aspirin in the risk of recurrent VTE following at least six months of standard anticoagulation therapy. The 10 mg dose was actually a little more effective in the study than the 20 mg dose of Xarelto.
Moving the needle?
Admittedly, it's hard for any single approval to move Johnson & Johnson stock very much. Total sales for Stelara, for example, currently only contribute around 5% of the company's total revenue. Xarelto and Simponi Aria make up even smaller percentages.
However, sometimes a cadence of good news can help drum up interest in a stock and cause it to go higher. October presents that opportunity for J&J.