Novartis AG (NVS - Free Report) announced that both the FDA and the European Medicines Agency (EMA) have accepted the New Drug Application (NDA) and Marketing Authorization Application (MAA), respectively, for pipeline candidate, siponimod (BAF312).
Siponimod, an experimental oral once-daily selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor, is being evaluated for the treatment of secondary progressive multiple sclerosis (SPMS) in adults.
The filings were based on positive data from the phase III study, EXPAND, which showed that siponimod had beneficial effects on disability relapses and magnetic resonance imaging (MRI) disease activities in typical SPMS patients.
Novartis used a review voucher to expedite the review of siponimod in the United States. A decision on approval is expected in March 2019 in the United States and late 2019 in Europe.
Additionally, Novartis conducted a phase II randomized placebo-controlled, adaptive dose-ranging study, BOLD, in patients with RRMS. Results from the study showed that siponimod significantly reduced the annualized rate of relapses (ARR) for more than six months compared to placebo.
A tentative approval will boost Novartis’ MS portfolio, which includes approved drugs like Gilenya and Extavia. Notably, Extavia is approved in the United States for the treatment of relapsing forms of MS. The drug is approved to treat people with relapsing-remitting MS and secondary progressive MS (SPMS) with active disease, in Europe.
The company has other pipeline candidates like OMB157 (ofatumumab), a fully human monoclonal antibody being evaluated for relapsing MS.
Novartis’ generic division, Sandoz markets Glatopa, a generic version of Teva Pharmaceuticals’ (TEVA - Free Report) Copaxone (both 20 and 40 mg), in partnership with Momenta Pharmaceuticals .
Approval of new drugs and label expansion of existing drugs bode well for Novartis. The company’s shares have gained 5.5% in the year so far compared with the industry’s growth of 10%.
We note that Biogen, Inc. (BIIB - Free Report) holds a strong position in the MS market with a wide range of products, including Avonex, Tysabri, Tecfidera and Plegridy.
Zacks Rank
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Novartis AG (NVS - Free Report) announced that both the FDA and the European Medicines Agency (EMA) have accepted the New Drug Application (NDA) and Marketing Authorization Application (MAA), respectively, for pipeline candidate, siponimod (BAF312).
Siponimod, an experimental oral once-daily selective modulator of specific subtypes of the sphingosine-1-phosphate (S1P) receptor, is being evaluated for the treatment of secondary progressive multiple sclerosis (SPMS) in adults.
The filings were based on positive data from the phase III study, EXPAND, which showed that siponimod had beneficial effects on disability relapses and magnetic resonance imaging (MRI) disease activities in typical SPMS patients.
Novartis used a review voucher to expedite the review of siponimod in the United States. A decision on approval is expected in March 2019 in the United States and late 2019 in Europe.
Additionally, Novartis conducted a phase II randomized placebo-controlled, adaptive dose-ranging study, BOLD, in patients with RRMS. Results from the study showed that siponimod significantly reduced the annualized rate of relapses (ARR) for more than six months compared to placebo.
A tentative approval will boost Novartis’ MS portfolio, which includes approved drugs like Gilenya and Extavia. Notably, Extavia is approved in the United States for the treatment of relapsing forms of MS. The drug is approved to treat people with relapsing-remitting MS and secondary progressive MS (SPMS) with active disease, in Europe.
The company has other pipeline candidates like OMB157 (ofatumumab), a fully human monoclonal antibody being evaluated for relapsing MS.
Novartis’ generic division, Sandoz markets Glatopa, a generic version of Teva Pharmaceuticals’ (TEVA - Free Report) Copaxone (both 20 and 40 mg), in partnership with Momenta Pharmaceuticals .
Approval of new drugs and label expansion of existing drugs bode well for Novartis. The company’s shares have gained 5.5% in the year so far compared with the industry’s growth of 10%.
We note that Biogen, Inc. (BIIB - Free Report) holds a strong position in the MS market with a wide range of products, including Avonex, Tysabri, Tecfidera and Plegridy.
Zacks Rank
Novartis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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