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MarketScreener Homepage  >  Equities  >  Nasdaq  >  Ultragenyx Pharmaceutical Inc    RARE

ULTRAGENYX PHARMACEUTICAL INC

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FDA, EMA to review Novartis' siponimod for secondary progressive MS

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10/09/2018 | 04:27am EST

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA and MAA have accepted applications for siponimod (BAF312) to treat secondary progressive multiple sclerosis (SPMS). The PDUFA date for the NDA is in March 2019; Novartis expects a decision from EMA in late 2019.

The pharma used a Priority Review voucher to speed siponimod's review. Novartis spokesperson Eric Althoff said the company used the voucher it purchased from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) in 2017; Novartis paid $130 million for the voucher (see "Novartis Buying Ultragenyx's Priority Review Voucher").

The applications are supported by data from the Phase III EXPAND trial which showed that siponimod reduced the risk of six-month confirmed disability progression by 26% compared with placebo (20% vs. 26%, HR=0.74, 95% CI: 0.6, 0.92, p=0.0058) in SPMS patients (see "Novartis Planning Submissions for Secondary Progressive MS Candidate").

Siponimod is a second-generation sphingosine 1-phosphate receptor 1 (S1PR1; S1P1; EDG1) agonist. It was designed to avoid some of the cardiovascular side effects seen with Novartis' MS drug Gilenya fingolimod, a first-generation S1P receptor agonist (see "Devil Is in the Dosing").

Celgene Corp. (NASDAQ:CELG) is developing ozanimod (RPC1063), a selective S1PR1 and S1PR5 modulator. In February, FDA issued a refusal to file letter for ozanimod in relapsing MS (see "Rocky Road").

In July, Celgene said it expects to submit in 1Q19 regulatory applications in the U.S. and EU for ozanimod.

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(C) 2018 M2 COMMUNICATIONS, source M2 PressWIRE

Stocks mentioned in the article
ChangeLast1st jan.
CELGENE CORPORATION 0.01% 90.69 Delayed Quote.41.49%
NOVARTIS 1.10% 90.08 Delayed Quote.7.19%
ULTRAGENYX PHARMACEUTICAL INC 2.15% 56.65 Delayed Quote.30.29%
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Financials ($)
Sales 2018 49,3 M
EBIT 2018 -376 M
Net income 2018 -201 M
Finance 2018 285 M
Yield 2018 -
P/E ratio 2018 -
P/E ratio 2019
EV / Sales 2018 52,3x
EV / Sales 2019 26,2x
Capitalization 2 865 M
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Number of Analysts 19
Average target price 72,4 $
Spread / Average Target 28%
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Emil D. Kakkis President, Chief Executive Officer & Director
Daniel G. Welch Non-Executive Chairman
Wladimir Hogenhuis Chief Operating Officer
Shalini Sharp Chief Financial Officer & Executive Vice President
Dennis Karl Huang Chief Technical Operations Officer & Senior VP
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