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ALNY

Alnylam

$75.04

-0.96 (-1.26%)

, SNY

Sanofi

$49.10

0.46 (0.95%)

07:02
09/20/17
09/20
07:02
09/20/17
07:02

Alnylam, Sanofi say APOLLO Phase 3 study met primary, secondary endpoints

Alnylam Pharmaceuticals (ALNY) and Sanofi Genzyme, the specialty care global business unit of Sanofi (SNY), announced that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint and all secondary endpoints. The primary endpoint for the study was the change from baseline in the modified neuropathy impairment score at 18 months. The key secondary endpoint was improvement in quality of life assessed by the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy. The APOLLO trial enrolled 225 hATTR amyloidosis patients with polyneuropathy, representing 39 genotypes, at 44 study sites in 19 countries around the world. Patients were randomized 2:1 to patisiran or placebo, with patisiran administered intravenously at 0.3 mg/kg once every three weeks for 18 months. For both the mNIS+7 and Norfolk QOL-DN endpoint measures, a lower score indicates a better clinical result. At 18 months, the mean change from baseline in mNIS+7 was significantly lower in the patisiran group as compared with placebo. Patients in the patisiran group experienced improvement in quality of life compared to placebo, as assessed by the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy. The mean and median changes in QOL scores for patisiran also both achieved negative values, indicating an improvement overall and in the majority of patients compared with baseline. All 5 other secondary endpoints also demonstrated statistically significant favorable differences in the patisiran arm compared to placebo. Based on these positive results, Alnylam expects to file its first New Drug Application in late 2017 and first Marketing Authorisation Application shortly thereafter. Sanofi Genzyme is currently preparing for regulatory filings for patisiran in Japan, Brazil and other countries, to begin in the first half of 2018. Pending regulatory approvals, Alnylam will commercialize patisiran in the U.S., Canada and Western Europe, with Sanofi Genzyme commercializing the product in the rest of the world.

ALNY

Alnylam

$75.04

-0.96 (-1.26%)

SNY

Sanofi

$49.10

0.46 (0.95%)

  • 18

    Oct

ALNY Alnylam
$75.04

-0.96 (-1.26%)

09/08/17
LEER
09/08/17
NO CHANGE
Target $72
LEER
Market Perform
Alnylam price target lowered to $72 from $83 at Leerink
Leerink analyst Paul Matteis lowered his price target for Alnylam Pharmaceuticals to $72 after removing sales from non-inhibitor patients from his valuation and reducing his odds-of-success for fitusiran in the inhibitor population to 35%. The changes follow Alnylam's announcement that dosing in the Phase 3 Atlas programs has been halted due to a fatal thrombotic event in a patient with hemophilia A without inhibitors. The analyst keeps a Market Perform rating on Alnylam.
09/14/17
NOMU
09/14/17
INITIATION
Target $56
NOMU
Reduce
Alnylam initiated with a Reduce at Nomura Instinet
Nomura initiated Alnylam with a Reduce and a $56 price target.
09/15/17
NOMU
09/15/17
INITIATION
Target $56
NOMU
Reduce
Nomura says reduce Alnylam exposure, starts with Reduce rating
Nomura Instinet analyst Christopher Marai last night initiated Alnylam Pharmaceuticals with a Reduce rating and $56 price target. The analyst recommends reducing exposure to the shares ahead of the patisiran Phase 3 Apollo readout. He sees a good chance of a successful readout, but notes that a "possible, unlikely disappointment" could send shares "substantially" lower. A patisiran launch will likely be "slow and disappointing," based on competition and the relatively poor product profile, Marai told investors in a research note.
09/18/17
JEFF
09/18/17
NO CHANGE
Target $102
JEFF
Buy
Jefferies says buy Alnylam ahead of Apollo data readout
Topline results for Alnylam Pharma's Apollo trial are expected in the next two weeks, which, if positive, can drive 15%-20% upside in the shares, Jefferies analyst Maury Raycroft tells investors in a research note. After speaking to a hereditary ATTR amyloidosis doctor, Raycroft says he would buy shares of Alnylam ahead of the data readout. He has a Buy rating on the shares with a $102 price target.
SNY Sanofi
$49.10

0.46 (0.95%)

07/31/17
ADAM
07/31/17
NO CHANGE
Target $522
ADAM
Buy
Dupixent authorization approval rate outweighs Q2 miss, says Canaccord
Regeneron (REGN) partner Sanofi (SNY) reported a "very high" 73%-83% prior authorization approval rate for Dupixent in Q2, which Canaccord analyst John Newman said outweighs the fact that sales for the drug at $30.6M were slightly below the $33M consensus forecast. The analyst, who sees rapid payor acceptance of Dupixent as "much more crucial" than the initial quarterly revenue, keeps a Buy rating and $522 price target on Regeneron shares.
08/30/17
HSBC
08/30/17
UPGRADE
Target $81
HSBC
Hold
Sanofi upgraded to Hold from Reduce at HSBC
HSBC analyst Steve McGarry upgraded Sanofi to Hold and increased its price target to $81 from $79 citing valuation and said he sees few catalysts to own the shares either.
08/30/17
08/30/17
UPGRADE

On The Fly: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Sanofi (SNY) upgraded to Hold from Reduce at HSBC, with analyst Steve McGarry citing valuation. 2. M.D.C. Holdings (MDC) upgraded to Market Perform from Underperform at Wells Fargo with analyst Stephen East saying he sees "little reason the equity would move meaningfully lower" from current levels. 3. Ciena (CIEN) upgraded to Buy from Neutral at Citi with analyst Stanley Kovler saying the risk/reward is positive into third quarter results. 4. Six Flags (SIX) upgraded to Buy from Neutral at Hilliard Lyons with analyst Jeff Thomison citing improved valuation based on its 13% year-to-date pullback. 5. Prospect Capital (PSEC) upgraded to Market Perform from Underperform at Raymond James with analyst Robert Dodd saying he expects near-term earnings will cover the lower dividend run-rate but notes downside risk remains. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
09/11/17
FBCO
09/11/17
NO CHANGE
Target $485
FBCO
Outperform
Regeneron, Sanofi asthma trial 'statistically significant,' says Credit Suisse
Credit Suisse analyst Alethia Young notes that Regeneron (REGN)/Sanofi (SNY) released top-line asthma results, and the overall trial was "statistically significant." Specifically, the trial hit in the overall population, but it is unclear if the trial was statistically significant in the low eosinophil level patients alone, she notes. The analyst reiterates an Outperform rating and $485 price target on Regeneron's shares.

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SO

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-0.225 (-0.52%)

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BA

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UNIT

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TROW

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BA

Boeing

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5.3515 (1.51%)

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SO

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$43.39

-0.08 (-0.18%)

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$43.43

-0.04 (-0.09%)

13:21
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General news
Treasury Action: yields remained relatively inert »

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WMT

Walmart

$92.00

-2.11 (-2.24%)

13:17
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Technical Analysis
Technical Take: Walmart moves up off lows of the day »

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$NSD

NASDAQ Market Internals

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BHGE

Baker Hughes

$27.68

1.24 (4.69%)

, GE

General Electric

$14.53

-0.21 (-1.42%)

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BHGE

Baker Hughes

$27.68

1.24 (4.69%)

GE

General Electric

$14.53

-0.21 (-1.42%)

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$NYE

NYSE Market Internals

13:16
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General news
Treasury's upsized $35 B 5-year auction was ok, as expected »

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SO

Southern Company

$43.29

-0.18 (-0.41%)

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CBRL

Cracker Barrel

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  • 06

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ILG

ILG

$32.19

-0.01 (-0.03%)

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SO

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$43.27

-0.2 (-0.46%)

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  • 21

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-0.2 (-0.46%)

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HUM

Humana

$269.42

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, MOH

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CNC

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HNT

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CALA

Calithera Biosciences

$7.70

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