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SRPT

Sarepta

$45.36

-1.79 (-3.80%)

, IONS

Ionis Pharmaceuticals

$50.70

-1.91 (-3.63%)

12:38
10/02/17
10/02
12:38
10/02/17
12:38

FDA head says events in database not necessarily caused by drug

The FDA released a statement from Commissioner Scott Gottlieb, M.D., on the agency's Adverse Event Reporting System, or FAERS, and new search tool. Last Thursday, the FDA launched a new dashboard to facilitate access to reports of adverse drug reactions. Speculation over patient deaths drove stock volatility in Friday's trading, including selloffs in Sarepta Therapeutics (SRPT) and Ionis Pharmaceuticals (IONS). "The database is used as a surveillance tool to help the agency look for new safety concerns that might be related to a marketed product. It is also used to evaluate a manufacturer's compliance with reporting regulations and responding to outside requests for information," Gottlieb explains. "By making the FAERS database more easily accessible through the dashboard, the agency's goal is to better inform patients and health care professionals of adverse events reported with drug and biologic products. FAERS can be a valuable tool but it is just one of many data sets that helps inform the agency of possible problems associated with a product," he adds. The Commissioner also cautions, "While the FAERS dashboard now offers stakeholders many more ways of searching for and organizing data on adverse events reported to the FDA for many drug and biologic products, there remain limitations to the data. For example, while FAERS contains reports on adverse events associated with a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic. Patients should still talk to their health care professional if they have any concerns regarding their medications." Sarepta shares today are up 7% to $48.60 on the heels of an analyst upgrade at Morgan Stanley. Ionis is up 2% to $51.69 in midday trading. Reference Link

SRPT

Sarepta

$45.36

-1.79 (-3.80%)

IONS

Ionis Pharmaceuticals

$50.70

-1.91 (-3.63%)

  • 10

    Oct

  • 18

    Oct

SRPT Sarepta
$45.36

-1.79 (-3.80%)

09/29/17
NOMU
09/29/17
NO CHANGE
Target $84
NOMU
Buy
Sarepta should be bought on today's weakness, says Nomura Instinet
The FDA Adverse Events Reporting System Public Dashboard became available this morning and highlighted three patients treated with Sarepta Therapeutics' Exondys-51, Nomura Instinet analyst Christopher Marai tells investors in an intraday research note titled "Deaths Consistent with DMD, Not Drug Related." The deaths reported are not related to the drug and are consistent with outcomes in late-stage Duchenne muscular dystrophy, Marai tells investors in a research note after speaking with the company. He believes the deaths highlight the "extreme unmet need faced by patients with DMD and importance of early dosing." The analyst recommends accumulating shares of Sarepta on today's weakness. Exondys-51's safety profile to date suggest it remains a "very safe therapeutic," Marai adds. He keeps a Buy rating on Sarepta with an $84 price target. The stock in midday trading is down 4% to $45.16.
09/29/17
WBLR
09/29/17
NO CHANGE
WBLR
Outperform
Sarepta should be bought on today's weakness, says William Blair
William Blair analyst Tim Lugo recommends using today's weakness in shares of Sarepta Therapeutics as a buying opportunity. The analyst believes the adverse events posted in the FDA's Adverse Event Reporting System are likely not related to Sarepta's Exondys 51.
10/02/17
MSCO
10/02/17
UPGRADE
MSCO
Overweight
Sarepta upgraded to Overweight from Equal Weight at Morgan Stanley
10/02/17
10/02/17
UPGRADE
Target $60

Overweight
Sarepta upgraded to Overweight, price target raised to $60 at Morgan Stanley
As previously reported, Morgan Stanley analyst Matthew Harrison upgraded Sarepta to Overweight from Equal Weight, saying the firm's recent survey work on Exondys 51 points to $55M in quarterly sales, which he notes is about 35% ahead of the consensus forecast of $40M. Moreover, there was no meaningful change in drop-out rate versus the prior survey, leading him to believe the upside is sustainable, he tells investors. Harrison, who also sees the company's long-term pipeline as underappreciated, raised his price target on Sarepta shares to $60 from $33.
IONS Ionis Pharmaceuticals
$50.70

-1.91 (-3.63%)

09/20/17
JEFF
09/20/17
NO CHANGE
Target $102
JEFF
Buy
Jefferies says Alnylam patisiran results a 'best-case scenario'
Jefferies analyst Maury Raycroft views Alnylam's (ALNY) topline results from the Apollo trial of patisiran as "highly positive" and a "best-case scenario" from a competitive perspective. The lack of any notable safety signal and benefit on secondary endpoints further distinguishes this "as a clear win" and should help the company's negotiations with payers, he tells investors. Patisiran appears to have a superior safety profile to Ionis' (IONS) inotersen, added Raycroft, who has a Buy rating and $102 price target on Alnylam shares.
09/21/17
LEHM
09/21/17
NO CHANGE
Target $127
LEHM
Overweight
Alnylam price target raised to $127 from $105 at Barclays
Barclays analyst Gena Wang raised her price target for Alnylam Pharmaceuticals (ALNY) to $127 citing the company's positive topline data from the Apollo Phase study in TTR amyloidosis. The analyst increased patisiran's probability of success to 95% from 85% and reiterates an Overweight rating on the shares. Wang also decreased her price target on Equal Weight-rated Ionis Pharmaceuticals (IONS) to $52 from $55 saying Alnylam's data suggest strong competition for inotersen.
09/29/17
WELS
09/29/17
NO CHANGE
WELS
Outperform
Ionis deaths in Spinraza patients related to disease, says Wells Fargo
Wells Fargo analyst Jim Birchenough noted Ionis Pharmaceuticals (IONS) shares have been weak today amid reports of deaths in patients treated with Spinraza for spinal muscular atrophy, but his review of the FAERS system data indicates that in each of the 12 deaths reported disease progression appears to be the cause of death. He said that, if anything, he would expect the disease-related deaths to accelerate approval of new born testing for early identification. Birchenough has an Outperform rating on Ionis shares.
09/29/17
BMOC
09/29/17
NO CHANGE
BMOC
Outperform
Ionis reaction to reports of death in database unwarranted, says BMO Capital
BMO Capital analyst Do Kim believes the pressure on Ionis shares after nine reported deaths of Spinraza patients were found using the FDA AERS database is unwarranted, noting that SMA Type 1 is usually fatal before one year. The analyst believes these deaths are not drug related and thinks the Q3 consensus Spinraza estimate is beatable. Kim keeps an Outperform rating on Ionis shares.

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KTOV

Kitov Pharmaceuticals

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FAF

First American

$51.89

0.02 (0.04%)

, FNF

Fidelity National

$37.23

0.14 (0.38%)

17:21
07/16/18
07/16
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Upgrade
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FAF

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$51.89

0.02 (0.04%)

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0.14 (0.38%)

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NAKD

Naked Brand Group

$4.95

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FNF

Fidelity National

$37.23

0.14 (0.38%)

17:20
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Upgrade
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LMT

Lockheed Martin

$319.13

0.69 (0.22%)

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  • 16

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FDEF

First Defiance Financial

$33.61

1.005 (3.08%)

17:18
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Earnings
First Defiance Financial reports Q2 adjusted EPS 54c, consensus 52c »

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LNT

Alliant Energy

$42.79

-0.14 (-0.33%)

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  • 22

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TRQ

Turquoise Hill

$2.94

0.11 (3.89%)

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AVEO

Aveo Pharmaceuticals

$2.85

-0.055 (-1.90%)

17:02
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Morgan Stanleey econo »

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$13.10

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Ally Financial

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OSG

Overseas Shipholding

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CHDN

Churchill Downs

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  • 02

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BAC

Bank of America

$29.77

1.235 (4.33%)

, DB

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IGT

International Game

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