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SRPT

Sarepta

$120.16

-4.81 (-3.85%)

08:26
08/20/19
08/20
08:26
08/20/19
08:26

FDA's CRL on Sarepta's golodirsen should lead to 'modest delay', says BTIG

BTIG analyst Timothy Chiang kept his Buy rating and $190 price target on Sarepta after it disclosed a complete response letter, or CRL, on golodirsen from the FDA, saying the 11% after-market stock price decline may be overdone since the "bulk" of his bull thesis on the stock is tied to the company's micro-dystrophin gene therapy program. The analyst notes that the CRL will likely push out the potential approval timing on golodirsen to 2020, and that he is removing the previously modeled $25M in in related 2019 sales from his forecasts. Chiang adds that the issues brought up by the FDA in the golodirsen are "addressable".

SRPT Sarepta
$120.16

-4.81 (-3.85%)

08/20/19
CANT
08/20/19
NO CHANGE
Target $175
CANT
Overweight
Sarepta price target lowered to $175 from $231 at Cantor Fitzgerald
Cantor Fitzgerald analyst Alethia Young cut her price target on Sarepta shares to $175 from $231 after the company announced the receipt of a complete response letter, or CRL, on golodirsen from the FDA. After speaking with Sarepta management, Young now expects a delay of at least one year. The analyst, who previously assumed 100% success for both golodirsen and casimersen, sees greater approval risk and lowered her view on the probability of success to 40% for both programs. Young, who believes some aspects of the FDA's pushback could be political, and therefore hard to handicap, keeps an Overweight rating on Sarepta shares, which are down $20.54, or 17%, to $99.77 in pre-market trading.
08/20/19
FBCO
08/20/19
NO CHANGE
Target $201
FBCO
Outperform
Sarepta price target lowered to $201 from $207 at Credit Suisse
Credit Suisse analyst Martin Auster lowered his price target for Sarepta to $201 from $207 after the company received surprise CRL for Vyondys 53, with FDA citing the risk of infections related to the intravenous infusion ports and renal toxicity seen in preclinical models and observed following administration of other antisense oligonucleotides. The analyst says that both of these findings on the surface appear to be "a bit surprising" considering the severity of DMD and lack of treatment options for boys amenable to exon 53 skipping. Auster reiterates an Outperform rating on the shares.
08/20/19
BARD
08/20/19
NO CHANGE
Target $181
BARD
Outperform
Sarepta price target lowered to $181 from $202 at Baird
Baird analyst Brian Skorney lowered his price target on Sarepta to $181 from $202 following the FDA rejection of golodirsen especially given the confidence management expressed earlier in the month. After backing out golodirsen and casimersen sales to 2024, the analyst lowered his target. Skorney maintained his Outperform rating on Sarepta shares.
08/20/19
NOMU
08/20/19
NO CHANGE
Target $230
NOMU
Buy
Sarepta weakness on golodirsen CRL a buying opportunity, says Nomura Instinet
Nomura Instinet analyst Christopher Marai said Sarepta management called the complete response letter for golodirsen a surprise as the FDA recently suggested approval was on track. While the CRL delays his estimate for golodirsen approval and launch to the second half of 2020 from the end of 2019, Marai said there is no read-through to Exondys-51, casimersen or the company's gene therapy, which makes the weakness an attractive buying opportunity in his view. He is also not concerned about renal toxicity, as this is a well-known issue for the antisense oligonucleotides class and Marai said golodirsen's "PMO-chemistry appears to be among the safest ASOs in this regard." The analyst keeps a Buy rating and $230 price target on Sarepta shares.

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GLD

SPDR Gold Shares

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VXRT

Vaxart

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-0.0307 (-5.03%)

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AAPL

Apple

$217.69

-3.22 (-1.46%)

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IIVI

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NVR

NVR

$3,632.55

-30.45 (-0.83%)

, JEF

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$19.47

-0.19 (-0.97%)

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NVR to replace Jefferies Financial Group in the S&P 500 at open on September 26 »

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-30.45 (-0.83%)

JEF

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$19.47

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SPB

Spectrum Brands

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NOC

Northrop Grumman

$368.25

-7.45 (-1.98%)

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PSMT

PriceSmart

$60.29

-0.39 (-0.64%)

, FNSR

Finisar

$24.31

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Breaking Hot Stocks news story on PriceSmart, Finisar »

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FNSR

Finisar

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  • 30

    Oct

IIVI

II-VI

$39.05

-0.5 (-1.26%)

, CPE

Callon Petroleum

$4.53

-0.015 (-0.33%)

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$4.53

-0.015 (-0.33%)

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  • 23

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NVR

NVR

$3,632.55

-30.45 (-0.83%)

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NHYDY

Norsk Hydro

$0.00

(0.00%)

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RESN

Resonant

$3.05

0.02 (0.66%)

17:03
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NINE

Nine Energy Services

$6.73

-0.33 (-4.67%)

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ATOM

Atomera

$3.70

0.17 (4.82%)

17:00
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Conference/Events
Atomera participates in a conference call with Loop Capital »

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MPWR

Monolithic Power

$154.21

-2 (-1.28%)

16:50
09/20/19
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16:50
Conference/Events
Monolithic Power participates in a conference call with Loop Capital »

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AAPL

Apple

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IDA

IDACORP

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MO

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EADSY

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$0.00

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Preliminary option volume of 23.5M today »

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PSX

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POST

Post Holdings

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