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SRPT

Sarepta

$41.08

-0.15 (-0.36%)

07:12
09/06/17
09/06
07:12
09/06/17
07:12

Sarepta announces 'positive' results in 4053-101 study

Sarepta Therapeutics announced muscle biopsy results from its 4053-101 study, a Phase 1/2 first-in-human study conducted in Europe to assess the safety, tolerability, pharmacokinetics, and efficacy of golodirsen in 25 boys with confirmed deletions of the DMD gene amenable to skipping exon 53. The study comprised two parts. In Part 1, 12 patients were randomized to receive a dose titration of golodirsen or placebo. At the end of Part 1, all 12 patients continued on golodirsen and an additional 13 patients started golodirsen. In Part 2, all 25 patients were treated for an additional 48 weeks at the time of muscle biopsy. The analysis included biopsies of the bicep muscle at baseline and on-treatment at the Part 2 Week 48 time point. All 25 participants displayed an increase in skipping exon 53 over baseline levels, representing a 100 percent response rate as measured by RT-PCR and demonstrating proof of mechanism. Mean dystrophin protein increased to 1.019 percent of normal compared to a mean baseline of 0.095 percent of normal as measured by Western blot, the primary biological endpoint in the study, representing a 10.7 fold increase from baseline. The study also showed a statistically significant increase in dystrophin immunofluorescence as measured by immunohistochemistry, the secondary biological endpoint in the study, confirming sarcolemma-associated protein expression and distribution. Francesco Muntoni, principal investigator for this study and Pediatric Neurologist, Great Ormond Street Hospital for Children NHS Foundation Trust and the UCL Great Ormond Street Institute of Child Health, said, "All treated boys showed the anticipated exon skipping after treatment and this resulted in a mean increase of dystrophin protein, as measured by Western blot, from 0.095 percent at baseline to 1.019 percent of normal after at least one-year of treatment with golodirsen. These data were also supported by the highly statistically significant increase of dystrophin expression at the sarcolemma, as measured by recently developed validated methodology. This is now the second exon-skipping agent to have shown a statistically significant increase in dystrophin production, validating the exon-skipping approach to treating DMD boys with amenable mutations."

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SRPT Sarepta
$41.08

-0.15 (-0.36%)

09/05/17
NOMU
09/05/17
NO CHANGE
Target $84
NOMU
Buy
Sarepta shares will start reflecting pipeline in 2018, says Nomura Instinet
Sarepta Therapeutics has indicated it will provide an update on dystrophin data from its Phase 1/2 study of SRP-4053 in patients with Duchenne muscular dystrophy amendable to skipping Exon-53 in Q4, Nomura Instinet analyst Christopher Marai tells investors in a research note. The preclinical data suggest a higher level of skipping efficiency of exon-53 relative to exon-51, "bonding well for the potential data set," the analyst contends. He expects Sarepta's gene-therapy pipeline including micro-dystrophin and GALGT2 programs will start to be reflected in the stock in 2018. The analyst views Sarepta as undervalued and keeps a Buy rating on the shares with an $84 price target.
09/04/17
SBSH
09/04/17
NO CHANGE
Target $28
SBSH
Buy
Congressman supporting approval of PTC's DMD treatment, says Citi
Citi analyst Joel Beatty found comments online from U.S. Congressman Collin Peterson that voice support for approval of PTC Therapeutics' (PTCT) Duchenne muscular dystrophy treatment ataluren, which is also known as Translarna. The document appears to have been posted last Thursday in response to the FDA's request for comments regarding its advisory panel meeting scheduled for September 28, and is written in the form of a speech to be given at the meeting, Beatty told investors Friday night in a research note. The analyst confirmed from the Congressman's office that a legislative assistant plans to read the letter on behalf of Rep. Peterson at the September 28 advisory meeting. The comments mention a constituent of Rep. Peterson's with DMD who will be in the audience and for whom "access to ataluren has allowed him to live and thrive well into his 20s with no side effects," Beatty cites the statement as saying. It added, "The full consideration of ataluren not only fulfills the Congressional intent of FDASIA and the 21st Century Cures Act, but also has the potential to save lives across the nation." Beatty believes political support could play a role in the FDA's review of Translarna. The analyst notes that Sarepta Therapeutics' DMD drug Exondys 51 was approved after favorable political support. Beatty sees $20 of upside potential in PTC shares, with only $3 downside risk, around the FDA panel meeting. The analyst has a Buy rating on the shares with a $28 price target. The stock closed Friday up 18c to $20.93. A positive panel vote will likely lead to FDA approval while a negative vote doesn't necessarily mean the FDA will not approve the drug, Beatty argues. His model assumes a 25% probability of success for Translarna.
08/17/17
JPMS
08/17/17
NO CHANGE
JPMS
JPMorgan lists top SMID Biotechnology picks following Q2 results
Analysts at JPMorgan continue think selectively remains important in the small-to-mid cap Biotechnology space. The analysts listed their favorite ideas in "five key buckets." Amicus (FOLD) is the top long-term pick, Ironwood (IRWD) is the top pick among relative underperformers, Otonomy (OTIC) is the top play for a clinical/binary event, Sarepta (SRPT) is the name to take advantage of the recent share weakness, and Ignyta (RXDX) is the "underfollowed/undervalued" favorite, according to JPMorgan's Biotech team.
07/25/17
PIPR
07/25/17
NO CHANGE
Target $50
PIPR
Overweight
Sarepta now has $620M of cash, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff estimates Sarepta Therapeutics has a pro forma cash position of $620M after issuing 7.65M shares at $42.50. The analyst reiterates an Overweight rating on the shares with a $50 price target.

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GE

General Electric

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GLPG

Galapagos NV

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BA

Boeing

$262.26

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SBLK

Star Bulk Carriers

$9.60

0.19 (2.02%)

16:53
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Earnings
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BDRBF

Bombardier

$2.43

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TSLA

Tesla

$315.05

2.55 (0.82%)

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GT

Goodyear Tire

$29.94

0.63 (2.15%)

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HMC

Honda

$32.62

0.02 (0.06%)

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PG

Procter & Gamble

$88.43

-0.82 (-0.92%)

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BHGE

Baker Hughes

$30.91

0.76 (2.52%)

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$18.21

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GE

General Electric

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CSCO

Cisco

$35.90

0.02 (0.06%)

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IBM

IBM

$148.97

-0.15 (-0.10%)

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GE

General Electric

$18.21

-0.04 (-0.22%)

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Periodicals
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GE

General Electric

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Periodicals
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TWX

Time Warner

$88.72

0.71 (0.81%)

, T

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TPIC

TPI Composites

$19.06

-0.97 (-4.84%)

07:25
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Conference/Events
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  • 05

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SYNA

Synaptics

$38.21

0.57 (1.51%)

04:55
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Conference/Events
Synaptics management to meet with KeyBanc »

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MKSI

MKS Instruments

$103.50

-0.35 (-0.34%)

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Brocade

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AVGO

Broadcom

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TCMD

Tactile Systems

$25.98

-0.23 (-0.88%)

LMOS

Lumos Networks

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WGL

WGL Holdings

$84.32

-0.14 (-0.17%)

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Earnings
WGL Holdings reports Q4 adjusted EPS (17c), consensus (19c) »

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TCMD

Tactile Systems

$25.98

-0.23 (-0.88%)

, LMOS

Lumos Networks

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Lumos Networks

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