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ONCE

Spark Therapeutics

$77.63

3.84 (5.20%)

07:38
08/07/18
08/07
07:38
08/07/18
07:38

Spark says Phase 1/2 data for SPK-8011 shows a 97% reduction in ABR

As of the July 13, 2018, data cutoff, 12 participants in the Phase 1/2 trial have received a single administration of investigational SPK-8011, including two at a dose of 5x1011 vector genomes /kg body weight, three at a dose of 1x1012 vg/kg and seven at a dose of 2x1012 vg/kg. Across all participants, at all three doses, beginning four weeks after vector infusion, there has been a 97-percent reduction in annualized bleeding rate and a 97-percent reduction in annualized infusion rate. The first two trial participants, who have been followed for greater than one year, have shown stable FVIII activity levels since reaching plateau for up to 66 weeks, with follow up ongoing. Additionally, there is evidence of a dose-dependent increase in mean FVIII activity levels across the three dose cohorts. Five of the participants in the 2x1012 vg/kg cohort have FVIII activity levels between 16 and 49 percent, with follow-up ranging from 12 to 30 weeks. The mean FVIII activity for these five participants is 30 percent, based on average FVIII levels post-12 weeks after vector infusion. These five participants have reduced their overall ABR by 100 percent and reduced their overall AIR by 100 percent. The other two participants in the 2x1012 vg/kg cohort had an immune response that caused their FVIII levels to decline to less than 5 percent. Clinically, both participants have moved from prophylactic to on-demand treatment and have seen meaningful reductions in their bleeding and infusion rates. One of these participants did not rapidly respond to oral steroids and he elected to be admitted to the hospital to receive two intravenous methylprednisolone infusions rather than have the infusions on an outpatient basis. The event was subsequently resolved. The admission to hospital for these infusions met the criteria for a serious adverse event. Of note, across the study, seven of the 12 participants received a tapering course of oral steroids in response to an alanine aminotransferase elevation above patient baseline, declining FVIII levels and/or positive IFN-g enzyme-linked immunospots. For these seven participants, steroids led to normalization of ALT and ELISPOTs. For all but the two above mentioned 2x1012 vg/kg cohort participants, oral steroids led to stabilization of target FVIII levels. Based on the totality of the results to date, Spark Therapeutics intends to initiate a Phase 3 run-in study in the fourth quarter of 2018. Following completion of the run-in study, Phase 3 participants are expected to receive 2x1012 vg/kg of SPK-8011. Additional details on the Phase 3 trial design will be determined following continued discussions with FDA and EMA, which are expected in the fourth quarter. Finally, the company has successfully scaled-up its mammalian-based manufacturing process in suspension to a capacity level of 200 liters and amended its agreement with Brammer Bio to secure a dedicated manufacturing suite, both of which will enable Spark Therapeutics to meet supply needs for Phase 3 clinical development as well as expected commercial requirements.

  • 07

    Aug

  • 10

    Sep

ONCE Spark Therapeutics
$77.63

3.84 (5.20%)

07/16/18
CANT
07/16/18
NO CHANGE
Target $103
CANT
Overweight
Start of Pfizer trial encouraging for Spark Therapeutics, says Cantor Fitzgerald
After Spark Therapeutics (ONCE) announced that partner Pfizer (PFE) initiated a Phase 3 study to evaluate the efficacy and safety of current factor IX prophylaxis replacement therapy in the usual care setting, Cantor Fitzgerald analyst Elemer Piros said he was encouraged that the program transfer is on track and he remains bullish on the fidanacogene elaparvovec program. He reiterates his Overweight rating and $103 price target on Spark shares.
07/19/18
RBCM
07/19/18
DOWNGRADE
RBCM
Sector Perform
Spark Therapeutics downgraded to Sector Perform from Outperform at RBC Capital
07/19/18
RBCM
07/19/18
DOWNGRADE
Target $75
RBCM
Sector Perform
Spark Therapeutics cut to Sector Perform at RBC Capital on SPK-801 concern
As reported earlier, RBC Capital analyst Kennen MacKay downgraded Spark Therapeutics to Sector Perform from Outperform and kept his $75 price target. The analyst notes that after a strong run-up in the stock price driven by lofty expectations for the ongoing Phase 1/2 trial of SPK-8011 in patients with hemophilia, achieving mean FVIII expression levels of 30-55% anticipated by the Street could prove "challenging" as "data to date has not indicated clear dose responsiveness." McKay also cites the possibility of regulatory delays to gain approval for sale of Luxturna among the risks for Spark Therapeutics.
07/19/18
07/19/18
DOWNGRADE

On The Fly: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Tesla (TSLA) downgraded to Underperform from Hold at Needham with analyst Rajvindra Gill saying the stock remains overvalued in spite of its 16% decline from the the June 2017 peak. 2. Procter & Gamble (PG) downgraded to Neutral from Buy at UBS with analyst Steven Strycula saying the company's reinvestment cycle limits earnings and stock upside. 3. Terex (TEX) downgraded to Market Perform from Outperform at Wells Fargo with analyst Andrew Casey saying his crane check was good but not great, with demand appearing to sequentially flatten. 4. Spark Therapeutics (ONCE) downgraded to Sector Perform from Outperform at RBC Capital with analyst Kennen MacKay saying that after a strong run-up in the stock price driven by lofty expectations for the ongoing Phase 1/2 trial of SPK-8011 in patients with hemophilia, achieving mean FVIII expression levels of 30-55% anticipated by the Street could prove "challenging" as "data to date has not indicated clear dose responsiveness." 5. Hyatt (H) downgraded to Hold from Buy at Berenberg with analyst El Kassir saying Hyatt continues to benchmark well on its pipeline, however, there is little scope for future growth to accelerate from current levels. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

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