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ONCE

Spark Therapeutics

$59.36

1.23 (2.12%)

18:34
07/13/17
07/13
18:34
07/13/17
18:34

Spark Therapeutics: Lancet publishes Phase 3 data of voretigene neparvovec

Spark Therapeutics announced The Lancet has published Phase 3 clinical trial data of voretigene neparvovec, an investigational, potential one-time gene therapy candidate for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease. In the trial, investigational voretigene neparvovec improved functional vision, light sensitivity and visual field in study participants with RPE65-mediated IRD. A natural history study has shown that people with this IRD eventually progress to complete blindness. The publication presents the results of the Phase 3 trial, including the intent-to-treat population of all randomized subjects, through the one-year timepoint. Results showed a statistically significant and clinically meaningful difference between intervention (n=21) and control participants (n=10) at one year, per the clinical trial's primary endpoint, mean bilateral multi-luminance mobility testing change score (difference of 1.6; 95% CI, 0.72, 2.41; p=0.0013). Participants maintained functional gains observed 30 days post-administration at the one-year primary endpoint. MLMT evaluates functional vision by documenting the participants' ability to navigate a mobility course under a variety of specified light levels ranging from one lux (equivalent to, for example, a moonless summer night) to 400 lux (equivalent to, for example, an office environment). Improvements seen in MLMT were accompanied by statistically significant improvements in two secondary endpoints, including full-field light sensitivity threshold testing averaged over both eyes (p=0.0004). A third secondary endpoint, the change in visual acuity averaged over both eyes, was not statistically significant between intervention and control participants (p=0.17). An additional protocol-specified endpoint using the Goldmann III4e test stimulus to measure the visual field area of the original intervention group showed significant improvement (p=0.0059), nearly doubling at year one, while a slight decrease was observed in the control group over the same time period. No serious adverse events associated with voretigene neparvovec or deleterious immune responses were observed. Most ocular events were mild in severity with the most common ocular adverse events being transient mild ocular inflammation, transient elevated intraocular pressure, cataracts and intraoperative retinal tears. Two participants in the intervention group, one with a pre-existing complex seizure disorder and another who experienced complications from oral surgery, had SAEs unrelated to study participation.

ONCE Spark Therapeutics
$59.36

1.23 (2.12%)

07/11/17
JEFF
07/11/17
NO CHANGE
JEFF
Jefferies fundamentally positive on Biotechnology, lists top picks
Jefferies analyst Michael Yee rolled out coverage of 12 Biotechnology names in a 550 page research report. The analyst is "fundamentally positive" on the sector, believing investor interest in large-caps will pick up "as the road to repair slowly continues." He believes the smid-cap space is "becoming a good stock-pickers' market." Yee's top picks in Biotech space include Celgene (CELG), Vertex (VRTX), Spark Therapeutics (ONCE), Prothena (PRTA) and Intercept (ICPT). The analyst's best picks in the smid-cap space are Spark, Prothena, Intercept and FibroGen (FGEN).
07/10/17
JEFF
07/10/17
INITIATION
Target $85
JEFF
Buy
Spark Therapeutics initiated with a Buy at Jefferies
Jefferies analyst Michael Yee initiated Spark Therapeutics with a Buy and an $85 price target.
07/07/17
BMOC
07/07/17
NO CHANGE
BMOC
BMO previews hemophilia space ahead of BioMarin update
BMO Capital analyst Ian Somaiya says BioMarin (BMRN) on July 11 will provide updated data in three of six patients from the ongoing BMN270 Hemophilia A study. He believes peak FVIII levels between 50%-90% of normal, not 50%-150%, represent a best case scenario. The analyst's deep-dive into hemophilia implies that Spark Therapeutics' (ONCE) SPK-8011 data should be more similar than different relative to BMN270. The analyst, however, views BMN270 as a "must-have" for BioMarin while SPK-8011 is "mostly a source of upside" for Once. Somaiya thinks potential volatility in BioMarin shares next week could provide an opportunity ahead of the likely "me-too" data for SPK-8011.
06/29/17
RHCO
06/29/17
NO CHANGE
RHCO
Expert upbeat on Spark Therapeutics hemophilia drug, says SunTrust
After speaking with a hemophilia expert, SunTrust analyst Edward Nash reports that the expert is upbeat on Spark's hemopihlia treatment, SPK-9001. Specifically, the expert says that the drug achieves "high FIX levels using a low dose," Nash reported. The expert adds that he does not believe that the drug's use of Padua raises any safety concerns, noted Nash. The analyst says that " SPK-9001 appears to be the most promising gene therapy program for the treatment of hemophilia B." He keeps a Buy rating on Spark.

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