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ONCE

Spark Therapeutics

$64.38

0.6 (0.94%)

, PFE

Pfizer

$34.42

0.3 (0.88%)

16:30
03/01/17
03/01
16:30
03/01/17
16:30

Spark and Pfizer say SPK-9001 granted access to PRIME program by EMA

Spark Therapeutics (ONCE) and Pfizer (PFE) announced that SPK-9001, the lead investigational candidate in the companies' SPK-FIX program has been granted support through the European Medicines Agency, EMA, PRIority MEdicines, PRIME, program. According to the EMA, PRIME is intended to enhance support for new treatments in development "that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. "We are pleased that investigational SPK-9001 has been granted access to the PRIME program, which potentially will help accelerate the delivery of this potential gene therapy to European patients living with hemophilia B," said Jeffrey D. Marrazzo, chief executive officer of Spark Therapeutics. "We appreciate the EMA's dedication to moving treatments forward for patients who are underserved with current options, and we look forward to our continued collaboration on SPK-9001." SPK-9001 is an experimental treatment for hemophilia B that is currently being investigated in an ongoing Phase 1/2 trial as a potential single-dose therapy. The PRIME program provides enhanced interaction and early dialogue with developers of promising medicines, which is intended to optimize development plans and speed up evaluation so these medicines can reach patients earlier.

ONCE

Spark Therapeutics

$64.38

0.6 (0.94%)

PFE

Pfizer

$34.42

0.3 (0.88%)

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ONCE Spark Therapeutics
$64.38

0.6 (0.94%)

12/05/16
RHCO
12/05/16
NO CHANGE
RHCO
Spark may be pressured but outlook still positive, says SunTrust
SunTrust analyst Edward Nash believes that Spark Therapeutics' stock "may be pressured" after a second patient experienced an immune response after taking its SPK-9001 drug. However, Nash says that, "both cases have been effectively managed and...neither has had a significant negative impact on the treatment benefit." He remains upbeat on SPK-9001's outlook and reiterates his $72 price target and Buy rating on the shares.
12/20/16
BMOC
12/20/16
INITIATION
BMOC
Outperform
Spark Therapeutics initiated at BMO Capital
As noted earlier, BMO Capital started coverage of Spark with an Outperform rating and a $69 price target. Analyst Matthew Luchini says that approval of Spark's voretigene neparvovec for rare eye disease "could transform the treatment of rare eye disease." The analyst is also upbeat on the company's treatment for hemophilia A, its treatment for hemophilia B, and its treatment for another rare eye disease, choroidermia. Data for hemphilia A and the choroidermia treatment should be announced by the middle of 23017, according to the analyst.
02/09/17
LEER
02/09/17
INITIATION
Target $85
LEER
Outperform
Spark Therapeutics initiated with an Outperform at Leerink
Leerink analyst Joseph Schwartz started Spark Therapeutics with an Outperform rating and $85 price target. The stock deserves a premium valuation given the company's "deep gene therapy expertise," Schwartz tells investors in a research note.
02/09/17
02/09/17
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Ulta Beauty (ULTA) initiated with a Hold at Loop Capital. 2. Spark Therapeutics (ONCE) initiated with an Outperform at Leerink. 3. GTT Communications (GTT) initiated with a Buy at BTIG. 4. Westlake Chemical (WLK) initiated with a Buy at Citi. 5. Bio-Techne (TECH) initiated with a Buy at Citi. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
PFE Pfizer
$34.42

0.3 (0.88%)

02/15/17
DBAB
02/15/17
NO CHANGE
DBAB
Deutsche not seeing Pfizer buying Bristol-Myers at this time
Following yesterday's speculation of a potential deal, Deutsche Bank analyst Gregg Gilbert said he would be surprised to see Pfizer (PFE) make a move on Bristol-Myers Squibb (BMY) at this stage. Such an acquisition "would represent a very large and concentrated opportunity/risk on immuno-oncology, an area fraught with near-term uncertainty," Gilbert told investors last night in a research note. He believes that if Pfizer were to use $90B for a deal, it would prefer to acquire a more diverse set of value drivers. The analyst keeps a Hold rating on Bristol and Buy rating on Pfizer. Bristol shares rose 3% yesterday to $53.71 amid speculation of a potential takeover. The conjecture had Roche (RHHBY), Novartis (NVS) and Pfizer potentially looking into a bid for Bristol.
02/21/17
OPCO
02/21/17
NO CHANGE
OPCO
Outperform
Momenta, Sandoz partner warning letter a modest positive for Teva, says Oppenheimer
Oppenheimer analyst Derek Archila notes that Momenta (MNTA)/Sandoz announced their contract fill/finish manufacturing partner Pfizer (PFE) received an FDA warning letter for its facility that is part of the companies' Copaxone supply chain. While they stated it will not impact the generic Copaxone 20mg product, the warning letter will have to be resolved ahead of an approval of their 40mg application, the analyst says. Archila continues to view Momenta/Sandoz's generic Copaxone 40mg as the most likely to reach the market in the near-term. The news is a modest positive for Teva (TEVA), but there remains risk of a generic 40mg approval from other generic filers, he adds. Archila reiterates an Outperform rating on Teva's shares.
02/21/17
FBCO
02/21/17
NO CHANGE
Target $42
FBCO
Outperform
Glatopa 40mg delay a 'surprising positive' for Teva, says Credit Suisse
Credit Suisse analyst Vamil Divan says the news that Pfizer (PFE) has received a warning letter at a plant that is involved with the production of Sandoz and Momenta's (MNTA) Glatopa products is a surprising positive for Teva (TEVA), noting that he has viewed Sandoz and Momenta as most likely to have the first generic Copaxone 40mg on the market. The analyst reiterated an Outperform rating on Teva's stock, and raised his price target on the shares to $42 from $41.
02/21/17
LEER
02/21/17
NO CHANGE
LEER
Outperform
Warning letter raises concerns on Momenta Copaxone catalyst, says Leerink
Leerink analyst Jason Gerberry notes that Momenta (MNTA) disclosed that its generic Copaxone 40mg ANDA will be delayed by an FDA warning letter at its fill-finish manufacturing partner, Pfizer (PFE). The analyst says that while a short delay to Momenta/Novartis' (NVS) g-Copaxone 40mg is not reason for concern, longer delays could diminish the market opportunity as there are four other generic challengers, but none have been able to prove bioequivalence to Teva's (TEVA) lower strength. He reiterates an Outperform rating on Momenta's shares.

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