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VYGR

Voyager Therapeutics

$21.17

-0.58 (-2.67%)

07:06
06/21/18
06/21
07:06
06/21/18
07:06

Voyager Therapeutics announces FDA RMAT designation granted for VY-AADC

Voyager Therapeutics announced that the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation for Voyager's VY-AADC gene therapy treatment for Parkinson's disease in patients with motor fluctuations that are refractory to medical management. Recently established under the 21st Century Cures Act, RMAT designation is an expedited program for the advancement and approval of regenerative medicine products, including gene therapy products. The designation includes all the benefits of the FDA's Fast Track and Breakthrough Therapy designation programs, with the ability for early interactions with the agency to discuss any surrogate or intermediate endpoints to support the potential acceleration of approval and satisfy post-approval requirements. An investigational drug or therapy is eligible for RMAT designation if it meets the definition of a "regenerative medicine therapy" as defined in the 21st Century Cures Act, it is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for such disease or condition. RMAT designation for VY-AADC was granted based on clinical data from the ongoing Phase 1b trial with VY-AADC in patients with Parkinson's disease. During this trial, one-time administrations of VY-AADC demonstrated robust and durable improvements in patients' motor function along with substantial reductions in use of daily oral levodopa and other Parkinson's disease medications. Infusions of VY-AADC have been well-tolerated in this trial with no vector-related serious adverse events reported to date.

VYGR Voyager Therapeutics
$21.17

-0.58 (-2.67%)

05/11/18
WEDB
05/11/18
UPGRADE
WEDB
Outperform
Voyager Therapeutics upgraded to Outperform from Neutral at Wedbush
05/11/18
05/11/18
UPGRADE

Outperform
Voyager Therapeutics upgraded to Outperform from Neutral at Wedbush
As previously reported, Wedbush analyst David Nierengarten upgraded Voyager Therapeutics to Outperform from Neutral, but lowered his price target on shares to $28 from $29. The analyst cited valuation, after a sell-off in the stock over the last two months cut the share price nearly in half, including a large dip in the stock on Thursday due to confusing hedging language in Voyager's 10Q filing. Nierengarten said the risk/reward is now more favorable at these levels ahead of the company's pivotal trial start for VY-AADC.
06/04/18
HCWC
06/04/18
INITIATION
Target $30
HCWC
Buy
Voyager Therapeutics initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Debjit Chattopadhyay started Voyager Therapeutics with a Buy rating and $30 price target. The company's VY-AADC is positioned to be a potentially superior alternative to deep brain stimulation, the analyst contends.
06/04/18
06/04/18
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. Ventas (VTR) initiated with a Neutral at Cantor Fitzgerald. 2. Voyager Therapeutics (VYGR) initiated with a Buy at H.C. Wainwright. 3. Wyndham Hotels & Resorts (WH) initiated with an Outperform at Oppenheimer as well as a Buy at Goldman Sachs and Stifel. 4. Five Below (FIVE) initiated with an Overweight at JPMorgan. 5. Origin Bancorp (OBNK) was initiated with a Strong Buy at Raymond James and an Overweight at Stephens. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

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