Pre-Open Stock Movers 10/17: (OMER) (QSII) (GRPN) Higher; (PTCT) (SGY) (P) Lower (more...)
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PTC Therapeutics (NASDAQ: PTCT) 22.4% LOWER; announced today that at the end of last week, the Office of Drug Evaluation I (ODE-I) of the U.S. Food and Drug Administration (FDA) denied the company's first appeal of the refuse to file letter issued by the FDA's Division of Neurological Products (DNP) on February 22, 2016 regarding PTC's New Drug Application (NDA) for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).
Omeros Corporation (NASDAQ: OMER) 20.6% HIGHER; announced positive data from the companys Phase 2 clinical trial of OMS721 for the treatment of kidney disorders, none of which currently have an approved treatment and all of which frequently lead to end-stage renal disease and dialysis. Statistical significance (p 0.017) was achieved on key endpoints of improvement in renal function. Omeros also reported the outcome of a recent FDA meeting regarding breakthrough therapy designation for OMS721 in immunoglobulin A (IgA) nephropathy (also known as Bergers disease). Based on that meeting, Omeros is pursuing FDA breakthrough therapy designation. In addition to the Phase 2 program in renal diseases, OMS721 is being evaluated in a Phase 3 program for patients with atypical hemolytic uremic syndrome (aHUS) and in a Phase 2 program for patients with thrombotic microangiopathies (TMAs), including hematopoietic stem cell transplant-associated TMAs and thrombotic thrombocytopenic purpura. OMS721 is Omeros lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.
Lipocine Inc. (NASDAQ: LPCN) 9.6% HIGHER; announced the completion of a Post Action meeting with the U.S. Food and Drug Administration (“FDA”) regarding its New Drug Application (“NDA”) for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The purpose of the meeting was to review the Complete Response Letter (“CRL”) and to determine actions needed to achieve approval of LPCN 1021.
Intersect ENT, Inc. (Nasdaq: XENT) 8.4% HIGHER; announced positive results from RESOLVE II, a randomized, blinded, multi-center clinical trial designed to assess the safety and efficacy of the companys investigational RESOLVE steroid releasing implant.
Stone Energy (NYSE: SGY) 8.2% LOWER; Barclays downgraded from Equalweight to Underweight with a price target of $3.00
Quality Systems (NASDAQ: QSII) 6.5% HIGHER; to hire UBS to explore sale - DealReporter
Groupon, Inc. (NASDAQ: GRPN) 6% HIGHER; Wedbush upgraded from Neutral to Outperform with a price target of $6.50 (from $4.50)
Kite Pharma (NASDAQ: KITE) 4.9% HIGHER; CEO on CNBC, also Jefferies was said CAR-T checks shows physicians are cautiously optimistic.
SUPERVALU INC. (NYSE: SVU) 4.5% HIGHER; announced that it has entered into a definitive agreement whereby an affiliate of Onex Corporation will acquire SUPERVALUs Save-A-Lot business for $1.365 billion in cash
Hasbro (NASDAQ: HAS) 4.4% HIGHER; reported Q3 EPS of $2.03, versus the analyst estimate of $1.74. Revenue for the quarter came in at $1.68 billion versus the consensus estimate of $1.56 billion.
AMD (NASDAQ: AMD) 3.3% HIGHER; Oppenheimer upgraded from Underperform to Perform.
Pandora (NYSE: P) 3% LOWER; BofA/Merrill Lynch downgraded from Neutral to Underperform with a price target of $9.00 (from $14.00
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