Pre-Open Movers 11/06: (TXMD) (VBLT) (CAVM) Higher; (S) (TMUS) (VZ) Lower (more...)
TherapeuticsMD, Inc. (NASDAQ: TXMD) 33.7% HIGHER; announced a regulatory update regarding the New Drug Application (NDA) for TX-004HR, the Company’s investigational applicator-free estradiol vaginal softgel capsule for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. On November 3, 2017, the Company participated in an in-person meeting with the Division of Bone, Reproductive, and Urologic Products of the Food and Drug Administration (FDA). At the meeting, the Division agreed to the resubmission of the NDA for TX-004HR without the need for an additional pre-approval study. The Company will commit to conduct a post-approval observational study. The Company believes it will be in a position to resubmit the NDA for TX-004HR within the coming weeks, with a potential approval of the NDA within two to six months after resubmission, depending on the classification of the review of the NDA.
VBL Therapeutics (Nasdaq: VBLT) 13% HIGHER; announces an exclusive license agreement with NanoCarrier Co., Ltd. (TSE Mothers: 4571) for the development, commercialization, and supply of ofranergene obadenovec (VB-111) in Japan. VBL Therapeutics (VBLT) retains rights to VB-111 in the rest of the world.
Cavium (NASDAQ: CAVM) 12.8% HIGHER; Marvell Technology (NASDAQ: MRVL) is in advanced talks to acquire Cavium (NASDAQ: CAVM) in a a deal that would create an entity with an enterprise value of approximately $15 billion, the Wall Street Journal reported late Friday.
Michael Kors (NYSE: KORS) 9.7% HIGHER; reported Q2 EPS of $1.33, $0.50 better than the analyst estimate of $0.83. Revenue for the quarter came in at $1.15 billion versus the consensus estimate of $1.04 billion. GUIDANCE: Michael Kors sees Q3 2018 revenue of $1.355-1.385 billion. Michael Kors sees FY2018 revenue of $4.59 billion, versus the consensus of $4.3 billion.
Marvell Technology (NASDAQ: MRVL) 7.8% HIGHER; is in advanced talks to acquire Cavium (NASDAQ: CAVM) in a a deal that would create an entity with an enterprise value of approximately $15 billion, the Wall Street Journal reported late Friday.
Qualcomm Incorporated (NASDAQ: QCOM) 5% HIGHER; Broadcom Limited (NASDAQ: AVGO) today announced a proposal to acquire all of the outstanding shares of Qualcomm Incorporated (NASDAQ: QCOM) for per share consideration of $70.00 in cash and stock.
Cree (NASDAQ: CREE) 4.8% HIGHER; Deutsche Bank initiates coverage with a Buy rating and a price target of $45.00 (from $26.00).
Teva (NASDAQ: TEVA) 4.2% HIGHER; Reports billionaire Len Blavatnik is considering taking a large stake in the company.
Horizon Pharma (NASDAQ: HZNP) 3.7% HIGHER; reported Q3 EPS of $0.26, $0.04 better than the analyst estimate of $0.22. Revenue for the quarter came in at $271.6 million versus the consensus estimate of $259.74 million.
American Outdoor Brands (NASDAQ: AOBC) 3.4% HIGHER; gains after Texas shooting
Sturm Ruger (NYSE: RGR) 3.4% HIGHER; gains after Texas shooting
Nutanix (NASDAQ: NTNX) 3.2% HIGHER; Raymond James upgraded from Market Perform to Outperform with a price target of $32.00.
Verizon (NYSE: VZ) 2.4% LOWER; Sprint and T-Mobile call off merger