Unusual 11 Mid-Day Movers 11/29: (GENE) (GLBS) (CBMX) Higher; (NVLS) (PZRX) (FOLD) Lower
- S&P 500, Nasdaq set records as tech, banks lead
- Texas Instruments (TXN) Tops Q4 EPS by 20c, Issues Solid Q1 Outlook
- Intuitive Surgical (ISRG) Tops Q4 EPS by 10c; $2B Accelerated Share Repurchase
- Seagate Technology (STX) Tops Q2 EPS by 30c
- After-Hours Stock Movers 01/24: (BOBE) (STX) (WDC) Higher; (NEWT) (MRCY) (CA) Lower (more...)
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Nivalis Therapeutics, Inc. (Nasdaq: NVLS) 58.1% LOWER; announced topline results from the Company's Phase 2 trial evaluating the efficacy and safety of two doses of cavosonstat, 200 mg and 400 mg, in adult patients with CF who had two copies of the F508del-CFTR mutation and were being treated with Orkambi. There were no dose limiting toxicities and cavosonstat was well tolerated at all doses in the trial. The trial failed, however, to demonstrate benefit in absolute change in percent predicted FEV1, the trial’s primary endpoint, or in sweat chloride reduction at 12 weeks.
Globus Maritime (Nasdaq: GLBS) 52.0% HIGHER; moving higher as volatility continues in the name.
CombiMatrix Corporation (Nasdaq: CBMX) 35.4% HIGHER; announces that its pre-implantation genetic screening (PGS) by next generation sequencing (NGS) test has received conditional approval from the New York State Department of Health. The CombiPGS™ test is for women undergoing in vitro fertilization (IVF) and screens embryo biopsy cells for chromosomal abnormalities prior to implantation of the embryo. The test assists in maximizing the chance of successful implantation and pregnancy progression, while decreasing the likelihood of miscarriage.
Dataram Corporation (Nasdaq: DRAM) 31.3% HIGHER; announced that it had finalized and filed the third and final amendment to its definitive agreement with U.S. Gold Corp. ("USGC"), a U.S. focused gold exploration and development company. Under the agreement, Dataram will acquire all of the outstanding shares of U.S. Gold Corp. and USGC subsidiaries. The original agreement was entered into in June 2016 and has been subsequently amended to reflect the successful capital raise by U.S. Gold, the Series D issuance by Dataram and also, the impact of the reverse split.
PhaseRx, Inc. (Nasdaq: PZRX) 22.4% LOWER; retracing following a 150 percent gain yesterday after the company announced that its lead candidate, PRX-OTC, which is being developed for the treatment of ornithine transcarbamylase deficiency (OTCD), has received orphan drug designation by the U.S. Food and Drug Administration (FDA).
Amicus Therapeutics (Nasdaq: FOLD) 21.9% LOWER; announces its planned regulatory pathway to collect additional data to support full approval for the oral precision medicine migalastat for Fabry disease. Following several collaborative discussions with the U.S. Food and Drug Administration (FDA), including the receipt of final written minutes from an in-person Type B meeting, the Company plans to collect additional data on gastrointestinal (GI) symptoms in Fabry patients who have an amenable mutation.
Novan, Inc. (Nasdaq: NOVN) 20.0% HIGHER; announced top-line results from the Company’s Phase 2 clinical trial with SB206 for the treatment of genital warts caused by human papillomavirus, or HPV. The highest dose tested, SB206 12%, demonstrated a statistically significant improvement (p<0.05) in the incidence of complete clearance of all baseline warts compared to vehicle treatment after 12 weeks in both the intent-to-treat and per-protocol analyses.
Skyline Medical Inc. (Nasdaq: SKLN) 18.7% LOWER; continuing lower following a 19 percent drop yesterday.
VBL Therapeutics (Nasdaq: VBLT) 17.0% HIGHER; announced top-line results from its exploratory Phase 2 study of VB-111 (ofranergene obadenovec) in patients with advanced, differentiated thyroid cancer.
TherapeuticsMD (NYSE: TXMD) 16.0% LOWER; highlighted as a short by Lakewood's Bozza at Robin Hood
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