09.03.2017 01:50:08
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Gainers & Losers Of Mar.8: GBT, CYCC, GNMX, MGCD, TRVN...
(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of March 8, 2017.
GAINERS
1. Global Blood Therapeutics Inc. (GBT)
Gained 21.02% to close Wednesday's (March 8) trading at $34.25.
News: No news
Recent event:
On Feb.27, 2017, the company announced the closing of its previously announced underwritten public offering of 5.86 million shares of its common stock at a price to the public of $24.50 per share.
Near-term catalysts:
-- Global Blood's lead product candidate is GBT440, which is under a phase III trial in people with sickle cell disease. The study, dubbed HOPE, is expected to enroll up to 400 adults and adolescents with SCD who have had at least one episode of vaso-occlusive crisis (VOC) in the previous year. Top-line data from the HOPE study are anticipated in the first half of 2019. -- GBT440 is also being explored as a potential treatment for acute and chronic hypoxemic pulmonary disorders. A phase IIa trial of GBT440 for the treatment of hypoxemia in patients with idiopathic pulmonary fibrosis (IPF) who are on supplemental oxygen at rest, initiated last November, is underway. This study, known as ZEPHYR, is designed to enroll a total of 16 IPF patients, 45 to 80 years of age - with data expected to be announced in the second half of this year. -- Another phase IIa trial evaluating the effect of GBT440 in adults with idiopathic pulmonary fibrosis (IPF) and hypoxemia, initiated last June, is also ongoing - with trial results expected in the second half of this year.
2. MYOS RENS Technology Inc. (MYOS)
Gained 19.64% to close Wednesday's trading at $3.35.
News: No news
MYOS RENS is the developer of muscle-health ingredient Fortetropin, the first clinically-proven, all natural myostatin-reducing agent. Fortetropin is the active ingredient in Re Muscle Health, a line of non-GMO protein bars, shakes, pudding mixes and powders that was launched by the company in March 2015.
Recent event:
On March 1, 2017, the company announced the upcoming launch of Qurr, its Fortetropin-powered product line formulated to support the vital role of muscle in overall well-being as well as in fitness.
According to the company, the Qurr family of products will initially consist of 1) Qurr Well, to help support healthy aging by increasing lean muscle, 2) Qurr Toned, for promoting healthy muscle which can lead to a beautiful lean and toned body, and 3) Qurr Strong, for athletes and anyone seeking to grow lean muscle as a part of their training and/or workout regimen.
3. Cyclacel Pharmaceuticals Inc. (CYCC)
Gained 15.37% to close Wednesday's trading at $4.58.
News: An article in the Journal of National Cancer Institute, a peer-reviewed journal, features Cyclacel's CYC065, a second-generation, clinical stage, CDK2/9 inhibitor, and CCT68127, a pre-clinical stage CDK2/9 inhibitor.
The article states that the compounds demonstrated prominent antitumor activity against lung cancer through anaphase catastrophe, a novel, cancer specific mechanism of action.
CYC065, is being evaluated in an ongoing, first-in-human, phase I trial in patients with advanced solid tumors.
4. Puma Biotechnology Inc. (PBYI)
Gained 13.20% to close Wednesday's trading at $40.30.
News: No news
Near-term catalysts
-- Report additional data from phase II of Neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer, dubbed CONTROL trial, in the second quarter of 2017 -- Reporting interim data from Phase I/II trial of Neratinib plus Kadcyla in HER2-positive metastatic breast cancer (MBC) in the second quarter of 2017 -- Report data from the phase II basket trial of Neratinib in patients with HER2 non-amplified solid tumors that have a HER2 mutation, known as SUMMIT, in the second quarter of 2017. -- Report data from the Phase III trial of Neratinib in third-line HER2-positive MBC patients in the first half of 2017 -- Report data from Phase II trial of Neratinib plus capecitabine in HER2-positive MBC patients with brain metastases, known as the TBCRC-022, in the second quarter of 2017 -- Report Phase II data from the SUMMIT basket trial of Neratinib in HER2-negative breast cancer patients with HER2 mutations in the second quarter of 2017. -- Report final 5-year disease free survival data from ExteNET Phase III trial of Neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer during the second half of 2017 -- Announce regulatory decisions in the United States and European Union on Neratinib for the extended adjuvant treatment of patients with HER2-positive early stage breast cancer in the third quarter of 2017.
5. Aevi Genomic Medicine Inc. (GNMX)
Gained 10.93% to close Wednesday's trading at $5.48.
News: No news
Near-term catalyst:
The company's most-advanced product in the pipeline is AEVI-001, a first-in-class mGluR neuromodulator, which is under a phase 2/3 efficacy study in adolescent patients with ADHD (attention-deficit/hyperactivity disorder) who have genetic disorders impacting the mGluR network.
The top-line results from this study, dubbed SAGA, are expected this month.
6. Second Sight Medical Products Inc. (EYES)
Gained 10.32% to close Wednesday's trading at $1.71.
News: No news
Anticipated event: Q4 and full-year 2016 financial results to be reported on March 9, 2017, after the close of the U.S. financial markets.
LOSERS
1. MGC Diagnostics Corp. (MGCD)
Lost 20.35% to close Wednesday's trading at $7.83.
News: Financial results for the first quarter ended January 31, 2017 reported.
Net loss for fiscal 2017 first quarter widened to $240,000 or $0.06 per share from $4,000 or $0.00 per share in the comparable year-ago quarter. First quarter fiscal 2017 revenue decreased by 6% to $8.7 million compared to $9.3 million in the prior year period.
2. InspireMD Inc. (NSPR)
Lost 15.09% to close Wednesday's trading at $1.97.
News: No news
The company's CGuard Embolic Prevention System (EPS) is designed to prevent peri-procedural and late embolization. It is CE Marked, but not approved for sale in the U.S. by the FDA.
Anticipated events:
-- Launch CGuard EPS in several leading German medical centers in the first half of 2017. -- Commence sales of CGuard EPS in Russia in the first half of this year. -- Regulatory approvals of CGuard EPS in India and Mexico where the company plans to launch sales initiatives in the second half of this year.
3. Sorrento Therapeutics Inc. (SRNE)
Lost 11.58% to close Wednesday's trading at $4.20.
News: No news
Near-term catalysts:
-- Resubmission of NDA for lead product candidate ZTlido, under 505(b)(2) regulatory pathway, is expected in mid-2017.
ZTlido is a next-generation lidocaine patch currently in development for the treatment of post-herpetic neuralgia ("PHN"), a severe neuropathic pain condition.
-- The Marketing Authorization Application for ZTlido in the European Union is also expected to be filed in mid-2017.
4. Trevena Inc. (TRVN)
Lost 11.53% to close Wednesday's trading at $3.53.
News: The Company reported financial results for the fourth quarter and full year ended December 31, 2016.
For the fourth quarter of 2016, Trevena reported a net loss attributable to common stockholders of $36.1 million or $0.67 per share on nil revenue. This compared with a net loss attributable to common stockholders of $15.5 million or $0.30 per share and collaboration revenue of $1.87 million in the year-ago quarter.
Anticipated event:
Submit NDA for OLINVO for the management of moderate-to-severe acute pain in Q4, 2017.
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Aktien in diesem Artikel
Cyclacel Pharmaceuticals Inc 6 % Conv Pfd Shs | 6,75 | 4,01% | |
Puma Biotechnology Inc | 3,21 | 2,07% | |
Sorrento Therapeutics Inc | 0,00 | -22,22% |