Company Overview and News
GTx Inc. stock dropped as much as 94% in Friday premarket trade after the company said that enobosarm, its therapy intended for post-menopausal women with stress urinary incontinence, did not meet the primary endpoint in a phase 2 clinical trial. The double-blind and placebo-controlled trial had enrolled nearly 500 women. Enobosarm is the company's main product candidate, which it has been developing in stress urinary incontinence as well as breast cancer.
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TEL-AVIV, Israel and RALEIGH, N.C., Sept. 20, 2018 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, today announced that Mr. Dror Ben-Asher, chief executive officer of RedHill, will present a corporate overview at the Ladenburg Thalmann 2018 Healthcare Conference, on Tuesday, Oct.
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2018-09-15 seekingalpha - 4
Discussion: FibroGen's anti-CTGF antibody pamrevlumab indicated in idiopathic pulmonary fibrosis (IPF) is now under Fast Track review of the FDA. The new status allows a rolling review of the marketing application of the drug. Idiopathic pulmonary fibrosis is a chronic lung disease in which the lung functions progressively decline. The disease is the most common type of interstitial lung disease (ILD) in which interstitium (i.
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2018-09-12 globenewswire - 1
TEL-AVIV, Israel and RALEIGH, N.C., Sept. 12, 2018 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, today announced that it recently concluded a positive End-of-Phase II/Pre-Phase III (Type B) meeting with the U.S. Food and Drug Administration (FDA) discussing the clinical and regulatory pathway towards potential U.
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2018-09-07 seekingalpha - 11
Discussion: On September 4, Recro Pharma (REPH) reported positive outcome of its meeting with the FDA regarding its NDA for IV meloxicam that was rejected in last May. Based on the discussion with the FDA, the company now plans to submit a revised NDA by the end of this month. Suggestions offered by the FDA now guides the company to include revised labelling language and further information on extractable and leachable items.
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Good day and welcome to the RedHill Biopharma Second Quarter 2018 Financial Results Conference Call. At this time, I’d like to introduce the conference call RedHill's CEO, Mr. Dror Ben-Asher; Mr. Micha Ben Chorin, RedHill's CFO; Mr. Gilead Raday, RedHill's Chief Operating Officer; and Mr. Guy Goldberg, RedHill's Chief Business Officer.
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TEL-AVIV, Israel and RALEIGH, N.C., Aug. 30, 2018 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, today reported its financial results for the quarter ended June 30, 2018 and provided an update on its operations.
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RedHill Biopharma (NASDAQ:RDHL) has had a strange couple months. It had a huge run starting in May and ending in mid-July (July 17), where the stock almost doubled. The ending is critical, and confusing, because the company declared what initially appeared to be positive results from its Crohn’s disease (CD) study of RHB-104 on July 30 - note that results came out 2 weeks after the stock began its fall.
TEL-AVIV, Israel and RALEIGH, N.C., Aug. 24, 2018 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, today announced that it will report its second quarter 2018 financial results on Thursday, August 30, 2018.
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2018-08-22 seekingalpha - 2
Discussion: AC Immune’s (ACIU) anti-Abeta vaccine development program recently reached two clinical milestones. To confirm the positive results of an earlier Phase 1 study of its candidate ACI-24 a Phase 2 trial has been initiated on patients with mild Alzheimer's disease (AD). Enrollment in the Phase 1b of a high dose cohort of the same candidate indicated in adults with Down syndrome with AD-like characteristics is now complete.
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Zayo Group Holdings, Inc. (ZAYO - Free Report) is scheduled to report fourth-quarter fiscal 2018 results after the closing bell on Aug 22. In the last reported quarter, the company delivered a negative earnings surprise of 18.2%. Let’s see how things are shaping up for this announcement. Factors to Consider During the fiscal fourth quarter, Zayo acquired a data center in McLean, VA. The buyout which includes tenants, data center systems and long-term leases was primarily driven by healthy demand in the Washington, D.
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Keysight Technologies Inc. (KEYS - Free Report) is set to release third-quarter fiscal 2018 results on Aug 21. The company has delivered positive earnings surprises in three of the trailing four quarters, recording an average beat of 10.4%.
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2018-08-20 globenewswire - 1
TEL-AVIV, Israel and RALEIGH, N.C., Aug. 20, 2018 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on proprietary drugs for gastrointestinal diseases, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a new formulation patent covering RHB-106, which is expected to be valid until at least 2033.
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Pure Storage Inc. (PSTG - Free Report) is scheduled to report second-quarter fiscal 2019 earnings on Aug 21. Notably, the company beat the Zacks Consensus Estimate for earnings in the trailing four quarters, recording an average positive surprise of 53.9%. In the last reported quarter, the company delivered a positive earnings surprise of 41.7%.
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2018-10-01 - Asif
Overview The following discussion and analysis should be read in conjunction with its unaudited interim condensed consolidated financial statements and the related notes that appear elsewhere in this quarterly report on Form 10-Q. This discussion contains forward-looking statements reflecting its current expectations that involve risks and uncertainties. Actual results may differ materially from those discussed in these forward-looking statements due to a number of factors, including those set forth in the section entitled “Risk Factors” in its most recent annual report on Form 10-K. For further information regarding forward-looking statements, please refer to the “Special Note Regarding Forward-Looking Statements and Projections” immediately after the index to this quarterly report on Form 10-Q. Alimera Sciences, Inc., and its subsidiaries (we or Alimera), is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharma...
2018-09-25 - Asif
Background DelMar Pharmaceuticals, Inc. is a clinical stage drug development company with a focus on the treatment of cancer. The company's mission is to benefit patients and create shareholder value by developing and commercializing anti-cancer therapies for patients whose tumors exhibit features that make them resistant to, or unlikely to respond to, currently available therapies, particularly for orphan cancer indications where patients have failed, or are unlikely to respond to, currently available therapy. DelMar Pharmaceuticals is developing VAL-083, a novel, DNA-targeting agent, for the treatment of glioblastoma multiforme (“GBM”) and potentially other solid tumors, including ovarian cancer. VAL-083 is a first-in-class, DNA-targeting chemotherapeutic that demonstrated activity against a range of tumor types in prior Phase 1 and Phase 2 clinical studies sponsored by the US National Cancer Institute (“NCI”). The company's recent research has highlighted the opportunit...
2018-09-18 - Asif
Overview Rigel Pharmaceuticals is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. The company's pioneering research focuses on signaling pathways that are critical to disease mechanisms. The company's first FDA-approved product is TAVALISSE™ (fostamatinib disodium hexahydrate), an oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. The company's current clinical programs include Phase 2 studies of fostamatinib in autoimmune hemolytic anemia and IgA nephropathy, and a Phase 1 study for its IRAK program. In addition, Rigel Pharmaceuticals has product candidates in development with partners BerGenBio AS, Daiichi Sankyo, and Aclaris Therapeutics. Since inception, Rigel Pharmaceuticals h...
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