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June 23, 2014
ROTH Healthcare Corporate Access Day to be held in London, England on June 23-24.
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December 18, 2014
07:05 EDTCRISCuris doses first patient in CUDC-907 Phase 1 trial
Curis announced that the first patient has initiated treatment with CUDC-907 in a Phase 1 clinical trial in patients with advanced or relapsed solid tumors, including hormone receptor positive/ HER2-negative breast cancer or midline carcinoma with certain NUT gene rearrangements. CUDC-907 is an oral, dual inhibitor of histone deacetylase, or HDAC, and phosphoinositide 3-kinase, or PI3K, enzymes that is currently under investigation in the first-in-human Phase 1 clinical study in patients with relapsed or refractory lymphomas and multiple myeloma.
06:35 EDTPTCTPTC Therapeutics initiated with a Buy at Citigroup
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December 16, 2014
17:05 EDTACRXAcelRx enters into separation agreement with CEO Richard King
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07:30 EDTACRXGuggenheim to hold a conference
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07:06 EDTBLRXBioLineRx and Novartis enter into strategic collaboration agreement
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07:04 EDTNEONeoGenomics enters research agreement with Lurie Cancer Center and NMDTI
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December 15, 2014
18:30 EDTPRTAOn The Fly: After Hours Movers
UP AFTER EARNINGS: VeriFone Systems (PAY), up 1.5%. ALSO HIGHER: Prothena (PRTA), up 10.7% after receiving FDA fast track designation for NEOD001... Boeing (BA), up 2.3% after increasing dividend by 25% and authorizing a $12B share repurchase plan... Yamana Gold (AUY), up 4.6% after reporting new discoveries at Chapada, El Penon. LOWER: Abraxas Petroleum (AXAS), down 2% after reporting fourth quarter volume guidance and fiscal 2015 production guidance.
16:09 EDTPRTAProthena receives FDA fast track designation for NEOD001
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09:18 EDTBLRXBioLineRx price target raised to $10.50 from $8 at Roth Capital
Roth Capital raised its price target on BioLineRx as the firm thinks the company showed the ability of its BL-8040 drug to affect the tumor microenvironment and regulate the apoptosis of tumor cells during its Investor Day. The firm keeps a Buy rating on the shares.
December 12, 2014
12:02 EDTPTCTPTC Therapeutics Translarna granted orphan drug designation
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07:06 EDTBLRXBioLineRx says trials in three added BL-8040 indications to be initiated in 2015
BioLineRx will disclose its multi-year development plan for BL-8040, a unique platform for the treatment of hematological cancers. The main development program for BL-8040 relates to acute myeloid leukemia. BL-8040 is currently undergoing a Phase 2a clinical trial for the treatment of relapsed or refractory AML. Positive data from the dose-escalation stage of the study, which was recently presented at the 2014 ASH Conference, has shown substantial mobilization of AML cancer cells from the bone marrow to the peripheral blood and robust apoptosis of these cells, as well as an excellent safety and tolerability profile. The dose-escalation stage of the study is expected to be completed in early 2015, while the full study results from both the dose- escalation and dose-expansion stages of the study are expected in the second half of 2015. Targeting a second AML treatment line, BL-8040 is scheduled to commence a Phase 2b trial, as a consolidation treatment for AML patients who have responded to standard induction treatment, in the first quarter of 2015. The trial will be conducted in collaboration with the German Study Alliance Leukemia Group. The trial aims to improve the response of AML patients to the second stage of AML treatment, termed consolidation therapy, by eliminating the minimal residual disease left in the bone marrow after the first stage of the standard treatment regimen, called induction therapy. BL-8040 will also target a third population of AML patients, and is scheduled to commence a Phase 1/2 trial, for the treatment of AML patients with the FLT3-ITD mutation, in the first quarter of 2015.
December 11, 2014
11:23 EDTBLRXBioLineRx to host investor and analyst breakfast meeting
Investor and Analyst Breakfast Meeting to present the company's 2015 clinical development strategy for BL-8040 will be held in New York on December 12 at 8 am. Webcast Link
08:40 EDTGALEGalena presents HER2 screening data results from NeuVax Phase 3 clinical trial
Galena Biopharma announced that initial immunohistochemistry, or IHC, screening data from the NeuVax Phase 3 PRESENT, or Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment, trial was presented at the 2014 San Antonio Breast Cancer Symposium, or SABCS. The poster, entitled, "HER2 Discordant Results in Local vs. Central Testing in the Phase 3 Nelipepimut-S Trial and Implementation of Leica Bond Oracle HER2 Immunohistochemistry System for Low and Intermediate Levels of HER2 Protein Expression as a Companion Diagnostic," demonstrated that with the implementation of the Leica Bond Oracle HER2 IHC assay, preliminary limited data indicated additional patients met HER2 eligibility for PRESENT and the assay identified more precisely patients at HER2 1+ and 2+. As part of the PRESENT trial, Galena has implemented central laboratory testing for all potential patients to confirm validated and robust entry criteria, and ensure the enrollment of the targeted patient population. To improve accuracy and specificity for the HER2 1+ and 2+ status testing, and develop a companion diagnostic for NeuVax, the Leica Bond Oracle HER2 IHC system has been incorporated as central HER2 IHC screening for the PRESENT study.
December 10, 2014
08:04 EDTACRXRoth Capital to hold an event
Corporate Access Event 2014 is being held in Park City, Utah on December 10-12.
December 9, 2014
12:15 EDTPTCTPTC Therapeutics mentioned positively by dealReporter
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December 8, 2014
09:20 EDTGALE, BLRXOn The Fly: Pre-market Movers
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07:08 EDTGALEGalena GALE-401 Phase 1 results show reduced platelet counts, tolerable safety
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07:06 EDTBLRXBioLineRx reports data from ongoing Phase 2a study of BL-8040
BioLineRx Ltd. announced that data from the on-going Phase 2a clinical trial of BL-8040 for the treatment of patients with relapsed or refractory acute myeloid leukemia were reported at the American Society of Hematology meeting, held on December 6-9, 2014, in San Francisco. Results reported to date in the dose-escalation stage of the Phase 2a study show that, even at the highest dose reached to date, there were no dose-limiting toxicity events or serious adverse events, nor early discontinuations attributable to BL-8040. Furthermore, BL-8040 triggered substantial mobilization of AML cancer cells from the bone marrow to the peripheral blood, with a median 6-fold increase of AML cells in the blood. This mobilization is crucial for exposing a higher ratio of AML cells to accompanying chemotherapy such as Ara-C. Additional results show that after only two days of BL-8040 monotherapy, there was a median decrease of approximately 70% in the amount of AML cells in the bone marrow, while the levels of normal progenitor cells remained stable. Furthermore, BL-8040 as a monotherapy showed a 3.5-fold increase in cell death of AML cells, both in the bone marrow and in peripheral blood samples.
December 5, 2014
10:00 EDTPRTAOn The Fly: Analyst Downgrade Summary
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06:34 EDTPRTAProthena downgraded to Underperform from Neutral at BofA/Merrill
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