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April 28, 2014
04:55 EDTALDR, ALDR, ALDR, ALDR, ALDR, ALDR, CNDO, CNDO, CNDO, CNDO, CNDO, CNDO, ISIS, ISIS, ISIS, ISIS, ISIS, ISIS, PTCT, PTCT, PTCT, PTCT, PTCT, PTCT, OPXA, OPXA, OPXA, OPXA, OPXA, OPXA, SRPT, SRPT, SRPT, SRPT, SRPT, SRPT, XNPT, XNPT, XNPT, XNPT, XNPT, XNPT, SNY, SNY, SNY, SNY, SNY, SNY, BIIB, BIIB, BIIB, BIIB, BIIB, BIIB, SYN, SYN, SYN, SYN, SYN, SYN, CYTK, CYTK, CYTK, CYTK, CYTK, CYTKAmerican Academy of Neurology to hold annual meeting
66th Annual Meeting of the AAN is being held in Philadelphia on April 26-May 3.
News For CYTK;SYN;BIIB;SNY;XNPT;SRPT;OPXA;PTCT;ISIS;CNDO;ALDR From The Last 14 Days
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September 11, 2014
05:27 EDTSNYGenzyme announces positive interim results from Lemtrada extension study
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September 10, 2014
07:09 EDTSNY, SYNAmericas Committee for Treatment & Research in MS to hold a meeting
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September 9, 2014
08:40 EDTXNPTXenoPort, NIAAA to conduct clincial trial of Horizant ER tablets
XenoPort and the National Institute on Alcohol Abuse and Alcoholism have entered into an agreement to conduct a clinical trial of HORIZANT Extended-Release Tablets as a potential treatment for alcohol use disorder. Under the terms of the agreement, XenoPort will supply clinical trial material and the NIAAA will conduct and pay all other expenses associated with the proposed clinical trial of HORIZANT. XenoPort will have access to study results generated under the proposed clinical trial to support potential regulatory filings for HORIZANT. The study is planned to be a randomized, double-blind, placebo-controlled clinical trial of the safety and efficacy of HORIZANT in patients who have AUD but are abstinent at treatment initiation. The study is expected to have a treatment period of six months and to enroll approximately 350 patients beginning in the first half of 2015. XenoPort and the NIAAA are planning to meet with the U.S. Food and Drug Administration Division of Anesthesia, Analgesia and Addiction Products in the fourth quarter of 2014 to discuss the trial design and the possibility of utilizing the results of this trial as the basis for a potential supplemental new drug application submission for HORIZANT for the maintenance of abstinence from heavy drinking of alcohol in patients with AUD.
08:07 EDTPTCTPTC Therapeutics completes enrollment of Phase 3 trial of Translarna
PTC Therapeutics announced that it has completed enrollment of ACT DMD, the Phase 3 confirmatory trial of Translarna, or ataluren, for patients with nonsense mutation Duchenne muscular dystrophy, or nmDMD. Top-line data from the trial is expected in the second half of 2015 and will support further approvals globally, following European approval received earlier this year.
September 8, 2014
14:16 EDTSNYSanofi announces FDA approval of Menactra vaccine
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09:27 EDTBIIBLeerink biotech analyst holds a luncheon meeting with a conference call
Biotech Analyst Schwartz provides an update on key trends and controversies for marketed MS therapies and discusses new data presented at ACTRIMS-ECTRIMS at a Luncheon Meeting with an Analyst/Industry conference call to be held in Boston on September 11 at 12:15 pm.
07:30 EDTOPXAOpexa Therapeutics to target NMO as next development program
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07:15 EDTBIIBIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
September 7, 2014
17:11 EDTSYNSynthetic Biologics highlights new data from C. difficile program
Synthetic Biologics announced preclinical data that further validate the company's novel approach to preventing Clostridium difficile,C. difficile. The U.S. Centers for Disease Control has identified C. difficile as an "urgent public health threat," and it has surpassed MRSA as the number one hospital-acquired infection in the United States. The data were highlighted on September 6 at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy, ICAAC, in Washington, D.C.
September 4, 2014
13:17 EDTSRPTSarepta rises after FDA seeks comment on proposed DMD drug guidance
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12:54 EDTSRPTSarepta strength attributed to circulation of DMD guidance document
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September 3, 2014
12:49 EDTSNYSanofi reports Dengue vaccine candidate achieves its phase 3 primary endpoint
Sanofi Pasteur, the vaccines division of Sanofi, announced that the final landmark phase 3 efficacy study of its dengue vaccine candidate in Latin America successfully achieved its primary clinical endpoint. Results showed an overall significant reduction of 60.8% of dengue disease cases in children and adolescents 9-16 years old after a three-dose vaccination schedule. Importantly, efficacy was observed against each of the four dengue serotypes. Additional observations of the results showed a clinically important reduction by 80.3% in the risk of hospitalization due to dengue during the study. The results also showed in the study population an efficacy against dengue haemorrhagic fever, the severe form of dengue, which is consistent with the results released from Sanofiís phase 3 dengue study in Asia. Lastly, the results suggest better protection in case of prior exposure to dengue.
September 2, 2014
20:26 EDTSNYSanofi has a conference call hosted by JPMorgan
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19:28 EDTISISIsis Pharmaceutical licensing partner Antisense reports ATL1103 phase II results
Antisense Therapeutics, or ANP, reported the primary efficacy results from its phase II clinical trial of ATL1103 in patients with the potentially life threatening growth disorder, acromegaly. The phase II trial met its primary efficacy endpoint showing a statistically significant average reduction in the serum insulin-like growth factor-I, or sIGF-1, levels of 26% from baseline at week 14 at the 400mg per week dose tested. All patients treated with 400mg per week of ATL1103 had a reduction in sIGF-I levels from baseline at week 14. Greater reductions in sIGF-I were observed in patients who had lower body weights and thereby received a relatively higher dose per kg bodyweight with the patients who received 5.5 mg/kg per week showing a 36% average reduction in their sIGF-I levels. The positive results achieved in this Phase II trial position ATL1103 to move into Phase III stage of development. Consequently, ANP will accelerate out-licencing activities to secure a pharmaceutical development partner for the drug's further development. ANP has 4 products in its development pipeline that it has in-licensed from Isis Pharmaceuticals, including ATL1103.
13:58 EDTSNYRegeneron expected to receive priority review at Piper Jaffray
Piper Jaffray expects Regeneron (REGN) and Sanofi (SNY) will receive priority review for alirocumab via the priority review voucher recently acquired from BioMarin (BMRN). Piper says potential approval of the drug is likely by mid-2015 and it reiterates an Overweight rating on Regeneron with a $382 price target.
08:35 EDTSNYIntrexon enters into ECC with Sanofi subsidiary to develop APIs
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07:36 EDTSYNSynthetic Biologics announces positive results from study of SYN-004
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07:25 EDTALDRAlder Biopharmaceuticals to host conference call
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07:21 EDTSNYRegeneron data positive, says RBC Capital
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07:10 EDTALDRAlder Biopharmaceuticals regains worldwide rights to clazakizumab
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