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August 11, 2014
07:07 EDTSNY, RXDXIgnyta names Adrian Senderowicz as Chief Medical Officer
Ignyta (RXDX) announced that Adrian Senderowicz, M.D., has been appointed as Chief Medical Officer and SVP, Clinical Development and Regulatory Affairs. Senderowicz was most recently Vice President, Global Regulatory Oncology at Sanofi (SNY).
News For RXDX;SNY From The Last 14 Days
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October 6, 2015
07:23 EDTSNYAmerican Society of Human Genetics to hold annual meeting
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October 5, 2015
16:12 EDTSNYRegulus to present new preclinical data on RG-012 for kidney disease
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October 2, 2015
16:32 EDTRXDXIgnyta files to sell 3M shares of common stock for holders
10:50 EDTSNYAmicus plunges after saying unlikely to submit migalastat NDA by year end
Shares of Amicus Therapeutics (FOLD) fell dramatically in morning trading after the company said it is unlikely to submit a New Drug Application for its Fabry disease treatment to the U.S. Food and Drug Administration by the end of the year. WHAT'S NEW: Amicus said this morning that it does not expect to be in the position to submit a New Drug Application for migalastat monotherapy, a treatment of Fabry disease, in the United States by the end of 2015 as a result of additional regulatory guidance from the FDA. The company said it received final FDA minutes from its September pre-NDA meeting and has had more follow-up meetings with the agency this week. Amicus said it plans to further evaluate several U.S. pathways to support submission requesting full approval, including gathering additional data. The FDA requested further integration of extant clinical data across studies, which requires more time to complete, the company said. WHAT'S NOTABLE: On September 15, Amicus Therapeutics said that, following a pre-NDA meeting with the FDA, it was still on track to submit an NDA for migalastat in the fourth quarter of 2015 under Accelerated Approval, which is only available to therapies for severe and life-threatening conditions that address "significant" unmet medical needs. In addition to the NDA submission, Amicus said it would submit for review the protocol for the Phase 4 study confirming "positive" effects of migalastat on gastrointestinal symptoms in patients. ANALYST OPINION: On September 16, Chardan analyst Gbola Amusa downgraded Amicus to Neutral from Buy, citing valuation and the stock's outperformance relative to the NASDAQ Biotechnology Index. At the time, Amusa said that Amicus' shares were near all-time highs and that he saw less scope for outperformance in the near-term. Amusa noted that, ahead of the Committee for Medicinal Products for Human Use's opinion on Amicus' Galafold, he thinks Amicus would be an "interesting" M&A target for Sanofi (SNY) and Shire (SHPG). Amusa said he sees a positive CHMP on Galafold by November or December, at which time the chances of Amicus getting acquired could increase. PRICE ACTION: Amicus Therapeutics dropped 32.07% to $9.28 in morning trading.
October 1, 2015
13:58 EDTSNYExpress Scripts hints at slow start for new cholesterol drugs
An interview with Express Scripts' (ESRX) Everett Neville hinted at slow adoption rates for a pair of new cholesterol treatments known as PCSK9 inhibitors, spurring Piper Jaffray analysts to weigh in on the matter this morning. REJECTION RATES: In a Reuters interview published Wednesday, Express Scripts VP of Pharma Strategies and Chief Trade Relations Officer Everett Neville commented that two new PCSK9 drugs would not be "budget busters" because most prescriptions for the treatments are actually being denied. Praluent from Regeneron (REGN) and Sanofi (SNY) as well as Amgen's (AMGN) Repatha were approved in recent months to treat high cholesterol, but their $14,000-plus yearly costs have come under fire, including from the Institute for Clinical and Economic Review. "We're seeing a lot of patients who either don't qualify or their physicians are not providing [necessary] information," Neville explained, indicating that use of the cholesterol treatments is coming in at the low end of expectations. ANALYST BREAKDOWN: Piper Jaffray analyst Edward Tenthoff said Neville's statements "validate" his view that PCSK9 adoption rates would be vulnerable to pushback from reimbursers like Express Scripts. Tenthoff added that he continues to see a slow launch for Regeneron's Praluent in particular, especially given the lack of cardiovascular outcomes data. Fellow Piper Jaffray analyst Joshua Schimmer took a more optimistic view, acknowledging the apparently high prescription rejection rate but arguing that the patient pool for the drugs is expected to "grow substantially" once cardiovascular data is released. PRICE ACTION: Express Scripts shares have slipped roughly 0.9% amid broader market losses, while shares of Regeneron, Sanofi, and Amgen are all showing minor declines of less than 1%.
13:00 EDTSNYAlnylam recent weakness a buying opportunity, says Piper Jaffray
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08:56 EDTSNYSanofi launches authorized generic version of Arava for arhritis
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07:01 EDTSNYGenzyme opts into ALN-AT3 Hemophilia Program
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September 30, 2015
17:34 EDTSNYExpress Scripts says many PCSK9 prescriptions denied, Reuters reports
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07:02 EDTRXDXIgnyta announces initiation of Startrk-2 Phase 2 entrectinib trial
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September 29, 2015
12:35 EDTSNYPerrigo shareholders pressure company to explore sale, Reuters says
Certain Perrigo (PRGO) shareholders have requested that company explore a sale, hoping for an alternative to Mylan's (MYL) approximately $25B hostile bid, Reuters reports, citing people familiar with the matter. The pressure represents a challenge to Perrigo's defense strategy, the report says. Some of the company's shareholders view Novartis (NVS), Sanofi (SNY), Procter & Gamble (PG), and Colgate-Palmolive (CL) as potential suitors, the report says. Reference Link
09:16 EDTRXDXLadenburg to hold a conference
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08:07 EDTSNYSanofi announces FDA accepted filing of NDA for lixisenatide
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05:16 EDTSNYSanofi announces NDA for Lixisenatide accepted for review by FDA
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September 28, 2015
09:35 EDTSNYEli Lilly and Sanofi reach settlement agreement in glargine litigation
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09:33 EDTSNYSanofi reaches patent settlement with Eli Lilly on Lantus
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07:52 EDTSNYIIR Holdings to hold a conference
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05:18 EDTSNYRegeneron and Sanofi announce of approval of Praluent in EU
Regeneron (REGN) and Sanofi (SNY) announced that the European Commission has granted marketing authorization for Praluent for the treatment of bad cholesterol, known as low-density lipoprotein cholesterol, in certain adult patients with hypercholesterolemia. Praluent is the only EC-approved PCSK9 inhibitor that is available in two starting doses as a single 1-milliter injection once every two weeks, offering two levels of efficacy. Praluent will be available in a single-dose pre-filled pen that patients self-administer. The EC approved Praluent for the treatment of adult patients with primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.
September 27, 2015
17:10 EDTRXDXIgnyta reports updated Phase 1 results on entrectinib
Ignyta announced updated interim results of its Phase 1 clinical trials of entrectinib, the company's proprietary oral tyrosine kinase inhibitor targeting solid tumors that harbor activating alterations to NTRK1, NTRK2, NTRK3, ROS1 or ALK. The clinical trials included the ALKA-372-001 study and the STARTRK-1 study, both designed to determine the maximum tolerated dose and/or recommended Phase 2 dose, as well as preliminary anti-cancer activity, of single agent entrectinib in patients with solid tumors with the relevant molecular alterations. Findings showed a total of 92 patients with a range of solid tumors had been dosed across both clinical trials, with nine patients treated at or above the RP2D beyond six months and one patient beyond one year. Entrectinib was well tolerated to date. The fixed daily dose RP2D was determined to be 600mg, taken orally once per day. Eighteen patients across both clinical trials met the company's expected Phase 2 eligibility criteria. The response rate in the 18 patients who met these criteria across both studies was 72%. Nine of these responders remain on study treatment with durable responses of up to 21 treatment cycles. An additional three patients remain on study with stable disease. The responses included three responses out of four patients with NTRK1/2/3 gene rearrangements, including patients with non-small cell lung cancer, colorectal cancer and salivary gland cancer, with one of the responding patients remaining on treatment at six months. A fourth patient with an astrocytoma remains on treatment after two months with stable disease. The responses also included six responses, including one complete response, out of eight patients with ROS1 gene rearrangements, all of which were in NSCLC. All of the patients who responded remain on treatment, the longest at 21 months. Additionally, data showed four responses out of six patients with ALK gene rearrangements, including two NSCLC patients and two patients with other solid tumors. Two of the four responders subsequently progressed.
September 25, 2015
07:22 EDTSNYEuropean Society for Medical Oncology to hold a conference
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