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February 24, 2014
09:06 EDTSNYArdelyx licenses NaP2b phosphate inhibitor program to Sanofi
Ardelyx announced that it has licensed to Sanofi its novel phosphate transport NaP2b inhibitor program,also known as NaPi2b, Npt2b and SLC34A2. Ardelyx will receive an undisclosed upfront payment from Sanofi. Total development and regulatory milestones could potentially reach up to $198M. Ardelyx would also be entitled to royalties on product sales. In addition, Ardelyx retains an option to participate in co-promotional activities for the U.S. market.
News For SNY From The Last 14 Days
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October 12, 2015
10:40 EDTSNYAnti-cholesterol drug makers react to Eli Lilly discontinuation
The shares of Eli Lilly (LLY) are falling after the company announced that it was halting development of the anti-cholesterol drug evacetrapib. The shares of Merck (MRK), which is developing a drug in the same class, are also falling. Regeneron (REGN) and Amgen (AMGN), whose recently approved drugs would have competed with evacetrapib but work differently, are rising. Also advancing is Esperion Technologies (ESPR), which is working on developing yet another type of anti-cholesterol drug. WHAT'S NEW: Eli Lilly announced that it was discontinuing development of its evacetrapib drug due to lack of efficacy in a clinical trial. Evacetrapib was supposed to increase high-density, "good" lipoprotein cholesterol, or HDL, and lower low-density lipoprotein, or LDL, cholesterol by manipulating the cholesterylester transfer protein, or CETP. Merck is developing anacetrapib, which also is supposed to lower LDL by manipulating CETP. In July, the FDA approved Praluent, Regeneron and Sanofi's (SNY) drug that lowers LDL by targeting a specific protein called PCSK9. The FDA approved Amgen's Repatha, which also lowers LDL by targeting PCSK9, in August. Esperion's ETC-1002, which penetrates the liver, has been shown in studies to reduce LDL when used in combination with statins, but the drug has not yet been approved by the FDA. PRICE ACTION: In morning trading, Eli Lilly sank 7.7% to $79.54, Merck fell 1.7% to $50, Regeneron gained 3.2% to $520, Amgen rose 1.5% to $151.80 and Esperion advanced 4.3% to $26 per share.
09:47 EDTSNYLilly discontinuation removes overhang on PCSK9 launches, says Piper Jaffray
Piper Jaffray analyst Joshua Schimmer thinks that Eli Lilly (LLY) discontinuing development of its CETP inhibitor evacetrapib removes an overhang on the ongoing PCSK9 launches from Amgen (AMGN) and Regeneron (REGN) and Sanofi (SNY). Additionally, Schimmer thinks the failure of evacetrapib to show efficacy is likely mechanism specific and doesn't affect the chances of success for the ongoing PCSK9 cardiovascular outcomes studies. The analyst has an Overweight rating and $200 price target on Amgen shares.
October 8, 2015
05:22 EDTSNYGenzyme reports positive 5-year investigational data from Lemtrada study
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October 7, 2015
07:36 EDTSNYInfectious Diseases Society of America to hold a conference
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07:23 EDTSNYEuropean Committee Treatment & Research in Multiple Sclerosis holds meeting
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05:37 EDTSNYGenzyme announces data demonstrate Aubagio slowed brain volume loss
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October 6, 2015
18:48 EDTSNYExpress Scripts to include Praluent and Repatha in its formulary
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13:32 EDTSNYBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
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
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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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
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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