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March 7, 2014
13:18 EDTREGN, SNY, AEGRRegeneron disclosed FDA contact about PCSK9 adverse events previously
Regeneron (REGN) stated in its 10-K filing on February 13 after the market close that the company its partner Sanofi (SNY) have been advised by the FDA that it has become aware of neurocognitive adverse events in the PCSK9 inhibitor class. Similar wording was included in a regulatory filing made today by Sanofi and may be a factor in the volatility seen in shares of Regeneron this afternoon. Shares of Regeneron are off their earlier lows but remain down about 7.8% near $312 per share. Shares of Aegerion (AEGR) spiked as Regeneron shares sold off, but are off their earlier highs. Aegerion remains up about 4.5% near $52.50 in afternoon trading.
News For SNY;REGN;AEGR From The Last 14 Days
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October 1, 2015
16:09 EDTREGNRegeneron announces collaboration with Mitsubishi Tanabe Pharma
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13:58 EDTSNY, REGNExpress 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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05:54 EDTREGNExpress Scripts hinted at slow anti-PCSK9 launches, says Piper Jaffray
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September 30, 2015
17:34 EDTREGN, SNYExpress Scripts says many PCSK9 prescriptions denied, Reuters reports
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07:11 EDTAEGRLeerink to hold a roundtable
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September 29, 2015
12:41 EDTAEGRSarissa raises stake in Aegerion to 8.23% from 7.07%
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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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 EDTREGN, SNYIIR Holdings to hold a conference
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05:18 EDTSNY, REGNRegeneron 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 25, 2015
16:17 EDTREGNOn The Fly: Top stock stories for Friday
Stocks opened with sharp gains the day after Fed Chair Janet Yellen gave some clarity to the market by suggesting the Fed will most likely raise interest rates by the end of the year. During afternoon trading, the news flow slowed and the volume lightened on the buy side, leaving the sellers with the upper hand. The Nasdaq was the first index to move into negative territory, led by broad weakness in biotech stocks, while the Dow was helped to stay in the green by a big post-earnings move higher in Nike (NKE). The averages limped into the close, leaving the market with an interesting set-up to begin next week. Outside of stock news, it was certainly a headline packed day, as Speaker of the House John Boehner announced that he will resign at the end of October, Chinese President Xi Jinping continued his U.S. visit and Pope Francis addressed the United Nations while spending a second day in New York City. ECONOMIC EVENTS: In the U.S., the third estimate of second quarter GDP showed the economy grew 3.9% quarter-over-quarter, versus expectations for the GDP growth estimate to stay at 3.7%. Personal consumption in Q2 is now believed to have grown 3.6%, up from the prior estimate of 3.1%. The final University of Michigan consumer sentiment reading for September came in at 87.2, which was down from August's 91.9 but above the expected 86.2 reading... Federal Reserve Chair Janet Yellen said during a speech at UMass Amherst last night that the central bank remains inclined to hike rates this year. Yellen's remarks were incrementally hawkish, but welcomed by the market, since they helped clarify the message the Fed delivered a week ago. Of note, the Fed chair paused multiple times toward the end of her speech and received medical attention afterward, but returned to her regular schedule later in the evening, with the bank explaining that Yellen was dehydrated after a long day but was otherwise fine. COMPANY NEWS: Nike jumped $10.23, or 8.9%, to $125.02 after Thursday night's report of better than expected earnings and futures orders prompted numerous price target hikes at Street research firms. Additionally, Sterne Agee upgraded Nike to Buy from Neutral, saying it thinks the company is benefiting from its "global grass roots engagement with its customers," which enables it to meet its customers' needs and determine to what extent it can raise prices. The firm, which thinks that the company is continuing to gain share, has a $150 price target on the athletic gear giant... Biotech stocks, which were already having a bad week, ended the week on a down note, as the iShares NASDAQ Biotechnology Index (IBB) fell 4.9%, giving it a weekly decline of about 13%. Among the biggest large-cap losers in the space were Vertex (VRTX), which fell 7%, Regeneron (REGN), which dropped 6% and Celgene (CELG), which slid 4.8%. MAJOR MOVERS: Among the notable gainers was Jabil Circuit (JBL), which advanced $2.38, or 12.2%, to $21.88 after it reported higher than expected earnings and gave guidance for its November quarter that was significantly above expectations. Also higher was Cirrus Logic (CRUS), which gained $3.90, or 14.4%, to $31.03 after tear downs of Apple's (AAPL) iPhone 6S and 6S Plus led analysts to conclude that the chipmaker appears poised to obtain more revenue from the new devices than from the previous generation of the market-leading smartphone. Among the noteworthy losers was Finish Line (FINL), which fell $4.86, or 19.6%, to $19.91 after reporting second quarter revenue that missed expectations and saying it expects adjusted earnings this fiscal year to increase in a low single to mid single digits percentage from last year. Also lower following its earnings report was smartphone and software maker BlackBerry (BBRY), which slid 7.68% to $6.49 after the company posted a second quarter loss that was steeper than analysts expected. BlackBerry also confirmed press reports that it plans to launch a new phone that uses Google's (GOOG) Android operating system instead of its own proprietary BB10 OS. Shares of Aratana Therapeutics (PETX), which dropped $6.81, or 38.97%, to $10.68 after the company said that, based on "mixed clinical and scientific results," it does not believe that canine lymphoma products AT-004 and AT-005 in their current, first-generation forms will capture the desired lymphoma market opportunity. INDEXES: The Dow rose 113.35, or 0.7%, to 16,314.67, the Nasdaq fell 47.98, or 1.01%, to 4,686.50, and the S&P 500 added/slipped 0.90, or 0.05%, to 1,931.34.
09:07 EDTREGNBayer says Eylea recommended for EU approval in additional indication
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07:22 EDTSNYEuropean Society for Medical Oncology to hold a conference
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September 24, 2015
08:33 EDTREGNRegeneron and Icahn School of Medicine enter antibody research agreement
Regeneron and The Experimental Therapeutics Institute at the Icahn School of Medicine at Mount Sinai today announced that they have entered into an agreement with the goal of accelerating the discovery of fully human antibodies directed against therapeutic targets being researched by Mount Sinai investigators. Regeneron will provide the ETI with access to VelocImmune technology and potential financial support to use the company's proprietary antibody discovery platform to generate antibodies against targets of interest and explore potential therapeutic applications for human disease. ETI will undertake preclinical research, and Regeneron has an exclusive option to negotiate a license to the antibody for future clinical development and commercialization.
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