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Stock Market & Financial Investment News

News Breaks
March 17, 2014
10:46 EDTREGN, SNY, RHHBY, GSK, AZN, TEVALeerink's biopharma analysts hold an analyst/industry conference call
Analysts, along with two MEDACorp key opinion leaders (KOL) discuss opportunities for respiratory biologics for the treatment of severe asthma, with an emphasis on antibodies to IL-5 (AZN/GSK/TEVA) IL-4 (SNY/REGN) and IL-13 (AZN/RHHBY) on an Analyst/Industry conference call to be held on March 17 at 11 am.
News For AZN;GSK;TEVA;SNY;REGN;RHHBY From The Last 14 Days
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March 17, 2015
08:13 EDTRHHBYCelldex announces clinical trial collaboration with Roche
Celldex Therapeutics (CLDX) announced that it has entered into a clinical trial collaboration with Roche (RHHBY) to evaluate the safety, tolerability and preliminary efficacy of varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A, Roche's investigational cancer immunotherapy in a Phase 1/2 study in renal cell carcinoma. Varlilumab and MPDL3280A are part of a new class of investigational medicines known as cancer immunotherapies that are designed to harness the body's own immune system to fight cancer through separate yet complementary mechanisms of action that may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells. Preclinical data suggest the combination of these two mechanisms are synergistic and may enhance anti-tumor immune response compared to either agent alone. In Celldex's Phase 1 study of varlilumab in multiple solid tumors, promising signs of clinical activity in patients with refractory renal cell carcinoma were observed, including a durable partial response that has continued to decrease in tumor volume over time and prolonged stable disease. Under the terms of this agreement, Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to begin in 2015.
08:02 EDTSNYSanofi says Shantha will provide up to 37M doses of Shan5
Sanofi Pasteur, the vaccines division of Sanofi, announced that its affiliate Shantha Biotechnics of Hyderabad, India has delivered the first 400,000 doses of its pediatric pentavalent vaccine Shan5 to support the immunization of children in the cities of Gwalior and Jabalpur, both in the state of Madhya Pradesh, India. In December 2014, following a two-year international tender, Shantha was awarded to supply global health organizations with a total of 37M doses of Shan5 in 2015 and 2016, in a ten-dose vial presentation. This tender provides the basis upon which purchase orders will be made for specific vaccine deliveries throughout the period, the company said.
07:43 EDTSNYSanofi upgraded to Outperform on abating concerns at Leerink
Leerink upgraded Sanofi to Outperform from Market Perform saying key concerns around the lack of a CEO, Toujeo positioning and guidance are either resolved or largely factored into expectations. The firm believes the company's currency risk is hedged over time and that its multibillion dollar PCSK9 and dupilumab therapy assumptions have further upside potential. It raised its price target for shares to EUR 106 from EUR 85.
07:07 EDTGSKVeeva says selected by GlaxoSmithKline for multichannel CRM
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07:06 EDTGSKVeeva selected by GSK as global multichannel CRM partner
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05:40 EDTSNYSanofi upgraded to Outperform from Market Perform at Leerink
March 16, 2015
11:40 EDTTEVAEnzo Biochem to request rehearing of court of appeals decision
Enzo Biochem (ENZ) said, acting upon advice of counsel, that it disagrees with the March 16 split 2-to-1 decision of the Court of Appeals sitting in panel for the Federal Circuit that reverses-in-part and vacates-in-part the judgment in Enzoís favor that Applera Corp., now Life Technologies (LIFE), infringed Enzoís patents covering pioneering technologies relating to compounds used in DNA sequencing systems to read the genetic code, and remands the case to the District Court as to whether the accused product infringes. Counter to the District Courtís construction of the Ď767 patent as allowing for directly-detectable labels on nucleotides and polynucleotides, and counter to the juryís verdict that the patent describes such labelling, the Court of Appeals, held such labelling excluded by claim 1 of that patent. Enzo notes also that the Courtís partial vacatur and reversal of the judgment does not end the case, but remands the case back to the District Court to find whether the accused product infringes. Enzo will request rehearing of that decision, both by the original panel and by the full en banc Court. Enzo believes rehearing is warranted by the panelís failure to give appropriate weight to fact findings, including facts found by the jury, consistent with a broader construction of the patent, as required by the Supreme Courtís recent decision in Teva Pharmaceuticals (TEVA).
10:28 EDTTEVAOptions with increasing implied volatility
Options with increasing implied volatility: PVA NFLX BMRN DNOW MYL TEVA PEP GE
08:44 EDTTEVAFDA warning on liquid bendamustine may help Eagle's EP-3102, says Piper Jaffray
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08:23 EDTSNY, REGNPCSK9 data continues to impress, says Leerink
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07:32 EDTGSKEmergent BioSolutions signs agreements with GSK, Oxford University, NIAID
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07:30 EDTAZNAmerican College of Cardiology to hold an expo
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07:16 EDTSNY, REGNRegeneron Sanofi dupilumab drug can generate $6B+ in revenue, says Bernstein
Bernstein believes that dupilumab, a drug made by Regeneron and Sanofi, has shown strong efficacy in patients with severe atopic dermatitis. The firm notes that the drug is currently in pivotal trials involving patients with severe levels of other common diseases. The firm thinks the drug can generate $1.5B of revenue by 2018 and $3.8B by 2020. Bernstein keeps a $500 price target and Outperform rating on Regeneron.
06:40 EDTSNY, REGNPCSK9 studies show potential improvement in heart health, WSJ says
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March 15, 2015
13:04 EDTSNY, REGNSanofi, Regeneron announce publication of results of ODYSSEY long term trial
Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) today announced that 18-month results of a Phase 3 trial of Praluent, alirocumab, an investigational therapy, involving 2,341 high risk patients with hypercholesterolemia were published online in The New England Journal of Medicine. In the ODYSSEY LONG TERM trial, Praluent 150 mg every two weeks reduced low-density lipoprotein cholesterol by an additional 62% at week 24 when compared to placebo, the primary efficacy endpoint of the study, with consistent LDL-C lowering maintained over 78 weeks."These results demonstrated the durable efficacy for Praluent when added to maximally-tolerated statin therapy and further reinforce its generally consistent safety profile," said Jennifer Robinson, M.D., M.P.H., Director of the Prevention Intervention Center, Professor, Departments of Epidemiology & Medicine, College of Public Health at the University of Iowa. "Additionally, the post hoc analysis of major cardiovascular events represents an important finding for Praluent -- we look forward to results from the ongoing ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential of Praluent to reduce cardiovascular events."
March 13, 2015
11:19 EDTAZNBioMarin rallies amid positive call on DMD drug timeline, takeover rumor
The shares of drug maker BioMarin (BMRN) are climbing after research firm Jefferies quoted a regulatory expert as saying that the company's drisapersen drug has a good chance of being approved on an accelerated basis by the FDA. Drisapersen is a treatment for Duchenne Muscular Dystrophy, or DMD. WHAT'S NEW: "There is a strong possibility" that the FDA will grant accelerated approval to drisapersen because there is currently no approved drug for the treatment of DMD, Jefferies analyst Eun Yang quoted the expert as saying. The expert is also optimistic about the outlook for accelerated approval because she had a good experience working with BioMarin while she was with the FDA and because BioMarin has a favorable track record with the FDA, according to Yang. There is a 60% chance that drisapersen will be approved by the end of this year and the stock can rise to $155, versus its current level of about $121.50, if that does occur, the analyst stated. Yang's price target on the stock increased to $135 from $125 and the analyst kept a Buy rating on the shares. WHAT'S NOTABLE: Pharmaceutical giant AstraZeneca (AZN) has been rumored to be interested in buying BioMarin for $175 per share in cash, British newspaper Daily Mail reported. , Piper Jaffray analyst Joshua Schimmer wrote in a note to investors this morning that BioMarin, along with Vertex (VRTX) and Incyte (INCY), have a "clear path" to joining the group of companies with market caps of over $10B projected to deliver greater than 20% EPS CAGR, which the analyst identified as a set of criteria that has previously pointed to companies that make good potential takeover targets. PRICE ACTION: In mid-morning trading, BioMarin climbed nearly 4% to $120.
10:51 EDTTEVAOptions with increasing implied volatility
Options with increasing implied volatility: PVA BBEP SLXP ENDP MYL BBBY TEVA ZTS
10:37 EDTSNYSanofi says NHS England de-lists cabazitaxel, aflibercept
Sanofi announcd that NHS England has confirmed that it is de-listing both cabazitaxel and aflibercept from the Cancer Drugs Fund, so that neither of these medicines will be available to new patients in England on the NHS. It added, "However regarding cabazitaxel NHS England have agreed to engage in talks to explore immediate ways of maintaining access to patients until it is reviewed by NICE." Tarja Stenvall, General Manager for Sanofi in the UK, commented, "We are hugely disappointed that cabazitaxel and aflibercept have been cut from the CDF and that new patients in England will no longer have access to these crucial cancer treatments. However NHS England remains in dialogue with Sanofi to explore immediate ways of maintaining access to patients for cabazitaxel until the outcome of any NICE review. Our concern is for patients who should continue to have access to cabazitaxel until a longer term solution is reached and who may feel confused and uncertain until this happens."
08:07 EDTAZNAstraZeneca rumored to have BioMarin 'on shopping list,' Daily Mail says
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05:47 EDTTEVAStocks with implied volatility movement; SLXP MNKD
Stocks with implied volatility movement; Salix (SLXP) 20, Teva (TEVA) 27 according to iVolatility.
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