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Stock Market & Financial Investment News

News Breaks
August 13, 2014
13:00 EDTSNY, ITMN, RHHBYInterMune received takeover bids from Sanofi, Roche, Bloomberg says
News For ITMN;SNY;RHHBY From The Last 14 Days
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March 30, 2015
07:24 EDTRHHBYStifel to hold a bus tour
BioTrek: 2015 West Coast Healthcare Therapeutics Bus Tour travels throughout San Francisco on March 30-April 1.
March 27, 2015
14:04 EDTSNYRegeneron price target raised to $500 from $450 at Argus
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March 26, 2015
11:13 EDTSNY, RHHBYBofA/Merrill European pharma analyst holds an analyst/industry conference call
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05:29 EDTSNYGenzyme reports Cerdelga data shows effectiveness in treating Gaucher disease
Genzyme, a Sanofi company, announced the publication of results from the ENCORE study exploring Cerdelga as a maintenance therapy suitable for adult patients who had reached pre-specific treatment goals on enzyme replacement therapy, or ERT, in the March 26 online issue of The Lancet. ENCORE is a randomized, multinational, Phase 3, open-label, non-inferiority study designed to determine whether patients with Gaucher disease type 1 who had been stabilized after 3 or more years of ERT infusions would remain stable after switching to Cerdelga, a novel, oral, selective inhibitor of glucosylceramide synthase. Eligible patients were randomized 2:1 to receive either oral Cerdelga or ERT with Cerezyme over a period of 12 months. The composite primary efficacy endpoint was the percentage of patients whose hematologic parameters and organ volumes remained stable, using the following stability criteria established for patients with Gaucher disease type 1 on maintenance therapy with Cerezyme: Hemoglobin concentration that did not decrease more than 1.5 g/dL; Platelet count that did not decrease more than 25%; Spleen volume that did not increase more than 25%; Liver volume that did not increase more than 20%. After 12 months, 85% of patients receiving Cerdelga and 94% of patients receiving Cerezyme met the composite endpoint of stability in all four of these measures. The difference between the two treatments was within the pre-specified margins. The principal secondary endpoints were stability with respect to the individual components of the primary endpoint. At least 93% of Cerdelga patients remained stable with respect to hemoglobin concentration, platelet count, spleen volume, and liver volume after 12 months of treatment. Additional endpoints evaluated bone disease, Gaucher disease severity, quality-of-life and Gaucher-disease associated biomarkers.
March 25, 2015
15:10 EDTRHHBYFoundation Medicine to host special shareholder meeting
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12:17 EDTSNYSanofi Pasteur announces FDA approval of Quadracel DTaP-IPV vaccine
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10:35 EDTRHHBYFDA approves expanded indication for Eylea
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March 24, 2015
07:45 EDTRHHBYFDA Pediatric Advisory Committee holds a meeting
The Committee discusses pediatric-focused safety reviews, as mandated by the FDA Safety and Innovation Act (FDASIA) for Eli Lilly's Cymbalta, Pfizer's Quillivant XR and Revatio, Johnson & Johnson's Risperdal, GlaxoSmithKline's Advair, HFA Altabax Ointment and Fluarix Quadrivalent, Supernus Pharmaceuticals' Oxtellar XR, Teva Pharmaceutical's Qnasl and Roche's Invirase. The Committee will also discuss the safety ongoing propriety of the humanitarian device exemption for the Medtronic Activa Dystonia Therapy and for the Liposorber LA-15 System in a meeting being held in Silver Spring, Maryland on March 24 at 8 am. Webcast Link
March 23, 2015
09:45 EDTSNYUBS to hold a field trip
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08:46 EDTRHHBYEli Lilly price target raised to $85 from $78 at Cowen
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06:32 EDTRHHBYFoundation Medicine announces board changes in connection to Roche transaction
Foundation Medicine (FMI) announced proposed changes to its board in connection with its pending strategic collaboration with Roche (RHHBY). Under the terms of the agreement with Roche, Foundation Medicine’s board will increase to nine directors upon the closing of the transaction, including three board designees selected by Roche. The pending transaction with Roche remains subject to the satisfaction of certain closing conditions, including the successful completion of the tender offer commenced by Roche on February 2, 2015 and the approval of certain matters at the special meeting of Foundation Medicine stockholders to be held on April 2, 2015. The closing is expected to occur in the second quarter of 2015.
March 20, 2015
11:33 EDTRHHBYFly Review: Analysts correctly predict jump in Biogen shares
The shares of Biogen (BIIB) are rallying after the company reported results for a Phase 1b study of its Alzheimer's drug, BIIB-037. On March 18, as reported on that day by The Fly, RBC Capital predicted that the stock would rise after the results were published. A number of other firms were also upbeat on the stock ahead of the data release. WHAT'S NEW: Earlier this morning Biogen announced that the three milligram, six milligram, and ten milligram dose versions of its Alzheimer's treatment, aducanumab, had reduced the amount of amyloid plaque in the brains of Alzheimer's patients taking the drug by statistically significant amounts compared with those taking placebos. Beta amyloid is a protein that produces plaque in the brain. Scientists suspect that plaques in the brain are a cause of Alzheimer's. The cognitive decline of patients taking BIIB-037 was also significantly less than that of patients who were taking placebos, the company reported. PRE-EVENT CALLS: RBC Capital analyst Michael Yee predicted earlier this week in a note to investors that Biogen would report strong data for BIIB-037 and the stock should "work higher" after the data is unveiled. Alzheimer's patients taking the high dose of Biogen's BIIB-037 drug should exhibit a stabilization of cognition levels, Yee stated. Conversely, the cognition levels of patients taking the placebo should drop slightly, the analyst predicted. On March 13, in a note summarized by The Fly on that day, JPMorgan recommended buying Biogen shares ahead of the data release. Investors still incorporated a low probability of success for the drug, and the stock could rise further, the firm wrote. On March 19, in a note also published by The Fly, Credit Suisse wrote that Biogen's multiple could rise if the data on BIIB-037 was positive. It raised its price target on the name to $500 from $400. ANALYST REACTION: This morning, Barclays raised Biogen's price target to $500 from $435 following the company's report of "impressive" full results from the Alzheimer's study. Piper Jaffray analyst Joshua Schimmer also raised his price target for Biogen shares to $500 this morning, calling today’s BIIB-037 results "robust and impressive." Schimmer believes the trial showed a "consistent and dramatic" dose effect on both radiographic and clinical disease features and thinks the side effects "pale in comparison" to the drug’s efficacy. OTHERS TO WATCH: Eli Lilly (LLY) and Roche (RHHBY) are also currently developing similar Alzheimer's treatments. PRICE ACTION: In late morning trading, Biogen rose 7% to $464. The stock is up about 9% since Wednesday. Eli Lilly shares are up 1.6% to $75.40 this morning, while Roche rose 2.2% to $35. Reference Link
09:01 EDTRHHBYEli Lilly up 2% to $75.75 in pre-market trading
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March 19, 2015
16:14 EDTRHHBYProthena report positive results from Phase 1 study of PRX002
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07:09 EDTSNYSanofi reports top-line results for Lyxumia for cardiovascular safety
Sanofi announced top-line results of the Phase IIIb ELIXA cardiovascular outcomes study, which compared lixisenatide to placebo in a high-risk population of adults with type 2 diabetes evaluating cardiovascular safety. The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety. The results will be included in the U.S. New Drug Application of lixisenatide, which is on track to be resubmitted to the FDA in Q3. Lixisenatide is not approved in the U.S.
07:02 EDTRHHBYSigma-Aldrich signs exclusive distribution agreement with Roche
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05:30 EDTSNYSanofi reports lixisenatide was non-inferior, though not superior to placebo
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March 18, 2015
12:48 EDTRHHBYFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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09:32 EDTSNYMannKind faces cash shortfall if $100M debt not settled, TheStreet says
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07:46 EDTRHHBYLilly Roche would have upbeat read through from strong BIIB data, says Bernstein
Bernstein notes that the data for Biogen's (BIIB) Alzheimer's treatment, due to be released on Friday, is widely expected to be positive. The firm thinks that positive data would boost the outlook for similar Alzheimer's drugs being developed by Eli Lilly (LLY) and Roche (RHHBY), since consensus estimates for those drugs are low. The firm keeps Outperform ratings on Eli Lilly and Roche.
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