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Stock Market & Financial Investment News

News Breaks
January 23, 2013
13:45 EDTBAYRY, BAYRY, BAYRY, CELG, CELG, CELG, LLY, LLY, LLY, ONXX, ONXX, ONXX, REGN, REGN, REGN, SNY, SNY, SNYLeerink's biotech analyst hosts a luncheon meeting
Biotech Analyst Liang discusses the ongoing ASCO GI Cancer Symposium, physician impressions of the new Phase 3 data on CELG’s Abraxane and LLY’s Ramucirumab, as well as market dynamics for new agents in colorectal cancer such as Zaltrap and Stivarga at a Luncheon Meeting being held in San Francisco on January 25 at 2 pm.
News For BAYRY;CELG;LLY;ONXX;REGN;SNY From The Last 14 Days
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March 20, 2015
13:04 EDTCELGCelgene reports results from long-term efficacy,safety analyses of Otezla trials
Celgene announced that results from long-term efficacy and safety analyses of the ESTEEM phase III clinical trial program of Otezla were presented at the 73rd Annual Meeting of the American Academy of Dermatology. OTEZLA is the company’s oral, selective inhibitor of phosphodiesterase 4 approved for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for the treatment of adults with active psoriatic arthritis. In ESTEEM 1 and 2, patients were randomized to treatment with OTEZLA 30 mg twice daily or placebo for the first 16 weeks. At week 16, patients either continued on OTEZLA or were switched from placebo to OTEZLA 30 mg twice daily through week 32. Patients initially randomized to OTEZLA who achieved a Psoriasis Area and Severity Index-75 response or PASI-50 response at week 32 were then re-randomized to either OTEZLA 30 mg twice daily or placebo. Celgene said improvements in the severity of preexisting nail, scalp and palmoplantar psoriasis achieved at week 16 were maintained in OTEZLA responders through week 52 in ESTEEM 2; OTEZLA improved the severity of palmoplantar psoriasis at week 16 in a subset of patients across three trials; Long-term safety profile for up to 104 weeks in ESTEEM 1 was consistent with previously reported data from OTEZLA clinical trial programs, with no new safety signals and no clinically meaningful changes in laboratory values.
13:01 EDTCELGCelgene announces positive Phase III study results evaluating Otezla
Celgene announced that results from its ongoing phase III LIBERATE trial evaluating Otezla, the company’s oral, selective inhibitor of phosphodiesterase 4, in patients with moderate to severe plaque psoriasis. The LIBERATE study evaluated the clinical efficacy and safety of either oral OTEZLA 30 mg twice daily or weekly subcutaneous etanercept 50 mg compared with placebo at week 16 in 250 patients who had no prior exposure to a biological therapy. It also examined the relative safety of a switch from etanercept to OTEZLA after week 16. At week 16, patients receiving OTEZLA 30 mg twice daily demonstrated statistically significant and clinically meaningful improvement when compared with placebo, as measured by the Psoriasis Area and Severity Index-75 response. At week 16, statistical significance was also achieved for patients receiving weekly injections of etanercept 50 mg when compared with placebo. A post-hoc analysis revealed no significant difference between OTEZLA and etanercept in PASI-75 at week 16. LIBERATE was not designed or powered to directly compare OTEZLA to etanercept.
11:33 EDTLLYFly 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
10:51 EDTCELGStocks with call strike movement; DAL CELG
Delta Air Lines (DAL) September 57.5 call option implied volatility decreased 1% to 34, Celgene (CELG) July 145 call option implied volatility increased 3% to 28 according to IVolatility.
10:00 EDTREGNOn The Fly: Analyst Initiation Summary
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09:57 EDTLLYLeerink major pharma analyst holds an analyst/industry conference call
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09:45 EDTCELGActive equity options trading on open
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09:01 EDTLLYEli Lilly up 2% to $75.75 in pre-market trading
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08:05 EDTREGNRegeneron initiated with a Buy at Chardan
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08:01 EDTLLYEli Lilly and Innovent Biologics announce strategic alliance
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07:41 EDTLLY, BAYRY, CELGAmerican Academy of Dermatology to hold annual meeting
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06:26 EDTCELGCelgene price target raised to $144 from $135 at Piper Jaffray
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March 19, 2015
09:37 EDTCELGActive equity options trading on open
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08:08 EDTLLYEli Lilly and Hanmi sign license and collaboration agreement
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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.
05:30 EDTSNYSanofi reports lixisenatide was non-inferior, though not superior to placebo
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March 18, 2015
17:07 EDTCELGCelgene GED-0301 Phase II data published in New England Journal of Medicine
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12:48 EDTLLYFly 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 EDTLLYLilly 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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