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Stock Market & Financial Investment News

News Breaks
July 14, 2014
16:45 EDTLLY, ANTHAnthera Pharmaceuticals acquires Sollpura from Eli Lilly
Anthera Pharmaceuticals (ANTH) announced that it has acquired Sollpura, a novel investigational Pancreatic Enzyme Replacement Therapy from Eli Lilly and Company (LLY). Sollpura is a soluble, stable and non-porcine enzyme product intended for the treatment of patients with low digestive enzyme levels, or Exocrine Pancreatic Insufficiency, due to cystic fibrosis, and potentially other diseases. EPI is characterized by low absorption of fat and other nutrients due to a reduction in digestive enzymes produced by the pancreas. EPI is a major cause of serious nutritional deficiencies and long-term development issues, particularly in children with cystic fibrosis. EPI is estimated to afflict more than 150,000 patients in the United States alone, with more than US$600M spent on enzyme replacement therapy annually. Anthera intends to sublicense all rights, obligations, and intellectual property for the development and commercialization of Sollpura to Alkira Therapeutics. In the future, Alkira will secure appropriate funding as a wholly-owned subsidiary of Anthera to advance Sollpura into a phase 3 pivotal registration trial as agreed with the United States Food and Drug Administration in 2013. It is intended that Alkira will make all future contingent milestone payments under the license agreement upon product approval and on certain annual sales achievements and will make royalty payments on any product sales after achieving certain sales thresholds of cumulative net sales of Sollpura.
News For ANTH;LLY From The Last 14 Days
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March 23, 2015
08:06 EDTLLYPfizer, Eli Lilly to resume Phase 3 chronic pain program for Tanezumab
Pfizer (PFE) and Eli Lilly and Company (LLY) announced that they are preparing to resume the Phase 3 clinical program for tanezumab. As a result, Pfizer expects to receive a $200M upfront payment from Lilly in accordance with their collaboration agreement. This announcement follows a decision by the U.S. FDA to lift the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab. The data were submitted to the FDA in February. In the prior clinical studies of more than 11,000 patients, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medicines. A partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since December 2012 due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed.
08:05 EDTLLYPfizer, Eli Lilly to resume Phase 3 chronic pain program for Tanezumab
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07:17 EDTLLYAmerican Academy of Dermatology to hold annual meeting
73rd Annual Meeting of AAD is being held in San Francisco on March 20-24.
March 20, 2015
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
09:57 EDTLLYLeerink major pharma analyst holds an analyst/industry conference call
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09:01 EDTLLYEli Lilly up 2% to $75.75 in pre-market trading
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08:01 EDTLLYEli Lilly and Innovent Biologics announce strategic alliance
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07:41 EDTLLYAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
15:02 EDTANTHAnthera gets $3M research award from Cystic Fibrosis Foundation
Anthera Pharmaceuticals announced it has received an award from Cystic Fibrosis Foundation Therapeutic of up to $3M to support the manufacturing and clinical development of Anthera's novel pancreatic enzyme replacement therapy, Sollpura-liprotamase. Cystic Fibrosis Foundation Therapeutics is a non-profit affiliate of the Cystic Fibrosis Foundation.
08:08 EDTLLYEli Lilly and Hanmi sign license and collaboration agreement
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March 18, 2015
12:48 EDTLLYFly Watch: Biogen predicted to report strong Alzheimer's data this Friday
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09:23 EDTANTHOn The Fly: Pre-market Movers
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08:45 EDTANTHAnthera Pharmaceuticals 5.5M share Spot Secondary priced at $4.50
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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.
March 17, 2015
19:42 EDTANTHOn The Fly: After Hours Movers
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16:07 EDTANTHAnthera Pharmaceuticals files to sell common stock, no amount given
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March 16, 2015
08:45 EDTANTHAnthera Pharmaceuticals completes interim analysis from trial with Blisibimod
Anthera Pharmaceuticals, in collaboration with its partner Zenyaku Kogyo, announced that the BRIGHT-SC study of blisibimod in patients with IgA nephropathy should continue to completion as planned. This follows the successful completion of an interim futility analysis, conducted by an independent statistician, which evaluated several important biomarkers of renal disease in patients who had completed at least 8 weeks of treatment. As previously disclosed, following meetings with the European Medicines Agency, the Japanese PMDA, the US FDA, and our partner Zenyaku Kogyo, the company amended the BRIGHT-SC protocol prior to the interim analysis to reflect collective feedback. All agencies were receptive to the use of proteinuria as a surrogate endpoint with appropriate post-marketing studies.
08:22 EDTANTHAnthera Pharmaceuticals reports Q4 EPS (32c), consensus (33c)
08:14 EDTANTHAnthera Pharmaceuticals enters $10.3M purchase agreement
Anthera has filed a supplement for the sale of up to $10,300,000 in shares of our common stock to Lincoln Park Capital Fund, LLC, or Lincoln Park, under a Purchase Agreement entered into on March 12, 2015, or the Purchase Agreement.
07:27 EDTLLYBiodel BIOD-961 Phase 1 clinical trial meets primary efficacy endpoint
Biodel (BIOD) announced positive preliminary results from Study 6-101, a Phase 1 clinical trial comparing Biodel's lyophilized glucagon formulation BIOD-961, designed for use in a proprietary Glucagon Emergency Management, or GEM, auto-reconstitution device, to Eli Lilly's (LLY) Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen HypoKit, which are marketed for the treatment of severe hypoglycemia. Study 6-101 was a randomized, single-center, double blind, six-period cross over study in 15 healthy volunteers who received each glucagon administered subcutaneously, or SC, and intramuscularly, or IM, in a randomized treatment sequence. The objectives of the study were to compare the pharmacokinetic, or PK, profiles, the pharmacodynamic, or PD, glucose, responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. Study 6-101 was a Phase 1 randomized, single-center, double blind, six-period cross over study designed to evaluate the PK and PD profiles of BIOD-961 compared to marketed glucagon formulations manufactured by Eli Lilly and Novo Nordisk. BIOD-961 is a lyophilized glucagon formulation designed for use in the GEM auto-reconstitution device. On six separate dosing days, each subject received 1 mg of one of the test glucagons delivered either SC or IM. Fifteen normal, healthy subjects were randomized into the study and ten completed all dosings. The objectives of the study were to compare the PK profiles, the PD responses, and the PK/PD relationships of IM and SC dosing, as well as to assess safety profiles of the three test glucagons. These data will facilitate selection of an appropriate marketed glucagon to use as a comparator in the planned pivotal study, in which the primary efficacy endpoint for approval is to demonstrate PK and PD bioequivalence of BIOD-961 to one of the marketed comparators.
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