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April 15, 2014
07:35 EDTNVS, ALNYAlnylam outlook not affected by Novartis decision, says JMP Securities
After Novartis (NVS) discontinued its RNAi drug discovery program, JMP Securities does not think the decision should affect the potential of Alnylam's (ALNY) pipeline. The firm believes that Novartis' inability to figure out RNAi technology - and not problems with RNAi as a whole - led to Nvoartis' decision. The firm reiterates a $110 price target and Outperform rating on Alnylam.
News For ALNY;NVS From The Last 14 Days
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July 29, 2015
05:28 EDTNVSNovartis announces equity stake in Mereo BioPharma Group
Novartis announced a swap of clinical assets for equity with Mereo BioPharma Group. The deal involves compounds in areas of unmet medical need including BPS-804, to improve bone density in brittle bone syndrome, an orphan disease; BCT-197 for acute exacerbations in COPD, and BGS-649 for obese men with hypogonadotrophic hypogonadism to normalize testosterone levels. Under the terms of the agreement, Novartis will have an equity stake in Mereo and will share in the success of the development of these compounds, including a share on milestones and royalties on future commercial sales.
July 28, 2015
07:25 EDTALNYAlnylam Pharmaceuticals to hold a roundtable
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July 27, 2015
08:05 EDTALNYAlnylam initiates Phase 1/2 clinical trial for ALN-AAT
Alnylam Pharmaceuticals (ALNY) has initiated a Phase 1/2 clinical trial with ALN-AAT, a subcutaneously administered investigational RNAi therapeutic targeting alpha-1 antitrypsin for the treatment of AAT deficiency-associated liver disease. The Phase 1/2 trial will be conducted initially in normal healthy volunteers, and, then, in patients with alpha-1 liver disease. Initiation of this trial is based on encouraging pre-clinical data presented at the Digestive Disease Week meeting May 16 – 19, 2015. The company expects to present initial clinical data from this trial in early 2016. ALN-AAT is a subcutaneously administered investigational RNAi therapeutic that utilizes Alnylam’s proprietary ESC-GalNAc-siRNA conjugate delivery technology. ESC-GalNAc-siRNA conjugates are designed to achieve targeted delivery of RNAi therapeutics to hepatocytes through uptake by the asialoglycoprotein receptor, and enable subcutaneous dosing with increased potency and durability and a wide therapeutic index. As per the filed CTA, the Phase 1/2 trial of ALN-AAT is a randomized, single-blind, placebo-controlled study being conducted in three parts. Parts A and B are single-dose and multi-dose, dose-escalation studies, designed to enroll up to a total of 48 healthy adult volunteers. Part C will be a multi-dose study designed to enroll up to a total of 24 adults with alpha-1 liver disease and mild-to-moderate liver fibrosis. The primary objective of the study is to evaluate safety and tolerability of single and multiple subcutaneous doses of ALN-AAT. Secondary objectives include evaluation of pharmacokinetics and clinical activity for ALN-AAT as measured by knockdown of serum AAT. In addition, biopsies will be obtained from subjects with alpha-1 liver disease to quantify the effects of treatment on levels of periodic acid-Schiff-stained globules, a measure of misfolded AAT accumulation observed in the livers of alpha-1 liver disease patients. In January 2014, Alnylam and Genzyme, a Sanofi (SNY) company, formed an alliance to accelerate and expand the development and commercialization of RNAi therapeutics across the world. The alliance is structured as a multi-product geographic alliance in the field of rare diseases. Alnylam retains product rights in North America and Western Europe, while Genzyme obtained the right to access certain programs in Alnylam's current and future Genetic Medicines pipeline, including ALN-AAT, in the rest of the world. In certain defined instances, Genzyme has co-development/co-commercialization and/or global product rights. Genzyme's rights are structured as an opt-in that is triggered upon achievement of human proof-of-principle.
July 24, 2015
10:56 EDTNVSNovartis announces FDA approval of Odomzo
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09:02 EDTNVSLigand says Revolade recommended by CHMP for EU approval for SAA
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07:17 EDTNVSNovartis combination therapy Tafinlar, Mekinist achieves regulatory milestones
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July 23, 2015
07:29 EDTALNYAlnylam to hold a roundtable
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July 22, 2015
07:03 EDTNVSIgnyta names Bernard Parker as Chief Commercial Officer
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July 21, 2015
11:49 EDTNVSNovartis may sell Amgen's cancer drug as soon as September, Bloomberg says
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05:20 EDTNVSNovartis backs FY15 revenue guidance of up mid-single digit
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05:17 EDTNVSNovartis reports Q2 core EPS $1.27, consensus $1.24
Reports Q2 revenue $12.7B, consensus $12.44B. Further strengthening of USD impacted sales by -11% and core operating income by -13%. Growth Products, an indicator of the rejuvenation of the portfolio, contributed 35% of continuing operations net sales in Q2, and were up 24%. In Pharmaceuticals, Growth Products contributed 44% of division net sales in the quarter, and sales for these products were up 38%.
July 20, 2015
08:25 EDTNVSNovartis management to meet with JPMorgan
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08:05 EDTALNYAlnylam initiates Phase 3 open label extension study with patisiran
Alnylam announced that it has initiated its Phase 3 open-label extension study, abbreviated APOLLO-OLE, with patisiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of TTR-mediated amyloidosis in patients with Familial Amyloidotic Polyneuropthy. All patients who complete the APOLLO Phase 3 trial with patisiran are eligible to enroll in APOLLO-OLE. The study will evaluate the long-term safety and efficacy of patisiran and will also measure effects of treatment toward a number of clinical endpoints, including the modified Neuropathy Impairment Score, or “mNIS+7,” which is an evaluation of muscle weakness, sensory and autonomic function, and nerve conductance. The company is also reiterating its previous guidance that – assuming positive study results in the APOLLO Phase 3 study – it expects to be in a position to file a New Drug Application for patisiran in the 2017 timeframe.
07:32 EDTNVSAlzheimer's Association to hold a conference
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