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May 14, 2014
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July 31, 2015
06:36 EDTIMGNImmunoGen: enrollment in expansion cohort for IMGN853 to complete by year end
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06:34 EDTIMGNImmunoGen sees FY16 revenue $70M-$80M, consensus $87.4M
Sees FY16 operating expenses $175M-$180. Sees FY16 net loss to be 120M-$125M. Sees FY16 cash used in operations $100M-$105M. Sees FY16 CapEx $13M-$15M. Sees FY16 cash and marketable securities anticipated to be $165M-$170M.
06:32 EDTIMGNImmunoGen reports Q4 EPS (35c), consensus (35c)
Reports Q4 revenue $12.61M, consensus $15.42.
July 30, 2015
13:06 EDTALKSAlkermes remains well positioned after Q2 results, says JPMorgan
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07:12 EDTALKSAlkermes raises FY15 adjusted EPS view to (31c)-(45c) from (37c)-(50c)
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07:10 EDTALKSAlkermes reports Q2 adjusted EPS (9c), consensus (10c)
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July 29, 2015
15:08 EDTALKSNotable companies reporting before tomorrow's open
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13:54 EDTALKSEarnings Watch: Alkermes up around 17% since last earnings report
Alkermes (ALKS) is scheduled to report second quarter earnings before the market open on Thursday, July 30 with a conference call scheduled for 8:30 am ET. Alkermes, an integrated biopharmaceutical company, engages in the research, development, and commercialization of pharmaceutical products to address unmet medical needs of patients in various therapeutic areas. EXPECTATIONS: Analysts are looking for a loss of (10c) per share on revenue of $142.8M, according to First Call. The consensus range for EPS is for a loss of (17c)-(4c) on revenue of $134.5M-$153.28M. LAST QUARTER: Alkermes reported first quarter EPS of 6c, compared to a consensus estimate of a loss of (3c), on revenue of $161.2M against estimates of $146.6M. The company reiterated all of its financial expectations for 2015 that it had previously given on March 9, when it cut its 2015 EPS view to (37c)-(50c) from (27c)-(40c). Q1 revenue from the company's anti-psychotic franchise, including Risperdal were $46.9M, compared to $49.6M for the same period in the prior year. Revenues from Amprya/Famprya were $36.5M, compared to $20.6M for the same period in the prior year. "Our results this quarter reflect strong revenues from our portfolio of key commercial products and focused investment in our promising late-stage pipeline of CNS product candidates that will drive our future growth," commented Alkermes CFO James Frates. Alkermes CEO Richard Pops noted that the company is on the "threshold" of its next growth phase and that Aripiprazole lauroxil, the company's long-acting atypical anti-psychotic for schizophrenia, is moving toward FDA approval and launch later this year. STREET RESEARCH: On June 26, Cowen said the clinical profile for Alkermes' ALKS 3831 continues to look interesting, as the firm's consultants believe data for the drug suggests a profile that would provide a significant benefit over Zyprexa for the treatment of schizophrenia. Cowen reiterated its Outperform rating and $80 price target on Alkermes shares. PRICE ACTION: Alkermes shares are up around 17% since the company's last earnings report on April 30, and are down almost 3% to $67.40 in midday trading ahead of Thursday's earnings release.
08:29 EDTIMGNImmunoGen price target raised to $24 from $13 at Oppenheimer
Oppenheimer hiked its price target on ImmunoGen as the firm thinks that updates on its '853 drug will better frame the drug's value. The firm believes that several other positive catalysts will propel the stock higher in 2016. It keeps an Outperform rating on the shares.
07:47 EDTARIAARIAD to receive $200M through syntehtic-royalty financing with PDL BioPharma
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07:43 EDTARIAARIAD to receive up to $200M through Iclusig synthetic-royalty financing with PDL BioPharma
ARIAD Pharmaceuticals (ARIA) announced that it will receive $100 million in cash – $50 million upon deal execution late yesterday and an additional $50 million in one year – through a synthetic-royalty financing from PDL BioPharma (PDLI) in exchange for paying PDL a mid-single-digit royalty on future sales of Iclusig until PDL receives a fixed internal rate of return. ARIAD also has an option, in its discretion, to receive up to an additional $100 million at any time between 6 and 12 months from the date of the agreement, in one or two tranches on comparable terms. ARIAD intends to use the base funds to conduct a front-line trial of brigatinib, its investigational ALK inhibitor, in patients with non-small cell lung cancer and to support brigatinib commercial readiness, as well as to continue its ongoing Iclusig initiatives. ARIAD is on track to complete enrollment in the pivotal ALTA trial of brigatinib in third quarter 2015, to file for approval in the U.S. next year, and subject to regulatory approval, to launch brigatinib by early 2017. Brigatinib has Breakthrough Designation from the U.S. Food and Drug Administration. “This financing allows us to accelerate initiation of the front-line trial of brigatinib and to ensure launch readiness as early as possible, while retaining strategic flexibility with respect to partnering and long-term commercialization of brigatinib,” said Harvey J. Berger, M.D., chairman and CEO of ARIAD. “We are confident based on the latest clinical data on brigatinib and other ALK‐inhibitors, that brigatinib may be an important new cancer medicine for patients with ALK+ lung cancer. With the funding provided by this royalty transaction, we expect to start the front-line trial by early next year, ahead of our expected filing for initial marketing approval of brigatinib in patients with refractory ALK+ NSCLC.”
July 28, 2015
07:25 EDTALNYAlnylam Pharmaceuticals to hold a roundtable
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July 27, 2015
10:40 EDTALKSLeerink major pharma analyst holds an analyst/industry conference call
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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 23, 2015
07:29 EDTALNYAlnylam to hold a roundtable
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July 22, 2015
10:01 EDTAGIOOn The Fly: Analyst Initiation Summary
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08:34 EDTAGIOAgios Pharmaceuticals initiated with an Outperform at Northland
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July 20, 2015
10:00 EDTEPZMOn The Fly: Analyst Downgrade Summary
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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.
07:16 EDTEPZMEpizyme downgraded to Neutral from Buy at H.C. Wainwright
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