Alkermes' schizophrenia candidate Aristada featured in Phase 3b published study » 07:0605/2005/20/20
Alkermes announced that…
Alkermes announced that data from its phase 3b ALPINE study were published in the Journal of Clinical Psychiatry. ALPINE was a six-month study evaluating the efficacy and safety of the Aristada Initio one-day initiation regimen, consisting of Aristada Initio and one single dose of 30 mg of oral aripiprazole, together with the Aristada two-month dose in patients experiencing an acute exacerbation of schizophrenia. Positive topline data were first reported in April 2019. Results from the study provide evidence to support the use of the Aristada Initio one-day regimen together with Aristada for treatment of an acute exacerbation of schizophrenia, started in the hospital setting and continued through the critical transition to outpatient care. ALPINE was a multi-center, randomized, double-blind, phase 3b study designed to examine the efficacy and safety of using either Aristada or Invega Sustenna to start treatment in hospitalized patients experiencing an acute exacerbation of schizophrenia and continue them on treatment during the transition to outpatient care for ongoing continuation phase therapy.
|Over a week ago|
Alkermes presents new data from schizophrenia portfolio at virtual SIRS congress » 07:1905/1405/14/20
Alkermes presented new…
Alkermes presented new data from its schizophrenia portfolio as part of the virtual 2020 Congress of the Schizophrenia International Research Society, or SIRS. New e-posters related to ALKS 3831, Aristada and epidemiological schizophrenia data are now posted on the SIRS website, including: results from the completed ENLIGHTEN-2-extension study evaluating the safety and tolerability of ALKS 3831 in patients with schizophrenia who completed the phase 3, 24-week ENLIGHTEN-2 study; data from an exploratory analysis for ARISTADA evaluating the feasibility and utility of wrist actigraphy to measure key activity and sleep parameters; findings from a retrospective cross-sectional analysis examining disease prevalence, comorbid conditions, and medication utilization in a large population of commercially- or Medicaid-insured individuals diagnosed with schizophrenia in the U.S. to characterize this patient population.
Alkermes expands patient access to Aristada, Vivitrol during COVID-19 pandemic » 07:4005/1105/11/20
Alkermes announced the…
Alkermes announced the expansion of several programs and services in support of patient access to its proprietary medicines during the COVID-19 crisis. During this unprecedented and rapidly evolving situation, the company remains focused on helping to assure that patients have uninterrupted access to Aristada, an injectable atypical antipsychotic for the treatment of schizophrenia in adults, and Vivitrol, indicated for the treatment of alcohol dependence and the prevention of relapse to opioid dependence following opioid detoxification. The company is expanding its injection site network to include additional appropriate retail pharmacies and clinics where patients can receive injections of Aristada and Vivitrol. As part of this initiative, Alkermes has added to its provider locator more than 900 on-site retail pharmacies. Pharmacists at designated Albertsons locations throughout the U.S. now are available to provide injections of Aristada and Vivitrol. These Albertsons sites extend Alkermes' existing provider locator network and offer patients additional injection options across the country.
Alkermes price target lowered to $23 from $25 at H.C. Wainwright » 07:1404/3004/30/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Douglas Tsao lowered the firm's price target on Alkermes to $23 from $25 and reiterates a Neutral rating on the shares. The company reported "solid" Q1 earnings though its guidance withdrawn as COVID-19 creates uncertainty, Tsao tells investors in a research note.
Alkermes price target lowered to $21 from $22 at Piper Sandler » 12:3704/2904/29/20
Piper Sandler analyst…
Piper Sandler analyst Danielle Brill lowered the firm's price target on Alkermes to $21 from $22 and keeps a Neutral rating on the shares after the company reported Q1 results and withdrew its guidance for 2020. Brill said that she remains concerned about Alkermes' pipeline needs and now its current product franchise is facing coronavirus-related headwinds. The analyst added that she lowered her revenue estimates to reflect the current reported trends throughout Q2, with some recovery in the back end of 2020. Brill also noted that an Ad Comm panel is expected for LKS-3831, adding further uncertainty to the future revenue outlook.
Alkermes price target lowered to $17 from $20 at Stifel » 12:2504/2904/29/20
Stifel analyst Paul…
Stifel analyst Paul Matteis lowered the firm's price target on Alkermes to $17 from $20 and keeps a Hold rating on the shares. The company withdrawing 2020 guidance confirms that Vivitrol and Aristada, along with long-acting injectable royalties, are likely more sensitive than the average biotech drug to pandemic-related behavioral changes, Matteis tells investors in a post-earnings research note. While Alkermes' Q1 results were "quite strong," there are reasons to be concerned that both Vivitrol and Aristada may come under pressure that could last beyond Q2, contends the analyst.
Alkermes withdraws previous FY20 guidance due to COVID-19 impact » 07:0504/2904/29/20
Due to uncertainties…
Due to uncertainties regarding the impact of the COVID-19 pandemic on Alkermes' operating and financial results, Alkermes withdraws the financial expectations for 2020 set forth in its press release dated Feb. 13, 2020. The company expects that the extent of the impact of COVID-19 on its business will be driven primarily by the severity and duration of the pandemic. While the company has adopted practices to mitigate the impact of COVID-19 disruptions, at this time, it is unable to reasonably estimate the impact of the pandemic on future results.
Alkermes reports Q1 adjusted EPS 1c, consensus (6c) » 07:0404/2904/29/20
Reports Q1 revenue…
Reports Q1 revenue $246.2M, consensus $228.23M.
|Over a month ago|
Alkermes' candidate ALKS 4230 shows anti-tumor efficacy in publication » 07:0504/2204/22/20
Alkermes announced the…
Alkermes announced the publication of preclinical data demonstrating the selectivity and anti-tumor efficacy of its investigational, immunotherapy candidate, ALKS 4230, in the Journal for ImmunoTherapy of Cancer. ALKS 4230, a novel cytokine, is an investigational, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the interleukin-2-induced activation of immunosuppressive cells. The data demonstrated that ALKS 4230 selectively activated the intermediate-affinity IL-2 receptor as intended. Additionally, data from a mouse B6F10 lung metastasis model demonstrated that treatment with ALKS 4230 achieved a maximum of 100% inhibition of tumor growth with one of the doses tested, as compared to treatment with recombinant human IL-2, which achieved a maximum of 70% inhibition of tumor growth with one of the doses tested. In this model, equivalent anti-tumor activity of ALKS 4230 was observed whether it was administered intravenously or subcutaneously. ALKS 4230 treatment of peripheral blood mononuclear cells (PBMCs) from patients with melanoma or renal cell carcinoma resulted in the selective expansion of CD8+ T cells and NK cells with negligible effects on Treg expansion. ALKS 4230 showed superior anti-tumor efficacy to rhIL-2 in a mouse B6F10 lung metastasis model and the ability to achieve equivalent anti-tumor efficacy when administered either intravenously or subcutaneously. ALKS 4230 is currently being studied in both monotherapy and combination settings as part of the Alkermes-sponsored ARTISTRY clinical development program.
Eyeforpharma to hold a virtual conference » 07:5304/1504/15/20
ABBV, ABEO, ALKS, AMGN, AMRN, AZN, BAYRY, BIIB, CRM, DIS, ESALY, FB, GSK, GTHX, LLY, MNK, MRK, MSFT, NVO, NVS, OTSKY, PFE, SEPR, SGEN, SNY, SYNH, TAK
Eyeforpharma Philadelphia will be held virtually on April 14-17 with webcasts starting at 9 am each day. Webcast Link