Target to $576 from $514
Wednesday, October 26, 2022
Bionano: Commercial Availability of 1st Ultra High Molecular Weight DNA Extraction Automation Solution
Hamilton and Bionano Genomics, Inc. (Nasdaq: BNGO) announced today that the Long String VANTAGE, a system for automated, high throughput isolation of ultra high molecular weight (UHMW) DNA for use in optical genome mapping (OGM) is commercially available. The Long String VANTAGE is the result of collaborative development from the companies and features new and innovative tools and consumables used for consistent, high-quality UHMW DNA extraction using human blood samples. The Long String VANTAGE is expected to begin shipping in Q1 2023.
Since first announcing their collaboration at the European Society of Human Genetics Conference in June 2022, the companies have continued to test and refine their walk-away automation solution for UHMW DNA extraction. Hamilton’s Long String Genomics product program supports the extraction of UHMW DNA at increased scale. Initial testing has been performed on cell lines and blood samples, with bone marrow aspirates (BMA) and other sample types expected soon. Results also confirmed that labs can process up to 12 UHMW DNA samples per run and 24 UHMW DNA samples with high consistency and reproducibility in an eight-hour workday. The automated workflow marks a significant improvement over the manual method, dramatically reducing the hands-on time and the number of samples that can be purified to UHMW DNA.
The companies continue to collaborate with select clinical research laboratories to test and further develop applications with different sample types for the use of the Long String VANTAGE and the Bionano Prep SP kits. Ongoing developments will focus on the automation of UHMW DNA extraction from BMA. Hamilton plans to start taking orders for new solutions October 25, 2022. Bionano will support orders with modified and automation ready versions of the Bionano Prep SP reagent kits, and a modified compatible direct label and stain (DLS) kit.
https://finance.yahoo.com/news/hamilton-bionano-genomics-announce-commercial-120000967.html
AstraZeneca: Capivasertib + FASLODEX improved progression-free survival vs. FASLODEX in Phase III trial
Positive high-level results from the CAPItello-291 Phase III trial showed that AstraZeneca’s capivasertib in combination with FASLODEX® (fulvestrant) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo plus FASLODEX in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-low or negative locally advanced or metastatic breast cancer, following recurrence or progression on or after endocrine therapy (with or without a CDK4/6 inhibitor).
The trial met both primary endpoints, improving PFS in the overall patient population and in a prespecified biomarker subgroup of patients whose tumors had qualifying alterations in the PIK3CA, AKT1 or PTEN genes. Although the overall survival (OS) data were immature at the time of the analysis, early data are encouraging. The trial will continue to assess OS as a key secondary endpoint.
The safety profile of capivasertib plus FASLODEX was similar to that observed in previous trials evaluating this combination.
https://finance.yahoo.com/news/capivasertib-plus-faslodex-fulvestrant-significantly-110000919.html
AstraZeneca: Camizestrant Improved Progression-free Survival Vs. FASLODEX in Phase II Breast Cancer
Positive high-level results from the SERENA-2 Phase II trial showed that AstraZeneca’s next-generation oral selective estrogen receptor degrader (ngSERD) camizestrant met the primary endpoint of demonstrating a statistically significant and clinically meaningful progression-free survival (PFS) benefit at both 75mg and 150mg dose levels versus FASLODEX® (fulvestrant) 500mg in post-menopausal patients with estrogen receptor (ER)-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy for advanced disease.
Camizestrant was well tolerated, and its safety profile was consistent with that observed in previous trials with no new safety signals identified.
https://finance.yahoo.com/news/camizestrant-significantly-improved-progression-free-110500642.html
Integra LifeSciences ups guidance after Q3
Third quarter revenues of $385 million decreased 0.4% on a reported basis and increased 3.5% on an organic basis compared to the prior year.
Third quarter GAAP earnings per diluted share of $0.60, compared to $0.51 in the prior year; adjusted earnings per diluted share of $0.86, compared to $0.86 in the prior year.
The Company completed the sale of its non-core traditional wound care (“TWC”) business at the end of August 2022.
The Company is raising its earnings per share outlook to a range of $3.29 to $3.33 and reaffirming its full-year 2022 revenue guidance at the midpoint of its prior guidance with a tightened range of $1,551 million to $1,563 million. The revenue range represents reported growth of 0.5% to 1.3%, inclusive of the divestiture of the TWC business and an updated foreign currency outlook, with organic growth of 3.7% to 4.5%.
Iqvia ups guidance after Q3
Full-Year 2022 Guidance
For the full year of 2022, the company continues to expect low-to-mid teens organic revenue growth at constant currency, excluding COVID-related work. To reflect primarily the impact of the strengthening US dollar and to a lesser extent, minor delays in the timing of certain trial deliveries due to external macro factors, the company is updating its full-year 2022 revenue guidance range assuming foreign exchange currency rates as of October 24, 2022. The company now expects revenue to be between $14,325 million and $14,425 million, representing growth of 7.4 to 8.2 percent at constant currency, and 3.2 to 4.0 percent on a reported basis. The company is also updating its Adjusted EBITDA guidance range to be $3,330 million to $3,360 million, representing growth of 10.2 to 11.2 percent. Additionally, the company is raising Adjusted Diluted Earnings per Share by 5 cents at the midpoint. Adjusted Diluted Earnings per Share is expected to be between $10.10 to $10.20, up 11.8 to 13.0 percent on a reported basis.
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