Lexicon Pharmaceuticals (NASDAQ: LXRX)
Previous close $8.45 | Premarket high $11.50
Why the move?
Shares of Lexicon Pharmaceuticals are trading over 32% higher in this morning’s pre-market session with highs hitting over $11 a share.
Lexicon this morning announced positive top line results for their phase III ‘TELESTAR’ clinical trial.
TELESTAR met its principal endpoint which was to demonstrate the effect of oral Telotristat etiprate in treating cancer patients with inadequately controlled carcinoid syndrome.
The results of the study showed that patients who added Telotristat to the standard of care at both the 250 mg and 500 mg doses experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period.
Lexicon President and Chief Executive Officer Lonnel Coats commented “We are extremely pleased with these top-line results. Carcinoid syndrome is severely debilitating, preventing many patients from leading active and predictable lives, and unfortunately, a majority of patients will not be adequately controlled over time with the current standard of care. We are committed to working closely with the FDA to file our first new drug application (NDA) and to bring this innovative new treatment to patients whose lives are already impacted by the challenges of cancer.”
This news suggests great things for Lexicon Pharmaceuticals in the future as the FDA orphan drug Fastrack they now have is not easy to come by and if approved Telotristat Etiprate will be the first addition to the standard of care for carcinoid syndrome in more than 16 years.
About Lexicon Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in oncology, diabetes and metabolism. www.lexpharma.com
Orasure Technologies. (NASDAQGS: OSUR)
Previous close $4.94 | Premarket high $5.58
Why the move?
Shares of OSUR gapped up over 10% this morning in pre-market trading.
This move followed the announcement of FDA Emergency use authorization for Orasures Rapid Diagnostic Ebola Test.
This test is not approved by the FDA however it has been authorized for use by laboratories and facilities deemed adequately capable of testing for Ebola, even extending to public health clinics.
The OraQuick(R) Ebola Rapid Antigen Test is designed to detect viral antigens in fingerstick and venous whole blood from patients presenting with signs and symptoms of Ebola infection in conjunction with epidemiological risk factors. The test is authorized only for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014). Positive (reactive) results may be read as soon as they appear and have been observed as early as 4 minutes. Negative (non-reactive) results have to be read at 30 minutes. The test can be used at ambient temperatures (up to 40*C / 104*F), is easy to use with only two operational steps, a simple visual read, and does not require instrumentation. Additionally, the test is shelf stable in a wide range of storage conditions.
Douglas A. Michels, President and CEO of OraSure, noted:
“The OraQuick(R) Rapid Ebola Antigen Test is an easy to use, rapid test, that we believe will be a critical tool in containing and controlling current outbreaks of the Ebola virus We are grateful to the FDA for working closely with us throughout the EUA process to expedite deployment of our test.”
About Orasure Technologies
OraSure Technologies is a leader in the development, manufacture and distribution of point of care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick(R) platform, oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications, and oral fluid laboratory tests for detecting various drugs of abuse. OraSure’s portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians’ offices, commercial and industrial entities and consumers. The Company’s products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health. www.orasure.com