Shares of Exelixis, Inc. (NASDAQ:EXEL) ended Tuesday session in red amid volatile trading. The shares closed down -0.28 points or -2.20% at $12.44 with 5.27 million shares getting traded. Post opening the session at $12.75, the shares hit an intraday low of $12.32 and an intraday high of $12.97 and the price vacillated in this range throughout the day. The company has a market cap of $2.85 billion and the numbers of outstanding shares have been calculated to be 230.33 million shares.
Exelixis, Inc. (EXEL) announced that the company and its partner Ipsen will jointly host a live investor and media briefing at the European Society for Medical Oncology (ESMO) 2016 Congress. The event will be held on Monday, October 10, 2016, with the program beginning at 19:00 CEST (local Copenhagen time) / 1:00 p.m. EDT / 10:00 a.m. PDT following on-site registration starting at 18:30 CEST.
During the briefing, Exelixis and Ipsen management and invited guests will discuss and provide context for clinical data for cabozantinib presented at the ESMO 2016 Congress. Key topics will include CABOSUN, the randomized phase 2 trial of cabozantinib compared with sunitinib in patients with previously untreated advanced renal cell carcinoma, which will be the subject of a late-breaking oral presentation during ESMO’s Presidential Symposium 3 earlier in the day. Presenters will also review data from the ongoing phase 1b trial evaluating the combination of cabozantinib and nivolumab in patients with genitourinary tumors.
The briefing will also be webcast live and available via conference call starting at 19:00 CEST / 1:00 p.m. EDT / 10 a.m. PDT on Monday, October 10. To access the webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under Investors & Media. Please connect to the company’s website at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be required to listen to the event. To participate by phone, please dial 855-299-5224 (domestic) or 631-267-4890 (international/toll dial) and use passcode 234-026-024. Please see the Event Calendar page for details on replay options once available.
Shares of AstraZeneca plc (ADR) (NYSE:AZN) ended Tuesday session in red amid volatile trading. The shares closed down -0.43 points or -1.30% at $32.57 with 5.42 million shares getting traded. Post opening the session at $32.97, the shares hit an intraday low of $32.33 and an intraday high of $33.27 and the price vacillated in this range throughout the day. The company has a market cap of $82.01 billion and the numbers of outstanding shares have been calculated to be 1.26 billion shares.
AstraZeneca plc (ADR) (AZN) announced that the US Food and Drug Administration (FDA) has approved a blood-based companion diagnostic for TAGRISSO® (osimertinib). The companion diagnostic for TAGRISSO is the only FDA-approved and clinically validated companion diagnostic test that uses either tissue or a blood sample to confirm the presence of a T790M mutation in patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), who have progressed on or after an EGFR tyrosine kinase inhibitor (TKI) medicine.
The approval provides a new, non-invasive option to identify patients with metastatic EGFR T790M mutation-positive NSCLC, ensuring that those patients who may not be suitable for biopsy procedures have an opportunity to be tested. Blood-based testing for the presence of the mutation is recommended only when a tumor biopsy cannot be obtained. Patients who test negative for the T790M mutation with the blood-based test, and their physicians, should re-evaluate the feasibility of tissue-based testing to confirm the presence of the EGFR T790M mutation.
The companion diagnostic, cobas® EGFR Mutation Test v2, was developed by Roche Molecular Systems. The test enables identification of patients who have the T790M mutation at disease progression, and is initially available through Baystate Health, Carolinas HealthCare System, Laboratory Corporation of America® Holdings (LabCorp®), and PhenoPath.
“Blood-based testing has the potential to rapidly identify patients eligible for targeted therapy, who may not be eligible for biopsy. Availability of this blood-based test may help aid treatment decisions,” said Balazs Halmos, MD, Montefiore Medical Park, Albert Einstein College of Medicine.
“The availability of an FDA-approved, blood-based companion diagnostic is a tremendous step forward for patients with lung cancer in need of a high-quality test that provides results with a rapid turnaround time. This development offers an important option for the identification of the T790M mutation in patients with metastatic EGFR mutation-positive NSCLC who have progressed on an EGFR TKI medicine, for whom a tissue biopsy may not be feasible,” said Andrew Coop, Vice President, US Medical Affairs, Oncology, AstraZeneca. “Delivering targeted therapies, such as TAGRISSO, to the right patients at the right time demonstrates our commitment to testing and quality companion diagnostics.”