Shares of AstraZeneca plc (ADR) (NYSE:AZN) ended Monday session in red amid volatile trading. The shares closed down -0.42 points or -1.24% at $33.55 with 4.24 million shares getting traded. Post opening the session at $33.67, the shares hit an intraday low of $33.43 and an intraday high of $33.71 and the price vacillated in this range throughout the day. The company has a market cap of $83.68 billion and the numbers of outstanding shares have been calculated to be 1.26 billion shares.
AstraZeneca plc (ADR) (AZN) on Aug. 9, 2016 announced results from the Phase III SELECT-1 trial of the MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment in patients with KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC). Array BioPharma (ARRY) was informed of these results on Monday, August 8, 2016.
The results showed that the trial did not meet its primary endpoint of progression-free survival (PFS), and selumetinib did not have a significant effect on overall survival (OS). The adverse event profiles for selumetinib and docetaxel were consistent with those seen previously.
SELECT-1 is an international trial with 510 randomised patients in over 200 centres. Patients received either selumetinib (75mg, orally, twice daily) or placebo in combination with docetaxel (intravenously, 75mg/m, on day one of every 21-day cycle).
Selumetinib is being explored as a treatment option in registration-enabling studies in patients with differentiated thyroid cancer where the treatment received Orphan Drug Designation, and patients with neurofibromatosis type 1, a genetic disorder that causes tumours to grow along nerve tissue.
Shares of Northwest Biotherapeutics, Inc (NASDAQ:NWBO) ended Monday session in green amid volatile trading. The shares closed up +0.077 points or 14.55% at $0.610 with 4.20 million shares getting traded. Post opening the session at $0.56, the shares hit an intraday low of $0.49 and an intraday high of $0.63 and the price vacillated in this range throughout the day. The company has a market cap of $66.92 million and the numbers of outstanding shares have been calculated to be 113.74 million shares.
Northwest Biotherapeutics, Inc (NWBO) on Sept. 6, 2016 announced that Nasdaq has accepted NW Bio’s proposed remediation plan to resolve Nasdaq’s finding, previously disclosed by the Company, that NW Bio failed to comply with certain Nasdaq listing rules with regard to certain securities issuances to Cognate BioServices, Inc. (“Cognate”). As a result of this acceptance, Nasdaq has notified the Company that it has regained compliance with these rules, and this matter is now closed.
During peak enrollment and expense periods in both the Company’s Phase III clinical trial of DCVax®-L for GBM brain cancer and the Company’s Phase I/II clinical trial of DCVax®-Direct for all types of inoperable solid tumors, the Company paid substantial portions of Cognate’s invoices in restricted stock rather than cash, in order to conserve Company resources, pursuant to agreements entered into in July, 2013 (the “2013 Agreement”), and January, 2014 (the “2014 Agreements). These payments in stock in lieu of cash enabled both of the clinical trials to proceed at full speed during 2013-2015, without suspension or reduction of the trials such as had occurred during the 2008-2011 financial crisis years, which would not otherwise have been possible.
The issuances to Cognate were unregistered restricted shares, were not thereafter registered despite contractual obligations for the Company to register them, and were subject to multi-year vesting and multi-year lock-up periods which prevented Cognate’s shares from coming into the market. Since the Contracts precluded Cognate for years from monetizing any of the shares it received in lieu of cash payment of its invoices, the Contracts also included most favored nation anti-dilution provisions such that if the Company entered into transactions with unrelated investors or creditors at a lower price per share while Cognate was locked up, then the terms of Cognate’s securities would be conformed to the terms of the unrelated investors or creditors.