On July 19, 2018 AVEO Oncology (NASDAQ: AVEO) reported the following statement regarding its recently revised guidance on the timing of topline data from the TIVO-3 study, its Phase 3 trial of tivozanib as a third-line treatment for advanced renal cell carcinoma (Press release, AVEO, JUL 19, 2018, View Source;p=RssLanding&cat=news&id=2358973 [SID1234527784]).

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"The Company expects to report topline results from the TIVO-3 study in the fourth quarter of 2018, approximately 6-8 weeks after the trial records 255 progression free survival (PFS) events. This change in guidance from the third quarter of 2018 is the result of PFS events occurring slower than forecasted, combined with ten patients being removed or ‘censored’ from the PFS event count. The one-time adjustment in the event count is the result of an administrative error that occurred from counting, as PFS events, the deaths of ten patients who had left the study without documented radiographic progression. These deaths will be counted only as overall survival (OS) events. Per regulatory guidance and the TIVO-3 protocol, among patients who leave the study without documented disease progression, only those who die within eight weeks of their last study assessment and have not started another therapy can be counted as a PFS event. Following the adjustment, and as of yesterday, the PFS event count is 243."

"Study data remains blinded to the Company and no changes in study assumptions have been made. The administrative error was discovered as part of the data cleaning and review process. The data review process was initiated in an effort to shorten the data analysis period between reaching the 255 PFS events (database lock) and the announcement of topline data. By correcting the administrative error prior to database lock, the intended statistical powering of the study has been unaffected. The Company plans to announce when 255 PFS events have occurred and the topline data analysis for the trial has been initiated."

On July 19, 2018 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:30 a.m. ET (1:30 p.m. BST) on Thursday, July 26, 2018, to discuss the company’s second quarter 2018 financial results (Press release, Alkermes, JUL 19, 2018, View Source;p=RssLanding&cat=news&id=2359115 [SID1234527783]). Management will also provide an update on the company.

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Thursday, July 26, 2018, through 5:00 p.m. ET (10:00 p.m. BST) on Thursday, Aug. 2, 2018, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.

On July 19, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported the appointment of Anthony G. Quinn, M.B Ch.B, Ph.D. as the Company’s President and Chief Executive Officer, effective immediately (Press release, Aeglea BioTherapeutics, JUL 19, 2018, View Source [SID1234527782]). Dr. Quinn has been a member of the Company’s Board of Directors since 2016 and had served as interim CEO since July 2017.

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"Aeglea has made great progress over the last 12 months with compelling data from the Company’s lead program pegzilarginase under Anthony’s leadership," said Armen Shanafelt, Ph.D., Chairman of Aeglea’s Board of Directors. "The Board is looking forward to continue working with him as we progress through the next phase of Aeglea’s evolution. In addition to his technical expertise, Anthony has shown himself to be an extremely talented executive who focuses on patients and on delivering shareholder value. As a Board, we are excited by both the potential of Aeglea’s pipeline and the clinically relevant treatment effects seen with pegzilarginase in patients with Arginase 1 Deficiency."

"I am honored to have the opportunity to lead Aeglea at this stage in the Company’s development and thrilled to be able to shape the next stage of our journey with the Aeglea team as we advance therapies with the potential to improve the lives of patients with devastating diseases," said Dr. Quinn. "The Company occupies a unique and exciting area in the biotechnology industry with its focus on discovering novel human enzyme-based therapeutics for patients with rare genetic diseases and cancer. I believe we are now well positioned for future growth with our pipeline programs and our expanded in-house drug-hunting capabilities."

Prior to joining Aeglea, Dr. Quinn served as executive vice president, head of research and development, and chief medical officer at Synageva Biopharma Corp. until the company’s acquisition by Alexion Pharmaceuticals in 2015. Dr. Quinn previously served as worldwide head of clinical research and exploratory development for inflammatory diseases at Roche. He also was a professor of dermatology at Barts and The London School of Medicine. Dr. Quinn received his Bachelor of Medical Science and his M.B Ch.B from the University of Dundee, and his Ph.D. from the University of Newcastle upon Tyne. Dr. Quinn completed a postdoctoral fellowship at the University of California San Francisco and is a fellow of the Royal College of Physicians London.

On July 19, 2018 Cerus Corporation (Nasdaq:CERS) reported that its second quarter results will be released on Thursday, August 2, 2018, after the close of the stock market (Press release, Cerus, JUL 19, 2018, View Source [SID1234527777]). The company will host a conference call and webcast at 4:15 P.M. EDT that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 8278017. The replay will be available approximately three hours after the call through August 16, 2018.

On July 18, 2018 BioCure Technology Inc. (CSE:CURE, OTCQB;BICTF) ("BioCure" or the "Company") reported that its wholly owned subsidiary BiocurePharm Corporation ("BP Korea"), has implemented the preclinical trial of Interferon Beta 1b since late 2017 and is pleased to update shareholders on their progress (Press release, Biocure Technology, JUL 18, 2018, View Source [SID1234628761]). BP Korea announces that it has completed most of the toxicity testing and has developed MCB (Master Cell Bank) and WCB (Working Cell Bank). Currently, BP Korea is in the middle of in-Vivo potency test. The Company has already produced 35,000 vials of Interferon Beta 1b for their pre-clinical trial and stability test at the GMP manufacturing facility in Korea. BP Korea expects the pre-clinical trial shall be completed by the end of Q1, 2019 and will advance to clinical trial in 3Q 2019.

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Dr. Sang Mok Lee, CEO comments "We are making every effort to commercialize Interferon Beta, 1b, the first Biosimilar of the Company by 2021. BP Korea is in discussion with potential foreign partners to implement a clinical trial and produce Interferon Beta 1b in their countries through a partnership, once the pre-clinical trial is completed in Korea. We strongly believe that such partnerships could provide patients in those countries with much more affordable access to Interferon Beta."