On October 29, 2018 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its third quarter 2018 financial results on Monday, November 5, after the close of the U.S. financial markets (Press release, Syndax, OCT 29, 2018, View Source [SID1234530322]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Monday, November 5, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 8397904
Domestic Dial-in Number: 855-251-6663
International Dial-in Number: 281-542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

On october 29, 2018 LSK BioPharma (LSKB, Company) reported it has completed patient enrollment in its pivotal Phase 3 trial, ANGEL, which is evaluating the efficacy and safety of rivoceranib plus Best Supportive Care (BSC) compared to placebo plus BSC in patients with advanced or metastatic gastric cancer (Press release, LSK BioPharma, OCT 29, 2018, View Source [SID1234530520]). The ANGEL study is designed to support approval by the U.S Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Korean Ministry of Food and Drug Safety (MFDS) and Taiwan Food and Drug Administration (TFDA).

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"Completion of enrollment in the ANGEL study is an important achievement and a critical milestone for our gastric cancer program and we appreciate all of the support from patients and investigators in accomplishing this global development milestone" said Dr. Sung Chul Kim, LSKB President, "Although rivoceranib has been approved in China, there is still no oral small-molecule angiogenesis inhibitor approved outside of China for gastric cancer. We believe it will be the first such drug for these patients worldwide."

The Company will now focus on follow-up of enrolled patients and preparation of the data for analysis with an expectation that the top-line, unblinded efficacy and safety data will be reported in the second half of 2019. The Company further expects to submit a New Drug Application for rivoceranib with the FDA in late 2019.

About the ANGEL Study

The ANGEL study is a prospective, randomized, double-blinded, placebo-controlled, multinational, multicenter, parallel-group, phase III study to evaluate the efficacy and safety of rivoceranib plus Best Supportive Care (BSC) compared to placebo plus BSC in patients with advanced or metastatic gastric cancer. A total of 459 patients have been randomized in the ANGEL study in 12 countries (in USA, EU, EEC, Japan, Korea and Taiwan). Details of the ANGEL Study can be found at the following link: View Source

About Rivoceranib (Apatinib)
Rivoceranib is the first successful oral small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder Jiangsu Hengrui Medicine Co., Ltd. LSK BioPharma holds the global rights (ex-China). The Company is currently conducting a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.

On October 29, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it will host a conference call on Monday, November 5, 2018, at 4:30 p.m. ET to review its third quarter 2018 financial results and provide an update on the company (Press release, Infinity Pharmaceuticals, OCT 29, 2018, View Source [SID1234530275]).

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A live webcast of the conference call can be accessed in the Investors/Media section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) or 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 8617458. An archived version of the webcast will be available on Infinity’s website for 30 days.

On October 26, 2018 Amgen (NASDAQ:AMGN) reported that it will report its third quarter 2018 financial results on Tuesday, Oct. 30, 2018, after the close of the U.S. financial markets (Press release, Amgen, OCT 26, 2018, View Source;p=RssLanding&cat=news&id=2373775 [SID1234530308]). The announcement will be followed by a conference call with the investment community at 2 p.m. PT. Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen’s senior management team.

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Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On October 26, 2018 XBiotech Inc. (NASDAQ: XBIT) announced today that it was awarded 11 new patents or patent allowances in the third quarter of 2018. Patents issued relate to the Company’s drug candidates bermekimab and 514G3, which target a crucial mediator of chronic inflammation and Staphylococcus aureus (including MRSA), respectively (Press release, XBiotech, OCT 26, 2018, View Source;p=RssLanding&cat=news&id=2373711 [SID1234530155]). The new patents include those issued from European authorities to protect bermekimab when used in the treatment of dermatological pathologies and cancer-associated cachexia. Patent allowances include one each in Australia, Canada, Israel, Mexico, the Philippines, Russia, and South Korea that include covering: bermekimab in the treatment of cardiovascular disease; the 514G3 antibody to treat Staphylococcus aureus infections; and key aspects of the Company’s True HumanTM antibody discovery platform.

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Stanley Kim, Ph.D., J.D., XBiotech’s Corporate Vice President of Intellectual Property, stated, "These recently issued patents reflect XBiotech’s efforts to develop significant worldwide protection for its emerging candidate therapies. The Company’s patent portfolio currently includes over 100 issued patents."

XBiotech’s substantial patent portfolio supports a diverse drug development platform. The Company is currently conducting clinical research with bermekimab as a combination therapy to treat pancreatic cancer. In addition, ongoing evaluation of results from XBiotech’s colorectal cancer programs continues to be conducted to investigate patient response to bermekimab and to further direct the Company’s oncology program. XBiotech has two separate dermatological clinical trials underway investigating response to bermekimab in patients with atopic dermatitis and hidradenitis suppurativa. Both studies are expected to be completed this year or by first quarter 2019. The Company is also currently exploring possibilities of conducting further clinical studies with 514G3 to prevent and treat Staphylococcus aureus infections, as well as bermekimab to prevent and treat cardiovascular disease. XBiotech continues to advance its pipeline for other infectious disease indications, including Clostridium difficile and varicella zoster virus (shingles).

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.