On September 14, 2020 ESSA Pharma Inc. (NASDAQ: EPIX) (TSXV: EPI) ("ESSA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer reported that the U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to EPI-7386, its oral and highly-selective N-terminal domain inhibitor of the androgen receptor, for the treatment of adult male patients with metastatic castration-resistant prostate cancer ("mCRPC") resistant to standard-of-care treatment (Press release, ESSA, SEP 14, 2020, View Source [SID1234565127]).

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"We are pleased with the FDA’s decision to grant Fast Track designation for development of EPI-7386 to treat mCRPC patients resistant to standard-of-care treatments," said Dr. David R. Parkinson, Chief Executive Officer of ESSA Pharma. "This designation signifies recognition of the unmet medical need for new and effective treatments for this patient population. EPI-7386 may represent a promising novel treatment option for these patients and the designation offers the opportunity to interact more closely with the FDA during the development of EPI-7386."

Fast Track is a designation granted by the FDA that is intended to facilitate development and expedite review of drugs to address an unmet medical need in the treatment of a serious life-threatening condition, and for which nonclinical or clinical data has demonstrated the potential of the drug to address this medical need.

A drug that receives Fast track Designation is eligible for some, or all, of the following:

Eligibility for accelerated approval and priority review, if relevant criteria are met
Rolling review, enabling ESSA Pharma to submit completed sections of its New Drug Application ("NDA") for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed (NDA review usually does not begin until the Company has submitted the entire NDA to the FDA)
More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data to support drug approval
More frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers
About EPI-7386 Phase 1 Study
The Phase 1 clinical trial (NCT04421222) expects to enroll approximately 18 mCRPC patients in the dose escalation part of the study at selected clinical sites in the United States and Canada, with an additional ten patients planned to be enrolled in a dose expansion cohort involving additional clinical sites. The study will evaluate the safety and tolerability of EPI-7386 while additionally characterizing the pharmacokinetic, biological and anti-tumor effects of therapy.

On September 14, 2020 Amyris, Inc. (Nasdaq: AMRS), a leading synthetic biotechnology company in Clean Health and Beauty markets through its consumer brands, and a top supplier of sustainable and natural ingredients, reported that John Melo, President and Chief Executive Officer, will provide a business overview and update on current affairs during the H.C. Wainwright 22nd Annual Global Investment Virtual Conference today (Press release, Amyris Biotechnologies, SEP 14, 2020, https://www.prnewswire.com/news-releases/amyris-to-provide-business-overview-and-update-on-current-affairs-at-hc-wainwright-22nd-annual-global-investment-conference-today-301129839.html [SID1234565126]). The company will also be participating in virtual one-on-one meetings during the conference.

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The company’s presentation is at 10:00 a.m. ET today. A live webcast of the presentation including slides and a replay will be available on the investor relations section of the company’s website at View Source Due to the format of the virtual conference, no audience question and answer session will be available.

On September 14, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that Marc N. Casper, chairman, president and chief executive officer, will present virtually at the Morgan Stanley Global Healthcare Conference on Tuesday, September 15, 2020, at 8:00 a.m. (ET) (Press release, Thermo Fisher Scientific, SEP 14, 2020, View Source [SID1234565125]).

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You can access the live webcast of the presentation via the Investors section of our website, www.thermofisher.com.

On September 14, 2020 Agendia, Inc. a world leader in precision oncology for breast cancer reported that new clinical data from its ongoing research in breast cancer is to be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, September 19-21 (Press release, Agendia, SEP 14, 2020, View Source [SID1234565123]).

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The first presentation will feature data on the use of MammaPrint to determine the need for endocrine therapy in postmenopausal patients. The findings of this study build on data from the Stockholm Tamoxifen Trial, previously published by Esserman, et al in JAMA Oncology. The second presentation will illustrate the fact that the 10 Hallmarks of Cancer, as described by Hanahan and Weinberg, are represented in the genomic signatures of MammaPrint and BluePrint.

"We are very pleased with the data that has been selected for presentation at this year’s virtual ESMO (Free ESMO Whitepaper) congress," said William Audeh, MD, Chief Medical Officer of Agendia, Inc. "We are excited to share these updates with world-renowned oncologists, researchers and the broader oncology community, to further highlight the essential value of MammaPrint and BluePrint for clarifying the complexity of breast cancer, and guiding treatment decisions that are the right fit for patients with early stage breast cancer."

The following posters will be available on the ESMO (Free ESMO Whitepaper) Website in the On-Demand E-Poster Display section beginning Thursday, September 17th at 9:00 AM CEST.

Presentation 171P: Avoid systemic overtreatment of postmenopausal breast cancer patients with ultralow MammaPrint result
Presentation 220P: Annotating MammaPrint and BluePrint gene profile to the Hallmarks of cancer and understanding the biology of MammaPrint extreme risk groups
These data underscore Agendia’s mission to further research and provide new tools that support early intervention and treatment planning for patients with breast cancer. For further information, please visit View Source

Please follow us on our Twitter, Facebook and LinkedIn pages for unique content we will be sharing throughout ESMO (Free ESMO Whitepaper) 2020.

On September 14, 2020 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the "Company") reported an update on the upcoming special meeting of stockholders (the "Meeting") in response to recent stockholder inquiries regarding the number of meeting adjournments (Press release, Titan Pharmaceuticals, SEP 14, 2020, View Source [SID1234565122]). The sole purpose of the Meeting is to seek approval of a proposal to amend Titan’s certificate of incorporation to increase the number of authorized shares of common stock.

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Without approval of the share increase, the several strategic alternatives management has been exploring with the Company’s bankers will not be possible. The failure to obtain stockholder approval will almost certainly result in the cessation of Titan’s operations and likely a total loss of value to stockholders, given the pledge of all of the Company’s assets as security for its outstanding debt.

The goal of Titan’s Board of Directors is to enable as many stockholders as possible to exercise their right to vote. In contrast to many other types of proposals, the amendment to effect the share increase requires a higher hurdle – the affirmative votes from a majority of the outstanding shares entitled to vote. Since Titan has a large retail stockholder base, this task poses greater challenges than in the past. Importantly, some of the newer, popular brokerage firms do not exercise their permitted discretion to vote shares held in their accounts without explicit direction from the beneficial holder, and companies such as Titan are finding it quite difficult and time consuming to reach individual investors who hold shares in street name.

Prior to each meeting adjournment, the Board examined the voting data and determined, in light of the fact that a substantial majority of votes received to date have been in favor of the proposal, that it would be in the best interest of stockholders to extend the date of the meeting, particularly in light of the stakes involved. As of the close of business on September 11, 2020, approximately 30.7 million shares (28.3% of the record date shares) had not yet been voted. Of those shares that were voted, approximately 72% were in favor of the amendment proposal. The affirmative vote of holders of only 1,251,207 shares (less than 1.5% of the record date shares) are now needed to file the amendment and effect the authorized share increase.

"I and my fellow Board members would like to thank those stockholders who have already voted in favor of the proposal, which if approved should enable the continuation of Titan’s operations by facilitating the raising of capital as well as the pursuit of strategic alternatives," said Titan’s Executive Chairman, Dr. Marc Rubin. "And, to those who have not yet voted, we implore you to do so now."