On January 2, 2019 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, reported that Matthew R. Patterson, Chairman and Chief Executive Officer, will provide a corporate overview and 2019 outlook at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, CA (Press release, Audentes Therapeutics, JAN 2, 2019, View Source [SID1234532343]). The presentation is scheduled for Tuesday, January 8, 2019, at 3:30 pm PST.

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To access a live webcast of the presentations, please visit the Events & Presentations page within the Investors & News section of the Audentes website. Replays of live webcasts will be available on the Audentes website for approximately 30 days following the conferences.

On January 2, 2019 Stemline Therapeutics, Inc. (NASDAQ:STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that Ivan Bergstein, M.D., Stemline’s CEO, will present at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019 at 5:00 PM PT at the Westin St. Francis Hotel in San Francisco, CA (Press release, Stemline Therapeutics, JAN 2, 2019, View Source [SID1234532342]). A live webcast of the presentation can be viewed on the company’s website at www.stemline.com.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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About ELZONRIS
ELZONRIS (tagraxofusp), a CD123-directed cytotoxin, was approved by the Food and Drug Administration (FDA) on December 21, 2018 for the treatment of adult and pediatric patients, two years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the European Medicines Agency (EMA) granted ELZONRIS accelerated assessment to the upcoming marketing authorization application (MAA), which is expected to be submitted in the first quarter of 2019. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF) and other CD123 positive diseases.

About BPDCN
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

On January 2, 2019 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on MDS, reported that it has submitted a Special Protocol Assessment request to the U.S. Food and Drug Administration (FDA) for a Phase 3 study of oral rigosertib combination therapy with azacitidine (Vidaza) for the treatment of adult patients with treatment-naïve higher-risk MDS (Press release, Onconova, JAN 2, 2019, Onconova Submits Special Protocol Assessment (SPA) To FDA For Phase 3 Trial Of Oral Rigosertib In Combination With Azacitidine (Vidaza) For First-Line Myelodysplastic Syndromes (MDS) [SID1234532341]). The request is part of the Company’s ongoing interaction with the FDA, following an End-of-Phase 2 Meeting with FDA guidance for the proposed Phase 3 study and Scientific Advice from the European Health Authorities, consistent with the Company’s strategy to study rigosertib in an earlier higher-risk MDS patient population with a more convenient mode of oral rigosertib administration. The End-of-Phase 2 Meeting also outlined that the primary endpoint of the proposed pivotal trial will be overall response rate (ORR), a composite of complete remission (CR), and partial remission (PR) based on the IWG Response Criteria.

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Dr. Steve Fruchtman, President of Onconova, commented: "We remain focused in 2019 on the completion of the pivotal INSPIRE trial studying intravenous rigosertib in higher-risk MDS after patients fail to respond to or progress on hypomethylation therapy, the standard of care. The timely achievement of this regulatory milestone of this SPA submission is an important step in advancing the development of rigosertib for patients with earlier stage higher-risk MDS. We believe that the promising data in hand, including the data from the Phase 2 expansion trial of oral rigosertib and azacitidine presented at this year’s 2018 ASH (Free ASH Whitepaper) Annual Meeting, provides a strong scientific rationale for the proposed Phase 3 program. As the INSPIRE trial continues to mature, we look forward to a constructive engagement with the FDA on future studies. We also aim to help fund these additional studies through expanding our partnerships."

The FDA’s SPA process fosters dialogue between the FDA and clinical trial sponsors before studies commence, in an attempt to reach potential agreement with the agency on the design and size of clinical trials, to determine if they adequately address the scientific and regulatory requirements for a study to ultimately support marketing approval. The Company expects its dialogue with the FDA on this SPA submission to conclude in H1 2019.

On January 2, 2019 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported that the company and its subsidiaries will present at upcoming investor conferences in San Francisco (Press release, Intrexon, JAN 2, 2019, View Source [SID1234532340]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Pieter Rottiers, PhD, Chief Executive Officer of ActoBio Therapeutics, will present at the Biotech Showcase on January 8th, 2019 at 9:00 AM PT at the Hilton San Francisco Union Square.

Thomas D. Reed, PhD, Chief Science Officer of Intrexon and Amit Patel, MD, Founder of Xogenex, will present at the Biotech Showcase on January 9th, 2019 at 8:45 AM PT at the Hilton San Francisco Union Square.

Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon, will present at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9th, 2019 at 11:30 AM PT at the Westin St. Francis Hotel. A live webcast of the presentation will be available on the Investors section of Intrexon’s website at View Source, and a replay of the webcast will be available for 30 days following the event.

Additionally, as previously announced, Helen Sabzevari, PhD, President of Precigen, will be presenting a first-look at Precigen’s preclinical and clinical portfolio at an investor event Monday, January 7, 2019 at 3:00pm PT. The presentation will be available via live audio webcast through Intrexon’s website at View Source. Spaces are available for individuals who would like to participate in-person at the onsite event. For in-person participation, RSVP is required, and all RSVPs must be received at [email protected] by January 6, 2019 at 5:00 pm PT.

On January 2, 2019 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that Kenneth C. Frazier, chairman and chief executive officer, and Dr. Roger M. Perlmutter, president, Merck Research Laboratories, are scheduled to participate at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Jan. 7, 2019 at 4:30 p.m. PST (7:30 p.m. EST) (Press release, Merck & Co, JAN 2, 2019, View Source [SID1234532339]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source