On January 2, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported that it will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 9th at 8:00 a.m. PST/ 11:00 a.m. EST. Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer will provide a corporate update at the conference (Press release, Mirati, JAN 2, 2019, View Source [SID1234532381]).

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The presentation will be webcast and made available through the "Investors" section of www.mirati.com, and replays will be made available for 90 days following the events.

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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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, 2018 FLX Bio, Inc., a clinical-stage, biopharmaceutical company focused on the development of oral small-molecule drugs that target immune drivers of cancer and other immune-related disorders, reported that Brian Wong, M.D., Ph.D., CEO will present at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9, 2019 at 7:30 a.m. Pacific Standard Time in San Francisco, CA (Press release, FLX Bio, JAN 2, 2019, View Source [SID1234532361]). Dr. Wong will provide a corporate update and company overview.

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On January 2, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that management will present at the J.P. Morgan Healthcare Conference onMonday, January 7, 2019 at 2:30 p.m. ET (11:30 a.m. PT) (Press release, Vertex Pharmaceuticals, JAN 2, 2019, View Source [SID1234532399]).

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The audio portion of management’s remarks can be accessed live through Vertex’s website, www.vrtx.com, in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company’s website.

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.