EDAP Showcases Focal One at the 12th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer

On February 18, 2020 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy-based therapies, reported that the company recently showcased its Focal One high intensity focused ultrasound (HIFU) device at the 12th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer, which was held February 9-11 in Washington, DC (Press release, EDAP TMS, FEB 18, 2020, View Source [SID1234554442]). This marks the first time that the symposium was held in the U.S. since FDA clearance of Focal One in June 2018.

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"We are pleased to have been featured in this very prestigious and highly specialized symposium on focal imaging and therapy that attracts urology thought leaders from around the world," said Marc Oczachowski, Chief Executive Officer of EDAP. "This annual gathering is the most important and referenced event for focal therapy in urology disorders, a rapidly growing modality for the treatment of prostate and kidney cancer, and we were extremely pleased to see the prominent positioning of HIFU in addressing this focal therapy strategy. As a recognized leader in the use of targeted ultrasound for this and possibly other indications in development, we have participated at this symposium since its inception and will continue to do so in the future."

This year’s gathering featured several presentations highlighting the Focal One technology and positive results that the process delivers, including presentations by Dr. Rafael Sanchez-Salas, MD, Department of Urology, L’Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France. Dr. Sanchez-Salas is a highly regarded Robotic Urologist Surgeon and long-time champion of EDAP’s Focal Therapy technologies.

EDAP will provide a detailed commercial and clinical update during the company’s upcoming fourth quarter 2019 results conference call.

About the 12th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer

This three-day symposium incorporates real-time imaging into the diagnostic and treatment strategies for prostate and kidney cancer. Taking part in this meeting hands attendees the opportunity to gain valuable insights through the interactive scientific program: state-of-the art lectures, video demonstrations and hands-on workshops, all delivered by a world-class faculty. The intimate meeting size allows everyone to network with faculty and exchange opinions and experiences.

Mustang Bio Announces First Subject Treated in Phase 1/2 Trial with the Optimized CD20-targeted CAR T Cell Therapy MB-106

On February 18, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that the first subject treated with the optimized MB-106 (CD20-targeted, autologous CAR T cell therapy) manufacturing process, developed in collaboration between Mustang and Fred Hutchinson Cancer Research Center ("Fred Hutch"), has achieved a complete response (CR) at the lowest starting dose in an ongoing Phase 1/2 clinical trial (Press release, Mustang Bio, FEB 18, 2020, View Source [SID1234554441]). The trial is evaluating the safety and efficacy of MB-106 in subjects with relapsed or refractory B-cell non-Hodgkin lymphomas.

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are thrilled to announce that we have achieved a complete response in the first subject dosed with MB-106 following Mustang and Fred Hutch’s enhancement to the cell process. MB-106 targets CD20, a commercially validated target on the surface of cancer cells that has lacked a strong CAR T-based clinical focus in the U.S. The complete response was seen on Day 28 in a subject with relapsed follicular lymphoma, and no cytokine release syndrome or neurologic toxicity were observed. The response was especially encouraging, since the subject received a dose of only 3.3 x 105 CAR T cells/kg. While this initial success of the optimized MB-106 is important, additional clinical testing is necessary. We are looking forward to follow-up data, as well as continuing to establish the safety of the therapy, which appears to be well tolerated to date. We are excited to work further with Fred Hutch to develop MB-106 and anticipate providing additional clinical results by year end."

The Phase 1/2, open-label, dose-escalation trial is evaluating the maximum tolerated dose of MB-106. Secondary endpoints include safety and toxicity, preliminary antitumor activity as measured by overall response rate and complete remission rate, progression-free survival, and overall survival. Fred Hutch intends to enroll approximately 30 subjects on the trial, which is being led by principal investigator Mazyar Shadman, M.D., M.P.H., Assistant Member of Fred Hutch’s Clinical Research Division.

About B-cell Non-Hodgkin Lymphoma (NHL)
There are several forms of NHL, including follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma and small lymphocytic lymphoma, which account collectively for about 45% of all cases of NHL. Most types of NHL are incurable with available therapies, except for allogenic hematopoietic stem cell transplant (allo-SCT). More than 70,000 new cases of B-cell NHL are diagnosed each year in the United States, and more than 19,000 patients die annually due to this group of diseases.

About MB-106 (CD20-targeted CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research partner, Fred Hutchinson Cancer Research Center, in the laboratory of Oliver Press, M.D., Ph.D., and Brian Till, M.D., in the Clinical Research Division and exclusively licensed to Mustang Bio in 2017. MB-106 has been optimized as a third-generation CAR derived from a fully human antibody and is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in B-cell non-Hodgkin lymphoma patients. Additional information on the trial can be found at www.clinicaltrials.gov using the identifier NCT03277729.

FibroGen to Report Fourth Quarter and Full Year 2019 Financial Results

On February 18, 2020 FibroGen, Inc. (NASDAQ: FGEN) reported that it will announce its fourth quarter and full year 2019 financial results after market close on Monday, March 2, 2020 (Press release, FibroGen, FEB 18, 2020, View Source [SID1234554440]). FibroGen will also conduct a conference call on that day at 5:00 p.m. (2:00 p.m. PT) with the investment community to further detail the company’s corporate and financial performance.

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Conference Call and Audio Webcast
Interested parties may access a live audio webcast of the conference call via the FibroGen website at View Source It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

Dial-In Information
Live (U.S./Canada): (877) 658-9081
Live (International): (602) 563-8732
Confirmation number: 8058848

A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (800) 585-8367 (domestic) or (404) 537-3406 (international), and use passcode 8058848#.

Synlogic Announces Participation in Upcoming Investor Conferences

On February 18, 2020 Synlogic (Nasdaq: SYBX) announced today that Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer, will participate in the following upcoming investor conferences (Press release, Synlogic, FEB 18, 2020, View Source [SID1234554439]):

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9th Annual SVB Leerink Global Healthcare Conference on Tuesday, February 25 at 1:00 pm ET in New York
Cowen 40th Annual Health Care Conference on Monday, March 2 at 2:10 pm ET in Boston
Live webcasts of the presentations can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. Archived webcast recordings will be available on the Synlogic website for approximately 30 days after each event.

Syndax Announces Participation at Two Upcoming Investor Conferences

On February 18, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that members of its management team will participate in two upcoming investor conferences (Press release, Syndax, FEB 18, 2020, View Source [SID1234554438]). The details for the two conferences are:

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BTIG Targeted Therapeutics Conference at the St. Regis New York on Monday, February 24, 2020. Panel discussion at 1:00 p.m. ET.
Cowen 40th Annual Healthcare Conference at the Boston Marriott Copley Place on Wednesday, March 4, 2020. Presentation at 11:20 a.m. ET.
A live webcast of the Cowen presentation can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.