On July 1, 2019 Merck (NYSE:MRK), known as MSD outside the United States and Canada, will hold its second-quarter 2019 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Tuesday, July 30 (Press release, Merck & Co, JUL 1, 2019, View Source [SID1234537343]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 4263838. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 4263838. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.

On July 1, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported the status of patient recruitment for the Company’s two pivotal phase II trials, one for omburtamab for the treatment of CNS/LM from neuroblastoma and the other for naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma (Press release, Y-mAbs Therapeutics, JUL 1, 2019, View Source [SID1234537342]).

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As of the end of June 2019, all of the 18 planned omburtamab patients have been enrolled. The Company expects the study to remain open and continue enrolling patients until the product potentially becomes available on the market and believes it remains on target to file a biologic license application ("BLA") by the end of 2019 under the breakthrough therapy designation ("BTD") the Company previously received from the FDA. The Company has also previously received orphan drug designation ("ODD") and a rare pediatric disease designation ("RPDD") for omburtamab from the FDA, in each case for the treatment of CNS/LM from neuroblastoma. The RPDD qualifies the Company for receipt of a priority review voucher ("PRV") upon approval of omburtamab for the treatment of CNS/LM from neuroblastoma, if such approval occurs.

For naxitamab, more than 30 patients of a planned total of 37 patients in the Company’s Study 201 have been enrolled as of the end of June 2019. The Company expects the remaining patients to be included in the coming weeks and believes it remains on target for a BLA filing in 2019 under the BTD the Company previously received from the FDA for naxitamab in combination with GM-CSF for the treatment of relapsed/refractory high-risk neuroblastoma. The Company has also previously received ODD and a RPDD from the FDA for naxitamab, in each case for the treatment of relapsed/refractory high-risk neuroblastoma. The RPDD qualifies the Company for receipt of a PRV upon approval of naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma, if such approval occurs.

"We are approaching an important milestone by reaching our initial patient recruitment goals for both compounds and focus on advancing these treatments to give children access," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer, continued, "We believe the two important BLA filings are on track in line with our timelines and previous guidance. We salute and thank health authorities, clinical sites and our staff for their combined efforts in moving these compounds forward towards registration. We hope to see both of these new and important cancer treatments on the market in 2020. We believe these new product candidates have the potential to become historic milestones for pediatric oncology."

On July 1, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (hereinafter "Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported the publication of an initiation report by KEPLER CHEUVREUX, a leading independent European financial services company specialized in research, execution and advisory services (Press release, Onxeo, JUL 1, 2019, View Source [SID1234537341]).

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KEPLER CHEUVREUX will now cover the ONXEO share on the stock exchange*.

The financial analysis published on June 28, 2019 by Kepler Cheuvreux is available on the website View Source, section "Research Public Access".

* This information does not constitute an offer to sell or subscribe, or the solicitation of an order to buy or subscribe for securities in France, Europe, the US or any other country. ONXEO and KEPLER CHEUVREUX have agreed on a service for the production and distribution of financial analyses.

On July 1, 2019 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported organizational changes to align with strategic priorities post European market approval for Hensify (NBTXR3) (Press release, Nanobiotix, JUL 1, 2019, View Source [SID1234537340]). The changes aim to reinforce necessary competencies as strategic priorities evolve, and to help accelerate the company’s longstanding mission to significantly improve outcomes for patients.

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New C-level Appointments and Executive Board Members
Recently appointed CMO Dr. Edwina Baskin-Bey will join the Executive Board. Ms. Anne-Juliette Hermant will be appointed CPO and will join the Executive Board as well.

C-level and Executive Board Departures
As mentioned in a previous press release, former CMO Dr. Elsa Borghi will leave the Executive Board to take on a new function leading innovation and drug discovery. CBO Dr. Bernd Muehlenweg will step down from the Executive Board and exit the company.

New Management Appointments and Responsibilities
Dr. Patrick Tricoli will remain CEO of Nanobiotix Corp, the company’s U.S. affiliate, while also taking on a new role as Global Head of Business Development. Mr. Brandon Owens will join Nanobiotix as its newly appointed VP of Strategic Marketing and Corporate Communications.

Newcomer Biographical Details
Ms. Anne-Juliette Hermant Anne-Juliette Hermant brings over 14 years of experience in HR, talent management and development, acquired across various entities at AXA. Ms. Hermant worked at AXA Partners for 3 years as Global Head of Talent, Development, Culture and Corporate Responsibility. Before AXA Partners, Anne-Juliette served as Chief Learning Officer of the AXA Group and was the Founder and Head of the AXA Research Fund, a €100 million fund created by the AXA Group to support frontier science in all fields related to an understanding of the risks faced by human society. 2 Anne-Juliette was born in Strasbourg, France and grew up between the French overseas territories of Guyane, Martinique and Guadeloupe. She relocated to Lyon and then to Paris to pursue her studies and has remained in the city throughout her career. Anne-Juliette graduated from the Ecole Normale Supérieure and studied Politics at Sciences Po Paris. She holds an Agregation and an M.A. in French literature.

Mr. Brandon Owens Brandon
Owens is a career communications professional that most recently functioned as a Vice President on the Citigroup account at Publicis New York. Mr. Owens was responsible for Citi’s global reputation management communications and focused on integrated campaigns meant to influence policy decisions relevant to banking in over 100 different countries.

Prior to Publicis, Brandon worked at agencies in both New York and Chicago, leading accounts including Procter and Gamble, Verizon Wireless, and Diageo.

Originally, Brandon comes from the Washington, D.C. area of the United States. After starting his career in sales for a small software firm in Baltimore, Maryland, he moved to Chicago to begin his career in advertising. From there he moved to New York City where he presently resides.

Brandon received his B.S. in Business from the Robert H. Smith School of Business at the University of Maryland.

On July 1, 2019 Cytori Therapeutics, Inc. (NASDAQ: CYTX) reported an update on the development of its proprietary drug, ATI-1123, based on recently obtained feedback from the United States Food and Drug Administration (FDA) (Press release, Cytori Therapeutics, JUL 1, 2019, View Source [SID1234537339]). ATI-1123 is a substantially redesigned and reformulated new drug based in part, on the active pharmaceutical ingredient, docetaxel. ATI-1123 may have future clinical utility in a number of difficult to treat cancers.

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The purpose of the Company’s submission was to clarify certain key aspects of the future development plan including: (1) the suitability of the 505(b)(2) pathway for approval of the proposed ATI-1123 drug product, including the proposed listed drug (LD), (2) the adequacy of the referenced clinical, nonclinical and pharmaceutical quality information, in combination with the proposed drug development program, to support the new drug application and (3) any concerns that the FDA may have with regard to other filing issues specific to the product.

Key feedback from the FDA included that a 505(b)(2) application appears to be an acceptable regulatory approach with docetaxel injection as a potentially acceptable LD. Furthermore, the FDA agreed that the completed nonclinical studies are sufficient to support the initiation of the clinical trial of ATI-1123 in patients with platinum-sensitive small cell lung cancer who have progressed at least 60 days after initiation of first-line therapy.

"Small cell lung cancer is an aggressive neuroendocrine malignancy characterized by high metastatic potential and poor relative outcomes," said Dr. Marc H. Hedrick, M.D. "Due to the propensity of small cell lung cancer to metastasize widely and early in the disease course, it is considered the most lethal lung cancer subtype and new therapies such as ATI-1123, are desperately needed for these patients."

ATI-1123 has completed a phase I trial. Based on the FDA feedback, the Company plans to proceed with a follow-on phase II trial in platinum-sensitive small cell lung cancer who have progressed at least 60 days after initiation of first-line chemotherapy.