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Delta-Fly Pharma, Inc. is granted Orphan Drug Designation by US Food and Drug Administration for DFP-10917

Business Wire
·1 min read

TOKUSHIMA, Japan, December 07, 2022--(BUSINESS WIRE)--Delta-Fly Pharma, Inc. announces that DFP-10917, a leading pipeline of the company, is granted Orphan Drug Designation (ODD) by US Food and Drug Administration (FDA) for the treatment of Acute Myeloid Leukemia (AML).

Be given to ODD, Delta-Fly Pharma, Inc. can be entitled to seven extra years of marketing exclusivity and receive some benefits such as R&D rebate by getting approval.

DFP-10917 is an anti-cancer agent in development for the treatment of patients with Refractory/Relapsed AML. A Phase 3 clinical study has been underway at MD Anderson Cancer Center in Texas and other major sites of Hematologic Cancer Treatment in USA. The company expects to complete the patients’ enrollment plan soon.

Delta-Fly Pharma, Inc. focuses not only on cancer itself but on the whole conditions of cancer patients, and aims to deliver medicines that are recommendable for cancer patients and their families.

Company profile

Company name

Delta-Fly Pharma, Inc. [Tokyo:4598]

Capital

3352 million Japanese Yen

Name and Title of Representative

Kiyoshi Eshima, PhD, President

Date of Incorporation

December 6, 2010

Description of Business

Research and development, manufacturing and marketing of pharmaceuticals

Head Office

37-5, Nishikino, Miyajima, Kawauchi-cho, Tokushima 771-0116, Japan

Branch Office

Tokyo, Beijing, Vancouver

View source version on businesswire.com: https://www.businesswire.com/news/home/20221206006153/en/

Contacts

Delta-Fly Pharma, Inc.
Inquiries: Yasuo Matsueda
TEL: +81-(0)3-6231-1278
ymatsueda1206@delta-flypharma.co.jp
https://www.delta-flypharma.co.jp/en/

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