DELTA-FLY-PHARMA
2.2.2024 07:16:29 CET | Business Wire | Press release
We are excited to share our latest development status.
As presented at 2022 ASCO Annual Meeting on June 6, 2022, DFP-14323 in combination with afatinib (20 mg/day) in stage III/IV non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutation positive in a Phase II clinical trial, has demonstrated fascinating longer median progression-free survival (mPFS; 23.1 months).
Subsequently, based on these results, we have been in negotiation with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan with the aim of submitting a conditional approval application, resulting in our decision to conduct a Phase III clinical trial (superiority study) of DFP-14323 in combination with afatinib (20 mg/day) versus afatinib (40 mg/day) alone in stage III/IV non-small cell lung cancer patients with uncommon EGFR mutation positive based on the PMDA's recommendation.
And finally, we are pleased to announce that the submission of the protocol for the Phase III study to the PMDA has been approved and are ready to initiate the study.
This Phase III clinical trial will be conducted at 30 sites in Japan and if the superiority of the add-on effect of DFP-14323 on progression-free survival (PFS) as primary endpoint, is confirmed in this trial, we believe that DFP-14323 will be a novel cancer immunotherapy drug with highly beneficial for patients and their families, as it is orally available, safe, and economical.
Furthermore, if non-inferiority to osimertinib (80 mg/day) can be confirmed in a comparative study, a huger market can be expected.
We intend to continue negotiations for out-licensing opportunities with pharmaceutical companies for the territory outside Japan.
Please find out the innovation for the miserable cancer patients by Delta-Fly Pharma Inc. (TOKYO:4598) and contact with us.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240201128942/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Empire State Building Observation Deck Debuts New Family Bundle Ticket Options13.7.2026 22:30:00 CEST | Press release
Groups of four can save up to 20% on Observation Deck tickets purchased online The Empire State Building Observation Deck (ESBOD), atop the “World’s Most Famous Building,” announced today new ticket bundle options for families of all ages to save on their visit to the famed New York City landmark. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260713003884/en/ Empire State Building Observation Deck Debuts New Family Bundle Ticket Options Groups of four who purchase the new Family Ticket Bundle can save up to 20 percent on tickets to the Empire State Building’s iconic 86th and 102nd Floor Observation Decks, with options for express access and flex admission. The Family Ticket Bundle is available online only. “The Empire State Building Observation Deck is one of the best activities for families in NYC with immersive, educational museum exhibits and Manhattan’s best skyline views,” said Dan Rogoski, observatory general manager.
Kinaxis Inc. to Host Second Quarter 2026 Financial Results Conference Call on August 6, 202613.7.2026 22:05:00 CEST | Press release
Kinaxis® Inc. (TSX:KXS), a global leader in end-to-end supply chain planning and orchestration, today announced that it has scheduled a conference call to discuss its financial results for the second quarter ended June 30, 2026. The call will be hosted on Thursday, August 6, 2026, at 8:30 a.m. Eastern Time by Razat Gaurav, Chief Executive Officer, and Peter Yaraskavitch, Vice President, Financial Planning and Analysis, followed by a question and answer period. The Company will report its financial results for the second quarter after the close of markets on Wednesday, August 5, 2026. CONFERENCE CALL DETAILS DATE: Thursday, August 6, 2026 TIME: 8:30 a.m. Eastern Time WEBCAST: https://events.q4inc.com/attendee/854228135 (available for three months) About Kinaxis Kinaxis is a leader in modern supply chain orchestration, powering complex global supply chains and supporting the people who manage them. Our powerful, AI-infused supply chain orchestration platform, Maestro, combines proprietar
PagerDuty Announces Arnaud Lagarde, Vice President of EMEA13.7.2026 22:05:00 CEST | Press release
PagerDuty, Inc. (NYSE: PD), a leader in AI-first operations management, today announced the appointment of Arnaud Lagarde as vice president of EMEA. Lagarde will lead PagerDuty’s next phase of growth in the EMEA region, bringing the entire incident management lifecycle to customers across EMEA to solve their biggest digital challenges. “We are thrilled to appoint Arnaud as vice president of EMEA, since he brings a wealth of enterprise sales relationships and years of experience growing this region,” said Todd McNabb, chief revenue officer at PagerDuty. “Arnaud brings a specific combination of deep technical expertise and leadership that will be critical for PagerDuty’s customers, partners and employees. He is a great fit for PagerDuty and we look forward to his impact.” Lagarde brings to the role over 20 years of experience spanning companies like Automation Anywhere, CA Technologies and BMC. Over the past two decades, he has worked closely with founders, investors and executive teams
Samos Energy Acquisition Corporation Announces Closing of $230 Million Initial Public Offering13.7.2026 21:42:00 CEST | Press release
Samos Energy Acquisition Corporation (the “Company”) announced today the closing of its initial public offering (“IPO”) of 23,000,000 units, including the full exercise by the underwriters of their overallotment option to purchase an additional 3,000,000 units. The offering was priced at $10.00 per unit, resulting in gross proceeds to the Company of $230,000,000. The units began trading on the New York Stock Exchange (the “NYSE”) under the ticker symbol “SAMO.U” on July 10, 2026. Each unit consists of one Class A ordinary share and one-half of one redeemable warrant, with each whole warrant entitling the holder thereof to purchase one of the Company’s Class A ordinary shares at an exercise price of $11.50 per share. Once the securities comprising the units begin separate trading, the Class A ordinary shares and warrants are expected to be listed on the NYSE under the symbols “SAMO” and “SAMO.WS,” respectively. Of the proceeds received from the consummation of the initial public offerin
Kina, EU-respondenter optimistiske om fremtidsudsigterne for samarbejde: GT survey13.7.2026 20:46:00 CEST | Pressemeddelelse
Kina og EU har haft etablerede diplomatiske forbindelser i mere end et halvt århundrede. Fra etableringen af formelle diplomatiske forbindelser til udviklingen til et omfattende strategisk partnerskab er Kina-EU-forbindelserne blevet et af de mest indflydelsesrige bilaterale forhold i verden i dag. Ud over Kina gennemførte Global Times Institute (GTI) fra den 16. oktober til den 4. november 2025 en spørgeskemaundersøgelse i 20 EU-medlemsstater, herunder Danmark, Sverige, Spanien, Belgien og Tyskland, ved hjælp af 21 sprog som spansk, fransk, tysk og kinesisk. Mere end 16.300 gyldige spørgeskemaer blev indsamlet. Undersøgelsesdataene viser, at et flertal af befolkningen i både Kina og EU er interesserede i hinandens kulturer, har stor tillid til fremtiden for det kinesisk-europæiske økonomiske og handelsmæssige samarbejde, og støtter styrket samarbejde mellem Kina og EU inden for global styring. Høj grad af bevidsthed og vilje til kommunikation Denne undersøgelse viser, at befolkningen
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom