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
Galderma’s Relfydess™ (relabotulinumtoxinA) Receives Approval in China for Frown Lines23.10.2026 07:00:00 CEST | Press release
The Chinese National Medical Products Administration (NMPA) has approved Relfydess™, the first and only ready-to-use liquid neuromodulator designed with PEARL™ Technology, for the temporary improvement of moderate-to-severe glabellar lines (frown lines) in adults1,2 The approval is based on phase III results from a local clinical trial conducted in China as well as global READY clinical trials, with local results reinforcing that Relfydess delivers significant improvements in frown lines, with a fast onset of action as early as day one, and sustained results for up to six months in some patients3-7 This approval underscores Galderma’s continued leadership in the Asia-Pacific region and further expands the global reach of Relfydess, which is already authorized in more than 35 markets worldwide Galderma (SIX: GALD) today announced that the Chinese NMPA has approved Relfydess for the temporary improvement of moderate-to-severe frown lines in adults, marking a significant expansion of the
Andersen Consulting får ny samarbejdspartner i Usbekistan22.10.2026 21:34:00 CEST | Pressemeddelelse
Andersen Consulting udvider sine kompetencer inden for cybersikkerhed og forretningstransformation gennem en samarbejdsaftale med Algoruni, et konsulentfirma med base i Usbekistan. Algoruni rådgiver organisationer om at opbygge cyberrobusthed og håndtere bredere prioriteter inden for ledelse, regulering og bæredygtighed. Virksomheden har base i Tasjkent og tilbyder tjenester inden for cybersikkerhedsstrategi og databeskyttelse, virksomhedsledelse og driftsforbedringer samt ESG-strategi og -rapportering. Fokus er på praktiske løsninger, der er tilpasset den enkelte kundes situation. "Enhver organisation står over for en unik kombination af risici og muligheder. Derfor mener vi, at effektive løsninger skal tage udgangspunkt i virksomhedens konkrete situation," udtalte Alisher Zaynutdinov, administrerende direktør for Algoruni. "Som samarbejdsvirksomhed med Andersen Consulting kan vi kombinere denne tilgang med et bredere netværk af internationale ressourcer og perspektiver, så vi får nye
Andersen Global udvider sine juridiske kompetencer i Argentina gennem samarbejde med MHR22.10.2026 20:20:00 CEST | Pressemeddelelse
Andersen Global styrker sine juridiske kompetencer i Argentina gennem en samarbejdsaftale med Martínez de Hoz & Rueda (MHR) efter integrationen af teamet fra MBP Partners i firmaet. MBP Partners var tidligere et samarbejdsfirma i Andersen Global og arbejdede sammen med organisationens medlemsfirmaer og samarbejdsfirmaer for at bistå klienter med både lokale og internationale forhold. Med integrationen af MBP Partners viderefører den nye samarbejdsaftale mellem Andersen Global og MHR det eksisterende samarbejde og styrker samtidig Andersen Globals juridiske kompetencer i Argentina. MHR er et fullservice advokatfirma, der rådgiver klienter inden for olie og gas, selskabsretlige og finansielle forhold, energi, minedrift, fintech, infrastruktur, teknologi og andre centrale sektorer. Firmaet bistår danske og internationale virksomheder, finansielle institutioner, investeringsfonde, fintechvirksomheder og andre organisationer med komplekse transaktioner, regulatoriske spørgsmål og strategisk
Mundipharma Announces Further Phase III ReSPECT Results Presented as a Late-Breaking Oral Presentation at IDWeek 202622.10.2026 19:03:00 CEST | Press release
For Trade and Medical Media Only Today Mundipharma announced additional results from the global Phase III ReSPECT clinical trial evaluating REZZAYO®(rezafungin acetate) for prophylaxis of invasive fungal diseases (IFDs) in adult patients undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT). The Phase III findings were presented today as a late-breaking oral presentation at IDWeek 2026. The presentation provides additional detail following the top line ReSPECT results announced in April 2026, including further endpoint analyses, the components contributing to fungal-free survival (FFS), pre-specified sensitivity analyses and detailed safety outcomes. The additional analyses were consistent with the previously announced topline findings. ReSPECT was a global, multicentre, randomised, double-blind Phase III study in which 402 patients were randomised to rezafungin and 200 to the standard antimicrobial regimen. As previously announced, the study met its primary endpoi
Tigo Energy Improves Installer Choice via Fronius Compatibility with TS4 Product Line22.10.2026 18:02:00 CEST | Press release
Compatibility between Tigo MLPE and multiple Fronius inverter families gives solar installers worldwide greater flexibility to design high-quality systems with the features customers want. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced a manufacturer declaration of compatibility from Fronius International GmbH, documenting compatibility between Tigo Flex MLPE products and multiple Fronius inverter families. The letter covers Tigo TS4-A-F, TS4-A-2F, TS4-A-O, and TS4-X-O products and the Fronius Primo GEN24, Primo GEN24 208-240, Symo GEN24, Verto, Tauro, and Tauro ECO inverter families, when configured according to the requirements specified by Fronius and Tigo. Building on established compatibility in Europe, the declaration extends manufacturer-confirmed compatibility to markets worldwide, including the United States and Canada, giving solar professionals greater flexibility to design high-q
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