Bifogade filer
Alligator Bioscience receives FDA endorsement of mitazalimab Phase 3 dose for pancreatic cancer
Prenumeration
Kalender
| Est. tid* | ||
| 2026-02-12 | 08:00 | Bokslutskommuniké 2025 |
| 2025-10-23 | 08:00 | Kvartalsrapport 2025-Q3 |
| 2025-07-10 | 08:00 | Kvartalsrapport 2025-Q2 |
| 2025-07-07 | N/A | X-dag ordinarie utdelning ATORX 0.00 SEK |
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| 2025-01-22 | - | Bokslutskommuniké 2024 |
| 2024-10-24 | - | Kvartalsrapport 2024-Q3 |
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| 2024-05-07 | - | Årsstämma |
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| 2022-02-11 | - | Bokslutskommuniké 2021 |
| 2021-11-08 | - | Extra Bolagsstämma 2021 |
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| 2021-02-26 | - | Bokslutskommuniké 2020 |
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| 2020-05-06 | - | X-dag ordinarie utdelning ATORX 0.00 SEK |
| 2020-05-05 | - | Årsstämma |
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| 2020-02-12 | - | Bokslutskommuniké 2019 |
| 2019-10-24 | - | Kvartalsrapport 2019-Q3 |
| 2019-07-11 | - | Kvartalsrapport 2019-Q2 |
| 2019-05-10 | - | X-dag ordinarie utdelning ATORX 0.00 SEK |
| 2019-05-09 | - | Årsstämma |
| 2019-04-17 | - | Kvartalsrapport 2019-Q1 |
| 2019-02-14 | - | Bokslutskommuniké 2018 |
| 2018-10-26 | - | Kvartalsrapport 2018-Q3 |
| 2018-07-12 | - | Kvartalsrapport 2018-Q2 |
| 2018-04-27 | - | X-dag ordinarie utdelning ATORX 0.00 SEK |
| 2018-04-26 | - | Årsstämma |
| 2018-04-26 | - | Kvartalsrapport 2018-Q1 |
| 2018-02-16 | - | Bokslutskommuniké 2017 |
| 2017-10-25 | - | Kvartalsrapport 2017-Q3 |
| 2017-08-23 | - | Kvartalsrapport 2017-Q2 |
| 2017-05-03 | - | X-dag ordinarie utdelning ATORX 0.00 SEK |
| 2017-05-02 | - | Årsstämma |
| 2017-05-02 | - | Kvartalsrapport 2017-Q1 |
| 2017-02-17 | - | Bokslutskommuniké 2016 |
| 2016-11-14 | - | Kvartalsrapport 2016-Q3 |
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Small Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Lund, Sweden – 13 June 2025 – Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has provided feedback supporting the selection of the 900 µg/kg dose of its CD40 agonist mitazalimab for the planned Phase 3 study in metastatic pancreatic ductal adenocarcinoma (mPDAC).
This positive regulatory feedback confirms Alligator’s dose selection and represents a key milestone in the late-stage development of mitazalimab.
“We are very pleased with the FDA’s timely and constructive response. This marks an important step forward as we finalize our Phase 3 program for mitazalimab in one of the most aggressive and underserved cancers. We are now in active partnering dialogues aiming to secure the right partner to take mitazalimab into Phase 3,” said Søren Bregenholt, CEO of Alligator Bioscience.
For further information, please contact:
Søren Bregenholt, CEO
E-mail: soren.bregenholt@alligatorbioscience.com
Phone: +46 (0) 46 540 82 00
The information was submitted for publication, through the agency of the contact person set out above, at 8:45 a.m. CEST on 13 June 2025.
About Alligator Bioscience
Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company’s lead drug candidate mitazalimab is currently in preparation for Phase 3 development, and has previously presented unprecedented survival data at 24-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1.
Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden.
For more information, please visit alligatorbioscience.com.