TuHURA Biosciences ISIN: US8989201038 Forum: Aktien Thema: Hauptdiskussion

Rakete

erstaunlich das die Glücksritter hier noch nicht aufgetaucht sind , bei knapp 150% in einer Woche hatte ich mehr im Forum erwartet :) https://www.merlintrader.com/tuhura-biosciences/

https://www.linkedin.com/company/tuhurabio

laut Ai"Die FDA hat dem experimentellen Wirkstoff IFx-2.0, entwickelt von TuHURA Biosciences, die Orphan Drug Designation für die Behandlung von Kutanemelanom im Stadium IIB bis IV erteilt. Diese offizielle Ankündigung erfolgte am 6. Februar 2026, nach Ergebnissen aus einer abgeschlossenen Phase-1-Studie, die die Sicherheit und klinische Wirksamkeit des Medikaments zeigte, insbesondere bei Patienten, die refraktär gegenüber bestehenden Immuntherapien wie Anti-PD-1-Behandlungen sind." Das wäre natürlich ein Meilenstein

TuHURA Biosciences Inc. (HURA:NASDAQ) gab bekannt, dass das Office of Orphan Products Development der U.S. Food and Drug Administration IFx-2.0 die Bezeichnung für das Hautanem der Stufe IIB bis Stadium IV als Orphan Drug Designation erteilt hat. Die Bezeichnung basierte auf Daten aus der zuvor abgeschlossenen Phase-1-Studie des Unternehmens zu IFx-2.0. https://www.streetwisereports.com/article/2026/02/06/fda-grants-orphan-drug-status-to-experimental-melanoma-therapy-after-phase-1-results.html

🤞🏻✊🏻👍🏻

TuHURA Biosciences received FDA Orphan Drug Designation for IFx-2.0 for the Treatment of Stage IIB to Stage IV Cutaneous Melanoma https://www.prnewswire.com/news-releases/tuhura-biosciences-received-fda-orphan-drug-designation-for-ifx-2-0-for-the-treatment-of-stage-iib-to-stage-iv-cutaneous-melanoma-302675770.html

Bad News,???

https://www.streetinsider.com/SEC+Filings/Form+4+TuHURA+Biosciences%2C+Inc.+For%3A+Jan+06+Filed+by%3A+Bianco+James+A./25827184.html

TuHURA Biosciences (NASDAQ:HURA) provided a corporate update on December 11, 2025 outlining program milestones, recent financing and scientific data. Key points: the lead Phase 3 IFx-2.0 trial in combination with Keytruda runs under an FDA SPA with enrollment targeted for completion in Q4 2026; a merger added a Phase 2‑ready VISTA antibody (TBS-2025); preclinical and ASH presentations highlighted the Delta Opioid Receptor target and ADC program; and a recent equity financing raised $15.6 million to fund multiple near-term milestones. Management will host a conference call on Dec 11, 2025.

https://www.prnewswire.com/news-releases/tuhura-biosciences-inc-announces-15-6-million-registered-direct-offering-302636732.html

.. da könnte man zuschlagen (Kauf) 😊👀👈🏻

TuHURA Biosciences, Inc. Announces $15.6 Million Registered Direct Offering

https://www.rttnews.com/3545239/tuhura-biosciences-says-fda-lifts-partial-hold-on-tuhura-s-ifx-2-0-phase-3-trial-for-metastatic-mcc.aspx

On May 15th, 2025, TuHURA Biosciences, Inc. (NASDAQ:HURA) reported first quarter 2025 financial and operational results and filed its Form 10-Q with the SEC. The company updated investors on the status of its IFx-2.0 Phase III trial in Merkel cell carcinoma (MCC) and the acquisition of Kineta. The Phase III trial is expected to begin and the Kineta acquisition is expected to close in 2Q:25. TuHURA recently launched a Phase Ib/II study for IFx-2.0 in MCC patients not eligible for the Phase III trial. Other important developments include presentations of clinical data at the American Association of Cancer Research (AACR) annual meeting in Chicago and the addition of a new executive. Below, we summarize 1Q:25’s financial results. TuHURA generated no revenues in 1Q:25 and expended $7.0 million on operational activities related to advancing IFx-2.0 and other programs producing a net loss of ($6.7) million or ($0.16) on a per share basis. For the quarter ending March 31st, 2025 and versus the same prior year period: Research & development expense totaled $4.6 million primarily attributable to greater expenses for preclinical research related to IFx-3.0 and myeloid derived suppressor cell (MDSC) initiatives and higher salary, personnel and facilities costs. General & administrative expense totaled $2.4 million, due to increases in non-stock compensation, costs related to being a public company and merger transaction costs related to the Kineta transaction; Other items included $253,000 in grant income related to Kintara’s REM-001 asset and reimbursements from Health and Human Services; Interest income was $100,000 related to income paid on cash balances held; Net loss was ($6.7) million or ($0.16) per share. As of March 31st, 2025, TuHURA held $6.2 million in cash on its balance sheet. 1Q:25 cash burn was ($4.8) million while cash used in financing was ($548,000) which consisted of warrant proceeds offset by transaction and liability payments related to Kintara. https://scr.zacks.com/news/news-details/2025/HURA-First-Quarter-2025-Results-article/default.aspx