– NDA submitted in 1Q 2025 for ziftomenib for the treatment of adult patients with relapsed or refractory AML with an NPM1 mutation – – Data from Phase 1b/2 registration-directed trial of ziftomenib selected for oral presentation at ASCO Annual Meeting – – $45.0 million milestone payment earned for NDA submission under collaboration agreement with Kyowa Kirin – – First patients dosed in Phase 1 trial of ziftomenib plus imatinib in GIST – – $703.2 million in pro forma cash, together with anticipated collabor ...

Core Insights - Er-Kim has signed an agreement with Puma Biotechnology to commercialize NERLYNX in select Eastern European and Central Asian countries [1][2] - NERLYNX is a treatment for HER2-positive breast cancer, approved for both early-stage and metastatic cases [3][7] - Breast cancer is the most common cancer among women globally, with 2.3 million new cases and 670,000 deaths reported in 2022 [4] Company Overview - Er-Kim, established in 1981, partners with over 40 global leaders and has revenues exceeding EUR 260 million, reaching over 600 million patients [6] - Puma Biotechnology focuses on developing innovative cancer care products and has successfully commercialized NERLYNX since its FDA approval in 2017 [7] Market Context - The agreement aims to improve access to NERLYNX in Russia and the Commonwealth of Independent States, addressing the disparity in treatment availability for breast cancer [5] - The burden of breast cancer varies significantly across different regions, highlighting the need for targeted treatment solutions [4][5]

Oslo, Norway, 30 April 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic ‘off the shelf’ T Cell Receptor based Natural Killer (TCR-NK) cells for the treatment of cancer, invites to a webcast presentation of its first quarter 2025 results, on Thursday, May 8, 2025. The presentation can be followed as a live webcast accessed through a link on www.zelluna.com at 09:00 CET on Thursday, May 8, 2025. The webcast presentation will be available on the Zelluna website, and it will be possible to post quest ...

Positive recommendation based on clinical, real-world and bioequivalence data supporting feasibility and safety of Phesgo’s administration outside of clinical settings, for example at home1-4 Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings3Phesgo has the potential to reduce treatment administration costs by up to 80% in Western Europe, and 85% of patients prefer SC over IV administration.7,3 B ...

Seagen (SGEN) Q1 2020 Earnings Call April 29, 2025 04:11 PM ET Speaker0 Good day, and welcome to the Seattle Genetics First Quarter twenty twenty Financial Results Conference Call. Today's call is being recorded. At this time, I would like to turn the conference over to Ms. Peggy Pinkston, Vice President of Investor Relations. Please go ahead. Speaker1 Thank you, operator, and good afternoon, everyone. I'd like to welcome all of you to Seattle Genetics first quarter twenty twenty conference call. With me to ...

Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2025Annamycin is potentially a highly versatile drug capable of working synergistically with numerous mechanistically different FDA approved anticancer first line therapies both in vitro and in vivo HOUSTON, April 29, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers an ...

BRISBANE, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that a presentation of new data supporting the immune component of amezalpat’s purported dual mechanism of action that reinforces its potential as a novel cancer treatment at the 2025 American Association for Cancer Research (AACR) Annual Meeting. “The data presented at the ...

CG Oncology, Inc. CGON announced on Saturday that cretostimogene grenadenorepvec monotherapy data were presented at the 2025 American Urological Association Annual Meeting.The Phase 3 BOND-003 Cohort C study is in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) treatment with carcinoma in situ (CIS) with or without Ta or T1 disease.The study reported 75.5% complete response (CR) at any time, with 34 confirmed CRs at 24 months and nine patient ...

ROCKVILLE, Md. and SUZHOU, China, April 28, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company engaged in discovering, developing, and commercializing therapies to address global unmet medical needs primarily for hematological malignancies, today announced that it has presented results from five preclinical studies during poster presentations at the 2025 American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30, 2025, in Ch ...

Core Viewpoint - SpringWorks Therapeutics, Inc. anticipates a favorable opinion from the CHMP of the EMA regarding the marketing authorization application for nirogacestat in Q2 2025, aimed at treating adults with desmoid tumors [1] Company Overview - SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, with FDA-approved products including OGSIVEO (nirogacestat) for desmoid tumors and GOMEKLI™ (mirdametinib) for neurofibromatosis type 1 associated plexiform neurofibromas [2]