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Verastem Oncology

FDA Grants Verastem Oncology’s Avmapki + Fakzynja Accelerated Approval for KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)

Shots: This accelerated approval for the combination of Avmapki (avutometinib) + Fakzynja (defactinib) was granted in advanced to the planned PDUFA of Jun 20, 2025 will be available in the US within a week as a co-pack. Approval was based on P-II (RAMP 201) trial assessing Avmapki (3.2mg, twice weekly) + Fakzynja (200mg, BID) in…

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Recursion

Recursion Presents Preliminary P-Ib/II (TUPELO) Trial Data of REC-4881 for Familial Adenomatous Polyposis (FAP) at DDW 2025

Shots: P-Ib/II (TUPELO) trial (enrolment ongoing) assessed REC-4881 (4 or 8mg, QD) in FAP, with P-II evaluating efficacy via upper & lower endoscopy at Wk. 0, 13 (on-treatment), & 25 (off-treatment) in pts (≥55yrs.) with APC mutations As of Mar 17, 2025, 4mg (n=6) showed a median 43% polyp burden decrease; 5/6 had reductions of…

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Realmada Therapeutics

Relmada Therapeutics Presents Initial P-II Trial Data of NDV-01 for High-Grade Non-Muscle Invasive Bladder Cancer (HG-NMIBC) at AUA 2025

Shots: Relmada has reported initial P-II trial data assessing NDV-01 in 20 pts with HG-NMIBC (8 BCG-naïve, 12 BCG-unresponsive), where 2 pts had CIS & 18 had papillary disease (Ta/T1); 26 pts are enrolled, with 20 reaching 3mos. & 7 reaching 6mos. assessments Trial showed 85% ORR, 83.3% HGRFS in Ta/T1, & 100% CR in…

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Vivavision Biotech

VivaVision Biotech Reports Topline P-II Trial Data of VVN461 for Non-Infectious Anterior Uveitis

Shots: VivaVision has reported topline P-II trial data assessing 1.0% or 0.5% VVN461 (JAK1/TYK2 inhibitor) vs 1% prednisolone acetate (PA) for the treatment of non-infectious anterior uveitis in 86 Chinese pts for 28 days Trial demonstrated non-inferior efficacy to PA, achieving a 2-step ACC grade reduction (measured via SUN scale) as the 1EP & significant improvements…

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Briacell

BriaCell Reveals P-II Trial Data of Bria-IMT Regimen for Metastatic Breast Cancer

Shots: BriaCell has reported P-II trial data comparing Bria-IMT + check point inhibitors (CPI) to Trodelvy's historical data in heavily pre-treated pts (n=54) with late-stage metastatic breast cancer 37 HR+ breast cancer pts of P-II trial were treated with the ongoing pivotal P-III (BRIA-ABC) trial formulation of Bria-IMT, showing favorable survival data Trial showed 25/37…

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Telix Pharmaceuticals

Telix Pharmaceuticals Reports Preliminary P-II (IPAX-Linz) Trial Data of TLX101 to Treat Glioma

Shots: The IIT P-II (IPAX-Linz) trial assessed TLX101 (IV) in 8 glioblastoma pts with recurrent tumors & PET-confirmed amino acid uptake, who received adaptive dosing with ~4GBq before & ~2GBq after, 2L EBRT; 5/8 had MGMT-unmethylated tumors Trial showed mOS of 12.4mos. or 32.2mos. from initial diagnosis, complementing P-I (IPAX-1) trial results of 13mos. & 23mos.,…

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