Cognition Therapeutics Reports Topline P-II (MAGNIFY) Trial Data of Zervimesine for Geographic Atrophy (GA)

Shots:Cognition has reported topline P-II (MAGNIFY/COG2201) trial data assessing zervimesine (200mg, QD, PO) vs PBO in adults with GA secondary to dry AMD; trial concluded after enrolling ~100 of 246 planned subjectsIn the trial, nearly 2/3 pts completed 12mos. & 1/3 completed 18mos. of dosing, showing a 28.6% slower GA progression & ~12%,…

ByRidhi RastogiMay 9, 2025

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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 30, 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…

ByRidhi RastogiMay 9, 2025

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Amgen Reports the MHRA’s Approval of Tepezza to Treat Thyroid Eye Disease

Shots:UK’s MHRA has approved Tepezza (teprotumumab) for the treatment of adult pts with mod. to sev. thyroid eye disease (TED)Approval was based on extensive clinical data incl. P-III (OPTIC) trial (n=83), P-II (TED01RV) trial (n=88), P-IV (HZNP-TEP-403) trial (n=62) & P-III (OPTIC-J) trial in Japan (n=54)OPTIC trial showed that 83% (34/41) of…

ByRidhi RastogiMay 8, 2025

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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 mutationsAs of Mar 17, 2025, 4mg (n=6) showed a median 43% polyp burden decrease; 5/6 had reductions of…

ByRidhi RastogiMay 5, 2025

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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. assessmentsTrial showed 85% ORR, 83.3% HGRFS in Ta/T1, & 100% CR in…

ByRidhi RastogiApril 29, 2025

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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 daysTrial demonstrated non-inferior efficacy to PA, achieving a 2-step ACC grade reduction (measured via SUN scale) as the 1EP & significant improvements…

ByRidhi RastogiApril 25, 2025

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Ipsen Reports P-II (ELMWOOD) Trial Data of Elafibranor for Primary Sclerosing Cholangitis (PSC)

Shots:Ipsen has reported P-II (ELMWOOD) trial data assessing elafibranor (80 or 120mg) vs PBO in 68 PSC pts for 12wks.; 96wks. OLE study evaluating elafibranor (120mg) is ongoingTrial demonstrated favorable safety & tolerability (1EP) at Wk. 12, with elafibranor 80 or 120mg vs PBO showing TRAEs 68.2%, 78.3% vs 69.6% pts, respectivelyElafibranor…

ByRidhi RastogiApril 24, 2025

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HUTCHMED Reports Enrollment Completion in P-II Trial of Savolitinib for Gastric Cancer in China

Shots:HUTCHMED has completed pts enrollment in P-II trial assessing savolitinib for G/GEJ adenocarcinoma pts (n=64) with MET amplification to evaluate ORR per IRC (1EP) & 2EPs incl. PFS & AE incidence; HUTCHMED plans to file for potential NMPA’s Approval in late 2025Interim analysis of the trial showed 45% cORR by IRC & 50% ORR in…

ByRidhi RastogiApril 22, 2025

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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 cancer37 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 dataTrial showed 25/37…

ByRidhi RastogiApril 17, 2025

News

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 tumorsTrial showed mOS of 12.4mos. or 32.2mos. from initial diagnosis, complementing P-I (IPAX-1) trial results of 13mos. & 23mos.,…

ByRidhi RastogiApril 17, 2025

Cognition Therapeutics Reports Topline P-II (MAGNIFY) Trial Data of Zervimesine for Geographic Atrophy (GA)

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

Amgen Reports the MHRA’s Approval of Tepezza to Treat Thyroid Eye Disease

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

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

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

Ipsen Reports P-II (ELMWOOD) Trial Data of Elafibranor for Primary Sclerosing Cholangitis (PSC)

HUTCHMED Reports Enrollment Completion in P-II Trial of Savolitinib for Gastric Cancer in China

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

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

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