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 2025 Interim analysis of the trial showed 45% cORR by IRC & 50% ORR in…

ByRidhi RastogiApril 22, 2025

NEWS

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…

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 tumors Trial 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

NEWS

Eli Lilly Reports P-II (ALPACA) Trial Data of Lepodisiran for Heart Diseases

Shots: The P-II (ALPACA) trial assessed lepodisiran (16, 96, or 400mg) vs PBO for ~18mos. in 320 pts, who were dosed at baseline & day 180, with an additional arm receiving 400mg at baseline & PBO at day 180; P-III [ACCLAIM-Lp(a)] trial enrollment is ongoing Trial met its 1EP, with 400mg reducing Lp(a) by 93.9%…

ByRidhi RastogiMarch 31, 2025

NEWS

Crinetics Pharmaceuticals Reports the EMA’s Acceptance of Paltusotine for Acromegaly

Shots: Following ODD grant, the EMA has accepted MAA of paltusotine for the treatment & long-term maintenance of acromegaly; NDA under the US FDA's review (PDUFA: Sep 25, 2025) Submission was supported by data from 18 trials, incl. 2 P-III trials (PATHFNDR-2 & PATHFNDR-1) assessing paltusotine vs PBO in treatment-naïve & experienced pts, respectively. These…

ByRidhi RastogiMarch 28, 2025

NEWS

Merck Partners with Jiangsu Hengrui Pharmaceuticals for HRS-5346, Expanding its Cardio-Metabolic Portfolio

Shots: Merck has entered into an exclusive license agreement with Jiangsu Hengrui Pharmaceuticals for HRS-5346 As per the deal, Merck has obtained exclusive rights to develop, manufacture & commercialize HRS-5346 globally excl. Greater China region in exchange for $200M upfront & ~$1.77B in development, regulatory & commercial milestones, along with net sales-based royalties; closing expected…

ByRidhi RastogiMarch 25, 2025

NEWS

AstraZeneca to Highlight Tagrisso’s Clinical Data for NSCLC at ELCC 2025

Shots: AstraZeneca to present Tagrisso’s data from P-III (LAURA & FLAURA2) & P-II (SAVANNAH & ORCHARD) trials at ELCC 2025 for EGFRm NSCLC pts who failed or received 1L therapy; data to support global filings In LAURA, Tagrisso showed favorable OS trend (mOS: 58.8 vs 54.1mos.; maturity: 31%) despite 78% of PBO pts receiving it…

ByRidhi RastogiMarch 25, 2025

NEWS

BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

Shots: The EC has approved Breyanzi for r/r follicular lymphoma adults treated with ≥2 previous lines of systemic therapy in 30 EEA states Approval was based on global P-II (TRANSCEND FL) study, assessing Breyanzi’s safety & efficacy to treat r/r indolent B-cell NHL incl. FL In pts treated in 3L+ setting, study met…

ByRidhi RastogiMarch 17, 2025

NEWS

Ono Pharma and Ionis Enter into License Agreement for Sapablursen to Treat Polycythemia Vera

Shots: Ionis has granted Ono Pharma an exclusive global license to develop & commercialize sapablursen for the treatment of polycythemia vera (PV) As per the deal, Ionis will get $280M upfront & ~$660M in development, regulatory & sales milestones, plus mid-teens net sales-based royalties as well as Ionis will be responsible to complete ongoing…

ByRidhi RastogiMarch 12, 2025

NEWS

HUTCHMED Reports Enrollment Completion in P-II Trial of Fanregratinib for Intrahepatic Cholangiocarcinoma in China

Shots: HUTCHMED has reported enrollment completion in P-II trial of fanregratinib to treat intrahepatic cholangiocarcinoma (IHCC) in pts with FGFR2 fusion or rearrangement; favorable trial results will support NMPA’s NDA submission The P-II trial of fanregratinib will assess ORR as 1EP whereas PFS, DCR, DoR, & OS as 2EPs in pts (n=87). Topline data…

ByRidhi RastogiMarch 7, 2025

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

Eli Lilly Reports P-II (ALPACA) Trial Data of Lepodisiran for Heart Diseases

Crinetics Pharmaceuticals Reports the EMA’s Acceptance of Paltusotine for Acromegaly

Merck Partners with Jiangsu Hengrui Pharmaceuticals for HRS-5346, Expanding its Cardio-Metabolic Portfolio

AstraZeneca to Highlight Tagrisso’s Clinical Data for NSCLC at ELCC 2025

BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

Ono Pharma and Ionis Enter into License Agreement for Sapablursen to Treat Polycythemia Vera

HUTCHMED Reports Enrollment Completion in P-II Trial of Fanregratinib for Intrahepatic Cholangiocarcinoma in China

Contact US

FOLLOW US