Shots:
The P-I/II (TWINPEAK) trial data assessed spevatamig alone & in combinations to treat advanced gastric, GEJ, pancreatic ductal or biliary tract adenocarcinomas in the US
As of Dec 12, 2025, 107 pts received spevatamig alone or in combination; 42 with 1L mPDAC were treated with spevatamig + GnP, with spevatamig (2mg/kg, QW) data presented…
Shots:
Foresee has entered into an exclusive global licensing agreement with Primevera for its MMP-12 inhibitor programs, which incl. FP-025, FP-020 & third-generation MMP-12 inhibitors in discovery stage
As per the deal, Foresee USA will receive a $10M upfront, ~$574.5M in milestones, & tiered single-digit royalties, or alternatively a tiered share of sublicense proceeds in lieu…
Shots:
Merck has initiated P-III (KANDLELIT-007) trial of calderasib (MK-1084) + Keytruda Qlex for the 1L treatment of pts with KRAS G12C-mutant, advanced or metastatic nonsquamous NSCLC
Trial will assess calderasib (PO, QD) + Keytruda Qlex (SC; Q6W) vs Keytruda Qlex + pemetrexed (IV) + CT in ~ 675 newly diagnosed pts with KRAS G12C-mutant nonsq. NSCLC, evaluating PFS as 1EP…
Shots:
Acesion Pharma has enrolled the first patients in the P-II trial assessing AP31969 in pts with atrial fibrillation, with completion anticipated by Q1’27
Trial will enrol 200 pts across eight EU countries, with AF burden as the 1EP. Safety will be monitored using implantable loop recorders for continuous 24/7 cardiac rhythm tracking
In 2025,…
Shots:
The US FDA has received an NDA of rusfertide (SC) for the treatment of adults with polycythemia vera (PV)
NDA was followed by 32wk. primary analysis & 52wk. data from the global P-III (VERIFY) trial (n=293) as well as P-II (REVIVE) study, where VERIFY met its 1EP & all key 2EPs, showing higher response…
Shots:
FDA has granted IND clearance to initiate its P-II trial of ASC30 (40, 60 & 80mg) vs PBO in ~100 pts with type 2 diabetes mellitus, with enrolment expected to begin in Q1’26
Trial will assess mean change in HbA1c up to 13wks. as 1EP & 2EPs will incl. mean change in fasting blood…
Shots:
HUTCHMED has initiated P-III portion of P-II/III trial of the combination of surufatinib, camrelizumab, nab-paclitaxel & gemcitabine (S+C+AG) as the 1L treatment of metastatic PDAC in China, with the first patient receiving the dose on Dec 30, 2025
Trial will evaluate the combination against nab-paclitaxel + gemcitabine in ~400 PDAC adults who have not…
Shots:
Mabwell has dosed the first patient with 9MW3811 in its P-II (CTR20254857) trial in China for pathological scarring
The trial will assess safety, tolerability, PK, & preliminary efficacy of 9MW3811 in pts with pathological scarring following P-I completion in healthy subjects across Australia & China
9MW3811 has shown significant preclinical efficacy in pulmonary fibrosis…
Shots:
The Chinese NMPA has accepted NDA & granted priority review to savolitinib for the treatment of LA/M gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma pts with MET amplification who have failed ≥2 prior systemic treatments
NDA was supported by the P-II trial of savolitinib in gastric cancer pts with MET amplification in China, which met its 1EP of improved ORR by…
Shots:
The Chinese NMPA has accepted NDA & granted priority review to fanregratinib (HMPL-453) for the treatment of adults with advanced, metastatic, or unresectable ICC with FGFR 2 fusion/rearrangement who have previously received systemic therapy
NDA was supported by the P-II trial in China, which met its 1EP of improved ORR, with 2EPs findings, …

