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Crinetics

Crinetics Pharmaceuticals Doses First Patient in P-II/III (BALANCE-CAH) Trial of Atumelnant for Pediatric Congenital Adrenal Hyperplasia

Shots: Crinetics has dosed the first patient with atumelnant in the P-II/III (BALANCE-CAH) trial for the treatment of classic congenital adrenal hyperplasia (CAH) in children & adolescents The study will evaluate atumelnant across 3 phases: a P-II semi-sequential dose-ranging Part A, followed by a P-III PBO-controlled Part B, & an OLE portion in Part C…

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Mabwell Doses First US Patient in P-I/II Trial of 7MW4911 for Gastrointestinal (GI) Cancers

Shots: Mabwell has dosed the first patient with 7MW4911 in a P- I/II study in the US for the treatment of advanced colorectal cancer & other advanced GI tumors Preclinical studies showed that 7MW4911 delivered potent antitumor activity across CDX/PDX GI tumor models & outperformed MMAE/DXd-based ADCs in multidrug-resistant settings. It also reversed tumor progression after…

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J&J Presents the P-Ib/II (OrigAMI-1) Trial Data on Rybrevant for Metastatic Colorectal Cancer at ASCO GI 2026

Shots: J&J has reported longer follow-up results from Cohorts D & E of the P-Ib/II (OrigAMI-1) trial assessing Rybrevant (amivantamab-vmjw; IV) ± FOLFOX/FOLFIRI in pts with RAS/BRAF wild-type mCRC At mFU of 16mos., Rybrevant + FOLFOX (n=20) or FOLFIRI (n=23) achieved a cORR of 51%, with early responses & median time to first response of 8.3wks.,…

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Madrigal Pharmaceuticals Broadens MASH Pipeline with Pfizer’s Ervogastat Deal

Shots: Madrigal has entered into an exclusive global license agreement with Pfizer for ervogastat (PF-06865571; PO) to treat metabolic dysfunction-associated steatohepatitis (MASH) As per the deal, Madrigal will receive an exclusive global license to develop, manufacture & commercialize ervogastat & 2 additional early-stage MASH assets, paying Pfizer $50M upfront with further milestone payments & net…

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Phanes Therapeutics Reports P-II (TWINPEAK) Trial Data on Spevatamig + CT in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

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…

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Foresee Pharmaceuticals Licenses MMP-12 Inhibitor Programs to Primevera Therapeutics in a ~$584.5M Deal

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…

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Merck Initiates P-III (KANDLELIT-007) trial of Calderasib + Keytruda Qlex for KRAS G12C-Mutant Nonsquamous NSCLC

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…

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