Shots:
Grünenthal has entered into an agreement with Bayer to acquire Stivarga for ~€375M (~$430.67M), subject to customary closing conditions incl. regulatory approval, with the transaction expected to close by the end of 2026 or early 2027
Stivarga (regorafenib) is an oral multikinase inhibitor indicated for metastatic colorectal cancer, hepatocellular carcinoma, & gastrointestinal stromal tumours…
Shots:
The US FDA has granted IND clearance to ACE723 for the initiation of P-I trial to treat patients with unresectable or metastatic hepatocellular carcinoma (HCC)
The P-I study will assess ACE723’s safety, tolerability, dose-limiting toxicities, PK & preliminary antitumor activity in above-mentioned pts, with dose-escalation portion of establishing recommended dose for further development &…
Shots:
The P-III (EMERALD-3) trial assessed single priming dose of Imjudo (300mg) + Imfinzi (1500mg) followed by Imfinzi (Q4W) + transarterial chemoembolisation (TACE) ± lenvatinib vs TACE alone in 760 pts unresectable HCC eligible for embolization
Imjudo + Imfinzi + Lenvatinib & TACE showed improved PFS (1EP) vs TACE alone, with OS (2EP) demonstrating a favorable trend in the…
Shots:
Akeso has dosed its first patient with cadonilimab + lenvatinib in P-II (COMPASSION-36/AK104-225) trial against lenvatinib for the treatment of advanced HCC in pts previously treated with Tecentriq & Avastin; study is ongoing in the US, EU & China
Cadonilimab has also shown superior efficacy in combination regimens, incl. 100% DCR with FOLFOX-HAIC in resectable multinodular HCC…
Shots:
Pilatus Biosciences & Roche have entered into a clinical trial collaboration to evaluate PLT012 + atezolizumab for HCC pts
Under the collaboration, Roche will supply atezolizumab (Tecentriq) for Pilatus' P-I study of PLT012 in combination therapy for HCC, with plans to expand to other cancers
PLT012 is a humanized mAb that blocks CD36-driven lipid uptake, targeting…
Shots:
The US FDA has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adults
Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg, Q4W) vs lenvatinib/sorafenib in 668 pts with advanced HCC who had not received prior systemic therapy.…
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The EC has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adult pts in 30 EEA states; sBLA under the US FDA’s priority review (PDUFA: Apr 21, 2025)
Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg,…
Active Ingredient: Nivolumab
Strength: 40 mg/4 mL, 100 mg/10 mL, & 240 mg/24 mL solution in a single-dose vial
Dosage Form: Injection
Mechanism of Action: Programmed cell death-1 receptor antagonists (PD-1)
First Approval: US (22 Dec 2014), EU (19 Jun 2015)
Revenue Analysis of Opdivo
BMS’ Opdivo gives tough competition to other drugs in the…
Shots:
Mahesh talked about the data presented on its lead candidate in hepatocellular carcinoma at the AACR 2022
Mahesh also spoke about Omega’s drug-development platform that identifies and targets specific and unique DNA sequences of regulatory elements
The interview gives a profound grip on Omega’s development strategies to use mRNA therapeutics as a new class…

