Zydus announced filing submission in US for saroglitazar (PPAR α/γ agonist) in 2L PBC

• Zydus announced it has filed its US NDA for saroglitazar (PPAR α/γ agonist) in 2L PBC and awaits FDA acceptance to provide anticipated approval timeline 
  • In FY2027, the company plans to invest additional INR 70M (~$723k) for commercialization  
• Zydus plans to launch saroglitazar in the US on its own, with commercialization strategy in preparation, through team hiring, and pre-launch activities 
  • Following favorable approval in the US, Zydus will assess co-partnering or licensing strategies for EU and other market launches 
• Zydus maintains a key commercial goal of increasing in its US commercial footprint through growth of its specialty pharmaceutical business driven by the planned launch of saroglitazar, the proposed acquisition of Assertio Holdings, specialized in oncology supportive care therapy, and its biosimilar initiatives  
• Management highlighted upcoming full data readout from the Ph2b/3 EPICS-III trial (N=196; PCD: Apr 2025) at EASL 2026 (LBO-001) 

 CI assessment: 

• While Zydus’ US NDA filing is broadly aligned with previous guidance of Q1 2026, the company remains vague regarding exact launch timelines, which depend on the upcoming FDA decision to formally accept the NDA 
  • Two potential scenarios remain, representing a slight delay from previous projections; if saroglitazar is granted fast track review (~6-9 mos from acceptance), approval could be expected as early Q1 2027 (compared to prior assumptions Q3 2026)
  •  For a standard review (~12 mos from acceptance), approval would be estimated for Q2 2027 (compared to prior assumptions Q1 2027) 
  • If approved in the US, saroglitazar would become the third PPAR agonist available in 2L PBC, joining Ipsen’s Iqirvo and Gilead’s Livdelzi, both approved in 2024 
• For the first time, Zydus mentioned explicit plans for an ex-US saroglitazar launch, signaling openness to potential commercial partners in the EU and other markets