GILD Obtains Positive CHMP Opinion for Liver Disease Drug

Core Viewpoint - Gilead Sciences, Inc. has received a positive recommendation from the CHMP for the approval of seladelpar for treating primary biliary cholangitis (PBC), which could significantly enhance its treatment portfolio in the EU [1][4]. Group 1: Drug Approval and Clinical Data - The CHMP recommended seladelpar for PBC treatment in combination with UDCA for adults with inadequate response to UDCA or as monotherapy for those intolerant to UDCA [1]. - The positive recommendation is based on the RESPONSE Study, which showed ALP normalization in 25% of participants at 12 months and a statistically significant reduction in pruritus compared to placebo [4]. - Seladelpar has been granted Priority Medicine designation in the EU, indicating its potential to address unmet medical needs [5]. Group 2: Market Impact and Financial Performance - Gilead's shares have increased by 14.3% year to date, contrasting with an 11.4% decline in the industry [3]. - The approval of seladelpar, branded as Livdelzi, strengthens Gilead's liver disease portfolio, which was bolstered by the acquisition of CymaBay Therapeutics for $4.3 billion [8]. Group 3: Strategic Initiatives and Collaborations - Gilead is actively seeking to enhance its pipeline through strategic acquisitions and collaborations, including a recent agreement with Tubulis for developing an antibody-drug conjugate [10][11]. - The company has also partnered with Merus to leverage its Triclonics platform for developing trispecific antibodies targeting tumor-associated antigens [12]. - Gilead's ongoing efforts to approve new drugs, including lenacapavir for HIV prevention, are expected to strengthen its market position amid increasing competition [14].