Gilead Sciences, Inc. GILD announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended approval of seladelpar.
The CHMP adopted a positive opinion recommending seladelpar for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
A final decision from the European Commission is expected in the first quarter of 2025.
Gilead’s shares have risen 14.3% year to date against the industry's decline of 11.4%.
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More on GILD’s Seladelpar
The positive recommendation is based on the RESPONSE Study, which demonstrated ALP normalization in 25% of participants at 12 months and statistically significant reduction of pruritus versus placebo.
PBC is a rare, chronic inflammatory liver disease primarily affecting women. A potential approval will make seladelpar an important treatment option for people living with this rare liver disease in the EU.
Seladelpar has been granted the Priority Medicine designation in the EU. This designation helps optimize the development of novel drugs that target conditions with an unmet medical need for which no treatment options exist or where they can offer a major therapeutic advantage over existing treatments. The drug is also under review by the UK Medicines and Healthcare Products Regulatory Agency.
Please note that the FDA granted accelerated approval for seladelpar for the treatment of PBC in combination with UDCA in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The drug was approved under the brand name Livdelzi.
As part of the FDA accelerated approval, Gilead has initiated a confirmatory long-term outcomes study, called AFFIRM, in people with compensated cirrhosis.
Continued approval of seladelpar for the approved indication may be contingent on verification and description of clinical benefit in confirmatory trial(s).
The approval of Livdelzi strengthens GILD’s liver disease portfolio.
Last month, Gilead announced data from a two-and-a-half-year interim analysis of the ongoing phase III ASSURE study. The analysis showed that 81% of PBC patients treated with Livdelzi achieved a composite biochemical response, demonstrating significant improvements in key measures of PBC progression.
Seladelpar was added to GILD’s portfolio/pipeline in March 2024, when CymaBay Therapeutics Inc. was acquired for $4.3 billion.
GILD Looks to Strengthen Its Portfolio
Gilead is looking to strengthen its pipeline through strategic acquisitions and deals.
The FDA’s approval of Livdelzi validated its CymaBay acquisition.
Gilead recently entered into an exclusive option and license agreement with Tubulis, a Germany-based biotech company.
The collaboration is aimed at discovering and developing an antibody-drug conjugate against a solid tumor target.
Gilead entered into a research collaboration, option and license agreement with Merus MRUS to discover novel dual tumor-associated antigens targeting trispecific antibodies.
Gilead and Merus agreed to collaborate on using the latter’s proprietary Triclonics platform and GILD’s oncology expertise to research and develop multiple, separate preclinical research programs.
While flagship HIV treatment Biktarvy maintains its dominant position for HIV across major markets, the Cell Therapy franchise, comprising Yescarta and Tecartus, is under pressure due to competitive headwinds, which are expected to continue in 2025.
Pipeline setbacks for Trodelvy have dented its growth prospects as well.
Hence, approval of new drugs should boost GILD’s portfolio.
The recent positive data on lenacapavir bodes well. Per GILD, lenacapavir, with its twice-yearly dosing, could set a new bar for HIV prevention and allow PrEP to reach a much broader population of people who could benefit from a prevention regimen.
Gilead Sciences, Inc. Price, Consensus and EPS Surprise
Gilead Sciences, Inc. price-consensus-eps-surprise-chart | Gilead Sciences, Inc. Quote
Approval of better HIV treatments should strengthen the HIV franchise in the wake of the increasing competition from GSK plc GSK and others.
GSK posted 8% growth in HIV sales in the third quarter, driven by strong patient demand for two drug regimens — Dovato and Juluca — and long-acting drugs (Cabenuva and Apretude).
GILD's Zacks Rank
Gilead currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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