Latest news with #GS-1720
Yahoo
2 days ago
- Business
- Yahoo
Citi sees Gilead clinical holds as only ‘minor setback'
Citi analyst Geoff Meacham keeps a Buy rating on Gilead (GILD) with a $125 price target after the company announced a clinical hold on its Phase 2 WONDERS trials evaluating the combination of GS-1720 and GS-4182 for once-weekly oral HIV treatment. The hold was initiated due to safety concerns, specifically decreases in CD4+ T-cell and absolute lymphocyte counts observed in a subset of participants receiving the combination therapy, the analyst tells investors in a research note. Citi says the setback impacts the targeted commercial launch of the GS-1720/GS-4182 regimen, previously anticipated in 2029 or 2030. The hold does not affect Gilead's other ongoing HIV programs, including lenacapavir development for both treatment and prevention including the monthly oral combinations, as no similar lymphocyte or CD4 effects have been observed in these studies, Citi points out. As such, the firm sees the holds as a 'minor setback' and continues to believe that lenacapavir in pre-exposure prophylaxis and expansion of several differentiated lenacapavir combos should offset potential Biktarvy 2028 Inflation Reduction Act negotiations. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on GILD: Disclaimer & DisclosureReport an Issue FDA placed clinical hold on Gilead HIV treatment trials of GS-1720 Gilead down 2% to $111.14 after FDA placed hold on some HIV trials Gilead Sciences: Strong Market Position and Growth Potential Drive Buy Rating Gilead Sciences' Oncology Advancements: Trodelvy's Potential to Boost Stock Value Gilead Sciences: Promising Pipeline and Strategic Advancements Justify Buy Rating Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
2 days ago
- Business
- Yahoo
FDA placed clinical hold on Gilead HIV treatment trials of GS-1720
The Food and Drug Administration has placed a clinical hold on Gilead's (GILD) HIV treatment trials of GS-1720 and/or GS-4182, the company said in a statement. The clinical hold is due to the identification of a safety signal of decreases in CD4+T-cell and absolute lymphocyte counts in a subset of participants receiving the combination of GS-1720 and GS-4182, the company explained. It added, 'Clinical trial investigators involved in the trials have been informed of these actions. GS-1720 and GS-1482 are investigational agents and have not been approved anywhere globally. We intend to investigate and pursue the potential of both agents and are committed to working with regulatory authorities to resolve the issues underlying the clinical hold. Gilead has multiple other long-acting oral and injectable investigational HIV treatment combinations under evaluation in clinical and preclinical studies, including combinations with weekly, monthly, quarterly, and twice-yearly dosing. This hold does not impact these combinations or their respective clinical or pre-clinical development programs.' Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See today's best-performing stocks on TipRanks >> Read More on GILD: Disclaimer & DisclosureReport an Issue Gilead Sciences: Strong Market Position and Growth Potential Drive Buy Rating Gilead Sciences' Oncology Advancements: Trodelvy's Potential to Boost Stock Value Gilead Sciences: Promising Pipeline and Strategic Advancements Justify Buy Rating Gilead Sciences: Buy Rating Driven by Promising HIV Treatment Pipeline and Strategic Growth Prospects Gilead Sciences: Buy Rating Affirmed on Promising Oncology Pipeline and Trodelvy's Potential as New Standard of Care
Yahoo
3 days ago
- Health
- Yahoo
US FDA pauses Gilead trials testing experimental HIV pill combination
By Sneha S K (Reuters) -The U.S. Food and Drug Administration has paused Gilead Sciences' trials testing a combination of two of its experimental HIV treatments due to low levels of a type of white blood cell in some patients, the company said on Tuesday. Shares of the company, a global leader in HIV drugs, were down 2.3% at $110.35. The agency placed the trials on hold after some patients who received the combination of the drugs, GS-1720 and GS-4182, were found to have low levels of a type of white blood cell called CD4+T-cell, the company said. Gilead did not provide more information on what caused the decline in the type of white blood cell, which is a key measurement in HIV management and serves as a guide for treatment. The company said it plans to investigate and will work with regulatory authorities to resolve the issues. The paused trials included two mid-to-late studies, and three more in the early phase, the company said. The mid-to-late stage trials were testing the oral combination treatment against Biktarvy, Gilead's once-a-day pill to treat HIV. "Today's update underscores the difficulties of improving upon the profile of Gilead's once-daily Biktarvy," said BMO Capital Markets analyst Evan Seigerman. GS-4182 is an experimental pill version of the company's approved HIV drug lenacapavir, while GS-1720 is a once-weekly therapy in development for treatment of HIV. The company said the hold is not related to Gilead's application seeking FDA's approval for lenacapavir in preventing HIV. The agency is set to decide on the application by June 19. The FDA had approved lenacapavir for HIV treatment in 2022 and is sold under the brand Sunlenca. Gilead has multiple other long-acting oral and injectable HIV treatment combinations under development, and this clinical hold does not impact those combinations, the drugmaker said.
