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On Tuesday, Morgan Stanley (NYSE:MS) reaffirmed its confidence in Gilead Sciences, maintaining an Overweight rating and a price target of $123.00 on the biopharmaceutical company’s stock, traded under (NASDAQ:GILD). The stock has shown remarkable strength, delivering a 51.35% return over the past year and currently trading near its 52-week high of $106.69. According to InvestingPro analysis, Gilead appears to be trading above its Fair Value, with analyst targets ranging from $80 to $126. The firm’s optimism follows the announcement that the U.S. Food and Drug Administration (FDA) has accepted Gilead’s New Drug Application (NDA) for Lenacapavir, a drug intended for HIV pre-exposure prophylaxis (PrEP), and granted it Priority Review status.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date for Lenacapavir on June 19, 2025. This expedited review is a consequence of the drug’s Breakthrough Designation and aligns with previous statements from Gilead’s management. As a prominent player in the Biotechnology industry with strong financial health (rated "GOOD" by InvestingPro), Gilead boasts impressive gross profit margins of 78.26% and generated over $10 billion in free cash flow over the last twelve months. The NDA submission is supported by positive outcomes from the PURPOSE-1 and PURPOSE-2 Phase 3 trials. Gilead is aiming to launch Lenacapavir in the United States during the summer of 2025.
Morgan Stanley’s analysts have projected sales for Lenacapavir in the U.S. to reach approximately $184 million in 2025, which surpasses the consensus estimate of $111 million among other analysts. The firm’s analysts suggest that there is room for upward revisions to these sales estimates following the drug’s launch. They also indicate the potential for further valuation multiple expansion as Gilead advances its next-generation HIV treatment strategy.
The announcement of Lenacapavir’s Priority Review by the FDA marks a significant milestone for Gilead Sciences as it moves closer to potentially bringing a new prophylactic treatment for HIV to market. Gilead has a history of leadership in the field of HIV treatment and prevention, and the introduction of Lenacapavir could reinforce its position in this therapeutic area.
Investors and industry observers will be closely monitoring the progress of Lenacapavir as it approaches its PDUFA date and potential market introduction. The drug’s performance in the PURPOSE-1 and PURPOSE-2 trials has set the stage for its anticipated launch and potential impact on Gilead’s financial performance in the coming years. For deeper insights into Gilead’s valuation, growth prospects, and 16 additional ProTips, including dividend history and financial health metrics, explore the comprehensive Pro Research Report available exclusively on InvestingPro.
In other recent news, Gilead Sciences has been making significant strides in various areas. The company’s New Drug Application (NDA) for lenacapavir, a twice-yearly injectable drug for HIV prevention, has been accepted by the FDA for priority review. Phase 3 trials have shown promising results, with significant reductions in HIV infections noted. Lenacapavir is also being submitted for accelerated assessment to the European Medicines Agency (EMA).
Analysts have responded positively to Gilead’s progress. TD Cowen raised its stock price target for the company to $100, citing strong fourth-quarter earnings and revenue performance. Similarly, RBC Capital increased its price target to $90, acknowledging Gilead’s potential growth drivers post-2025. BMO Capital and Piper Sandler also raised their price targets to $115 and $110 respectively, underlining Gilead’s solid performance and robust prospects.
These are recent developments that underline Gilead’s strong position in the market and its commitment to innovation in HIV treatment and prevention. The company’s recent financial results and ongoing strategic initiatives have been met with optimism by various analyst firms.
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