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Gilead 's twice-yearly shot reduced HIV infections by 96% in a second large study, the company said Thursday. The positive phase three trial data on lenacapavir sets the stage for likely approval by the U.S. Food and Drug Administration for HIV prevention. The company said 99.9% of participants who received lenacapavir did not acquire HIV, with two cases among 2,180 people. Gilead in June also said lenacapavir was 100% effective at preventing HIV in another late-stage trial with cisgender women. The trial results should lead to an FDA approval and launch in the market by 2025, Yee said.
Persons: Gilead, Daniel O'Day, lenacapavir, Michael Yee, Yee Organizations: U.S . Food, Drug Administration, PrEP, Centers for Disease Control, Jefferies, CNBC, YouTube Locations: Gilead
Here are Monday's biggest calls on Wall Street: UBS reiterates Nvidia as buy UBS raised its price target on Nvidia to $150 per share from $120. Stifel upgrades Ecolab to buy from hold Stifel said it's bullish on shares of the food safety company. KBW upgrades Charles Schwab to outperform from market perform KBW said it's getting bullish on shares of Charles Schwab. Wells Fargo reiterates Meta as overweight Wells raised its price target on Meta to $625 per share from $593. Wells Fargo reiterates Roblox as overweight Wells raised its price target on the stock to $43 per share from $41 ahead of earnings on August 1.
Persons: Stifel, it's, Morgan Stanley, Charles Schwab, KBW, Guggenheim, ServiceNow, Wells, Riley, Emerson, Redburn, Wolfe, JPM, Raymond James, Gilead, Bumble, TD Cowen, Oppenheimer, Jefferies, Baird, Wedbush, RBLX Organizations: UBS, Nvidia, Taiwan Semiconductor, Meta, PNC, Bank of America, underperform Bank of America, Medicines, NSC, Apple, JPMorgan, Disney Locations: 2H24, Columbia, Norfolk, Asia
Gilead 's experimental twice-yearly medicine to prevent HIV was 100% effective in a late-stage trial, the company said Thursday. The results bring Gilead one step closer to introducing a new form of pre-exposure prophylaxis, or PrEP, and broadening its HIV business. If those results are positive, the company could bring lenacapavir for PrEP to market as soon as late 2025. RBC Capital Markets analyst Brian Abrahams expects Gilead's shot will significantly increase the number of people interested in preventive HIV medicine. In its statement disclosing the lenacapavir trial results Thursday, Gilead said it plans to share an update on how it plans to address access in such countries where people suffer high incidence rates of HIV.
Persons: Gilead, Jared Baeten, Gilead's Truvada, Bruce Richman, Tim Oliver, they'd, Brian Abrahams, Gilead's, — CNBC's Leanne Miller Organizations: Food and Drug Administration, PrEP, Centers for Disease Control, Prevention, Health, FDA, RBC Capital Locations: U.S, New York
The results are a blow to Gilead, which is working to become a power player in the cancer space. Patients with advanced or metastatic non-small cell lung cancer who took Trodelvy lived longer than those who got chemotherapy alone, according to Gilead. The drugmaker said it will discuss the results with regulators and identify whether certain lung cancer patients may still benefit from the drug. Jefferies analyst Michael Yee said Gilead's trial results are not "totally surprising" to the firm because data from early studies was mixed and data for competing drugs was "lackluster." Yee added that the trial results could "dent" investor confidence about whether Gilead will have significant sales in oncology.
Persons: Trodelvy, Michael Yee, Yee, Gilead Organizations: Jefferies Locations: Gilead
[1/2] Gilead Sciences is seen during the outbreak of the coronavirus disease (COVID-19), in Oceanside, California, U.S., April 29, 2020. REUTERS/Mike Blake/File PhotoCompanies Gilead Sciences Inc FollowAug 3 (Reuters) - Gilead Sciences (GILD.O) on Thursday reported lower second-quarter profit as costs from a legal settlement and sharply lower sales of its COVID-19 treatment offset another strong performance by HIV drugs. The drugmaker raised its full-year revenue forecast, even as it trimmed its estimate for COVID antiviral Veklury due to lower pandemic-related hospitalizations. Wall Street analysts had expected an adjusted profit of $1.64 per share on revenue of $6.44 billion, according to Refinitiv data. The California-based company raised the low end of its 2023 revenue forecast range to $26.3 billion from $26.0 billion, but kept the high end at $26.7 billion.
Persons: Mike Blake, Gilead, Deena Beasley, Michael Erman, Bill Berkrot Organizations: Gilead Sciences, REUTERS, Wall Street, Thomson Locations: Oceanside , California, U.S, Gilead, California
BMO Capital Markets says Gilead Sciences is a "best-in-class" therapy franchise that could soon see multiple expansion. The firm upgraded shares to outperform from market perform and raised its price target to $100 from $90. The new price target implies shares rallying 27.5% from Monday's close. Analyst Evan David Seigerman said that, in addition to Gilead's strong therapy franchise, its improving solid tumor oncology business and durable-growth anchored by its HIV/virology division could lead to strong growth. "While we note that Gilead currently trades at a discount to large-cap peers, continued de-risking of its oncology franchise could drive multiple expansion."
Foster City, California-based Gilead collaborated with the CDC in the mid-2000s to test if Truvada could prevent HIV as well as treat it. The government received four patents for HIV prevention drug regimens that CDC researchers invented. Its lawsuit claims the patents also cover Gilead's pre-exposure prophylaxis (PrEP) drug regimen for lowering HIV infection risk. The U.S. Food and Drug Administration approved Gilead's Truvada for HIV prevention in 2012 and approved its related drug Descovy for the same purpose in 2019. Descovy, which earned Gilead over $1.8 billion last year, is its fourth-best selling drug behind the HIV drugs Biktarvy and Genvoya and COVID-19 treatment Veklury.
The U.S. is trying to enforce four patents issued to the Centers for Disease Control and Prevention on a two-drug regimen known as pre-exposure prophylaxis, or PrEP for short. The government accuses Gilead of reaping billions of dollars in PrEP sales without paying royalties to the CDC. Gilead has rejected U.S. allegations that the company's sales of its PrEP oral medications, Truvada and Descovy, infringe on any CDC patents. "Indeed, Gilead has reaped billions from PrEP through the sale of Truvada and Descovy, but has not paid any royalties to CDC." Gilead rejects CDC claims that agency scientists developed the the PrEP regimen.
Citi is bullish on Merck , saying that the company's drug pipeline is underappreciated by the market. The exclusive license and collaboration agreement for ADC development helps Merck in developing more cancer treatment drugs — and Citi thinks it could rival its competitors' offerings. Citi anticipates further upside for Merck shares from the Inflation Reduction Act. To be sure, Baum noted a key downside risk to his valuation is if the ADC pipeline disappoints. Further risks include lower-than-anticipated value share capture by the company's Melanoma treatment drug Keytruda, and a slowdown in its animal health business.
Higher-than-anticipated interest rates could lead to economic pain and even a credit shock. Top-1% fund manager James Abate explained why he hasn't given up on stocks yet. Here are 13 value stocks to buy in this shaky environment, according to Abate. Leading fund manager James Abate isn't predicting a repeat of the financial crisis, but he is worried that banks could get their biggest test in years if interest rates keep rising. While nothing is guaranteed in markets, Abate said that 2023 will provide many opportunities for fund managers like him to outperform.
Dec 27 (Reuters) - Gilead Sciences (GILD.O) will buy all the remaining rights for an experimental cancer therapy, GS-1811, from Jounce Therapeutics (JNCE.O) for $67 million, the drugmaker said on Tuesday. Shares of Jounce more than doubled to $1.68, while Gilead's shares fell marginally in after market trading. In 2020, the drugmakers had agreed to collaborate on development of GS-1811, when Gilead made an upfront payment of $85 million to Jounce. Under the initial terms, Jounce was eligible to get up to $685 million in milestone payments from Gilead, of which it has received $40 million so far. With the amendment, Jounce will no longer receive the remaining milestone payments or any of the sales-based royalties for the therapy.
Cantor Fitzgerald analysts named six big events to mark on your calendar. While the majority of the expected events are set to come from smaller biotech companies, bigger companies — like Roche, Gilead, and Alnylam — have their own events coming through the pipeline. Here are the six major events from big biotech companies that could send stocks soaring:1. Cantor Fitzgerald analysts give Gilead's stock a neutral rating and they have an overweight rating on Arcus. Lenacapavir "could become a much bigger piece of the HIV growth narrative over the next few years," according to Cantor Fitzgerald analysts.
Piper Sandler and Truist upgraded the stock to overweight and buy ratings, respectively, after the company topped earnings expectations for the recent quarter and shared upbeat guidance. Both firms said they anticipate solid growth from Gilead's oncology and HIV franchises going forward, saying now is the time to get in on the stock. Kim upped the firm's price target on the stock to $96 from $79 a share, suggesting 37% upside from Thursday's close. Truist's Robyn Karnauskas highlighted the potential of Gilead's cancer drugs and therapies in a note to clients, hiking the firm's price target on the stock to $91 per share. Gilead's stock jumped nearly 5% in Friday's premarket.
"That said, the biggest drugs usually feature one, or best case two, of these attributes." Seven drugs on Meacham's list are already in the market, and have already hit the $10 billion or more benchmark. That means some of these drugs may be already hitting the end of their peak sales period. Meacham has previously said that one of the drugs in this bucket, Eli Lilly's tirzepatide, could be the first $100 billion drug . But many investors are hopeful about its potential as an obesity treatment .
Sept 28 (Reuters) - A federal judge in New York has frozen the assets of dozens of people and entities accused of operating a massive nationwide scheme to distribute counterfeit bottles of Gilead Sciences Inc (GILD.O) HIV drugs, including two alleged "kingpins." HIV drugs accounted for $7.6 billion of Gilead's $12.6 billion revenue in the first half of the year. read moreThe newly added defendants include alleged "kingpins" Lazaro Roberto Hernandez, who was arrested on drug counterfeiting and money laundering charges in June as part of a related federal investigation and remains under house arrest, and Armando Herrera, who lives in Florida. The Foster City, California-based company first announced it was pursuing counterfeiters in August 2021, shortly after filing its lawsuit. read moreIn addition to the alleged kingpins, the case now includes alleged mid-level leaders and a complex web of shell companies, distributors and pharmacies.
A woman holds a small bottle labelled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe in this illustration taken October 30, 2020. The virus has since evolved, and mounting evidence from lab tests suggests the two therapies - sotrovimab as well as casirivimab-imdevimab - have limited clinical activity against the latest iterations of the virus. Another COVID therapy that emerged early in pandemic was Gilead's (GILD.O) antiviral remdesivir. The WHO expanded its conditional recommendation for the drug, advising that it can be used in patients with severe COVID as well as non-severe COVID patients at the highest risk of hospitalization. There are a handful of existing COVID therapeutics that remain useful in the fight against the virus, and others in development that are expected to also benefit patients.
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