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The hotly anticipated results are in from a landmark pair of major clinical trials of a long-acting, injectable HIV-prevention drug that only requires dosing every six months. The pharma giant has already secured approval for the injectable drug in treating highly drug-resistant HIV. Given the clear statistical superiority of lenacapavir over Truvada, the trial’s blinded phase will now be ended several months early. When taken as prescribed, Truvada is over 99% effective at preventing HIV; Descovy is comparably effective. This chorus is sure to get louder now that lenacapavir is officially highly effective at protecting gay and bisexual men and trans people as well.

Persons: lenacapavir, ”, Jared Baeten, “, ” Jen Kates, ” Gilead, Gilead, Truvada, ViiV Healthcare’s, Amy Killelea, Jirair Ratevosian, Hansel Tookes, ” Tookes, Dr, Boghuma, “ lenacapavir, Tim Horn Organizations: Gilead Sciences, pharma, NBC, Food and Drug Administration, Disease Control, PrEP, Yale School of Nursing, University of Miami Miller School of Medicine, NBC News, Southern, Affordable, CDC, Emory University Locations: Gilead, United States, ”, U.S, Australia, United Kingdom, Arlington , Virginia, America, South Africa, Thailand, Truvada, Atlanta, Saharan Africa

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

☆ Twice-a-year injection reduced risk of HIV infection by 96%, drug company says — more than daily PrEP pill
▼ + stars: | 2024-09-12 | by ( Deidre Mcphillips | ) edition.cnn.com time to read: +2 min

CNN —A drug currently used to treat HIV has also been found to dramatically reduce the risk of infection, significantly more than the primary option available for pre-exposure prophylaxis or PrEP. In a Phase 3 clinical trial, 99.9% of participants who took a twice-a-year injection of lenacapavir for HIV prevention did not acquire an infection, according to data from drugmaker Gilead Sciences. There were only two cases among 2,180 patients – effectively reducing the risk of HIV infection by 96% and proving 89% more effective than Truvada, a pill taken once a day. It’s a “significant breakthrough in HIV prevention,” according to a news release from the World Health Organization in July. Gilead said it will use these trial data to start the drug approval process in multiple countries by the end of the year.

Persons: lenacapavir, ”, Onyema Ogbuagu, Dr, Sanjay Gupta, It’s, Gilead Organizations: CNN, Gilead Sciences, Yale, Research, CNN Health, World Health Organization Locations: Gilead, Argentina, Brazil, Mexico, Peru, South Africa, Thailand, United States, Africa

☆ Stocks making the biggest moves midday: Kroger, Petco, Moderna, Roku and more
▼ + stars: | 2024-09-12 | by ( Alex Harring | ) www.cnbc.com time to read: +2 min

That builds on Wednesday's post-earnings rally of nearly 33%, which marked the stock's best day on record. Moderna — The stock plummeted nearly 16% after the drugmaker said it will cut $1.1 billion in expenses by 2027. Interpublic Group of Companies — The advertising stock was trading 2% lower following a downgrade from UBS to sell from neutral. U.S. Bancorp — The bank stock slipped nearly 2% despite announcing a dividend hike and a $5 billion share buyback plan. Oracle – Shares of the software company rose nearly 2% after Bernstein named it a top investment idea .

Persons: Kroger –, Kroger, Moderna, Adam Berlin, Bernstein, Yun Li, Michelle Fox, Sean Conlon, Samantha Subin, Lisa Kailai Han, Sarah Min Organizations: Kroger, Moderna, Gilead Sciences, Alaska Air Group, Interpublic, Companies, UBS, Amazon, Pfizer, Bancorp, Diageo, Bank of America, Wolfe Research, Oracle – Locations: Gilead, Alaska, U.S

☆ Twice-yearly shot proves successful at preventing HIV infection among women, trial data shows
▼ + stars: | 2024-07-24 | by ( Jacqueline Howard | ) edition.cnn.com time to read: +9 min

CNN —Two shots a year of a drug currently used to treat HIV infections were dramatically effective at preventing infections in a study among young women and adolescent girls in Africa. The twice-yearly injection of the drug lenacapavir can provide total protection against HIV infections, demonstrating 100% efficacy in Phase 3 trial data released by drugmaker Gilead and published Wednesday in the New England Journal of Medicine. The twice-a-year injections of lenacapavir could add another option at preventing HIV infections to the toolbox. The latest Phase 3 findings are part of Gilead’s PURPOSE program, which comprises five HIV prevention trials around the world. “While Gilead awaits additional phase 3 clinical trial data and the potential regulatory filings for HIV prevention administered twice-yearly, it is too early to state the price of lenacapavir for PrEP (prevention).

Persons: drugmaker Gilead, ” Linda, Gail Bekker, Desmond Tutu, “, ”, Dan Barouch, hasn’t, Gilead, Dr, Jason Zucker, Barouch, ” Zucker, Lenacapavir, Gilead spokeperson, lenacapavir, Sanjay Gupta, Daniel O’Day Organizations: CNN, New England, of Medicine, International AIDS, PrEP, University of Cape, International AIDS Society, Center, Virology, Vaccine, Beth Israel Deaconess Medical, United, lenacapavir, Columbia University Irving Medical Center, ”, US Food and Drug Administration, AIDS, CNN Health, People’s Medicines Alliance, Medicines Locations: Africa, Munich, University of Cape Town, South Africa, Uganda, Argentina, Brazil, Mexico, Peru, Thailand, United States, United Kingdom, Germany, Gilead, Europe

☆ CNBC Daily Open: S&P 500 briefly crosses 5,500, closes lower
▼ + stars: | 2024-06-21 | by ( Abid Ali | ) www.cnbc.com time to read: +3 min

This report is from today's CNBC Daily Open, our international markets newsletter. CNBC Daily Open brings investors up to speed on everything they need to know, no matter where they are. S&P 500 slips from record highThe S&P 500 briefly passed the 5,500 mark for the first time before ending the session lower. Open AI challengerAnthropic, a leading AI competitor to OpenAI, unveiled Claude 3.5 Sonnet, its most advanced AI model to date. [PRO] AI real estateCiti analysts pinpoint a "compelling emerging" real estate trend fueled by AI and nearshoring.

Persons: Gilead, Anthropic, Claude, Donald Trump's, Trump, Masato Kanda Organizations: New York Stock Exchange, CNBC, Nasdaq, Nvidia, Dow Jones, Gilead Sciences, Google, Trump Media, New, Nikkei, Bank of, Reuters, United, CSI, Citi Locations: New York City, U.S, New York, Japan, United States, Asia, Pacific

☆ Gilead’s twice-yearly shot to prevent HIV succeeds in late-stage trial
▼ + stars: | 2024-06-20 | by ( Angelica Peebles | In Angelicapeebles | ) www.cnbc.com time to read: +3 min

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

☆ Stocks making the biggest moves midday: Gilead Sciences, Accenture, Trump Media, AMD and more
▼ + stars: | 2024-06-20 | by ( Michelle Fox | ) www.cnbc.com time to read: +3 min

Trump Media & Technology Group — After former President Donald Trump's company said on Tuesday that the Securities and Exchange Commission had declared effective Trump Media's registration of additional shares, the stock dropped 13.5%. Super Micro Computer — Shares jumped 5% after Elon Musk said the company will help his AI firm, xAI, build a supercomputer . Winnebago reported $1.13 in adjusted earnings per share on $786 million of revenue for its fiscal third quarter. Commercial Metals — Shares gained 5.6% after the company reported a revenue beat for its third quarter. Analysts surveyed by LSEG had forecasted $1.80 earnings per share and $1.65 billion in revenue.

Persons: lenacapavir, Donald Trump's, Elon Musk, Piper Sandler, Winnebago, FactSet, Heather Balsky, Jabil, LSEG, —, Alex Harring, Hakyung Kim, Sarah Min, Jesse Pound, Lisa Han Organizations: Accenture, Gilead Sciences, Trump Media & Technology, Securities and Exchange Commission, Trump, Darden, Garden, LongHorn, LSEG . Revenue, Winnebago Industries, Bank of America, Jazz Pharmaceuticals, Metals, Revenue, KB

☆ A top Wall Street analyst names 6 major events that could send biotech stocks soaring between now and the end of 2022
▼ + stars: | 2022-11-14 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +5 min

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.

☆ Merck to start studying lower dose of HIV drug after FDA hold
▼ + stars: | 2022-09-20 | by ( ) www.reuters.com time to read: +1 min

Register now for FREE unlimited access to Reuters.com RegisterThe Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. The FDA has reviewed and agreed with the plan to study lower-dose versions of the once-daily pillfor treating HIV patients, the company said. The drugmaker, however, said it was discontinuing development of a once-a-month dose of islatravir for preventing HIV infection. Some studies using a higher-dose version of islatravir remain under clinical hold. Register now for FREE unlimited access to Reuters.com RegisterReporting by Manas Mishra and Khushi Mandowara in Bengaluru; Editing by Anil D'SilvaOur Standards: The Thomson Reuters Trust Principles.

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