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☆ What we'd like to see from 3 economic readings and 2 earnings reports next week
▼ + stars: | 2023-11-11 | by ( Zev Fima | ) www.cnbc.com time to read: +9 min

The major averages advanced again this week as earnings results came in largely better than expected, interest rates stabilized and oil prices dropped below $80 a barrel. Looking ahead, we'll get a couple more earnings results and some key inflationary data to chew on. In this past week, we bought 150 shares of DuPont (DD) and added 75 shares of Wynn Resorts (WYNN). As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust's portfolio.

Persons: Stocks, Wynn Resort's, WYNN, we'll, That's, —, we're, it's, PANW, Tyson, Henry Schein, Spero, Sanara, Sara Lee Corp, JD.com, Woodward, Jim Cramer's, Jim Cramer, Jim, Mario Anzuoni Organizations: Nasdaq, Dow Jones, Coterra Energy, Emerson, Disney, PPI, TJX, Palo Alto Networks, DuPont, Wynn Resorts, WYNN, Tyson Foods, TSN, Tower Semiconductor, Partners, Genius Sports, Spero Therapeutics, Star Bulk Carriers Corp, Beauty Health, Asure, Gladstone Capital Corp, TeraWulf Inc, Harrow Health, Afya, Sea, Paysafe Group Holdings, Solar Inc, Aramark Holdings Corp, Lending, Holding, BioXcel Therapeutics, IHS Inc, Rewalk Robotics, Acurx Pharmaceuticals, Energizer Holdings, Power Solutions, Rekor Systems, Wine Estates, Momentus Inc, SIGMA Lithium Corporation, AlTi, QuickLogic Corporation, Arcturus Therapeutics, Dada Nexus, Solutions, Target Corp, Parts, ZIM Integrated Shipping Services, Alto Networks, Cisco Systems, Chemical & Mining Co, PennantPark Investment Corp, Copa Holdings S.A, Walmart, Arcos Dorados Holdings, ARCO, NICE, Body, Warner Music Group Corp, Ross Stores, Homes, Dolby Laboratories Inc, American Software, ESCO Technologies, ZTO, International, BJ's Wholesale, Jim Cramer's Charitable, CNBC, Maxx Locations: Macau, Chile, Cayman, Pasadena , California

☆ Jefferies upgrades this little-known biotech stock with more than 100% upside
▼ + stars: | 2023-11-10 | by ( Lisa Kailai Han | ) www.cnbc.com time to read: +1 min

The firm upgraded shares of the late-stage biotech to buy from hold, lifting its price target to $26 from $18. Shares of Vera Therapeutics have fallen 37.8% this year, but analyst Farzin Haque believes the stock's recent pullback now means an attractive entry point for investors. VERA YTD mountain VERA YTD chart "W/ shares down –30% (vs XBI –13%) since Sept 21 TVTX data release, we have become more optimistic about atacicept (dual BAFF/APRIL) clin profile," Haque wrote. Atacicept, which Vera took over from Merck, is a drug that treats certain autoimmune diseases. "W/ recent increasing focus on eGFR, VERA's OLE data from ph.II for longer-term eGFR data (expected 1Q24) has now become an important catalyst for the stock," Haque said.

Persons: Vera, Jefferies, Vera Therapeutics, Farzin Haque, VERA YTD, VERA, Haque, Lupus nephritis, — CNBC's Michael Bloom Organizations: Vera, Merck Locations: ph.II

☆ Gonorrhea Is Becoming Drug Resistant. Scientists Just Found a Solution.
▼ + stars: | 2023-11-10 | by ( Apoorva Mandavilli | More About Apoorva Mandavilli | ) www.nytimes.com time to read: +4 min

About half of infected people show no symptoms, but in others gonorrhea can lead to painful joints and burning urination. It has become resistant to azithromycin and is increasingly resistant to another antibiotic called ceftriaxone, which is now the standard of care. Based on previous research, the drug is unlikely to be as effective in the throat and rectum, said Dr. Marrazzo. In studies, zoliflodacin appears to be effective against a wide range of resistant strains of gonorrhea. The partnership’s agreement minimizes that chance: The nonprofit plans to manage how the drug is distributed, and to see that it is used only to treat gonorrhea.

Persons: gonorrhea, ”, Manica Balasegaram, “ I’ll, that’s, Ramanan Laxminarayan, Jeanne Marrazzo, Marrazzo, zoliflodacin, Margaret Koziel Organizations: Global, Research, Development, Pharmaceutical, European Union, Therapeutics, Princeton University, National Institute of Allergy Locations: American

Executives of some beaten-down companies, including one battered biotech name and a popular soft drinks maker, scooped up shares of their own stock in the past week. Here are the top insider buys: Energy Transfer — Executive Chairman Kelcy Warren bought one million shares Monday at $13.53 per share for a total value of $13.53 million. Shares are up more than 2% over the past month. Enstar Group CEO bought swathes of shares Wednesday, the day after the company reported its earnings for the third quarter. The stock has gained about 8% so far this year and shares are up roughly 4% over the past month.

Persons: Kelcy Warren, Dominic F, Silvester, Nigel W, Morris, Richard Barry, Verity, Douglas Ingram, Keurig Dr Pepper, Timothy P, Cofer, Dr Pepper's, Dr Pepper —, Dr Pepper, Mott's —, Enstar Organizations: CNBC Pro, —, Global, Therapeutics, Remitly, FDA, U.S . Securities, Exchange, Enstar Locations: Canada

☆ Stocks making the biggest moves midday: Groupon, Wynn Resorts, Plug Power, Illumina and more
▼ + stars: | 2023-11-10 | by ( Alex Harring | ) www.cnbc.com time to read: +4 min

Wynn Resorts — The resort-and-casino stock dropped 7.3% as analysts focused on EBITDAR, which includes restructuring, tied to its operations in Macao. Plug Power — Shares of the clean energy company tumbled more than 34%, reaching a new 52-week low, after third-quarter earnings and revenue missed analysts' estimates. TKO Group — The WWE parent slid 7.9% after Executive Chairman Vince McMahon said he planned to sell 8.4 million shares. Treace Medical Concepts — Shares tumbled 40% after the medical device company missed third-quarter expectations and lowered its full-year revenue guidance. The company also cut revenue guidance for the year.

Persons: Vince McMahon, Treace, Freyr, Wells, Synaptics, LSEG, Vera Therapeutics, Vera, —, Sarah Min, Hakyung Kim, Pia Singh Organizations: Wynn Resorts, Diageo —, Diageo, RBC, JPMorgan, WWE, Wall, Analysts, Jefferies Locations: billings, Macao, America, Caribbean, Wells Fargo, Hawaii

☆ Beware these companies due to report earnings that have negative profit momentum
▼ + stars: | 2023-11-09 | by ( Lisa Kailai Han | ) www.cnbc.com time to read: +4 min

CNBC Pro screened for the S & P 500 companies still reporting next week that analysts have expressed the most caution on — by cutting their earnings estimates ahead of the reports. Analyst consensus earnings estimates are down at least 5% over the past three months. Analyst consensus earnings estimates are down at least 5% over the past six months. CTLT YTD mountain Catalent YTD chart "Catalent (CTLT) became a very noticeable laggard in the life science space about fifteen months ago. Meat producer Tyson Foods , which is due to report earnings premarket on November 13, was also among the stocks with negative earnings momentum.

Persons: Gordon Haskett, Don Bilson, Bilson, Catalent, Michael Lasser, Lasser, Morgan Stanley, BBWI, Alex Straton, Tyson Foods, — CNBC's Michael Bloom Organizations: CNBC Pro, Biotechnology, Sarepta Therapeutics, Dystrophy, UBS, 3Q, Body Locations: Columbus , Ohio, Bath

☆ Octarine Bio makes sustainable dyes for the fashion industry. Check out the 11-slide pitch deck it used to raise $4.6 million.
▼ + stars: | 2023-11-08 | by ( Tasmin Lockwood | ) www.businessinsider.com time to read: +3 min

A Danish biotechnology startup making sustainable dyes for the fashion industry just raised 3.4 million euros ($4.6 million). Octarine Bio started out focusing on cannabinoid and psilocybin-derived therapeutics but has since pivoted to natural dyes. On top of that, natural dyes don't always work well with synthetic fabrics such as polyester and nylon. "This is a huge value inflection point" as Octarine Bio's colors are scalable thanks to fermentation and work well on synthetic fabrics, Gallage said. Octarine BioOctarine BioOctarine BioOctarine BioOctarine BioOctarine BioOctarine BioOctarine BioOctarine BioOctarine Bio

Persons: Octarine, Nethaji Gallage, Gallage Organizations: Nordic, Unconventional Ventures, Óskare Capital, Firm, bioscience, Dsm Locations: Danish, Copenhagen

☆ Bristol Myers buys Orum's blood cancer therapy for up to $180 mln
▼ + stars: | 2023-11-06 | by ( ) www.reuters.com time to read: 1 min

A sign stands outside a Bristol Myers Squibb facility in Cambridge, Massachusetts, U.S., May 20, 2021. REUTERS/Brian Snyder/File Photo Acquire Licensing RightsNov 6 (Reuters) - Bristol Myers Squibb (BMY.N) has acquired Orum Therapeutics' experimental therapy to treat a type of blood cancer for a total value of up to $180 million, the privately held company said on Monday. The therapy, ORM-6151, which helps degrade a specific protein hard to treat previously, has received the U.S. Food and Drug Administration's (FDA) clearance for an early stage study. The deal includes an upfront payment of $100 million and milestone payments, Orum said, without disclosing further details. Reporting by Khushi Mandowara in Bengaluru; Editing by Dhanya Ann Thoppil and Sriraj KalluvilaOur Standards: The Thomson Reuters Trust Principles.

Persons: Brian Snyder, Orum, Khushi, Dhanya Ann Thoppil Organizations: Bristol Myers Squibb, REUTERS, Orum Therapeutics, U.S . Food, Thomson Locations: Cambridge , Massachusetts, U.S, Bengaluru

☆ These 4 stocks report quarterly results next week. Here's what we hope to see
▼ + stars: | 2023-11-04 | by ( Zev Fima | ) www.cnbc.com time to read: +11 min

The major averages rebounded strongly this week as quarterly earnings came in largely better than expected and interest rates fell on softer economic data. The Dow Jones Industrial Average rose more than 5% for its best week since October 2022. The big theme next week is earnings and the four portfolio companies delivering their quarterly results. Here's the full rundown of all the important domestic data in the week ahead as we consider a number areas of our portfolio for trades next week. ET: Treasury budget statement for October (See here for a full list of the stocks in Jim Cramer's Charitable Trust.)

Persons: FactSet, we'll, Hulu —, Krystal, Horton, Zimmer, LEV, Armour, Ralph Lauren Corporation, CRON, Patterson, Walt Disney, MARA, Ginkgo, FREYR Battery, FREY, Arcelor Mittal, Wynn, Jim Cramer's, Jim Cramer, Jim Organizations: Dow Jones, Nasdaq, ISM, Services, Coterra Energy, Emerson Electric, Wall, National Instruments, Disney, Hulu, CNBC, Comcast, ESPN —, Wynn Resorts, WYNN, Asia that's, Wynn, Wynn's, Wynn Interactive, United, Brookfield Asset Management, Axsome Therapeutics, Network Corporation, Krystal Biotech, Ceragon Networks, Kosmos Energy Ltd, TreeHouse Foods Inc, Air Lease Corporation, Inc, Eversource Energy, Fennec Pharmaceuticals Inc, Graham Corporation, Aereas Inteligentes, Hilton, Energy, Realty Income Corp, Semiconductors, Vertex Pharmaceuticals Inc, Clover Health, Contura Energy, Diamondback Energy, FS KKR Capital Corp, Celanese Corp, Eos Energy Enterprises, Goodyear Tire & Rubber Company, WEN, Pall Corp, TransMedics, Emerson, Uber Technologies, Holdings, Melco Resorts, Entertainment, Zimmer Biomet Holdings, ACM Research, Lion Electric Company, Emerson Electric Co, Vertex Energy, Waters Corp, Air Products & Chemicals, Esperion Therapeutics, Fidelity National Information Services Inc, Bowlero Corp, Hotels, KKR, Co, Devon Energy Corp, Occidental Petroleum Corp, Dutch Bros Inc, Gilead Sciences, ContextLogic Inc, Akamai Technologies, Viatris Inc, Technologies, Corsair, Enovix Corporation, eBay, EBAY, DaVita Inc, Pan American Silver Corp, Roblox Corporation, Fisker Inc, Warner Bros ., Nuvei Corporation, Farms, Akebia Therapeutics, Biogen Inc, 3D Systems Corporation, Gray Television Inc, BlackSky Technology Inc, Cronos, EVgo Inc, Lumentum Holdings Inc, Nexstar Media Group, UTI Energy, Starwood Property Trust, AMC Entertainment Holdings, Marathon Digital Holdings, IonQ Inc, Digital Turbine, Virgin Galactic Holdings , Inc, Arm Holdings plc, ARM, Ginkgo Bioworks Holdings, Suncor Energy, AppLovin Corporation, B2Gold Corp, Luminar Technologies, MGM Resorts International, MGM, Bloom Energy Corporation, Li Auto Inc, Oatly, Kopin Corp, Fiverr International, YETI Holdings, YPF S.A, Ship Lease, Himax Technologies Inc, Dickinson, CommScope Holding, RBC, Agile Therapeutics, Apyx Medical Corporation, Grab Holdings, Hawaiian Electric Industries, Profire Energy, Flags Inc, Stereotaxis Inc, TransDigm, US Foods Holding Corp, Utz Brands, Valvoline Inc, Weibo Corporation, Wix.com Ltd, Trade, Petroleo Brasileiro SA Petrobras, Growth, Aurora Cannabis Inc, Navitas Semiconductor Corp, Archer Aviation Inc, Semiconductor, Energy Fuels Corp, Illumina Inc, Spike Investment Corp, Algonquin Power & Utilities Corp, AngloGold, Central Puerto S.A, Hudson Global, AirSculpt Technologies, Partners, Soho House, Jim Cramer's Charitable, Handout, Getty Locations: U.S, Macao, Asia, China, Las, Singapore, Wynn's Vegas, Boston, United Arab Emirates, Gilead, VVV, Central, Soho

☆ Eli Lilly's rally on blowout Mounjaro sales signals a new leg higher for the stock
▼ + stars: | 2023-11-02 | by ( Kevin Stankiewicz | In Kevinstankiewicz | ) www.cnbc.com time to read: +8 min

LLY YTD mountain Eli Lilly's year-to-date stock performance. Investors are understandably cheering the results, sending Eli Lilly shares higher by more than 4%. "Eli Lilly today is beginning its next leg of going up," Jim Cramer said during Thursday's Morning Meeting . The most important line item was Mounjaro sales, which cleared Wall Street's high bar. Excluding that divestiture and the $387 million in Covid antibody sales in the year-ago quarter, Eli Lilly's sales grew 24% on an annual basis — a highly respectable figure.

Persons: Eli Lilly, LLY, Mounjaro, it's, Eli Lilly's, Jim Cramer, Jim, It's, Novo's, Lilly, We're, Dave Ricks, Ricks, Trulicity, Anat Ashkenazi, Lilly —, Ashkenazi, Jim Cramer's, David Ricks, Eli Lilly Scott Mlyn Organizations: Drug Administration, FDA, Novo Nordisk, CNBC, Management, Dice Therapeutics, Therapeutics Locations: North, Concord , North Carolina, U.S, Indianapolis

☆ Eli Lilly results top estimates on Mounjaro strength but slashes full-year profit outlook
▼ + stars: | 2023-11-02 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Eli Lilly on Thursday reported third-quarter revenue and adjusted earnings that topped estimates on strong demand for its diabetes drug Mounjaro, but slashed its full-year profit guidance due to charges primarily related to its recent acquisitions. Eli Lilly recorded pre-tax "in-process research and development" charges of $2.98 billion, which are primarily related to a slew of recent buyouts, including DICE Therapeutics, Versanis Bio and Emergence Therapeutics AG. "This is essentially the future value of business development deals we have done," Eli Lilly CEO David Ricks said on CNBC's "Squawk Box" on Thursday. But Eli Lilly reiterated its full-year revenue forecast of between $33.4 billion and $33.9 billion. With a market cap of roughly $526 billion, Eli Lilly is the largest pharmaceutical company based in the U.S.

Persons: Eli Lilly, Jardiance, David Ricks Organizations: LSEG, Therapeutics, U.S Locations: Mounjaro, Wednesday's

☆ Former FDA commissioner Dr. Scott Gottlieb on the future of gene therapy
▼ + stars: | 2023-11-01 | by ( ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailFormer FDA commissioner Dr. Scott Gottlieb on the future of gene therapyFormer FDA commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss the future of gene therapy, after Sarepta Therapeutics revealed new data for its Duchenne Muscular Dystrophy gene therapy fell short of expectations, the state of Covid-19, and more.

Persons: Scott Gottlieb Organizations: Former, Sarepta Therapeutics Locations: Covid

☆ AstraZeneca to invest $245 mln in Cellectis to boost gene therapy prospects
▼ + stars: | 2023-11-01 | by ( ) www.reuters.com time to read: +1 min

The logo for AstraZeneca is seen outside its North America headquarters in Wilmington, Delaware, U.S., March 22, 2021. Cellectis' gene-editing technology and manufacturing capabilities to design novel cell and gene therapy products will help strengthen AstraZeneca's growing offering in the space, it said. AstraZeneca said that as part of the deal, it will pay Cellectis $105 million by the end of this year. That includes an $80 million equity investment, which will be followed by another $140 million in early 2024, which will give AstraZeneca a stake of about 44% in the French company. The Anglo-Swedish pharma company said it had exclusive rights to 25 genetic targets, of which up to 10 candidate products could be explored for development.

Persons: Rachel Wisniewski, Aby Jose Koilparambil, Savio D'Souza Organizations: AstraZeneca, REUTERS, Swedish pharma, Thomson Locations: North America, Wilmington , Delaware, U.S, Swedish, Bengaluru

☆ Stocks making the biggest moves after hours: SolarEdge, Qualcomm, Etsy, Clorox and more
▼ + stars: | 2023-11-01 | by ( Alex Harring | ) www.cnbc.com time to read: +4 min

SolarEdge — The solar stock cratered 23% after SolarEdge posted a dismal third-quarter report and outlook for the current quarter's revenue. SolarEdge lost 55 cents per share, excluding items, while analysts polled by LSEG, formerly known as Refinitiv, forecast a gain of 89 cents per share. The company guided revenue for the current quarter to between $300 million and $350 million, well under the $688 million anticipated by analysts. Qualcomm surpassed analysts' estimates in its fiscal fourth quarter, reporting adjusted earnings of $2.02 per share on revenue of $8.67 billion. Etsy beat analysts' estimates for earnings in the third quarter but fell short of Wall Street's expectations on revenue.

Persons: SolarEdge, LSEG, Josh Silverman, Etsy, Roku, Roku's, DoorDash, Clorox, Sarepta, FactSet, Darla Mercado, Sarah Min, Jesse Pound, Scott Schnipper Organizations: LSEG, Revenue, Qualcomm —, Qualcomm, Electronic Arts, Arts, Wall Street, Tandem Diabetes Care, Ritz, Therapeutics Locations: FactSet

☆ FDA panel says Vertex/CRISPR to assess safety risks of gene therapy in follow-up study
▼ + stars: | 2023-10-31 | by ( ) www.reuters.com time to read: +2 min

[1/2] A sign hangs in front of the world headquarters of Vertex Pharmaceuticals in Boston, Massachusetts, U.S., October 23, 2019. REUTERS/Brian Snyder/File Photo Acquire Licensing RightsOct 31 (Reuters) - A panel of advisers to the U.S. health regulator said on Tuesday Vertex Pharmaceuticals (VRTX.O) and CRISPR Therapeutics (CRSP.BN) could assess potential safety risks of their sickle cell disease gene therapy after approval. If the therapy is approved, Vertex has proposed a 15-year follow up of patients to evaluate the safety outcomes of the therapy. Patients who were treated with the therapy were free from severe vaso-occlusive crisis for 12 months from the infusion of exa-cel. "It was made pretty clear that any theoretical off-target editing concerns do not outweigh the benefits of drug approval," said Salim Syed, analyst at Mizuho.

Persons: Brian Snyder, Scot Wolfe, Salim Syed, Sriparna Roy, Krishna Chandra Organizations: Vertex Pharmaceuticals, REUTERS, CRISPR Therapeutics, Staff, U.S . Food, Drug Administration, UMass Chan Medical, Analysts, FDA, Mizuho, Thomson Locations: Boston , Massachusetts, U.S, Bengaluru

☆ Panel Says That Innovative Sickle Cell Cure Is Safe Enough for Patients
▼ + stars: | 2023-10-31 | by ( Gina Kolata | More About Gina Kolata | ) www.nytimes.com time to read: +1 min

Family members are affected too — they may need to take time off work during the most intensive phase of the treatment. Additionally, most Americans with sickle cell are Black and may not trust a health care system that has often failed to provide the most basic preventive and therapeutic care for those with the disease. Some with sickle cell are anxious about undergoing a medical treatment that is on the cutting edge of biotechnology. “We are finally at a spot where we can envision broadly available cures for sickle cell disease,” said Dr. John Tisdale, director of the cellular and molecular therapeutics branch at the National Heart, Lung and Blood Institute and a member of the advisory committee. Kyra is now in intensive care as doctors try to control her pain.

Persons: It’s, ”, John Tisdale, Dana Jones, San Antonio, Kyra Organizations: Blood Institute

☆ Amgen sales rise, but shares off as investors await obesity data
▼ + stars: | 2023-10-31 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

Third quarter sales of Horizon's gout drug Krystexxa rose to $253 million from $192 million. Amgen raised its post-acquisition forecast for full-year sales to between $28 billion and $28.4 billion from a previous estimate of $26.6 billion to $27.4 billion. Total revenue for the quarter rose 4% to $6.9 billion, in line with analyst expectations. Sales of cancer drug Lumakras fell 31% to $52 million and sales of psoriasis drug Otezla fell 10% to $567 million. Sales of Amjevita, Amgen's new biosimilar version of AbbVie's (ABBV.N) blockbuster arthritis drug Humira, rose 30% to $152 million.

Persons: Robert Galbraith, Amgen, Jefferies, Michael Yee, Bill Smead, Tepezza, We're, we've, Peter Griffith, AMG340, William Blair, Matt Phipps, Lumakras, Otezla, Deena Beasley, Leroy Leo, Bill Berkrot Organizations: REUTERS, Horizon Therapeutics, Smead Capital Management, Wall Street, U.S . Federal Trade Commission, Thomson Locations: South San Francisco , California, California, Los Angeles, Bengaluru

Six of the 11 major S&P 500 sectors were trading lower, with information technology (.SPLRCT) leading losses. Pfizer's shares (PFE.N) fell 1.5% after the drugmaker reported its first quarterly loss since 2019. U.S. equities are tracking their third straight month in the red, with the S&P 500 (.SPX) and the Nasdaq (.IXIC) on course for their worst October since 2018. The Fed kicks off a two-day monetary policy meeting on Tuesday. The Fed's commentary on Wednesday would be crucial in assessing how long monetary policy could stay restrictive amid recent signs of economic strength.

Persons: Brendan McDermid, Andrew Hunter, Amruta Khandekar, Shashwat Chauhan, Saumyadeb Chakrabarty, Shounak Dasgupta, Maju Samuel Organizations: New York Stock Exchange, REUTERS, Corp, Dow, Nasdaq, Federal, Nvidia, Microsoft, Caterpillar, Chicago PMI, Capital Economics, Dow Jones, PDD Holdings, VF Corp, Vans, Arista Networks, Sarepta Therapeutics, NYSE, Thomson Locations: New York City, U.S, China, Bengaluru

☆ Murky road ahead for Duchenne gene therapy as confirmatory trial misses main goal
▼ + stars: | 2023-10-31 | by ( Meg Tirrell | ) edition.cnn.com time to read: +4 min

Sarepta gave the one-time drug a price tag of $3.2 million, making it the second most-expensive medicine in the world. DMD affects one in 3,500 to 5,000 newborns, mostly boys because of the way it’s inherited, according to Johns Hopkins Medicine. The primary goal of the confirmatory trial was improvement on a measure known as the North Star Ambulatory Assessment, a scale of how well kids can stand, walk and perform other movements. The difference wasn’t statistically significant, meaning technically the study failed to meet its main goal. The company said no new safety issues emerged in the trial, which it called EMBARK.

Persons: Doug Ingram, ” Ingram, Sarepta, “, Dr, Sanjay Gupta, Ingram, ” Organizations: CNN, US Food and Drug Administration, Sarepta Therapeutics, FDA, Johns Hopkins Medicine, North Star, CNN Health

☆ F.D.A. Experts Will Vote on Safety of a Cure for Sickle Cell Disease
▼ + stars: | 2023-10-30 | by ( Gina Kolata | More About Gina Kolata | ) www.nytimes.com time to read: +4 min

An estimated 100,000 people in the United States have sickle cell disease, most of whom have African ancestry. will decide on another application for sickle cell gene therapy made by Bluebird Bio. Two other companies and an academic center, Boston Children’s Hospital, are testing their own sickle cell gene therapies. While these therapies could reduce the suffering of sickle cell patients in the United States and other wealthy countries, there is an even greater need for them in some developing countries like Nigeria. One company, Beam, is testing a way to provide gene editing that requires nothing more than a single infusion in a doctor’s office.

Persons: “, Mariah Jacqueline Scott, Scott, ”, Stephan Grupp, What’s Organizations: Institute for Clinical, CRISPR Therapeutics, Children’s Hospital of Philadelphia, Bluebird, Boston Children’s Hospital Locations: United States, Highland Park, N.J, Boston, Nigeria

☆ A New Sickle Cell Treatment Will Change Lives — but How Many? - The New York Times
▼ + stars: | 2023-10-30 | by ( Daniela J. Lamas | ) www.nytimes.com time to read: +3 min

And though comprehensive sickle cell care — at dedicated centers with expert hematologists, social workers and pain management specialists — reduces hospitalizations, and is the standard for diseases like cystic fibrosis and hemophilia, which do not disproportionately affect Black people, these centers are few and far between for sickle cell. Into this complicated landscape enters the possibility of gene therapy. It’s important to note that this isn’t the first cure for sickle cell. is expected to review another gene therapy from the company Bluebird Bio that targets sickle cell disease but does not use CRISPR; this was the therapy Mr. Holmes received as part of the N.I.H. When she was 17 and hospitalized, facing the reality of her chronic illness, she told her mother that she was ready to pursue gene therapy.

Persons: Holmes, Elizabeth Ford, Ford Organizations: Vertex Pharmaceuticals, CRISPR Therapeutics, Bluebird

☆ Here are 5 anti-obesity drug stocks besides Novo Nordisk and Eli Lilly to watch into year-end
▼ + stars: | 2023-10-29 | by ( Christina Cheddar Berk | ) www.cnbc.com time to read: +11 min

Novo Nordisk and Eli Lilly reign over the anti-obesity drug market, and don't expect this duopoly to end soon, analysts say. All this goes on amid robust demand for Novo's semaglutide, which is sold as Ozempic for type 2 diabetes and as Wegovy for weight loss, and Lilly's tirzepatide, which hopes to receive regulatory approval for weight loss this year. Orforglipron is an oral drug Eli Lilly is developing. It has several other compounds in the pipeline, but Suvannavejh expects the weight loss drug to receive increased attention. "This range would also be competitive with LLY's orforglipron [an oral GLP-1 drug] weight loss at day 28," Smith said.

Persons: Eli Lilly, Piper Sandler, Yasmeen Rahimi, Cantor Fitzgerald, Louise Chen, Lilly, Lilly's, Chen, Price, Kyle Rasbach, We've, Rasbach, Altimmune Altimmune, NASH, Piper's, Rahimi, Cantor's Chen, it's, Eli Lilly's Mounjaro, Goldman Sachs, Chris Shibutani, David Risinger, Risinger, Jonathan Wolleben, Wolleben, Orforglipron, Graig Suvannavejh, Suvannavejh, Thomas Smith, LLY's, Smith, Yale Jen, Jen Organizations: Novo Nordisk, Pfizer, Novo, pharma, Pfizer Pfizer, danuglipron, Therapeutics, Leerink, Mizuho Securities, Viking Therapeutics Viking Therapeutics, Laidlaw & Co Locations: Novo, GLP, Eventide

☆ US Shifting COVID Antivirals to Commercial Market on Nov. 1
▼ + stars: | 2023-10-27 | by ( Oct. | At P.M. | ) www.usnews.com time to read: +2 min

The government has been overseeing distribution of the treatments, alongside vaccines and tests, but has transferring that work to traditional commercial channels. Commercial ordering for the treatments is set to start on Nov. 1. The U.S. government paid around $530 per course for Paxlovid, the most commonly prescribed at home COVID-19 treatment in the country, and made it available at no cost. Returns will begin on Nov. 15, the official said, and will be accepted through the end of the year. The government is recommending returns start in December enough time for the establishment of patient assistance programs and securing of commercially-labeled doses.

Persons: Ahmed Aboulenein WASHINGTON, Lagevrio, Ahmed Aboulenein, Marguerita Choy Organizations: U.S, Pfizer, Paxlovid, U.S . Department of Health, Human Services Locations: U.S

The government has been overseeing distribution of the treatments, alongside vaccines and tests, but has transferring that work to traditional commercial channels. Commercial ordering for the treatments is set to start on Nov. 1. Returns will begin on Nov. 15, the official said, and will be accepted through the end of the year. The government is recommending returns start in December enough time for the establishment of patient assistance programs and securing of commercially-labeled doses. Reporting by Ahmed Aboulenein Editing by Marguerita ChoyOur Standards: The Thomson Reuters Trust Principles.

Persons: Lagevrio, Ahmed Aboulenein, Marguerita Choy Organizations: U.S, Pfizer, Paxlovid, U.S . Department of Health, Human Services, Thomson Locations: U.S

☆ Bristol Myers Squibb earnings top estimates even as top-selling drug fights generic competition
▼ + stars: | 2023-10-26 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Bristol Myers Squibb on Thursday reported quarterly adjusted earnings that topped expectations and posted revenue in line with estimates, even as sales of the company's popular blood cancer drug Revlimid plummeted due to generic competition. Bristol Myers also reiterated its full-year revenue guidance of a low single-digit percentage decline. Bristol Myers said both older and new drug products helped offset the lower sales of Revlimid for the third quarter. Eliquis, which Bristol Myers shares with Pfizer , is among the first ten drugs selected to face price negotiations with the federal Medicare program. Bristol Myers will hold an earnings call with investors at 8 a.m. E.T.

Persons: Revlimid, Bristol Myers, –, Eliquis, FactSet, Opdualag Organizations: Bristol Myers Squibb, Bristol, LSEG, Pfizer, FactSet, Therapeutics Locations: Wednesday's

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