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☆ A.L.S. Drug Relyvrio Will Be Taken Off the Market, Its Maker Says
▼ + stars: | 2024-04-04 | by ( Pam Belluck | ) www.nytimes.com time to read: +1 min

The maker of the newest treatment approved for amyotrophic lateral sclerosis said Thursday that it would withdraw the drug from the market because a large clinical trial did not produce evidence that the treatment worked. The company, Amylyx Pharmaceuticals, said in a statement that it had started the process of withdrawing the drug in the United States, where it is called Relyvrio, and in Canada, where it is called Albrioza. As of Thursday, no new patients will be able to start the drug, while current patients who wish to continue taking the medication can be transitioned to a free drug program, the company said. It decided to greenlight the medication anyway, instead of waiting two years for results of a large clinical trial, citing data showing the treatment to be safe and the desperation of A.L.S. The disease robs patients of their ability to control muscles, speak and breathe without assistance and often causes death in two to five years.

Organizations: Amylyx Pharmaceuticals, and Drug Administration Locations: United States, Canada

Amylyx said Friday it would discuss its plans for Relyvrio with patients and the FDA, which “may include voluntarily withdrawing” the drug. The latest company study showed that the drug did not slow the disease compared with a dummy treatment. Amylyx’s medication is part of a string of drugs for deadly, degenerative diseases that have won FDA approval in recent years despite questionable proof that they work. That commitment seemed to reassure FDA's advisers who voted in favor of the drug's approval, despite the questionable data. In the months before the decision the FDA faced intense pressure from ALS patients, advocates and members of Congress.

Persons: Lou Gehrig’s, Amylyx, ”, “, Relyvrio Organizations: WASHINGTON, Drug Administration, Amylyx Pharmaceuticals, Relyvrio, FDA, Cambridge, Amylyx Pharmaceuticals Inc, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: U.S

☆ Stocks making the biggest moves midday: Nvidia, Marvell Technology, Costco, Eli Lilly and more
▼ + stars: | 2024-03-08 | by ( Samantha Subin | ) www.cnbc.com time to read: +4 min

Marvell Technology — The chip company sank more than 11% on light first-quarter earnings and revenue guidance. Marvell Technology said it anticipated adjusted earnings of 23 cents per share for the first quarter, below the 40 cents expected by analysts polled by LSEG, formerly known as Refinitiv. Samsara posted $276 million in revenue, compared to analysts' expectations for $258 million, per LSEG. DocuSign reported adjusted earnings of 76 cents per share on revenue of $712 million for the period. Analysts polled by LSEG had called for earnings of 64 cents per share on $699 million in revenue.

Persons: Carvana, Eli Lilly —, Goldman Sachs, MongoDB, NYCB, DocuSign, LSEG, Morgan Stanley, Yun Li, Jesse Pound, Pia Singh, Sarah Min, Michelle Fox, Hakyung Kim Organizations: Nvidia —, Nvidia, Marvell Technology, LSEG, RBC Capital Markets, Costco, U.S . Food, Drug Administration, Broadcom, Textron — Textron, Bank of America, Old Navy, New York Community Bancorp, Moody's Investors Service, Amylyx Pharmaceuticals, UBS — U.S, UBS, Auto, Deutsche Bank Locations: U.S, Swiss, China

☆ These smaller stocks could see big gains in 2024, Bank of America says
▼ + stars: | 2024-01-30 | by ( Lisa Kailai Han | ) www.cnbc.com time to read: +5 min

Against this backdrop, Bank of America on Monday released a list of best small- and mid-cap ideas for 2024. Strategist Jill Carey Hall added that this year's basket of 31 stocks has average 12-month potential upside of 29%, and is slightly tilted towards value stocks over growth. Shares of Bath & Body Works have trailed the market, rising 2.4% in 2023 and 0.4% so far in 2024. Bank of America also named United Airlines one of its top SMID ideas for 2024. Other names on Bank of America's list of SMID picks included e-commerce retailer Wayfair and aircraft leasing company Air Lease .

Persons: That's, Russell, Jill Carey Hall, Lorraine Hutchinson, Hutchinson, BofA, Geoff Meacham, Lou Gehrig's, Meacham, CyberArk, Tal Liani, Liani, Max, Andrew Didora, UAL, Didora, — CNBC's Michael Bloom Organizations: Wall, Bank of America, Monday, Body, Pharmaceuticals, TAM, United Airlines, Boeing, Bank of, Air Lease Locations: U.S, Amylyx, cybersecurity, CY26, Chicago

☆ Stocks making the biggest moves midday: Affirm, Disney, Krispy Kreme, TransDigm and more
▼ + stars: | 2023-11-09 | by ( Sarah Min | ) www.cnbc.com time to read: +3 min

Affirm posted $496.5 million in revenue, more than the $444.5 million consensus estimate, according to FactSet. It posted adjusted per-share earnings of $8.03, greater than the consensus estimate of $7.55, according to FactSet. The media conglomerate expanded its cost-cutting measures by $2 billion, and reported stronger-than-expected adjusted earnings for the fiscal fourth quarter. Becton, Dickinson and Company — Shares dropped more than 8% after Becton, Dickinson and Company reported disappointing quarterly earnings. The medical technology company posted adjusted earnings of $3.42 per share, lower than the $3.43 per share anticipated by analysts polled by LSEG, formerly Refinitiv.

Persons: Duolingo, Valaris, FactSet, Dickinson, Krispy Kreme, Amylyx, CNBC's Lisa Han, Alex Harring, Hakyung Kim Organizations: . Virgin Galactic Holdings, TransDigm, — Aerospace, TransDigm Group, Disney —, Disney, Barclays, Arm, Company, LSEG, Revenue, AMC Entertainment, Pharmaceuticals

☆ FDA staff reviewers raise concerns over BrainStorm Cell's ALS therapy
▼ + stars: | 2023-09-25 | by ( ) www.reuters.com time to read: +2 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. Brainstrom's therapy, NurOwn, is being reviewed for the treatment of ALS, also known as Lou Gehrig's Disease, which affects nerve cells in the brain and spinal cord. The FDA had in November last year refused to accept the application for the therapy after BrainStorm failed to meet the main goal in a late-stage study. Over the last one year, the FDA has given accelerated approvals to Amylyx Pharmaceuticals' (AMLX.O) drug Relyvrio and Biogen's (BIIB.O) Qalsody for treatment of ALS. A panel of external advisors to the FDA is set to vote on the effectiveness of the therapy in ALS patients on Wednesday.

Persons: Andrew Kelly, Lou Gehrig's Disease, Amylyx, Mariam Sunny, Leroy Leo, Krishna Chandra Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug, Cell Therapeutics, Amylyx Pharmaceuticals, ALS Association, Thomson Locations: White Oak , Maryland, U.S, Bengaluru

☆ Goldman upgrades this biotech, sees the shares doubling
▼ + stars: | 2023-07-24 | by ( Alex Harring | ) www.cnbc.com time to read: +2 min

It's a good time to buy into beat-down Amylyx Pharmaceuticals as investors could be underestimating one of its trials, according to Goldman Sachs. Analyst Corinne Jenkins upgraded the pharmaceutical stock to buy from neutral and increased her price target by $4 to $49. Her new price target implies shares can surge 117% from Friday's close. But investors have been concerned about the stock because of low expectations going into the phase 3 Phoenix study for Relyvrio. But Jenkins also said the approval would likely be a positive catalyst for the beat-down stock.

Persons: Goldman Sachs, Corinne Jenkins, Jenkins, Lou Gehrig's, — CNBC's Michael Bloom Organizations: Pharmaceuticals, PHOENIX Locations: Friday's, U.S

☆ Here are Monday's biggest analyst calls: Apple, Tesla, Meta, Nvidia, Shopify, Netflix, Disney & more
▼ + stars: | 2023-07-24 | by ( Michael Bloom | ) www.cnbc.com time to read: +9 min

Goldman Sachs initiates Amylyx Pharmaceuticals as buy Goldman said it sees an attractive entry point for shares of the biotech company. " Goldman Sachs reiterates Nvidia as buy Goldman said it's standing by its buy rating on Nvidia and that it likes stocks with "room for meaningful positive EPS revisions." UBS downgrades Tesla to neutral from buy UBS said in its downgrade of Tesla that strong growth is already priced in. Goldman Sachs initiates Savers Value Village as buy Goldman said the thrift store operator is a share gainer. Goldman Sachs reiterates ServiceNow as buy Goldman said it sees more upside in shares of ServiceNow as the stock remains a key beneficiary.

Persons: Piper downgrades Estee Lauder, Piper, Baird, Goldman Sachs, Goldman, Wells, Evercore, it's, Stifel, Lam, Tesla, Moffett, Rosenblatt, Raymond James, Becton Dickinson, SLB, Horton, BTIG, Needham, ServiceNow Organizations: Express, Netflix, Amylyx Pharmaceuticals, Bank of America, NTR, RBC, Research, Nvidia, MU, UBS, Semiconductor, Deutsche Bank, Apple, Deutsche, Mac, Med Tech, Schlumberger, Disney, DIS, American Express Locations: China, underperform, ServiceNow

☆ Citi names its top biotech and pharma stock picks, giving one nearly 90% upside
▼ + stars: | 2023-05-17 | by ( Weizhen Tan | ) www.cnbc.com time to read: +2 min

The healthcare sector outperformed in Europe, India and China last month, according to Citi, which named its top picks worldwide. It gave Amylyx a price target of $53, giving it upside of around 88% from current levels. It gave Beam a price target of $60, implying upside of around 67%. Other European picks from Citi include Swiss healthcare company Roche and British pharma and biotech firm AstraZeneca . Asia stocks In Asia, Citi named Japanese pharmaceutical company Daiichi Sankyo , South Korean biotech firm Samsung Biologics and China's Wuxi Biologics as top picks.

☆ FDA neurosciences chief Billy Dunn to leave immediately, analysts raise concern
▼ + stars: | 2023-02-28 | by ( ) www.reuters.com time to read: +2 min

Feb 28 (Reuters) - The U.S. Food and Drug Administration neurosciences head Billy Dunn will retire from his role effective immediately, the health regulator told Reuters on Tuesday. Wall Street analysts said Dunn's departure could impact the regulator's stance on neurological drug decisions in the near term, sending down shares of Reata Pharmaceuticals Inc (RETA.O) 30% on Monday when media reports on the exit surfaced. Texas-based Reata is expecting FDA's decision by Tuesday on its drug to treat a rare neuromuscular disorder called Friedreich's ataxia. The departure of Dunn, 53, was announced in an internal message to the agency's employees on Monday. Newly appointed deputy director Teresa Buracchio will also serve in Dunn's role on an interim basis at the Office of Neuroscience, the agency told Reuters.

☆ Citi names its top biotech stock picks for 2023 — and gives one 73% upside
▼ + stars: | 2022-12-30 | by ( Weizhen Tan | ) www.cnbc.com time to read: +2 min

Biotech has been a "stock-pickers market" — and it may have just what it takes to remain one in 2023, according to Citi. Under a bad recession scenario, Citi prefers names with large cash balances and which have already commercialized drugs, or which are on the verge of drug approvals. Some names that meet those criteria include Apellis Pharmaceuticals , Acadia Pharmaceuticals and Amylyx Pharmaceuticals , Citi said. Its pre-clinical pipeline could also "drive long-term value across a number of large market opportunities." "[Its] strong cash position makes BEAM attractive even in a hard-landing scenario," Citi said.

☆ A controversial ALS drug potentially worth $1 billion is on the cusp of FDA approval. It could change Amylyx's fortunes and be a much-needed treatment for the rare disease.
▼ + stars: | 2022-09-26 | by ( Yeji Jesse Lee | ) www.businessinsider.com time to read: +7 min

The FDA may soon approve a new treatment for ALS, also known as Lou Gehrig's disease. If approved, Amylyx Pharmaceuticals's drug, AMX0035, will be a new treatment option for patients. A new drug for amyotrophic lateral sclerosis, more commonly known as ALS or Lou Gehrig's disease, is on the cusp of approval from the US Food and Drug Administration. The association said that treatment has the support of the larger ALS community and urged the FDA to "swiftly approve" AMX0035. By comparison, there are around 30,000 ALS patients in the US, meaning reimbursing AMX0035 would pose a much lighter burden on the CMS.

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