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Companies Biogen Inc FollowWASHINGTON, Dec 29 (Reuters) - The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen's (BIIB.O) Alzheimer's drug Aduhelm, which was "rife with irregularities," a congressional report showed on Thursday. The Medicare program restricted its coverage, which has led to severely limited use of the Biogen drug. He pointed to the FDA's internal review finding its staff's interactions with Biogen appropriate. "As stated in the congressional report, an (FDA) review concluded that, 'There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation,'" Biogen said. Documents obtained by the committees show that FDA staff and Biogen held at least 115 meetings, calls, and email exchanges over a 12-month period starting July 2019.

☆ Eisai, Biogen's new Alzheimer's drug should be priced below Aduhelm - report
▼ + stars: | 2022-12-23 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Issei KatoDec 23 (Reuters) - An influential drug pricing research group said Eisai Co Ltd (4523.T) and Biogen Inc's (BIIB.O) new Alzheimer's disease treatment lecanemab should be priced lower than the drug Aduhelm that was developed by the companies. Biogen halved the price of its first Alzheimer's drug Aduhelm last year to $28,200 for a person with average weight, amid tepid sales and reimbursement hurdles. Treatment with lecanemab for patients with Alzheimer's appears to be "promising but inconclusive," ICER said. Eisai and Biogen did not immediately respond to requests for comment on the ICER report. Shares of Eisai fell on Friday after a report of a third death in a trial of lecanemab.

☆ Stocks making the biggest moves premarket: Tesla, Nutanix, Meta and more
▼ + stars: | 2022-12-23 | by ( Peter Schacknow | ) www.cnbc.com time to read: +2 min

Check out the companies making headlines before the bell:Tesla (TSLA) – Tesla CEO Elon Musk said he would refrain from selling any more Tesla stock for 18 to 24 months. Tesla gained 1.2% in the premarket. Nutanix (NTNX) – Nutanix tumbled 16.6% in the premarket following a report that Hewlett Packard Enterprise (HPE) has ended talks to acquire the cloud computing company. Meta Platforms (META) – Meta and users of its Facebook platform settled a privacy class action lawsuit, with Meta agreeing to pay $725 million. Oilfield services stocks – Halliburton (HAL) gained 1.4% in the premarket, with Schlumberger (SLB) up 1.3% and Baker Hughes (BKR) rising 1%.

☆ A top 1% performing fund manager explains why history proves the S&P 500 will fall another 30% in the next 3-to-9 months — and shares 11 compelling stocks to buy in 2023 that will power through a rece
▼ + stars: | 2022-12-21 | by ( Lisa Kailai Han | ) www.businessinsider.com time to read: +6 min

He foresees the S&P 500 falling another 30% and bottoming within the next three to nine months. Abate shared 11 compelling stocks to buy to mitigate looming recessionary risks. But with the looming threat of a recession, Abate believes that the days of big contrarian trade ideas are now behind us. Especially "idiosyncratic stocks that have kind of already felt the pain of a downturn, so even if a recession happens, their backlogs can get them through recessionary conditions." Two biotechnology names Abate noted as standout idiosyncratic ideas are Biogen (BIIB) and Gilead (GILD).

☆ Dow dips ahead of Powell speech; Nasdaq kept afloat by growth stocks
▼ + stars: | 2022-11-30 | by ( Shreyashi Sanyal | ) www.reuters.com time to read: +3 min

The Dow Jones Industrial Average (.DJI) has gained 17.5% in the last two months, while the Nasdaq index (.IXIC) has added 4.2%. Traders expect the Fed to increase rates by 50 basis points in December, with the rates peaking in June 2023. So I don't really make much out of that, I'd like to see what Powell has to say," Saluzzi added. Declining issues outnumbered advancers for a 1.15-to-1 ratio on the NYSE and a 1.09-to-1 ratio on the Nasdaq. The S&P index recorded three new 52-week highs and one new low, while the Nasdaq recorded 51 new highs and 120 new lows.

☆ Wall St set to open flat as focus turns to Powell speech
▼ + stars: | 2022-11-30 | by ( Shreyashi Sanyal | ) www.reuters.com time to read: +3 min

The Dow Jones Industrial Average (.DJI) has gained nearly 18% in the last two months, while the Nasdaq index (.IXIC) has added about 4%. Traders expect the Fed to increase rates by 50 basis points in December, with the rates peaking in June 2023. The data is expected to show 200,000 job additions in November, compared with 261,000 jobs in the prior month. So I don't really make much out of that, I'd like to see what Powell has to say," Saluzzi added. Biogen Inc (BIIB.O) jumped 4.3% after its experimental Alzheimer's drug slowed cognitive decline in a closely watched trial.

☆ Stocks making the biggest moves premarket: Hormel, Petco, CrowdStrike and more
▼ + stars: | 2022-11-30 | by ( Peter Schacknow | ) www.cnbc.com time to read: +2 min

Earnings beat estimates, but sales came up short of Wall Street forecasts. Petco (WOOF) – Petco's adjusted quarterly earnings of 16 cents per share matched Street forecasts, but revenue was slightly above estimates. CrowdStrike (CRWD) – CrowdStrike plunged 17.6% in the premarket after the cybersecurity company's subscription numbers came in below analyst forecasts. NetApp (NTAP) – NetApp tumbled 10.9% in the premarket on a weaker than expected forecast from the cloud computing company, which reported better than expected quarterly earnings. Hewlett Packard Enterprise (HPE) – Hewlett Packard Enterprise added 1.9% in the premarket after the enterprise computing company reported record quarterly sales and issued strong revenue guidance.

☆ Dow falls ahead of Powell speech; Tesla shares boost Nasdaq
▼ + stars: | 2022-11-30 | by ( Shreyashi Sanyal | ) www.reuters.com time to read: +4 min

The Dow Jones Industrial Average (.DJI) has gained 17.5% in the last two months, while the Nasdaq index (.IXIC) has added 4.2%. Traders expect the Fed to increase rates by 50 basis points in December, with the rates peaking in June 2023. China Merchants Bank International said Tesla's sales in China in November were boosted by price cuts and incentives offered on its Model 3 and Model Y. So I don't really make much out of that, I'd like to see what Powell has to say," Saluzzi added. The S&P index recorded two new 52-week highs and no new low, while the Nasdaq recorded 35 new highs and 74 new lows.

☆ Jim Cramer's top 10 to watch Wednesday: Fed's Powell, Alzheimer's data
▼ + stars: | 2022-11-30 | by ( Jim Cramer | ) www.cnbc.com time to read: +4 min

Club holding Salesforce (CRM) is set to report fiscal third-quarter 2023 financial results after the closing bell Wednesday. Atlantic Equities says there's "no easy fix" at Club holding Disney (DIS) for returning CEO Bob Iger. As a subscriber to the CNBC Investing Club with Jim Cramer, you will receive a trade alert before Jim makes a trade. THE ABOVE INVESTING CLUB INFORMATION IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY , TOGETHER WITH OUR DISCLAIMER . NO FIDUCIARY OBLIGATION OR DUTY EXISTS, OR IS CREATED, BY VIRTUE OF YOUR RECEIPT OF ANY INFORMATION PROVIDED IN CONNECTION WITH THE INVESTING CLUB.

☆ Eisai, Biogen Alzheimer's drug slows cognitive decline, safety for some becomes focus
▼ + stars: | 2022-11-30 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

The drug, lecanemab, was associated with a type of brain swelling in 12.6% of trial patients, a side effect previously seen with similar drugs. He suggested that could be because homozygous study patients who were given a placebo fared better than expected. Overall, lecanemab patients benefited by 23% to 26% compared with a placebo on these secondary trial goals. Detailed data from the study were presented at the Clinical Trials on Alzheimer's Disease meeting in San Francisco and published in the New England Journal of Medicine. Dr. Howard Fillit, chief science officer at the Alzheimer’s Drug Discovery Foundation, said doctors always balance the benefits and risks of therapies.

☆ What increasing confidence in Biogen's latest Alzheimer's drug means for Eli Lilly
▼ + stars: | 2022-11-30 | by ( ) www.cnbc.com time to read: +6 min

Donanemab is the name of Eli Lilly's Alzheimer's drug in its own late-stage trials. JPMorgan has a neutral (hold) rating on Biogen shares and an overweight (buy) rating on Eli Lilly shares. What it means for Eli Lilly Eli Lilly has a phase three trial underway for its donanemab Alzheimer's drug that is similar to lecanemab, which is why the Biogen-Eisai data has been interpreted as favorable for the Club holding. Clumps of the protein, known as amyloid plaques, are one of the key markers of Alzheimer's disease. Previous drugs developed around the a-beta hypothesis — including those from Eli Lilly — have failed to meaningfully delay the disease's progression.

☆ Futures rise as focus turns to Powell speech
▼ + stars: | 2022-11-30 | by ( Shreyashi Sanyal | ) www.reuters.com time to read: +3 min

"Fed Chair Powell is speaking, but past comments have done little other than chant 'hike, hike, hike'," said Paul Donovan, chief economist, UBS Global Wealth Management. "Powell has yet to explain the mechanism by which hiking rates is supposed to reduce inflation (which matters to analyzing when rates might peak) ... today's speech should signal a slowing of rate hikes." Hopes that the Fed will now hike rates in smaller increments and recent data pointing to a mild cooling in prices have positioned the benchmark S&P 500 index (.SPX) for its second straight month of gains. Traders see the Fed increasing rates by 50 basis points in December, with the rates peaking in June 2023. Reporting by Shreyashi Sanyal & Devik Jain; Additional reporting by Shubham Batra; Editing by Anil D'SilvaOur Standards: The Thomson Reuters Trust Principles.

☆ Eisai shares plunge 10% in Tokyo after report of death in Alzheimer's trial
▼ + stars: | 2022-11-29 | by ( ) www.reuters.com time to read: +1 min

TOKYO, Nov 29 (Reuters) - Shares in Japanese drugmaker Eisai Co (4523.T) headed for their biggest plunge in more than a year on Tuesday after a report that a woman in a trial of the company's Alzheimer's disease treatment died. Eisai's shares sank 10% to 8,595 yen, leading decliners on the benchmark Nikkei index (.N225), which slid 0.5% in the morning session. Shares in Biogen sank 4.3% on Monday. Eisai and Biogen shares have been on a roller coaster in recent years on prospects for their candidates to battle dementia. Lecanemab was shown to slow cognitive and functional decline in a large trial of patients in the early stages of Alzheimer's disease, Eisai and Biogen said in September.

☆ Rare success for Alzheimer's research unlocks hope for future therapies
▼ + stars: | 2022-11-29 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +6 min

Eisai and Biogen are scheduled to present full data from their lecanemab study on Tuesday at the Clinical Trials on Alzheimer's Disease conference in San Francisco. Lecanemab’s success rests on years of research into the causes of Alzheimer’s as well as advances in measuring amyloid deposits through brain scans and spinal fluids. At least 16 treatments are being tested in clinical trials, with results expected over the next three years, according to a Reuters review of the clinicaltrials.gov registry. The drugmaker has been largely absent from the Alzheimer's space after the high-profile failure of its drug verubecestat five years ago. But several antibody therapies from Lilly, Biogen and AbbVie(ABBV.N) that were designed to slow the rate of tau accumulations failed outright last year.

S&P 500 stocksAll 11 S&P 500 sector indexes declined, led by real estate (.SPLRCR), down 2.81%, and a 2.74% loss in energy (.SPNY). The S&P 500 declined 1.54% to end the session at 3,963.95 points. With two trading days left in November, the S&P 500 is on track for a gain of 2.4% for the month. Trading was mixed in other heavyweight growth stocks, including Microsoft Corp (MSFT.O), Meta Platforms Inc (META.O), Nvidia Corp (NVDA.O) and Tesla Inc (TSLA.O). The S&P 500 posted 12 new highs and two new lows; the Nasdaq recorded 93 new highs and 174 new lows.

S&P 500 stocksAll 11 S&P 500 sector indexes declined, led by real estate (.SPLRCR), down 2%, followed by a 1.91% loss in energy (.SPNY). In afternoon trading, the S&P 500 (.SPX) was down 1.20% at 3,977.86 points. Trading was mixed in other heavyweight growth stocks, including Microsoft Corp (MSFT.O), Meta Platforms Inc (META.O), Nvidia Corp (NVDA.O) and Tesla Inc (TSLA.O). Declining stocks outnumbered rising ones within the S&P 500 (.AD.SPX) by a 7.7-to-one ratio. The S&P 500 posted 11 new highs and two new lows; the Nasdaq recorded 75 new highs and 120 new lows.

Rare protests in major Chinese cities over the weekend against the country's strict zero-COVID curbs have hit growth expectations in the world's second-largest economy. U.S.-listed shares of Chinese companies such as Bilibili Inc , Alibaba Group Holding Ltd , JD.com Inc , Baidu Inc and Nio Inc , however, eked out gains, rising between 1% and 2.2%. Declining issues outnumbered advancers for a 2.47-to-1 ratio on the NYSE and for a 1.95-to-1 ratio on the Nasdaq. The S&P index recorded 11 new 52-week highs and two new lows, while the Nasdaq recorded 74 new highs and 102 new lows. Reporting by Ankika Biswas and Shreyashi Sanyal in Bengaluru; Editing by Shounak Dasgupta and Anil D'SilvaOur Standards: The Thomson Reuters Trust Principles.

☆ Stocks making the biggest moves in the premarket: Apple, Taboola, Biogen and more
▼ + stars: | 2022-11-28 | by ( Peter Schacknow | ) www.cnbc.com time to read: +2 min

A person familiar with assembly operations told Bloomberg that Apple and Foxconn do expect to be able to make up that shortfall in 2023. Apple slid 1.7% in premarket trading. Wynn Resorts (WYNN), MGM Resorts (MGM), Melco Resorts (MLCO), Las Vegas Sands (LVS) – Casino stocks rallied in off-hours trading after the Chinese government granted the companies provisional licenses to continue operating in Macau. Exxon Mobil (XOM), Chevron (CVX) – These and other energy stocks fell in the premarket as WTI Crude touches its lowest level in 11 months. First Solar (FSLR) – The solar company's stock fell 2.6% in the premarket following a downgrade by J.P. Morgan to "neutral" from "overweight."

Nov 22 (Reuters) - Australian drugmaker CSL Ltd (CSL.AX) on Tuesday set the list price of its one-time gene therapy for hemophilia B at $3.5 million, making it the world's most expensive treatment, following its approval by the U.S. health regulator. The first gene therapy for the rare genetic blood clotting disorder offers a long-term solution for patients as against current treatments from Biogen (BIIB.O), Pfizer (PFE.N) and others that focus on regular infusions. The gene therapy consists of an engineered virus carrying a gene expressed in the liver to produce clotting factor IX. While Zynteglo was priced at $2.8 million, Skysona had a wholesale cost of $3.0 million. CSL shares were up 1% at A$300.62 on the Australian stock exchange, while UniQure stock edged up 0.9% in extended trading.

The comments follow a softer-than-expected inflation report last week, which had buoyed hopes that the Fed could scale back its hefty interest rate hikes and helped drive a euphoric market rally. The S&P 500 in the previous session logged its biggest weekly percentage gain in about five months, while the tech-heavy Nasdaq (.IXIC) notched its best week since March. "The market is expecting the Fed to continue its hawkish rhetoric on rates. ET, the S&P 500 (.SPX) was down 17.25 points, or 0.43%, at 3,975.68, and the Nasdaq Composite (.IXIC) was down 115.13 points, or 1.02%, at 11,208.20. The S&P 500 information technology sector (.SPLRCT) was down 1.2% and among the leading sectoral decliners on the benchmark index.

The comments follow a softer-than-expected inflation report last week, which had buoyed hopes that price pressures were easing and the Fed could scale back its hefty interest rate hikes. "The market is expecting the Fed to continue its hawkish rhetoric on rates," said Peter Cardillo, chief market economist at Spartan Capital Securities. Once they (Fed) raise rates at 50 (bps), there's a possibility that they might indicate slower rates." Traders now expect the Fed to hike interest rates in December by a half point, and expect terminal rate in the range of 4.75%-5.0% next year. ET, Dow e-minis were down 50 points, or 0.15%, S&P 500 e-minis were down 11.5 points, or 0.29%, and Nasdaq 100 e-minis were down 62 points, or 0.52%.

☆ Roche's Alzheimer's drug fails to meet goal in long awaited trial
▼ + stars: | 2022-11-14 | by ( Ludwig Burger | ) www.reuters.com time to read: +4 min

Nov 14 (Reuters) - Roche said (ROG.S) its Alzheimer's drug candidate could not clearly be shown to slow dementia progression in two drug trials, failing to draw level with a recent development success by rivals Biogen (BIIB.O) and Eisai (4523.T). Within each study, volunteers were randomly assigned to receive either the injectable antibody drug gantenerumab or a placebo. The quest to develop an Alzheimer's drug, targeting beta-amyloid or other molecules, has been beset by a long list of study failures. But rival Biogen in September scored a surprise trial success with an experimental Alzheimer's drug that it developed with Eisai, rebuilding confidence among industry executives and researchers in the beta-amyloid approach. Schwan earlier this year sought to curb expectations for the Graduate trials but the head of Roche's pharma unit last month acknowledged that Biogen's success with lecanemab had reignited hopes.

☆ Stocks making the biggest moves in the premarket: Hasbro, Oatly, Advanced Micro Devices and more
▼ + stars: | 2022-11-14 | by ( Peter Schacknow | ) www.cnbc.com time to read: +2 min

Advanced Micro Devices (AMD) – The chip maker's stock rose 3.2% in the premarket after receiving upgrades at both Baird and UBS. Amazon.com (AMZN) – Amazon fell 1.7% in premarket trading after Bank of America removed the stock from its "US 1" list, although it maintained a "buy" rating. Teva Pharmaceutical (TEVA) – Teva was downgraded to "underweight" from "neutral" at J.P. Morgan Securities, which cited continuing growth challenges for the drugmaker. Teva fell 2.3% in premarket action. Lilly added 1.5% in premarket trading, while Biogen rallied 5.8%.

☆ Roche reminds investors big drug bets have risks
▼ + stars: | 2022-11-14 | by ( ) www.reuters.com time to read: +2 min

LONDON, Nov 14 (Reuters Breakingviews) - Shareholders in Swiss drug giant Roche (ROG.S) are learning the downside of making big bets on new drugs. Credit Suisse analysts reckoned the drug could eventually generate around $10 billion of sales. If shareholders had valued that revenue at the same 4 times multiple at which Roche currently trades, the drug could have added nearly $40 billion of value to the company. That suggests investors were attaching a less than one-in-three chance of the drug being a success. Roche investors should brace for more big bets.

☆ What Cramer is watching Monday — two AMD upgrades, Microsoft hesitancy, Alzheimer's results
▼ + stars: | 2022-11-14 | by ( Jim Cramer | ) www.cnbc.com time to read: +5 min

Baird upgrades Advance Micro Devices (AMD) to outperform from neutral (buy from hold) and raises price target to $100 per share from $65. UBS goes to a buy from neutral as well and raises price target to $95 from $75. Oppenheimer cuts price target on Club holding Nvidia (NVDA) to $225 per share from $250. Credit Suisse analyst Scott Deuschle assumes coverage on Honeywell (HON) with a neutral rating and a $202-per-share price target. Good for Club holding Eli Lily (LLY) and Biogen (BIIB), which are each working on separate experiment treatments for the disease.

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