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☆ These stocks were oversold during this week's sell-off and could be due for a bounce
▼ + stars: | 2024-04-05 | by ( Brian Evans | ) www.cnbc.com time to read: +3 min

We used the CNBC Pro Stock Screener Tool to identify companies that are oversold based on their 14-day relative strength index. The stock is slightly oversold with a 14-day RSI reading of 24.52. Biopharmaceutical firm Biogen also made the list, with a 14-day RSI reading of 29.71. BIIB YTD mountain Biogen stock. Other oversold stocks on the list include Starbucks and Nike .

Persons: McDonald's, Krispy Kreme, Biogen, Wall, Baird, Brian P, Skorney Organizations: Dow Jones Industrial, Federal Reserve, CNBC, Israel, Starbucks, Nike Locations: Latin America

REUTERS/Andrew Kelly/File PhotoAug 7 (Reuters) - The U.S. drug regulator's approval of Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) first-of-its-kind postpartum depression (PPD) pill is unlikely to allay the drugmakers' growth concerns, analysts said on Monday. Adverse commentary after their PPD drug was approved by the U.S. Food and Drug Administration (FDA) on Friday sent Sage shares tumbling 40%, while Biogen dropped 3% in premarket trading. Zurzuvae's use as a clinical depression treatment represents a more than $1 billion sales opportunity compared with $250 million to $500 million potential for postpartum depression, said Jefferies analyst Michael Yee. "Postpartum depression is not necessarily where a big commercial opportunity is," Biogen CEO Christopher Viehbacher said last month. The U.S. FDA said last week that additional studies might be required to support the drug's approval for major depressive disorder (MDD), or clinical depression.

Persons: Andrew Kelly, Sage, Biogen, Baird, Brian Skorney, Skorney, Zurzuvae, Jefferies, Michael Yee, Christopher Viehbacher, Yee, Mariam Sunny, Bhanvi, Manas Mishra, Vinay Dwivedi Organizations: Food and Drug Administration, FDA, REUTERS, Sage Therapeutics, U.S . Food, Drug Administration, U.S, Thomson Locations: White Oak , Maryland, U.S, Bengaluru

July 28 (Reuters) - Biogen (BIIB.O) agreed to buy rare disease drugmaker Reata Pharmaceuticals (RETA.O) for nearly $6.5 billion, the first large acquisition under new CEO Christopher Viehbacher as he seeks to return the drugmaker to growth. Through the deal, Biogen said it will gain Texas-based Reata's recently approved drug Skyclarys to treat a rare genetic disorder that causes progressive damage to the nervous system. It already makes Spinraza, a treatment for the rare muscle-wasting disorder called spinal muscular atrophy, and a treatment for a rare type of amyotrophic lateral sclerosis. Biogen said it will pay Reata $172.50 per share in cash, which represents a 58.9% premium to the stock's last closing price. Reuters GraphicsShares of Reata surged nearly 52% to $164.76 in early trading, while Biogen's shares fell marginally to $261.14.

Persons: Christopher Viehbacher, Viehbacher, Biogen, Eisai, Baird, Brian Skorney, Manas Mishra, Bhanvi, Shinjini Organizations: Pharmaceuticals, Reuters, Thomson Locations: Texas, United States, Bengaluru

Companies Gilead Sciences Inc FollowJuly 21 (Reuters) - Gilead Sciences Inc (GILD.O) said on Friday it was stopping a late-stage trial of its blood cancer combination treatment following an analysis that showed it would not be effective. Gilead, whose shares dropped over 1% in after-market trading, recommended that treatment with magrolimab in patients with MDS should be stopped. The company gained access to magrolimab with its $4.9 billion buyout of Forty Seven Inc in March 2020. Magrolimab is also in development for other types of cancer such as acute myeloid leukemia and solid tumours. Reporting by Sriparna Roy in Bengaluru Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.

Persons: Gilead, Robert W, Baird, Brian Skorney, Magrolimab, Sriparna Roy, Vinay Dwivedi Organizations: Gilead Sciences, Gilead Sciences Inc, Seven Inc, Thomson Locations: Bengaluru

If successful, Amgen would claim ownership of all antibodies that inhibit the PCSK9 protein, the mechanism of action for both Repatha and Praluent. Other companies could then do the same with their own antibody treatments in other disease areas. The case might also affect newer technologies used in medicine, such as CRISPR gene editing and messenger RNA, she said. A Washington, D.C.-based federal appeals court that covers U.S. patent cases invalidated Amgen's patent claiming ownership of all PCSK9 inhibitors as a whole in 2021. Amgen sued Sanofi and Regeneron in 2014.

☆ Sarepta slides as FDA about-turn on panel clouds gene therapy approval path
▼ + stars: | 2023-03-17 | by ( Aditya Samal | ) www.reuters.com time to read: +2 min

[1/2] Sign is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File PhotoMarch 17 (Reuters) - Shares of Sarepta Therapeutics Inc (SRPT.O) slumped as much as 21% on Friday on uncertainty over its gene therapy for Duchenne muscular dystrophy after the U.S. health regulator reversed its decision on a panel meeting. The U.S. Food and Drug Administration planned to hold a meeting of its independent experts to review the gene therapy, the company said late on Thursday, less than a month after saying it would not do so. Sarepta is developing SRP-9001 as the first gene therapy for the treatment of Duchenne muscular dystrophy, an inherited disorder of progressive muscular weakness typically seen in boys. Gene therapies such as BioMarin's (BMRN.O) bleeding disorder therapy have faced setbacks and tough scrutiny in the past, but the FDA approved multiple such products in 2022.

☆ Reata shares triple after surprise FDA nod for rare disease drug
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +2 min

March 1 (Reuters) - Shares of Reata Pharmaceuticals Inc (RETA.O) tripled in value on Wednesday after the U.S. Food and Drug Administration (FDA) approved its rare disease drug, ending years of uncertainty over its future. The U.S. biotech firm's shares jumped to $93, the highest since late 2021, on more than 16 million shares traded, a record one-day volume for the stock. Reata's drug Skyclarys is the first approved treatment for Friedreich's Ataxia, a rare genetic disorder that causes progressive damage to the nervous system and can lead to premature death. The nod follows years of back and forth between Reata and the FDA. Reata's shares had tumbled 30% following Dunn's resignation as investors fretted about the possibility of approval under a new division head.

☆ Reata shares hit 1-year high after surprise FDA nod for rare disease drug
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +2 min

March 1 (Reuters) - Shares of Reata Pharmaceuticals Inc (RETA.O) soared 175% to hit a one-year high in early trading on Wednesday, after the U.S. Food and Drug Administration (FDA) approved its rare disease drug and ended years of uncertainty over its future. The U.S. biotech firm's shares jumped to $86, their highest since December 2021. The nod follows years of back and forth between Reata and the FDA. Reata's shares had tumbled 30% following Dunn's resignation as investors had fretted about the possibility of approval under a new division head. "We've followed some pretty dramatic stories in the past, but the Reata odyssey is in the Hall of Fame," said Baird analyst Brian Skorney.

☆ Reata shares surge after surprise FDA nod for rare disease drug
▼ + stars: | 2023-03-01 | by ( ) www.reuters.com time to read: +1 min

March 1 (Reuters) - Shares of U.S. biotech firm Reata Pharmaceuticals Inc (RETA.O) more than doubled in premarket trading on Wednesday, a day after the Food and Drug Administration (FDA) approved its rare disease drug and ended years of uncertainty over its future. The drug Skyclarys is the first approved treatment for Friedreich's Ataxia, a rare genetic disorder that causes progressive damage to the nervous system and can lead to premature death. The approval follows years of back and forth between Reata and the FDA, which in 2020 said the data from a mid-stage trial was not enough to support an approval. The FDA has previously approved drugs for neurological conditions based on limited data such as for Biogen Inc's Alzheimer's drug Aduhelm and Amylyx's (AMLX.O) ALS drug. Reata's shares were up 174.2% to $85.47 before the bell.

☆ Eli Lilly Alzheimer's drug setback extends rival Biogen's lead - analysts
▼ + stars: | 2023-01-20 | by ( ) www.reuters.com time to read: +2 min

Jan 20 (Reuters) - The U.S. health regulator's rejection of accelerated approval for Eli Lilly and Co's Alzheimer's disease drug extends the market lead for rivals Eisai and Biogen's treatment by months, analysts said. "This is a modest positive for Biogen" because it delays donanemab's launch, Jefferies analyst Michael Yee said, adding that Eli Lilly could file for traditional approval by mid-2023. The setback for Lilly comes just weeks after the FDA granted Biogen Inc (BIIB.O) and Japanese drugmaker Eisai Co Ltd's (4523.T) accelerated approval for their Alzheimer's drug Leqembi. read moreAnalysts are waiting for the traditional approval of Biogen's drug and for wider health insurance coverage before they expect sales of the drug to pick up. "But if there is anything wrong with the (Eli Lilly) data set, it is easier to reject an unapproved drug than remove an approved drug from market," said Skorney.

☆ Eisai, Biogen's Alzheimer's drug price should not dent demand, analysts say
▼ + stars: | 2023-01-09 | by ( ) www.reuters.com time to read: +2 min

Jan 9 (Reuters) - The $26,500-per-year price tag for Eisai Co Ltd (4523.T) and Biogen Inc's (BIIB.O) newly approved Alzheimer's disease drug is slightly above expectations, but should not dent demand for the promising therapy, Wall Street analysts said. The U.S. health regulator on Friday granted accelerated approval to the drug, Leqembi, and the decision was hailed by patient groups. However, the price tag is lower than that of Eisai and Biogen's first Alzheimer's disease drug, Aduhelm, which was initially priced at $56,000 annually before the drugmakers halved the price amid controversy over its approval. Eisai and Biogen said on Saturday the Japanese drugmaker had applied for full approval by the U.S. Food and Drug Administration. Some analysts expect broader coverage by Medicare if the drug is granted full approval.

The trial results released on late Tuesday could mark a rare victory in the search for a treatment for the memory-robbing disease after years of clinical failures. Biogen's stock surged 46.6% to $290.99 in premarket trading, putting it on track to add over $13.5 billion in market capitalization. BMO analyst Evan Seigerman called the data an "unequivocal win" for Biogen and Alzheimer's patients. The latest trial boost for Biogen and Eisai's lecanemab has raised hope for success in trials testing Roche's gantenerumab and Lilly's donanemab. Shares of smaller Alzheimer's drug developers also rose in premarket U.S. trading.

☆ Here's why Biogen's promising Alzheimer's drug data is also good news for Eli Lilly
▼ + stars: | 2022-09-28 | by ( Kevin Stankiewicz | ) www.cnbc.com time to read: +8 min

The move helped Eli Lilly notch a fresh 52-week high Wednesday, the only stock in the S & P 500 to do so. Bottom line Biogen's topline data appears to be encouraging, suggesting the Alzheimer's drug helped slowed cognitive decline. Plus, we think Eli Lilly has more going for it overall than Biogen, making it a more attractive investment. Drug background Like Biogen's Alzheimer's drug lecanemab, Lilly's donanemab is an antibody that tries to reduce buildup on the brain of the amyloid beta protein . The Eli Lilly logo is shown on one of the company's offices in San Diego, California, September 17, 2020.

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