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Dayforce, Scholar Rock, and More Stocks See Action From Activist Investors
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Updated Dec 27, 2023, 7:34 am EST / Original Dec 27, 2023, 4:26 am EST
Stock futures traded slightly lower Wednesday after the S&P 500 finished higher Tuesday and just 0.45% below its record close of 4,796.56 hit Jan. 3, 2022. The broad market index has risen 24% this year and has gained 4.5% this month as traders bet the Federal Reserve will begin cutting interest rates as soon as March.
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Bristol Myers Squibb will acquire radiopharmaceutical therapeutics company RayzeBio for $62.50 a share in cash.
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Two weeks ago, bluebird bio secured Food and Drug Administration approval for its gene therapy for sickle cell disease, a significant milestone for the roughly 100,000 people in the U.S. who suffer from the condition.
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Dec 19, 2023, 4:31 am EST
Stock futures traded flat Tuesday, a day after the S&P 500 finished up 0.5% and moved closer to its all-time. The broad market index stands just 1.2% below its record of 4,796.56 reached in early January 2022.
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Stock futures pointed higher Friday as Wall Street returned for a shortened trading session following the Thanksgiving holiday. Retailers will be in focus on Black Friday, which marks the unofficial start to the Christmas shopping season.
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Ardelyx Inc.
ARDX,
on Tuesday won its long fight for U.S. regulatory approval of a treatment designed to help patients with chronic kidney disease.
The biopharma company said late Tuesday that the U.S. Food and Drug Administration approved tenapanor, marketed under the brand name Xphozah, for control of serum phosphorus in patients with chronic kidney disease on dialysis. A high level of phosphorus in the blood is often a sign of kidney damage and can lead to weak bones, joint pain, cardiovascular problems and other issues.
The approval concludes an extraordinary comeback for Xphozah. Ardelyx’s application for approval of the treatment was previously rejected by the FDA in July 2021, when the agency said the drug’s effect was “small and of unclear clinical significance.” To preserve cash, Ardelyx a few months later said it would cut its workforce by 65%, but it also pursued multiple appeals of the agency’s decision. An FDA advisory committee voted last November that the benefits of Xphozah outweigh its risks. The agency late last year ultimately granted Ardelyx’s appeal, and the company resubmitted its Xphozah application to the FDA in April.
More than 550,000 people in the U.S. have chronic kidney disease and are on maintenance dialysis. The vast majority of them have high phosphorus levels, also called hyperphosphatemia, according to Ardelyx.
High phosphorus levels “must be taken care of in these patients, and the current therapies are mostly insufficient in doing so,” Ardelyx CEO Mike Raab told MarketWatch.
Chronic kidney disease patients with high phosphorus levels have traditionally been treated with phosphate binders that can soak up phosphorus from food during digestion, but that approach can require patients to swallow a large number of pills. The Xphozah treatment requires two pills a day, “each the size of a Tic Tac,” Raab said.
The FDA approved Xphozah as add-on therapy in patients who can’t tolerate or have an inadequate response to phosphate binders, Ardelyx said in a release.
Xphozah, which will be Ardelyx’s second U.S. product launch, should be available sometime in November, Raab said.
Ardelyx will present updated data on Xphozah for hyperphosphatemia at an American Society of Nephrology meeting in early November, the company said in a release Monday.
Ardelyx shares jumped in late September after Japanese regulators approved tenapanor for hyperphosphatemia in adults with chronic kidney disease on dialysis.
Ardelyx shares fell 0.6% on Tuesday and have gained 21% in the year to date, while the S&P 500
SPX
has gained 13.9%.
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Updated Oct. 17, 2023 2:47 am ET
Lonza Group warned that its profitability will take a hit next year from losing revenue from an agreement with Moderna and the risk of a smaller business with Kodiak Sciences.
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The Food and Drug Administration late Friday approved the first-ever pill that can be taken at home for postpartum depression.
The medication, called zuranolone, and jointly developed by pharmaceutical companies Biogen Inc.
BIIB,
and Sage Therapeutics
SAGE,
is taken daily for two weeks, the FDA said in its release.
In a pair of clinical trials involving women who experienced severe depression after having a baby, the drug improved symptoms including anxiety, trouble sleeping, loss of pleasure, low energy, guilt or social withdrawal as soon as three days after the first pill.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness — even, in severe cases, thoughts of harming themselves or their child,” said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research.
”And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” she said.
Women who are breastfeeding or had mild or moderate depression weren’t included in the trials.
Until now, the only available option for this condition has been an intravenous injection that the FDA approved in 2019. It requires patients to stay in a hospital for two-and-a-half days.
Postpartum depression affects one in eight new mothers in the U.S., according to the Centers for Disease Control and Prevention. Researchers suggest the actual rate may be higher and that half of such cases go undiagnosed.
Research finds that postpartum depression is more intense and lasts longer than the typical worries, sadness or tiredness that many women experience after giving birth. The condition can make it harder for mothers to bond with their babies and may increase the likelihood of developmental delays in infants.
Drug overdoses and suicides are leading causes of maternal death in the U.S., contributing to nearly one in four pregnancy-related deaths, according to the CDC.
Zuranolone stimulates a brain receptor called GABA that slows down the brain and helps control anxiety and stress. The drug, through trials, is thought to calm women suffering from postpartum depression enough to allow them to rest, which also improves symptoms.
Shares of Biogen are up 23% over the past year, and Sage has lost 14%, while the S&P 500
SPX
is up 8% over the same time.
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https://www.barrons.com/articles/solaredge-stock-guidanceprice-solar-e54cc9fb
SolarEdge Technologies
was falling sharply Wednesday after issuing disappointing third-quarter guidance, the latest solar company to do so.
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Pfizer Stock Gains After Earnings Beat. Revenue and Outlook Aren’t So Good.
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By Anthony O. Goriainoff
AstraZeneca said Thursday that its and MSD’s Lynparza cancer treatment had been approved in the U.S. for the treatment of metastatic castration-resistant prostate cancer, or mCRPC.
The Anglo-Swedish pharma giant said Lynparza, in combination with abiraterone and prednisone, reduced the risk of disease progression or…
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https://www.barrons.com/articles/first-solar-stock-buying-solar-tech-firm-evolar-da85f0b1
First Solar
stock rose sharply Friday as the company disclosed a deal it said would bolster its technological position in the solar energy space.
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Nearly two years after biotechnology stocks began to tumble, executives at small and midsize companies in the space are finally accepting that share prices aren’t bouncing back anytime soon.
With reality setting in, it’s a buyer’s market for companies looking for acquisitions and partnerships, according to many of the pharmaceutical and medical technology executives who gathered at this year’s
J.P. Morgan
healthcare investor conference, which wrapped up in San Francisco on Thursday.
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