Shares of Biogen soared Tuesday after the biotechnology company said it is seeking regulatory approval for an early Alzheimer's treatment drug. The surprise announcement, which sent shares up nearly 40 percent in early trading hours, comes months after the company discontinued its research on the drug and has sent a wave of optimism through those affected by the disease.
Biogen said that after receiving new data, the company determined that its test patients who received the treatment — called aducanumab — did show signs of improved cognitive and functional capabilities. If accepted by the U.S. Food and Drug Administration, aducanumab will be the first approved treatment that reduces the effects of Alzheimer's.
"With such a devastating disease that affects tens of millions worldwide, today's announcement is truly heartening in the fight against Alzheimer's," said Biogen's CEO Michel Vounatsos.
In March, Biogen ($BIIB) halted its trial of aducanumab because the drug failed the so-called "futility analysis," which suggested a clinical trial would fail to achieve its objectives. The discontinuation sent the company's stock plummeting at the time. New data, however, later became available that provided researchers with a larger dataset that showed different, far more positive results.
Biogen said that patients who received high doses of aducanumab experienced significant improvements in their cognition abilities, like memory and orientation, and greater functional capabilities, which eased daily activities like shopping, cleaning, and traveling independently. The company had been developing the treatment in collaboration with Eisai, a Japanese pharmaceutical company, since October 2017.
"There is tremendous unmet medical need, and the Alzheimer's disease community has been waiting for this moment," said Dr. Anton Porsteinsson, the director of the Alzheimer's Disease Care, Research, and Education Program at the University of Rochester and a principal investigator in Biogen's study.
First diagnosed in 1906, Alzheimer's is a devastating brain disease that has vexed the medical and pharmaceutical communities for decades.
In June, for instance, Pfizer came under pressure after reports surfaced claiming that the biopharmaceutical giant chose not to pursue clinical trials after internal researchers determined that one of the company's popular drugs may also reduce the risk of Alzheimer's. Pfizer claimed that the decision was made because a clinical trial was unlikely to succeed. Critics, however, accused the company of not pursuing a promising lead to avoid more costly research.
In 2018, an estimated 5.7 million Americans were living with Alzheimer's, according to the Alzheimer's Association. The vast majority of patients are over 65 years old but roughly 200,000 people last year were afflicted with younger-onset forms of the disease.
"We have never been as optimistic as we are today," the Alzheimer's Association, which supports Alzheimer's care and research nationwide, said in a statement Tuesday. "We eagerly anticipate reviewing a full report of [Biogen's] findings from these studies."
The Rev. Al Sharpton is set to lead a protest march on Wall Street to urge corporate America to resist the Trump administration’s campaign to roll back diversity, equity and inclusion initiatives. The New York civil rights leader will join clergy, labor and community leaders Thursday in a demonstration through Manhattan’s Financial District that’s timed with the anniversary of the Civil Rights-era March on Washington in 1963. Sharpton called DEI the “civil rights fight of our generation." He and other Black leaders have called for boycotting American retailers that scaled backed policies and programs aimed at bolstering diversity and reducing discrimination in their ranks.
President Donald Trump's administration last month awarded a $1.2 billion contract to build and operate what's expected to become the nation’s largest immigration detention complex to a tiny Virginia firm with no experience running correction facilities.
Chipmaker Nvidia is poised to release a quarterly report that could provide a better sense of whether the stock market has been riding an overhyped artificial intelligence bubble or is being propelled by a technological boom that’s still gathering momentum.
Cracker Barrel said late Tuesday it’s returning to its old logo after critics — including President Donald Trump — protested the company’s plan to modernize.
Low-value imports are losing their duty-free status in the U.S. this week as part of President Donald Trump's agenda for making the nation less dependent on foreign goods. A widely used customs exemption for international shipments worth $800 or less is set to end starting on Friday. Trump already ended the “de minimis” rule for inexpensive items sent from China and Hong Kong, but having to pay import taxes on small parcels from everywhere else likely will be a big change for some small businesses and online shoppers. Purchases that previously entered the U.S. without needing to clear customs will be subject to the origin country’s tariff rate, which can range from 10% to 50%.
Southwest Airlines will soon require plus-size travelers to pay for an extra seat in advance if they can't fit within the armrests of one seat. This change is part of several updates the airline is making. The new rule starts on Jan. 27, the same day Southwest begins assigning seats. Currently, plus-size passengers can pay for an extra seat in advance and later get a refund, or request a free extra seat at the airport. Under the new policy, refunds are still possible but not guaranteed. Southwest said in a statement it is updating policies to prepare for assigned seating next year.
Cracker Barrel is sticking with its new logo. For now. But the chain is also apologizing to fans who were angered when the change was announced last week.
Elon Musk on Monday targeted Apple and OpenAI in an antitrust lawsuit alleging that the iPhone maker and the ChatGPT maker are teaming up to thwart competition in artificial intelligence.
