Eli Lilly shares slipped Friday after regulators said they need to see more data on the company's application for a quick approval of its potential Alzheimer's disease treatment.
Lilly said the U.S. Food and Drug Administration wants information from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab. The drugmaker gave the update after markets closed Thursday.
The potential treatment aims to clear a plaque from the brain that is a key hallmark of the mind-robbing disease.
Lilly said it had more than 100 patients in the study used for its accelerated approval application. But many were able to stop taking the drug as early as 6 months into treatment due to the reduction in plaque.
The FDA's accelerated approval program allows drugs to launch in the U.S. based on promising early results, before they're a confirmed benefit to patients. The agency granted accelerated approval earlier this month to another Alzheimer's drug, Leqembi from Japan's Eisai.
Lilly is still seeking full approval for its drug. The company expects to report early results from a late-stage study in the second quarter.
The drugmaker may have to add data from that research to its application for accelerated approval. A Lilly spokesman said the company is working with the FDA on determining next steps to take.
SVB Securities analyst David Risinger called the accelerated approval delay "immaterial." He said in a research note that the drug's sales prospects depend more on the late-stage study the drugmaker is wrapping up.
Shares of Indianapolis-based Eli Lilly and Co. slipped more than US$4, or about 1%, to $346 Friday morning. Broader indexes climbed slightly.
Giving away used clothes for a second life feels like an act of charity 鈥 and it often is. But it鈥檚 become more complicated. A W5 investigation has discovered allegations that organized crime players are muscling in on charities to access their donation bins.
An Israeli attack on Iran damaged facilities at a secretive military base southeast of the Iranian capital that experts in the past have linked to Tehran's onetime nuclear weapons program.
Not all that glitters is gold, but the value of the precious metal has been surging this year.
Dodgers superstar Shohei Ohtani partially dislocated his left shoulder during the seventh inning of Saturday's Game 2 of the World Series against the New York Yankees when he tried to steal second base.
Five things to watch for in the Canadian business world in the coming week: Bank of Canada, GDP figures, and results for Enbridge, Parkland, and Imperial Oil.
Former U.S. president Donald Trump has repeatedly referred to CNN anchor Anderson Cooper with a woman's first name in recent days as the Republican presidential nominee focuses his closing message on a hypermasculine appeal to men.
Canadian cities are struggling with the seemingly intractable problem of homelessness and trying various approaches to stop people from sleeping rough, often with mixed results.
RCMP Commissioner Mike Duheme says there has been a 鈥渟ignificant reduction鈥漷o the public safety threat since six Indian diplomatic officials were expelled from the country last week.
Republican vice presidential nominee JD Vance insisted that Donald Trump鈥檚 attacks on 'the enemy within' were not directed at Democratic Party leaders but dissenting Americans he described as 'far-left lunatics.'
Giving away used clothes for a second life feels like an act of charity 鈥 and it often is. But it鈥檚 become more complicated. A W5 investigation has discovered allegations that organized crime players are muscling in on charities to access their donation bins.
Huntsville OPP and the Special Investigations Unit (SIU) are conducting a homicide investigation after three individuals were found dead in a Huntsville neighbourhood Friday evening.
Author and historian Brent Wilson released a new book on New Brunswick airmen from the First World War.
Canadian cities are struggling with the seemingly intractable problem of homelessness and trying various approaches to stop people from sleeping rough, often with mixed results.
When B.C. teenager Amanda Todd sat in front of her computer and detailed the relentless bullying and extortion she'd faced on social media, it sent a shock wave to parents around the world.
Elections BC released its first partial results of the final count in B.C.'s 2024 provincial election Saturday afternoon, and the data shows NDP candidates gaining in some tight races.
Republican vice presidential nominee JD Vance insisted that Donald Trump鈥檚 attacks on 'the enemy within' were not directed at Democratic Party leaders but dissenting Americans he described as 'far-left lunatics.'
Kamala Harris and Tim Walz will crisscross the United States to visit all seven battleground states in the coming days, part of a final blitz before the Nov. 5 election.
An Israeli attack on Iran damaged facilities at a secretive military base southeast of the Iranian capital that experts in the past have linked to Tehran's onetime nuclear weapons program.
Former U.S. president Donald Trump has repeatedly referred to CNN anchor Anderson Cooper with a woman's first name in recent days as the Republican presidential nominee focuses his closing message on a hypermasculine appeal to men.
Israel attacked military targets in Iran with pre-dawn airstrikes Saturday in retaliation for the barrage of ballistic missiles the Islamic Republic fired on Israel earlier this month. It was the first time Israel's military has openly attacked Iran.
Commonwealth leaders, ending a week-long summit in Samoa, said on Saturday the time had come for a discussion on whether Britain should commit to reparations for its role in the transatlantic slave trade.
RCMP Commissioner Mike Duheme says there has been a 鈥渟ignificant reduction鈥漷o the public safety threat since six Indian diplomatic officials were expelled from the country last week.
Minister Gary Anandasangaree has apologized to a group of Ontario First Nations for mismanagement of their money over a century ago.
A veteran Ottawa journalist is firing back against what he says are "entirely false" claims by a former Conservative cabinet minister that he acted as a Russian agent.
Whole Foods Market is joining the growing list of brands whose frozen waffles have been recalled in Canada this week because of possible listeria contamination.
Angela Salvatore had been away from her father's hospital bedside for just over an hour when she says she got a frantic call from a nurse, pleading with her to calm him down.
A U.S.-based food manufacturer that supplies frozen waffles to major grocery chains across North America has launched a voluntary recall over concerns its products carry the potential for illness.
The U.S. Bureau of Land Management has hosted the online competition since 2019 to raise awareness about the bat's ecological importance.
Law enforcement agencies across the U.S. are cracking down on a troubling spread of child sexual abuse imagery created through artificial intelligence technology 鈥 from manipulated photos of real children to graphic depictions of computer-generated kids.
The search for a popular tortoise that went missing from his home in Piedmont is over after his owner said he came home.
Lizzo has taken a rather silly reference to her on a recent 'South Park' episode and elevated it to a hilarious Halloween costume.
'I鈥檓 not here as a celebrity, I鈥檓 not here as a politician. I鈥檓 here as a mother,' Beyonc茅 said at a campaign rally for Kamala Harris.
Phil Lesh, a classically trained violinist and jazz trumpeter who found his true calling reinventing the role of rock bass guitar as a founding member of the Grateful Dead, died Friday at age 84.
Five things to watch for in the Canadian business world in the coming week: Bank of Canada, GDP figures, and results for Enbridge, Parkland, and Imperial Oil.
Natural gas producers in Western Canada have white-knuckled it through months of depressed prices, with the expectation that their fortunes will improve when LNG Canada comes online in the middle of next year.
Bank of Canada governor Tiff Macklem says the world has become more prone to supply shocks which create more risks to inflation, but the central bank is in a better place to deal with them now that inflation is under control.
Two witches talk about their daily rituals, from spell-casting to TikTok posting, and how they discovered their magic.
New Brunswicker Jillea Godin鈥檚 elaborate cosplay pieces attract thousands to her online accounts, as well as celebrities requesting their own pieces.
Archeologists have uncovered a tiny house in Pompeii that is filled with elaborate 鈥 and sometimes erotic 鈥 frescoes, further revealing the ornate way in which Romans decorated their homes.
Former Chicago Blackhawks star and Hall of Fame hockey executive Bill Hay, who was also a past president and CEO of the Calgary Flames, has died. He was 88.
Inter Miami beat Atlanta United 2-1 on Friday in what was Lionel Messi's Major League Soccer (MLS) playoff debut.
Stuart Skinner made 27 saves for his fifth career shutout and Evan Bouchard and Mattias Ekholm each had a goal and an assist as the Edmonton Oilers snapped a two-game losing skid with a 4-0 victory over the Pittsburgh Penguins on Friday.
Based on initial appearances, there are signs indicating the automobile industry is in healthy shape 鈥 for now.
A town in southern Alberta will be one of the first to let golf carts be driven on select roads as part of a provincial pilot program.
An increased risk of fire has prompted the recall of thousands of Honda hybrid vehicles in Canada.
A new resident at a Manitoba animal rescue has waddled her way into people's hearts.
Hundreds of people ran to the music of German composer and pianist Beethoven Wednesday night in a unique race in Halifax.
He is a familiar face to residents of a neighbourhood just west of Roncesvalles Avenue.
A meteor lit up our region's sky last night 鈥 with a large fireball shooting across the horizon over Lake Erie at around 7:00 p.m.
Residents of Ottawa's Rideauview neighbourhood say an aggressive wild turkey has become a problem.
A man who lost his life while trying to rescue people from floodwaters, and a 13-year-old boy who saved his family from a dog attack, are among the Nova Scotians who received a medal for bravery Tuesday.
A newly minted Winnipegger is hoping a world record attempt will help bring awareness for the need for more pump track facilities in the city.
A Springfield, Ont. man is being hailed a 'hero' after running into his burning home to save his two infant children.
Hortense Anglin was the oldest graduate to make her way across the platform at York University's Fall Convocation ceremony this week. At the age of 87, she graduated with an Honours degree in Religious Studies.
Elections BC released its first partial results of the final count in B.C.'s 2024 provincial election Saturday afternoon, and the data shows NDP candidates gaining in some tight races.
Three people have suffered serious but non-life-threatening injuries following a stabbing at a New Westminster casino in the early hours of Saturday morning.
Work crews were called to deal with a barge that appeared to be stuck near the shore of the Fraser River in Langley Saturday morning.
More Torontonians will be able to get their doses of a new COVID-19 vaccine on Monday. Here's what to know.
Federal Transport Minister Anita Anand is requesting a meeting with her provincial counterpart to tackle the rising issue of re-Vinning and fraudulent vehicle registrations.
Canadian Ryan James Wedding finished in 24th place in the parallel giant slalom at the 2002 Winter Games in Salt Lake City, but the snowboarder wouldn鈥檛 go on to improve his results in Torino four years later.
A day of hope turned into a day of despair for the Saskatchewan Roughriders on Saturday.
One person is in hospital with potentially life-threatening injuries after a crash between a motorized scooter and a vehicle.
Following an investigation, four Albertans have been charged in relation to the murder of a Manning, Alberta resident.
Atl茅tico Ottawa will have their first shot in their quest to hoist the North Star cup on Sunday.
Ontario Provincial Police say a 16-year-old has been charged with second-degree murder after a 15-year-old was found dead at a home in Perth, Ont. Friday afternoon.
A veteran Ottawa journalist is firing back against what he says are "entirely false" claims by a former Conservative cabinet minister that he acted as a Russian agent.
Seven people were hit by a vehicle during a brawl between a group of individuals that got out of hand in Montreal.
The dockworkers at the Port of Montreal are on strike on Sunday, as they had announced, due to the impasse in negotiations for the renewal of their collective agreement.
Montreal police (SPVM) are investigating an alleged case of voyeurism on the metro involving an 18-year-old woman, with video footage of the incident now circulating on social media
Following an investigation, four Albertans have been charged in relation to the murder of a Manning, Alberta resident.
RCMP are looking for a man they believe is armed and dangerous in the Lac La Biche area.
A worker was killed on the job in Stony Plain on Tuesday, one day after a worker was killed in northwest Edmonton.
Nova Scotia residents could find themselves in the midst of a snap provincial election campaign as early as Sunday.
Canadian cities are struggling with the seemingly intractable problem of homelessness and trying various approaches to stop people from sleeping rough, often with mixed results.
Author and historian Brent Wilson released a new book on New Brunswick airmen from the First World War.
Winnipeg police have arrested and charged a man believed to be connected with an assault at a University of Manitoba dorm room.
The mystery of a 100-year-old letter sent from Manitoba to Ireland is slowly unraveling thanks to the work of one amateur sleuth.
Pop culture connoisseurs made their way by the masses to the fourth annual Winnipeg Comiccon this weekend.
The Calgary Stampeders picked up their first road victory of the season Saturday, defeating the Saskatchewan Roughriders 27-12 in the final regular-season game of the year.
Saskatchewan was one of the regions that experienced one of the hottest heat waves in Canada this summer, according to Environment and Climate Change Canada (ECCC).
A group of Regina youth gathered to give back to veterans of the First World War.
Police are investigating after a Guelph home was broken into early Saturday morning.
Fire crews responded to a fire at a Waterloo waste management site Friday evening.
All the evidence has now been called at the trial of Erick Buhr, who has pleaded not guilty to second degree murder in the death of his grandmother, Viola Erb.
Saskatoon fire crews responded to a major house fire on the 400 block of 24th Street West on Friday evening.
The Saskatoon Police Service is cautioning residents about a phone scam involving fraudulent lottery claims.
The Calgary Stampeders picked up their first road victory of the season Saturday, defeating the Saskatchewan Roughriders 27-12 in the final regular-season game of the year.
One person is dead after a crash involving an all-terrain vehicle (ATV) in eastern Ontario. Frontenac County OPP responded to a crash involving an ATV on a trail in Ardoch, Ont., 30 km north of Sharbot Lake.
Huntsville OPP and the Special Investigations Unit (SIU) are conducting a homicide investigation after three individuals were found dead in a Huntsville neighbourhood Friday evening.
Creditors have moved to take ownership of most of the properties in northern Ontario owned by a group of 11 insolvent companies.
Trillium Care in Norwich, Ont. has announced they will be closing their facilities, citing 鈥渁n emergency lack of financial resources necessary to sustain daily operations.鈥
Identical twins Chase and Sydney Brown talk on the phone every night. That was until this week, when, for the first time ever, the brothers will play against each other on a football field.
One down, four more to go. That鈥檚 the mentality of the Western Mustangs football team after a 46-10 win in their playoff opener.
Huntsville OPP and the Special Investigations Unit (SIU) are conducting a homicide investigation after three individuals were found dead in a Huntsville neighbourhood Friday evening.
A man was charged after allegedly crashing into a parked OPP cruiser in Tay Township early Sunday morning.
A commercial truck driver was stopped for allegedly travelling nearly twice the speed limit through a community safe zone in Caledon Saturday morning.
Donated and reusable household items piled up in trucks outside the Windsor Family Credit Union Centre Saturday afternoon in an effort to divert goods from the landfill.
Chatham-Kent Police Service (CKPS) has charged a man after they were contacted over a disturbance at a home on Sheldon Avenue in Chatham.
Windsor police say the death of a 69-year-old man has been ruled a homicide.
Elections BC released its first partial results of the final count in B.C.'s 2024 provincial election Saturday afternoon, and the data shows NDP candidates gaining in some tight races.
There were tense moments at a ferry terminal outside Victoria, B.C., on Friday after the lion鈥檚 share of standby spots on an early sailing were claimed by 鈥渁ssured loading鈥 passengers 鈥 leaving regular customers who had been waiting for hours out of luck.
Hulitan Early Years Centre is a brand new, 48-seat childhood learning centre in Colwood. It was built to support Indigenous children throughout the capital region.
More than two years after Alannah Brown and Douglas Barker were found dead north of Penticton, police are asking for help identifying a vehicle they believe was associated with the crime.
Dave Lindsey began growing giant pumpkins to bring a bit of magic to his grandkids' Halloween.
A U.S. District Court judge in Montana has sentenced a 27-year-old man from Kelowna, B.C., to 18 months in prison for using fake names to buy guns with the aim of selling them in Canada.
A tentative agreement has been reached between the City of Lethbridge and more than 900 employees belonging to CUPE Local 70.
The Hurricanes will be happy to be back home in Lethbridge Saturday night after losing their third in a row on the road Friday night, a 4-1 decision to the Broncos in Swift Current.
About 15,000 students are enrolled at Lethbridge鈥檚 post-secondary schools, and now the city is working with those schools to try to find ways to get them s to stick around a while.
Creditors have moved to take ownership of most of the properties in northern Ontario owned by a group of 11 insolvent companies.
Ontario Provincial Police have been cleared in the case of a woman who crashed her vehicle intentionally while she was high on drugs and fled into the woods earlier this year.
The union that represents hospital workers across the province is used a symbol from Greek mythology Friday in Espanola to drive home its campaign about the perils of privatization in health care.
Teams are facing off in a new eastern Newfoundland hockey league aiming to bring competitive play 鈥 and a few extra years on the ice 鈥 for young women in the province.
Investigators found the remains of a 77-year-old American man on Wednesday at the scene of a fire that destroyed a hotel in western Newfoundland earlier on the weekend.
Police in western Newfoundland say a 77-year-old man visiting the province from Kansas is missing after a fire at a hotel in Deer Lake, N.L.
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