Calliditas: SNDA For TARPEYO Granted Priority Review By FDA
Calliditas Therapeutics AB (CALT) said the U.S. Food and Drug Administration has accepted the submission for the supplemental New Drug Application or sNDA for TARPEYO delayed release capsules and granted Priority Review. The sNDA is based on the full data set from the Phase 3 NefIgArd clinical trial. The Prescription Drug User Fee Act or PDUFA goal date is 20 December 2023.
TARPEYO is currently approved under accelerated approval to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression.
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Dunkin' To Unveil Spiked Coffee And Tea Drinks
Dunkin’ Donuts is introducing a collection of new spiked iced coffee and tea beverages.
Dunkin’ Spiked reportedly received label approval in May from the Alcohol and Tobacco Tax and Trade Bureau or TTB. A launch date of the product is yet to be announced.
As per the company website, Dunkin’ Spiked offers four flavors of iced drinks with alcohol in both coffee and tea. The coffee options include Original Iced Coffee, Caramel Iced Coffee, Mocha Iced Coffee, and Vanilla Iced Coffee.
Further, the spiked iced tea flavors include Dunkin’s Slightly Sweet Iced Tea, Half & Half Iced Tea, Strawberry Dragonfruit Iced Tea Refresher, and Mango Pineapple Iced Tea Refresher.
Coffee products with Alcohol by volume or ABV of 6% are available in Dunkin’ Spiked Iced Coffee Mix Pack, 12oz. Can 4-pack, 19.2oz can single serve.
Iced tea drinks have ABV of 5% and available as Dunkin’ Spiked Iced Tea Mix Pack, 12oz. Can 6-pack, 19.2oz can single serve.
According to VinePair, the Massachusetts-based doughnut and coffee chain is partnering with Boston-based brewery Harpoon Brewery to produce the malt-based alcoholic beverages.
The companies earlier had partnered to offer various products, including Harpoon Dunkin’ Boston Kreme and Harpoon Dunkin’ Jelly Donut. Last year, they offered Harpoon Dunkin’ Box O’ Beer.
Estee Lauder Guides FY24 Well Above Estimates – Update
While reporting financial results for the fourth quarter on Thursday, Estee Lauder Cos., Inc. (EL) initiated its earnings and adjusted earnings guidance for the full-year 2024, well above estimates, and provided outlook for the first quarter, well below estimates.
For the first quarter, the company expects a loss in a range of $0.34 to $0.23 per share and adjusted earnings in a range of $0.31 to $0.21 per share or $0.29 to $0.19 per share in constant currency, on reported and organic net sales decline of 12 to 10 percent.
On average, analysts polled by Thomson Reuters expect the company to report earnings of $0.99 per share on a revenue decline of 0.1 percent to $3.94 billion for the quarter. Analysts’ estimates typically exclude special items.
Looking ahead to fiscal 2024, the company now projects earnings in a range of $3.43 to $3.70 per share and adjusted earnings in a range of $3.50 to $3.75 per share on reported net sales growth of 5 to 7 percent, with organic net sales growth of 6 to 8 percent.
The Street is looking for earnings of $3.36 per share on a sales decline of 10.9 percent to $15.81 billion for the year.
Separately, the company announced a quarterly dividend on the Company’s Class A and Class B Common Stock of $0.66 per share, payable on September 15, 2023 to stockholders of record at the close of business on August 31, 2023.
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Buckle, Inc. Q2 Net Income Declines; Comps. Down 3.3%
The Buckle, Inc. (BKE) reported second-quarter net income of $45.6 million, or $0.92 per share compared with $50.1 million, or $1.01 per share, prior year. Analysts polled by Thomson Reuters expected the company to report profit per share of $0.81, for the quarter. Analysts’ estimates typically exclude special items.
Net sales for the 13-week fiscal quarter ended July 29, 2023 decreased 3.2 percent to $292.4 million from net sales of $302.0 million, prior year 13-week fiscal quarter ended July 30, 2022. Analysts on average had estimated $290.36 million in revenue. Online sales decreased 5.6 percent to $43.6 million.
Comparable store net sales for the 13-week period ended July 29, 2023 decreased 3.3 percent.
Shares of Buckle, Inc are down 4% in pre-market trade on Friday.
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Gold Steadies As Dollar And Bond Yields Ease
Gold prices rose slightly on Friday but were on track for a third weekly fall on fears of U.S. interest rates remaining higher for longer.
Spot gold edged up 0.2 percent to $1,893.09 per ounce, while U.S. gold futures were up 0.4 percent at $1,922.25.
China concerns persisted and the dollar and bond yields eased from recent highs, helping increase bullion’s appeal.
The 10-year U.S. Treasury yield fell back below 4.3 percent, after settling at the highest since November 2007 in the U.S. trading session.
Overnight, new jobless claims data pointed to a still tight labor market and a gauge of regional manufacturing activity rebounded in August to show its first positive reading in nearly a year, keeping alive fears of interest rates remaining higher for longer.
Risk-off sentiment prevails in financial markets amid concerns about spreading debt defaults in China’s property market and shadow banking industry.
China’s property developer Evergrande filed for bankruptcy protection in a U.S. court, raising concerns about ripple effects.
A liquidity crisis at one of China’s top asset managers Zhongzhi Enterprise Group has raised worries of a contagion risk to the financial sector.
Oil Heads For Weekly Loss On China, US Rate Concerns
Oil prices traded lower on Friday and were on course to end a seven-week winning streak on worries surrounding the Chinese economy and fears of interest rates remaining higher for longer.
Benchmark Brent crude futures dropped half a percent to $83.72 a barrel, while WTI crude futures were down 0.3 percent at $80.12.
Both contracts are on track to lose over 3 percent this week, after having rallied for the past seven weeks post extended supply cuts by major producers Saudi Arabia and Russia.
Amid much uncertainty over the path of U.S. monetary policy, investors now look to next week’s gathering of policymakers at Jackson Hole in Wyoming for direction.
Elsewhere in China, the world’s largest crude importer, investors remain concerned about spreading debt defaults in China’s property market and shadow banking industry.
China’s property developer Evergrande filed for bankruptcy protection in a U.S. court, raising concerns about ripple effects.
A liquidity crisis at one of China’s top asset managers Zhongzhi Enterprise Group has raised worries of a contagion risk to the financial sector.