Benzinga
- Medtronic Plc MDT says the FDA Circulatory System Devices Panel (CSDP) voted unanimously (13-0) on safety and in favor (7-6) of the effectiveness of the Symplicity blood pressure procedure, Spyral Renal Denervation (RDN) System.
- But the Committee's vote was closely divided on the benefit/risk profile of the device (tied at 6-6 and one abstention), with the panel chair breaking the tie, resulting in a final 6-7 vote, recommending against the approval of Medtronic's blood pressure treatment device, saying associated do not outweigh the benefits.
Cheaper Version Of Blockbuster Arthritis Treatment Humira - CVS Health Teams With Sandoz
- CVS Health Corp CVS has launched Cordavis, a wholly-owned subsidiary, to work directly with manufacturers to commercialize and/or co-produce biosimilar products in the U.S. pharmaceutical market.
- Cordavis has contracted with Sandoz to commercialize and bring Hyrimoz (adalimumab-adaz), a biosimilar for AbbVie Inc's ABBV flagship product Humira, under its private label.
Reuters
Supplier Spirit Aerosystems Issue Delays Boeing's 737 Deliveries
- Boeing Co BA has recently encountered another setback regarding its 737 MAX. A supplier-related issue with Spirit Aerosystems Holdings, Inc SPR has emerged, wherein inappropriately drilled holes have been discovered on the aft pressure bulkhead of the aircraft.
- This component is pivotal in the plane's pressure sealing system, ensuring the aircraft remains safe from potential ruptures due to elevated internal pressures.
- In April, Boeing brought to light that Spirit had made errors in attaching brackets connecting the aft fuselage to the aircraft's vertical tail.
AstraZeneca Under Legal Lens, Faces Two COVID-19 Vaccine Lawsuits In London
- AstraZeneca Plc AZN, the Anglo-Swedish pharmaceutical giant, is reportedly under legal scrutiny as it faces two lawsuits related to its COVID-19 vaccine in London.
- The U.K. was among the first nations to introduce the AstraZeneca vaccine to its populace at the onset of 2021. However, concerns over a minimal risk of blood clotting led to its restricted use among individuals below 40.
United Airlines Reaches $30M Settlement With Quadriplegic Man It Treated Badly: Details
- United Airlines Holdings Inc UAL has reached a $30 million settlement with the family of a quadriplegic man who went into a vegetative state after deplaning.
- The details of the settlement with the family of Nathaniel Foster Jr, known as N.J. were divulged in San Francisco federal court.
- About $12 million from the settlement is expected to cover the legal fees and $3 million for the other expenses.
Wall Street Journal
United States Steel Loses Bidder Esmark Amid Pressure From Union Workers
- Industrial conglomerate Esmark has reportedly backed out of bidding for the acquisition of United States Steel Corp X.
- The move came amid pressure from the United States Steel's workers union, who support the bid from Cleveland-Cliffs Inc CLF.
- Last week, Esmark CEO James Bouchard stated their intention to offer $35 per share to United Steel, following an offer of the same amount by CLF.
Earnings
Chinese Twitter Peer Weibo Boasts Stronger User Base and Welcomes Alibaba Executive to Board
- Weibo Corp (NASDAQ: WB) reported a second-quarter FY23 revenue decline of 2% year-on-year to $440.2 million, marginally missing the consensus of $440.9 million. Revenue grew by 5% Y/Y on a CC basis.
- The non-GAAP operating margin expanded by 300 bps to 35% as profits climbed by 5.8% Y/Y. Non-GAAP EPS of $0.53 beat the consensus of $0.51.
Petco Health and Wellness Trades Lower On Lower Outlook
- Petco Health and Wellness Co Inc WOOF Q2 sales of $1.53 billion, up 3.4% Y/Y, came in line with the consensus. The increase was driven by strength in the consumables business, up 6.8%, and services & other business, up 30.6% Y/Y, partially offset by the company's supplies and companion animal business, down 9.4%.
- Adjusted EPS of $0.06 was also in line with the street view.
- Guidance: The company lowered the outlook for adjusted EBITDA to $460 million-$480 million (from $520 million-$540 million) and adjusted EPS to $0.24 - $0.30 (from $0.40-$0.48) compared to the consensus of $0.42.
Guess Shares Trading Higher On Better Than Expected Q2 Earnings, Guidance
- Guess? Inc's GES Q2 FY24 net revenue rose 3% Y/Y (reported and constant currencies) to $664.5 million, beating the consensus of $640.5 million.
- Adjusted EPS of $0.72 beat the consensus of $0.40.
- Outlook: In Q3, management expects revenue to grow 2.5%-4.5%, adjusted operating margin of 7.5%-8.3%, and adjusted EPS of $0.55-$0.64 (vs. consensus $0.71).
Apparel Retailer Burlington Stores Warns Weakness In Core Consumer Base, Stock Falls
- Burlington Stores Inc BURL reported Q2 FY23 sales growth of 9% Y/Y to $2.175 billion, almost in line with the consensus of $2.17 billion, with the management guidance of sales growth of 8%-10%.
- Adjusted EPS of $0.60 surpassed the consensus of $0.43 and the management guidance of $0.35 - $0.45.
- Outlook: Burlington forecasts FY23 adjusted EPS of $5.60-$5.90, down from prior guidance of $5.50 - $6.00 versus the Street view of $5.88.
Dollar Tree Shares Plunge After Q2 Earnings
- Dollar Tree Inc DLTR reported second-quarter FY23 sales growth of 8.2% year-on-year to $7.33 billion, beating the analyst consensus of $7.18 billion.
- Adjusted EPS of $0.91 beat the consensus of $0.87.
- Outlook: Dollar Tree sees Q3 sales of $7.3 billion - $7.5 billion versus the consensus of $7.3 billion.
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