WLL SHAREHOLDER ALERT: Kaskela Law LLC Announces Investigation of Whiting Petroleum Corp. and Encourages Current Stockholders to Contact the Firm

PR Newswire


PHILADELPHIA
, May 28, 2022 /PRNewswire/ — Kaskela Law LLC announces that it is investigating Whiting Petroleum Corp. (“Whiting”) (NYSE: WLL) on behalf of the company’s current shareholders.

On March 7, 2022, Whiting announced that it had entered into an agreement to combine with Oasis Petroleum Inc. (“Oasis”).  According to the announcement, Whiting shareholders are expected to receive 0.5774 shares of Oasis common stock and $6.25 in cash for each share of Whiting common stock currently owned.

The investigation seeks to determine whether Whiting and/or the company’s representatives violated the securities laws or breached their fiduciary duties to investors by failing to maximize the buyout price for the Company’s shareholders, and whether Whiting has properly disclosed all potential conflicts of interest to its shareholders.


Whiting


shareholders who wish to protect their investment are


encouraged to contact


Kaskela Law LLC


(D. Seamus Kaskela, Esq. or Adrienne Bell, Esq.) at (484) 229 – 0750, or by email (



[email protected]



) or online at



https://kaskelalaw.com/cases/whiting-petroleum-corp/



 , for additional information about this investigation and their legal rights and options. 

Kaskela Law LLC exclusively represents investors in securities fraud, corporate governance, and merger & acquisition litigation.  For additional information about the firm please visit www.kaskelalaw.com.  This notice may constitute attorney advertising in certain jurisdictions.

CONTACT:

D. Seamus Kaskela, Esq.
Adrienne Bell, Esq.
KASKELA LAW LLC
18 Campus Blvd., Suite 100
Newtown Square, PA 19073
(484) 229 – 0750
(888) 715 – 1740
www.kaskelalaw.com

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SOURCE Kaskela Law LLC

FCFS SHAREHOLDER ALERT: Kaskela Law LLC Announces Investigation of FirstCash Holdings, Inc. and Encourages Long-Term FCFS Investors to Contact the Firm

PR Newswire


PHILADELPHIA
, May 28, 2022 /PRNewswire/ — Kaskela Law LLC announces that it is investigating FirstCash Holdings, Inc. (“FirstCash” or the “Company”) (NASDAQ: FCFS) on behalf of the Company’s long-term investors. 

On November 12, 2021, the Consumer Financial Protection Bureau (“CFPB”) filed a lawsuit alleging that FirstCash and had violated the Military Lending Act (“MLA”) by charging higher than the allowable 36% annual percentage rate on over 3,600 pawn loans to more than 1,000 active-duty service members and their dependents.  Following this news, shares of FirstCash’s common stock fell $7.50 per share on November 12, 2021.  Over the following week, the Company’s shares declined an additional $10.00 per share.

The investigation seeks to determine whether the members of FirstCash’s board of directors breached their fiduciary duties in connection with the above alleged misconduct.


Current FirstCash stockholders who purchased or acquired shares of the Company’s stock prior to November 12, 2021 are encouraged to contact Kaskela Law LLC (D. Seamus Kaskela, Esq. or Adrienne Bell, Esq.) at (484) 229 – 0750, or by email ([email protected]) or online at https://kaskelalaw.com/cases/firstcash-holdings-inc/ , to receive additional information about this investigation and their legal rights and options.

Kaskela Law LLC exclusively represents investors in securities fraud, corporate governance, and merger & acquisition litigation.  For additional information about the firm please visit www.kaskelalaw.com.  This notice may constitute attorney advertising in certain jurisdictions.

CONTACT: 
D. Seamus Kaskela, Esq. 
Adrienne Bell, Esq. 
KASKELA LAW LLC 
18 Campus Blvd., Suite 100 
Newtown Square, PA 19073 
(888) 715 – 1740
(484) 229 – 0750
www.kaskelalaw.com 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/fcfs-shareholder-alert-kaskela-law-llc-announces-investigation-of-firstcash-holdings-inc-and-encourages-long-term-fcfs-investors-to-contact-the-firm-301556983.html

SOURCE Kaskela Law LLC

EHTH SHAREHOLDER ALERT: Kaskela Law LLC Announces Investigation of eHealth, Inc. and Encourages Long-Term EHTH Investors to Contact the Firm

PR Newswire

PHILADELPHIA , May 28, 2022 /PRNewswire/ — Kaskela Law LLC announces that it is investigating eHealth, Inc. (NASDAQ: EHTH) (“eHealth” or the “Company”) on behalf of the Company’s long-term investors. 

Recently a securities fraud complaint was filed against eHealth on behalf of certain investors who purchased shares of the Company’s common stock between March 19, 2018 and July 23, 2020. 

According to the complaint, on April 7, 2020, research firm Muddy Waters Capital published a report alleging that eHealth had engaged in accounting misconduct.  Among other thing, the report alleged that eHealth’s financial statements for 2019: (i) overstated revenue by $128 million; (ii) overstated operating profit by $263 million; and (iii) understated an operating loss of –$181 millionFollowing the release of this report, shares of the eHealth’s stock declined $13.70 per share, or 11% in value, to close on April 8, 2020 at $103.20 per share.

Then, on July 23, 2020, when eHealth announced its earnings results for the second quarter of fiscal 2020, the company’s stock price fell again as the information contained in its announcement confirmed substantive aspects of the “member churn” allegations previously asserted in the Muddy Waters report. Following this additional news, shares of eHealth’s stock declined an additional $34.83 per share, or over 30% in value, to close on July 24, 2020 at $79.17 per share.

The investigation seeks to determine whether the members of eHealth’s board of directors breached their fiduciary duties in connection with the above alleged misconduct.


Current eHealth


s


tockholders who purchased or acquired shares of the Company’s common stock



prior to March 19, 2018



 are encouraged to contact Kaskela Law LLC (D. Seamus Kaskela, Esq. or Adrienne Bell, Esq.) at (484) 229 – 0750, or by email ([email protected]) or online at https://kaskelalaw.com/cases/ehealth-inc/ , to receive additional information about this investigation and their legal rights and options.

Kaskela Law LLC exclusively represents investors in securities fraud, corporate governance, and merger & acquisition litigation.  For additional information about the firm please visit 

www.kaskelalaw.com. This notice may constitute attorney advertising in certain jurisdictions. 

CONTACT:   

D. Seamus Kaskela, Esq.  
Adrienne Bell, Esq.  
KASKELA LAW LLC  
18 Campus Blvd., Suite 100  
Newtown Square, PA 19073  
(888) 715 – 1740  
(484) 229 – 0750  
www.kaskelalaw.com 

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/ehth-shareholder-alert-kaskela-law-llc-announces-investigation-of-ehealth-inc-and-encourages-long-term-ehth-investors-to-contact-the-firm-301556978.html

SOURCE Kaskela Law LLC

INVESTOR DEADLINE: Natera, Inc. Investors with Substantial Losses Have Opportunity to Lead Natera Class Action Lawsuit – NTRA

INVESTOR DEADLINE: Natera, Inc. Investors with Substantial Losses Have Opportunity to Lead Natera Class Action Lawsuit – NTRA

SAN DIEGO–(BUSINESS WIRE)–Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Natera, Inc. (NASDAQ: NTRA) common stock between February 26, 2020 and April 19, 2022, inclusive (the “Class Period”) have until June 27, 2022 to seek appointment as lead plaintiff in Schneider v. Natera, Inc., No. 22-cv-00398 (W.D. Tex.). The Natera class action lawsuit charges Natera and certain of its top executive officers with violations of the Securities Exchange Act of 1934.

If you suffered substantial losses and wish to serve as lead plaintiff, please provide your information here:

https://www.rgrdlaw.com/cases-natera-inc-class-action-lawsuit-ntra.html

You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at [email protected].

CASE ALLEGATIONS: Headquartered in Austin, Texas, Natera offers genetic testing in the areas of women’s health, oncology, and organ health. Among other things, Natera produces and markets a non-invasive prenatal test (“NIPT”) called “Panorama,” and a screening test for kidney transplant failure called “Prospera.”

The Natera class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) Panorama was not reliable and resulted in high rates of false positives; (ii) Prospera did not have superior precision compared to competing tests; (iii) as a result of defendants’ false and misleading claims about Natera’s technology, Natera was exposed to substantial legal and regulatory risks; (iv) Natera relied upon deceptive sales and billing practices to drive its revenue growth; and (v) therefore, defendants’ statements about Natera’s business, operations, and prospects lacked a reasonable basis.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Natera common stock during the Class Period to seek appointment as lead plaintiff. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class.

ABOUT ROBBINS GELLER: Robbins Geller is ranked #1 on the 2021 ISS Securities Class Action Services Top 50 Report for recovering nearly $2 billion for investors last year alone – more than triple the amount recovered by any other plaintiffs’ firm. With 200 lawyers in 9 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world, and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig. Please visit the following page for more information:

https://www.rgrdlaw.com/services-litigation-securities-fraud.html

Attorney advertising.

Past results do not guarantee future outcomes.

Services may be performed by attorneys in any of our offices.

Robbins Geller Rudman & Dowd LLP

655 W. Broadway, San Diego, CA 92101

J.C. Sanchez, 800-449-4900

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Legal Professional Services

MEDIA:

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INVESTOR DEADLINE: Investors in Okta, Inc. with Substantial Losses Have Opportunity to Lead the Okta Class Action Lawsuit – OKTA

INVESTOR DEADLINE: Investors in Okta, Inc. with Substantial Losses Have Opportunity to Lead the Okta Class Action Lawsuit – OKTA

SAN DIEGO–(BUSINESS WIRE)–Robbins Geller Rudman & Dowd LLP announces that investors that purchased or otherwise acquired Okta, Inc. (NASDAQ: OKTA) securities between March 5, 2021 and March 22, 2022, inclusive (the “Class Period”) have until July 19, 2022 to seek appointment as lead plaintiff in City of Miami Fire Fighters’ and Police Officers’ Retirement Trust v. Okta, Inc., No. 22-cv-02990 (N.D. Cal.). The Okta class action lawsuit charges Okta and certain of its top executive officers with violations of the Securities Exchange Act of 1934.

If you suffered substantial losses and wish to serve as lead plaintiff of the Okta class action lawsuit, please provide your information here:

https://www.rgrdlaw.com/cases-okta-inc-class-action-lawsuit-okta.html

You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at [email protected].

CASE ALLEGATIONS: Okta provides identity solutions for enterprises, small and medium-sized businesses, universities, non-profits, and government agencies in the United States and internationally.

The Okta class action lawsuit alleges that, throughout the Class Period, defendants made false and misleading statements and failed to disclose that: (i) Okta had inadequate cybersecurity controls; (ii) as a result, Okta’s systems were vulnerable to data breaches; (iii) Okta ultimately did experience a data breach caused by a hacking group, which potentially affected hundreds of Okta customers; (iv) Okta initially did not disclose and subsequently downplayed the severity of the data breach; (v) all the foregoing, once revealed, was likely to have a material negative impact on Okta’s business, financial condition, and reputation; and (vi) as a result, Okta’s public statements were materially false and misleading at all relevant times.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Okta securities during the Class Period to seek appointment as lead plaintiff. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the class action lawsuit. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

ABOUT ROBBINS GELLER: Robbins Geller is one of the world’s leading complex class action firms representing plaintiffs in securities fraud cases. The Firm is ranked #1 on the 2021 ISS Securities Class Action Services Top 50 Report for recovering nearly $2 billion for investors last year alone – more than triple the amount recovered by any other plaintiffs’ firm. With 200 lawyers in 9 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig. Please visit the following page for more information:

https://www.rgrdlaw.com/services-litigation-securities-fraud.html

Attorney advertising.

Past results do not guarantee future outcomes.

Services may be performed by attorneys in any of our offices.

Robbins Geller Rudman & Dowd LLP

655 W. Broadway, San Diego, CA 92101

J.C. Sanchez, 800-449-4900

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Legal Professional Services

MEDIA:

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Molecular Data Inc. Receives NASDAQ Notification Regarding Minimum Bid Requirements

PR Newswire


SHANGHAI
, May 27, 2022 /PRNewswire/ — Molecular Data, Inc. (“Molecular Data” or the “Company”) (NASDAQ: MKD), a technology-driven platform in China, announced today that on May 25, 2021, it had received a letter from The Nasdaq Stock Market LLC (“Nasdaq”), notifying the Company that its minimum closing bid price per share for its ordinary shares had fallen below $1.00 for a period of 30 consecutive business days and that the Company did not meet the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). On November 29, 2021, the Company was provided with an additional 180 calendar day compliance period, or until May 23, 2022, to demonstrate compliance.

On May 24, 2022, the Company received notice from Nasdaq that it has not regained compliance with Listing Rule 5550(a)(2) and that its American Depository Shares (“ADS”) would be delisted from the Capital Markets and a Form 25- NSE filed with the Securities and Exchange Commission (the “SEC”) to remove the Company’s securities from listing and registration on The Nasdaq Stock Market unless the Company requests a hearing for an appeal.

On May 26, 2022, the Company submitted a hearing request to a Hearings Panel (the “Panel”) for an appeal pursuant to the procedures set forth in the Nasdaq Listing Rule 5800 Series. The hearing request will stay the suspension and delisting action pending the issuance of a written Panel decision.

About Molecular Data, Inc.

Molecular Data Inc. is a technology-driven platform in China’s chemical industry, connecting participants along the chemical value chain through integrated solutions. The Company delivers e-commerce solutions, financial solutions, warehousing and logistics solutions, and SaaS suite that are intended to solve pain points for participants in the traditional chemical industry. Built upon a comprehensive knowledge engine and artificial intelligence (AI) capabilities, the Company’s e-commerce solutions are mainly offered through its online platform, consisting of molbase.com, molbase.cn, Moku Data WeChat account, Chemical Community APP and other ancillary platforms.

Forward-Looking Statements

This announcement contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact in this announcement are forward-looking statements, including the potential impact of COVID-19 on our business within and outside of China. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations and projections about future events and financial trends that the Company believes may affect its financial condition, results of operations, business strategy and financial needs. Investors can identify these forward-looking statements by words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results.

Cision View original content:https://www.prnewswire.com/news-releases/molecular-data-inc-receives-nasdaq-notification-regarding-minimum-bid-requirements-301557018.html

SOURCE Molecular Data Inc.

Sands to Participate in the Bernstein Strategic Decisions Conference

PR Newswire


LAS VEGAS
, May 27, 2022 /PRNewswire/ — Las Vegas Sands (NYSE: LVS) will participate in the 38th Annual Bernstein Strategic Decisions Conference in New York, NY on Wednesday, June 1, 2022.

Mr. Robert G. Goldstein, Chairman and Chief Executive Officer, will participate in a discussion which is scheduled to begin at approximately 1:30 p.m. Eastern Time (10:30 a.m. Pacific Time).

A webcast of the discussion may be accessed at the Investor Relations section of the company’s website at www.sands.com.

About Sands (NYSE: LVS)

Sands is the world’s preeminent developer and operator of world-class Integrated Resorts.

Our iconic properties drive valuable leisure and business tourism and deliver significant economic benefits, sustained job creation, financial opportunities for local businesses and community investment to help make our host regions ideal places to live, work and visit.

Sands’ portfolio of properties includes Marina Bay Sands in Singapore and The Venetian Macao, The Plaza and Four Seasons Hotel Macao, The Londoner Macao, The Parisian Macao and Sands Macao in Macao SAR, China, through majority ownership in Sands China Ltd.

Sands is dedicated to being a leader in corporate responsibility, anchored by our core tenets of serving people, planet and communities.  Our ESG leadership has led to inclusion on the Dow Jones Sustainability Indices for World and North America and recognition as one of Fortune’s World’s Most Admired Companies.  To learn more, visit www.sands.com.

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/sands-to-participate-in-the-bernstein-strategic-decisions-conference-301556988.html

SOURCE Las Vegas Sands

Six Flags St. Louis Kicks Off Summer Season with the New CATWOMAN Whip and Adventure Cove

Six Flags St. Louis Kicks Off Summer Season with the New CATWOMAN Whip and Adventure Cove

Guests Will Experience New Thrills in Both the Theme Park and Water Park

EUREKA, Mo.–(BUSINESS WIRE)–Six Flags St. Louis, The Gateway to Thrills, debuts two new guest experiences to officially start the summer season of fun. The much-anticipated CATWOMAN Whip, a dual spinning thrill ride, and Adventure Cove, a multi-level water attraction, will both open Memorial Day weekend.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220527005428/en/

The much anticipated CATWOMAN Whip at Six Flags St. Louis spins riders first one direction and then another, 164-ft in the air at 52 mph. This ride delivers plenty of airtime as the open air pods spin independently and unpredictably with each rotation of the massive arm and gives a little different ride experience each time. (Photo: Business Wire)

The much anticipated CATWOMAN Whip at Six Flags St. Louis spins riders first one direction and then another, 164-ft in the air at 52 mph. This ride delivers plenty of airtime as the open air pods spin independently and unpredictably with each rotation of the massive arm and gives a little different ride experience each time. (Photo: Business Wire)

“We are excited to finally bring our guests the long-awaited opening of these two great additions,” said Park President Phil Liggett. “CATWOMAN Whip combines height, speed and dual motion to add yet another heart-pounding experience for thrill seekers, while Adventure Cove combines interactive features, slides and new technology to create the perfect water adventure for our younger guests.”

Six Flags St. Louis, in partnership with Warner Bros. Themed Entertainment and DC, launches CATWOMAN Whip, with its dual spinning, one-of-a-kind experience. The thrilling ride will catapult guests 16-stories into the air while spinning around in a giant vertical circle as open-air pods flip the riders head-over-heels. Guests will be greeted by a statue of the iconic DC Super-Villain CATWOMAN at the entrance of the new ride, which is located at the top of the park in the newly renovated plaza area of CATWOMAN Whip and The Screamin’ Eagle.

CATWOMAN Whip mind-boggling facts:

  • Open-air pods seat eight guests, four across and back to back, with riders’ feet dangling in the air;
  • Guests are catapulted 164-feet into the air, then whipped back down toward the ground, only to complete the rotation again and again; and
  • As the ride’s massive arm whips around at up to 52 mph, the pods simultaneously flip upside down with each rotation.

The new, multi-level Adventure Cove is a centerpiece in Hurricane Harbor, providing the ultimate water play area. The structure’s interactive features use SmartWorks Control Technology to move more water over a greater distance than traditional manual features, making them easier for kids to use and enjoy.

Adventure Cove water-fun highlights:

  • Seventy-one electronic ignition features including water cannons, jets, blasters, geysers and more;
  • A 30-ft tall Hydro Storm bucket, which releases 750 gallons of water in a 360° array; and
  • A pirate ship and four slides that allow younger guests to take a plunge into the water.

For more information on CATWOMAN Whip and Adventure Cove visit www.sixflags.com/stlouis.

The park is hiring for the summer. Applicants, age 14 and older, can text FUN to 636-245-2717 or complete an application at www.sixflagsjobs.com. The park offers flexible hours and great perks, with most jobs starting at $12.50 per hour, and paying up to $18 per hour for Ride Operators and Lifeguards.

New for 2022, Six Flags offers a three-tiered Pass Program focused on maximizing the value and experience for guests. The Thrill Seeker Pass is perfect for frequent home park visitation. The Extreme Pass is ideal for live-on-the-edge thrills all year, without block-out dates. The Ultimate Pass provides the best value for everything offered: it includes all of the advantages of an Extreme Pass, plus more! For additional benefits and savings, TWO Junior Passes will be given with the purchase of an Extreme or Ultimate Pass. The Junior Pass is for guests under 42”. For more information on these best offers, visit www.sixflags.com.

About Six Flags Entertainment Corporation

Six Flags Entertainment Corporation is the world’s largest regional theme park company and the largest operator of water parks in North America, with 27 parks across the United States, Mexico and Canada. For 60 years, Six Flags has entertained millions of families with world-class coasters, themed rides, thrilling water parks and unique attractions. Six Flags is committed to creating an inclusive environment that fully embraces the diversity of our team members and guests. For more information, visit www.sixflags.com.

About Six Flags St. Louis and Hurricane Harbor

Six Flags St. Louis opened in 1971 and is one of the three original Six Flags parks. The theme park is home to a host of thrilling rides, shows, and attractions, including 10 heart-pounding roller coasters and a special section just for kids. Six Flags Hurricane Harbor, a 12-acre water park, features a variety of water slides, a lazy river, a kid’s area and a 30,000-sq ft. wave pool. Six Flags St. Louis and Hurricane Harbor are the Gateway to Thrills and family fun.

Follow us on Twitter @SixFlags

Like us on Facebook at facebook.com/sixflags

About Warner Bros. Themed Entertainment

Warner Bros. Themed Entertainment (WBTE), part of Warner Bros. Discover Global Brands and Experiences, is a worldwide leader in the creation, development and licensing of location-based entertainment, live events, exhibits and theme park experiences based on Warner Bros.’ iconic characters, stories, and brands. WBTE is home to the groundbreaking global locations of The Wizarding World of Harry Potter, Warner Bros. World Abu Dhabi, WB Movie World Australia, and countless other experiences inspired by DC, Looney Tunes, Scooby, Game of Thrones, Friends and more. With best-in-class partners, WBTE allows fans around the world to physically immerse themselves inside their favorite brands and franchises.

About DC

DC creates iconic characters, enduring stories, and immersive experiences that inspire and entertain audiences of every generation around the world and is one of the world’s largest publishers of comics and graphic novels. As a creative division, DC is charged with strategically integrating its stories and characters across film, television, consumer products, home entertainment, interactive games, DC UNIVERSE INFINITE digital subscription service and community engagement portal. For more information visit dccomics.com and dcuniverseinfinite.com.

All DC characters and elements © & ™ DC Comics. (s22)

Media Contact:

Elizabeth Gotway

636-938-5300, ext. 7101550

[email protected]

Kelsey Sullentrup

[email protected]

KEYWORDS: United States North America Missouri

INDUSTRY KEYWORDS: Theme Parks Men Entertainment Family Vacation Consumer Destinations Travel General Entertainment Teens Children Women Licensing (Entertainment)

MEDIA:

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Photo
Photo
The giant 164-ft arm of CATWOMAN Whip, with open air pods on each end, towers above Six Flags St. Louis. Riders spin counter clockwise and then clockwise, at 52 mph, while the pods spin independently and unpredictably. Each ride is different based on the direction the arm is spinning and the distribution of riders. (Photo: Business Wire)
Photo
Photo
The much anticipated CATWOMAN Whip at Six Flags St. Louis spins riders first one direction and then another, 164-ft in the air at 52 mph. This ride delivers plenty of airtime as the open air pods spin independently and unpredictably with each rotation of the massive arm and gives a little different ride experience each time. (Photo: Business Wire)
Photo
Photo
Six Flags St. Louis debuts Adventure Cove, a multi-level kids play area in Hurricane Harbor water park. This interactive attraction features a hydro storm bucket that sprays 750 gallons of water in a 360° array as well as 71 electronic ignition water features that kids can activate including geysers, cannons, blasters, jets, water wheels and more. (Photo: Business Wire)

CORRECTING and REPLACING Franklin Templeton to Reposition Four ETFs in U.S.

CORRECTING and REPLACING Franklin Templeton to Reposition Four ETFs in U.S.

NEW YORK–(BUSINESS WIRE)–
Headline of release should read: Franklin Templeton to Reposition Four ETFs in U.S. (instead of Franklin Templeton to Reposition Four ETFs U.S.).

The updated release reads:

FRANKLIN TEMPLETON TO REPOSITION FOUR ETFS IN U.S.

Franklin Templeton today announced plans to reposition and rename four index-based ETFs, effective on or about August 1, 2022. With this repositioning, the firm will change the ticker symbols and investment goal, strategies and policies for each Fund. The index provider for each Fund will change from MSCI Inc. to Morningstar, Inc. and the underlying index for each Fund will change as described below. With these changes, the firm will also reduce the unitary management fee rate for each Fund.

The following ETFs will seek to track an index that seeks a higher dividend yield than the broad market (as measured by each respective parent index), while limiting expected tracking error to the parent index:

FROM

TO

Unitary Management Fee Rate (%)

Effective on or about 8/1

FLQD

Franklin LibertyQ

Global Dividend ETF

UDIV

Franklin U.S. Core Dividend Tilt Index ETF

0.06%

Franklin U.S. Core Dividend Tilt Index ETF (UDIV) will seek to provide investment results that closely correspond, before fees and expenses, to the performance of the Morningstar® US Dividend Enhanced Select IndexSM (the Underlying Index). The Underlying Index is a systematic, rules-based proprietary index that is maintained and calculated by Morningstar, Inc. The Underlying Index starts from the Morningstar® US Target Market Exposure Index (Parent Index) and aims to deliver a higher dividend yield than the Parent Index, while limiting expected tracking error to the Parent Index (i.e., to provide a “dividend tilt” through the selection and weighting of securities from the Parent Index). The Parent Index targets large- and mid-capitalization U.S. stocks representing the top 85% of the U.S. equity market by float-adjusted market capitalization.

FROM

TO

Unitary Management Fee Rate (%)

Effective on or about 8/1

FLQH

Franklin LibertyQ International Equity Hedged ETF

DIVI

Franklin International Core Dividend Tilt Index ETF

0.09%

Franklin International Core Dividend Tilt Index ETF (DIVI) willseek to provide investment results that closely correspond, before fees and expenses, to the performance of the Morningstar® Developed Markets ex-North America Dividend Enhanced Select IndexSM (the Underlying Index). The Underlying Index is a systematic, rules-based proprietary index that is maintained and calculated by Morningstar, Inc. The Underlying Index starts from the Morningstar® Developed Markets ex-North America Target Market Exposure Index (Parent Index) and aims to deliver a higher dividend yield than the Parent Index, while limiting expected tracking error to the Parent Index (i.e., to provide a “dividend tilt” through the selection and weighting of securities from the Parent Index). The Parent Index is designed to cover 85% of the float-adjusted market capitalization of the developed markets equity markets excluding North America.

FROM

TO

Unitary Management Fee Rate (%)

Effective on or about 8/1

FLQE

Franklin LibertyQ

Emerging Markets ETF

DIEM

Franklin Emerging Market Core Dividend Tilt Index ETF

0.19%

Franklin Emerging Market Core Dividend Tilt Index ETF (DIEM) will seek to provide investment results that closely correspond, before fees and expenses, to the performance of the Morningstar® Emerging Markets Dividend Enhanced Select IndexSM (the Underlying Index). The Underlying Index is a systematic, rules-based proprietary index that is maintained and calculated by Morningstar, Inc. The Underlying Index starts from the Morningstar® Emerging Markets Target Market Exposure Index (Parent Index) and aims to deliver a higher dividend yield than the Parent Index, while limiting expected tracking error to the Parent Index (i.e., to provide a “dividend tilt” through the selection and weighting of securities from the Parent Index). The Parent Index is designed to cover 85% of the float-adjusted market capitalization of emerging equity markets.

The following ETF will seek to track a market-cap weighted index, which targets large- and mid-capitalization U.S. stocks:

FROM

TO

Unitary Management Fee Rate (%)

Effective on or about 8/1

FLQG

Franklin LibertyQ

Global Equity ETF

USPX

Franklin U.S. Equity Index ETF

0.03%

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U.S. Food and Drug Administration Approves Two Opdivo® (nivolumab)-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma

U.S. Food and Drug Administration Approves Two Opdivo® (nivolumab)-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Opdivo in combination with chemotherapy and Opdivo plus Yervoy® (ipilimumab) approved based on a Phase 3 trial showing improved overall survival versus chemotherapy alone1,2

Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers1

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved both Opdivo® (nivolumab) (injection for intravenous use) in combination with fluoropyrimidine- and platinum-containing chemotherapy and Opdivo® plus Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) regardless of PD-L1 status. The approvals are based on the Phase 3 CheckMate -648 trial, which evaluated Opdivo in combination with chemotherapy (n=321) and Opdivo plus Yervoy (n=325) each compared to chemotherapy alone (n=324), and was the largest Phase 3 trial of an immunotherapy in first-line ESCC.1

In the trial, Opdivo in combination with chemotherapy demonstrated superior overall survival (OS) compared to chemotherapy alone, both in all randomized patients, a secondary endpoint, which was hierarchically tested (Hazard Ratio [HR] 0.74, 95% Confidence Interval [CI]: 0.61 to 0.90, P=0.0021) and in patients whose tumors express PD-L1 (≥1%), a primary endpoint (HR 0.54, 95% CI: 0.41 to 0.71, P<0.0001).1,2 In all randomized patients the median OS (mOS) was 13.2 months (95% CI: 11.1 to 15.7) with Opdivo in combination with chemotherapy versus 10.7 months (95% CI: 9.4 to 11.9) with chemotherapy alone.1 In patients whose tumors express PD-L1 (≥1%) the mOS was 15.4 months (95% CI: 11.9 to 19.5) for Opdivo in combination with chemotherapy versus 9.1 months (95% CI: 7.7 to 10) with chemotherapy alone.1 The median progression-free survival (PFS) in all randomized patients, which was a hierarchically tested secondary endpoint, was 5.8 months (95% CI: 5.6 to 7.0) for Opdivo in combination with chemotherapy and 5.6 months (95% CI: 4.3 to 5.9) for chemotherapy alone (HR= 0.81; 95% CI: 0.67 to 0.99, P=not significant). Per pre-specified analysis, PFS did not meet statistical significance.1 The median PFS in patients whose tumors express PD-L1 (≥1%), which was a co-primary endpoint, was 6.9 months (95% CI: 5.7 to 8.3) for Opdivo in combination with chemotherapy and 4.4 months (95% CI: 2.9 to 5.8) for chemotherapy alone (HR 0.65; 95% CI: 0.49 to 0.86, P=0.0023).1

Opdivo plus Yervoy also improved OS compared to chemotherapy in all-randomized patients, a secondary endpoint, which was hierarchically tested (HR 0.78, 95% CI: 0.65 to 0.95, P=0.0110) and patients whose tumors express PD-L1 (≥1%), a primary endpoint (HR 0.64, 95% CI: 0.49 to 0.84, P=0.0010).1,2 The mOS was 12.8 months (95% CI: 11.3 to 15.5) with Opdivo plus Yervoy versus 10.7 months (95% CI: 9.4 to 11.9) with chemotherapy alone in all randomized patients and 13.7 months (95% CI: 11.2 to 17.0) with Opdivo plus Yervoy versus 9.1 months (95% CI: 7.7 to 10) with chemotherapy alone in patients whose tumors express PD-L1 (≥1%).1 The median PFS in patients whose tumors express PD-L1 (≥1%), which was a co-primary endpoint, was 4.0 months (95% CI: 2.4 to 4.9) for Opdivo plus Yervoy and 4.4 months (95% CI: 2.9 to 5.8) for chemotherapy alone (HR 1.02; 95% CI: 0.78 to 1.34, P=not significant). Per pre-specified analysis, PFS did not meet statistical significance.1,2 Median PFS in the PD-L1 (≥1%) population was not statistically significant and therefore it was not hierarchically tested in the all comers population.

Opdivo alone and Opdivo plus Yervoy are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis and renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.1Please see the Important Safety Information section below.

“Today brings welcome news for many advanced or metastatic esophageal squamous cell carcinoma patients and oncologists,” said Jaffer A. Ajani, M.D., CheckMate -648 co-first author and lead U.S. investigator, and professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. “Unresectable advanced or metastatic esophageal squamous cell carcinoma is a challenging disease, and there’s a need for additional treatment options that may extend survival in the first-line setting.3,4 In the CheckMate -648 trial, two nivolumab-based combinations showed a survival benefit compared to chemotherapy alone, offering new treatment options regardless of PD-L1 status.”1

This application was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.5

“At Bristol Myers Squibb, we recognize the need that exists for many patients facing upper gastroesophageal cancers, including advanced or metastatic esophageal squamous cell carcinoma, and we are focused on our goal to bring forward new treatment options with proven survival benefits regardless of PD-L1 status and histology,” said Adam Lenkowsky, senior vice president and general manager, U.S., Cardiovascular, Immunology, Oncology, Bristol Myers Squibb.6 “Today’s approvals bring two first-line immunotherapy-based treatment options at once, Opdivo in combination with chemotherapy and Opdivo plus Yervoy as the first dual immunotherapy option, to newly diagnosed patients with unresectable advanced or metastatic esophageal squamous cell carcinoma, further building on the role of Opdivo-based regimens in upper gastroesophageal cancers.”1

About CheckMate -648

CheckMate -648 is a randomized Phase 3 study evaluating Opdivo plus Yervoy or Opdivo in combination with chemotherapy (fluorouracil and cisplatin) against chemotherapy (fluorouracil plus cisplatin) alone in adult patients with previously untreated unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.1,2 The primary endpoints of the trial are overall survival (OS) and progression-free survival (PFS) determined by blinded independent central review (BICR) in patients whose tumors express PD-L1 (≥1%) for both Opdivo-based combinations versus chemotherapy.2 Secondary endpoints of the trial, including OS and PFS as determined by BICR in the all randomized population, were tested hierarchically only if corresponding primary endpoints were significant.1,2

In the Opdivo plus Yervoy arm, patients received treatment with Opdivo 3 mg/kg every 2 weeks and Yervoy 1 mg/kg every 6 weeks up to 2 years or until disease progression or unacceptable toxicity.1,2 In the Opdivo in combination with chemotherapy arm, patients received treatment with Opdivo 240 mg on Day 1 and Day 15, fluorouracil 800 mg/m²/day on Day 1 through Day 5 for five days, and cisplatin 80 mg/m² on Day 1 of a four-week cycle.1,2 Patients were treated with Opdivo until disease progression, unacceptable toxicity, or up to 2 years.1,2 In patients who received Opdivo in combination with chemotherapy and in whom either fluorouracil and/or cisplatin were discontinued, other components of the treatment regimen were allowed to be continued. 2 Patients who discontinued combination therapy because of an adverse reaction attributed to ipilimumab were permitted to continue Opdivo as a single agent.2

Select Safety Profile from CheckMate -648 Study

Opdivo and/or chemotherapy were discontinued in 39% of patients and were delayed in 71% of patients for an adverse reaction.1 Serious adverse reactions occurred in 62% of patients receiving Opdivo in combination with chemotherapy.1 The most frequent (≥2%) serious adverse reactions in patients receiving Opdivo in combination with chemotherapy were pneumonia (11%), dysphagia (7%), esophageal stenosis (2.9%), acute kidney injury (2.9%), and pyrexia (2.3%).1 Fatal adverse reactions occurred in 5 (1.6%) patients treated with Opdivo in combination with chemotherapy; these included pneumonitis, pneumatosis intestinalis, pneumonia, and acute kidney injury.1 The most common (≥20%) adverse reactions in patients treated with Opdivo in combination with chemotherapy were nausea (65%), decreased appetite (51%), fatigue (47%), constipation (44%), stomatitis (44%), diarrhea (29%), and vomiting (23%).1

Opdivo and/or Yervoy were discontinued in 23% of patients and were delayed in 46% of patients for an adverse reaction.1 Serious adverse reactions occurred in 69% of patients receiving Opdivo plus Yervoy.1 The most frequent (≥2%) serious adverse reactions in patients receiving Opdivo plus Yervoy were pneumonia (10%), pyrexia (4.3%), pneumonitis (4%), aspiration pneumonia (3.7%), dysphagia (3.7%), hepatic function abnormal (2.8%), decreased appetite (2.8%), adrenal insufficiency (2.5%), and dehydration (2.5%).1 Fatal adverse reactions occurred in 5 (1.6%) patients treated with Opdivo plus Yervoy; these included pneumonitis, interstitial lung disease, pulmonary embolism, and acute respiratory distress syndrome.1 The most common (≥20%) adverse reactions in patients treated with Opdivo plus Yervoy were rash (31%), fatigue (28%), pyrexia (23%), nausea (22%), diarrhea (22%), and constipation (20%).1

About Esophageal Cancer

In the United States, it is estimated that approximately 20,640 new cases of esophageal cancer will be diagnosed and approximately 16,410 deaths will result from the disease in 2022 alone.7 Esophageal cancer, which can impact the patient’s ability to swallow and eat, is a type of gastroesophageal cancer that starts in the inner layer of the esophagus (the mucosa) and grows.8,9 The mucosa is normally lined with squamous cells.9 Cancer starting in these cells is called squamous cell carcinoma, which is most often found in the upper and middle part of the esophagus, and accounts for less than 30% of esophageal cancers in the United States.9 For about 39% of patients, esophageal cancer is diagnosed in the advanced stage, which is typically harder to treat.10

INDICATIONS

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%).

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%).

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%).

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%).

In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%).

In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%).

In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%).

In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis.

Immune-Mediated Nephritis with Renal Dysfunction

OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%).

Immune-Mediated Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients, including Grade 3 (1.1%) and Grade 2 (2.2%).

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or OPDIVO in combination with YERVOY or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; other (hematologic/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: nervous system: autoimmune neuropathy (2%), myasthenic syndrome/myasthenia gravis, motor dysfunction; cardiovascular: angiopathy, temporal arteritis; ocular: blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: pancreatitis (1.3%); other (hematologic/immune): conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis.

Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.

Infusion-Related Reactions

OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with OPDIVO or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between OPDIVO or YERVOY and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO and YERVOY prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on its mechanism of action and findings from animal studies, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and YERVOY and for at least 5 months after the last dose.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

There are no data on the presence of OPDIVO or YERVOY in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 5 months after the last dose.

Serious Adverse Reactions

In Attraction-3, serious adverse reactions occurred in 38% of patients receiving OPDIVO (n=209). Serious adverse reactions reported in ≥2% of patients who received OPDIVO were pneumonia, esophageal fistula, interstitial lung disease, and pyrexia. The following fatal adverse reactions occurred in patients who received OPDIVO: interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%). In Checkmate 577, serious adverse reactions occurred in 33% of patients receiving OPDIVO (n=532). A serious adverse reaction reported in ≥2% of patients who received OPDIVO was pneumonitis. A fatal reaction of myocardial infarction occurred in one patient who received OPDIVO. In Checkmate 648, serious adverse reactions occurred in 62% of patients receiving OPDIVO in combination with chemotherapy (n=310). The most frequent serious adverse reactions reported in ≥2% of patients who received OPDIVO with chemotherapy were pneumonia (11%), dysphagia (7%), esophageal stenosis (2.9%), acute kidney injury (2.9%), and pyrexia (2.3%). Fatal adverse reactions occurred in 5 (1.6%) patients who received OPDIVO in combination with chemotherapy; these included pneumonitis, pneumatosis intestinalis, pneumonia, and acute kidney injury. In Checkmate 648, serious adverse reactions occurred in 69% of patients receiving OPDIVO in combination with YERVOY (n=322). The most frequent serious adverse reactions reported in ≥2% who received OPDIVO in combination with YERVOY were pneumonia (10%), pyrexia (4.3%), pneumonitis (4.0%), aspiration pneumonia (3.7%), dysphagia (3.7%), hepatic function abnormal (2.8%), decreased appetite (2.8%), adrenal insufficiency (2.5%), and dehydration (2.5%). Fatal adverse reactions occurred in 5 (1.6%) patients who received OPDIVO in combination with YERVOY; these included pneumonitis, interstitial lung disease, pulmonary embolism, and acute respiratory distress syndrome. In Checkmate 649, serious adverse reactions occurred in 52% of patients treated with OPDIVO in combination with chemotherapy (n=782). The most frequent serious adverse reactions reported in ≥2% of patients treated with OPDIVO in combination with chemotherapy were vomiting (3.7%), pneumonia (3.6%), anemia (3.6%), pyrexia (2.8%), diarrhea (2.7%), febrile neutropenia (2.6%), and pneumonitis (2.4%). Fatal adverse reactions occurred in 16 (2.0%) patients who were treated with OPDIVO in combination with chemotherapy; these included pneumonitis (4 patients), febrile neutropenia (2 patients), stroke (2 patients), gastrointestinal toxicity, intestinal mucositis, septic shock, pneumonia, infection, gastrointestinal bleeding, mesenteric vessel thrombosis, and disseminated intravascular coagulation.

Common Adverse Reactions

In Attraction-3, the most common adverse reactions (≥20%) in OPDIVO-treated patients (n=209) were rash (22%) and decreased appetite (21%). In Checkmate 577, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=532) were fatigue (34%), diarrhea (29%), nausea (23%), rash (21%), musculoskeletal pain (21%), and cough (20%). In Checkmate 648, the most common adverse reactions (≥20%) in patients treated with OPDIVO in combination with chemotherapy (n=310) were nausea (65%), decreased appetite (51%), constipation (44%), stomatitis (44%), fatigue (32%), diarrhea (29%), and vomiting (23%). In Checkmate 648, the most common adverse reactions reported in ≥20% of patients treated with OPDIVO in combination with YERVOY were rash (31%), fatigue (28%), pyrexia (23%), nausea (22%), diarrhea (22%), and constipation (20%). In Checkmate 649, the most common adverse reactions (≥20%) in patients treated with OPDIVO in combination with chemotherapy (n=782) were peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), and musculoskeletal pain (20%).

Please see US Full Prescribing Information for OPDIVO and YERVOY.

Clinical Trials and Patient Populations

Attraction-3—esophageal squamous cell carcinoma; Checkmate 577—adjuvant treatment of esophageal or gastroesophageal junction cancer; Checkmate 648—previously untreated, unresectable advanced, metastatic esophageal squamous cell carcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy; Checkmate 648—previously untreated, unresectable advanced, or metastatic esophageal squamous cell carcinoma, in combination with YERVOY; Checkmate 649—previously untreated advanced or metastatic gastric or gastroesophageal junction or esophageal adenocarcinoma

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

About Bristol Myers Squibb’s Patient Access Support

Bristol Myers Squibb remains committed to providing assistance so that cancer patients who need our medicines can access them and expedite time to therapy.

BMS Access Support®, the Bristol Myers Squibb patient access and reimbursement program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance, as well as co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support can be obtained by calling BMS Access Supportat 1-800-861-0048 or by visiting www.bmsaccesssupport.com.

About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, whether Opdivo in combination with Yervoy or chemotherapy for the additional indications described in this release will be commercially successful, that any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of such combination treatments for the additional indication described in this release may be contingent upon verification and description of clinical benefit in confirmatory trials. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2021, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

References

  1. Opdivo Prescribing Information. Opdivo U.S. Product Information. Last updated: May 2022. Princeton, NJ: Bristol-Myers Squibb Company.
  2. Chau I, Doki Y, Ajani JA, et al. Nivolumab plus Ipilimumab or Nivolumab plus Chemotherapy versus Chemotherapy as First-line Treatment for Advanced Esophageal Squamous Cell Carcinoma: First Results of the CheckMate 648 study. Poster presented at: 2021 American Society of Clinical Oncology (ASCO) Virtual Congress. June 4-8, 2021.
  3. American Cancer Society. Treating Esophageal Cancer by Stage. https://www.cancer.org/cancer/esophagus-cancer/treating/by-stage.html. Updated May 21, 2021. Accessed April 7, 2022.
  4. Dahiya DS, Kichloo A, Singh J, et al. Current Immunotherapy in Gastrointestinal Malignancies A Review. J Investig Med. 2021;69:689-696.
  5. U.S. Food & Drug Administration. Real-Time Oncology Review Pilot Program. https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review. Updated March 10, 2022. Accessed May 24, 2022.
  6. Myint ZW, Goel G. Role of Modern Immunotherapy in Gastrointestinal Malignancies: a Review of Current Clinical Progress. J Hematol Oncol. 2017 Apr 24;10(1):86.
  7. American Cancer Society. Key Statistics for Esophageal Cancer. https://www.cancer.org/cancer/esophagus-cancer/about/key-statistics.html. Updated January 12, 2022. Accessed May 24, 2022.
  8. PDQ® Adult Treatment Editorial Board. PDQ Esophageal Cancer Treatment (Adult). https://www.cancer.gov/types/esophageal/patient/esophageal-treatment-pdq. Last updated: November 18, 2021. Accessed May 24, 2022. Bethesda, MD: National Cancer Institute.
  9. American Cancer Society. What Is Cancer of the Esophagus? https://www.cancer.org/cancer/esophagus-cancer/about/what-is-cancer-of-the-esophagus.html. Updated March 20, 2020. Accessed May 24, 2022.
  10. SEER. Cancer Stat Facts: Esophageal Cancer. https://seer.cancer.gov/statfacts/html/esoph.html. Accessed May 24, 2022.

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