Market Newsdesk

STOCKHOLM, Sept. 14, 2021 /PRNewswire/ — Calliditas Therapeutics AB (publ) (“Calliditas” or the “Company”) (Nasdaq Stockholm: CALTX) (Nasdaq – CALT), a biopharma company focused on identifying, developing and commercializing novel treatments in orphan indications, today announced that the U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its New Drug Application (NDA) seeking accelerated approval for Nefecon to December 15, 2021.

In March 2021 Calliditas filed for FDA approval using the Accelerated Approval Program, based on the proteinuria endpoint as previously discussed with the Agency, reflecting data from the 200 patients in Part A of the NefIgArd trial.

In its review of the NDA, the FDA has requested further analyses of the NeflgArd trial data which the company has provided to the FDA. The Agency has classified these analyses as a major amendment to the NDA. The amendment mainly provides additional eGFR and other related analyses as further support of the proteinuria data provided in the NDA submission. The FDA has therefore extended the PDUFA goal date to December 15, 2021.

“Our NDA for Nefecon is the first time that the FDA is considering an approval on the basis of proteinuria as a surrogate endpoint for accelerated approval in IgA nephropathy, requiring an in-depth review process. We will continue to cooperate closely with the FDA as they complete the review of our NDA,” said Renée Aguiar-Lucander, CEO at Calliditas.

For further information, please contact:

Renée Aguiar-Lucander, CEO at Calliditas

E-mail: [email protected]

Marie Galay
, Corporate Communications and IR

Tel.: +44 7955 129 845, e-mail: [email protected]

The information in the press release is inside information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons above, on September 14, 2021 at 3:10 pm ET.

About Calliditas  

Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas read out topline data from Part A of its global Phase 3 study in IgAN in November 2020 and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT).

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas’ strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Calliditas’ business, operations, the potential for and timing of FDA approval of its regulatory marketing application for Nefecon, the potential for FDA’s review extension on the NDA for Nefecon to lead to marketing approval, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled “Risk Factors” in Calliditas’ reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Calliditas’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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SOURCE Calliditas Therapeutics

DALLAS, Sept. 14, 2021 /PRNewswire/ — EnLink Midstream, LLC (NYSE: ENLC) (EnLink) today announced that it donated 50,000 gallons of propane to support residents of Southeast Louisiana experiencing extended power outages as a result of Hurricane Ida. EnLink is partnering with O’Nealgas, a full-service propane company that is delivering the propane directly to first responders and local residents, via onsite service trucks, and the Louisiana Association of Business and Industry Foundation (LABI) to ensure the propane is serving those in need.

“EnLink has a 60-plus-year history in the state of Louisiana, which has seen severe devastation in the wake of Hurricane Ida,” EnLink Chairman and CEO Barry E. Davis said. “We want to assist our neighbors in this trying time and are thankful for the partnership of O’Nealgas. This propane normally would be sold into pipeline markets but now will go directly into the hands of people in need, helping run generators, cook food, and power on-the-ground response operations, while they await the return of electricity to their communities.”

EnLink operates a large network of assets in Louisiana and along the Gulf Coast, including one of the largest gas transmission pipeline systems in Louisiana. O’Nealgas, which was founded in Louisiana, initially reached out to EnLink about obtaining a donation of propane to help residents. O’Nealgas and EnLink have had a strong working relationship for many years.

“When I approached EnLink about helping us get desperately needed propane to the hardest hit communities in south Louisiana, they agreed without hesitation,” said Tom O’Neal, President of O’Nealgas. “The only surprise was the incredible generosity – donating 50,000 gallons of propane to the residents of those communities was an amazing, Texas-sized lifeline that literally helped people keep the lights on and feed their families.”

The EnLink donation is already making its way into the hands of Louisianans, as O’Nealgas and LABI began delivering it last week to lines of eager residents.

“This is just another example of our members representing the best of Louisiana,” said LABI President and CEO Stephen Waguespack. “The overwhelming generosity of these two companies will help families get back on their feet and on the road to recovery following Ida. It’s what Louisianans do, and LABI is incredibly proud and honored to serve alongside them.”

For more information on EnLink’s commitment to local communities and overall sustainability efforts, visit http://sustainability.enlink.com.

About EnLink Midstream
EnLink Midstream reliably operates a differentiated midstream platform that is built for long-term, sustainable value creation. EnLink’s best-in-class services span the midstream value chain, providing natural gas, crude oil, condensate, and NGL capabilities. Our purposely built, integrated asset platforms are in premier production basins and core demand centers, including the Permian Basin, Oklahoma, North Texas, and the Gulf Coast. EnLink’s strong financial foundation and commitment to execution excellence drive competitive returns and value for our employees, customers, and investors. Headquartered in Dallas, EnLink is publicly traded through EnLink Midstream, LLC (NYSE: ENLC). Visit www.EnLink.com to learn how EnLink connects energy to life.

About O’Nealgas 
In March of 1952 in his small hometown of Choudrant, LA, John A. O’Neal founded O’Neal Butane. Today as a full-service propane company, O’Nealgas, Inc. has a fleet of delivery and service trucks and nearly 70 employees in nine office locations, 22 parishes in Louisiana, and eight counties in Arkansas. For all of your gas needs, O’Nealgas has the experience, resources, products, and service specialists to get the job done. For more information, visit onealgas.com.

About LABI Foundation
LABI Foundation is a 501 (c)(3) organization dedicated to sponsoring and working with other nonprofits to aid communities and small businesses in their recovery from natural disasters. LABI Foundation also develops and co-sponsors events, such as policy-specific summits, to educate the citizens on policy issues impacting the state.

Investor Relations: 
Brian Brungardt, Director of Investor Relations, 214-721-9353, [email protected]
Media Relations: Jill McMillan, Vice President of Strategic Relations & Public Affairs, 214-721-9271, [email protected]

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SOURCE EnLink Midstream, LLC

FOLSOM, Calif., Sept. 14, 2021 /PRNewswire/ — Richmond American Homes of California, Inc., a subsidiary of M.D.C. Holdings, Inc. (NYSE: MDC), is pleased to announce the debut of two new model homes at Stone Bluff at White Rock Springs Ranch (RichmondAmerican.com/StoneBluffAtWhiteRockSpringsRanch) in Folsom.

This exceptional new community offers ranch-style luxury homes that are brand new to the Sacramento area, each boasting hundreds of design and structural options. Prices start from the $700s.

Model Home Tours

Prospective homebuyers and area agents are encouraged to stop by Stone Bluff at White Rock Springs Ranch between 10 a.m and 6 p.m. on Saturday, September 18, and Sunday, September 19, to explore the brand-new Dominc and Daniel models and learn about other available floor plans at the community.

Community Highlights:

• New homes from the $700s
• Six sought-after ranch-style floor plans
• 2 to 4 bedrooms, approx. 1,940 to 2,510 sq.ft.
• Easy access to outdoor attractions at Folsom Lake and South Lake Tahoe
• Close proximity to Palladio Shopping Center and Apple Hill

Those who choose to build a new home from the ground up at this community will have the opportunity to work with professional design consultants to select colors, textures, finishes and fixtures for their new living spaces—a complimentary service!

Stone Bluff at White Rock Springs Ranch is located at 3369 Rock Springs Ranch Drive in Folsom. Call 916.472.7392 or visit RichmondAmerican.com for more information. View health and safety updates at RichmondAmerican.com/COVID-19.

About M.D.C. Holdings, Inc.

Operating under the name Richmond American Homes, MDC’s homebuilding subsidiaries have built more than 220,000 homes since 1977. Among the nation’s largest homebuilders, MDC’s subsidiary companies have operations in Arizona, California, Colorado, Florida, Idaho, Maryland, Nevada, Oregon, Pennsylvania, Tennessee, Utah, Virginia and Washington. Mortgage lending, plus insurance and title services are offered by the following MDC subsidiaries, respectively: HomeAmerican Mortgage Corporation, American Home Insurance Agency, Inc. and American Home Title and Escrow Company. M.D.C. Holdings, Inc. is traded on the New York Stock Exchange under the symbol “MDC.” For more information, visit MDCHoldings.com.

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SOURCE M.D.C. Holdings, Inc.

SHANGHAI, Sept. 14, 2021 /PRNewswire/ — Yum China Holdings, Inc. (the “Company” or “Yum China“) (NYSE: YUMC and HKEX: 9987) today updated stakeholders on the impact of recent COVID-19 developments.

Impact of the Delta Variant Outbreak

In our second quarter 2021 earnings release, we mentioned that the latest COVID-19 outbreak of the Delta variant, which started in late July in Nanjing, was evolving quickly. Since then, this outbreak has become the most widely spread regional outbreak since the national outbreak in 2020, impacting 16 provinces. A large number of areas were identified by the government as medium to high risk. As a preventative health measure, several major cities were locked down. For example, Nanjing and Yangzhou, key cities in eastern China, the most vibrant economic region and the most important market for us, were the most affected. Zhengzhou and Wuhan, the capital cities of Henan and Hubei provinces respectively, were also significantly affected. Strict public health measures were implemented across the country, including closures of many tourist locations. These actions led to substantially lower travel volume, cancelled summer holiday trips and fewer social activities, which significantly impacted the restaurant industry.

At the peak of the outbreak in August 2021, more than 500 of our stores in 17 provinces were closed or offered only takeaway and delivery services. Same-store sales in August 2021 declined by mid-teens percentage year over year, or close to an approximately 20% decline compared to August 2019. This was mainly due to a same-store dine-in sales decline in that month of approximately 20% to 30%, and a sharp drop in sales at our transportation and tourist locations of approximately 40% to 50% year over year, also on a same-store basis.

While the outbreak has subsided in recent days and restaurant traffic is gradually recovering, our operations continue to be heavily impacted. As we have previously noted, our business recovery remains to be uneven and nonlinear, as regional outbreaks occur and corresponding public health measures are implemented. The Company expects a recovery of same-store sales to take time.

As a result of the Delta variant outbreak, the Company has experienced significant operating deleveraging, and based on the current trend, our adjusted operating profit, which excludes special items, may be reduced by approximately 50% to 60% for the third quarter of 2021, compared to the same period last year. This is primarily due to the significant sales deleverage impact from sharply reduced sales, which is especially pronounced in the third quarter, a seasonally strong quarter for sales and margins. Moreover, as we have previously discussed, our restaurant margins are further pressured by the diminishing favorable impact of commodity prices, by wage inflation of mid to high single digits, and as we step up value promotions to drive traffic.

Resiliency Helps Mitigate Short Term Challenges

Since the onset of the pandemic, the wellbeing of our employees and customers has been our utmost priority. The Company has demonstrated its resiliency and agility in responding to the past outbreaks. We will continue to focus on the elements of the business that we do best to drive sales and build on the strengths of execution and innovation, including to:

1) Leverage our over 330 million member base, privilege programs, Super Apps and other digital channels to drive repeat purchases.

2) Capture off-premise occasions with our delivery and takeaway friendly menu, as well as to leverage our store network and dedicated riders to ensure availability and coverage to drive our off-premise sales.

3) Address the rising trend of single dining and at-home consumption with our ready-to-cook, ready-to-heat and ready-to-eat retail products, such as steak, pasta and fried rice. These products are available in store as well as through online omni-channels. 

4) Excite customers with innovative new products and great value, for example, the upgraded hand-tossed pizza at Pizza Hut, which is especially suitable for delivery.

5) Proactively manage costs to alleviate cost pressures and continue to improve labor productivity and operating efficiency using technology and automation. 

Confidence in Long-Term Growth

The COVID-19 pandemic may pose volatility in the near-term, but the fundamentals of our business remain strong. We are confident in the long-term growth potential of China. We will continue to act to ensure the Company remains well-positioned to capture future opportunities. The Company will accelerate its store network expansion, expecting to open 1,300 gross new stores in 2021, strengthen offerings for dine-in, delivery, takeaway and retail, and invest in digital and technology.

Please join us at the virtual Investor Day on Thursday, September 23, 2021 (Beijing/Hong Kong Time) where management will provide additional perspective on Yum China’s business and long-term strategy. A webcast will be available at Yum China’s Investor Relations website at http://ir.yumchina.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. We intend all forward-looking statements to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally can be identified by the fact that they do not relate strictly to historical or current facts and by the use of forward-looking words such as “expect,” “expectation,” “believe,” “anticipate,” “may,” “could,” “intend,” “belief,” “plan,” “estimate,” “target,” “predict,” “project,” “likely,” “will,” “continue,” “should,” “forecast,” “outlook” or similar terminology. These statements are based on current estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we believe are appropriate and reasonable under the circumstances, but there can be no assurance that such estimates and assumptions will prove to be correct. Forward-looking statements include, without limitation, statements regarding the future strategies, growth, business plans, investment, dividend and share repurchase plans, earnings, performance and returns of Yum China, anticipated effects of population and macroeconomic trends, the expected impact of the COVID-19 pandemic, the anticipated effects of our innovation, digital and delivery capabilities and investments on growth and beliefs regarding the long-term drivers of Yum China’s business. Forward-looking statements are not guarantees of performance and are inherently subject to known and unknown risks and uncertainties that are difficult to predict and could cause our actual results or events to differ materially from those indicated by those statements. We cannot assure you that any of our expectations, estimates or assumptions will be achieved. The forward-looking statements included in this press release are only made as of the date of this press release, and we disclaim any obligation to publicly update any forward-looking statement to reflect subsequent events or circumstances, except as required by law. Numerous factors could cause our actual results or events to differ materially from those expressed or implied by forward-looking statements, including, without limitation: whether we are able to achieve development goals at the times and in the amounts currently anticipated, if at all, the success of our marketing campaigns and product innovation, our ability to maintain food safety and quality control systems, changes in public health conditions, including the COVID-19 pandemic and regional outbreaks caused by existing or new COVID-19 variants, our ability to control costs and expenses, including tax costs, as well as changes in political, economic and regulatory conditions in China. In addition, other risks and uncertainties not presently known to us or that we currently believe to be immaterial could affect the accuracy of any such forward-looking statements. All forward-looking statements should be evaluated with the understanding of their inherent uncertainty. You should consult our filings with the Securities and Exchange Commission (including the information set forth under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q) for additional detail about factors that could affect our financial and other results.

About Yum China Holdings, Inc.

Yum China Holdings, Inc. is a licensee of Yum! Brands in mainland China. It has exclusive rights in mainland China to KFC, China’s leading quick-service restaurant brand, Pizza Hut, the leading casual dining restaurant brand in China, and Taco Bell, a California-based restaurant chain serving innovative Mexican-inspired food. Yum China also owns the Little Sheep, Huang Ji Huang, East Dawning and COFFii & JOY concepts outright. In addition, Yum China has partnered with Lavazza to explore and develop the Lavazza coffee shop concept in China. The Company had 11,023 restaurants in over 1,500 cities at the end of June 2021. Yum China ranked #363 on the Fortune 500 list and was named to TIME100 Most Influential Companies list in 2021. Yum China has been named the Industry Leader for the Restaurant & Leisure Facilities Industry in the 2020 Dow Jones Sustainability Indices. In 2021, Yum China was named to the Bloomberg Gender-Equality Index and was certified as a Top Employer 2021 in China by the Top Employers Institute, both for the third consecutive year. For more information, please visit http://ir.yumchina.com.

Investor Relations Contact:
Tel: +86 21 2407 7556
[email protected]    

Media Contact:

Tel: +86 21 2407 7510
[email protected]

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SOURCE Yum China Holdings, Inc.