FDA approves Epizyme’s treatment for epithelioid sarcoma

Epizyme (NASDAQ:EPZM) says the Food and Drug Administration granted accelerated approval of its Tazverik (tazemetostat) treatment for the patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma, a rare, slow-growing type of cancer.

The company says continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.

Tazverik, Epizyme’s lead drug candidate, also is in multiple clinical trials for other types of cancer including follicular lymphoma, which is under review by the FDA.

https://seekingalpha.com/news/3534219-fda-approves-epizymes-treatment-for-epithelioid-sarcoma

Coronavirus scare shutters Shanghai Disney

Shanghai Disneyland (NYSE:DIS) will be closed from Saturday to help prevent the spread of a deadly coronavirus that broke out in the Chinese city Wuhan.

It’s a crucial time for the theme park, with China on a seven-day Lunar New Year holiday starting Friday.

Last year, Shanghai Disney had to stop selling tickets to visitors as the park was overcrowded.

https://seekingalpha.com/news/3534237-coronavirus-scare-shutters-shanghai-disney

Community Health prices debt offering

Community Health Systems (NYSE:CYH) has priced its $1.462B aggregate principal amount of 6.625% Senior Secured Notes due 2025 at par.

The size of the offering was increased by ~$442M.

Net proceeds will be used to purchase 5.125% Senior Secured Notes due 2021, redeem the remaining 2021 Notes, purchase in one or more privately negotiated transactions or redeem ~$425.5M 6.250% Senior Secured Notes due 2023 and pay related fees and expenses.

The sale of the Notes is expected on February 6.

https://seekingalpha.com/news/3534266-community-health-prices-debt-offering

Ipsen hits potential roadblock with palovarotene

Ipsen (OTCPK:IPSEY) has suspended dosing in its Phase 3 clinical trial, PVO-1A-301, evaluating palovarotene in patients with fibrodysplasia ossificans progressiva (FOP) as well as its Phase 2 extension studies, PVO-1A-202 and PVO-1A-204, after a futility analysis by the Independent Data Monitoring Committee (IDMC) showed that the late-stage study was unlikely to meet the primary endpoint.

Citing “signs of encouraging therapeutic activity” in preliminary post-hoc analyses of the 301 trial, the company will conduct further assessments of the dataset. The IDMC did not recommend terminating the study. It noted that the highly contrasting data precluded a confident conclusion about futility.

The FDA’s partial clinical hold for the pediatric population under the age of 14 for FOP and multiple osteochondromas instituted on December 4, 2019, remains in effect (suspended further enrollment).

Management will provide updated guidance next month with its earnings announcement.

Ipsen acquired the rights to palovarotene via its acquisition of Clementia Pharmaceuticals in April 2019.

https://seekingalpha.com/news/3534282-ipsen-hits-potential-roadblock-palovarotene

Tonix Pharma up 42% premarket on advancement of TNX-102 SL

Tonix Pharmaceuticals (NASDAQ:TNXP) has completed fed-fasting and dose proportionality tests of TNX-102 SL in healthy volunteers, data that, it says, should satisfy the pharmacokinetic requirements for its U.S. marketing applications for posttraumatic stress disorder (PTSD) and fibromyalgia.

Preliminary data showed no significant effect from a fatty meal on the rate or extent of absorption of TNX-102 SL 5.6 mg administered as 2 x 2.8 mg sublingual tablets.

Observed dose proportionality confirmed the prototype 2.4 mg formulation.

Shares up 42% premarket.

https://seekingalpha.com/news/3534291-tonix-pharma-up-42-premarket-on-advancement-of-tnxminus-102-sl

Walmart debuts gym memberships for a ‘$9 a paycheck’

The average gym membership costs about $700 annually. Walmart’s is a lot cheaper.
The retailer, which brought in $514 billion in revenue in 2019, announced it’s rolling out gym memberships to its 1.5 million U.S. employees and their families starting a $9 a paycheck, which is about $234 a year based on 26 paychecks annually.
A Walmart spokesperson confirmed to FOX Business that employees are paid bi-weekly.
Users can visit Walmart’s gym page to find access to 9,000 facilities in all 50 states.
“We’re committed to providing associates and their families access to high-quality medical coverage along with tools and resources to manage their health and well-being,” Senior Vice president of U.S. Benefits Adam Stavisky said in a statement “The Walton Life Fitness Pass is another example of how we’re working to help our associates and their families.”

Walmart’s gesture is not uncommon for big companies that want to keep their employees happy. Earlier this week, airline Delta announced it would give its 90,000 employees a bonus worth about two months’ salary on Valentine’s Day, a total value of $1.6 billion.
Walmart’s stock is up more than 17 percent on the year.
https://www-foxbusiness-com.cdn.ampproject.org/c/s/www.foxbusiness.com/lifestyle/walmart-debuts-gym-memberships-for-a-9-a-paycheck.amp

Schools, Tourist Sites Shut Down as Virus Spreads to Nearly All Parts of China

Eight Chinese city governments announced on Jan. 23 that they have initiated a quarantine to curb the outbreak of a new type of viral pneumonia.

Major sightseeing locations were also shut down by local authorities to avoid mass gatherings of people as the disease, caused by a new strain of coronavirus, continues to spread.

Meanwhile, five more provinces announced their first diagnosed cases—meaning the only regions that remain free of the disease are Qinghai and Tibet.
We are now seeing second and third generation spread,” Dr. David Heymann, assistant director-general for Health Security and Environment at the World Health Organization (WHO), told CNN on Thursday.
Heymann explained that patients infected after handling animals at the fresh food market in Wuhan that is linked to the outbreak belong to the first generation. Patients who were infected through contact with an initial patient, belong to the second or third generation.
Heymann warned that now the virus can spread through contact with an infected person who is  sneezing or coughing.

Quarantined Cities

The central Chinese city of Wuhan, where the outbreak started in December, has 11 million residents. Beginning at 10 a.m. Thursday local time, the city was under lockdown, with all public transportation, including subways, ferries, and intercity buses suspending operations. The city’s airports and train stations were also closed.
A few hours later, governments of nearby cities within Hubei Province—Huanggang, Ezhou, Chibi, Zhijiang, Xiantao, Lichuan, and Qianjiang—also announced their quarantines.
Huanggang City health authorities said that all theaters, internet bars, indoor entertainment sites, and resorts will also be closed.
Also on Thursday, the Hubei provincial education bureau announced that it would postpone the start of the new school term for all primary and middle schools in the province.

Closings

Worried that the virus can easily spread in crowded places, local governments around China also closed down famous tourist sites.
In the capital Beijing, the administrators of Forbidden City announced that the museum will be closed indefinitely beginning on Jan. 25.
Near Beijing, the Tanzhe and Jietai temples; Miaofeng Mountain, a Taoist site of worship; and other tourist sites would also be closed beginning Jan. 24.
During the Lunar New Year festivities, when the entire country goes on public holiday from Jan. 24 to Jan. 30, people often go to temples to burn incense and wish for good luck in the new year.
Hangzhou is the capital city of Zhejiang Province, a scenic town and one of China’s hottest tourist destinations. On Jan. 23, the city government announced that all major sightseeing locations, temples, and museums would be closed from Jan. 24.
On the same day, the Central Academy of Fine Arts in Beijing and Shanghai University announced that due to the new disease, college entrance examinations for prospective students that were planned for February would be postponed. The schools said they will notify students when they decide on a future date.
https://www.theepochtimes.com/chinese-authorities-shut-down-schools-tourist-sites-as-viral-pneumonia-spreads-to-nearly-all-parts-of-china_3214253.html