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DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) -- Chimerix(NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted TEMBEXA (brincidofovir) tablets and oral suspension approval for the treatment of smallpox. TEMBEXA is approved for adult and pediatric patients, including neonates.

We are delighted to report our first FDA approved products for the treatment of smallpox, particularly as the importance of pandemic preparedness has been put into focus over the last year. With this approval in hand, we now look forward to advancing our discussions with the Biomedical Advanced Research and Development Authority (BARDA) toward a procurement contract to support national preparedness, said Mike Sherman, Chief Executive Officer of Chimerix.

Chimerix developed the TEMBEXA oral formulations as medical countermeasures for the treatment of smallpox under an ongoing collaboration with BARDA, part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, under contract number HHSO100201100013C.

TEMBEXAs approval is based on efficacy data in two lethal orthopoxvirus animal models of human smallpox disease, the rabbitpox model (New Zealand White rabbits infected with rabbitpox virus) and the mousepox model (BALB/c mice infected with ectromelia virus). In the pivotal studies in each model, TEMBEXA treatment resulted in statistically significant survival benefit versus placebo following delayed treatment after animals were infected with a lethal viral dose. The FDAs Animal Rule allows for testing of investigational drugs in animal models to support effectiveness in diseases which are not ethical or feasible to study in humans. The TEMBEXA U.S. Prescribing Information has a BOXED WARNING for increased risk for mortality when used for longer duration; see below for Important Safety Information.

AboutChimerix

Chimerix is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. Most recently, the Company obtained FDA approval for brincidofovir as a medical countermeasure for the treatment of smallpox. The Company has two other advanced clinical-stage development programs, ONC201 and dociparstat sodium (DSTAT). ONC201 is currently in a registrational clinical program for recurrent H3 K27M-mutant glioma and a blinded independent central review is expected later in 2021. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia.

About Smallpox

Smallpox is a highly contagious disease caused by the variola virus. Historically, smallpox was one of the deadliest diseases in history with a case fatality rate of approximately 30%. Despite successful eradication of smallpox in the 1970s, there is considerable concern that variola virus could reappear, either through accidental release or as a weapon of bioterrorism. According to the U.S. Centers for Disease Control and Prevention (CDC), variola virus is ranked in the highest risk category for bioterrorism agents (Category A) due to its ease of transmission, high mortality rate, and potential to cause public panic and social disruption.

About TEMBEXA

TEMBEXA is an oral antiviral formulated as 100mg tablets and 10mg/mL oral suspension dosed once weekly for two weeks. TEMBEXA is indicated for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. TEMBEXA is not indicated for the treatment of diseases other than human smallpox disease. The effectiveness of TEMBEXA for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible and inducing smallpox disease in humans to study the drugs efficacy is not ethical. TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals.

TEMBEXA (brincidofovir) is a nucleotide analog lipid-conjugate designed to mimic a natural monoacyl phospholipid to achieve effective intracellular concentrations of the active antiviral metabolite, cidofovir diphosphate. Cidofovir diphosphate exerts its orthopoxvirus antiviral effects by acting as an alternate substrate inhibitor for viral DNA synthesis mediated by viral DNA polymerase.

IMPORTANT SAFETY INFORMATION Including BOXED WARNING

An increased incidence of mortality was seen in TEMBEXA-treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA was evaluated in another disease.

WARNINGS AND PRECAUTIONS

Elevations in Hepatic Transaminases and Bilirubin: May cause increases in serum transaminases (ALT or AST) and serum bilirubin. Monitor liver laboratory parameters before and during treatment.

Diarrhea and Other Gastrointestinal Adverse Events: Diarrhea and additional gastrointestinal adverse events including nausea, vomiting, and abdominal pain may occur. Monitor patients, provide supportive care, and if necessary, do not give the second and final dose of TEMBEXA.

Coadministration with Related Products: TEMBEXA should not be co-administered with intravenous cidofovir.

Carcinogenicity: TEMBEXA is considered a potential human carcinogen. Do not crush or divide TEMBEXA tablets and avoid direct contact with broken or crushed tablets or oral suspension.

Male Infertility: Based on testicular toxicity in animal studies, TEMBEXA may irreversibly impair fertility in individuals of reproductive potential.

ADVERSE REACTIONS

Common adverse reactions (adverse events assessed as causally related by the investigator in 2% of subjects) experienced in the first 2 weeks of dosing with TEMBEXA were diarrhea, nausea, vomiting and abdominal pain.

USE IN SPECIFIC POPULATIONS

Pregnancy

Based on findings from animal reproduction studies, TEMBEXA may cause fetal harm when administered to pregnant individuals. Pregnancy testing should be performed before initiation of TEMBEXA in individuals of childbearing potential to inform risk. An alternative therapy should be used to treat smallpox during pregnancy, if feasible.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things, the advancement of discussions with BARDA toward a procurement agreement for the sale of TEMBEXA to the SNS and the timing of the confirmatory response rate assessment for ONC201. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that Chimerixwill not obtain a procurement contract for TEMBEXA in smallpox in a timely manner or at all; Chimerixs reliance on a sole source third-party manufacturer for drug supply; risks that ongoing or future trials may not be successful or replicate previous trial results, or may not be predictive of real-world results or of results in subsequent trials; risks and uncertainties relating to competitive products and technological changes that may limit demand for our drugs; risks that our drugs may be precluded from commercialization by the proprietary rights of third parties; and additional risks set forth in the Company's filings with theSecurities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.

CONTACT:

Investor Relations:Michelle LaSpaluto919 972-7115ir@chimerix.com

Will OConnorStern Investor Relations212-362-1200will@sternir.com

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Chimerix Receives US Food and Drug Administration Approval for TEMBEXA - GlobeNewswire

GUANGZHOU, China, June 04, 2021 (GLOBE NEWSWIRE) -- EHang Holdings Limited (Nasdaq: EH) (EHang or the Company), the world's leading autonomous aerial vehicle (AAV) technology platform company, announced today its flagship passenger-grade AAV EHang 216 successfully performed its maiden Japan unmanned and autonomous trial flight to showcase safe, autonomous, eco-friendly urban air mobility (UAM) solutions. Ahead of the trial flight, the EHang 216 obtained a trial flight permit from the Ministry of Land, Infrastructure, Transport and Tourism of Japan (MLIT) with a local partner. EHang 216 was the first passenger-grade AAV granted permission for outdoor open airspace trial flights in Japan.

One of the trial flights was completed at the Leading the Revolution of Urban Air Mobility event, organized by the Okayama Kurashiki Mizushima Aero & Space Industry Cluster Study Group (MASC) and EHang at Kasaoka Air Station in Okayama Prefecture, Japan. Looking ahead, EHang and MASC will collaborate to further develop new air transportation use cases in Japan.

At the event, the Chief Cabinet Secretary Mr. Kato Katsunobu appointed his secretary, Mr. Sugihara Yohei, to attend the event and delivered a speech on his behalf, saying, "At present, many companies around the world have launched such flying car projects, and are conducting research and development and demonstration projects. As the government, we will actively improve aviation regulations while supporting private enterprises in a timely and appropriate manner."

Other guests included Ms. Ito Kaori, the Mayor of Kurashiki City, Okayama Prefecture, Mr. Yoshifumi Kobayashi, the Mayor of Kasaoka City, Okayama Prefecture, Mr. Inoue Mineichi, the Head of the Kurashiki Chamber of Commerce and Industry, and Mr. Sugimoto Tetsuya, the Head of Kasaoka Chamber of Commerce and Industry, etc. Mr. Hashimoto Gaku, member of the Japan House of Representatives and Mr. Narisawa Koichi, the Counselor of Civil Aviation Bureau at MLIT, sent their best regards and comments.

Mr. Hashimoto said, I am very pleased that Japans first trial flight of a flying car took place in the land of Okayama. We have high expectations for flying cars as a new generation for the growth industries. We look forward to developing flying cars as social services through public-private cooperation.

In 2018, the Japanese government established the "Public-Private Council for Air Transportation Revolution" and formulated a Roadmap towards Air Transportation Revolution. The Council aims to start the business services of air transportation of goods and people utilizing flying vehicles by 2023 with gradual expansion from rural areas to urban areas. According to the blueprint, the Civil Aviation Bureau of the MLIT is studying and improving related systems such as the type and airworthiness safety standards for flying cars and the certification of pilots.

Watch the video of the EHang 216 trial flights in Japan: https://youtu.be/2WaYLNG5zX0

About EHang EHang (Nasdaq: EH) is the world's leading autonomous aerial vehicle (AAV) technology platform company. Our mission is to make safe, autonomous, and eco-friendly air mobility accessible to everyone. EHang provides customers in various industries with AAV products and commercial solutions: air mobility (including passenger transportation and logistics), smart city management, and aerial media solutions. As the forerunner of cutting-edge AAV technologies and commercial solutions in the global Urban Air Mobility (UAM) industry, EHang continues to explore the boundaries of the sky to make flying technologies benefit our life in smart cities. For more information, please visit http://www.ehang.com.

About MASC MASC was established in 2017 as a study group for the realization of an aerospace industry cluster in the Mizushima area of Kurashiki City, Okayama Prefecture, and became a general incorporated association MASC (Kurashiki City, Okayama Prefecture, Chairman Koji Kirino) in April 2021. With the aerospace industry at its core, related industries will take on the challenge of new establishments and new businesses in Kurashiki City and the Takaryo River basin to develop local manufacturing and give "dreams" to the next generation with advanced technology that can be used. MASC regards the flying car industry as a growing industry shouldering the air mobility revolution, and will carry out substantial business activities and promote the realization of various social services. https://aerospace-kurashiki.net/

Safe Harbor Statement This press release contains statements that may constitute forward-looking statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as will, expects, anticipates, aims, future, intends, plans, believes, estimates, likely to and similar statements. Management has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While they believe these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond management's control. These statements involve risks and uncertainties that may cause EHang's actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by these forward-looking statements.

Media Contact: pr@ehang.com

Investor Contact: ir@ehang.com In the U.S.: Julia@blueshirtgroup.com In China: Susie@blueshirtgroup.com

Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/fe9f187b-200a-452b-8dbc-34e5c5000c20https://www.globenewswire.com/NewsRoom/AttachmentNg/cbf92d95-65a6-4d6c-88f7-23ac225dc6ef

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EHang 216 AAV Conducted Trial Flights in Japan - GlobeNewswire

MEMPHIS Having split the first two games against the top-seeded Jazz in a series that now shifts to FedExForum, these gritty and growing Grizzlies have discovered a few things about themselves in their first foray into the NBA playoffs.

That list includes a formula for success.

Were trying to educate our guys through the numbers and through the film, coach Taylor Jenkins insisted as the Grizzlies close in on a pivotal Game 3 at home Saturday night. We know what our recipe can be to beat this team. Its hard. Youve got to be committed to it for 48 minutes on both sides of the floor. Were capable. We just have to find that gear.

As the youngest team in the NBA playoffs, the Grizzlies are very much a work in progress as they navigate the choppy waters of the postseason against a veteran Jazz team that secured the leagues best record this season. Yet make no mistake about it these NextGen Grizzlies are committed to making the absolute most of the moment right now.

Fueled by a competitive feistiness, a collective defiance, one of the NBAs most dynamic young stars in 21-year-old Ja Morant and a group of mid-career vets in the midst of career seasons, the Grizzlies are just in this series against Utah.

Theyve clawed their way into position to take control of it.

We know what our recipe can be to beat this team. Its hard. Youve got to be committed to it for 48 minutes on both sides of the floor. Were capable. We just have to find that gear.

Heading into the franchises first home playoff game in four years, the Grizzlies are leaning on their relentless effort and an expected raucous environment at FedExForum to push them forward on an improbable postseason run. The last time the Grizzlies were at home, they used a 27-4 early spurt to blitz the Spurs on the way to a win in the opener of the Play-In Tournament. From there, Memphis knocked off the Warriors on the road to secure the No. 8 and final playoff seed in the West to face the No. 1-seeded Jazz.

After stealing Game 1 and sending a clear message that they wont be a pushover in Game 2, the Grizzlies hope to bounce back from Wednesdays 141-129 loss that featured a historic, franchise-record 47-point performance from Morant.

Its been a rapid rise into playoff contention for Memphis. The organization is just two years removed from selecting Morant with the No. 2 overall pick to boost a reset that began the previous year when the team drafted Jaren Jackson Jr. fourth overall.

Now, after a 38-34 regular season finish that marked their first winning record in four years, the Grizzlies will enter their home arena staring down the top team in the NBA with a healthy respect, but no hint of fear.

I expect a lot of energy, said Morant, whose 73 points in this series are most in NBA history through a players first two playoff games. Playing against Spurs recently, the gym was very loud, there was a lot of energy and we fed off that. Im happy were home and can feed off our home crowd. Hopefully they return the boos Utah was giving us, and we just play hard.

Playing hard hasnt been an issue for the Grizzlies. Playing consistently and efficiently, especially on the defensive end, is the priority going into Game 3 after surrendering 141 points in Game 2.

All-Star guard Donovan Mitchells return from an ankle injury for Game 2 boosted a Utah offensive attack that produced 19 made three-pointers, 25 made free throws and placed seven scorers in double figures. The Jazz executed their vaunted pick-and-roll sets to build a 22-point lead before the Grizzlies fought their way back with a 43-point outburst in the third quarter.

Playing against Spurs recently, the gym was very loud, there was a lot of energy and we fed off that. Im happy were home and can feed off our home crowd. Hopefully they return the boos Utah was giving us, and we just play hard.

Foul trouble has limited some of the Grizzlies key starters in each of the two games in Utah. Grizzlies center Jonas Valanciunas believes adjusting to the physicality and nature in which playoff games are officiated is a priority entering Game 3.

Theyre tough because theyre shooting threes out of pick-and-rolls, and theyve got decent big guys who can roll, so its a tough job to stop that, Valanciunas said. But weve got to do a better job of (defending) that play and taking away something.

Being available and staying on the court will be crucial to an improved defense for both Valanciunas and Jackson, who are essential in the Grizzlies quest to protect the rim.

We have to be smarter with our hands, cant gamble as much, Jackson Jr. said. Depending on how theyre calling the game, we have to be prepared for what were getting into. Weve got to communicate more. Theyre a team that moves the ball really fast, theyre cutting everywhere. So weve got to be aware of who the scorers are when theyre out there, really key in on that. The games are about adjustments and communicating. Weve got to handle that.

Jenkins would like to see his team get back to the blueprint from Game 1, when the defense was disruptive and generated a combined 29 steals and deflections in a 112-109 win to open the series. In that game, the Jazz missed 35 of 47 attempts from three-point range.

Offensively, Jenkins wants the Grizzlies to get back to pushing in transition and limiting possessions when they go against a stacked Jazz defense in halfcourt sets.

Depending on how theyre calling the game, we have to be prepared for what were getting into. Weve got to communicate more. Theyre a team that moves the ball really fast, theyre cutting everywhere. So weve got to be aware of who the scorers are when theyre out there, really key in on that. The games are about adjustments and communicating. Weve got to handle that.

Were taking the necessary feedback from one game to apply it to the next, Jenkins said of necessary adjustments. Its definitely heightened more now. Its the chess match. But its a first-time experience for many of our guys to go through this, and attention to detail changes from one game to the next. But you have to be who you are, your focus has to be there, your edge has to be there as it changes now from Game 2 to Game 3.

Staying in this postseason fight requires maximizing the moment.

The Grizzlies are geared up to go hard for their home fans.

Not only do we deserve it, but the fans deserve it, guard DeAnthony Melton said of seizing the opportunity to take control of the series. Memphis feeds off this type of energy and these type of games. I feel these next two games are really important. We just have to keep attacking with full force. If we have our discipline, you never know whats going to happen.

These Grizzlies arent just here to learn the intricacies of NBA playoff basketball.

From the comforts of home this weekend, theyll have a chance to lead.

The contents of this page have not been reviewed or endorsed by the Memphis Grizzlies. All opinions expressed by Michael Wallace are solely his own and do not reflect the opinions of the Memphis Grizzlies or its Basketball Operations staff, owners, parent companies, partners or sponsors. His sources are not known to the Memphis Grizzlies and he has no special access to information beyond the access and privileges that go along with being an NBA accredited member of the media.

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MikeCheck: Hyped and home, Grizzlies eager to seize control of series against top-seeded Jazz - Grizzlies.com

WHAT: Delayed by a year, students who graduated in 2020 will finally get their chance to experience the time-honored tradition of walking in their Washington University in St. Louis Commencement.

The 2020 universitywide Commencement ceremony was canceled in the midst of the pandemic. The university recognized the Class of 2020s graduation through online ceremonies and celebrations last May.

WHO: Julie L. Gerberding, MD, the first woman to serve as director of the Centers for Disease Control and Prevention, will deliver the address to the returning graduates at each of the three ceremonies.

More than 1,300 members of the Class of 2020 will be back on campus to take part in the ceremonies, and more than 160 will join virtually.

WHERE: Francis Olympic Field, at Forsyth Boulevard and Olympian Way, near Big Bend Boulevard

WHEN: Sunday, May 30. The university is holding three ceremonies beginning at 8:30 a.m. The morning and noon ceremonies will be for those who earned undergraduate degrees, divided in alphabetical order by last name. A ceremony at 3:30 p.m. is for graduate and professional schools graduates.

For a list of ceremonies and times, visit the Commencement website.

NOTE: Please call Sue Killenberg McGinn at 314-603-6008 if you plan to cover any of the ceremonies.

Per guidance from the universitys COVID Monitoring Team and thelocal health department, both of which advise wearing masks in large group situations, the university still will require masking for all guests.

MEDIA PARKING: Parking will be available on the surface parking lot directly east of the Athletic Complex. Enter from Forsyth Boulevard at Olympian Way.

Interview some graduates

Last spring, 15 graduating students who embodied the spirit of the Class of 2020 were profiled. Visit The Source to read these postcards of appreciation to a sampling of undergraduate, graduate and professional students who contributed to the Washington University and St. Louis communities.

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MEDIA ADVISORY: Washington University's delayed in-person Commencement ceremonies for Class of 2020 | The Source | Washington University in St. Louis...

A video of Brooks Koepka getting annoyed at Bryson DeChambeau during an interview has turned into a viral meme on Twitter, and even Tom Brady has joined in.

The Denver Broncos social media team decided to enter the meme conversation on Wednesday, showing their reaction to fans voicing their desire to bring in a new quarterback.

pic.twitter.com/FkCvXnOXam

Denver Broncos (@Broncos) May 26, 2021

Some fans werent happy with the tweet.

yea the ole boo the fans for wanting to have a good qb

Talkin Jake (@TalkinJake) May 26, 2021

We couldve drafted a franchise qb on justin fields, but no, lOCk iS OUr gUy We better trade for rodgers

Math Perez (@matheeusperez_) May 26, 2021

interesting position considering the

*checks tally marks carved into upper arm*

four losing seasons in a row

Cal (@UppercutOf) May 26, 2021

Ruining a perfectly good meme right at its apex, nice

Ryan Neumann (@neumdawg) May 26, 2021

So the Broncos annoyed at the fans who want to see a winning season? Right right right

Jen B (@Jb84107) May 26, 2021

Osweiler, Siemian, Lynch, Keenum, Flacco, Lock, Bridgewater Wonder why fans want to get a competent QB in the building, huh, @Broncos ? https://t.co/7vBhSiNLrr

Guillermo Azuara (@AzuaraGuillermo) May 27, 2021

lol says the team who tried to trade for Stafford, was in on Deshaun Watson and traded for Teddy Bridgewater. https://t.co/vqW9mYlB8f

Richie Carni (@RichieCarni) May 26, 2021

Maybe the last thing the Broncos should be doing is mocking fans that would just like to see some competent QB play on the field, but thats none of my business https://t.co/iajXZmPaW7

Adam Malnati (@AdamMalnati16) May 26, 2021

Not all fans were upset by the meme, and some fans showed support for the social media team.

The broncos fans in the comments pretending the social media team has any control over the roster is literally proving the point of the tweet https://t.co/ETN4IQOhXN

Patrick (@patrickadawson1) May 27, 2021

I think Broncos fans missed the point of this tweet, its saying the media team has no control over trades and draft picks. https://t.co/7Vx51whYVG

Tyler Gaynor (@tyler_sgaynor) May 26, 2021

W Broncos social media need more lighthearted content like this

Nick (@MileHigh_Nick) May 26, 2021

Its not the social media teams fault either. Thats the whole point of the post. Has nothing to do with yall wanting a qb lol.

Dalton Schoenberger (@djschoen24) May 26, 2021

Theyre rolling their eyes at the fact that 1) the social media team has no control over this and 2) literally any post they make gets completely inundated with those comments regardless of what the post is about

Mark Harbison (@darthharbison) May 26, 2021

Well done Broncos!!

Broncos Outsider (@BroncosOutside) May 26, 2021

The rest is here:
Broncos joined viral Twitter meme trend, but not every fan liked it - Broncos Wire