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Chimerix

Chimerix Inc. is a biopharmaceutical company based in the United States that engages in the research, development, and commercialization of medicines. Its portfolio includes treatment for acute myeloid leukemia (or AML) and antiviral treatment for smallpox. The company generates revenue through revenue related to non-refundable upfront fees, royalties and milestone payments earned under license agreements, also by royalty revenue related to sales of TEMBEXA made by Emergent after the Asset Sale. The company operates only in one business segment namely pharmaceuticals.

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WHO Expands Emergency Use List For Mpox Diagnostics, Adds Cepheid's Xpert Mpox PCR Test And Roche's Cobas MPXV Assay As PCR-Based Gold Standard Options

<a href="https://pasadenanow.com/main/mpox-cases-double-in-los-angeles-county-health-officials-urge-vaccination#:~:text=Los%20Angeles%20County%20health%20officials,the%20previous%20four%2Dweek%20period.">https://pasadenanow.com/main/mpox-cases-double-in-los-angeles-county-health-officials-urge-vaccination#:~:text=Los%20Angeles%20County%20health%20officials,the%20previous%20four%2Dweek%20period.</a>
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Los Angeles County health officials are reporting a significant uptick in mpox cases, prompting renewed calls for vaccination among&nbsp;high-risk&nbsp;groups.
The County's Department of Public Health announced that 52 mpox cases were reported in the past four weeks, compared to 24 in the previous&nbsp;four-week&nbsp;period.&nbsp;
About 70% of new cases in the last six months occurred in&nbsp;unvaccinated&nbsp;individuals.
Health officials strongly recommend vaccination for several high-risk groups, including men and transgender people who have sex with men or transgender persons, persons of any gender or sexual orientation who have sex or intimate physical contact with others in association with large public events or engage in commercial and/or transactional sex, and those living&nbsp;with&nbsp;HIV.
"Vaccination is an important tool in preventing the spread of mpox," the County health department said in a statement. The two-dose JYNNEOS vaccine is available at pharmacies for insured residents and at Los Angeles County Department of Public Health Clinics for free&nbsp;without&nbsp;appointments.
Officials advise residents to practice safe sex, limit sexual partners, and avoid intimate contact with anyone showing mpox symptoms, which include rash, fever, and swollen lymph nodes. Additional prevention measures include asking partners about symptoms, reducing the number of partners, and proper use of condoms&nbsp;and&nbsp;gloves.
The County emphasizes the importance of testing for those who develop symptoms consistent with mpox. The Department of Public Health is collaborating with healthcare providers and community organizations to intensify surveillance, contact tracing, and outbreak investigations to&nbsp;curb&nbsp;transmission.
Mpox, previously referred to as Monkeypox, is mainly spread through close physical contact. Residents seeking more information can visit<a href="http://ph.lacounty.gov/mpox"> ph.lacounty.gov/mpox</a> or call the Department of Public Health Call Center&nbsp;at&nbsp;1-833-540-0473.

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'Mpox Cases Double In Los Angeles County, Health Officials Urge Vaccination; Los Angeles County Public Health Officials Report Increase, Recommend Prevention Measures' - Pasadena Now

<a href="https://www.youtube.com/watch?v=ZFW3ONApp4w" title="https://www.youtube.com/watch?v=ZFW3ONApp4w">https://www.youtube.com/watch?v=ZFW3ONApp4w</a>

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Biden On Sudan Says End This War Now; Let's Move Quickly To Face Mpox Outbreak In Africa

CDC Says No Cases Of Clade IA Mpox Have Been Reported Outside Central African Countries Where Clade IA MPVX Is Endemic

<a href="https://www.ema.europa.eu/en/news/ema-recommends-extending-indication-mpox-vaccine-adolescents#:~:text=EMA%20has%20recommended%20extending%20the,the%20vaccinia%20virus%20in%20adults.">https://www.ema.europa.eu/en/news/ema-recommends-extending-indication-mpox-vaccine-adolescents#:~:text=EMA%20has%20recommended%20extending%20the,the%20vaccinia%20virus%20in%20adults.</a>
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EMA has recommended extending the indication of the smallpox and mpox vaccine <a href="https://www.ema.europa.eu/node/65501">Imvanex</a> to adolescents from 12 to 17 years of age.
Imvanex is already authorised in the European Union (EU) to protect against smallpox, mpox and the disease caused by the vaccinia virus in adults. It contains a live, highly weakened form of a virus called "modified vaccinia virus Ankara" (MVA-BN), which is related to the smallpox virus. EMA's human medicines committee (CHMP) based the recommendation to extend the use of Imvanex to adolescents on the <a href="https://www.clinicaltrials.gov/study/NCT05740982">interim results of a study</a> that compared the vaccine's ability to generate an immune response (produce virus-specific antibodies) in 315 adolescents and in 211 adults.
The immune response in adolescents was similar to adults. Therefore, it is inferred that the vaccine will provide similar protection in adolescents to that expected in adults. According to the submitted data, the safety profile of Imvanex in adolescents was comparable to that seen in adults and no additional risk has been identified. As part of its recommendation, EMA has requested the marketing authorisation holder to submit the final results of the study by 30 May 2025 to further characterise the information about safety in adolescents.
The Agency's assessment has important implications for the global response to the mpox outbreak in the Democratic Republic of the Congo (DRC) and other countries, which was <a href="https://www.who.int/news/item/14-08-2024-who-director-general-declares-mpox-outbreak-a-public-health-emergency-of-international-concern">declared a public health emergency of international concern (PHEIC)</a> by the World Health Organization (WHO) on 14 August 2024.
EMA is the regulatory agency of record for <a href="https://www.who.int/news/item/13-09-2024-who-prequalifies-the-first-vaccine-against-mpox">prequalification of this vaccine by WHO</a> on 13 September 2024. This means that CHMP's assessment constitutes the basis for WHO prequalification approval to facilitate timely and increased access to this vaccine in communities with urgent need. Previously, EMA's assessment was also taken into account by the national regulatory authority of the DRC in the fast-track approval of the vaccine. In addition, WHO has cooperated in EMA's assessment of the extension of indication in adolescents, a population that is particularly vulnerable to mpox.
Mpox is a disease that is transmitted to people by animals, mainly rodents, but can also spread between people with direct contact. It is endemic in certain parts of Central and West Africa. The current surge in cases in the DRC and several neighbouring countries is driven by the mpox clade I strain that is known to cause a more severe form of mpox in humans than the mpox clade II strain that spread during the 2022/2023 PHEIC. Mpox can be fatal for people with weak immune systems.
Data indicate that Imvanex protects against both the clade I and clade II mpox strains.
In the EU, decisions on how vaccinations should be given are the prerogative of the expert bodies guiding vaccination campaigns in each Member State. The European Centre for Disease Prevention and Control (ECDC) <a href="https://www.ecdc.europa.eu/en/infectious-disease-topics/mpox/rapid-scientific-advice-public-health-measures-mpox-2024">published advice for public health authorities for mpox</a> on their website.

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'EMA Recommends Extending Indication Of Mpox Vaccine To Adolescents' - EMA

Morocco Records First Case Of Mpox

CDC Says There Have Been No Reported Cases Of Clade I Mpox In The U.S. As Of September 6; In The U.S., Clade II Mpox Is Still Circulating At Low Levels

<a href="https://www.nbcnews.com/health/health-news/us-prepares-possible-arrival-severe-strain-mpox-rcna169926">https://www.nbcnews.com/health/health-news/us-prepares-possible-arrival-severe-strain-mpox-rcna169926</a>
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Senior Biden administration officials said Friday that the United States is preparing for the possible arrival of <a href="https://www.nbcnews.com/health/health-news/mpox-strain-spreads-cdc-who-stronger-warnings-rcna165155">a more severe version of mpox</a>, which has taken off in the Democratic Republic of Congo and other countries in Africa resulting in more than 600 deaths there.
As of Thursday, there have been more than 24,800 reported cases of this version of the virus, <a href="https://www.nbcnews.com/health/health-news/mpox-virus-outbreak-symptoms-2024-spread-rcna166778">known as clade 1</a>, so far this year, the World Health Organization said at a separate briefing Friday.&nbsp;The WHO declared the outbreak a<a href="https://www.nbcnews.com/health/health-news/who-declares-mpox-global-public-health-emergency-second-time-rcna166601"> global health emergency</a> in August.
Last month,<a href="https://www.nbcnews.com/health/health-news/sweden-confirms-first-case-mpox-strain-congo-rcna166763"> Sweden confirmed a case of clade 1</a>, the first known case outside of Africa, followed by a case in Thailand several days later. Both patients had spent time in Africa.
A different version of mpox, clade 2, triggered a global outbreak in 2022 and a surge of cases in the U.S. Clade 1 is more severe and can kill up to 10% of people infected, though recent death rates have been around 1% to 3.3%, <a href="https://www.cdc.gov/poxvirus/mpox/about/index.html">according to the CDC.</a>
On a call with reporters, senior administration officials said that as infections have risen in Africa, the U.S. has been gearing up for its own cases.&nbsp;
"We've been preparing for the arrival of clade 1 in the United States for many months now, especially as we saw the outbreak in DRC and neighboring countries accelerate," one official said.
The government is expanding its mpox surveillance efforts, primarily through wastewater analysis, and is reaching out to the medical community to educate members on what to watch for, including the severity of clade 1 and how it spreads, according to officials.
Officials said they're also making sure testing is more widely available.
Any doctor in the U.S. can order an mpox test that can be run through a national laboratory. If positive, it can be tested for clade 2. If those results are negative for clade 2, the doctor can make a presumptive diagnosis of clade 1; that diagnosis will need to be officially confirmed by the Centers for Disease Control and Prevention, according to officials.
The Jynneos mpox vaccine, given in two doses, is effective against both clade 1 and clade 2 of mpox.
The CDC's vaccine recommendation remains limited to anyone who is considered at high risk of catching the virus, mainly gay and bisexual men.&nbsp;
Most people with health insurance can get the vaccine at major pharmacy retail chains including CVS and Walgreens, the officials said. The vaccine is also available for free at public health departments and community health centers.
More vaccines are being held in the U.S. national stockpile, officials said, although they declined to say how many.&nbsp;
"There is a sufficient amount of vaccine for the U.S. population," an official said.&nbsp;
The U.S. is also working with government scientists and drug companies to develop potential new treatments. There are currently no approved treatments for mpox. The Food and Drug Administration has approved an antiviral treatment known as TPOXX for smallpox, which is closely related to mpox, although a recent clinical trial found that the drug is <a href="https://www.nih.gov/news-events/news-releases/antiviral-tecovirimat-safe-did-not-improve-clade-i-mpox-resolution-democratic-republic-congo">not effective against clade 1</a>.&nbsp;

'U.S. Prepares For Possible Arrival Of More Severe Strain Of Mpox; There Have Been Nearly 25,000 Cases Of The Clade 1 Version Of Mpox In Africa So Far This Year" - NBC

<a href="https://ec.europa.eu/commission/presscorner/detail/en/ip_24_4523">https://ec.europa.eu/commission/presscorner/detail/en/ip_24_4523</a>
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Today, close to 100,000 mpox vaccine doses will arrive in the Democratic Republic of Congo (DRC), making these the first delivery of the vaccine to the country. A second delivery amounting to around 100,000 vaccines is expected to arrive in the coming days.
These vaccines are part of the 215,000 MVA-BN&#xAE; <a href="https://ec.europa.eu/commission/presscorner/detail/en/ip_24_4244">vaccine doses</a> that the European Commission's Health Emergency Preparedness and Response Authority (HERA) procured and pledged to share to affected countries in Africa as an immediate response to the mpox outbreak.
Via Team Europe, an additional 351,500 of doses from France, Germany, Spain, Malta, Portugal, Luxembourg, Croatia, Austria, Poland, and potentially some other Member States, will be donated to the Africa CDC to distribute to affected countries. This brings the total number of vaccine doses donated from Team Europe to at least 566,500, which includes the above 215,000 doses that were donated by HERA in cooperation with the Bavarian Nordic pharmaceutical company.
EU support for the mpox outbreak
This initiative is part of a comprehensive set of EU actions put in place as part of the EU Global Health Strategy, which represents the external dimension of a strong European Health Union and is a key component of Global Gateway, to support partners in the rest of the world.
The Commission is actively coordinating the response of EU Member States to the mpox outbreak via regular meetings of the HERA Board and the Health Security Committee, which allows prompt coordination when dealing with health threats.
The Emergency Response Coordination Centre (ERCC) is in contact with EU Member States given that, if activated, the EU Civil Protection Mechanism (rescEU) can be used to channel mpox vaccines and therapeutics to countries in need. Specialised expertise, medical items and equipment could also be deployed based on these needs.
Under the Global Gateway investment strategy, the Commission is committed to advancing public health in Africa. The Commission has focused on strengthening health systems, securing pharmaceutical supply chains, and developing local manufacturing through investment in infrastructure and a supportive regulatory environment. An example of this is the Team Europe Initiative on manufacturing and access to vaccines, medicines and health technologies (Mav+) and on Sustainable Health Security.
The European Centre for Disease Prevention and Control (ECDC) is supporting epidemiological work on the ground in the DRC, working with the Africa CDC to identify priority areas for mpox research, and is leading coordination of the Network of Major CDCs globally. HERA is also working with the Africa CDC with the aim of expanding access to mpox diagnostics and sequencing in the region, with a €9.4 million grant foreseen for early autumn.
The Commission has released €1 million in humanitarian aid to support care, prevention, epidemiological surveillance, risk communication and distribution of kits in the eastern DRC as well as €200,000 in Burundi to assist the Burundi Red Cross in preparing for and responding to the epidemic. Under the European Humanitarian Response Capacity (EHRC), in cooperation with the ECDC, two epidemiologists were deployed on 4 September to the DRC. In addition, the Commission provides regular humanitarian funding for surveillance programmes, including in Uganda and Kenya's camps and settlements and expertise to assist in the response.

'First Delivery Of Mpox Vaccine Doses From The Commission Arrive Today In The Democratic Republic Of Congo' - European Commission

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WHO Chief Tedros Says Mpox Vaccines Could Be Ready For Emergency Use Listing Within Two Weeks; Some Mpox Vaccines Expected To Arrive In Congo In The Next Few Days

WHO Chief Tedros Says Received First Expression Of Interest For Emergency Use Listing From Mpox Diagnostics Manufacturer; WHO Officials Discuss Polio Vaccination Plan In Gaza, Confirm Applications From Bavarian Nordic And KM Biologics For Mpox Vaccines Emergency Use Listing, And Announce 230,000 Doses Available For Congo

CDC Says Clade I Mpox Outbreak Originating In Central Africa; Risk Of Mpox Coming Into U.S. Is Low; No Cases Of Clade I Mpox Have Been Reported In The U.S. At This Time; Best Protection Against Mpox Is Two Doses Of Jynneos Vaccine If Eligible; Working With Other U.S. Government Agencies & Partners On Strategy For Vaccination In Democratic Republic Of Congo

<a href="https://www.reviewjournal.com/life/health/mpox-case-reported-at-clark-county-detention-center-3148320/">https://www.reviewjournal.com/life/health/mpox-case-reported-at-clark-county-detention-center-3148320/</a>
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One case of mpox has been reported at the Clark County Detention Center, according to the Metropolitan Police Department.
While police were unable to confirm which date the case was reported, Metro said it was during the week of August 19.
The person with mpox, which is formerly known as monkeypox, is no longer in custody, police said Tuesday, adding that there were no other reported cases.
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According to the Centers for Disease Control, the virus is part of the same family as the virus that causes smallpox. Symptoms commonly include a rash that scabs before healing.
The disease can be spread between animals and people, the <a href="https://www.cdc.gov/poxvirus/mpox/about/index.html">CDC</a> website reads. It is spread through skin-to-skin contact.

Reported August 27, 2024 'Mpox Case Reported At Clark County Detention Center' - Las Vegas Review-Journal

WHO Launches Global Strategic Preparedness And Response Plan To Contain Mpox Outbreak

<a href="https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-member-states-information-session-on-mpox-23-august-2024">https://www.who.int/director-general/speeches/detail/who-director-general-s-opening-remarks-at-member-states-information-session-on-mpox-23-august-2024</a>
Honourable Ministers, Excellencies, dear colleagues and friends,
Good morning, good afternoon and good evening to all Member States, and thank you for joining us once again.
Since the start of the global mpox outbreak in 2022, more than one hundred thousand confirmed mpox cases have been reported to WHO.
The virus continues to circulate at low levels globally.
The African Region has had an unprecedented increase and geographical expansion.
Transmission is now centred in the Democratic Republic of the Congo, with 90% of the reported cases in 2024. There have been more than sixteen thousand suspected cases - including 575 deaths - this year alone.
This upsurge is being driven by two separate outbreaks – in different parts of the country - of two strains, or clades, of the virus that causes mpox.
The rapid spread of a new clade, clade 1b, is the main reason for my decision to declare a public health emergency of international concern, following the International Health Regulations Emergency Committee meeting on the 14th of August 2024.
I issued temporary recommendations five days later.
In the past month, cases of clade 1b have been reported in four countries neighbouring DRC, which had not reported mpox before: Burundi, Kenya, Rwanda and Uganda.
This week, cases have also been reported in Thailand and Sweden.
WHO and partners have developed a Global Mpox Strategic Preparedness and Response Plan to stop outbreaks of human-to-human transmission of mpox through coordinated global, regional, and national efforts.
The plan focuses on implementing comprehensive surveillance and response strategies; advancing research and equitable access to medical countermeasures; minimizing zoonotic transmission; and empowering communities to actively participate in outbreak prevention and control.
At the global-level, the emphasis is on strategic leadership, timely evidence-based guidance, and access to medical countermeasures for the most at-risk groups in affected countries.
We are working with a broad range of international, regional, national and local partners and networks to enhance coordination across key areas of preparedness, readiness and response.
This includes engagement with the Act-A Principals group; the Standing Committee on Health Emergency Prevention, Preparedness and Response; the R&amp;D Blueprint for Epidemics; and the i-MCM Net.
WHO regional offices have also established Incident Management Support Teams – IMSTs- to lead preparedness and response activities, and we are significantly scaling up staff in affected countries.
Within the Africa Region, where need is greatest, the WHO Regional Office for Africa, in collaboration with Africa CDC, will jointly spearhead the coordination of mpox response efforts.
Together, WHO AFRO and Africa CDC have agreed on a one-plan, one-budget approach as part of the Africa Continental Mpox Strategic Preparedness and Response Plan.
At the national and sub-national level, health authorities will adapt strategies to current epidemiological trends.
Let me be clear: this new mpox outbreak can be controlled and can be stopped.
Doing so requires concerted action between international agencies and national and local partners, civil society, researchers and manufacturers, and you, our Member States.
As with all global health actions, our approach must adhere to the principles of equity, global solidarity, community empowerment, human rights, and coordination across sectors.
For today's presentation, on behalf of the mpox IMST, Dr Maria Van Kerkhove and Scott Pendergast will present an overview of the temporary recommendations; actions being taken by WHO, Member States and partners; and an overview of the Global Mpox Strategic Preparedness and Response Plan.
Responding to this complex outbreak requires a comprehensive and coordinated international response.
To fund this work and to stop the outbreak as quickly as possible, our initial estimates are that the SPRP requires approximately US$ 135 million over the next six months for the acute phase of the outbreak.
That amount will likely increase as we update the plan in light of growing needs.
A dedicated WHO funding appeal will be released early next week. We are appealing to donors to provide the needed resources, and thank those who have already made pledges to WHO and other partners.
So far, for this mpox outbreak in 2024, we have released about US$ 1.5 million from the WHO Contingency Fund for Emergencies, and we plan to release more in the coming days, until funding from donors for the response comes in.
WHO will coordinate the global response, working closely with each of the affected countries, to prevent transmission, treat those infected, and save lives.
I'd like to close by noting that today's information meeting was requested by members of the Standing Committee on Health Emergency Prevention, Preparedness and Response, which held their first extraordinary meeting last Thursday, just 24 hours after the PHEIC had been declared.
Further updates will be discussed at the fifth meeting of the Standing Committee on the 3rd and 4th of September.
As always, we are grateful for your engagement with today's presentations, and we look forward to your questions, comments and guidance.
I thank you.&nbsp;

WHO Director-General's Opening Remarks At Member States Information Session On Mpox – 23 August 2024

WHO: Côte d'Ivoire Reports First Cases Of Clade II Mpox Since The Start Of The Multi-Country Outbreak In 2022

<a href="https://www.fox2detroit.com/news/mpox-wayne-county-health-department-confirms-first-case-since-2022?taid=66c643be103e400001efc3e9&amp;utm_campaign=trueanthem&amp;utm_medium=trueanthem&amp;utm_source=twitter">https://www.fox2detroit.com/news/mpox-wayne-county-health-department-confirms-first-case-since-2022?taid=66c643be103e400001efc3e9&amp;utm_campaign=trueanthem&amp;utm_medium=trueanthem&amp;utm_source=twitter</a>
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The Wayne County Health Department (WCPH) says it has its first case of mpox since the global outbreak two years ago.
In a release from the WCPH, a case of MPOX was confirmed in a resident in the county – but says there is a low risk to the public due to the nature of how MPOX is spread.
The WCPH is awaiting the specific virus type and said that there have been no new cases of the new strain of mpox (Clade 1 type) that are linked to an outbreak in sub-Saharan Africa. The World Health Organization declared a global health emergency due to the nature of the outbreak in the Democratic Republic of Congo where there have been over 14,000 cases and 524 deaths.
Mpox does not spread through the air between people, though an individual with mpox is contagious for a total of 2-4 weeks.&nbsp;
Symptoms include flu-like symptoms including fevers, muscle aches, swollen lymph nodes, fatigue, and respiratory symptoms. There's also a rash that resembles pimples or blisters and symptoms start within 1 days after exposure.
The health department is recommending vaccines for those at risk of exposure. Taken four weeks apart, two doses are needed for full protection.

'Mpox In Wayne County: Health Department Confirms First Case Since 2022' - Fox 2 Detroit

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Vaccine Group Gavi Says It Has Up To $500M Available For Mpox Response

HC Wainwright &amp; Co. analyst Edward White reiterates Chimerix (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMRX#NASDAQ">CMRX</a>) with a Buy and maintains $11 price target.

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HC Wainwright & Co. Reiterates Buy on Chimerix, Maintains $11 Price Target

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WHO Says Expert Committee Will Propose Adoption Of Mpox Vaccines Under Emergency Use Listing Around Mid Sept

WHO official says mpox is 'not the new COVID,' calls for coordinated response

There's a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on Chimerix (CMRX – Research Report) and Ocuphire Pharm...

Analysts Offer Insights on Healthcare Companies: Chimerix (CMRX) and Ocuphire Pharma (OCUP)

There's a lot to be optimistic about in the Healthcare sector as 3 analysts just weighed in on Ocuphire Pharma (OCUP – Research Report), Chimerix (...

Analysts Offer Insights on Healthcare Companies: Ocuphire Pharma (OCUP), Chimerix (CMRX) and Mersana Therapeutics (MRSN)

Bavarian Nordic rebounds as new mpox vaccine order boosts outlook

Mpox stocks in focus as Thailand reports first case in Asia linked to new strain

WHO reportedly greenlights mpox vaccine purchases before approval

UNICEF issues emergency tender to secure mpox vaccines

Bavarian Nordic stock slides on Moderna mpox vaccine study

Morocco reports first mpox case amid ongoing global outbreak

First mpox case linked to African outbreak reported in U.K.

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Chimerix Reports First Quarter 2024 Financial Results and Provides Operational Update

Chimerix to Participate in Fireside Chat at Jefferies Global Healthcare Conference

Chimerix Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Chimerix to Report Second Quarter 2024 Financial Results and Provide an Operational Update on August 13, 2024

Rapid Advancements of Innovative Antiviral – COVID-19 Drugs Generating Major Growth in Global Antiviral Drugs Market

Chimerix Reports Second Quarter 2024 Financial Results and Provides Operational Update

Chimerix Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Chimerix to Present at H.C. Wainwright 26th Annual Global Investment Conference

Chimerix to Report Third Quarter 2024 Financial Results and Provide an Operational Update on November 7, 2024

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