Dernières nouvelles pour Chimerix (NASDAQ:CMRX) Stock

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.

Chimerix Inc

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

WIIM

Chimerix shares are trading higher after the company announced that the U.S. FDA accepted its New Drug Application seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma.

<ul>
<li>Potential First Approval for Patients with Recurrent H3 K27M-mutant Diffuse Glioma</li>
<li>PDUFA Target Action Date of August 18, 2025</li>
<li>No Advisory Committee Meeting Currently Planned to Discuss Application</li>
</ul>

Chimerix Secures FDA Priority Review For Dordaviprone, Advancing Potential First Treatment For Recurrent H3 K27M-Mutant Diffuse Glioma

<a href="https://www.manchestereveningnews.co.uk/news/health/new-case-mpox-detected-uk-30876004">https://www.manchestereveningnews.co.uk/news/health/new-case-mpox-detected-uk-30876004</a>
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A new case of Mpox has been confirmed in the UK, the UK Health Security Agency (UKHSA) has said.
The latest case of Clade Ib Mpox is the seventh confirmed case since October 2024 after a sixth patient <a href="https://www.manchestereveningnews.co.uk/news/uk-news/new-mpox-case-detected-uk-30823540">was admitted to hospital last week</a>.
<a href="https://www.gov.uk/government/news/ukhsa-detects-first-case-of-clade-ib-mpox?utm_medium=email&amp;utm_campaign=govuk-notifications-topic&amp;utm_source=d72f8bd1-0516-4336-9e7d-b4f8a791ba9a&amp;utm_content=immediately">The UKHSA says</a> the infected patient had recently travelled to Uganda and that the risk to the UK population "remains low". The UKHSA and <a href="https://www.manchestereveningnews.co.uk/all-about/nhs">NHS</a> says it will not be disclosing any further details about the infected person.
Professor Susan Hopkins, Chief Medical Adviser at UKHSA, said: "The risk to the UK population remains low. Close contacts have been identified and offered appropriate advice in order to reduce the chance of further spread."
Mpox, previously known as monkeypox, is a rare infection most commonly found in parts of central and east Africa.
There is currently community transmission of the virus in Uganda, which has so far recorded <a href="https://www.afro.who.int/countries/uganda/publication/mpox-outbreak-uganda-situation-update-22-january-2025">2,209 confirmed Mpox cases</a> and 13 deaths since July 2024.
The Clade Ib variant is a new form of the virus, the which the World Health Organisation (WHO) declared as a global health emergency in August.
WHO says common symptoms of Mpox include a skin rash or lesions which can last two to four weeks, as well as a fever, headache, muscle aches, back pain, low energy and swollen lymph nodes.
<a href="https://www.nhs.uk/conditions/mpox/">The NHS says</a> Mpox can be passed on from person to person through:
Close physical contact with Mpox blisters or scabs
Touching clothing, bedding or towels used by someone with Mpox
The coughs or sneezes of a person with Mpox when they're close to you

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"New Case Of Mpox Detected In The UK After 'Concerning' Surge In Cases In Uganda" - Manchester Evening News

Chimerix (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMRX#NASDAQ">CMRX</a>) has been analyzed by 4 analysts in the last three months, revealing a diverse range of perspectives from bullish to bearish.
The following table encapsulates their recent ratings, offering a glimpse into the evolving sentiments over the past 30 days and comparing them to the preceding months.
<table>
<thead>
<tr>
<th></th>
<th align="right">Bullish</th>
<th align="right">Somewhat Bullish</th>
<th align="right">Indifferent</th>
<th align="right">Somewhat Bearish</th>
<th align="right">Bearish</th>
</tr>
</thead>
<tbody>
<tr>
<td>Total Ratings</td>
<td align="right">3</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>Last 30D</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>1M Ago</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>2M Ago</td>
<td align="right">1</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>3M Ago</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
</tbody>
</table>
Analysts have set 12-month price targets for Chimerix, revealing an average target of $9.75, a high estimate of $11.00, and a low estimate of $6.00. Consistency is reflected as the current average remains at the same level as the previous average price target. 
<img src="https://www.benzinga.com/files/images/story/2024/1735581609_0.png" alt="price target chart" />
<h2>Investigating Analyst Ratings: An Elaborate Study</h2>
The standing of Chimerix among financial experts is revealed through an in-depth exploration of recent analyst actions. The summary below outlines key analysts, their recent evaluations, and adjustments to ratings and price targets.
<table>
<thead>
<tr>
<th>Analyst</th>
<th>Analyst Firm</th>
<th>Action Taken</th>
<th>Rating</th>
<th>Current Price Target</th>
<th>Prior Price Target</th>
</tr>
</thead>
<tbody>
<tr>
<td>Edward White</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$11.00</td>
<td>$11.00</td>
</tr>
<tr>
<td>Edward White</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$11.00</td>
<td>$11.00</td>
</tr>
<tr>
<td>David Nierengarten</td>
<td>Wedbush</td>
<td>Maintains</td>
<td>Outperform</td>
<td>$6.00</td>
<td>$6.00</td>
</tr>
<tr>
<td>Edward White</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$11.00</td>
<td>$11.00</td>
</tr>
</tbody>
</table>
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: Analysts frequently update their recommendations based on evolving market conditions and company performance. Whether they 'Maintain', 'Raise' or 'Lower' their stance, it reflects their reaction to recent developments related to Chimerix. This information provides a snapshot of how analysts perceive the current state of the company.</li>
<li>Rating: Gaining insights, analysts provide qualitative assessments, ranging from 'Outperform' to 'Underperform'. These ratings reflect expectations for the relative performance of Chimerix compared to the broader market.</li>
<li>Price Targets: Analysts navigate through adjustments in price targets, providing estimates for Chimerix's future value. Comparing current and prior targets offers insights into analysts' evolving expectations.</li>
</ul>
Navigating through these analyst evaluations alongside other financial indicators can contribute to a holistic understanding of Chimerix's market standing. Stay informed and make data-driven decisions with our Ratings Table.
<a href="https://www.benzinga.com/quote/CMRX/analyst-ratings?utm_source=Benzinga Insights">Stay up to date on Chimerix analyst ratings.</a>
If you are interested in following small-cap stock news and performance <a href="https://www.benzinga.com/news/small-cap">you can start by tracking it here</a>.
<h2>Unveiling the Story Behind Chimerix</h2>
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.
<h3>Financial Milestones: Chimerix's Journey</h3>
Market Capitalization: Exceeding industry standards, the company's market capitalization places it above industry average in size relative to peers. This emphasizes its significant scale and robust market position.
Revenue Growth: Over the 3 months period, Chimerix showcased positive performance, achieving a revenue growth rate of 136.36% as of 30 September, 2024. This reflects a substantial increase in the company's top-line earnings. In comparison to its industry peers, the company trails behind with a growth rate lower than the average among peers in the Health Care sector.
Net Margin: Chimerix's net margin is below industry averages, indicating potential challenges in maintaining strong profitability. With a net margin of -87996.15%, the company may face hurdles in effective cost management.
Return on Equity (ROE): Chimerix's financial strength is reflected in its exceptional ROE, which exceeds industry averages. With a remarkable ROE of -15.7%, the company showcases efficient use of equity capital and strong financial health.
Return on Assets (ROA): The company's ROA is below industry benchmarks, signaling potential difficulties in efficiently utilizing assets. With an ROA of -13.57%, the company may need to address challenges in generating satisfactory returns from its assets.
Debt Management: Chimerix's debt-to-equity ratio is below the industry average. With a ratio of 0.0, the company relies less on debt financing, maintaining a healthier balance between debt and equity, which can be viewed positively by investors.
<h2>The Core of Analyst Ratings: What Every Investor Should Know</h2>
Experts in banking and financial systems, analysts specialize in reporting for specific stocks or defined sectors. Their comprehensive research involves attending company conference calls and meetings, analyzing financial statements, and engaging with insiders to generate what are known as analyst ratings for stocks. Typically, analysts assess and rate each stock once per quarter.
Some analysts publish their predictions for metrics such as growth estimates, earnings, and revenue to provide additional guidance with their ratings. When using analyst ratings, it is important to keep in mind that stock and sector analysts are also human and are only offering their opinions to investors.
Which Stocks Are Analysts Recommending Now?
Benzinga Edge gives you instant access to all major analyst upgrades, downgrades, and price targets. Sort by accuracy, upside potential, and more. <a href="https://www.benzinga.com/premium/ideas/benzinga-edge-checkout/?t=be8be9arja3be22bz21&amp;utm_source=benzinga-insights">Click here to stay ahead of the market</a>.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

A Glimpse Into The Expert Outlook On Chimerix Through 4 Analysts

Chimerix Confirms That It Has Submitted New Drug Application With FDA Seeking Accelerated Approval For Dordaviprone As Treatment For Patients With Recurrent H3 K27M-mutant Diffuse Glioma In US

Chimerix (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMRX#NASDAQ">CMRX</a>), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today confirms that the Company has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma in the United States.

Government

Regulations

Chimerix Seeks FDA Approval for New Drug Targeting Deadly Brain Cancer

<h3>Gainers</h3>
<ul>
<li>Chimerix (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMRX#NASDAQ">CMRX</a>) shares moved upwards by 150.9% to $2.17 during Tuesday's pre-market session. The market value of their outstanding shares is at $195.1 million. </li>
<li>Cumberland (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPIX#NASDAQ">CPIX</a>) shares rose 136.29% to $2.93. The company's market cap stands at $41.1 million. </li>
<li>Cardiff Oncology (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRDF#NASDAQ">CRDF</a>) shares rose 47.54% to $3.6. The market value of their outstanding shares is at $184.0 million. </li>
<li>NewAmsterdam Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NAMS#NASDAQ">NAMS</a>) stock rose 35.74% to $25.14. The market value of their outstanding shares is at $2.3 billion. </li>
<li>Psyence Biomedical (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PBM#NASDAQ">PBM</a>) stock moved upwards by 31.88% to $2.73. The market value of their outstanding shares is at $2.3 million. </li>
<li>Gelteq (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GELS#NASDAQ">GELS</a>) stock increased by 23.87% to $4.41. The company's market cap stands at $41.6 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>CervoMed (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRVO#NASDAQ">CRVO</a>) stock decreased by 73.8% to $2.69 during Tuesday's pre-market session. The company's market cap stands at $22.2 million. </li>
<li>Biora Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIOR#NASDAQ">BIOR</a>) stock fell 47.78% to $0.7. The company's market cap stands at $3.1 million. </li>
<li>Radiopharm Theranostics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RADX#NASDAQ">RADX</a>) stock decreased by 23.75% to $7.0. The market value of their outstanding shares is at $15.2 billion. </li>
<li>Iterum Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ITRM#NASDAQ">ITRM</a>) shares declined by 16.87% to $2.42. The market value of their outstanding shares is at $66.5 million. </li>
<li>China SXT Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SXTC#NASDAQ">SXTC</a>) shares declined by 15.07% to $0.41. The market value of their outstanding shares is at $1.6 million. </li>
<li>BioSig Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BSGM#NASDAQ">BSGM</a>) shares decreased by 13.64% to $0.95. The company's market cap stands at $16.3 million. 
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</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Tuesday's Pre-Market Session

U.S. stocks traded mixed toward the end of trading, with the S&amp;P 500 falling by around 0.1% on Tuesday.
The Dow traded down 0.02% to 44,393.25 while the NASDAQ rose 0.03% to 19,743.54. The S&amp;P 500 also fell, dropping, 0.06% to 6,049.44.
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Leading and Lagging Sectors Communication services shares jumped by 2.3% on Tuesday.
In trading on Tuesday, real estate shares fell by 1%.
Top Headline
On Tuesday, AutoZone, Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AZO#NYSE">AZO</a>) reported weaker-than-expected earnings and sales results for its fiscal first quarter.
The company posted earnings per share of $32.52, missing the Street view of $33.76. Quarterly revenues of $4.28 billion (+2.1% year over year) missed the analyst consensus of $4.30 billion.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Chimerix, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMRX#NASDAQ">CMRX</a>) shares shot up 213% to $2.71 after the company announced it will submit dordaviprone for accelerated approval to the FDA for patients with recurrent H3 K27M-mutant diffuse glioma.</li>
<li>Shares of Cumberland Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPIX#NASDAQ">CPIX</a>) got a boost, surging 94% to $2.4001 after the company announced the FDA has approved its supplemental new drug application for acetadote.</li>
<li>uniQure N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QURE#NASDAQ">QURE</a>) shares were also up, gaining 129% to $16.71 after the company announced an agreement with the FDA on key elements of an accelerated pathway for AMT-130.</li>
</ul>
Equities Trading DOWN
<ul>
<li>CervoMed Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRVO#NASDAQ">CRVO</a>) shares dropped 77% to $2.34 after the company announced its Phase 2b trial of Neflamapimod failed to meet its key endpoints for the treatment of dementia.</li>
<li>Shares of Yext, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/YEXT#NYSE">YEXT</a>) were down 17% to $7.07 following third-quarter results.</li>
<li>MEDIROM Healthcare Technologies Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRM#NASDAQ">MRM</a>) was down, falling 46% to $1.52. MEDIROM Healthcare priced its $5 million public offering of 2.86 million American Depositary Shares at $1.75 per ADS.</li>
</ul>
Commodities In commodity news, oil traded up 0.7% to $68.84 while gold traded up 1.2% at $2,718.80.
Silver traded up 0.4% to $32.73 on Tuesday, while copper fell 0.1% to $4.2730.
Euro zone
European shares closed lower today. The eurozone's STOXX 600 fell 0.52%, Germany's DAX fell 0.08% and France's CAC 40 fell 1.14%. Spain's IBEX 35 Index fell 0.38%, while London's FTSE 100 fell 0.86%.
Asia Pacific Markets
Asian markets closed mixed on Monday, with Japan's Nikkei 225 gaining 0.18%, Hong Kong's Hang Seng Index gaining 2.76%, China's Shanghai Composite Index falling 0.05% and India's BSE Sensex falling 0.25%.
Economics
U.S. nonfarm business sector labor productivity increased by 2.2% in the third quarter, in-line with the preliminary reading.&nbsp;&nbsp;&nbsp;&nbsp;
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Chimerix shares are trading higher after the company announced it will submit dordaviprone for accelerated approval to the FDA for patients with recurrent H3 K27M-mutant diffuse glioma.

U.S. stocks traded mostly higher midway through trading, with the Nasdaq Composite gaining around 50 points on Tuesday.
The Dow traded up 0.02% to 44,412.05 while the NASDAQ rose 0.25% to 19,786.14. The S&amp;P 500 also rose, gaining, 0.07% to 6,057.30.
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Leading and Lagging Sectors Communication services shares jumped by 2.5% on Tuesday.
In trading on Tuesday, real estate shares fell by 0.9%.
Top Headline
Ollie's Bargain Outlet Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OLLI#NASDAQ">OLLI</a>) shares jumped over 14% on Tuesday after the company released third-quarter results.
The company reported third-quarter adjusted earnings per share of 58 cents, beating the street view of 57 cents. Quarterly sales of $517.43 million (+7.8%) beat the analyst consensus of $517.36 million. The increase in net sales was the result of new store unit growth.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Chimerix, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMRX#NASDAQ">CMRX</a>) shares shot up 207% to $2.67 after the company announced it will submit dordaviprone for accelerated approval to the FDA for patients with recurrent H3 K27M-mutant diffuse glioma.</li>
<li>Shares of Cumberland Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPIX#NASDAQ">CPIX</a>) got a boost, surging 93% to $2.3888 after the company announced the FDA has approved its supplemental new drug application for acetadote.</li>
<li>uniQure N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QURE#NASDAQ">QURE</a>) shares were also up, gaining 130% to $16.78 after the company announced an agreement with the FDA on key elements of an accelerated pathway for AMT-130.</li>
</ul>
Equities Trading DOWN
<ul>
<li>CervoMed Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRVO#NASDAQ">CRVO</a>) shares dropped 78% to $2.2250 after the company announced its Phase 2b trial of Neflamapimod failed to meet its key endpoints for the treatment of dementia.</li>
<li>Shares of Yext, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/YEXT#NYSE">YEXT</a>) were down 18% to $7.01 following third-quarter results.</li>
<li>MEDIROM Healthcare Technologies Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRM#NASDAQ">MRM</a>) was down, falling 47% to $1.50. MEDIROM Healthcare priced its $5 million public offering of 2.86 million American Depositary Shares at $1.75 per ADS.</li>
</ul>
Commodities In commodity news, oil traded up 0.8% to $68.94 while gold traded up 1.2% at $2,718.90.
Silver traded up 0.3% to $32.710 on Tuesday, while copper fell 0.3% to $4.2635.
Euro zone
European shares closed lower today. The eurozone's STOXX 600 fell 0.52%, Germany's DAX fell 0.08% and France's CAC 40 fell 1.14%. Spain's IBEX 35 Index fell 0.38%, while London's FTSE 100 fell 0.86%.
Asia Pacific Markets
Asian markets closed mixed on Monday, with Japan's Nikkei 225 gaining 0.18%, Hong Kong's Hang Seng Index gaining 2.76%, China's Shanghai Composite Index falling 0.05% and India's BSE Sensex falling 0.25%.
Economics
U.S. nonfarm business sector labor productivity increased by 2.2% in the third quarter, in-line with the preliminary reading.&nbsp;&nbsp;&nbsp;&nbsp;
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U.S. stocks traded mixed this morning, with the Dow Jones index falling around 150 points on Tuesday.
Following the market opening Tuesday, the Dow traded down 0.36% to 44,242.81 while the NASDAQ rose 0.43% to 19,820.91. The S&amp;P 500 also fell, dropping, 0.01% to 6,052.43.
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Leading and Lagging Sectors Communication services shares jumped by 2.3% on Tuesday.
In trading on Tuesday, utilities shares fell by 1.1%.
Top Headline
Oracle Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ORCL#NYSE">ORCL</a>) posted weaker-than-expected earnings and sales results for its second quarter on Monday.
The company reported second-quarter revenue of $14.06 billion, up 9% year-over-year. The revenue total missed a Street consensus estimate of $14.11 billion.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Chimerix, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMRX#NASDAQ">CMRX</a>) shares shot up 172% to $2.36 after the company announced it will submit dordaviprone for accelerated approval to the FDA for patients with recurrent H3 K27M-mutant diffuse glioma.</li>
<li>Shares of Cumberland Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPIX#NASDAQ">CPIX</a>) got a boost, surging 112% to $2.6400 after the company announced the FDA has approved its supplemental new drug application for acetadote.</li>
<li>uniQure N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QURE#NASDAQ">QURE</a>) shares were also up, gaining 104% to $15.00 after the company announced an agreement with the FDA on key elements of an accelerated pathway for AMT-130.</li>
</ul>
Equities Trading DOWN
<ul>
<li>CervoMed Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRVO#NASDAQ">CRVO</a>) shares dropped 75% to $2.54 after the company announced its Phase 2b trial of Neflamapimod failed to meet its key endpoints for the treatment of dementia.</li>
<li>Shares of Biora Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIOR#NASDAQ">BIOR</a>) were down 44% to $0.7499.</li>
<li>MEDIROM Healthcare Technologies Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRM#NASDAQ">MRM</a>) was down, falling 41% to $1.65. MEDIROM Healthcare priced its $5 million public offering of 2.86 million American Depositary Shares at $1.75 per ADS.</li>
</ul>
Commodities In commodity news, oil traded up 0.1% to $68.40 while gold traded up 1% at $2,712.20.
Silver traded up 0.4% to $32.750 on Tuesday, while copper fell 0.6% to $4.2500.
Euro zone
European shares were mostly lower today. The eurozone's STOXX 600 fell 0.2%, Germany's DAX rose 0.2% and France's CAC 40 fell 0.6%. Spain's IBEX 35 Index fell 0.1%, while London's FTSE 100 fell 0.6%.
Asia Pacific Markets
Asian markets closed mixed on Monday, with Japan's Nikkei 225 gaining 0.18%, Hong Kong's Hang Seng Index gaining 2.76%, China's Shanghai Composite Index falling 0.05% and India's BSE Sensex falling 0.25%.
Economics
U.S. nonfarm business sector labor productivity increased by 2.2% in the third quarter, in-line with the preliminary reading.&nbsp;&nbsp;&nbsp;&nbsp;
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</ul>

ORCL

Dow Falls 150 Points; Oracle Posts Downbeat Results

On Monday, Chimerix (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMRX#NASDAQ">CMRX</a>) announced that, following extensive dialogue with the FDA, the company plans to submit a complete New Drug Application (NDA) seeking accelerated approval for dordaviprone for recurrent H3 K27M-mutant diffuse glioma in <a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/g42399560/chimerix-to-submit-dordaviprone-for-accelerated-approval-to-u-s-fda-for-patients-with-recurrent-h3" rel="noreferrer noopener">the U.S. before year-end</a>.
A glioma is&nbsp;a tumor that originates in the glial cells of the brain or spinal cord and is the most common primary brain tumor.
Chimerix stock is trading higher on a strong session volume of 4.31 million, compared to an average volume of 497.04K, as per data from <a target="_blank" href="https://www.benzinga.com/pro/feature/newsfeed" rel="noreferrer noopener">Benzinga Pro</a>.
The following recent program milestones and additional supportive data were extensively discussed with the FDA and will be included in the NDA:
<ul>
<li>Substantial enrollment of the Phase 3 ACTION study.</li>
<li>Phase 2 objective response rate of the 50-patient primary efficacy analysis as the primary basis of efficacy in the NDA.</li>
<li>Several response assessments, under which dordaviprone demonstrated an objective response rate of 28%, a median duration of response of 10.4 months, and a median time to response of 4.6 months.</li>
<li>Additional clinical data sets and patient narratives supportive of the primary efficacy analysis.</li>
<li>Clinical and nonclinical demonstration of dordaviprone-driven reversal of the central hallmark of H3 K27M-mutant glioma, H3K27 trimethyl loss.</li>
<li>Comprehensive safety database of glioma patients and healthy volunteers that supports a favorable benefit/risk profile.</li>
<li>Comprehensive clinical pharmacology and chemistry, manufacturing, and controls (CMC) studies.</li>
</ul>
Chimerix will request a Priority Review for the NDA. If granted, the resulting six-month FDA review period is expected to result in a potential initial Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2025.
Dordaviprone has received Rare Pediatric Disease Designation for H3 K27M-mutant glioma and is eligible to apply for a Rare Pediatric Disease Priority Review Voucher.
&#8220;In anticipation of a potential approval, we have bolstered our commercial leadership team and will be ready for a U.S. launch as early as the third quarter of 2025, pending application acceptance and Priority Review, if granted,&#8221; said Mike Andriole, CEO of Chimerix.
Price Action: CMRX stock is up 153.20% at $2.19 at last check on Tuesday.
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</ul>

Health Care

Why Is Cancer-Focused Chimerix Stock Trading Higher On Tuesday?

Shares of C3.ai, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AI#NYSE">AI</a>) rose sharply in today's pre-market trading session after the company reported better-than-expected <a href="https://www.benzinga.com/news/earnings/24/12/42400744/c3ai-stock-rallies-after-q2-results-seventh-consecutive-quarter-of-accelerating-revenue-growth">second-quarter financial results</a>.
C3.ai reported quarterly losses of six cents per share, which beat the analyst consensus estimate for losses of 16 cents. Quarterly revenue clocked in at $94.34 million, which beat the consensus estimate of $91.02 million and is an increase over sales of $73.23 million from the same period last year.
C3.ai shares jumped 7.8% to $44.91 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>Chimerix, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMRX#NASDAQ">CMRX</a>) gained 117.3% to $1.88 in pre-market trading after the company announced it will submit dordaviprone for accelerated approval to the FDA for patients with recurrent H3 K27M-mutant diffuse glioma.</li>
<li>Cumberland Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPIX#NASDAQ">CPIX</a>) rose 103.2% to $2.52 in pre-market trading after the company announced the FDA has approved its supplemental new drug application for acetadote.</li>
<li>TNL Mediagene  (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNMG#NASDAQ">TNMG</a>) gained 69.8% to $25.81 in pre-market trading.</li>
<li>Processa Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PCSA#NASDAQ">PCSA</a>) gained 54.8% to $1.92 in pre-market trading after jumping around 17% on Monday.</li>
<li>Gelteq Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GELS#NASDAQ">GELS</a>) rose 39.8% to $4.98 in pre-market trading after jumping 78% on Monday.</li>
<li>The Glimpse Group, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRAR#NASDAQ">VRAR</a>) gained 36.9% to $1.15 in pre-market trading after rising over 13% on Monday.</li>
<li>Nanobiotix S.A. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NBTX#NASDAQ">NBTX</a>) climbed 21% to $3.63 in pre-market trading. NANOBIOTIX announced the completion of Phase 1 study of NBTXR3 (JNJ-1900) in pancreatic cancer.</li>
<li>Jet.AI Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JTAI#NASDAQ">JTAI</a>) gained 20.7% to $5.13 in pre-market trading after jumping 6% on Monday.</li>
<li>New Era Helium Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NEHC#NASDAQ">NEHC</a>) gained 17.3% to $9.85 in pre-market trading after dipping 29% on Monday.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>MEDIROM Healthcare Technologies Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRM#NASDAQ">MRM</a>) shares tumbled 38.6% to $1.72 in pre-market trading after the company priced $5 million public offering of 2.86M American Depositary Shares at $1.75 per ADS.</li>
<li>Twin Vee Powercats Co. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VEEE#NASDAQ">VEEE</a>) declined 19.7% to $0.37 in pre-market trading after gaining over 5% on Monday.</li>
<li>Huize Holding Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HUIZ#NASDAQ">HUIZ</a>) shares fell 18.4% to $4.93 in pre-market trading after reporting third-quarter results.</li>
<li>Asset Entities Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ASST#NASDAQ">ASST</a>) shares fell 16.1% to $0.5750 in pre-market trading after gaining 49% on Monday.</li>
<li>Fangdd Network Group Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DUO#NASDAQ">DUO</a>) fell 15% to $0.7476 in pre-market trading after jumping 52% on Monday. Fangdd announced the pricing of $7.0 million registered direct offering.</li>
<li>Momentus Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNTS#NASDAQ">MNTS</a>) fell 14.8% to $0.4797 in pre-market trading after the company announced a reverse stock split.</li>
<li>LightPath Technologies Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LPTH#NASDAQ">LPTH</a>) dipped 13.5% to $1.60 in pre-market trading.</li>
<li>Radiopharm Theranostics Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RADX#NASDAQ">RADX</a>) shares dipped 13% to $7.99 in pre-market trading after dipping 51% on Monday.</li>
<li>Algorhythm Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RIME#NASDAQ">RIME</a>) fell 11% to $0.1039 in pre-market trading after jumping 27% on Monday.</li>
<li>Yext, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/YEXT#NYSE">YEXT</a>) fell 10.8% to $7.60 in today's pre-market trading after reporting third-quarter results.</li>
</ul>
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Pre-Market Outlook

ASST

HUIZ

JTAI

LPTH

MNTS

NBTX

NEHC

PCSA

RIME

TNMG

VEEE

VRAR

Why C3.ai Shares Are Trading Higher By Around 8%; Here Are 20 Stocks Moving Premarket

Potential Approval in Q3 2025 in Recurrent H3 K27M-Mutant Diffuse Glioma
Submission Plan Follows Productive and Collaborative Pre-NDA Interactions with FDA
Company to Host Conference Call on Tuesday, December 10 at 8:30 AM ET
DURHAM, N.C., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMRX#NASDAQ">CMRX</a>), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced that, following extensive dialogue with the U.S. Food and Drug Administration (FDA), the Company plans to submit a complete New Drug Application (NDA) seeking accelerated approval for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma in the United States before year-end.

Chimerix To Submit Dordaviprone For Accelerated Approval To U.S. FDA For Patients With Recurrent H3 K27M-Mutant Diffuse Glioma Before Year-End

<a href="https://worldhealthorg.shinyapps.io/mpx_global/" title="https://worldhealthorg.shinyapps.io/mpx_global/">https://worldhealthorg.shinyapps.io/mpx_global/</a>

World Health Organization Says Mpox Continues To Constitute A Public Health Emergency Of International Concern

Wedbush analyst David Nierengarten reiterates Chimerix (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMRX#NASDAQ">CMRX</a>) with a Outperform and maintains $6 price target.

Wedbush Reiterates Outperform on Chimerix, Maintains $6 Price Target

Press Releases

Chimerix Announces Updated Phase 2 Response Assessment of Dordaviprone in Recurrent H3 K27M Glioma at the 2024 SNO Meeting

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

Chimerix to Submit Dordaviprone for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma Before Year-End

Stocks to Watch in December 2025: LDTC, CPIX, PNPN.V, ZEO, and More Inside

Chimerix Submits Dordaviprone New Drug Application for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma

Politics

Chimerix to Speak Today at The White House Cancer Moonshot Forum

Chimerix to Present at JonesTrading Virtual Precision Medicine Symposium

Chimerix Announces FDA Acceptance and Priority Review of New Drug Application for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse Glioma

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