Syndax Pharmaceuticals Azioni (NASDAQ: SNDX)

Ultime notizie per Syndax Pharmaceuticals (NASDAQ:SNDX) Azioni

Syndax Pharmaceuticals

Syndax Pharmaceuticals Inc is a clinical-stage biopharmaceutical company focused on developing a pipeline of combination therapies in multiple cancer indications. The company's product candidates are entinostat which has direct effects on both cancer cells and immune regulatory cells, SNDX-6352 and SNDX-6352, an anti-CSF-1R monoclonal antibody, to enhance the body's immune response on tumors that have shown sensitivity to immunotherapy. Business activity of the group is primarily functioned through the region of United States.

Syndax Pharmaceuticals, Inc. - Common Stock

Syndax Pharmaceuticals Inc

– Approval based on positive data from the AUGMENT-101 clinical trial, in which Revuforj delivered robust and durable rates of remission in R/R acute leukemia patients with a KMT2A translocation –
– Syndax to host conference call today at 6:00 p.m. ET –
WALTHAM, Mass., Nov. 15, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) today announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj&#xAE; (revumenib) as the first and only menin inhibitor for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older. The FDA previously granted Breakthrough Therapy and Fast Track designations as well as Priority Review for Revuforj. The New Drug Application (NDA) received approval through the FDA's Real Time Oncology Review (RTOR) program.

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SNDX

Syndax Announces FDA Approval Of Revuforj, The First And Only Menin Inhibitor To Treat Adult And Pediatric Patients With Relapsed Or Refractory Acute Leukemia With A KMT2A Translocation

<h3>Gainers</h3>
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<li>CERo Therapeutics Hldgs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CERO#NASDAQ">CERO</a>) shares increased by 46.12% to $0.29. The market value of their outstanding shares is at $43.0 million. </li>
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<h3>Losers</h3>
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<li>Heron Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HRTX#NASDAQ">HRTX</a>) stock decreased by 40.2% to $1.1 during Tuesday's pre-market session. The market value of their outstanding shares is at $166.8 million. As per the press release, Q3 earnings came out today. </li>
<li>Neurogene (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NGNE#NASDAQ">NGNE</a>) stock decreased by 31.36% to $49.1. The company's market cap stands at $728.0 million. </li>
<li>Neuronetics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/STIM#NASDAQ">STIM</a>) shares declined by 27.28% to $0.8. The market value of their outstanding shares is at $24.2 million. The company's, Q3 earnings came out today. </li>
<li>Rockwell Medical (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RMTI#NASDAQ">RMTI</a>) shares decreased by 25.81% to $3.45. The market value of their outstanding shares is at $107.0 million. The company's, Q3 earnings came out today. </li>
<li>Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) stock fell 25.3% to $16.27. The market value of their outstanding shares is at $1.3 billion. </li>
<li>Quantum-Si (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QSI#NASDAQ">QSI</a>) shares declined by 18.4% to $0.82. The market value of their outstanding shares is at $116.1 million. As per the press release, Q3 earnings came out today. 
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This article was generated by Benzinga's automated content engine and reviewed by an editor.

Movers

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

On Tuesday,&nbsp;Syndax Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) revealed topline results from the relapsed or refractory (R/R) mutant NPM1 (mNPM1) acute myeloid leukemia (AML) cohort in the pivotal Phase 2 portion of the AUGMENT-101 <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/n41896457/syndax-announces-positive-pivotal-topline-results-from-relapsed-or-refractory-mnpm1-aml-cohort-in-" rel="noreferrer noopener">trial of revumenib</a>.
The cohort met the primary endpoint with a complete remission (CR) plus CR with a partial hematological recovery (CRh) rate of 23% among the efficacy evaluable adults.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40396645/fda-approves-incytesyndax-partnered-drug-for-chronic-graft-versus-host-disease-a-post-transplant-" rel="noreferrer noopener">FDA Approves Incyte/Syndax Partnered Drug For Chronic Graft-Versus-Host Disease, A Post-Transplant Complication</a>
Among the patients who achieved CR/CRh, 12 had a CR, and three had a CRh.
At the data cutoff, the observed median duration of CR/CRh responses was 4.7 months, with three patients remaining in response.
Minimal residual disease (MRD) status was assessed in 14 of 15 patients who achieved CR/CRh, 64% (9/14) of whom were MRD negative. The overall response rate (ORR)&nbsp;was 47%.
17% of patients who achieved an overall response underwent hematopoietic stem cell transplant (HSCT) following treatment with revumenib, with three resuming revumenib therapy post-transplant.
The safety population included 84 adult and pediatric patients with R/R mNPM1 AML in the Phase 2 portion of the AUGMENT-101 trial.
The safety profile observed with revumenib in this population was consistent with previously reported data.
Treatment-related adverse events (TRAEs) leading to treatment discontinuations were 5%
The company is conducting several trials of revumenib across the treatment landscape in mNPM1 and KMT2A-rearranged (KMT2Ar) acute leukemias.
Syndax expects to achieve the following upcoming revumenib milestones:
<ul>
<li>Receive FDA approval for R/R KMT2Ar acute leukemias in the fourth quarter of 2024.</li>
<li>Initiate a pivotal combination trial with venetoclax/azacitidine in newly diagnosed mNPM1 AML or KMT2Ar acute leukemias by year-end 2024.</li>
<li>Publish pivotal AUGMENT-101 results in R/R mNPM1 AML patients and present results at a medical conference in the first half of 2025.</li>
<li>Submit a supplemental NDA for R/R mNPM1 AML in the first half of 2025.</li>
</ul>
Price Action: SNDX stock is down 22.1% at $16.96&nbsp;at last check Tuesday.
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Health Care

Syndax Pharmaceuticals Stock Falls After Data From Mid-Stage Study Of Revumenib In Form Of Blood Cancer

HC Wainwright &amp; Co. analyst Edward White maintains Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) with a Buy and raises the price target from $47 to $49.

Price Target

Analyst Ratings

HC Wainwright & Co. Maintains Buy on Syndax Pharmaceuticals, Raises Price Target to $49

WIIM

Syndax Pharmaceuticals shares are trading lower. The company announced topline results from the relapsed or refractory mutant NPM1 acute myeloid leukemia cohort in the Phase 2 portion of the AUGMENT-101 trial of revumenib.

<ul>
<li>Primary endpoint met with CR/CRh rate of 23% in pivotal Ph 2 cohort of R/R mNPM1 AML patients (p-value = 0.0014).</li>
<li>47% (30/64) ORR in a heavily pre-treated population, including 75% with prior venetoclax exposure in the efficacy population.</li>
<li>Favorable safety and tolerability profile; only 5% of patients discontinued due to treatment-related adverse events.</li>
<li>Results highlight consistency of revumenib's compelling clinical profile.</li>
<li>sNDA filing in R/R mNPM1 AML expected in 1H25, pending anticipated FDA approval of revumenib in R/R KMT2Ar acute leukemia in 4Q24</li>
</ul>

Syndax Pharmaceuticals Announced Topline Results From The Relapsed Or Refractory Mutant Npm1 Acute Myeloid Leukemia Cohort In The Phase 2 Portion Of The AUGMENT-101 Trial Of Revumenib

Goldman Sachs analyst Chris Shibutani maintains Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) with a Buy and raises the price target from $30 to $33.

Goldman Sachs Maintains Buy on Syndax Pharmaceuticals, Raises Price Target to $33

HC Wainwright &amp; Co. analyst Edward White maintains Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) with a Buy and raises the price target from $45 to $47.

HC Wainwright & Co. Maintains Buy on Syndax Pharmaceuticals, Raises Price Target to $47

Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) .

Guidance

Syndax Pharmaceuticals FY2024 R&D expenses forecast: $245M-$250M.

Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) reported quarterly losses of $(0.98) per share which beat the analyst consensus estimate of $(1.02) by 3.92 percent. The company reported quarterly sales of $12.500 million which beat the analyst consensus estimate of $11.199 million by 11.62 percent.

Earnings

Earnings Beats

Syndax Pharmaceuticals Q3 2024 GAAP EPS $(0.98) Beats $(1.02) Estimate, Sales $12.500M Beat $11.199M Estimate

– Rapid responses and symptom improvement observed in inflammatory and fibrotic manifestations of chronic GVHD in heavily pretreated patients –
WALTHAM, Mass., Nov. 5, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>), today announced that multiple abstracts evaluating Niktimvo&#x2122; (axatilimab-csfr), an anti-CSF-1R antibody for the treatment of chronic graft-versus-host disease (GVHD), have been accepted for presentation at the 66th American Society of Hematology (ASH) Annual Meeting being held in San Diego, California, December 7-10, 2024. The presentations will highlight a secondary analysis of overall and organ-specific responses and findings from an exposure-response analysis in patients with chronic GVHD from the pivotal Phase 2 AGAVE-201 trial of Niktimvo, as well as preclinical data further characterizing the Niktimvo mechanism of action.

Syndax Announces New Data From Secondary Analysis Of The Pivotal AGAVE-201 Trial Of Niktimvo In Chronic Graft-Versus-Host Disease To Be Presented At 66th ASH Annual Meeting

RPRX

Royalty Pharma Enters $350M Royalty Funding Agreement With Syndax Pharmaceuticals To Support Launches And Development Of Niktimvo And Revumenib, Boosting Proforma Cash To Nearly $800M

Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) is gearing up to announce its quarterly earnings on Tuesday, 2024-11-05. Here's a quick overview of what investors should know before the release.
Analysts are estimating that Syndax Pharmaceuticals will report an earnings per share (EPS) of $-1.11.
Investors in Syndax Pharmaceuticals are eagerly awaiting the company's announcement, hoping for news of surpassing estimates and positive guidance for the next quarter.
It's worth noting for new investors that stock prices can be heavily influenced by future projections rather than just past performance.
<h3>Earnings Track Record</h3>
Last quarter the company beat EPS by $0.11, which was followed by a 4.36% drop in the share price the next day.
Here's a look at Syndax Pharmaceuticals's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
<th>Q4 2023</th>
<th>Q3 2023</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>-0.91</td>
<td>-0.98</td>
<td>-0.99</td>
<td>-0.78</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>-0.80</td>
<td>-0.85</td>
<td>-1</td>
<td>-0.73</td>
</tr>
<tr>
<td>Price Change %</td>
<td>-4.0%</td>
<td>-2.0%</td>
<td>-2.0%</td>
<td>0.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2024/1730750533_0_0.png" alt="eps graph" />
<h3>Tracking Syndax Pharmaceuticals's Stock Performance</h3>
Shares of Syndax Pharmaceuticals were trading at $18.98 as of November 01. Over the last 52-week period, shares are up 30.34%. Given that these returns are generally positive, long-term shareholders are likely bullish going into this earnings release. 
<a href="https://www.benzinga.com/quote/SNDX/earnings">To track all earnings releases for Syndax Pharmaceuticals visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Syndax Pharmaceuticals's Earnings: A Preview

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Watching Syndax Pharmaceuticals; Traders Circulate Ray Blanco Mentions Stock As A Pick On Investors Newsletter

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades and downgrades, please see our <a href="https://www.benzinga.com/analyst-stock-ratings">analyst ratings page</a>.
<ul>
<li><a href="https://www.benzinga.com/analyst-stock-ratings/analyst/5e414381efd7b70001cae312/scott-buck">HC Wainwright &amp; Co. analyst Scott Buck</a> initiated coverage on WidePoint Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/WYY#NYSE">WYY</a>) with a Buy rating and announced a price target of $7. WidePoint shares closed at $3.68 on Wednesday. <a href="https://www.benzinga.com/quote/MSFT/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>UBS analyst David Dai initiated coverage on Syndax Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) with a Buy rating and announced a price target of $37. Syndax Pharmaceuticals shares closed at $18.54 on Wednesday. <a href="https://www.benzinga.com/quote/SNDX/analyst-ratings">See how other analysts view this stock.</a></li>
<li>Jefferies analyst Julien Dumoulin-Smith initiated coverage on Sempra (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SRE#NYSE">SRE</a>) with a Buy rating and announced a price target of $98. Sempra shares closed at $85.96 on Wednesday. <a href="https://www.benzinga.com/quote/SRE/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Leerink Partners analyst David Risinger initiated coverage on Tenax Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TENX#NASDAQ">TENX</a>) with an Outperform rating and announced a price target of $16. Tenax Therapeutics shares closed at $4.32 on Wednesday. <a href="https://www.benzinga.com/quote/TENX/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>UBS analyst David Dai initiated coverage on CG Oncology, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CGON#NASDAQ">CGON</a>) with a Buy rating and announced a price target of $60. CG Oncology shares closed at $35.61 on Wednesday. <a href="https://www.benzinga.com/quote/CGON/analyst-ratings">See how other analysts view this stock.</a></li>
</ul>
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Initiation

Pre-Market Outlook

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UBS analyst David Dai initiates coverage on Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) with a Buy rating and announces Price Target of $37.

UBS Initiates Coverage On Syndax Pharmaceuticals with Buy Rating, Announces Price Target of $37

Stifel analyst Bradley Canino maintains Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) with a Buy and raises the price target from $40 to $41.

Stifel Maintains Buy on Syndax Pharmaceuticals, Raises Price Target to $41

INCY

Incyte, Syndax Report Publication Of Data From Pivotal AGAVE-201 Trial Of Niktimvo; Trial Met The Primary Endpoint Across All Cohorts

Syndax Pharmaceuticals Partnered With Foundation Medicine To Develop A Companion Diagnostic For The Identification Of Acute Myeloid Leukemia Patients Harboring An NPM1 Mutation

Citigroup analyst Yigal Nochomovitz maintains Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) with a Buy and raises the price target from $30 to $34.

Citigroup Maintains Buy on Syndax Pharmaceuticals, Raises Price Target to $34

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Leerink notes that Syndax (SNDX) has disclosed topline pivotal data for menin-MLL inhibitor revumenib in NPM1m acute leukemia, which the firm sees ...

Leerink views Syndax data as potentially positive for Kura Oncology's ziftomenib

Syndax: Fall On NPM1m AML Data Of Revumenib Creates Buy Opportunity

Scotiabank analyst George Farmer lowered the firm's price target on Syndax (SNDX) to $18 from $23 and keeps a Sector Perform rating on the shares. ...

Syndax price target lowered to $18 from $23 at Scotiabank

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Mizuho Securities analyst Salim Syed has maintained their bullish stance on SNDX stock, giving a Buy rating yesterday. Salim Syed has given his Buy...

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The Food and Drug Administration approved Revuforj from Syndax (SNDX) Pharmaceuticals, a menin inhibitor, for relapsed or refractory acute leukemia...

FDA approves Syndax's Revuforj for acute leukemia

Syndax wins FDA approval for leukemia drug revumenib

Syndax (SNDX) Pharmaceuticals announced that the U.S. FDA has approved Revuforj as the first and only menin inhibitor for the treatment of relapsed...

Syndax confirms FDA approval of Revuforj for acute leukemia

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Press Releases

Syndax Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Syndax Pharmaceuticals and Royalty Pharma Enter into $350 Million Royalty Funding Agreement for Niktimvo™

Financing

Royalty Pharma and Syndax Pharmaceuticals Enter Into $350 Million Royalty Funding Agreement for Niktimvo

Syndax Announces New Data from Secondary Analysis of the Pivotal AGAVE-201 Trial of Niktimvo™ (axatilimab-csfr) in Chronic Graft-Versus-Host Disease to Be Presented at 66th ASH Annual Meeting

Syndax Announces Revumenib Abstracts to Be Presented at the 66th ASH Annual Meeting

Syndax to Host ASH Investor Event in Person and via Webcast on December 9, 2024

Syndax Reports Third Quarter 2024 Financial Results and Provides Business Update

Syndax Announces Positive Pivotal Topline Results from Relapsed or Refractory mNPM1 AML Cohort in AUGMENT-101 Trial of Revumenib

Small Cap

Opinion

Biotech Companies' Q3 Updates: Promising Cancer Treatments on the Horizon

Syndax Announces FDA Approval of Revuforj® (revumenib), the First and Only Menin Inhibitor to Treat Adult and Pediatric Patients with Relapsed or Refractory Acute Leukemia with a KMT2A Translocation

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