Syndax Pharmaceuticals Stock (NASDAQ: SNDX)

Syndax Pharmaceuticals Stock (NASDAQ:SNDX), Trade Ideas

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.

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SNDX

Syndax Pharmaceuticals Inc (NASDAQ: SNDX) shares are trading higher after the company shared data from multiple trials of revumenib in combination with standard-of-care agents in patients with nucleophosmin mutant (mNPM1) and KMT2A-rearranged (KMT2r) relapsed/refractory 

What&#39;s Going On With Leukemia-Focused Syndax Pharmaceuticals Stock Today?

Syndax Pharmaceuticals Inc (NASDAQ: SNDX) announced topline data from the AUGMENT-101 trial of revumenib in adult and pediatric patients with relapsed/refractory (R/R) KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML) and 

What&#39;s Going On With Syndax Pharmaceuticals Stock Monday?

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Syndax Pharmaceuticals, Inc. - Common Stock

Syndax Pharmaceuticals Inc

<ul>
<li>Consistent safety and efficacy profiles across adult and pediatric populations &ndash;</li>
<li>Majority of pediatric patients who achieved an overall response proceeded to transplant; patients receiving post-transplant revumenib maintenance remained in remission as of data cutoff date &ndash;</li>
<li>No treatment-related discontinuations or dose reductions</li>
</ul>

Syndax Pharmaceuticals Announced The Presentation Of Data From AUGMENT-101 Trial In Pediatric Patients With Relapsed/Refractory KMT2A-rearranged Acute Myeloid Leukemia And Acute Lymphoid Leukemia Treated With Revumenib

Analyst Ratings

Live On CNBC, StemPoint Capital CIO Michelle Ross Mentioned Syndax Pharmaceuticals, Shares Spiked Higher

HC Wainwright &amp; Co. analyst Edward White reiterates Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) with a Buy and maintains $41 price target.

Price Target

Reiteration

HC Wainwright & Co. Reiterates Buy on Syndax Pharmaceuticals, Maintains $41 Price Target

Syndax Disclosed Completion Of Enrollment In AUGMENT-101 Pivotal Trial Cohort Of Patients With Relapsed/Refractory mNPM1 Acute Myeloid Leukemia & Expects Topline Data In Q1 2024

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 maintains $41 price target.

HC Wainwright & Co. Maintains Buy on Syndax Pharmaceuticals, Maintains $41 Price Target

– PDUFA action date set for September 26, 2024 –
– NDA being reviewed under FDA's RTOR program –

Syndax Reports FDA Priority Review Of NDA For Revumenib For Treatment Of Relapsed/Refractory KMT2Ar Acute Leukemia

JP Morgan analyst Anupam Rama maintains Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) with a Overweight and raises the price target from $31 to $34.

JP Morgan Maintains Overweight on Syndax Pharmaceuticals, Raises Price Target to $34

For the&nbsp;first quarter&nbsp;of 2024, the Company expects research and development expenses to be&nbsp;$56&nbsp;to&nbsp;$62 million&nbsp;and total operating expenses to be&nbsp;$82&nbsp;to&nbsp;$88 million. For the full year of 2024, the Company expects research and development expenses to be&nbsp;$240&nbsp;to&nbsp;$260 million&nbsp;and total operating expenses to be&nbsp;$355&nbsp;to&nbsp;$375 million, which includes an estimated&nbsp;$43 million&nbsp;in non-cash stock compensation expense.

Guidance

Syndax Pharmaceuticals Expects $600M In Cash And Equivalents To Provide Runway Through 2026;

Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) reported its Q4 earnings results on Tuesday, February 27, 2024 at 04:05 PM.
Here's what investors need to know about the announcement.
<h3>Earnings</h3>
Syndax Pharmaceuticals missed estimated earnings by -1.0%, reporting an EPS of $-1.0 versus an estimate of $-0.99.
Revenue was down $0 from the same period last year.
<h3>Past Earnings Performance</h3>
Last quarter the company beat on EPS by $0.05 which was followed by a 0.0% increase in the share price the next day.

To track all earnings releases for Syndax Pharmaceuticals <a href="https://www.benzinga.com/quote/SNDX/earnings">visit their earnings calendar here.</a> 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Earnings

Syndax Pharmaceuticals: Q4 Earnings Insights

Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) reported quarterly losses of $(1.00) per share which missed the analyst consensus estimate of $(0.99) by 1.01 percent.

Earnings Misses

Syndax Pharmaceuticals Q4 2023 GAAP EPS $(1.00) Misses $(0.99) Estimate

Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) is set to give its latest quarterly earnings report on Tuesday, 2024-02-27. Here's what investors need to know before the announcement.
Analysts estimate that Syndax Pharmaceuticals will report an earnings per share (EPS) of $-0.99. 
Syndax Pharmaceuticals bulls will hope to hear the company announce they've not only beaten that estimate, but also to provide positive guidance, or forecasted growth, for the next quarter.
New investors should note that it is sometimes not an earnings beat or miss that most affects the price of a stock, but the guidance (or forecast).
<h3>Past Earnings Performance</h3>
Last quarter the company beat EPS by $0.05, which was followed by a 0.14% increase 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>Q3 2023</th>
<th>Q2 2023</th>
<th>Q1 2023</th>
<th>Q4 2022</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>-0.78</td>
<td>-0.73</td>
<td>-0.60</td>
<td>-0.65</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>-0.73</td>
<td>-0.64</td>
<td>-0.59</td>
<td>-0.62</td>
</tr>
<tr>
<td>Price Change %</td>
<td>0.0%</td>
<td>-3.0%</td>
<td>7.000000000000001%</td>
<td>-2.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2024/1708963280_0.png" alt="eps graph" />
<h3>Stock Performance</h3>
Shares of Syndax Pharmaceuticals were trading at $23.13 as of February 23. Over the last 52-week period, shares are down 5.92%. Given that these returns are generally negative, long-term shareholders are likely bearish 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.

Earnings Preview: Syndax Pharmaceuticals

Scotiabank analyst George Farmer downgrades Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>) from Sector Outperform to Sector Perform and lowers the price target from $36 to $23.

Downgrades

Scotiabank Downgrades Syndax Pharmaceuticals to Sector Perform, Lowers Price Target to $23

The company said it is working with the FDA during their review of regulatory submissions while diligently preparing for the potential launch of two first- and best-in-class products in the U.S. in 2024.&nbsp;The company now believes that it has sufficient cash runway to fund its clinical and commercial operations through 2026.

Syndax Highlights Recent Updates And Anticipated 2024 Milestones; Says Completion Of $230M Follow-on Offering In December Extends Runway Through 2026

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 lowers the price target from $42 to $41.

HC Wainwright & Co. Maintains Buy on Syndax Pharmaceuticals, Lowers Price Target to $41

Mizuho analyst Mara Goldstein 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 $45.

Initiation

Mizuho Initiates Coverage On Syndax Pharmaceuticals with Buy Rating, Announces Price Target of $45

The offering is expected to close on December 19, 2023, subject to customary closing conditions.

Syndax Prices $200M Public Offering of 10,810,810 Common Shares At $18.50/Share

Offerings

Syndax Announces Proposed $150M Public Offering Of Common Stock

– Pivotal AUGMENT-101 trial met its primary endpoint at interim analysis of the pooled KMT2Ar AML and ALL cohorts (p-value = 0.0036); CR/CRh rate consistent across adult and pediatric patients –
– 63% overall response rate; responses observed across all major subgroups –
&nbsp;– Median overall survival at time of data cutoff of 8.0 months –
– Favorable safety and tolerability profile; treatment discontinuations were low at 6% with none due to differentiation syndrome or QTc prolongation –
– Supportive results from the AUGMENT-101 trial, including post-transplant maintenance data, continues to demonstrate consistent clinically meaningful responses across subgroups –
WALTHAM, Mass., Dec. 12, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNDX#NASDAQ">SNDX</a>), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today presented positive data from the protocol-defined pooled analysis of the pivotal AUGMENT-101 trial of revumenib, a first-in-class menin inhibitor, in adult and pediatric patients with relapsed/refractory (R/R) KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL) at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023 in San Diego, California. The pivotal results were featured in a late-breaking oral presentation titled "Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemia: Topline Efficacy and Safety Results from the Pivotal AUGMENT-101 Phase 2 Study."
Additional supportive results from the AUGMENT-101 trial, including data from patients in the Phase 1 portion and patients who received revumenib maintenance therapy after hematopoietic stem cell transplant (HSCT), were also featured in two poster presentations at the meeting, titled "Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemia: Efficacy and Safety Results from the AUGMENT-101 Phase 1/2 Study" and "Revumenib Maintenance Therapy Following Revumenib-Induced Remission and Transplant."
"We are thrilled to present additional detail on the positive results for revumenib in KMT2Ar acute leukemia that continue to demonstrate its consistently impressive clinical profile as a potential monotherapy for these patients," said&nbsp;Michael A. Metzger, Chief Executive Officer of Syndax. "We look forward to delivering on several important, near-term milestones across our pipeline, including submitting a New Drug Application to the U.S. Food and Drug Administration for revumenib for the treatment of R/R KMT2Ar acute leukemia at year-end."
Pivotal Phase 2 Portion of AUGMENT-101 Trial
The AUGMENT-101 trial met its primary endpoint at the protocol-defined interim analysis with a complete remission (CR) or a CR with partial hematological recovery (CRh) rate of 23% (13/57; 95% confidence interval [CI]: [12.7, 35.8, one-sided p-value = 0.0036]) among the 57 efficacy evaluable patients in the pooled KMT2Ar acute leukemia population. The CR/CRh rate was 23% (10/44; 95% CI: 11.5, 37.8) in adult patients and 23% in pediatric patients (3/13; 95% CI: 5.0, 53.8), with a median time to CR/CRh of 1.9 months (95% CI: 0.9, 4.5). The CR/CRh responses in both the overall population and the AML subset were durable with a 6.4-month (95% CI: 3.4, NR) median duration as of the July 24, 2023 data cutoff, with 46% (6/13) remaining in response. Minimal residual disease (MRD) status was assessed in 10 of the 13 patients who achieved a CR/CRh, 70% (7/10) of whom were MRD negative. In patients who achieved a CRc (CR+CRh+CRp+Cri), 68% (15/22) achieved MRD negative status.
In the efficacy-evaluable patients, the overall response rate1 was 63% (36/57; 95% CI: [49.3, 75.6]), and the composite response rate (CRc) was 44% (25/57). Minimal residual disease (MRD) status was assessed in 22 of the 25 patients who achieved a CRc, 68% (15/22) of whom were MRD negative.&nbsp; Responses were observed in all major subgroups, including across the number of prior treatments and prior stem cell transplant. A total of 14 (39%) patients who achieved an overall response underwent HSCT, eight of whom did not achieve a CR or CRh prior to transplant. Half (7/14) of the patients who had an HSCT received post-transplant maintenance with revumenib and three additional patients (3/14; 21%) were in follow-up and are eligible to restart revumenib as post-transplant maintenance. Median overall survival at the time of data cutoff was 8.0 months (95% CI: 4.1, 10.9).
"I am pleased that&nbsp;this pivotal dataset of revumenib as a monotherapy in heavily pretreated R/R patients continues to support its profile as a potential best- and first-in-class therapy," said&nbsp;Ibrahim Aldoss, M.D., Attending Physician and Associate Professor, Division of Leukemia, Department of Hematology &amp; Hematopoietic Cell Transplantation at City of Hope, and Principal Investigator in the AUGMENT-101 trial.&nbsp;"Of particular note, the data presented today demonstrate rapid responses with revumenib, with a median time to CR/CRh of 1.9 months, which is particularly impressive in this patient population. Responses were also observed across all major subgroups, with a similar CR/CRh rate across adult and pediatric patients, which speaks to the wide clinical utility of revumenib across this underserved patient population."
AUGMENT-101 enrolled a total of 94 acute leukemia patients in the KMT2Ar cohorts of the pivotal trial as of the July 2023 data cutoff, 57 of whom had central confirmation of their KMT2Ar status, sufficient follow-up and were in the efficacy-evaluable population. The majority of patients included in the efficacy-evaluable population (56%; 32/57) relapsed following treatment with at least one salvage regimen (refractory relapse patients) prior to enrollment, including nearly half (46%; 26/57) having undergone prior stem cell transplant. Seventy-two percent (41/57) of patients were previously treated with venetoclax.&nbsp;
Revumenib was well tolerated and the safety profile was consistent with the Company's previously reported data.&nbsp; Treatment-related adverse events (TRAEs) leading to dose reductions and treatment discontinuation were low at 9% (8/94) and 6% (6/94), respectively. TRAEs of any grade in greater than 20% of patients included nausea (28%), differentiation syndrome (DS) (27%), and QTc prolongation (23%).&nbsp; Grade 3 DS was observed in 15% (14/94) of patients while one patient (1%) experienced Grade 4 DS and no patients experienced a Grade 5. Grade 3 QTc prolongation was observed in 14% (13/94) of patients, with no Grade 4 or 5 events.&nbsp; There were no discontinuations related to DS, cytopenias or QTc prolongation on the trial.
Revumenib Maintenance Therapy Post-HSCT
Data featured in a poster presentation from AUGMENT-101 Phase 1 patients who received revumenib maintenance therapy, including some ongoing for more than one year after HSCT, demonstrated revumenib duration of treatment in the maintenance setting at the time of this analysis ranged from 1 to 701 days, with treatment ongoing for nine of the 16 patients. CRc was maintained in 12 patients after HSCT and maintenance revumenib. MRD negative remissions were maintained in six patients as of the data cutoff with one patient converting from an MRD+ to MRD- response. Three patients remain on revumenib maintenance therapy for more than one-year post-transplant.
Phase 1 Portion of AUGMENT-101 Trial
In the Phase 1 portion of the study, patients were assigned to one of six dose-escalation cohorts designed to identify a recommended phase 2 dose (RP2D) for concomitant administration with a strong CYP3A4 inhibitor and without a strong CYP3A4 inhibitor. As of the July 2023 data cutoff, 77 patients with R/R KMT2Ar acute leukemia were enrolled in the Phase 1 study and were included in the overall population.&nbsp; Most patients were female (60%), and 34% of patients had ≥4 prior lines of therapy and 47% had prior HSCT.
Updated follow-up on Phase 1 data presented at the meeting continues to demonstrate clinically meaningful response, high percentage of responders proceeding to transplant, consistency of response across subgroups, and a manageable safety profile in heavily pretreated patients with R/R KMT2Ar acute leukemia. Phase 1 KMT2Ar patients demonstrated a CR/CRh rate of 31.2%, and ORR of 64.9%, with 38% proceeding to HSCT. In adults with AML (n=51), the CR/CRh rate was 37.3% and ORR was 68.6%, with 40% of responders proceeding to HSCT. Pediatric patients (n=15) demonstrated consistent response rates, with a CR/CRh rate of 20.0% and an ORR of 66.7%, with 40% of responders proceeding to transplant.
Copies of the ASH presentations are available in the&nbsp;<a href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4048123-1&amp;h=2002908944&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3733600-1%26h%3D3012339855%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3388061-1%2526h%253D3814280736%2526u%253Dhttps%25253A%25252F%25252Fsyndax.com%25252Fpipeline%25252Fpublications%25252F%2526a%253DPublications%252Band%252BMeeting%252BPresentations%26a%3DPublications%2Band%2BMeeting%2BPresentations&amp;a=Publications+and+Meeting+Presentations">Publications and Meeting Presentations</a>&nbsp;section of Syndax's website.
About&nbsp;Revumenib
Revumenib is a potent, selective, small molecule inhibitor of the menin-KMT2A binding interaction that is being developed for the treatment of KMT2A-rearranged, also known as mixed lineage leukemia rearranged or MLLr, acute leukemias including ALL and AML, and NPM1-mutant AML. Revumenib was granted Orphan Drug Designation by the&nbsp;FDA and&nbsp;European Commission&nbsp;for the treatment of patients with AML, and Fast Track designation by the&nbsp;FDA for the treatment of adult and pediatric patients with R/R acute leukemias harboring a KMT2A rearrangement or NPM1 mutation. Revumenib was granted BTD by the FDA for the treatment of adult and pediatric patients with R/R acute leukemia harboring a KMT2A rearrangement. Syndax expects to complete an NDA submission for KMT2Ar acute leukemia under the Oncology Center of Excellence Review RTOR Program&nbsp;by year-end 2023.
About AUGMENT-101
AUGMENT-101 is a Phase 1/2 open-label trial designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of orally administered revumenib. The Phase 1 dose escalation portion of AUGMENT-101 included two cohorts based on concomitant treatment with a strong CYP3A4 inhibitor. Arm A enrolled patients not receiving a strong CYP3A4 inhibitor, while Arm B enrolled patients receiving a strong CYP3A4 inhibitor. The Phase 2 pivotal portion of AUGMENT-101 has enrolled R/R patients across the following trial populations: patients with mNPM1 AML, patients with KMT2Ar AML, and patients with KMT2Ar ALL.&nbsp; Following the receipt of Breakthrough Therapy designation from the FDA for revumenib for the treatment of R/R acute leukemia harboring a KMT2A rearrangement, regardless of age or tumor type, and based on discussions with the FDA, the Company decided to pool data from the AUGMENT-101 cohorts enrolling R/R KMT2Ar AML and R/R KMT2Ar ALL.&nbsp; Based on the Independent Data Monitoring Committee (IDMC) recommendation at the protocol pre-specified interim analysis, the Company stopped the trial to further accrual in the KMT2A cohorts. The trial continues to enroll R/R patients with mNPM1 AML and expects to complete enrollment of this cohort in late 1Q24 or early 2Q24. &nbsp;The primary endpoint for each of the cohorts is efficacy as measured by complete remission rate (CR + CRh) per protocol, with secondary endpoints including duration of response (DOR) and overall survival (OS).&nbsp;
About KMT2A (MLL) Rearranged Acute Leukemia
Rearrangements of the KMT2A (mixed lineage leukemia or MLL) gene give rise to KMT2Ar acute leukemia that is known to have a poor prognosis.&nbsp; KMT2A genes produce fusion proteins that require interaction with the protein called menin to drive leukemic cancer growth. Disruption of the menin-KMT2Ar interaction has been shown to halt the growth of KMT2Ar leukemic cells.&nbsp; KMT2Ar acute leukemia&nbsp;can phenotypically appear as AML, ALL, or mixed phenotype acute leukemia (MPAL) and is routinely diagnosed through currently available cytogenetic or molecular diagnostic techniques.&nbsp;The median overall survival (OS) after standard of care first-line treatment, including intensive chemotherapy and transplant, is less than one year and the majority of patients suffer relapse within five years. With third line treatment or beyond, less than 5% of patients achieve complete remission (CR), and the median OS is less than three months. There are currently no approved therapies indicated for KMT2A-rearranged acute leukemia.

Events

Syndax Presents Data From Pivotal AUGMENT-101 Trial Of Revumenib In Relapsed/Refractory KMT2Ar Acute Leukemia At Oral Presentation During ASH Meeting; Trial Met Its Primary Endpoint At Interim Analysis Of The Pooled KMT2Ar AML And ALL Cohorts

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Press Releases

Incyte Announces U.S. Food and Drug Administration Grants Priority Review for Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease

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

Syndax Announces Appointment of Steven Closter as Chief Commercial Officer

Syndax Announces FDA Priority Review of NDA for Revumenib for the Treatment of Relapsed/Refractory KMT2Ar Acute Leukemia

Management

Zymeworks Announces Appointment of Dr. Neil Gallagher to its Board of Directors

Syndax Announces Completion of Enrollment in AUGMENT-101 Pivotal Trial Cohort of Patients with Relapsed/Refractory mNPM1 Acute Myeloid Leukemia

Syndax Presents Positive Pediatric Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia at ASPHO Plenary Session