Welcome to our dedicated page for Syndax Pharmaceuticals news (Ticker: SNDX), a resource for investors and traders seeking the latest updates and insights on Syndax Pharmaceuticals stock.
Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX) is a commercial-stage biopharmaceutical company whose news flow centers on cancer drug development, regulatory milestones, and commercialization updates. The company’s announcements emphasize progress with its two FDA-approved therapies: Revuforj® (revumenib), an oral menin inhibitor for specific relapsed or refractory acute leukemias, and Niktimvo™ (axatilimab-csfr), a CSF-1 receptor-blocking antibody for chronic graft-versus-host disease after at least two prior systemic therapies.
News for SNDX often covers quarterly and annual financial results, product revenue trends for Revuforj and Niktimvo, and guidance on research and development as well as selling, general and administrative expenses. Investors can follow updates on clinical trial milestones, such as Phase 2 and Phase 3 studies of revumenib in newly diagnosed and relapsed or refractory NPM1-mutated and KMT2A-rearranged AML, and trials of axatilimab in chronic GVHD and idiopathic pulmonary fibrosis.
Press releases also highlight regulatory events, including FDA approvals and label expansions, inclusion of revumenib in clinical practice guidelines, and special designations such as Orphan Drug, Fast Track, and Breakthrough Therapy. Scientific and medical conference activity is another recurring theme, with multiple abstracts and oral presentations at meetings like the American Society of Hematology and appearances at investor conferences and healthcare forums.
In addition, Syndax issues news on collaborations and access initiatives, such as its agreement with the World Orphan Drug Alliance to launch a multi-regional Managed Access Program for Revuforj outside the United States. For investors and observers tracking SNDX, the news stream provides insight into commercial performance, pipeline evolution, partnership activity, and the company’s stated path toward profitability.
Incyte and Syndax Pharmaceuticals announced FDA approval of Niktimvo™ (axatilimab-csfr) for treating chronic graft-versus-host disease (GVHD) after failure of at least two prior systemic therapies in adults and pediatric patients weighing ≥40 kg. Niktimvo is the first approved anti-CSF-1R antibody targeting inflammation and fibrosis drivers in chronic GVHD.
Key points from the AGAVE-201 study:
- 75% overall response rate within 6 months
- 60% maintained response at 12 months
- 56% achieved ≥7-point improvement in modified Lee Symptom Scale score
- Responses across all affected organs
Niktimvo will be co-commercialized by Incyte and Syndax in the U.S., with launch expected by early Q1 2025.
Syndax Pharmaceuticals (NASDAQ: SNDX) announced the publication of data from the pivotal AUGMENT-101 trial of revumenib in the Journal of Clinical Oncology. The trial met its primary endpoint for patients with KMT2Ar AML and ALL. The FDA is reviewing the New Drug Application (NDA) for revumenib under Priority Review, with a PDUFA action date of December 26, 2024.
Key highlights:
- Revumenib showed impressive clinical profile in relapsed/refractory KMT2Ar acute leukemia
- NDA is being reviewed under FDA's Real-Time Oncology Review Program
- Potential for revumenib to be a paradigm-changing treatment
- Topline data for mNPM1 AML expected in Q4 2024, possibly supporting a supplemental NDA in H1 2025
Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company focused on developing cancer therapies, has announced the granting of inducement awards to nine new employees. The awards, issued on August 1, 2024, consist of stock options to purchase up to 104,600 shares of common stock under the Company's 2023 Inducement Plan.
The stock options have a four-year vesting schedule, with 25% of the shares vesting on the one-year anniversary of the vesting commencement date. The remaining shares will vest monthly at a rate of 1/48th over the following 36 months, contingent on the employee's continued service with Syndax.
Syndax Pharmaceuticals (Nasdaq: SNDX) reported Q2 2024 financial results and provided a clinical update. Key highlights include:
1. Axatilimab BLA for refractory chronic GVHD under Priority Review with PDUFA date of August 28, 2024.
2. Revumenib NDA for R/R KMT2Ar acute leukemia under RTOR review with PDUFA date extended to December 26, 2024.
3. Pivotal AUGMENT-101 topline data for mNPM1 AML expected in Q4 2024.
4. Q2 2024 net loss of $68.1 million ($0.80 per share).
5. Cash position of $454.6 million as of June 30, 2024.
6. Full-year 2024 R&D expenses expected to be $240-$260 million, with total operating expenses of $355-$375 million.
7. Sufficient capital to fund operations through 2026.
Syndax Pharmaceuticals (NASDAQ: SNDX) announced that the FDA has extended the PDUFA action date for the New Drug Application (NDA) of revumenib to December 26, 2024. This three-month extension from the original date of September 26, 2024, allows the FDA additional time to review supplemental information provided by Syndax in response to their requests. The submission was deemed a Major Amendment to the NDA.
Revumenib is being developed for the treatment of adults and pediatric patients with relapsed or refractory KMT2Ar acute leukemia. Upon approval, it would be the first drug indicated for this specific condition. The NDA has been granted Priority Review and is being reviewed under the FDA's Real-Time Oncology Review program. Revumenib has also received Breakthrough Therapy, Fast Track, and Orphan Drug designations.
Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company focused on developing innovative cancer therapies, has announced it will release its second quarter 2024 financial results on August 1, 2024. The company will host a conference call and live audio webcast at 4:30 p.m. ET on the same day to discuss the results and provide a business update.
Investors can access the webcast through the Events & Presentations page on Syndax's website or join the conference call using the provided dial-in numbers. For those unable to attend, a replay will be available on the company's website for 90 days following the call.
Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company, announced the grant of inducement awards to eight new employees. These awards, totaling options to purchase up to 124,000 shares of common stock, were granted under the Company's 2023 Inducement Plan on July 1, 2024. According to the vesting schedule, 25% of the shares will vest after one year, with the remaining shares vesting monthly over the next 36 months, contingent on continued employment with Syndax.
Syndax Pharmaceuticals announced updated positive data from two combination trials of revumenib in patients with acute leukemias at the EHA 2024 Congress.
In the BEAT AML trial, a 96% composite complete remission (CRc) rate was observed in newly diagnosed AML patients treated with revumenib in combination with venetoclax and azacitidine. The AUGMENT-102 trial showed a 52% CRc rate in relapsed/refractory acute leukemia patients treated with revumenib and fludarabine-cytarabine.
Both trials demonstrated strong efficacy and an acceptable safety profile. No new safety signals were observed, and most adverse events were manageable. These results support revumenib's potential as a promising treatment in various settings of acute leukemia, and further trials are planned.
Syndax Pharmaceuticals announced the advancement into Phase 1b of its Phase 1/2 trial of revumenib for relapsed or refractory metastatic MSS colorectal cancer (CRC). This decision follows a favorable safety profile observed in Phase 1a, as reviewed by the Independent Data Monitoring Committee (IDMC). In Phase 1a, 19 patients were treated across three dose levels, with revumenib being well-tolerated and no Grade 3 or higher treatment-related adverse events reported. Preliminary efficacy showed that 33% of patients had stable disease at 16 weeks. The trial will proceed with a 276 mg TID dosage in Phase 1b.
Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company, will participate in the Goldman Sachs 45th Annual Global Healthcare Conference. CEO Michael A. Metzger will join a fireside chat on June 12, 2024, at 8:40 a.m. ET. The event will be webcast live on the company's website, with a replay available for a time.