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Syndax Pharmaceuticals, Inc. (symbol: SNDX) is a clinical-stage biopharmaceutical company headquartered in Waltham, Massachusetts. Dedicated to the development of combination therapies, the company primarily focuses on innovative treatments for various cancer indications.
Syndax's pipeline is rich with promising drugs aimed at improving the lives of cancer patients. The company's leading candidates include entinostat, an agent that targets both cancer cells and immune regulatory cells, and revumenib, a selective inhibitor of the menin-KMT2A binding interaction. This agent is particularly geared towards addressing acute leukemias such as KMT2A-rearranged (KMT2Ar) and NPM1-mutant acute myeloid leukemia (AML). Another notable product in development is axatilimab, a monoclonal antibody designed to enhance the immune response against tumors through CSF-1R inhibition.
Syndax operates primarily within the United States and has achieved several milestones. Recently, the company completed enrollment in the pivotal AUGMENT-101 trial for revumenib targeting relapsed/refractory mutant nucleophosmin (mNPM1) AML. The trial aims to evaluate revumenib's safety, tolerability, and efficacy, with topline data expected by the end of 2024. Positive results from this trial could support new drug applications in early 2025.
Revumenib has achieved several regulatory designations, including Orphan Drug, Fast Track, and Breakthrough Therapy by the FDA, reflecting its potential to address unmet clinical needs in leukemias. Syndax has also reported encouraging outcomes from its studies, including high response rates and favorable safety profiles in both adult and pediatric populations suffering from acute leukemia.
Financially, Syndax maintains a robust position to advance its clinical programs. The company regularly updates stakeholders through earnings calls and investor presentations, with a recent update scheduled for May 2024. Syndax's progress is further bolstered by strategic partnerships and collaborations that support its mission to innovate and deliver significant value to patients and shareholders alike.
Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial stage biopharmaceutical company focused on developing innovative cancer therapies, has announced the granting of inducement awards under its 2023 Inducement Plan. On October 1, 2024, the company granted stock options to five new employees, allowing them to purchase up to 62,700 shares of common stock.
The stock options have a four-year vesting schedule. Specifically, 25% of the underlying shares will vest on the one-year anniversary of the vesting commencement date. Following that, 1/48th of the underlying shares will vest monthly over the next 36 months. These vesting terms are subject to the employee's continued service relationship with Syndax throughout the applicable vesting dates.
Incyte and Syndax Pharmaceuticals announced the publication of pivotal Phase 2 AGAVE-201 trial results for Niktimvo™ (axatilimab-csfr) in The New England Journal of Medicine. The trial met its primary endpoint across all dose cohorts, with 74% of patients achieving a complete or partial response within the first six months of treatment at the 0.3 mg/kg every 2 weeks dose. Niktimvo has been approved by the U.S. FDA for treating chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. It has also been added to the latest NCCN Guidelines® for chronic GVHD treatment. The drug showed rapid, durable responses in all organs studied and patient subgroups, with 60% of patients reporting clinically meaningful symptom burden reduction.
Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial stage biopharmaceutical company focused on developing innovative cancer therapies, has announced the granting of an inducement award under its 2023 Inducement Plan. On September 1, 2024, the company granted stock options to purchase up to 60,000 shares of common stock to a new employee. The stock options have a four-year vesting schedule, with 25% of the shares vesting after one year and the remaining shares vesting monthly over the subsequent 36 months. This vesting is contingent on the employee's continued service with Syndax.
Foundation Medicine has partnered with Syndax Pharmaceuticals to develop a companion diagnostic for identifying acute myeloid leukemia (AML) patients with NPM1 mutations. This collaboration aims to support regulatory approval for an assay based on the FoundationOne®Heme platform. NPM1 mutations occur in about 30% of newly diagnosed AML cases, with no currently approved targeted treatments. The partnership focuses on advancing Syndax's menin inhibitor, revumenib, as a potential targeted therapy for NPM1-mutated AML.
If approved, this assay could become the first next-generation sequencing companion diagnostic for detecting genomic alterations in hematologic neoplasms. Foundation Medicine, a leader in companion diagnostic approvals, sees this collaboration as a critical step in expanding precision medicine options for blood cancer patients.
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.
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