Syndax Pharmaceuticals, Inc. (SNDX), a clinical-stage healthcare company that focuses on an HDAC inhibitor for tumors and specializes in cancer therapies, announced the latest positive data from Phase 1 of the trial inclusive of the dose escalation portion of the ongoing Phase 1/2 AUGMENT-101 trial of SNDX-5613 in patients with mixed lineage leukemia. SNDX stock price plunged immensely adjacent to the news.
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Syndax Pharmaceuticals Inc. (SNDX) shares were falling -27.92% to trade at $13.97 in the current market at the last check. The price range of the company’s shares fluctuated between $18.89 and $20.9599. SNDX’s shares have declined by -8.89% in the last five days, while they have lost -15.81% in the last month. SNDX stock has had a 50-day moving average of $22.66, which is above the 200-day moving average of $19.67. Moreover, the stock is currently trading at a RSI of 37.26.
About Syndax Interim Data.
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As of a March 12, 2021 data cutoff date, 43 patients consisting of an average of 3 therapies beforehand, inclusive of stem cell transplant, and chemotherapy, were given doses in the Phase 1 part of the AUGMENT-101 trial. 31 patients were evaluated for the efficacy of the treatment, with the remaining 12 patients not carrying either the MLLr or NPM1c mutation.
Data from the ongoing Phase 1/ 2 AUGMENT 101 trial indicates a 48% overall response rate in patients with MLLr or NPM1c, with 67% of patients who responded achieving least residual disease-negative status.
FDA granted SNDX drug designation.
FDA has also granted an orphan drug designation to Syndaxfor treatment of people effected with idiopathic pulmonary fibrosis, a potentially fatal lung disease. The orphan drugs are granted to treat rare diseases, averaging less than 200,000 patients. This grant entitles syntax with various benefits which include tax exemptions for clinical trial expenses, and marketing exclusivity.
As per company data, approximately 150,000 people could be effected by idiopathic pulmonary fibrosis and potential approval could skyrocket Syndax’s growth for the future, with the company currently evaluating the safety of the drug.
SNDX stock price plummeted as investors expected ground breaking news, however, SNDX interim data did not provide adequate results, with 5% of the patients facing adverse effects such as prolongation, anemia, and differentiation syndrome. Furthermore, among all patients treated, 9% of patients experienced grade 3 QT prolongation, hence shareholders were skeptical about the future of the company.