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Syndax's (SNDX) Leukemia Drug Gets FDA Breakthrough Therapy Tag
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Syndax Pharmaceuticals, Inc. (SNDX - Free Report) announced that the FDA granted Breakthrough Therapy designation to its highly selective, oral menin inhibitor, revumenib for the treatment of relapsed or refractory (R/R) acute leukemia in adult and pediatric patients harboring a KMT2A rearrangement (KMT2Ar).
Following this, revumenib became the first and only investigational treatment for R/R KMT2Ar acute leukemia to be granted a Breakthrough Therapy tag by the FDA.
A Breakthrough Therapy designation is granted to medicines being evaluated for serious conditions where early clinical evidence indicates said medicines’ potential for substantial improvement over available therapies.
Shares of Syndax were up 3.2% in after-hours trading on Monday following the announcement of the news. The stock has improved 16.2% so far this year against the industry’s decline of 16.3%.
Image Source: Zacks Investment Research
The Breakthrough Therapy tag granted to revumenib was based on data from the phase I AUGMENT-101 study. Data from the same showed that treatment with revumenib led to a 27% complete remission (CR)/ CR with partial hematologic recovery (CRh) rate in KMT2A patients treated with the recommended phase II dose.
No discontinuation owing to treatment-related adverse side effects was reported.
Per the company, if approved, revumenib has the potential to become the first drug to treat patients with KMT2Ar leukemia, an area that has a significant unmet medical need.
Syndax plans to file a new drug application for revumenib to treat r/r KMT2A-rearranged acute leukemia by the end of 2023.
SNDX is working with the FDA to speed up the potential approval of revumenib.
Apart from revumenib, Syndax is developing another pipeline candidate, axatilimab, a monoclonal antibody that blocks the colony-stimulating factor 1 (CSF-1) receptor.
In November 2022, Syndax and partner Incyte (INCY - Free Report) completed enrollment in the pivotal AGAVE-201 study evaluating axatilimab in patients with chronic graft-versus-host disease (cGVHD) following two or more prior lines of therapy. Top-line data from the same is expected in mid-2023 while a biologics license application for axatilimab is expected to be filed later in 2023.
Syndax along with Incyte plans to initiate a phase I study evaluating axatilimab in combination with INCY’s ruxolitinib for treating steroid-naive cGVHD in the first quarter of 2023.
SNDX also plans to begin a phase IIb study evaluating the efficacy, safety and tolerability of axatilimab in patients with idiopathic pulmonary fibrosis shortly.
In the absence of a marketed drug, the successful development of its pipeline candidates remains in key focus for Syndax.
Loss per share estimates for Repare Therapeutics have narrowed 76.1% for 2022 and 0.3% for 2023 in the past 60 days.
Earnings of Repare Therapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. RPTX witnessed an earnings surprise of 240.65% on average.
Loss per share estimates for Celularity have narrowed 47.6% for 2022 and 6.7% for 2023 in the past 60 days.
Earnings of Celularity surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. CELU witnessed an earnings surprise of 51.01% on average.
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Syndax's (SNDX) Leukemia Drug Gets FDA Breakthrough Therapy Tag
Syndax Pharmaceuticals, Inc. (SNDX - Free Report) announced that the FDA granted Breakthrough Therapy designation to its highly selective, oral menin inhibitor, revumenib for the treatment of relapsed or refractory (R/R) acute leukemia in adult and pediatric patients harboring a KMT2A rearrangement (KMT2Ar).
Following this, revumenib became the first and only investigational treatment for R/R KMT2Ar acute leukemia to be granted a Breakthrough Therapy tag by the FDA.
A Breakthrough Therapy designation is granted to medicines being evaluated for serious conditions where early clinical evidence indicates said medicines’ potential for substantial improvement over available therapies.
Shares of Syndax were up 3.2% in after-hours trading on Monday following the announcement of the news. The stock has improved 16.2% so far this year against the industry’s decline of 16.3%.
Image Source: Zacks Investment Research
The Breakthrough Therapy tag granted to revumenib was based on data from the phase I AUGMENT-101 study. Data from the same showed that treatment with revumenib led to a 27% complete remission (CR)/ CR with partial hematologic recovery (CRh) rate in KMT2A patients treated with the recommended phase II dose.
No discontinuation owing to treatment-related adverse side effects was reported.
Per the company, if approved, revumenib has the potential to become the first drug to treat patients with KMT2Ar leukemia, an area that has a significant unmet medical need.
Syndax plans to file a new drug application for revumenib to treat r/r KMT2A-rearranged acute leukemia by the end of 2023.
SNDX is working with the FDA to speed up the potential approval of revumenib.
Apart from revumenib, Syndax is developing another pipeline candidate, axatilimab, a monoclonal antibody that blocks the colony-stimulating factor 1 (CSF-1) receptor.
In November 2022, Syndax and partner Incyte (INCY - Free Report) completed enrollment in the pivotal AGAVE-201 study evaluating axatilimab in patients with chronic graft-versus-host disease (cGVHD) following two or more prior lines of therapy. Top-line data from the same is expected in mid-2023 while a biologics license application for axatilimab is expected to be filed later in 2023.
Syndax along with Incyte plans to initiate a phase I study evaluating axatilimab in combination with INCY’s ruxolitinib for treating steroid-naive cGVHD in the first quarter of 2023.
SNDX also plans to begin a phase IIb study evaluating the efficacy, safety and tolerability of axatilimab in patients with idiopathic pulmonary fibrosis shortly.
In the absence of a marketed drug, the successful development of its pipeline candidates remains in key focus for Syndax.
Zacks Rank & Other Stocks to Consider
Syndax currently carries a Zacks Rank #1 (Strong Buy). Other top-ranked stocks worth considering in the biotech sector are Repare Therapeutics Inc. (RPTX - Free Report) and Celularity Inc. (CELU - Free Report) , both carrying the same Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Repare Therapeutics have narrowed 76.1% for 2022 and 0.3% for 2023 in the past 60 days.
Earnings of Repare Therapeutics surpassed estimates in three of the trailing four quarters and missed on the other occasion. RPTX witnessed an earnings surprise of 240.65% on average.
Loss per share estimates for Celularity have narrowed 47.6% for 2022 and 6.7% for 2023 in the past 60 days.
Earnings of Celularity surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. CELU witnessed an earnings surprise of 51.01% on average.