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Stoke Therapeutics (STOK) Up on Upbeat Dravet Syndrome Study Data
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Stoke Therapeutics, Inc. (STOK - Free Report) reported encouraging new data from two phase I/IIa studies and two open-label extension (OLE) studies evaluating investigational candidate,STK-001, in children and adolescents aged two to 18 years with Dravet syndrome.
STK-001 is Stoke Therapeutics’ novel proprietary antisense oligonucleotide with the potential to become the first disease-modifying therapy to address the genetic cause of Dravet syndrome, rather than just treating the symptoms like currently available treatments.
Per the data readout from the studies, treatment with STK-001 demonstrated clinically meaningful effects, including substantial and durable reductions in convulsive seizure frequency and improvements in multiple measures of cognition and behavior that support the potential for disease modification.
These positive effects of treatment with STK-001 were observed in a highly refractory group of patients already taking the best available anti-seizure medicines. The candidate has also been overall well tolerated in the studies to date, with an acceptable safety profile.
Stoke Therapeutics also reported that the FDA has allowed the company to treat patients with three doses of STK-001 70mg followed by continued dosing at 45mg.
The company is currently gearing up to meet with regulatory agencies to discuss a registrational study that includes initial doses of STK-001 70mg followed by continued dosing at 45mg in Dravet syndrome patients, based on the regulatory update and positive data from the studies of the candidate. An update regarding the same is expected later in 2024.
Stoke Therapeutics’ stock rallied 58.3% on Mar 26 and continued to gain another 5% in the after-market hours as the investors cheered the encouraging regulatory and development update for STK-001. In the past year, shares of STOK have gained 28.1% against the industry’s 8.5% decline.
Image Source: Zacks Investment Research
The two separate phase I/IIa studies evaluated one, two or three doses of STK-001 70mg in children and adolescents who have an established diagnosis of Dravet syndrome.
In the one dose of STK-001 70mg cohort, patients achieved a median reduction of 43% and 57% in convulsive seizure frequency from baseline at three months and six months after the last dose, respectively.
Similarly, in the two or three doses of STK-001 70mg cohort, patients achieved a median reduction of 85% and 74% in convulsive seizure frequency from baseline at three months and six months after the last dose, respectively.
The two OLE studies enrolled eligible Dravet syndrome patients who completed treatment in the phase I/IIa studies of STK-001. Continued treatment with the candidate resulted in durable reductions in convulsive seizure frequency. Improvements in multiple measures of cognition and behavior were also observed in the OLEs.
In a separate press release, Stoke Therapeutics also reported its fourth-quarter 2024 financial results. The company reported a loss of 60 cents per share, narrower than the Zacks Consensus Estimate of a loss of 62 cents.
The company reported revenues of $3 million in the fourth quarter of 2023, which missed the Zacks Consensus Estimate of $4 million. Stoke Therapeutics earns revenues from upfront license fees and services provided under a license and collaboration agreement with Acadia Pharmaceuticals.
Research and development expenses were $21.8 million in the reported quarter, marginally up from the $21.1 million reported in the year-ago quarter.
General and administrative expenses were $10.6 million in the fourth quarter of 2023, up about 13% from the year-ago quarter.
Operating expenses increased primarily due to improvements in costs associated with operations and development activities for pipeline candidates.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. In the past year, shares of ADMA have surged 102.5%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. In the past year, shares of FGEN have plunged 87%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2024 loss per share has narrowed from $1.81 to $1.72. During the same period, the consensus estimate for Adicet’s 2025 loss per share has narrowed from $1.87 to $1.84. In the past year, shares of ACET have plunged 59.4%.
ACET beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average negative surprise of 0.17%.
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Stoke Therapeutics (STOK) Up on Upbeat Dravet Syndrome Study Data
Stoke Therapeutics, Inc. (STOK - Free Report) reported encouraging new data from two phase I/IIa studies and two open-label extension (OLE) studies evaluating investigational candidate,STK-001, in children and adolescents aged two to 18 years with Dravet syndrome.
STK-001 is Stoke Therapeutics’ novel proprietary antisense oligonucleotide with the potential to become the first disease-modifying therapy to address the genetic cause of Dravet syndrome, rather than just treating the symptoms like currently available treatments.
Per the data readout from the studies, treatment with STK-001 demonstrated clinically meaningful effects, including substantial and durable reductions in convulsive seizure frequency and improvements in multiple measures of cognition and behavior that support the potential for disease modification.
These positive effects of treatment with STK-001 were observed in a highly refractory group of patients already taking the best available anti-seizure medicines. The candidate has also been overall well tolerated in the studies to date, with an acceptable safety profile.
Stoke Therapeutics also reported that the FDA has allowed the company to treat patients with three doses of STK-001 70mg followed by continued dosing at 45mg.
The company is currently gearing up to meet with regulatory agencies to discuss a registrational study that includes initial doses of STK-001 70mg followed by continued dosing at 45mg in Dravet syndrome patients, based on the regulatory update and positive data from the studies of the candidate. An update regarding the same is expected later in 2024.
Stoke Therapeutics’ stock rallied 58.3% on Mar 26 and continued to gain another 5% in the after-market hours as the investors cheered the encouraging regulatory and development update for STK-001. In the past year, shares of STOK have gained 28.1% against the industry’s 8.5% decline.
Image Source: Zacks Investment Research
The two separate phase I/IIa studies evaluated one, two or three doses of STK-001 70mg in children and adolescents who have an established diagnosis of Dravet syndrome.
In the one dose of STK-001 70mg cohort, patients achieved a median reduction of 43% and 57% in convulsive seizure frequency from baseline at three months and six months after the last dose, respectively.
Similarly, in the two or three doses of STK-001 70mg cohort, patients achieved a median reduction of 85% and 74% in convulsive seizure frequency from baseline at three months and six months after the last dose, respectively.
The two OLE studies enrolled eligible Dravet syndrome patients who completed treatment in the phase I/IIa studies of STK-001. Continued treatment with the candidate resulted in durable reductions in convulsive seizure frequency. Improvements in multiple measures of cognition and behavior were also observed in the OLEs.
In a separate press release, Stoke Therapeutics also reported its fourth-quarter 2024 financial results. The company reported a loss of 60 cents per share, narrower than the Zacks Consensus Estimate of a loss of 62 cents.
The company reported revenues of $3 million in the fourth quarter of 2023, which missed the Zacks Consensus Estimate of $4 million. Stoke Therapeutics earns revenues from upfront license fees and services provided under a license and collaboration agreement with Acadia Pharmaceuticals.
Research and development expenses were $21.8 million in the reported quarter, marginally up from the $21.1 million reported in the year-ago quarter.
General and administrative expenses were $10.6 million in the fourth quarter of 2023, up about 13% from the year-ago quarter.
Operating expenses increased primarily due to improvements in costs associated with operations and development activities for pipeline candidates.
Stoke Therapeutics, Inc. Price and Consensus
Stoke Therapeutics, Inc. price-consensus-chart | Stoke Therapeutics, Inc. Quote
Zacks Rank and Other Stocks to Consider
Stoke Therapeutics currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the drug/biotech industry worth mentioning are ADMA Biologics (ADMA - Free Report) , FibroGen (FGEN - Free Report) and Adicet Bio, Inc. (ACET - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN and ACET carry a Zacks Rank #2 each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. In the past year, shares of ADMA have surged 102.5%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. In the past year, shares of FGEN have plunged 87%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2024 loss per share has narrowed from $1.81 to $1.72. During the same period, the consensus estimate for Adicet’s 2025 loss per share has narrowed from $1.87 to $1.84. In the past year, shares of ACET have plunged 59.4%.
ACET beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average negative surprise of 0.17%.