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Denali (DNLI) Provides Update on Hunter Syndrome Study
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Denali Therapeutics (DNLI - Free Report) announced positive interim results of the ongoing phase I/II study of DNL310 (ETV:IDS) in children with MPS II, which is also known as Hunter syndrome.
The early-stage study is an open-label, single-arm study, evaluating the efficacy and safety of DNL310 in treating MPS II. DNL310 is an investigational brain-penetrant enzyme replacement therapy designed to address the neurological manifestations of MPS II.
Among the 13 patients who reached the two-year treatment mark at the time of the interim analysis, a significant mean reduction of 64% from baseline in serum neurofilament light (NfL) levels was observed.
NfL is a well-established marker of neuroaxonal damage. It has already demonstrated its utility as a biomarker for assessing therapeutic responses in various neurodegenerative diseases.
Denali recently received a recommendation from the FDA to evaluate NfL as an exploratory endpoint. This assessment aims to determine NfL's potential as a biomarker for diagnosing, predicting outcomes, or evaluating treatment response in individuals with neuronopathic MPS II.
The positive changes observed in clinical outcome measures, along with the robust reduction and normalization of cerebrospinal fluid heparan sulfate, further support the potential of DNL310 as a treatment option for individuals with MPS II.
Shares of Denali have risen 13.7% year to date against the industry’s 7.2% decline.
Image Source: Zacks Investment Research
MPS II is a rare genetic disease that has affected more than 2,000 individuals worldwide. It is caused by mutations in the iduronate-2-sulfatase gene, leading to a deficiency of the iduronate-2-sulfatase enzyme.
Denali will be presenting additional interim data from the phase I/II study of DNL310 later this year.
DNL310 received Fast Track designation from the FDA in March 2021 for treating MPS II patients. Additionally, the European Medicines Agency granted DNL310 the Priority Medicines designation in May 2022. These designations provide the company with additional market exclusivity and expedited regulatory paths.
Denali is enrolling patients to evaluate DNL310 in the phase II/III COMPASS study. The study will enroll approximately 54 MPS II patients. Completion of the ongoing phase I/II study, along together with data from the global COMPASS study, will potentially support registration.
The Zacks Consensus Estimate for Akero Therapeutics has narrowed from a loss of $2.96 per share to a loss of $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have nosedived 0.4% year to date.
AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%.
The consensus estimate for ADMA Biologics has narrowed from a loss of 19 cents per share to 9 cents for 2023 in the past 90 days. Shares of ADMA Biologics have risen 1.3% year to date.
ADMA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
The consensus mark for Omega Therapeutics has narrowed from a loss of $2.51 per share to $2.05 for 2023 in the past 90 days. Shares of the company have rallied 31.1% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.
Image: Bigstock
Denali (DNLI) Provides Update on Hunter Syndrome Study
Denali Therapeutics (DNLI - Free Report) announced positive interim results of the ongoing phase I/II study of DNL310 (ETV:IDS) in children with MPS II, which is also known as Hunter syndrome.
The early-stage study is an open-label, single-arm study, evaluating the efficacy and safety of DNL310 in treating MPS II. DNL310 is an investigational brain-penetrant enzyme replacement therapy designed to address the neurological manifestations of MPS II.
Among the 13 patients who reached the two-year treatment mark at the time of the interim analysis, a significant mean reduction of 64% from baseline in serum neurofilament light (NfL) levels was observed.
NfL is a well-established marker of neuroaxonal damage. It has already demonstrated its utility as a biomarker for assessing therapeutic responses in various neurodegenerative diseases.
Denali recently received a recommendation from the FDA to evaluate NfL as an exploratory endpoint. This assessment aims to determine NfL's potential as a biomarker for diagnosing, predicting outcomes, or evaluating treatment response in individuals with neuronopathic MPS II.
The positive changes observed in clinical outcome measures, along with the robust reduction and normalization of cerebrospinal fluid heparan sulfate, further support the potential of DNL310 as a treatment option for individuals with MPS II.
Shares of Denali have risen 13.7% year to date against the industry’s 7.2% decline.
Image Source: Zacks Investment Research
MPS II is a rare genetic disease that has affected more than 2,000 individuals worldwide. It is caused by mutations in the iduronate-2-sulfatase gene, leading to a deficiency of the iduronate-2-sulfatase enzyme.
Denali will be presenting additional interim data from the phase I/II study of DNL310 later this year.
DNL310 received Fast Track designation from the FDA in March 2021 for treating MPS II patients. Additionally, the European Medicines Agency granted DNL310 the Priority Medicines designation in May 2022. These designations provide the company with additional market exclusivity and expedited regulatory paths.
Denali is enrolling patients to evaluate DNL310 in the phase II/III COMPASS study. The study will enroll approximately 54 MPS II patients. Completion of the ongoing phase I/II study, along together with data from the global COMPASS study, will potentially support registration.
Denali Therapeutics Inc. Price and Consensus
Denali Therapeutics Inc. price-consensus-chart | Denali Therapeutics Inc. Quote
Zacks Rank and Stocks to Consider
Denali currently has a Zacks Rank #3 (Hold).
The Zacks Consensus Estimate for Akero Therapeutics has narrowed from a loss of $2.96 per share to a loss of $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have nosedived 0.4% year to date.
AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%.
The consensus estimate for ADMA Biologics has narrowed from a loss of 19 cents per share to 9 cents for 2023 in the past 90 days. Shares of ADMA Biologics have risen 1.3% year to date.
ADMA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
The consensus mark for Omega Therapeutics has narrowed from a loss of $2.51 per share to $2.05 for 2023 in the past 90 days. Shares of the company have rallied 31.1% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.
Some better-ranked stocks in the biotech sector are Akero Therapeutics (AKRO - Free Report) , ADMA Biologics, Inc. (ADMA - Free Report) and Omega Therapeutics (OMGA - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.