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Orchard's (ORTX) Rare Neuro Drug Gets FDA Priority Tag, Stock Up
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Orchard Therapeutics announced that the FDA has accepted its biologics license application (BLA) for OTL-200 to treat pediatric patients with metachromatic leukodystrophy (MLD) under Priority Review. A decision from the regulatory body is expected on Mar 18, 2024.
The BLA filing is based on the positive results from two clinical studies evaluating the efficacy of OTL-200 in 39 pediatric patients with early-onset MLD compared with natural history data from 49 untreated patients. Per Orchard, it was observed that the treatment with OTL-200 resulted in the preservation of motor function and cognitive development in most patients compared with disease natural history with up to 12 years of follow-up.
OTL-200 was also found to be generally well-tolerated in the patient population with no treatment-related serious adverse events or deaths.
Shares of the company soared 16.4% in the last trading session due to the encouraging news. Year to date, shares of ORTX have shot up 61.7% against the industry’s 14% fall.
Image Source: Zacks Investment Research
Notably, OTL-200 enjoys both Rare Pediatric Disease and Regenerative Medicine Advanced Therapy designations from the FDA. The drug is also currently approved in the EU, U.K., Iceland, Liechtenstein and Norway. It is marketed under the brand name, Libmeldy (atidarsagene autotemcel), for the treatment of MLD in pediatric patients.
Per Orchard, Libmeldy is the first therapy approved for eligible patients with early-onset MLD.
MLD is a rare hereditary disease of the body’s metabolic system which affects approximately one in every 100,000 live births. It causes damage to the nervous system over a period of time, resulting in neurological problems, such as motor, behavioral and cognitive regression, severe spasticity and seizures.
MLD takes a serious toll on the quality of life of patients suffering from it as they gradually lose the ability to move, talk, swallow, eat and see.
Potential approval in the MLD indication could boost the company significantly, generating revenues to meet operational goals.
Orchard Therapeutics PLC Sponsored ADR Price and Consensus
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has remained constant at 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have risen by 27.5%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 59.1%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
In the past 30 days, the Zacks Consensus Estimate for Better Therapeutics’ 2023 loss per share has remained constant at 98 cents. During the same period, Better Therapeutics’ 2024 loss per share has also remained constant at 80 cents. Year to date, shares of BTTX have lost 57%.
BTTX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 24.22%.
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Orchard's (ORTX) Rare Neuro Drug Gets FDA Priority Tag, Stock Up
Orchard Therapeutics announced that the FDA has accepted its biologics license application (BLA) for OTL-200 to treat pediatric patients with metachromatic leukodystrophy (MLD) under Priority Review. A decision from the regulatory body is expected on Mar 18, 2024.
The BLA filing is based on the positive results from two clinical studies evaluating the efficacy of OTL-200 in 39 pediatric patients with early-onset MLD compared with natural history data from 49 untreated patients. Per Orchard, it was observed that the treatment with OTL-200 resulted in the preservation of motor function and cognitive development in most patients compared with disease natural history with up to 12 years of follow-up.
OTL-200 was also found to be generally well-tolerated in the patient population with no treatment-related serious adverse events or deaths.
Shares of the company soared 16.4% in the last trading session due to the encouraging news. Year to date, shares of ORTX have shot up 61.7% against the industry’s 14% fall.
Image Source: Zacks Investment Research
Notably, OTL-200 enjoys both Rare Pediatric Disease and Regenerative Medicine Advanced Therapy designations from the FDA. The drug is also currently approved in the EU, U.K., Iceland, Liechtenstein and Norway. It is marketed under the brand name, Libmeldy (atidarsagene autotemcel), for the treatment of MLD in pediatric patients.
Per Orchard, Libmeldy is the first therapy approved for eligible patients with early-onset MLD.
MLD is a rare hereditary disease of the body’s metabolic system which affects approximately one in every 100,000 live births. It causes damage to the nervous system over a period of time, resulting in neurological problems, such as motor, behavioral and cognitive regression, severe spasticity and seizures.
MLD takes a serious toll on the quality of life of patients suffering from it as they gradually lose the ability to move, talk, swallow, eat and see.
Potential approval in the MLD indication could boost the company significantly, generating revenues to meet operational goals.
Orchard Therapeutics PLC Sponsored ADR Price and Consensus
Orchard Therapeutics PLC Sponsored ADR price-consensus-chart | Orchard Therapeutics PLC Sponsored ADR Quote
Zacks Rank and Other Stocks to Consider
Orchard currently has a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the overall medical sector, worth mentioning, are Dynavax Technologies (DVAX - Free Report) , Corcept Therapeutics (CORT - Free Report) and Better Therapeutics (BTTX - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has remained constant at 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 3 cents. Year to date, shares of DVAX have risen by 27.5%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 59.1%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
In the past 30 days, the Zacks Consensus Estimate for Better Therapeutics’ 2023 loss per share has remained constant at 98 cents. During the same period, Better Therapeutics’ 2024 loss per share has also remained constant at 80 cents. Year to date, shares of BTTX have lost 57%.
BTTX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 24.22%.