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Rocket (RCKT) Heart Disease Drug Gets Fast Track & Orphan Drug Tag
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Rocket Pharmaceuticals (RCKT - Free Report) announced that the FDA has granted fast track designation as well as orphan drug designation to its gene therapy candidate, RP-A601, for the treatment of plakophilin-2 related arrhythmogenic cardiomyopathy (PKP2-ACM). RP-A601 is the company’s proprietary adeno-associated virus-based gene therapy.
The designations granted by the FDA are based on the extensive proof-of-concept data presented by Rocket for RP-A601, from preclinical studies, which showed decreased arrhythmias and increased survival in PKP2-ACM patients. The company also recently received clearance for its investigational new drug (IND) application for RP-A601 on the back of the reported preclinical data.
The stock of the company gained 2.3% in the after-market hours on Thursday, following the positive news. So far this year, shares of Rocket have gained 19.9% against the industry’s 7.6% fall.
Image Source: Zacks Investment Research
The FDA’s fast track designations intend to expedite development and review timelines when preliminary nonclinical and clinical evidence indicates the drug may demonstrate substantial improvement over available therapies to address unmet medical needs for serious or life-threatening conditions. The fast track tag enables close communication between the FDA and sponsor to improve the efficiency of product development to get new therapeutics to patients faster.
The orphan drug designation, on the other hand, will grant Rocket’s market exclusivity for a predefined time period for the above indication, along with the exemption of FDA application fees and tax credits for qualified clinical studies, all subject to approval. This designation is granted to support the development of medicines for rare disorders that affect fewer than 200,000 patients in the United States.
PKP2-ACM is a progressive and inherited heart disease that can cause life-threatening arrhythmias, cardiac structural abnormalities and sudden cardiac death. The current standard-of-care treatment regimens include medical therapy, implantable cardioverter defibrillators (ICDs) and ablation procedures, but none of them ensure a cure. RCKT estimates an approximate number of 50,000 people in the United States and EU who are affected by this disease.
Currently, Rocket is initiating a phase I dose-escalation study to evaluate the safety and preliminary efficacy of RP-A601 in at least six adult PKP2-ACM patients with ICDs and who have an overall high risk for life-threatening arrhythmias. The study aims to assess the impact of RP-A601 on certain pre-determined concerns.
In the past 90 days, the Zacks Consensus Estimate for Adaptimmune Therapeutics’ 2023 loss per share has remained stable at 46 cents. During the same period, the estimate for Adaptimmune Therapeutics’ 2024 loss per share has narrowed from 74 cents to 56 cents. In the year so far, shares of Adaptimmune Therapeutics have fallen by 30.8%.
ADAP beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 36.89%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.80. During the same period, the estimate for Akero Therapeutics’ 2024 loss per share has narrowed from $3.66 to $3.32. In the year so far, shares of Akero Therapeutics have fallen by 5.7%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. The consensus estimate for ADMA Biologics’ 2024 earnings is pegged at 7 cents per share. In the year so far, shares of ADMA Biologics have gained by 2.3%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
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Rocket (RCKT) Heart Disease Drug Gets Fast Track & Orphan Drug Tag
Rocket Pharmaceuticals (RCKT - Free Report) announced that the FDA has granted fast track designation as well as orphan drug designation to its gene therapy candidate, RP-A601, for the treatment of plakophilin-2 related arrhythmogenic cardiomyopathy (PKP2-ACM). RP-A601 is the company’s proprietary adeno-associated virus-based gene therapy.
The designations granted by the FDA are based on the extensive proof-of-concept data presented by Rocket for RP-A601, from preclinical studies, which showed decreased arrhythmias and increased survival in PKP2-ACM patients. The company also recently received clearance for its investigational new drug (IND) application for RP-A601 on the back of the reported preclinical data.
The stock of the company gained 2.3% in the after-market hours on Thursday, following the positive news. So far this year, shares of Rocket have gained 19.9% against the industry’s 7.6% fall.
Image Source: Zacks Investment Research
The FDA’s fast track designations intend to expedite development and review timelines when preliminary nonclinical and clinical evidence indicates the drug may demonstrate substantial improvement over available therapies to address unmet medical needs for serious or life-threatening conditions. The fast track tag enables close communication between the FDA and sponsor to improve the efficiency of product development to get new therapeutics to patients faster.
The orphan drug designation, on the other hand, will grant Rocket’s market exclusivity for a predefined time period for the above indication, along with the exemption of FDA application fees and tax credits for qualified clinical studies, all subject to approval. This designation is granted to support the development of medicines for rare disorders that affect fewer than 200,000 patients in the United States.
PKP2-ACM is a progressive and inherited heart disease that can cause life-threatening arrhythmias, cardiac structural abnormalities and sudden cardiac death. The current standard-of-care treatment regimens include medical therapy, implantable cardioverter defibrillators (ICDs) and ablation procedures, but none of them ensure a cure. RCKT estimates an approximate number of 50,000 people in the United States and EU who are affected by this disease.
Currently, Rocket is initiating a phase I dose-escalation study to evaluate the safety and preliminary efficacy of RP-A601 in at least six adult PKP2-ACM patients with ICDs and who have an overall high risk for life-threatening arrhythmias. The study aims to assess the impact of RP-A601 on certain pre-determined concerns.
Rocket Pharmaceuticals, Inc. Price and Consensus
Rocket Pharmaceuticals, Inc. price-consensus-chart | Rocket Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Rocket Pharmaceuticals currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Adaptimmune Therapeutics , Akero Therapeutics (AKRO - Free Report) and ADMA Biologics, Inc. (ADMA - 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.
In the past 90 days, the Zacks Consensus Estimate for Adaptimmune Therapeutics’ 2023 loss per share has remained stable at 46 cents. During the same period, the estimate for Adaptimmune Therapeutics’ 2024 loss per share has narrowed from 74 cents to 56 cents. In the year so far, shares of Adaptimmune Therapeutics have fallen by 30.8%.
ADAP beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 36.89%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.80. During the same period, the estimate for Akero Therapeutics’ 2024 loss per share has narrowed from $3.66 to $3.32. In the year so far, shares of Akero Therapeutics have fallen by 5.7%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. The consensus estimate for ADMA Biologics’ 2024 earnings is pegged at 7 cents per share. In the year so far, shares of ADMA Biologics have gained by 2.3%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.