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ARS Pharma (SPRY) Gets FDA Panel Vote for Epinephrine Nasal Spray
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ARS Pharmaceuticals’ (SPRY - Free Report) shares rallied almost 78% on Friday. The significant increase was due to a positive vote for neffy (previously referred to as ARS-1) by an FDA advisory committee for treating severe allergic reactions.
Neffy is a nasal spray device that administers epinephrine to treat severe allergic reactions that could lead to anaphylaxis in both adults and children.
The Pulmonary-Allergy Drug Advisory Committee voted 16:6 in favor of neffy for adults and 17:5 for children.
The vote was based on the review of data from clinical studies developed in agreement with the FDA. This supported a positive risk-benefit profile for intranasal (IN) epinephrine’s safety and effectiveness compared with epinephrine injection.
The studies demonstrated that neffy has comparable pharmacokinetic data, similar or greater pharmacodynamic response, effective IN delivery of systemic epinephrine and comparable safety to an injection without needle-related risks.
Shares of the company have declined 5.7% year to date against the industry's 0.1% growth.
Image Source: Zacks Investment Research
There are approximately 25-40 million people in the United States with type I allergic reactions and only 3.3 million of them have an active epinephrine autoinjector prescription at present.
The nasal spray device is small and needle-free, making it easier for patients and caregivers to carry and administer epinephrine without the anxiety and hesitation associated with a needle-based device.
The new drug application (NDA) for neffy was accepted by the FDA in the fourth quarter of 2022. The FDA will be considering the outcome of the committee’s vote in its review of the drug’s NDA. If approved, neffy would be the first non-injectable treatment available to patients with allergic reactions, including anaphylaxis.
The PDUFA target action date is anticipated in mid-2023. In Europe, market authorization application for the product was filed and validated for review by European Medicines Agency in the fourth quarter of 2022.
Additionally, neffy's sprayer device has been approved by the FDA for drug delivery of six other approved products in the market. One of them is Emergent BioSolutions’ (EBS - Free Report) Narcan nasal spray, an emergency treatment for opioid overdose.
In March, Emergent received over-the-counter status for Narcan. EBS anticipates the OTC version of the drug to be available in the market by late summer this year.
Another nasal spray, Tosymra, marketed by Dr. Reddy's Laboratories (RDY - Free Report) , uses the same intravail formulation as neffy. RDY’s nasal spray is used to treat acute migraine. It was approved by the FDA in 2019.
Loss per share estimates for Ocuphire Pharma have narrowed from 29 cents to 24 cents for 2023 and from 86 cents to 81 cents for 2024 in the past 60 days.
The company’s shares have surged 70.9% in the year-to-date period. Ocuphire’s earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 23.85%.
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ARS Pharma (SPRY) Gets FDA Panel Vote for Epinephrine Nasal Spray
ARS Pharmaceuticals’ (SPRY - Free Report) shares rallied almost 78% on Friday. The significant increase was due to a positive vote for neffy (previously referred to as ARS-1) by an FDA advisory committee for treating severe allergic reactions.
Neffy is a nasal spray device that administers epinephrine to treat severe allergic reactions that could lead to anaphylaxis in both adults and children.
The Pulmonary-Allergy Drug Advisory Committee voted 16:6 in favor of neffy for adults and 17:5 for children.
The vote was based on the review of data from clinical studies developed in agreement with the FDA. This supported a positive risk-benefit profile for intranasal (IN) epinephrine’s safety and effectiveness compared with epinephrine injection.
The studies demonstrated that neffy has comparable pharmacokinetic data, similar or greater pharmacodynamic response, effective IN delivery of systemic epinephrine and comparable safety to an injection without needle-related risks.
Shares of the company have declined 5.7% year to date against the industry's 0.1% growth.
Image Source: Zacks Investment Research
There are approximately 25-40 million people in the United States with type I allergic reactions and only 3.3 million of them have an active epinephrine autoinjector prescription at present.
The nasal spray device is small and needle-free, making it easier for patients and caregivers to carry and administer epinephrine without the anxiety and hesitation associated with a needle-based device.
The new drug application (NDA) for neffy was accepted by the FDA in the fourth quarter of 2022. The FDA will be considering the outcome of the committee’s vote in its review of the drug’s NDA. If approved, neffy would be the first non-injectable treatment available to patients with allergic reactions, including anaphylaxis.
The PDUFA target action date is anticipated in mid-2023. In Europe, market authorization application for the product was filed and validated for review by European Medicines Agency in the fourth quarter of 2022.
Additionally, neffy's sprayer device has been approved by the FDA for drug delivery of six other approved products in the market. One of them is Emergent BioSolutions’ (EBS - Free Report) Narcan nasal spray, an emergency treatment for opioid overdose.
In March, Emergent received over-the-counter status for Narcan. EBS anticipates the OTC version of the drug to be available in the market by late summer this year.
Another nasal spray, Tosymra, marketed by Dr. Reddy's Laboratories (RDY - Free Report) , uses the same intravail formulation as neffy. RDY’s nasal spray is used to treat acute migraine. It was approved by the FDA in 2019.
ARS Pharmaceuticals, Inc. Price and Consensus
ARS Pharmaceuticals, Inc. price-consensus-chart | ARS Pharmaceuticals, Inc. Quote
Zacks Rank and Stock to Consider
ARS Pharmaceuticals currently carries a Zacks Rank #4 (Sell).
A better-ranked stock for investors interested in the same sector is Ocuphire Pharma (OCUP - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Ocuphire Pharma have narrowed from 29 cents to 24 cents for 2023 and from 86 cents to 81 cents for 2024 in the past 60 days.
The company’s shares have surged 70.9% in the year-to-date period. Ocuphire’s earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 23.85%.