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ARS Pharmaceuticals (SPRY) Down on CRL for Nasal Spray
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Shares of ARS Pharmaceuticals, Inc. (SPRY - Free Report) plummeted 55.8% on Sep 20 after the company received a complete response letter (CRL) regarding its new drug application (NDA) for its nasal spray neffy (epinephrine nasal spray).
The NDA was seeking approval of neffy in the treatment of allergic reactions (type I), including anaphylaxis for adults and children ≥30 kg.
The FDA requested the completion of a pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy compared with repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions to support approval.
The cost outlay of another study and the delay in approval have most likely disappointed investors, as neffy is the company’s lead candidate.
Shares of the company have plunged 41.5% year-to-date compared with the industry's 6.9% decline.
Image Source: Zacks Investment Research
These type I severe allergic reactions are deadly events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions.
Although epinephrine autoinjectors have been shown to be highly effective, there are well-published limitations (like fear of the needle, lack of portability, needle-related safety concerns and lack of reliability) that result in many patients and caregivers delaying or not administering treatment in an emergency.
Neffy is a needle-free option for such emergencies and is supposedly an alternative to injections like EpiPen.
The CRL was unexpected, as the FDA Advisory Committee in May 2023 recommended approving neffy without the need for additional studies to demonstrate its efficacy or safety. The committee voted 16:6 in favor of adults and 17:5 in favor of children (≥30 kg) for the treatment of patients with allergic reactions (Type I), including anaphylaxis.
None of the committee members had then raised specific concerns about the result of the completed study in people with allergen-induced acute rhinitis with single-dose neffy, which showed enhanced absorption during the time period when a clinical response would be expected.
The company and the regulatory body had previously aligned in August 2023 on physician’s labeling and a post-marketing requirement to conduct this study as informative for labeling.
As the company had previously agreed with the FDA to conduct a repeat-dose study under allergen-induced allergic rhinitis conditions as a post-marketing commitment, ARS Pharma anticipates a resubmission to the FDA in the first half of 2024, positioning it for an anticipated FDA action date in the second half of 2024.
The company expects to have cash, cash equivalents and short-term investments on hand of approximately $195 million at the anticipated launch time of neffy, assuming tentative approval in the second half of 2024.
The CRL requested additional information on nitrosamine impurities to be tested for, based on the new draft guidance issued after the NDA submission. Hence, ARS Pharma does not believe the additional testing would be a rate-limiting step for its resubmission to the FDA.
A marketing authorization application for the nasal spray is also under review by the European Medicines Agency, with a Committee for Medicinal Products for Human Use opinion expected by 2023-end. Submissions to other regulatory authorities in additional countries are planned for 2024.
Zacks Rank and Stocks to Consider
ARS Pharmaceuticals currently carries a Zacks Rank #3 (Hold).
Some well-placed stocks in the industry are Eton Pharmaceuticals (ETON - Free Report) and Dynavax Technologies (DVAX - Free Report) . Eton currently carries a Zacks Rank #1 (Strong Buy) and Dynavax carries a Rank #2 (Buy).
Loss estimates for Eton for 2023 have narrowed to 10 cents from 31 cents in the past 60 days, while earnings estimates for 2024 are pegged at 26 cents per share.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pegged at 3 cents per share.
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ARS Pharmaceuticals (SPRY) Down on CRL for Nasal Spray
Shares of ARS Pharmaceuticals, Inc. (SPRY - Free Report) plummeted 55.8% on Sep 20 after the company received a complete response letter (CRL) regarding its new drug application (NDA) for its nasal spray neffy (epinephrine nasal spray).
The NDA was seeking approval of neffy in the treatment of allergic reactions (type I), including anaphylaxis for adults and children ≥30 kg.
The FDA requested the completion of a pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy compared with repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions to support approval.
The cost outlay of another study and the delay in approval have most likely disappointed investors, as neffy is the company’s lead candidate.
Shares of the company have plunged 41.5% year-to-date compared with the industry's 6.9% decline.
Image Source: Zacks Investment Research
These type I severe allergic reactions are deadly events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions.
Although epinephrine autoinjectors have been shown to be highly effective, there are well-published limitations (like fear of the needle, lack of portability, needle-related safety concerns and lack of reliability) that result in many patients and caregivers delaying or not administering treatment in an emergency.
Neffy is a needle-free option for such emergencies and is supposedly an alternative to injections like EpiPen.
The CRL was unexpected, as the FDA Advisory Committee in May 2023 recommended approving neffy without the need for additional studies to demonstrate its efficacy or safety. The committee voted 16:6 in favor of adults and 17:5 in favor of children (≥30 kg) for the treatment of patients with allergic reactions (Type I), including anaphylaxis.
None of the committee members had then raised specific concerns about the result of the completed study in people with allergen-induced acute rhinitis with single-dose neffy, which showed enhanced absorption during the time period when a clinical response would be expected.
The company and the regulatory body had previously aligned in August 2023 on physician’s labeling and a post-marketing requirement to conduct this study as informative for labeling.
As the company had previously agreed with the FDA to conduct a repeat-dose study under allergen-induced allergic rhinitis conditions as a post-marketing commitment, ARS Pharma anticipates a resubmission to the FDA in the first half of 2024, positioning it for an anticipated FDA action date in the second half of 2024.
The company expects to have cash, cash equivalents and short-term investments on hand of approximately $195 million at the anticipated launch time of neffy, assuming tentative approval in the second half of 2024.
The CRL requested additional information on nitrosamine impurities to be tested for, based on the new draft guidance issued after the NDA submission. Hence, ARS Pharma does not believe the additional testing would be a rate-limiting step for its resubmission to the FDA.
A marketing authorization application for the nasal spray is also under review by the European Medicines Agency, with a Committee for Medicinal Products for Human Use opinion expected by 2023-end. Submissions to other regulatory authorities in additional countries are planned for 2024.
Zacks Rank and Stocks to Consider
ARS Pharmaceuticals currently carries a Zacks Rank #3 (Hold).
Some well-placed stocks in the industry are Eton Pharmaceuticals (ETON - Free Report) and Dynavax Technologies (DVAX - Free Report) . Eton currently carries a Zacks Rank #1 (Strong Buy) and Dynavax carries a Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for Eton for 2023 have narrowed to 10 cents from 31 cents in the past 60 days, while earnings estimates for 2024 are pegged at 26 cents per share.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pegged at 3 cents per share.