neffy is now included in three new formularies, improving access for patients managing Type 1 allergic reactions.
Quiver AI Summary
ARS Pharmaceuticals, Inc. has announced the addition of neffy® (epinephrine nasal spray) to the formularies of Cigna Healthcare, Navitus Health Systems, and OptumRx, expanding access to approximately half of all patients managing Type 1 allergic reactions in the U.S. This brings the total number of formulary platforms covering neffy to 30. With improved coverage, millions of patients can access neffy through commercial insurance at a low copay of $25, without prior authorizations or restrictive measures. This move addresses the critical need for a needle-free epinephrine option, especially for those at risk of anaphylaxis. The company is also working to add neffy to the UnitedHealthcare formulary and offers various assistance programs to help patients navigate coverage challenges. Neffy is the first FDA-approved nasal spray for emergency treatment of Type I allergic reactions and is designed for ease of use and portability.
Potential Positives
- neffy has been included on three additional formularies, expanding access to half of all patients managing Type 1 allergic reactions.
- The addition of neffy improves coverage for approximately 20 million people diagnosed with severe Type I allergic reactions who need epinephrine therapy.
- Patients insured by Cigna Healthcare, Navitus Health Systems, and OptumRx can access neffy at the lowest branded copay of $25 without prior authorizations or restrictive step therapies.
- The company expects further product availability with the supplemental NDA for neffy 1 mg, anticipated to be available by the end of May 2025, expanding the product's reach to younger patients.
Potential Negatives
- Despite the announcement of increased access to neffy through three additional formularies, there is reliance on external health plans and pharmaceutical benefit managers, creating potential uncertainty for future coverage expansions, such as with UnitedHealthcare.
- The press release cites significant challenges related to the adoption of epinephrine auto-injectors, highlighting a market hesitance that could reflect negatively on neffy's potential uptake and revenue generation.
- There are numerous safety warnings and possible adverse reactions associated with neffy, which may deter potential users and impact public perception of the product.
FAQ
What is neffy and its purpose?
neffy is an FDA-approved nasal spray for emergency treatment of Type I allergic reactions, including anaphylaxis, for patients weighing 30 kg or more.
Which health plans now cover neffy?
neffy is now covered by Cigna Healthcare, Navitus Health Systems, and OptumRx, increasing access for patients nationwide.
What are the cost benefits of neffy?
Patients may qualify for a low copay of $25 through ARS Pharma’s assistance when prescribed neffy, with no prior authorization needed.
What is the significance of neffy’s formulary expansion?
The addition of neffy to new formularies expands access to half of patients managing Type 1 allergic reactions, enhancing treatment availability.
When will the 1 mg version of neffy be available?
The expected availability of neffy 1 mg for children weighing 15 to 30 kg is anticipated by the end of May 2025, pending approval.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$SPRY Insider Trading Activity
$SPRY insiders have traded $SPRY stock on the open market 73 times in the past 6 months. Of those trades, 0 have been purchases and 73 have been sales.
Here’s a breakdown of recent trading of $SPRY stock by insiders over the last 6 months:
- RICHARD E LOWENTHAL (PRESIDENT AND CEO) has made 0 purchases and 19 sales selling 800,000 shares for an estimated $10,876,472.
- SARINA TANIMOTO (CHIEF MEDICAL OFFICER) has made 0 purchases and 19 sales selling 800,000 shares for an estimated $10,876,472.
- JAMES E FLYNN has made 0 purchases and 8 sales selling 563,270 shares for an estimated $10,143,705.
- JUSTIN CHAKMA (Chief Business Officer) has made 0 purchases and 11 sales selling 529,245 shares for an estimated $7,087,279.
- LAURA SHAWVER has made 0 purchases and 6 sales selling 300,000 shares for an estimated $3,859,380.
- ADVISORS LLC ORBIMED has made 0 purchases and 2 sales selling 153,195 shares for an estimated $1,993,620.
- PETER A. THOMPSON has made 0 purchases and 2 sales selling 153,195 shares for an estimated $1,993,620.
- BRIAN DORSEY (Chief Operating Officer) has made 0 purchases and 2 sales selling 40,000 shares for an estimated $493,858.
- ERIC KARAS (Chief Commercial Officer) has made 0 purchases and 3 sales selling 20,000 shares for an estimated $280,423.
- KATHLEEN D. SCOTT (Chief Financial Officer) sold 12,500 shares for an estimated $200,000
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$SPRY Hedge Fund Activity
We have seen 85 institutional investors add shares of $SPRY stock to their portfolio, and 71 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ALLIANCEBERNSTEIN L.P. added 3,807,074 shares (+5168.4%) to their portfolio in Q4 2024, for an estimated $40,164,630
- ALYESKA INVESTMENT GROUP, L.P. added 1,128,724 shares (+903.0%) to their portfolio in Q4 2024, for an estimated $11,908,038
- UBS GROUP AG added 902,819 shares (+821.6%) to their portfolio in Q4 2024, for an estimated $9,524,740
- PERCEPTIVE ADVISORS LLC removed 867,319 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $12,576,125
- FRANKLIN RESOURCES INC removed 860,840 shares (-30.3%) from their portfolio in Q4 2024, for an estimated $9,081,862
- STATE STREET CORP added 700,359 shares (+34.2%) to their portfolio in Q4 2024, for an estimated $7,388,787
- RUBRIC CAPITAL MANAGEMENT LP removed 639,203 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $9,268,443
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
Approximately five months after launch, the inclusion of
neffy
on these three additional formularies has expanded access to half of all patients and caregivers managing Type 1 allergic reactions, bringing the total number of formulary platforms covering
neffy
to 30
SAN DIEGO, Feb. 20, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from allergic reactions that could lead to anaphylaxis, announced today that Cigna Healthcare, Navitus Health Systems and OptumRx, through their Group Purchasing Organization (GPO) Emisar, have added
neffy
®
(epinephrine nasal spray) to their National Formularies.
“Millions of patients nationwide now have improved access to
neffy
through their commercial insurance, thanks to coverage from leading pharmaceutical benefit managers and health plans.
neffy
will also be available at the lowest branded copay for patients insured by OptumRx, Cigna Healthcare, and Navitus Health Systems - without the need for prior authorizations or restrictive step therapies,” said Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma. “As a result, more patients will qualify for the low copay price of $25 for
neffy
,
when they apply the ARS Pharma copay assistance, and healthcare providers can prescribe it without the need for additional paperwork.”
“This announcement also underscores the critical demand for a nasal spray epinephrine option within the severe allergy community and we remain committed to ensuring continued access for as many patients and caregivers as possible. While Emisar represents both OptumRx and UnitedHealthcare as their GPO at this time only OptumRx has agreed to the Emisar terms. ARS Pharma is working closely with UnitedHealthcare, as one of the country’s largest healthcare providers, to add
neffy
to their formulary as soon as possible,” said Lowenthal.
The addition of
neffy
to these formularies improves coverage for the approximately 20 million people who have been diagnosed and treated for the more severe Type I allergic reactions that may lead to anaphylaxis and need epinephrine therapy to protect themselves in their daily lives. To assist patients in navigating coverage and affordability challenges, ARS Pharma offers a number of programs for patients and caregivers. For more information, visit
www.neffy.com/savings
.
neffy
2 mg is for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh ≥30 kg (66 lbs.). It is the first and only FDA-approved epinephrine nasal spray that provides a needle-free alternative to traditional injectable epinephrine. It’s simple and intuitive design enables rapid administration, helping patients and caregivers act quickly and confidently, and the small size is easy to carry. Additionally,
neffy
has a shelf-life of 30 months and temperature exclusions up to 122 degrees Fahrenheit.
The supplemental NDA for
neffy
1 mg
, for children over four years of age who weigh 15 to 30 kg, has a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025. Based on review timelines and subject to approval, product availability of
neffy
1 mg
is expected by the end of May 2025. ARS Pharma anticipates that by the epinephrine prescription renewal period, which occurs over the summer for many children in the United States, that school age children who meet the weight and age criteria will have access to
neffy
.
About
neffy
®
neffy
is an intranasal epinephrine product for patients with Type I allergic reactions including food, medications, and insect bites that could lead to life-threatening anaphylaxis.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR
neffy
(epinephrine nasal spray)
INDICATION
neffy
2 mg is indicated for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater.
IMPORTANT SAFETY INFORMATION
It is recommended that patients are prescribed and have immediate access to two
neffy
nasal sprays at all times. In the absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of
neffy
in the same nostril with a new nasal spray starting 5 minutes after the first dose.
neffy
is for use in the nose only.
Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.
Absorption of
neffy
may be affected by underlying structural or anatomical nasal conditions.
Administer with caution to patients who have heart disease; epinephrine may aggravate angina pectoris or produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or taking cardiac glycosides, diuretics, or anti-arrhythmics.
The presence of a sulfite in
neffy
should not deter use.
neffy
may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including
neffy
.
Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions.
Epinephrine can temporarily exacerbate the underlying condition or increase symptoms in patients with the following: hyperthyroidism, Parkinson’s disease, diabetes, renal impairment. Epinephrine should be administered with caution in patients with these conditions, including elderly patients and pregnant women.
Adverse reactions to
neffy
may include throat irritation, intranasal paresthesia, headache, nasal discomfort, feeling jittery, paresthesia, fatigue, tremor, rhinorrhea, nasal pruritus, sneezing, abdominal pain, gingival pain, hypoesthesia oral, nasal congestion, dizziness, nausea, and vomiting.
These are not all of the possible side effects of
neffy
. To report suspected adverse reactions, contact ARS Pharmaceuticals Operations, Inc. at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
.
For additional information on
neffy
, please see Full Prescribing Information at
www.
neffy
.com
.
About Type I Allergic Reactions Including Anaphylaxis
Type I allergic reactions are serious and potentially life-threatening 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. While epinephrine auto-injectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, over the last three years, approximately 20 million people have been diagnosed and treated for severe Type I allergic reactions that may lead to anaphylaxis, but (in 2023, for example) only 3.2 million filled their active epinephrine auto-injector prescription, and of those, only half consistently carry their prescribed auto-injector. Even if patients or caregivers carry an auto-injector, more than half either delay or do not administer the device when needed in an emergency.
About ARS Pharmaceuticals, Inc.
ARS Pharmaceuticals is a biopharmaceutical company dedicated to empowering at-risk patients and their caregivers to better protect patients from allergic reactions that could lead to anaphylaxis. The Company is commercializing
neffy
®
2 mg (trade name
EUR
neffy
®
in the EU) (previously referred to as ARS-1), an epinephrine nasal spray indicated in the U.S. for emergency treatment of Type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 30 kg or greater, and in the EU for emergency treatment of allergic reactions (anaphylaxis) due to insect stings or bites, foods, medicinal products, and other allergens as well as idiopathic or exercise induced anaphylaxis in adults and children who weigh 30 kg or greater. For more information, visit
www.ars-pharma.com
.
Forward-Looking Statements
Statements in this press release that are not purely historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the expected impact from the inclusion of
neffy
on OptumRx, Cigna Healthcare and Navitus Health Systems’ National Formularies; ARS Pharmaceuticals’ expectation that other payors, such as UnitedHealthcare, will agree to terms to provide access to
neffy
and the timing by which they will provide such access, the critical demand for a nasal spray epinephrine option, the expectation that
neffy
will save lives; the effectiveness of
neffy
; the expected timing for product availability of
neffy
1 mg
; and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “expects,” “if,” “may,” “potential,” “on track to,” “plans,” “will,” “would,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharmaceuticals’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: potential safety and other complications from
neffy
; ARS Pharmaceuticals’ reliance on its licensing partners; the ability to maintain regulatory approval for
neffy
in its currently approved indication and to obtain and maintain regulatory approval for
neffy
for additional indications; the labelling for
neffy
in any future indication or patient population, if approved; the scope, progress and expansion of developing and commercializing
neffy
; the potential for governments and payors to delay, limit or deny coverage for
neffy
; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-à-vis intramuscular injectable products; ARS Pharmaceuticals’ ability to protect its intellectual property position; and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption “Risk Factors” in ARS Pharmaceuticals’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the Securities and Exchange Commission (“SEC”) on November 13, 2024. These documents can also be accessed on ARS Pharmaceuticals’ website at www.ars-pharma.com by clicking on the link “Financials & Filings” under the “Investors & Media” tab.
The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharmaceuticals assumes no obligation and does not intend to update these forward-looking statements, except as required by law. For more information, visit
www.ars-pharma.com
, and follow us on
LinkedIn
and
X
.
ARS Investor Contact:
Justin Chakma
ARS Pharmaceuticals
justinc@ars-pharma.com
ARS Media Contact:
Christy Curran
Sam Brown Inc.
615.414.8668
christycurran@sambrown.com
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