SAN DIEGO - ARS Pharmaceuticals, Inc. (NASDAQ:SPRY), a $1.2 billion market cap biotech company whose stock has surged over 137% in the past year, has announced that its partners in China, Japan, and Australia have submitted regulatory filings for the approval of neffy® (epinephrine nasal spray) 2 mg, a treatment for severe allergic reactions including anaphylaxis. This move follows the recent U.S. approval of neffy for adults and children weighing at least 30 kg (66 lbs). According to InvestingPro data, the company's strong momentum has attracted significant investor attention, with 12 additional exclusive insights available to subscribers.
According to Richard Lowenthal, President and CEO of ARS Pharmaceuticals, the company's goal is to make neffy globally available, emphasizing its needle-free administration and suitability for the Asia Pacific market due to its small size, high-temperature tolerance, and extended shelf life. Analysts tracked by InvestingPro project substantial sales growth for the current year, with revenue expected to increase by over 267%.
Clinical trials conducted in Japan and China have been supportive of the filings. In Japan, a Phase 3 study involving pediatric patients showed that all participants responded to neffy, with a median time to complete resolution of anaphylaxis symptoms of 16 minutes. Similarly, an 81-person PK/PD study in China yielded results consistent with U.S. clinical trials.
ARS Pharmaceuticals retains U.S. rights for neffy and has established licensing partnerships in China, Japan, Australia, and New Zealand with Pediatrix Therapeutics, Alfresa Pharma, and CSL (OTC:CSLLY) Seqirus, respectively. Additionally, ARS has an exclusive agreement with ALK-Abelló for the commercialization of neffy in Europe, Canada, and other non-U.S. territories, with EU approval granted in August 2024. The company maintains a strong financial position with more cash than debt on its balance sheet and a healthy current ratio of 12.56, indicating robust liquidity to support its global expansion plans. For deeper insights into SPRY's financial health and growth potential, investors can access comprehensive analysis through InvestingPro.
neffy is an intranasal epinephrine product designed for emergency treatment of Type I allergic reactions. The company recommends that patients have access to two neffy nasal sprays at all times and seek emergency medical assistance following its use. The product's safety profile includes potential side effects such as throat irritation, headache, and dizziness.
Type I allergic reactions are acute and can be life-threatening, making immediate treatment with epinephrine essential. Despite the availability of epinephrine autoinjectors, their use is often delayed or avoided due to various limitations.
This article is based on a press release statement from ARS Pharmaceuticals, Inc. The company's forward-looking statements regarding neffy's potential life-saving impact and anticipated regulatory approvals are subject to risks and uncertainties, and actual results may differ. The company's filings and updates on these developments can be accessed through their official website.
In other recent news, ARS Pharmaceuticals has inked a global deal with ALK-Abelló A/S for its epinephrine nasal spray, EURneffy, excluding the United States and a few other regions. The agreement includes an upfront payment of $145 million from ALK and potential milestones that could reach up to $300 million. ARS Pharmaceuticals also secured a supply deal with Nuova Ompi S.r.l. for glass microvials for its emergency medication, neffy®, and updated its manufacturing agreement with Renaissance Lakewood, LLC for the production of neffy nasal unit dose sprays.
The FDA has approved neffy, a needle-free epinephrine treatment for Type I Allergic Reactions, which is now available by prescription across the United States. ARS Pharmaceuticals is also seeking FDA approval for neffy 1 mg, targeting younger children with severe allergies. The European Commission has given the green light to EURneffy, marking a significant milestone in allergy treatment.
Cantor Fitzgerald initiated coverage of ARS Pharmaceuticals, indicating a positive outlook for the company's potential. These are some of the recent developments within ARS Pharmaceuticals, demonstrating the company's commitment to expanding its product offerings and strengthening its global partnerships.
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