SAN DIEGO - ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) has submitted its response to the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) concerning the Marketing Authorization Application (MAA) for neffy®, an investigational epinephrine nasal spray for severe allergic reactions. The company addressed the CHMP's feedback from the fourth quarter of 2023, which included a repeat dose study under nasal allergen challenge (NAC) conditions and updated nitrosamine testing.
The response submission follows the completion of a clinical study in February 2024, which assessed repeat doses of neffy in patients with seasonal allergic rhinitis under NAC conditions. Additionally, ARS Pharma conducted nitrosamine testing in line with FDA draft guidance from August 2023, detecting no measurable levels of nitrosamines.
The CHMP is expected to issue its opinion on neffy's MAA in the second quarter of 2024, as per the timetable included in the Day 180 comments.
Concurrently, ARS Pharma entered into an exclusive licensing deal with CSL (OTC:CSLLY) Seqirus for the commercialization of neffy in Australia and New Zealand. CSL Seqirus, a subsidiary of CSL Limited (ASX: CSL), the largest Australian pharmaceutical company by market capitalization, will handle regulatory approval, reimbursement, and commercialization in those countries. ARS Pharma will continue to manage manufacturing and product supply.
Danielle Dowell, CSL Seqirus Executive Director of Commercial Operations Asia-Pacific, expressed enthusiasm about the partnership, highlighting the potential benefits of a needle-free adrenaline device for anaphylaxis treatment in the region. Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma, also expressed optimism about the partnership and the product's global approval prospects.
ARS Pharma will receive an upfront payment and is eligible for milestone payments upon achieving certain events. Post-regulatory approval, the company will supply the finished product to CSL Seqirus.
ARS Pharmaceuticals is focused on developing products to protect patients from severe allergic reactions leading to anaphylaxis. neffy is designed as an intranasal epinephrine product for patients and caregivers dealing with Type I allergic reactions, including those due to food, medications, and insect bites. The information in this article is based on a press release statement.
InvestingPro Insights
As ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) works towards the potential approval and commercialization of its flagship product neffy, the company's financial health and market performance provide a broader context for investors. According to InvestingPro data, ARS Pharma holds a market capitalization of $833.29 million, reflecting its valuation within the biotech industry. Despite facing challenges, such as weak gross profit margins indicated by a gross profit of -$20.04 million for the last twelve months as of Q4 2023, the company is buoyed by a strong cash position relative to its debt, an important factor for investors considering the financial resilience of a company in the capital-intensive biotech sector.
InvestingPro Tips highlight that analysts are optimistic about sales growth in the current year, which could be driven by strategic partnerships like the one with CSL Seqirus for neffy's commercialization in Australia and New Zealand. However, analysts remain cautious about the company's profitability in the short term, as they do not anticipate ARS Pharma will be profitable this year. This cautious stance is also reflected in the company's negative P/E ratio of -15.06, which suggests that ARS Pharma is not currently generating net income relative to its share price.
Despite the near-term profitability concerns, the company has experienced a significant price uptick over the last six months, with a total return of 140.9%, potentially indicating investor confidence in its long-term prospects. With additional PRONEWS24 promocode, investors can get an extra 10% off a yearly or biyearly Pro and Pro+ subscription to access more detailed InvestingPro Tips for ARS Pharmaceuticals, Inc. Currently, there are 11 additional tips listed on InvestingPro, providing a more comprehensive analysis for those interested in the company's financial and market performance.
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