SAN DIEGO - ARS Pharmaceuticals, Inc. (NASDAQ:SPRY) has submitted a response to the U.S. Food and Drug Administration (FDA) addressing the requirements outlined in a Complete Response Letter (CRL) received in September 2023.
The company has provided updated data from a repeat dose pharmacokinetic/pharmacodynamic (PK/PD) study of its epinephrine nasal spray, neffy®, and confirmed testing that detected no measurable nitrosamine levels.
The CRL, a standard communication from the FDA indicating that an application cannot be approved in its present form, requested additional information regarding neffy, a needle-free option for treating Type I allergic reactions, including anaphylaxis. ARS Pharma's recent submission includes positive results from a repeat dose PK/PD study under nasal allergen challenge (NAC) conditions, and updated nitrosamine testing in accordance with FDA guidance from August 2023.
ARS Pharma's President and CEO, Richard Lowenthal, expressed confidence in the company's comprehensive response to the FDA's concerns. The company believes its efforts will pave the way for neffy to provide a valuable alternative for the approximately 40 million people in the United States who experience severe allergic reactions.
The original New Drug Application (NDA) for neffy was submitted in August 2022, and in May 2023, the FDA Advisory Committee recognized a favorable benefit-risk profile for the drug in both adults and children. The anticipated FDA review period for the resubmission is up to six months, with a Prescription Drug User Fee Act (PDUFA) target action date set for October 2, 2024.
Type I allergic reactions are acute and can be life-threatening, necessitating immediate treatment with epinephrine. Current epinephrine autoinjectors, while effective, have limitations that can lead to delays or avoidance of administration. Neffy is designed to address these concerns with a needle-free, portable, and user-friendly delivery system.
This news is based on a press release statement from ARS Pharmaceuticals. The company's forward-looking statements are subject to various risks and uncertainties, and there is no assurance that neffy will receive FDA approval or that its launch will proceed as anticipated.
InvestingPro Insights
In the wake of ARS Pharmaceuticals, Inc.'s (NASDAQ:SPRY) ongoing efforts to secure FDA approval for their epinephrine nasal spray, neffy®, investors and industry watchers are keeping a close eye on the company's financial health and market performance. Here are some key insights from InvestingPro that could provide context to the company's current position in the market:
ARS Pharmaceuticals currently holds a market capitalization of $895.53 million, reflecting investor sentiment and its valuation in the pharmaceutical industry. Despite the challenges faced with the FDA, the company has demonstrated a remarkable price performance, with a 68.73% total return over the last three months and a 136.73% return over the last six months. This performance might indicate a strong investor confidence in the potential of neffy® and the company's strategic direction.
On the financial front, ARS Pharmaceuticals exhibits some cautionary metrics. With a negative P/E ratio of -16.53 and an adjusted P/E ratio for the last twelve months as of Q4 2023 at -18.39, the company is not currently profitable. Moreover, a gross profit margin of -66786.67% for the same period underscores the financial hurdles the company faces. Nevertheless, InvestingPro Tips highlight that ARS Pharmaceuticals holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations, indicating a level of financial stability that could be crucial as it navigates the FDA approval process.
For those interested in a deeper analysis, there are additional InvestingPro Tips available that shed light on ARS Pharmaceuticals' position as a niche player in the pharmaceutical industry and the lack of dividend payments to shareholders. With the use of the promo code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking access to these valuable insights.
As ARS Pharma awaits the FDA's decision, the InvestingPro platform provides a comprehensive look at the financial metrics and expert analysis that can help investors make informed decisions. With the next earnings date approaching on May 13, 2024, all eyes will be on the company's next moves and the market's response.
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