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ARS Pharmaceuticals(SPRY) - 2024 Q2 - Quarterly Report
2024-08-06 20:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Common Stock, par value $0.0001 per share SPRY The Nasdaq Stock Market LLC FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |---------------------------------------------------------------------------------|------------------ ...
ARS Pharmaceuticals(SPRY) - 2024 Q2 - Quarterly Results
2024-08-06 20:04
Exhibit 99.1 ARS Pharmaceuticals Provides Business Highlights and Reports Second Quarter 2024 Financial Results neffy® (epinephrine nasal spray) New Drug Application (NDA) under review by FDA; discussions are ongoing to finalize labeling with FDA; PDUFA date in early October 2024 EURneffy® (adrenaline nasal spray) recommended for approval by EMA's CHMP; formal marketing authorization anticipated in the third quarter of 2024 Outpatient study of neffy for urticaria (hives) on track to initiate in the fourth q ...
ARS Pharmaceuticals Announces EURneffy (adrenaline nasal spray) Recommended for Approval by CHMP for Emergency Treatment of Allergic Reactions (anaphylaxis)
Newsfilter· 2024-06-28 10:30
EURneffy positioned to be the first and only needle-free adrenaline option authorized for emergency treatment of allergic reactions (anaphylaxis) in Europe Same data package under review by FDA with a PDUFA date of October 2, 2024 "Today's announcement marks a major milestone in the treatment of severe allergies and moves us one step closer to bringing EURneffy to patients in the EU as the first and only needle-free adrenaline option for the emergency treatment of allergic reactions, up to anaphylaxis," sai ...
ARS Pharmaceuticals Announces EURneffy (adrenaline nasal spray) Recommended for Approval by CHMP for Emergency Treatment of Allergic Reactions (anaphylaxis)
GlobeNewswire News Room· 2024-06-28 10:30
Same data package under review by FDA with a PDUFA date of October 2, 2024 Following grant of marketing authorization by the EC expected in Q3 2024, ARS Pharma anticipates that EURneffy will be made available to patients in Europe in Q4 2024 by a pharmaceutical company with an already established commercial footprint in Europe. About ARS Pharmaceuticals, Inc. ARS Investor Contact: Justin Chakma ARS Pharmaceuticals justinc@ars-pharma.com "Today's announcement marks a major milestone in the treatment of sever ...
ARS Pharmaceuticals(SPRY) - 2024 Q1 - Quarterly Report
2024-05-09 20:12
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | Trading | Name of each exchange | | --- | --- | --- | | Title of each class | Symbol(s) | on which registered | | Common Stock, par value $0.0001 per | SPRY | The Nasdaq Stock Market LL ...
ARS Pharmaceuticals(SPRY) - 2024 Q1 - Quarterly Results
2024-05-09 20:08
Exhibit 99.1 ARS Pharmaceuticals Highlights neffy Regulatory Progress and Reports First Quarter 2024 Financial Results neffy® (epinephrine nasal spray) New Drug Application (NDA) and CRL response under review by FDA with anticipated review completion by early October 2024 Response submitted for neffy Marketing Authorization Application (MAA) to EMA’s CHMP; CHMP opinion expected in the second quarter of 2024 Preparing to initiate outpatient study of neffy for urticaria (hives) in second half of 2024 $223.6 m ...
ARS Pharmaceuticals(SPRY) - 2023 Q4 - Annual Report
2024-03-21 20:09
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39756 ARS Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) Delaware 81-1489190 (State or other jurisdicti ...
ARS Pharmaceuticals(SPRY) - 2023 Q4 - Annual Results
2024-03-21 20:06
SAN DIEGO -- March 21, 2024 -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today reported business updates and financial results for the fourth quarter and full year 2023. "We started the year by turning the page and quickly addressing the two deficiencies identified in the FDA's CRL for neffy late last year and are now working to finaliz ...
ARS Pharmaceuticals(SPRY) - 2023 Q3 - Quarterly Report
2023-11-09 21:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39756 ARS Pharmaceuticals, Inc. (I.R.S. Employer Identification No.) 11682 El Camino Real, Suite 120 San Diego, California 9 ...
ARS Pharmaceuticals(SPRY) - 2023 Q2 - Quarterly Report
2023-08-10 20:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39756 ARS Pharmaceuticals, Inc. (Exact name of Registrant as specified in its Charter) Delaware 81-1489190 (State or other jurisd ...