ARS Pharmaceuticals, Inc. (SPRY)
After hours:
| Previous Close | 9.46 |
| Open | 9.66 |
| Bid | 9.73 x 300 |
| Ask | 9.77 x 100 |
| Day's Range | 9.39 - 9.76 |
| 52 Week Range | 2.55 - 11.27 |
| Volume | |
| Avg. Volume | 732,403 |
| Market Cap | 944.72M |
| Beta (5Y Monthly) | N/A |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | N/A |
| Earnings Date | N/A |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | N/A |
- GlobeNewswire
ARS Pharmaceuticals Submits Response for neffy® (epinephrine nasal spray) Marketing Authorization Application to EMA’s CHMP and Enters License Agreement with CSL Seqirus for Commercialization of neffy in Australia and New Zealand
CHMP opinion on neffy Marketing Authorization Application anticipated in the second quarter of 2024 Response addresses all issues previously identified by CHMP, and includes results from a repeat dose PK/PD study of neffy under NAC conditions and updated testing concerning nitrosamine levels Exclusive licensing deal for Australia and New Zealand with CSL Seqirus; CSL Seqirus will be responsible for applying for regulatory approval, reimbursement and commercialization of neffy. ARS Pharmaceutical
- GlobeNewswire
ARS Pharmaceuticals Submits Response to FDA Complete Response Letter for neffy® (Epinephrine Nasal Spray)
Response addresses all additional requests in FDA CRL, including positive data from a repeat dose PK/PD study of neffy under nasal allergen challenge (NAC) conditions, and updated testing that detected no measurable nitrosamine levels, conducted per August 2023 FDA GuidanceSubmission of CRL response triggers up to six-month review period by the FDA SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk p
- GlobeNewswire
ARS Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results
Preparing to submit response to the FDA’s CRL for neffy® (epinephrine nasal spray) in Type I allergic reactions in early Q2 2024, following successful completion of neffy repeat dose nasal allergen challenge study and nitrosamine assessments, with expected up to six-month review period In Phase 2 urticaria clinical trial, neffy met primary endpoints and showed rapid symptom control; planning to initiate outpatient study later in 2024, potentially followed by initiation of a single pivotal effica
