ARS-1

INVESTIGATION REMINDER: The Schall Law Firm Announces it is Investigating Claims Against ARS Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the Firm

Retrieved on: 
星期五, 五月 12, 2023
Class Action Lawsuit, Professional Services, Legal, ARS, Absorption, ARS-1, Translation, Certification, Suite, Patient, Anaphylaxis, Adrenaline, Ethics, FDA, News, Safety, Security (finance), Pharmaceutical industry

The Schall Law Firm , a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of ARS Pharmaceuticals, Inc. (“ARS” or “the Company”) (NASDAQ: SPRY ) for violations of the securities laws.

Key Points: 
  • The Schall Law Firm , a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of ARS Pharmaceuticals, Inc. (“ARS” or “the Company”) (NASDAQ: SPRY ) for violations of the securities laws.
  • The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.
  • ARS announced in a May 9, 2023, press release that the FDA posted briefing documents for an upcoming review of the Company’s NDA for neffy® (ARS-1).
  • The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against ARS Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the Firm

Retrieved on: 
星期三, 五月 10, 2023
Professional Services, Class Action Lawsuit, ARS, Absorption, ARS-1, Translation, Certification, Suite, Patient, Anaphylaxis, Adrenaline, Ethics, FDA, News, Safety, Security (finance), Pharmaceutical industry

The Schall Law Firm , a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of ARS Pharmaceuticals, Inc. (“ARS” or “the Company”) (NASDAQ: SPRY ) for violations of the securities laws.

Key Points: 
  • The Schall Law Firm , a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of ARS Pharmaceuticals, Inc. (“ARS” or “the Company”) (NASDAQ: SPRY ) for violations of the securities laws.
  • The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.
  • ARS announced in a May 9, 2023, press release that the FDA posted briefing documents for an upcoming review of the Company’s NDA for neffy® (ARS-1).
  • The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation.

ARS Pharmaceuticals Investigated by Block & Leviton For Potential Securities Law Violations; Investors Who Have Lost Money Are Encouraged to Contact the Firm

Retrieved on: 
星期三, 五月 10, 2023
Injection, ARS, NDA, ARS-1, Translation, Block & Leviton, Patient, Anaphylaxis, Adrenaline, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

BOSTON, May 10, 2023 (GLOBE NEWSWIRE) -- Block & Leviton is investigating ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) for potential securities law violations.

Key Points: 
  • BOSTON, May 10, 2023 (GLOBE NEWSWIRE) -- Block & Leviton is investigating ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) for potential securities law violations.
  • Investors who have lost money in their ARS Pharmaceuticals investment should contact the firm to learn more about how they might recover those losses.
  • Anyone who purchased ARS Pharmaceuticals, Inc. stock and has lost money may be eligible, whether or not they have sold their investment.
  • Block & Leviton is investigating whether the Company committed securities law violations and may file an action to attempt to recover losses on behalf of investors who have lost money.

ARS Pharmaceuticals Announces Presentation of Data Supporting neffy (epinephrine nasal spray) and Real-World Burden of Needle Injectors

Retrieved on: 
星期四, 二月 23, 2023
Patient, Allergy, ARS-1, PD, American Academy of Allergy, Asthma, and Immunology, Adrenaline, OTC, Research, ARS, Emergency, NDA, AAAAI, New Drug Application, Dislike (film), Prescription, Asthma, Psychosocial treatment of needle phobia in children, Failure, Caregiver, Anaphylaxis, American Academy, Pharmaceutical industry, Generic drug

SAN DIEGO, Feb. 23, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced that positive data supporting neffy® (previously referred to as ARS-1), the potential first non-injectable medicine for treatment of allergic reactions (Type I), including anaphylaxis, will be presented during the 2023 American Academy of Allergy, Asthma and Immunology (AAAAI) meeting. The meeting is being held February 24-27, 2023, in San Antonio, Texas.

Key Points: 
  • The meeting is being held February 24-27, 2023, in San Antonio, Texas.
  • “We are excited to share these data from two of our primary clinical trials and the integrated analysis demonstrating the performance of neffy.
  • Patients indicated they would be more likely to fill a prescription for a needle-free device versus an epinephrine autoinjector.
  • A majority of patients indicated they would use a needle-free device instead of or before an OTC product.

ARS Pharmaceuticals Reacquires European Marketing Rights to neffy® (ARS-1) for the Treatment of Type I Allergic Reactions Including Anaphylaxis

Retrieved on: 
星期三, 二月 22, 2023
Allergy, ARS-1, Pain, Adrenaline, European Medicines Agency, ARS, FDA, Fear, Patient, Regulation of tobacco by the U.S. Food and Drug Administration, NDA, SAN, EMA, Rhinitis, MAA, Nature, Caregiver, Food, Anaphylaxis, Pharmacokinetics, Pharmaceutical industry, EU

The agreement followed a portfolio review conducted by Recordati aimed at focusing commercial efforts on core strategic therapeutic areas.

Key Points: 
  • The agreement followed a portfolio review conducted by Recordati aimed at focusing commercial efforts on core strategic therapeutic areas.
  • Today, ARS is in a strong position, with approximately $275 million in cash as of year-end 2022, and an anticipated 2023 US launch of neffy, if approved.
  • ARS’ cash is projected to be at least three years of operating runway based on the company’s current operating plan.
  • “This agreement with ARS to re-acquire our rights was made as part of a portfolio review process.

NEURELIS CONGRATULATES INTRAVAIL® LICENSEE, ARS PHARMACEUTICALS, FOR FDA ACCEPTANCE OF INTRANASAL EPINEPHRINE NDA

Retrieved on: 
星期四, 十二月 8, 2022
Biting, Suicidal ideation, Adrenaline, Health, Schedule, Anticonvulsant, New Drug Application, Intraocular pressure, Headache, Nasal mucosa, Benzodiazepine, Patient, Behavior, Pharmacokinetics, PDUFA, Drug, Risk, Allergy, CCMS, Glaucoma, Food, Central nervous system, Boxed warning, Death, Pain, Multimedia, Benzyl alcohol, AED, Coma, Regulation of tobacco by the U.S. Food and Drug Administration, Mania, Science, Epilepsy, Diazepam, Quality of life, Nature, Somnolence, SAN, Hypoventilation, Fear, Emergency, Therapy, ROCK, Seizure, Hemangioma, NDA, Schizophrenia, AND, FDA, Rhinitis, ARS, Anaphylaxis, ARS-1, Caregiver, Depression, Metabolic acidosis, CNS, Pharmaceutical industry, Dietary supplement, Birth control, Medicine, Gustav Neuring

"The FDA's acceptance of the neffy NDA marks a major milestone in the development of a non-injectable anaphylactic rescue medication.

Key Points: 
  • "The FDA's acceptance of the neffy NDA marks a major milestone in the development of a non-injectable anaphylactic rescue medication.
  • As compared to currently available epinephrine treatment options, this is a simple to use, needle-free, low-dose aqueous formulation of epinephrine for nasal administration, developed with Neurelis' Intravail transmucosal absorption enhancement technology.
  • Intravail enhances drug absorption through the nasal mucosa,enabling noninvasive delivery of a broad range of protein, peptide, and small-molecule drugs.
  • To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ).

ARS Pharmaceuticals Announces Presentation of Clinical Data Supporting neffy® (epinephrine nasal spray) for the Treatment of Allergic Reactions (Type I) including Anaphylaxis

Retrieved on: 
星期四, 十一月 10, 2022
Asthma, American College of Allergy, Asthma and Immunology, Adrenaline, Thigh, Emergency, PDUFA, Biting, Company, Absorption, ARS-1, Anaphylaxis, Blood pressure, Review, Intramuscular injection, Heart rate, Food, Fear, SEC, Allergy, U.S. Securities and Exchange Commission, Time, Government, Patient, Agency, American College, Private Securities Litigation Reform Act, Epinephrine autoinjector, PK, Use, Advocacy, Medicine, ARS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Growth, NDA, Via, FDA, Caregiver, PD, ACAAI, GLOBE, Nature, New Drug Application, Injection, IM, Rhinitis, NASDAQ, Safety, Pain, U.S. FDA, Pharmaceutical industry, Generic drug

SAN DIEGO, Nov. 10, 2022 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) (ARS or the Company), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced that positive clinical data supporting neffy® (previously referred to as ARS-1), the potential first non-injectable medicine for treatment of allergic reactions (Type I), including anaphylaxis, will be presented during the 2022 American College of Allergy Asthma and Immunology Annual Scientific Meeting (ACAAI). The meeting is being held November 10-14, 2022, in Louisville, Kentucky.

Key Points: 
  • Severe allergic reactions can be life-threatening, and todays standard of care is needle-bearing injectable devices associated with numerous administration challenges.
  • Data Summary: Epinephrine absorption via neffy 2.0 mg under rhinitis resulted in more rapid absorption due to nasal symptoms including mucosal oedema.
  • ARS is a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis.
  • ARS assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

ARS Pharmaceuticals Closes Merger with Silverback Therapeutics

Retrieved on: 
星期二, 十一月 8, 2022
Cooley LLP, Adrenaline, Therapy, PDUFA, Biting, Company, Form 10-K, ARS-1, Security (finance), Marketing, Review, Food, Fear, Anxiety, Board, SEC, U.S. Securities and Exchange Commission, Time, Government, Anaphylaxis, Patient, CEO, European Medicines Agency, Private Securities Litigation Reform Act, Nasdaq, Regulation of tobacco by the U.S. Food and Drug Administration, Allergy, HIV disease progression rates, ARS, EMA, Growth, MAA, NDA, FDA, Caregiver, GLOBE, Commercialization, Nature, Education, LLP, Safety, Treasury, LLC, Pharmaceutical industry, Management, Financial adviser, Gorilla

SAN DIEGO, Nov. 08, 2022 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) (ARS or the Company), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced the closing of its merger with Silverback Therapeutics, Inc. (Silverback). This follows the satisfaction of all customary closing conditions, including approval of the merger by the stockholders of Silverback. The combined company will operate as ARS Pharmaceuticals, Inc., and shares of its common stock will commence trading under the trading symbol “SPRY” on November 9, 2022, on the Nasdaq Global Select Market. Effective as of the closing of the merger, ARS has over $280 million in cash and marketable securities.

Key Points: 
  • This follows the satisfaction of all customary closing conditions, including approval of the merger by the stockholders of Silverback.
  • Effective as of the closing of the merger, ARS has over $280 million in cash and marketable securities.
  • With the funding from our merger with Silverback, ARS is also dedicated to significant efforts on patient education and support of advocacy groups working to protect the community of allergy patients with this disease.
  • SVB Securities LLC acted as financial advisor to Silverback, and Cooley LLP served as legal counsel to Silverback for the merger.

Silverback Therapeutics, Inc. announces the FDA’s acceptance of ARS Pharmaceuticals’ NDA for neffy® (epinephrine nasal spray) for the Treatment of Allergic Reactions (type I) including Anaphylaxis

Retrieved on: 
星期五, 十月 21, 2022
Biotechnology, General Health, FDA, Health, Pharmaceutical, Allergy, Caregiver, Time, PDUFA, U.S. Securities and Exchange Commission, IR, Fear, Communication, Disease, Therapy, Telephone, SEC, Review, ANY, New Drug Application, Biting, NDA, Person, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, AND, Nasdaq, Adrenaline, ARS, Rhinitis, Cancer, Private Securities Litigation Reform Act, Food, Anaphylaxis, Pharmacokinetics, Emergency, Pain, Nature, CEO, ARS-1, FDA, COVID-19, Name, Pharmaceutical industry, Security (finance), Holding company, Mergers and acquisitions, Gorilla

If approved by the FDA, neffy would be the first non-injectable treatment available to patients with allergic reactions (type I) including anaphylaxis.

Key Points: 
  • If approved by the FDA, neffy would be the first non-injectable treatment available to patients with allergic reactions (type I) including anaphylaxis.
  • The majority of adverse events in clinical trials were mild in nature without any meaningful nasal irritation or pain.
  • There are approximately 25 to 40 million people in the United States who experience Type I severe allergic reactions.
  • ARS Pharma is dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis.

ARS Pharmaceuticals Announces FDA Acceptance of NDA for neffy® (epinephrine nasal spray) for the Treatment of Allergic Reactions (type I) Including Anaphylaxis

Retrieved on: 
星期五, 十月 21, 2022
FDA, Health, Research, Pharmaceutical, Science, Biotechnology, Allergy, Caregiver, PDUFA, Fear, Review, Biting, NDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Adrenaline, ARS, Rhinitis, Food, Anaphylaxis, Pharmacokinetics, Emergency, CEO, Pain, Nature, ARS-1, FDA, Pharmaceutical industry

If approved by the FDA, neffy would be the first non-injectable treatment available to patients with allergic reactions (type I) including anaphylaxis.

Key Points: 
  • If approved by the FDA, neffy would be the first non-injectable treatment available to patients with allergic reactions (type I) including anaphylaxis.
  • The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date that is anticipated in mid-2023.
  • There are approximately 25 to 40 million people in the United States who experience Type I severe allergic reactions.
  • ARS Pharmaceuticals is dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis.