ARS

ARS Pharmaceuticals Submits Response to FDA Complete Response Letter for neffy® (Epinephrine Nasal Spray)

Retrieved on: 
Wednesday, April 3, 2024
Nitrosamine, Anaphylaxis, Symantec Endpoint Protection, Entrepreneurship, ARS, Caregiver, NAC, PD, New Drug Application, Patient, Adrenaline, CRL, Allergy, NDA, Food, FDA, PDUFA, Pharmaceutical industry

In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.

Key Points: 
  • In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under NAC conditions.
  • ARS Pharma also completed the nitrosamine testing requested with no measurable levels of nitrosamines detected.
  • In May 2023, the FDA Advisory Committee (PADAC) determined a favorable benefit-risk profile for neffy (16:6 for adults and 17:5 for children).
  • ARS Pharma anticipates an FDA review period of up to six months, and the PDUFA date is anticipated to be October 2, 2024, based on the submission receipt date of April 2, 2024.

ARS Pharmaceuticals Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 21, 2024
Research, Nitrosamine, Anaphylaxis, Symantec Endpoint Protection, Absorption, Human, ARS, MAA, Patent, Caregiver, PD, New Drug Application, SAN, Patient, Adrenaline, Journal, CRL, NDA, American Academy, EMA, Quality of life, Trial of the century, Flare, American College, Investment, Clinical trial, Erythema, Lower respiratory tract infection, Asthma, Body surface area, Itch, Allergy, FDA, AAAAI, Total, Food, Pharmaceutical industry

SAN DIEGO, March 21, 2024 (GLOBE NEWSWIRE) -- 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.

Key Points: 
  • In February 2024, ARS Pharma announced the successful completion of the repeat dosing study of neffy in seasonal allergic rhinitis under nasal allergen challenge conditions.
  • R&D Expenses: Research and development expenses were $3.4 million and $20.3 million for the quarter and year ended December 31, 2023, respectively.
  • G&A Expenses: General and administrative expenses were $6.8 million and $47.3 million for the quarter and year ended December 31, 2023, respectively.
  • Net Loss: Net loss was $7.2 million and $54.4 million for the quarter and year ended December 31, 2023, respectively.

ARS Advertising Completes Acquisition of Manifest

Retrieved on: 
Wednesday, March 20, 2024
Partnership, Advertising, Acquisition, Marketing, ARS, Creativity, Commerce, Industrial design

CHICAGO, March 20, 2024 (GLOBE NEWSWIRE) -- ARS Advertising, an advertising collective run by Ross Shelleman, has completed the acquisition of Manifest, an award-winning content experience agency specializing in innovative content.

Key Points: 
  • CHICAGO, March 20, 2024 (GLOBE NEWSWIRE) -- ARS Advertising, an advertising collective run by Ross Shelleman, has completed the acquisition of Manifest, an award-winning content experience agency specializing in innovative content.
  • Driven by an integrated team composed of journalists, best-in-class ad creatives and performance strategists, Manifest designs and delivers breakthrough brand stories for its clients.
  • Manifest will continue to operate independently under its existing brand, retaining its core values, unique identity, and unwavering dedication to delivering unmistakable creative and marketing solutions.
  • The acquisition aligns Manifest's creative and performance marketing prowess & industry-leading content capabilities with Aisle Rocket’s strategic, guided approach to branded omnichannel growth performance.

ReAlta Life Sciences Announces New Research Collaboration with the National Institute of Allergy and Infectious Diseases to Evaluate RLS-0071 as a Medical Countermeasure for Acute Radiation Syndrome

Retrieved on: 
Thursday, March 28, 2024
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Radiation, Acute radiation syndrome, Attack, ARS, Inflammation, Education, Chronic obstructive pulmonary disease, RNCP, USUHS, Virus, IND, European Medicines Agency, Outline of health sciences, Nausea, Accident, Hypoxia (medical), NIAID, Defense Threat Reduction Agency, AFRRI, HIE, Vaccine, Collection, Vomiting, Food, FDA, Defense, Infection, Peptide, Pharmaceutical industry

“We are very pleased to partner with NIAID and AFRRI to evaluate ReAlta’s lead drug candidate, RLS-0071, as a radiation countermeasure for GI-ARS,” says Dr. Ulrich Thienel, Chief Executive Officer of ReAlta.

Key Points: 
  • “We are very pleased to partner with NIAID and AFRRI to evaluate ReAlta’s lead drug candidate, RLS-0071, as a radiation countermeasure for GI-ARS,” says Dr. Ulrich Thienel, Chief Executive Officer of ReAlta.
  • AFRRI is unique and powerful radiobiological research institute, with six decades of active, robust, and outstanding support to the U.S. Department of Defense through research, reach-back, and education.
  • It is the only U. S. Department of Defense medical R&D facility dedicated solely to nuclear and radiological defense.
  • ReAlta Life Sciences, Inc. is a mid-stage clinical biotech company dedicated to saving lives by rebalancing the inflammatory response to address life threatening acute inflammatory and rare diseases.

Corporacion America Airports Reports Fourth Quarter and Full Year 2023 Results

Retrieved on: 
Wednesday, March 20, 2024
Other Transport, Air, Transportation, Transport, Travel, PAX, Euro, Growth, ARS, International, Section, Adjustment, Zvartnots International Airport, Yoy, CAAP, Airport, Inflation, USD, Government, LTM, Airline

Delivered YoY increases across key operating metrics:

Key Points: 
  • Delivered YoY increases across key operating metrics:
    13.1% in passenger traffic to 20.7 million, reaching 99.1% of 4Q19 levels.
  • Adjusted EBITDA margin ex-IFRIC12 expanded to 92.9% from 37.4% in 4Q22, or to 41.1% when excluding the Natal positive impact.
  • Net debt to LTM Adjusted EBITDA improved to 1.4x as of December 31, 2023, from 1.6x as of September 30, 2023.
  • Commenting on the results for the quarter Mr. Martín Eurnekian, CEO of Corporación América Airports, noted: “The strong momentum experienced throughout the year continued into the fourth quarter, with passenger traffic growing 13% year-on-year and revenue growth ex-IAS29 surpassing the increase in traffic.

LeafHouse and iJoin Announce Launch of Automated Personalized Portfolio™ Program Powered by Dimensional offering State Street GTC Retirement Income Builder Series Funds

Retrieved on: 
Thursday, April 4, 2024
GTC, ARS, Partnership, State Street Global Advisors, Human voice, Retirement, APP, State Street, Financial adviser

SCOTTSDALE, Ariz. , April 4, 2024 /PRNewswire/ -- LeafHouse, iJoin, and ARS are excited to announce a new partnership to deliver personalized advice that features the State Street GTC Retirement Income Builder Series (Series) target date funds within a managed account offering.

Key Points: 
  • SCOTTSDALE, Ariz. , April 4, 2024 /PRNewswire/ -- LeafHouse, iJoin, and ARS are excited to announce a new partnership to deliver personalized advice that features the State Street GTC Retirement Income Builder Series (Series) target date funds within a managed account offering.
  • The State Street GTC Retirement Income Builder Series combines State Street Global Advisors' cost-efficient asset management expertise with ARS's patent-pending lifetime income innovation to help Americans become more retirement-ready.
  • The solution's core investment, the State Street GTC Retirement Income Builder Series, delivers growth potential, retirement risk mitigation, and a personalized lifetime income strategy by embedding ARS' patent-pending Lifetime Income Builder into the core portfolio's glidepath.
  • The State Street GTC Retirement Income Builder Series will be used as the core investment, providing a lifetime income strategy coupled with State Street's low-cost investment experience.

NeoImmuneTech Appoints Dr. Luke Oh, Ph.D. as New Chief Executive Officer

Retrieved on: 
Tuesday, April 2, 2024
Mallinckrodt, Inflammation, Pharmacology, McGill University, Organization, Acute radiation syndrome, ARS, KOSDAQ, Research, EDT, Senior, Doctor of Philosophy, IL-7, Human Genome Sciences, Drug development, Division, NIT, Vertex Pharmaceuticals

ROCKVILLE, Md., April 2, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (KOSDAQ: 950220), announced that Luke Oh, Ph.D. has been appointed as President and Chief Executive Officer (CEO) of NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), effective from March 29, 2024 (EDT).

Key Points: 
  • ROCKVILLE, Md., April 2, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (KOSDAQ: 950220), announced that Luke Oh, Ph.D. has been appointed as President and Chief Executive Officer (CEO) of NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), effective from March 29, 2024 (EDT).
  • Se Hwan Yang, Ph.D., as Chief Executive Officer of NeoImmuneTech, Inc.
  • In his new role, Dr. Oh will lead NeoImmuneTech from its Rockville headquarters and overview all the operations in Korea.
  • Se Hwan Yang initiated, aligning the company on our business priorities, and stepping up this new phase of NeoImmuneTech."

ARS Pharmaceuticals Reviews Recent Clinical Updates and Commercial Opportunity at neffy® Investor Day

Retrieved on: 
Thursday, March 7, 2024
Type 1, Allergy, SAN, Anxiety, EMA, Caregiver, CRL, New Drug Application, ARS, FDA, Food, Larynx, University of South Florida, Anaphylaxis, Vomiting, Entrepreneurship, Symantec Endpoint Protection, Angioedema, University, Event, Tongue, Webcast, Patient, Pediatrics, Adrenaline, Population growth, Prescription, Irritation, Face, Pharmaceutical industry

The event included presentations by members of the ARS Pharma management team and by two distinguished allergists, Dr. Jonathan Spergel, M.D., Ph.D. and Dr. Thomas B. Casale, M.D.

Key Points: 
  • The event included presentations by members of the ARS Pharma management team and by two distinguished allergists, Dr. Jonathan Spergel, M.D., Ph.D. and Dr. Thomas B. Casale, M.D.
  • Of the patients that do fill their prescription, 80-90% either do not carry or use their treatment as indicated.
  • In late-February, the Company announced positive clinical data from a Phase 2 trial evaluating neffy in adults with chronic spontaneous urticaria.
  • The webcast replay and accompanying slides from today’s investor event may be accessed through the Events & Presentations page in the Investors & Media section of the Company's website.

AirBoss Reports 4th Quarter and Full Year 2023 Results

Retrieved on: 
Thursday, March 7, 2024
Acquisition, International, Manufacturing, Research, AirBoss of America, Traction, ARS, Special, Investment, TSX, Health, Growth, Original equipment manufacturer, TTM, Adjustment, AMP, HHS, BOS, Public expenditure, OTCQX, Table tennis rubber, Natural rubber, Bank statement, International Financial Reporting Standards, Depreciation

For the quarter and 2023, volume was down 17.5% with decreases across the majority of sectors given softness in many customer sectors.

Key Points: 
  • For the quarter and 2023, volume was down 17.5% with decreases across the majority of sectors given softness in many customer sectors.
  • Tolling volume was down 63.0% in the quarter and 59.6% in 2023, from the comparable periods in 2022.
  • Non-tolling volume was down 9.9% for the quarter and by 7.4% in 2023, compared to the same periods in 2022.
  • AirBoss now reports results under two segments: (1) AirBoss Rubber Solutions (“ARS”), and (2) AirBoss Manufactured Products (“AMP”).

ARS Pharmaceuticals to Participate in the Leerink Partners Global Biopharma Conference 2024

Retrieved on: 
Wednesday, March 6, 2024
SAN, Caregiver, ARS, Anaphylaxis, Entrepreneurship, Conference, Allergy, Webcast, Patient

SAN DIEGO, March 06, 2024 (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 its participation in the Leerink Partners Global Biopharma Conference 2024 being held March 11-13, 2024 in Miami, Florida.

Key Points: 
  • SAN DIEGO, March 06, 2024 (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 its participation in the Leerink Partners Global Biopharma Conference 2024 being held March 11-13, 2024 in Miami, Florida.
  • Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma and Eric Karas, Chief Commercial Officer of ARS Pharma will participate in a fireside chat on Wednesday, March 13, 2024, at 10:00 a.m.
  • A live webcast of the fireside chat will be available here and in the Investors & Media section of the Company’s website.
  • A replay of the webcast will be archived on the Company’s website for 90 days.