Adrenaline

ARS Pharmaceuticals Highlights neffy Regulatory Progress and Reports First Quarter 2024 Financial Results

Retrieved on: 
Donnerstag, Mai 9, 2024
CSL Limited, FDA, Investment, NDA, Research, MAA, CHMP, ASX, Trial of the century, ARS, PDUFA, European Medicines Agency, Patient, Adrenaline, Anaphylaxis, CSL, EMA, Caregiver, Committee, Allergy, Upper respiratory tract infection, CRL, Clinical trial, SAN, Journal, G&A

SAN DIEGO, May 09, 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 reported business updates and financial results for the first quarter of 2024.

Key Points: 
  • Assuming approval on or before the anticipated PDUFA date, ARS Pharma anticipates launching neffy in the U.S. in the second half of 2024.
  • Following local regulatory approval of neffy, ARS Pharma will be responsible for supplying finished product to CSL Seqirus at a transfer price paid to ARS Pharma.
  • G&A expenses decreased from 2023 to 2024 primarily due to a pause in pre-commercial launch activities related to neffy.
  • Net Loss: Net loss was $10.3 million for the quarter ended March 31, 2024, compared to $15.0 million for the quarter ended March 31, 2023.

Aquestive Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
Dienstag, Mai 7, 2024
Angioedema, FDA, Mouth, NDA, Food, Swelling, Skin, Research, Attention deficit hyperactivity disorder, Insurance, Trial of the century, ADHD, Lennox–Gastaut syndrome, Dermatology, Seizure, Prescription, Public expenditure, Riluzole, Vomiting, Patent, Patient, Adrenaline, Common stock, Anaphylaxis, Epilepsy, Diazepam, PD, Therapy, Serdexmethylphenidate/dexmethylphenidate, Type, Pharmaceutical industry

“We continue to successfully execute on our growth strategy as demonstrated by our first quarter results,” said Daniel Barber, Chief Executive Officer of Aquestive.

Key Points: 
  • “We continue to successfully execute on our growth strategy as demonstrated by our first quarter results,” said Daniel Barber, Chief Executive Officer of Aquestive.
  • Total revenues increased to $12.1 million in the first quarter 2024 from $11.1 million in the first quarter 2023.
  • Research and development expenses increased to $5.9 million in the first quarter 2024 from $3.5 million in the first quarter 2023.
  • Non-GAAP adjusted EBITDA loss was $7.2 million in the first quarter 2024, compared to non-GAAP adjusted EBITDA loss of $3.9 million in the first quarter 2023.

Nussbaum Law Group, P.C. and Roberts Law Firm US, PC Announce A $50 Million Class Action Settlement with Pfizer on Behalf of Direct Purchasers of EpiPen® or Generic EpiPen

Retrieved on: 
Donnerstag, Mai 2, 2024
Class Action Lawsuit, Professional Services, Legal, Mylan, Central Time, Safety, Class, P.C, King Pharmaceuticals, Pfizer, Adrenaline, Court, Defendant, Epinephrine autoinjector, Settlement, Insurance

and Roberts Law Firm US, PC:

Key Points: 
  • and Roberts Law Firm US, PC:
    If you purchased EpiPen® or generic EpiPen directly from the manufacturer, you may receive a payment from a $50 million class action settlement with Pfizer.
  • A proposed settlement (“Settlement”) has been reached in a class action lawsuit with Pfizer, Inc., Meridian Medical Technologies, Inc., and King Pharmaceuticals, Inc. (n/k/a King Pharmaceuticals LLC) (together, “Pfizer”).
  • Under the settlement, Pfizer agreed to pay $50,000,000 into a settlement fund for the Direct Purchaser Settlement Class (“Settlement Fund”).
  • The settlement does not resolve claims against Mylan, and the lawsuit against Mylan will continue until it is resolved.

Allergy & Asthma Day Capitol Hill on May 8: Advancing Health Equity for All

Retrieved on: 
Mittwoch, Mai 1, 2024
Education, Congress, Law, Bangladesh Technical Education Board, Health equity, EPA, Investment, HELP, Risk, NIH, CDC, Allergy, Health, Collection, Research, Asthma, Native, Patient, Adrenaline, Legislation, Anaphylaxis, Clinical trial, Pharmaceutical industry

On May 8, Allergy & Asthma Network is hosting its 27th annual Allergy & Asthma Day Capitol Hill (AADCH) in Washington, DC to advocate for healthcare policies and legislation that leave no one behind – regardless of race, ethnicity, education, income level or where they live.

Key Points: 
  • On May 8, Allergy & Asthma Network is hosting its 27th annual Allergy & Asthma Day Capitol Hill (AADCH) in Washington, DC to advocate for healthcare policies and legislation that leave no one behind – regardless of race, ethnicity, education, income level or where they live.
  • The theme this year is "Breaking Barriers: Advancing Health Equity for All."
  • "Health disparities create barriers to accessing care and achieving optimal health," says Lynda Mitchell, CEO of Allergy & Asthma Network.
  • "We are excited to head back to Capitol Hill to advocate for legislation that is patient-first and reinforces health equity," says Charmayne Anderson, Director of Advocacy at Allergy & Asthma Network.

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

Retrieved on: 
Mittwoch, 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.

Aquestive Therapeutics Strengthens Board of Directors with Experienced Biotech Executive

Retrieved on: 
Montag, April 1, 2024
Patient, Adrenaline, Therapy, Management

“I am very pleased to welcome Abbey to the Aquestive Board of Directors.

Key Points: 
  • “I am very pleased to welcome Abbey to the Aquestive Board of Directors.
  • “The appointment of Abbey is one of our first steps in re-establishing our commercial capabilities.”
    Aquestive’s Board of Directors will now be comprised of eight directors, seven of whom are independent directors.
  • “We are delighted to welcome Abbey to the Board of Directors,” said Santo J. Costa, Chairman of the Board of Aquestive.
  • “Abbey is a highly skilled and experienced leader who will significantly contribute to the Board of Directors carrying out its mandate.

Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19

Retrieved on: 
Freitag, März 22, 2024
Diphenhydramine, Anaphylaxis, Hook effect, Pre-exposure prophylaxis, Half-life, Risk, Bone marrow, COVID-19, Patient, Metoprolol, Adrenaline, Epitope, DSM-IV codes, SARS-CoV-2, Death, Adolescence, Bank statement, Post-exposure prophylaxis, Clinical trial, CDC, Antibody, Vaccination, Safety, Immunodeficiency, Vaccine, FDA, Food, Medicine

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

Key Points: 
  • Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
  • “The PEMGARDA EUA marks a transformational moment for Invivyd and for the many moderately to severely immunocompromised people who are vulnerable to COVID-19 disease in the U.S.
  • It was developed using INVYMAB™, the company’s platform approach which combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering.
  • The severity of the reactions was generally mild (17/27) or moderate (8/27), but two reactions were life-threatening.

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

Retrieved on: 
Donnerstag, März 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.

Aquestive Therapeutics Announces Pricing of $75 Million Underwritten Public Offering of Common Stock

Retrieved on: 
Mittwoch, März 20, 2024
SVB Securities, Epilepsy, Anaphylaxis, Telephone, Patient, Adrenaline, Ageing, Oppenheimer Holdings, Sale, Public expenditure, Attention, Prospectus, Therapy, Nicollet Mall, State Street

WARREN, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the pricing of an underwritten public offering of 16,666,667 shares of its common stock at a public offering price of $4.50 per share.

Key Points: 
  • WARREN, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the pricing of an underwritten public offering of 16,666,667 shares of its common stock at a public offering price of $4.50 per share.
  • The gross proceeds of the offering to Aquestive, before deducting the underwriting discounts and commissions and other offering expenses payable by Aquestive, are expected to be approximately $75.0 million.
  • In addition, Aquestive has granted the underwriters a 30-day option to purchase up to an additional 2,500,000 shares of its common stock at the public offering price, less underwriting discounts and commissions.
  • The offering is expected to close on or about March 22, 2024, subject to satisfaction of customary closing conditions.

Aquestive Therapeutics Announces Proposed Public Offering of Common Stock

Retrieved on: 
Dienstag, März 19, 2024
SVB Securities, Epilepsy, Anaphylaxis, Form, Telephone, Patient, Ageing, Adrenaline, Oppenheimer Holdings, Sale, Public expenditure, Attention, Security (finance), Prospectus, Therapy, Nicollet Mall, State Street, Pharmaceutical industry

WARREN, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (Nasdaq: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients’ lives through innovative science and delivery technologies, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.

Key Points: 
  • WARREN, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (Nasdaq: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients’ lives through innovative science and delivery technologies, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.
  • In addition, Aquestive expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock sold in the public offering.
  • All of the securities in the public offering are being offered by Aquestive.
  • The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.