ACAAI

KalVista Pharmaceuticals Highlights Strategic Plans for Coming Fiscal Year

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星期三, 五月 1, 2024
Research, FDA, Children, Clinical Trials, Health, Consumer, Pharmaceutical, Other Science, Science, Shanda, ACAAI, Conference, Adolescence, KALV, Hereditary angioedema, Patient, EAACI, ODT, Strategy, HAE

(NASDAQ: KALV), today announced its strategic plans for fiscal year 2025, beginning May 1, including for sebetralstat, the Company’s investigational novel, oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE).

Key Points: 
  • (NASDAQ: KALV), today announced its strategic plans for fiscal year 2025, beginning May 1, including for sebetralstat, the Company’s investigational novel, oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE).
  • “2024 has been an exciting and busy year for KalVista, as we achieved key milestones with our positive phase 3 KONFIDENT data and the completion of a substantial financing,” said Ben Palleiko, Chief Executive Officer of KalVista.
  • “For the coming fiscal year, we have set a high bar as we finalize multiple regulatory filings for sebetralstat and plan for rapid commercialization upon approval.
  • Therefore, further development of the program will be dependent upon collaboration with a strategic partner with expertise and resources to support advancement of the clinical candidates in these potential indications.

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

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星期三, 四月 10, 2024
Abele, AAAAI, FDA, Citizenship, Research, Healthcare Improvement Scotland, Trial of the century, SMC, IND, Record, Intellectual property, National Congress, American Academy, Attack, Food, ACAAI, Conference, Hereditary angioedema, MHRA, HAE, Therapy, Network, EOP, Book, PRO, Chemistry, CMC, G&A, Investigational New Drug, Doctor of Philosophy, Medication, Research and development, American College, Mass meeting, Health care, Administration, Bank statement, Annual general meeting, Heredity, Pharmaceutical industry

Pharvaris is currently enrolling in RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsule (PHVS416) for the on-demand treatment of HAE attacks.

Key Points: 
  • Pharvaris is currently enrolling in RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsule (PHVS416) for the on-demand treatment of HAE attacks.
  • Effective April 15, 2024, David Nassif, J.D., will join Pharvaris as Chief Financial Officer and will be responsible for refining and implementing Pharvaris’ corporate financial strategy and activities including financial reporting and operations.
  • Loss for the fourth quarter of 2023 was €32.7 million, resulting in basic and diluted loss per share of €0.74.
  • Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board.

UPDATE Latitude Food Allergy Care Announces the Opening of its Second New York City Location; Brooklyn Heights Clinic Will Provide Exceptional Food Allergy Care

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星期四, 二月 1, 2024
Medical director, AAAAI, American College, Asthma, Food, OIT, Patient, Pediatrics, Food allergy, American Academy, Court Street, ACAAI, Allergy, Private practice

The new clinic will open on February 1 at 32 Court Street in Brooklyn Heights.

Key Points: 
  • The new clinic will open on February 1 at 32 Court Street in Brooklyn Heights.
  • Dr. Joanne Moreau, who currently practices at Latitude’s Manhattan office on the Upper East Side, will move to the Brooklyn Heights clinic full-time in March 2024.
  • Dr. Brian Novick, a board-certified allergist and immunologist with 40 years of experience, has joined Latitude’s Upper East Side clinic, continuing to provide exceptional care to food allergy patients.
  • “We are thrilled to welcome Dr. Brian Novick to our amazing team of board-certified allergists,” said Kimberley Yates, co-founder and CEO of Latitude Food Allergy Care.

Latitude Food Allergy Care Announces the Opening of its Second New York City Location; Brooklyn Heights Clinic Will Provide Exceptional Food Allergy Care

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星期二, 一月 30, 2024
Medical director, AAAAI, American College, Asthma, Food, OIT, Patient, Pediatrics, Food allergy, American Academy, Court Street, ACAAI, Allergy, Private practice

The new clinic will open on February 1 at 32 Court Street in Brooklyn Heights.

Key Points: 
  • The new clinic will open on February 1 at 32 Court Street in Brooklyn Heights.
  • Dr. Joanne Moreau, who currently practices at Latitude’s Manhattan office on the Upper East Side, will move to the Brooklyn Heights clinic full-time in March 2024.
  • Dr. Brian Novick, a board-certified allergist and immunologist with 40 years of experience, has joined Latitude’s Upper East Side clinic, continuing to provide exceptional care to food allergy patients.
  • “We are thrilled to welcome Dr. Brian Novick to our amazing team of board-certified allergists,” said Kimberley Yates, co-founder and CEO of Latitude Food Allergy Care.

Alladapt Immunotherapeutics Receives FDA Fast Track Designation for ADP101 for the Treatment of Mono- and Multi-Food Allergies

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星期三, 十一月 22, 2023
Biologics license application, Empoasca decipiens, Allergen, Food, FDA, OIT, Salmon, Peanut, Letter, Immunoglobulin E, Food allergy, American College, Hazelnut, ACAAI, Patient, Safety, Data collection, Harmony, Therapy, Fast Track, BLA, Pharmaceutical industry

MENLO PARK, Calif., Nov. 22, 2023 (GLOBE NEWSWIRE) -- Alladapt Immunotherapeutics, Inc., a private, clinical-stage biopharmaceutical company developing prescription therapeutics to address IgE-mediated food allergy, today announced that ADP101, its investigational multi-food oral immunotherapy (mOIT) designed to simultaneously treat allergy to one or more of the world’s most significant food allergens, received Fast Track Designation from the U.S. Food and Drug Administration (FDA). ADP101 is the most advanced multi-food OIT pharmaceutical candidate in development.

Key Points: 
  • Our team is thrilled to be at the forefront of developing a new treatment that addresses such a huge unmet need.
  • FDA’s Fast Track program is designed to expedite the development of new drugs intended to treat serious or life-threatening conditions.
  • Fast Track allows more frequent meetings and written communications with FDA to discuss the drug's development plan, clinical trial design, and data collection.
  • Alladapt is also conducting the Encore Study, an open-label extension study of the Harmony study assessing long term use of ADP101 in mono- and multi-food allergic patients.

BioCryst Presents New Real-world Data Showing Reduced Attack Rates in Patients with HAE with Normal C1-inhibitor Following Long-term Treatment with ORLADEYO® (berotralstat)

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星期五, 十一月 10, 2023
Medicine, Anaheim Convention Center, SEM, Safety, BioCryst Pharmaceuticals, Attack, Month, Lanadelumab, Convention, American College, Androgen, Hereditary angioedema, HAE, Day, RESEARCH, Allergy, ACAAI, Pharmaceutical industry, Nightclub, Patient

These real-world observations suggest ORLADEYO can have a meaningful impact on the lives of people who have HAE with normal C1-INH.

Key Points: 
  • These real-world observations suggest ORLADEYO can have a meaningful impact on the lives of people who have HAE with normal C1-INH.
  • The company also announced a new post-hoc analysis from the APeX-S clinical trial that showed a sustained reduction in HAE attacks compared to patients’ self-reported baseline attack rates.
  • “The ability to compare patients’ treatment outcomes with their HAE attack rates at baseline is tremendously helpful to characterize the impact of a prophylactic therapy.
  • Patients who were treated with ORLADEYO experienced a sustained reduction in HAE attacks compared to their self-reported baseline attack rates, suggesting a reduction in disease burden and durable treatment effect.

Aquestive Therapeutics to Present Positive Data from Pharmacokinetic and Pharmacodynamic Studies for Anaphylm™ at American College of Allergy Asthma and Immunology (ACAAI) Annual Meeting

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星期五, 十一月 10, 2023
Therapy, Section, Patient, American College, Adrenaline, ACAAI, Pharmaceutical industry

WARREN, N.J., Nov. 10, 2023 (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 two posters recapping the positive data from pharmacokinetic (PK) and pharmacodynamic (PD) pre-clinical and clinical studies of Anaphylm™ (epinephrine) Sublingual Film will be presented at the American College of Allergy Asthma and Immunology (ACAAI) annual meeting, which will be held from November 9-13 in Anaheim, California.

Key Points: 
  • WARREN, N.J., Nov. 10, 2023 (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 two posters recapping the positive data from pharmacokinetic (PK) and pharmacodynamic (PD) pre-clinical and clinical studies of Anaphylm™ (epinephrine) Sublingual Film will be presented at the American College of Allergy Asthma and Immunology (ACAAI) annual meeting, which will be held from November 9-13 in Anaheim, California.
  • “We are thrilled to have a significant presence at ACAAI this year and are excited to share the positive results from our completed Anaphylm pharmacokinetic and pharmacodynamic studies with leaders in the allergy community,” said Dan Barber, Aquestive’s President and Chief Executive Officer.
  • “These positive results are encouraging as we continue to evaluate the potential of Anaphylm and its ability to provide an important advancement for the treatment of acute allergic reactions, if approved by the FDA.”
    Location: ePoster Section - Exhibit Hall, Monitor 11
    Poster Title: Epinephrine Administered via Sublingual Film, Manual Injection, or Auto-Injectors in Healthy Adults: Pharmacodynamic Results
    Location: ePoster Section - Exhibit Hall, Monitor 11

ARS Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Updates

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星期四, 十一月 9, 2023
NDA, SAN, ARS, European Medicines Agency, D, Pediatrics, Upper respiratory tract infection, Investment, Asthma, MAA, EMA, Patient, Journal, Research, U.S. FDA, FDA, American College, G&A, Caregiver, Anaphylaxis, BMI, Trial of the century, CRL, Symantec Endpoint Protection, Adrenaline, R, Human, ACAAI, Vaccine, Fine chemical, Pharmaceutical industry, Allergy

SAN DIEGO, Nov. 09, 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 reported business updates and financial results for the third quarter of 2023.

Key Points: 
  • ARS Pharma expects to report its findings from this study in the first quarter of 2024.
  • R&D Expenses: Research and development (R&D) expenses were $3.0 million for the quarter ended September 30, 2023.
  • G&A Expenses: General and administrative (G&A) expenses were $15.0 million for the quarter ended September 30, 2023.
  • Net Loss: Net loss was $14.9 million for the quarter ended September 30, 2023.

DBV Technologies Announces 2-Year Results from Ongoing Phase 3 Open-Label Extension to the EPITOPE Trial (EPOPEX) of Viaskin™ Peanut in Toddlers

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星期四, 十一月 9, 2023
Webcast, Editorial, Safety, BLA, Month, DBV Technologies, Asthma, Risk, Database, Patient, OLE, FDA, American College, DBV, EST, Children's Hospital Colorado, Immunotherapy, Food allergy, ACAAI, Anaphylaxis, Pharmaceutical industry, Dietary supplement, Vaccine, Cryptocurrency, Wine, Silviculture, Euronext

Company to host investor conference call and webcast at 5:00pm ET today, Thursday, November 9th, to discuss the results.

Key Points: 
  • Company to host investor conference call and webcast at 5:00pm ET today, Thursday, November 9th, to discuss the results.
  • DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced positive interim results from its ongoing Open-Label Extension (OLE) Study of EPITOPE (Phase 3 trial of Viaskin™ Peanut 250 µg [VP250] in toddlers ages 1 to 3 years), which is named EPOPEX.
  • After completing participation in the EPITOPE study, eligible subjects could enroll in EPOPEX to receive a total of three years of Viaskin Peanut treatment.
  • “We are thrilled with the results generated from the two-year open-label extension to the Phase 3 EPITOPE trial.

KalVista Pharmaceuticals Presents Real-World Data at the 2023 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology

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星期二, 十一月 14, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Syringe, Real, Attack, Asthma, Lung compliance, Patient, Division, American College, Internal medicine, Hereditary angioedema, Anxiety, KALV, HAE, University, Pain, University of California, Freie Berliner Kunstausstellung, ACAAI, Rheumatology, Immunology

“We continue to learn from people living with HAE that currently available parenteral on-demand treatments are simply not meeting their needs,” said Andrew Crockett, Chief Executive Officer of KalVista.

Key Points: 
  • “We continue to learn from people living with HAE that currently available parenteral on-demand treatments are simply not meeting their needs,” said Andrew Crockett, Chief Executive Officer of KalVista.
  • “Whether this is related to always carrying their syringes or vials, challenges in preparing and administering injectable or infused treatments outside the home, or anxiety related to potential injection-site reactions and pain, patients struggle to follow treatment guidelines.
  • This can lead to non-compliance and preference for long-term prophylaxis, even in cases where on-demand treatments would otherwise suffice.
  • We also note that despite the use of long-term prophylaxis, HAE patients require HAE-related home health visits and seek ER treatment more often than would be expected.