Body surface area

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

Retrieved on: 
Thursday, March 21, 2024
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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 Pharmaceuticals announces neffy® meets primary endpoints and shows rapid symptom control in Phase 2 urticaria clinical study

Retrieved on: 
Monday, February 26, 2024
SAN, Incidence, The Study, AAAAI, Caregiver, Angioedema, Histamine, Principal, ARS, FDA, Quality of life, Anaphylaxis, Body surface area, Data, Convention center, Skin, Safety, Joint task force, Allergy, Patient, Flare, Data analysis, CSU, Erythema, Pediatrics, Asthma, Adrenaline, Itch, American Academy, Pharmaceutical industry

Urticaria is a skin disorder that causes itchy hives and/or angioedema; 50% of chronic urticaria cases1 are non-responsive to first-line antihistamine therapy.

Key Points: 
  • Urticaria is a skin disorder that causes itchy hives and/or angioedema; 50% of chronic urticaria cases1 are non-responsive to first-line antihistamine therapy.
  • “Urticaria is not only a standalone type I allergy disease, but also represents the most frequent symptom observed during type I allergic reactions including anaphylaxis.
  • neffy may provide episodic symptomatic relief of these acute flares or exacerbations to improve the quality of life of urticaria patients.
  • This would follow the anticipated FDA approval of neffy for allergic reactions (Type I) including anaphylaxis in the second half of 2024.

Journal of the American Academy of Dermatology Publishes ZORYVE (roflumilast) Foam, 0.3% Results for Seborrheic Dermatitis from Pivotal Phase 3 Trial

Retrieved on: 
Monday, January 29, 2024
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“Despite being very common, seborrheic dermatitis has traditionally been a disease with limited treatment options.

Key Points: 
  • “Despite being very common, seborrheic dermatitis has traditionally been a disease with limited treatment options.
  • These results highlight the effectiveness and safety of roflumilast foam, a steroid-free treatment and the first novel mechanism of action approved for seb derm in two decades.
  • Roflumilast foam also demonstrated statistically significant improvement over vehicle on all secondary endpoints, including itch, scaling, and erythema (redness).
  • The most common adverse reactions (≥1%) reported, per the prescribing information, include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

Hoth Therapeutics Announces it Received FDA Approval to Expand HT-001 Clinical Trial to Treat Severely Ill Patients

Retrieved on: 
Thursday, January 18, 2024
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NEW YORK, Jan. 18, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to implement a number of protocol amendments to its ongoing clinical trial for HT-001, which is being developed as a potential treatment for cancer patients undergoing treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRI). The trial is being conducted under Hoth's open Investigational New Drug Application (IND) for HT-001.

Key Points: 
  • The trial is being conducted under Hoth's open Investigational New Drug Application (IND) for HT-001.
  • "We are extremely pleased to announce clearance of our clinical trial optimization plan for HT-001.
  • These latest developments underscore Hoth Therapeutics' continued commitment to delivering a safe and effective treatment for this very underserved patient population," said Robb Knie, Chief Executive Officer of Hoth Therapeutics.
  • The dose effect, together with the application site safety assessments, and therapeutic effects based on the primary and secondary endpoints will be evaluated.

Dermavant Announces Positive Data from the ADORING Phase 3 Development Program in Atopic Dermatitis with VTAMA® (tapinarof) Cream, 1% in Adults and Children as Young as 2 Years Old

Retrieved on: 
Thursday, January 11, 2024
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The ADORING 3 study, which consists of 728 patients in total, includes patients who previously completed ADORING 1, ADORING 2, or the Maximal Usage Pharmacokinetics (MUPK) study for AD.

Key Points: 
  • The ADORING 3 study, which consists of 728 patients in total, includes patients who previously completed ADORING 1, ADORING 2, or the Maximal Usage Pharmacokinetics (MUPK) study for AD.
  • In the ADORING pivotal studies, a mean itch reduction was observed as early as 24 hours after first application.
  • “Atopic dermatitis is a burdensome disease, especially for pediatric patients, the most frequently affected patient population.
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.

Aldeyra Therapeutics Provides Clinical and Regulatory Update and Announces Advancement of RASP Platform in Systemic and Retinal Inflammatory Diseases

Retrieved on: 
Thursday, January 4, 2024
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ADX-629, administered twice daily over 90 days, has completed initial clinical testing in three adult patients in an investigator-sponsored clinical trial.

Key Points: 
  • ADX-629, administered twice daily over 90 days, has completed initial clinical testing in three adult patients in an investigator-sponsored clinical trial.
  • Highlighting the advancement of the RASP platform and the selection of key clinical indications for future development, Aldeyra released a focused pipeline.
  • “With the success achieved in our ADX-629 program, which includes a number of positive, signal-finding clinical results, we are excited to advance our RASP modulator pipeline to systemic and retinal immune-mediated diseases, as well as metabolic diseases, exacerbated by RASP,” stated Dr. Brady.
  • “We anticipate 2024 to provide a variety of clinical-stage catalysts, as Aldeyra continues to progress its novel RASP platform.”

Human medicines European public assessment report (EPAR): Atriance, nelarabine, Date of authorisation: 22/08/2007, Revision: 27, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
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Human medicines European public assessment report (EPAR): Atriance, nelarabine, Date of authorisation: 22/08/2007, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Atriance, nelarabine, Date of authorisation: 22/08/2007, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): Norvir, ritonavir, Date of authorisation: 25/08/1996, Revision: 70, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
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Human medicines European public assessment report (EPAR): Norvir, ritonavir, Date of authorisation: 25/08/1996, Revision: 70, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Norvir, ritonavir, Date of authorisation: 25/08/1996, Revision: 70, Status: Authorised

Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed, Date of authorisation: 18/09/2015, Revision: 8, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
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Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed, Date of authorisation: 18/09/2015, Revision: 8, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Pemetrexed Sandoz, pemetrexed, Date of authorisation: 18/09/2015, Revision: 8, Status: Authorised

Aldeyra Therapeutics Announces Statistically and Clinically Significant Improvement from Baseline in Phase 2 Clinical Trial of ADX‑629 in Patients with Atopic Dermatitis

Retrieved on: 
Tuesday, December 19, 2023
Biotechnology, Optical, Health, Clinical Trials, Atopic dermatitis, Principal, Body surface area, Therapy, Clinical trial, IGA, BAI, Patient, Safety, RASP, Pharmaceutical industry

Relative to baseline, over three months of treatment, improvement was observed in all patients.

Key Points: 
  • Relative to baseline, over three months of treatment, improvement was observed in all patients.
  • EASI thresholds for 50% improvement (EASI‑50), 75% improvement (EASI-75), and 90% improvement (EASI-90) were met in four patients (50%), three patients (38%), and one patient (13%), respectively.
  • Statistical significance was achieved for improvement in depression (HAM-D, p=0.02) and numerical improvement was observed for improvement in anxiety (BAI, p=0.1).
  • ET today, December 19, 2023, to discuss the top-line results of the Phase 2 clinical trial of ADX-629 in atopic dermatitis.