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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.

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

Retrieved on: 
Thursday, March 14, 2024
Research, Atopic dermatitis, PD, Inflammation, Patient, SAN, American Academy, Allergy, Investment, Antibody, Pharmacokinetics, SAD, AAAAI, Annual general meeting, Pharmaceutical industry

Research and development expenses were $53.8 million in the fourth quarter of 2023 compared to $35.4 million in the fourth quarter of 2022, an increase of $18.4 million.

Key Points: 
  • Research and development expenses were $53.8 million in the fourth quarter of 2023 compared to $35.4 million in the fourth quarter of 2022, an increase of $18.4 million.
  • Allakos reported a net loss of $62.6 million in the fourth quarter of 2023 compared to $43.0 million in the fourth quarter of 2022.
  • Net loss per basic and diluted share was $0.71 for the fourth quarter of 2023 compared to $0.50 in the fourth quarter of 2022.
  • Allakos ended the fourth quarter of 2023 with $170.8 million in cash, cash equivalents and investments resulting in a net decrease in cash, cash equivalents and investments of $23.1 million during the fourth quarter of 2023.

KalVista Pharmaceuticals Awarded UK Promising Innovative Medicine (PIM) Designation for Sebetralstat

Retrieved on: 
Tuesday, March 12, 2024
Health, General Health, Research, Pharmaceutical, Science, Biotechnology, EAMS, Patient, HAE, National Health Service, Health care, NHS, American Academy, KALV, Expanded access, Marketing, MHRA, PIM, Hereditary angioedema, Safety, AAAAI, Pharmaceutical industry

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the Promising Innovative Medicine (PIM) designation for sebetralstat, an investigational novel, oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE).

Key Points: 
  • KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the Promising Innovative Medicine (PIM) designation for sebetralstat, an investigational novel, oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE).
  • The PIM is the first step in the Early Access to Medicines Scheme (EAMS) which would allow KalVista to treat patients with sebetralstat prior to receiving a Marketing Authorisation.
  • “We are proud to have sebetralstat designated as a Promising Innovative Medicine by the MHRA, which is similar to Expanded Access in the US,” said Ben Palleiko, Chief Executive Officer of KalVista.
  • KalVista recently provided phase 3 data for sebetralstat at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, which displayed clinically and statistically significant results across all endpoints, and an excellent safety and tolerability profile.

KalVista Pharmaceuticals Reports Third Fiscal Quarter Results and Provides Operational Update

Retrieved on: 
Monday, March 11, 2024
Health, Pharmaceutical, Research, CFO, Patient, HAE, Health care, CBO, NDA, American Academy, KALV, Factor, MHRA, Clinical trial, Hereditary angioedema, Safety, Pharmacology, AAAAI, Fiscal year, Food, Pharmaceutical industry

(NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the third fiscal quarter ended January 31, 2024.

Key Points: 
  • (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the third fiscal quarter ended January 31, 2024.
  • Third Fiscal Quarter Financial Results:
    Revenue: No revenue was recognized for the three months ended January 31, 2024, or January 31, 2023.
  • The increase in R&D expenses during the quarter primarily reflects the ongoing Phase 3 KONFIDENT and KONFIDENT-S trials.
  • The decrease in the net cash and marketable securities position was due to cash consumption from operating expenses.

Thomas M. Krummel, MD Joins Silicon Valley Innovations, Inc. Board of Directors

Retrieved on: 
Wednesday, March 13, 2024
Vagina, Bacterial vaginosis, SVI, Amazon, Plague, Patient, Pharmacy, American Academy, Stanford University, Silicon, American College, Fungal infection, Woman, OTC, Asthma, Nose, HRG, AAAAI, Medicine

SILICON VALLEY, Calif., March 13, 2024 /PRNewswire/ -- Silicon Valley Innovations (SVI) announced today that Thomas M. Krummel, MD, an internationally acclaimed surgeon, former Chair of the Department of Surgery at Stanford University, and med-tech innovator, has joined the company's Board of Directors.

Key Points: 
  • SILICON VALLEY, Calif., March 13, 2024 /PRNewswire/ -- Silicon Valley Innovations (SVI) announced today that Thomas M. Krummel, MD, an internationally acclaimed surgeon, former Chair of the Department of Surgery at Stanford University, and med-tech innovator, has joined the company's Board of Directors.
  • "We're very fortunate to have Dr. Krummel joining us at SVI," says CEO and Founder of SVI, Gail Lebovic, MD.
  • "We share a vision for the future of medicine that includes creating clinically relevant medical technology and placing it into the hands of patients."
  • Dr. Krummel sees major potential clinical benefits and market opportunities for SVI's offerings.

Jasper Therapeutics Reports Fiscal 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Monday, March 4, 2024
AAAAI, Research, Syndrome, Omalizumab, Anaphylaxis, Option, Risk, Allergy, Annual general meeting, Therapy, Patient, Employment, CD117, CSU, Pharmaceutical industry

“2023 was a highly productive year for Jasper, as we shifted our operational focus toward briquilimab development in mast cell driven diseases,” said Ronald Martell, President and Chief Executive Officer.

Key Points: 
  • “2023 was a highly productive year for Jasper, as we shifted our operational focus toward briquilimab development in mast cell driven diseases,” said Ronald Martell, President and Chief Executive Officer.
  • Obtained regulatory clearance in the US and EU for initiation of its Phase 1b/2a BEACON study of subcutaneous briquilimab in CSU.
  • Jasper expects to report initial data from at least the first four cohorts of the study in the third quarter of 2024.
  • Jasper expects to conduct the study across four clinical sites in the EU and has activated three sites to date.

Cogent Biosciences Reports Recent Business Highlights and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Monday, February 26, 2024
HER2, PFS, AAAAI, KIT, Research, Completeness, TSS, ASCO, ASH, WT, Cash, Part, Safety, PEAK, AACR, Cogent, Conference, GIST, Society, PPR, Patient, The, PIPE, FGFR2, Clinical trial, Poster, G&A, Sunitinib, Initiate, IND, Brain, TKI, APEX, Cancer, American Academy, Pharmaceutical industry

WALTHAM, Mass. and BOULDER, Colo., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2023.

Key Points: 
  • and BOULDER, Colo., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and reported financial results for the fourth quarter and full year of 2023.
  • SUMMIT is a registration-directed, randomized, double-blind, placebo-controlled, global, multicenter, clinical trial of bezuclastinib in patients with nonadvanced systemic mastocytosis (NonAdvSM).
  • Cash and Cash Equivalents: As of December 31, 2023, Cogent had cash, cash equivalents and marketable securities of $273.2 million.
  • During the quarter Cogent also completed and paid for bulk manufacturing campaigns of bezuclastinib to continue supporting the company’s clinical trials.

BioCryst Reports Fourth Quarter and Full Year 2023 Financial Results and Upcoming Key Milestones

Retrieved on: 
Monday, February 26, 2024
Human services, Inflation, AAAAI, Research, Investment, Growth, GAAP, HAE, Tranche, Webcast, Patient, Public expenditure, BioCryst Pharmaceuticals, Net, EPS, Workforce, American Academy, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., Feb. 26, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • The number of new ORLADEYO prescribers in the fourth quarter of 2023 (Q4 2023) was the largest number of new prescribers of any quarter in 2023.
  • The increase was primarily due to $90.9 million in ORLADEYO net revenue in the fourth quarter of 2023, compared to $70.7 million in the fourth quarter of 2022.
  • Revenue in the fourth quarter of 2023 also included $2.3 million of net revenue from RAPIVAB related sales, compared to $8.7 million in the fourth quarter of 2022.
  • Interest expense was $24.6 million in the fourth quarter of 2023, compared to $26.5 million in the fourth quarter of 2022.

Celldex Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, February 26, 2024
AAAAI, Injection, KIT, Research, Dermatology, Omalizumab, Eosinophilic esophagitis, B cell, Hypersensitivity, Quality of life, Work, Prurigo nodularis, Loss, DLQI, ILT4, Data, PD-1, Contingency, Inflammation, Cell, Myelocyte, Rockefeller University, Therapy, PN, Allergy, WCI, UAS7, Patient, Dermatology Life Quality Index, CSU, Survival, Congress, Disease, G&A, Itch, SRS, American Academy, Pharmaceutical industry

HAMPTON, N.J., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Celldex is currently planning two Phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer.
  • Celldex is currently planning for the initiation of a Phase 2 subcutaneous study in prurigo nodularis (PN) in early 2024.
  • The litigation settlement related loss had a ($0.26) impact on net loss per share for the twelve months ended December 31, 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2023 are sufficient to meet estimated working capital requirements and fund current planned operations into 2026.

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.