Kaizen Biosciences Announces Multiple Abstract Acceptances and Presents Pediatric Antibiotic PK Data to ISOM; Targets FDA's New CNPV Pathway Ahead of September NDA Filing
The acceptance of our work at major clinical meetings, along with our anticipated engagement with the FDA's new CNPV program, underscores the significance and urgency of our approach
In addition, the company recently presented new pharmacokinetic data at the International Society of Pharmacometrics (ISoP/ISOM) a biennially meeting, spotlighting a novel amoxicillin-reduced clavulanate formulation for use in children aged 3-24 months.
The data, presented by Dr. Carl Peck, former Director of the FDA Center for Drug Evaluation and Research (CDER), compared the pharmacokinetics of Augmentin ES-600 with the amoxicillin-reduced clavulanate formulation. The study revealed that Augmentin ES-600 delivered elevated clavulanic acid exposures—exceeding the amount found in adult approved Augmentin formulations, suggesting a need to revisit clavulanate dosing found in the current pediatric approved oral suspension formulations. Dr. Peck further highlighted that the proposed formulation, while containing less clavulanate, still provided the AUC/MIC required for bacterial killing or net bacterial stasis when tested against 5 different H. influenzae strains.
Kaizen Biosciences is preparing to submit a New Drug Application (NDA) in September 2025 for its novel amoxicillin-reduced clavulanate formulation. The company is also actively pursuing the FDA's recently announced Commissioner's National Priority Voucher (CNPV) Program, which is designed to accelerate review periods. Kaizen intends to formally request consideration under this pathway, highlighting the public health need for an optimized antibiotic and beta-lactamase inhibitor for children aged 3–24 months, while also supporting increased domestic drug manufacturing—a hallmark of national security.
'We're excited to share this important data with the medical and regulatory communities and we remain committed to pursuing our company philosophy of 'Change, For the Better,'' said Keith-Harrison Dewedoff, Co-Founder & Executive Chair. 'The acceptance of our work at major clinical meetings, along with our anticipated engagement with the FDA's new CNPV program, underscores the significance and urgency of our approach.'
About Kaizen Biosciences
Kaizen Biosciences is a clinical-stage biotechnology company focused on serving patients in a variety of therapeutic areas where big, traditional pharmaceutical companies often overlook. The company's lead program is an improved amoxicillin-clavulanate formulation which reduced the unnecessary quantities of clavulanic acid in children aged 3–24 months while remaining efficacious against S. pneumoniae, H. influenzae, or M. catarrhalis pathogens.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
16 minutes ago
- Business Wire
Felycin®-CA1 (Sirolimus Delayed-Release Tablets) is the First and Only Drug FDA Approved for the Management of Ventricular Hypertrophy in Cats with Subclinical Hypertrophic Cardiomyopathy (HCM), A Condition Affecting as Many as One in Seven Cats
SHAWNEE, Kan.--(BUSINESS WIRE)--PBI-Gordon Companies, Inc. the parent company of TriviumVet, which holds sole conditional approval from the FDA for Felycin®-CA1 (sirolimus delayed-release tablets) sold under the PRN Pharmacal brand of its affiliated company Pegasus, today announced the product is now available via licensed veterinarians nationwide. PBI-Gordon Companies, Inc. confirms that Felycin®-CA1 is the only drug currently legally marketed under conditional approval from the Food and Drug Administration (FDA) for the management HCM in cats. Felycin®-CA1 is a specifically designed dosage formulation of sirolimus comprising an enteric coated delayed-release technology that results in a specific pharmacokinetic profile to ensure both the safety and effectiveness of Felycin®-CA1 for cats with HCM. The RAPACAT study was conducted to obtain conditional approval, while the HALT study is currently enrolling cats and being conducted to pursue the full new animal drug approval of Felycin®-CA1 for cats with HCM. 'The use of compounded rapamycin (sirolimus) or the human approved version of Rapamune® has not been approved by the FDA for the management of HCM in cats and has the potential to be very dangerous or even life-threatening if used in cats,' said Dr. Heather Davis DVM, PhD, DACVS-LA, Director of Clinical Affairs and Veterinary Services, Pegasus Laboratories, Inc. Feline HCM is extremely common, affecting 1 in 7 of all pet cats. In cats 9 years of age and older, the prevalence rises to approximately 1 in 3 and is a leading cause of mortality in adult cats. The disease is characterized by abnormal thickening and impaired function of the ventricular wall of the heart. While some cats remain asymptomatic, around half go on to develop congestive heart failure or other severe complications. Subclinical HCM refers to cases that have ventricular wall thickening but have not yet developed clinical signs. PBI-Gordon Companies, Inc. President & CEO Steve Clifford, added, 'We are very pleased to issue this update to provide both clarity and comfort for pet owners and veterinarians to ensure that cats with asymptomatic ventricular HCM are receiving the one and only FDA-conditionally approved prescription therapy for this condition.' Felycin®-CA1 is available now through licensed veterinarians nationwide and is set to fundamentally change the HCM treatment landscape – a market severely underserved. About PBI-Gordon Companies PBI-Gordon Companies has been in business in the Kansas City metro area since 1947 and is 100 percent employee-owned. It is the parent company to four subsidiaries which develop, manufacture, and market leading products for Turf and Ornamental (PBI-Gordon Corporation), Companion Animal Pharmaceuticals (Pegasus Laboratories & TriviumVet), and Companion Animal Nutritional Supplements and Grooming Supplies (PetAg). About Pegasus Laboratories Founded in 1986, Pegasus Laboratories is a pharmaceutical development and manufacturing organization focused on novel products to treat chronic conditions in cats, dogs, and horses. Pegasus provides full-service Contract Development and Manufacturing Organization (CDMO) focusing on the development and manufacturing with full turn-key technical services in an FDA-registered facility that is in compliance with current Good Manufacturing Practices (cGMPs). Pegasus also provides a full portfolio of pharmaceuticals, nutritional therapeutics and supplements, parasite control and surgical and wound care under the PRN® Pharmacal and Sē·Qual™ brands. About TriviumVet TriviumVet is an Ireland-based research and development company working with some of the leading veterinarians and therapeutic specialists around the world to address the gaps in disease management by developing innovative new therapeutic solutions for some of the most serious and underserved conditions. Focused on finding effective treatments for unmet needs in cardiology, renal health, pain management, gastroenterology, wellness testing, and age-related diseases.
Business Wire
16 minutes ago
- Business Wire
Felycin®-CA1 (Sirolimus Delayed-Release Tablets) is the First and Only Drug FDA Approved for the Management of Ventricular Hypertrophy in Cats with Subclinical Hypertrophic Cardiomyopathy (HCM), A Con
SHAWNEE, Kan.--(BUSINESS WIRE)--PBI-Gordon Companies, Inc. the parent company of TriviumVet, which holds sole conditional approval from the FDA for Felycin®-CA1 (sirolimus delayed-release tablets) sold under the PRN Pharmacal brand of its affiliated company Pegasus, today announced the product is now available via licensed veterinarians nationwide. PBI-Gordon Companies, Inc. confirms that Felycin®-CA1 is the only drug currently legally marketed under conditional approval from the Food and Drug Administration (FDA) for the management HCM in cats. Felycin®-CA1 is a specifically designed dosage formulation of sirolimus comprising an enteric coated delayed-release technology that results in a specific pharmacokinetic profile to ensure both the safety and effectiveness of Felycin®-CA1 for cats with HCM. The RAPACAT study was conducted to obtain conditional approval, while the HALT study is currently enrolling cats and being conducted to pursue the full new animal drug approval of Felycin®-CA1 for cats with HCM. 'The use of compounded rapamycin (sirolimus) or the human approved version of Rapamune® has not been approved by the FDA for the management of HCM in cats and has the potential to be very dangerous or even life-threatening if used in cats,' said Dr. Heather Davis DVM, PhD, DACVS-LA, Director of Clinical Affairs and Veterinary Services, Pegasus Laboratories, Inc. Feline HCM is extremely common, affecting 1 in 7 of all pet cats. In cats 9 years of age and older, the prevalence rises to approximately 1 in 3 and is a leading cause of mortality in adult cats. The disease is characterized by abnormal thickening and impaired function of the ventricular wall of the heart. While some cats remain asymptomatic, around half go on to develop congestive heart failure or other severe complications. Subclinical HCM refers to cases that have ventricular wall thickening but have not yet developed clinical signs. PBI-Gordon Companies, Inc. President & CEO Steve Clifford, added, 'We are very pleased to issue this update to provide both clarity and comfort for pet owners and veterinarians to ensure that cats with asymptomatic ventricular HCM are receiving the one and only FDA-conditionally approved prescription therapy for this condition.' Felycin®-CA1 is available now through licensed veterinarians nationwide and is set to fundamentally change the HCM treatment landscape – a market severely underserved. About PBI-Gordon Companies PBI-Gordon Companies has been in business in the Kansas City metro area since 1947 and is 100 percent employee-owned. It is the parent company to four subsidiaries which develop, manufacture, and market leading products for Turf and Ornamental (PBI-Gordon Corporation), Companion Animal Pharmaceuticals (Pegasus Laboratories & TriviumVet), and Companion Animal Nutritional Supplements and Grooming Supplies (PetAg). About Pegasus Laboratories Founded in 1986, Pegasus Laboratories is a pharmaceutical development and manufacturing organization focused on novel products to treat chronic conditions in cats, dogs, and horses. Pegasus provides full-service Contract Development and Manufacturing Organization (CDMO) focusing on the development and manufacturing with full turn-key technical services in an FDA-registered facility that is in compliance with current Good Manufacturing Practices (cGMPs). Pegasus also provides a full portfolio of pharmaceuticals, nutritional therapeutics and supplements, parasite control and surgical and wound care under the PRN® Pharmacal and Sē·Qual™ brands. About TriviumVet TriviumVet is an Ireland-based research and development company working with some of the leading veterinarians and therapeutic specialists around the world to address the gaps in disease management by developing innovative new therapeutic solutions for some of the most serious and underserved conditions. Focused on finding effective treatments for unmet needs in cardiology, renal health, pain management, gastroenterology, wellness testing, and age-related diseases.
Business Wire
16 minutes ago
- Business Wire
Weave Named a Leader Across 34 Categories in G2's 2025 Summer Report
LEHI, Utah--(BUSINESS WIRE)-- Weave (NYSE: WEAV), a leading all-in-one customer experience and payments software platform for small and medium-sized healthcare businesses, ranked first in 34 categories in G2's 2025 Summer Report. The company also earned 63 badges and was again named a leader in the Grid for Patient Relationship Management (PRM) Software. G2 is the largest and most trusted software marketplace. Placement in the G2 Report is based on authentic customer reviews, customer satisfaction, and market presence. Weave's inclusion in 94 reports this quarter is a testament to the company's commitment to putting customers first and creating outstanding products that address everyday patient and provider needs. Weave recently acquired TrueLark, an AI-powered receptionist and front-desk automation platform. By integrating agentic AI to manage communication workflows 24/7, Weave is helping healthcare teams shift from reactive responses to proactive engagement—capturing every opportunity, even outside business hours. "Receiving multiple G2 leadership badges reinforces that we're on the right path with our AI-first approach to healthcare automation," said Brett White, CEO of Weave. "Customer feedback consistently shows demand for smarter automation solutions, and these awards validate our strategy of integrating conversational AI to solve real operational pain points. ' Weave ranked first in the following categories: Small-Business Grid® Report for Patient Relationship Management (PRM) Grid® Report for Patient Relationship Management (PRM) Momentum Grid® Report for Patient Intake Small-Business Usability Index for Patient Intake Small-Business Results Index for Patient Intake Results Index for Patient Intake Small-Business Relationship Index for Patient Intake Small-Business Implementation Index for Patient Intake Implementation Index for Patient Intake Small-Business Grid® Report for Patient Intake Grid® Report for Patient Intake Momentum Grid® Report for Patient Relationship Management (PRM) Momentum Grid® Report for Optometry Small-Business Usability Index for Patient Engagement Usability Index for Patient Engagement Small-Business Usability Index for Veterinary Practice Management Usability Index for Veterinary Practice Management Small-Business Usability Index for Patient Scheduling Usability Index for Patient Scheduling Results Index for Patient Engagement Results Index for Veterinary Practice Management Results Index for Patient Scheduling Small-Business Implementation Index for Patient Engagement Implementation Index for Patient Engagement Implementation Index for Veterinary Practice Management Small-Business Implementation Index for Patient Scheduling Implementation Index for Patient Scheduling Grid® Report for Patient Case Management Small-Business Grid® Report for HIPAA Compliant Messaging Grid® Report for HIPAA Compliant Messaging Small-Business Grid® Report for Patient Scheduling Small-Business Grid® Report for Optometry Grid® Report for Patient Scheduling Grid® Report for Optometry Weave enables healthcare practices to automate tasks, improve data accuracy, streamline payment workflows, and provide seamless care to patients. Weave's strong performance in the G2 2025 Winter Report follows multiple awards for workplace excellence, business performance, and employee satisfaction. These include ranking in the top 20 best places to work in Utah, being named a Great Place to Work list in the U.S. and India, being featured on Inc.'s Annual List of Best Workplaces for 2024 as well as being named an Inc. 2024 Power Partner Award Winner. For more information on how Weave helps healthcare providers grow their practices, visit About Weave Weave is the all-in-one experience platform for small- and medium-sized healthcare businesses. From the first phone call to the final invoice and every touchpoint in between, Weave connects the entire customer journey. Weave's software solutions transform how local healthcare providers attract, communicate with, and engage patients to grow their practice. In the past year, Weave has been named a G2 leader in Patient Relationship Management, Patient Engagement, Optometry, and Dental Practice Management software. To learn more, visit
