Infinia inhalation (human alpha-1 antitrypsin inhalation) / Kamada - LARVOL DELTA

Kamada Reports Record Top and Bottom Line 2024 Financial Results and Affirms 2025 Guidance Representing Double-Digit Profitable Growth (GlobeNewswire) - "Total revenues for 2024 were $161.0 million, a 13% increase from the $142.5 million generated in 2023. The increase in revenues was primarily attributable to KEDRAB and CYTOGAM growth year-over-year...Obtained positive feedback from the U.S. FDA, confirming the Agency's agreement with the Company's previously proposed relaxed two-sided Type 1 error rate control of 10% (p-value of 0.1) for the inhaled AAT pivotal Phase 3 study, reducing the study sample size from 220 patients to approximately 180 patients, while maintaining the statistical power of the trial. Announced its plan to conduct an interim futility analysis for the inhaled AAT pivotal Phase 3 study by the end of 2025."

Commercial • FDA event • P3 data • Alpha-1 Antitrypsin Deficiency • Cytomegalovirus Infection • Infectious Disease

Inhaled alpha-1 antitrypsin (AAT) restores lower respiratory tract protease-antiprotease homoeostasis and reduces inflammation in AAT-deficient individuals: a randomised phase 2 study. (PubMed, ERJ Open Res) - "AAT for inhalation was well tolerated. Inhaled AAT restores protease-antiprotease homoeostasis and may represent a safe and effective therapy."

Journal • P2 data • Alpha-1 Antitrypsin Deficiency • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • ELANE

Kamada Ltd (KMDA) Q3 2020 Earnings Call Transcript (The Motley Fool) - "...current status of our InnovAATe Phase III clinical program....We recently resumed recruitment to the study, the COVID-19 pandemic has slowed down the rate of recruitment and the current pandemic situation, mainly across Europe, affects of ability to currently open new study....In the third quarter, total revenues were $35.3 million....These results were driven by 19% year-over-year increase in sales of our proprietary products, which is attributable to increase in sales of GLASSIA and KEDRAB to our partners, Takeda and Kedrion....We sell GLASSIA outside of the US in multiple markets and that business is growing by us either identifying additional patients, applying for reimbursement and submission and registration in addition countries."

Enrollment status • Sales • Alpha-1 Antitrypsin Deficiency

Kamada Ltd (KMDA) Q2 2020 Earnings Call Transcript (The Motley Fool) - "Let's now turn to the current status of our InnovAATe Phase 3 clinical program for our proprietary Inhaled AAT for the treatment of Alpha-1 Antitrypsin deficiency....I am pleased to report today that recruitment into the study restarted..."

Enrollment status • Alpha-1 Antitrypsin Deficiency

Kamada Reports First Quarter 2020 Financial Results and Highlights Recent Corporate Progress (GlobeNewswire, Kamada Ltd.) - "Enrolment in the pivotal Phase 3 InnovAATe clinical trial...was temporarily halted due to the impact of COVID-19 pandemic on healthcare systems....The Company anticipates resuming enrollment into the study in the third quarter of 2020, pending appropriate conditions at clinical trial sites....Obtained U.S. Food and Drug Administration (FDA) acceptance for the protocol design of a 30 patients sub-study, designed to evaluate the effect of Kamada‘s Inhaled AAT on pharmacokinetics of IV-AAT and collect safety and immunogenicity data, including the effect of anti-drug antibodies (ADA) on AAT levels in plasma."

Enrollment status • FDA event • Alpha-1 Antitrypsin Deficiency

Kamada Announces Enrollment of First Patient into its Pivotal Phase 3 InnovAATe Clinical Trial of Inhaled AAT for the Treatment of Alpha-1 Antitrypsin Deficiency (GlobeNewswire, Kamada Ltd.) - "Kamada...announced today that the first patient has been randomized in Europe into its pivotal Phase 3 InnovAATe clinical trial evaluating the safety and efficacy of the Company’s proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). The study is being led by Jan Stolk, M.D., Department of Pulmonology, Member of European Reference Network LUNG, Leiden University Medical Center, The Netherlands."

Enrollment open • New trial

Kamada reports financial results for second quarter and first six months of 2019 (Nasdaq) - "Kamada intends to conduct a unified global pivotal Phase 3 clinical trial for inhaled AAT for AAT Deficiency in the U.S. under an Investigational New Drug application (IND), and in Europe under a Clinical Trial Authorization (CTA) in order to submit marketing applications for regulatory approval in both regions....In Europe, we expect to begin dosing the first patients in this pivotal Phase 3 trial before the end of the year. Patients recruitment to this study in the U.S. is pending IND approval..."

IND • New P3 trial • Trial initiation date

Kamada reports financial results for first quarter of 2019 (GlobeNewswire) - "Operating expenses, including R&D, Sales & Marketing and G&A expenses, totaled $6.0 million in the first quarter of 2019, as compared to $5.8 million in the first quarter of 2018. As Kamada intends to initiate its Inhaled AAT Phase 3 clinical trial...the Company expects that its annual R&D expenses will increase for the full-year as compared to 2018."

Commercial • Sales