Business
Jaguar Health Announces that Orphan Drug Designation Application Submitted to the FDA for Crofelemer for a Severe Congenital Diarrheal Disorder (CDD) Has Been Accepted for Review
Microvillus Inclusion Disease (MVID), a CDD, Is a Life-Threatening and Rare Autosomal Recessive Disease That Affects Newborns and Children and Leads to
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Microvillus Inclusion Disease (MVID), a CDD, Is a Life-Threatening and Rare Autosomal Recessive Disease That Affects Newborns and Children and Leads to Significant Morbidity and Mortality From Severe Secretory DiarrheaReplay Link for Jaguar's August 22, 2022 Investor Webcast Can Be Accessed by Clicking Here; Q2 2022 Represented the Fourth Consecutive Quarter of Growth in Mytesi® Net RevenueSAN FRANCISCO, CA / ACCESSWIRE / August 23, 2022 / Jaguar Health (NASDAQ:JAGX) today announced that its Orphan Drug Designation (ODD) application for crofelemer submitted to the U.S. Food and Drug Administration for a rare congenital diarrheal disorder called microvillus inclusion disease (MVID) has been accepted by the FDA for review. A response from the FDA on the application is expected by the end of September 2022.Jaguar today also provided the replay link for the company's August 22, 2022 investor webcast, which can be accessed by clicking here.\"Although our message may have been lost with the overall market turndown yesterday, we were very pleased to announce that our prescription product net revenue was approximately $2.9 million in the second quarter of 2022, representing an increase of approximately 12% over Mytesi net revenue in the first quarter of 2022, which totaled approximately $2.6 million, and an increase of approximately 641% over Mytesi net revenue in the second quarter of 2021, which totaled approximately $0.4 million,\" said Lisa Conte, Jaguar's president and CEO. \"This is the FOURTH consecutive quarter of growth in Mytesi net revenue - which largely represents the funds collected after various insurance and government chargebacks. The continued improvement in net revenue - a key reportable financial measure of commercial performance under GAAP (generally accepted accounting principles) - is largely a result of the efficiencies realized by the transition we completed this past January to a closed network of specialty pharmacies - an initiative that resulted in a meaningful reduction in Mytesi distribution costs as well as a higher average net price.\"As announced, Napo Therapeutics, the Italian corporation Jaguar established in Italy in 2021 that focuses on expanding crofelemer access in Europe with an initial focus on orphan designated diseases, submitted an ODD application for crofelemer this past May for MVID to the E...