Jaguar Health submits final 'major' filing for approval of Canalevia » 08:3905/2805/28/20
Jaguar Health announced…
Jaguar Health announced that it has submitted to the FDA's Center for Veterinary Medicine, or CVM, what the Company expects is the final major regulatory filing to support approval of its oral plant-based drug candidate Canalevia to treat chemotherapy-induced diarrhea, or CID, in dogs. The company said in a release, "According to current estimates, more than 230,000 dogs in the U.S. receive chemotherapy treatment for various cancers each year, and roughly one in four will experience diarrhea as a side effect of treatment. There currently is no FDA-approved anti-secretory prescription product to manage this debilitating diarrhea in dogs. In addition to CID, Jaguar also is seeking conditional approval to market Canalevia for exercise-induced diarrhea in dogs."
|Over a week ago|
Jaguar Health reports Q1 EPS (56c), consensus (51c) » 08:1405/1505/15/20
Reports Q1 revenue…
Reports Q1 revenue $869,000 vs. $1.59M last year. "We remain fully committed to expanding access to Mytesi, the FDA-approved plant-based, non-opioid prescription drug product of Jaguar's wholly owned subsidiary, Napo Pharmaceuticals, to all patients in need. As announced, with this goal in mind, we expanded the NapoCares patient support program for Mytesi last month," commented Ian Wendt, Jaguar's vice president of commercial strategy. "The expansion meaningfully increased co-pay support for commercially insured patients, which includes allowing the co-pay amount to remain the same whether a patient fills a 30-day or 90-day prescription of Mytesi. I'm pleased to report that commercially insured patients increased utilization of this program by 27% in Q1 2020 versus Q4 2019. The program also raises income limits on HIV patients eligible for our uninsured, free-drug program."
Jaguar Health to sell $2.75M in Mytesi accounts receivable to Oasis Capital » 08:4305/1305/13/20
Jaguar Health (JAGX)…
Jaguar Health (JAGX) announced that Jaguar and its wholly owned subsidiary, Napo Pharmaceuticals have jointly entered into an accounts receivable purchase agreement with Oasis Capital pursuant to which Oasis has initially agreed to purchase all of the company's accounts receivable related to the April sales of the company's Mytesi drug product to Cardinal Health (CAH). The April accounts receivable have a gross value of $2.75M. Per the terms of the agreement, Oasis will receive a fee of 5.45% of the $2.75M April accounts receivable following their purchase of the April accounts receivable for $1.03M. Oasis will return to the company within five days any amount that exceeds the sum of the purchase price and the fee. As with all Mytesi gross sales, the April accounts receivable will be reduced by Medicare, ADAP 340B chargebacks, returns and wholesale distribution fees based on historical trends to determine net sales. Under the agreement, Oasis is entitled to a one-time transaction fee of $25,000 and may be entitled to additional transaction fees to the extent Oasis purchases additional accounts receivable under the agreement, which fees will not exceed $5,000 per transaction. The initial term of the agreement is one year, which will automatically renew for successive one-year periods unless notice of non-renewal is provided by the company at least 30 days prior to the expiration of a term. Notwithstanding the foregoing, either Oasis or the company may terminate the agreement on 60 days' prior written notice.
Jaguar Health clears regulatory hurdle to gain FDA approval to market Canalevia » 08:3805/1205/12/20
Jaguar Health announced…
Jaguar Health announced that it has cleared an important regulatory hurdle in the company's effort to gain FDA approval to market Canalevia, the company's oral plant-based prescription drug candidate, for the treatment of exercise-induced diarrhea, or EID, in dogs. Jaguar has been informed by the FDA's Center for Veterinary Medicine, or CVM, that the Environmental Impact technical section has been deemed Complete as part of the Company's application for conditional approval of Canalevia for EID under the Minor Use/Minor Species, or MU/MS, section of The Minor Use and Minor Species Animal Health Act of 2004. This section provides an assessment of a drug's potential direct and indirect effect on the environment.
|Over a month ago|
Jaguar Health enters deal with Atlas Science to develop NP-500 » 08:4004/1604/16/20
Jaguar Health announced…
Jaguar Health announced it has entered into an agreement with Atlas Sciences, LLC to develop NP-500, a non-core Jaguar plant-based type II diabetes drug candidate which has successfully completed Phase 1 clinical trials. The deal involves the receipt of $1.5 million by Napo Pharmaceuticals, Inc. (Napo), Jaguar's wholly-owned subsidiary, for sale of NP-500's technology and intellectual property to Atlas Sciences. Concurrently with this sale, Jaguar received an exclusive 10-year license to develop and commercialize NP-500 technology in all territories worldwide except greater China, inclusive of the right to sublicense NP-500 development and commercialization rights. NP-500 is a plant-based drug product candidate for treatment of type II diabetes and insulin-resistance syndrome in humans. Under the terms of the license, Jaguar is obligated to initiate a proof of concept Phase 2 study of NP-500 under an investigational new drug, or IND, application with the FDA or an IND-equivalent dossier under appropriate regulatory authorities within six months of April 15. If Jaguar fails to initiate the study by this date for any reason, including the timely receipt of adequate funding to initiate the study, Jaguar will incur aggregate trial delay fees of $2,265,000 payable monthly over a period of approximately ten months. Atlas Sciences has the right to terminate the license in the event that Jaguar fails to complete the Phase 2 study within five years of April 15, 2020 or has not timely initiated the Phase 2 study and thereafter fails to make monthly trial delay fee payments.
Jaguar Health files to sell 6.02M shares of common stock for holders 17:3204/0604/06/20
Jaguar Health expands patient support program for Mytesi » 09:0504/0204/02/20
Napo Pharmaceuticals announced it will expand NapoCares, its patient support program for Mytesi, the company's FDA-approved plant-based, non-opioid prescription drug indicated for the symptomatic relief of non-infectious diarrhea in adult patients living with HIV (PLWH) on antiretroviral therapy. The expansion raises income limits on patients eligible for the uninsured, free-drug program and significantly increases co-pay support for commercially insured patients, allowing the co-pay amount to remain the same whether a patient fills a 30-day or 90-day prescription of Mytesi. These changes are effective April 1.
|Over a quarter ago|
Jaguar Health files to sell 3.75M shares of common stock for holders 16:5701/2201/22/20
Jaguar Health study indicates crofelemer could treat abdominal pain from IBS-D » 08:4701/0801/08/20
Jaguar Health announced…
Jaguar Health announced that a study appearing in the December 2019 issue of Clinical and Translational Gastroenterology, a peer-reviewed journal published by the American College of Gastroenterology, indicates that crofelemer could be a treatment option for abdominal pain associated with diarrhea-predominant irritable bowel syndrome, or IBS-D. This multicenter, phase 2, randomized, double-blind, placebo-controlled trial evaluated the effect of crofelemer on abdominal pain in women with IBS-D. A total of 240 women were enrolled, and participants were randomized to crofelemer or placebo twice daily for 12 weeks. Following an analysis by the FDA-issued revised recommendations for outcome measures in IBS clinical trials in 2010, the proportion of monthly abdominal pain responders was significantly higher in the crofelemer group during months one through two as well as during the entire three months when compared with placebo. No significant differences were observed in the proportion of stool consistency monthly responders based on the revised FDA guidelines. These observed trends of improvement in monthly abdominal pain responders suggest that crofelemer may have a use for treatment in abdominal pain in IBS-D patients without having significant changes to bowel habits. Currently there are very few treatment options to address the visceral pain associated with IBS-D. Crofelemer has a distinct and novel antisecretory mechanism of action of modulation of cystic fibrosis transmembrane conductance regulator and/or calcium-activated chloride channels that may provide a new non-opiate or antibiotic-based option to treat the visceral abdominal pain and discomfort for IBS-D patients.
Jaguar Health price target lowered to $3 from $10 at H.C. Wainwright » 07:0911/1811/18/19
H.C. Wainwright analyst…
H.C. Wainwright analyst Vernon Bernardino lowered his price target for Jaguar Health to $3 from $10 after adjusting for issuance of common stock in raises that were conducted during Q3. The analyst, however, reiterates a Buy rating on the shares. He expects Mytesi sales to return to growth.