Roth Capital maintains Buy on RedHill after 'noisy' quarter » 07:3608/1408/14/20
Roth Capital analyst…
Roth Capital analyst Scott Henry maintained a Buy rating and $16 price target on RedHill Biopharma following a "noisy" Q2 report that was "fundamentally within expectations." He added that COVID-19 data in Q4, possibly as soon as September, could be a catalyst for the stock going forward.
Fly Intel: Pre-market Movers » 09:0008/1308/13/20
AAPL, PENN, BCRX, TPR, RDHL, GRWG, MGIC, DSSI, VBLT, VRM, CSCO, PTON, STC, IVZ
Check out this morning's…
RedHill Biopharma reports Q2 EPS (4c), consenus (7c) » 07:1608/1308/13/20
Reports Q2 revenue $21M,…
Reports Q2 revenue $21M, consensus $22.99M. Dror Ben-Asher, RedHill's Chief Executive Officer, said: "This has been a standout period for RedHill with the acquisition of Movantik from AstraZeneca and the launch of Talicia. From an R&D perspective, we have been making progress against some of the world's most pressing healthcare challenges - COVID-19, infectious diseases and antibiotic resistance. We have worked diligently and rapidly to initiate in parallel global Phase 2/3 and U.S. Phase 2 studies, with potential global emergency use applications expected as early as the fourth quarter of this year. We are also making the necessary preparations to make opaganib widely available, subject to positive results from the two ongoing studies and potential global emergency use authorizations, if granted. We are also delighted with the recent FDA clearance to initiate the pivotal Phase 3 study with RHB-204 in first-line pulmonary NTM infections, a rare and highly resistant infectious disease with no FDA-approved first-line therapy. In summary, with three FDA-approved products being promoted, commercial operations largely resumed, growing revenues, and our late-stage development programs progressing as planned, we are well-positioned for continued and rapid growth, with a number of near- and long-term growth drivers."
RedHill Biopharma and Cosmo Pharma sign licensing and manufacturing agreement » 06:1308/1308/13/20
RedHill Biopharma has…
RedHill Biopharma has entered into a binding term sheet with Cosmo Pharmaceuticals for an exclusive licensing and manufacturing agreement for multiple products. The transaction is expected to close in the coming weeks. The companies will co-develop a novel next-generation therapy for the eradication of H. pylori infection. Cosmo is to receive the exclusive European rights to the new drug and will pay RedHill $7M upon signing of the license agreement and an additional $2M upon approval in Europe, and 30% royalties. The companies plan to jointly execute clinical trials pursuing simultaneous regulatory approvals in the U.S. and Europe, with a cost split 70% RedHill and 30% Cosmo. Cosmo will become the exclusive worldwide manufacturer for the novel next-generation therapy for the eradication of H. pylori infection, Movantik, which RedHill recently acquired from AstraZeneca, and RHB-204 for pulmonary nontuberculous mycobacteria infections. Cosmo will be paid EUR5.5M for tech transfer, formulation and development work with respect of these products. Additionally, Cosmo will finance the planned pivotal Phase 3 clinical study with RHB-204, which recently received FDA clearance to proceed, with a payment of $5M upon signing of the agreement and an additional $7M in two milestone payments. Cosmo will be entitled to 15% royalty payments.
CFA Society of Minnesota to hold a virtual conference » 09:0608/1208/12/20
GIS, GGG, CLXT, ASB, APG, APAM, NVEC, RDHL, IIN, MOS, TECH, TCF, PNR, VSTO, XEL, EBS, BKH, CF
Intellisight 2020 Virtual…
Intellisight 2020 Virtual Conference will be held on August 12. Webcast Link
|Over a week ago|
RedHill Biopharma Phase 2/3 COVID-19 study approved in Mexico » 08:0508/0608/06/20
RedHill Biopharma announced approval from the Mexican Federal Committee for the Protection against Sanitary Risks for the Company's Clinical Trial Authorization application for the Phase 2/3 study evaluating opaganib in patients hospitalized with severe SARS-CoV-2 infection and pneumonia. RedHill's study has now been approved in Mexico, the UK, and Russia and is under review in Italy, Brazil and additional countries. Further expansion of the study to other countries is planned. The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study is set to enroll up to 270 patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects will be randomized at a 1:1 ratio to receive either opaganib or placebo, along with standard-of-care therapy. The primary endpoint of the study is to evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14. An unblinded futility interim analysis will be conducted by an independent data safety monitoring board when approximately 100 subjects have been evaluated for the primary endpoint. In parallel, enrollment in the U.S. Phase 2 clinical study with opaganib is approximately 50% complete and is expected to be completed this month. This randomized, double-blind, placebo-controlled study, which is not powered for statistical significance, is set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen.
RedHill Biopharma announces agreement with Daiichi Sankyo for Movantik » 07:1808/0308/03/20
RedHill Biopharma (RDHL)…
RedHill Biopharma (RDHL) announced that it has replaced its existing 2015 co-commercialization agreement with Daiichi Sankyo (DSNKY) for Movantik, which was assigned to RedHill under its April 2020 acquisition agreement with AstraZeneca, with a new royalty-bearing agreement. Under the terms of the new agreement, RedHill will bear all responsibilities and costs for commercializing Movantik in the U.S. During the term of this new agreement, RedHill will pay Daiichi Sankyo a mid-teen royalty rate on net sales of Movantik in the U.S., in addition to three lump sum payments each year starting in 2021 and ending in 2023. In addition, the companies also entered a subscription agreement under which Daiichi Sankyo received 283,387 in American Depositary Shares of RedHill as a partial consideration in relation to Movantik. RedHill acquired the global rights, excluding Europe, Canada and Israel, to Movantik for the treatment of opioid induced constipation from AstraZeneca in April 2020 and immediately initiated promotion in the U.S. with its expanded sales force.
RedHill gets FDA clearance for Phase 3 study with RHB-204 for NTM infections » 07:0507/3107/31/20
RedHill Biopharma announced that the U.S. Food and Drug Administration, FDA, has cleared its Investigational New Drug application for a pivotal Phase 3 study to evaluate the efficacy and safety of RHB-204 in adults with pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex, MAC, infection. Kevin L. Winthrop, MD, M.P.H., Professor of Infectious Diseases and Public Health at the Oregon Health & Science University - Portland State University (OHSU-PSU) School of Public Health and Principal Investigator of the study, said: "NTM infections are enormously challenging, resistant to most antibiotics, and can cause significant lung damage - and they are becoming more prevalent. There is a tremendous unmet need with regard to FDA-approved therapies for NTM, and both physicians and patients need additional treatment options." Gilead Raday, RedHill's Chief Operating Officer, added: "There is currently no FDA-approved first-line, standard-of-care therapy for patients suffering from pulmonary NTM infections. We are looking forward to completing our discussions with FDA and initiating this pivotal study at leading clinical sites across the U.S., evaluating RHB-204 as a first-line, stand-alone, orally-administered therapy."
RedHill Biopharma initiates global Phase 2/3 study for COVID-19 » 07:5707/3007/30/20
RedHill Biopharma announced that it has initiated a global Phase 2/3 clinical study evaluating opaganib in patients hospitalized with severe SARS-CoV-2 infection and pneumonia requiring treatment with supplemental oxygen. The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study is set to enroll up to 270 patients in up to 40 clinical sites across European, Latin American and other countries. Further expansion of the study to additional countries is planned. Subjects enrolled in the study will be randomized at a 1:1 ratio to receive either opaganib or placebo, along with standard-of-care therapy. The primary endpoint of the study is to evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14. An unblinded futility interim analysis will be conducted by an independent data safety monitoring board when approximately 100 subjects have been evaluated for the primary endpoint. Enrollment is also ongoing for a randomized, double-blind, placebo-controlled Phase 2 clinical study with opaganib in the U.S. This study is set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen, with enrollment expected to be completed in August. This clinical trial is not powered for statistical significance.
RedHill increases patient access to Talicia with EnvisionRx Formularies » 07:2307/2707/27/20
RedHill Biopharma (RDHL)…
RedHill Biopharma (RDHL) announced that EnvisionRx, a Pharmacy Benefit Manager and division of EnvisionRxOptions, a wholly owned subsidiary of Rite Aid (RAD), added Talicia to its Formularies, as the unrestricted branded agent for H. pylori treatment, effective July 1, 2020.