Ironwood Pharmaceuticals announced that the company and its collaborators will present clinical data for IW-3718, and both clinical and non-clinical data for linaclotide during Digestive Disease Week being held in San Diego, CA, May 18 through May 21, 2019. During an oral presentation, Michael Vaezi, M.D., Ph.D., of Vanderbilt University will share Phase IIb data on the effect of IW-3718 on a spectrum of symptoms associated with persistent gastroesophageal reflux disease despite treatment with proton pump inhibitors. Additional data will be presented in poster sessions highlighting the prevalence and significant burden of illness for patients living with persistent GERD, as well as the development and validation of a patient-reported outcome instrument to measure treatment benefit in clinical trials of persistent GERD. IW-3718 is being evaluated in Phase III clinical trials for the treatment of persistent GERD, a condition affecting an estimated 10 million Americans who continue to suffer from heartburn and regurgitation despite receiving treatment with PPIs, the current standard of care. Bile acids, which are produced in the intestine and play an important role in the digestive process, have been implicated as contributors to GERD symptoms. With regard to linaclotide, data will be featured in a poster of distinction which introduces a new patient-reported outcome measure developed for the abdominal symptoms of IBS-C, called the Diary for Irritable Bowel Syndrome Symptoms-Constipation. The DIBSS-C is being used in an ongoing Phase IIIb study that is evaluating the efficacy and safety of linaclotide 290 mcg on multiple abdominal symptoms including pain, bloating and discomfort in adult patients with IBS-C. In other poster sessions, researchers will present data on the expression of the GC-C receptor -the pharmacological target of linaclotide in IBS-C and CIC-in pediatric patients; real-world evidence on the use of opioids for pain management among patients with chronic gastrointestinal disorders including IBS; and preclinical data on the mechanisms of action of the effect of linaclotide on visceral pain in the GI tract and in related visceral organs.
https://thefly.com/landingPageNews.php?id=2906893
Thursday, May 9, 2019
Paratek Pharmaceuticals price target lowered to $12 from $17 at Wedbush
Wedbush analyst Robert Driscoll lowered his price target for Paratek Pharmaceuticals to $12 from $17 following quarterly results. The analyst sees a measured launch ahead for Nuzyra, with momentum continuing toward an “ultimately successful” commercial launch of a differentiated antibiotic. He reiterates an Outperform rating on the shares.
https://thefly.com/landingPageNews.php?id=2906907
https://thefly.com/landingPageNews.php?id=2906907
Blueprint Medicines reports Q1 EPS ($1.98), consensus ($1.86)
Reports Q1 revenue $730K, consensus $1.7M.
Perrigo says ‘actively’ pursuing CBD
With the cannabidiol market growing at approximately 50% per year with a total market opportunity estimated at $2B by 2022, the company is announcing that it is in active discussions with “several leading CBD companies to identify the best partner to create high-quality reliable CBD products. Several of the largest U.S. retailers have already announced plans to sell CBD-containing products and are looking for partners such as Perrigo to deliver a safe and reliable product.”
Repligen raises FY19 adjusted EPS view to 84c-90c from 81c-86c
Raises FY19 revenue view to $-$241M from $218M-$225M, consensus $225.3M. Current guidance reflects overall revenue growth of 21%-24%, and organic revenue growth of 22%-25%. Gross margin is expected to be 56%-57% on both a GAAP and non-GAAP basis, consistent with previous guidance.
Spectrum announces asset purchase, license for immuno-oncology platform
Spectrum Pharmaceuticals announced the closure of an asset purchase and license agreement with ImmunGene, Inc., a privately held biotechnology company. The deal includes an exclusive license for the intellectual property related to the FIT antibody-interferon fusion technology drug delivery platform originally developed by scientists at UCLA. The license also includes two novel assets derived from this platform. The first asset is an antibody-interferon fusion molecule directed against CD20 . This drug candidate is in Phase 1 development for treating relapsed or refractory non-Hodgkin lymphoma, including diffuse large b-cell lymphoma patients where a considerable unmet medical need exists. Research for this program received financial support through the Therapy Acceleration Program of The Leukemia & Lymphoma Society, Inc, and an LLS research grant to UCLA. The second asset is an antibody-interferon fusion molecule directed against GRP94, a target for which currently there are no existing approved therapies. It has the potential for treating both solid and hematologic malignancies. Under the terms of the agreement, Spectrum will pay an upfront cash payment of approximately $3 million, up to $156 million in development and sales milestones, and royalties on net sales in the high-single digits.
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