Investor Conference Call on the Pharmaceutical Business will be held on September 13 at 8 am. Weblink: https://edge.media-server.com/m6/p/rhr5yhf6
Wednesday, September 12, 2018
JPMorgan remains positive on Ascendis after management meeting
After hosting an investor event with management, JPMorgan analyst Jessica Fye remains positive on shares of Ascendis Pharma. The analyst sees “multiple potential inflection points ahead,” including topline data from the Phase I SAD study for TransCon CNP in healthy volunteers in Q4, disclosure of the next therapeutic vertical in early 2019, and topline Phase III data for TransCon Growth Hormone in Q1 of 2019. Ascendis is experiencing a “multi-year evolution” as it transitions from a single product story to one with multiple orphan endocrine assets in the clinic and platform that will expand its existing orphan endocrine portfolio. Fye believes the company will “significant value” over time and keeps an Overweight rating on Ascendis Pharma.
https://thefly.com/landingPageNews.php?id=2789031
RedHill Biopharma announces meeting with FDA for colitis med
RedHill Biopharma announced that it recently concluded a positive end-of-Phase II/pre-Phase III meeting with the FDA discussing the clinical and regulatory pathway towards potential U.S. approval of Bekinda for the treatment of diarrhea-predominant irritable bowel syndrome , or IBS-D. In light of the clarity provided by the FDA, RedHill plans to finalize the design of two pivotal Phase III studies with Bekinda and to accelerate global pharma partnership discussions, including U.S. co-promotion opportunities. The FDA meeting followed the positive results of the randomized, double-blind, placebo-controlled Phase II study with Bekinda for IBS-D. The study, which was conducted in the U.S. and enrolled 126 subjects, successfully met its primary endpoint, improving the primary efficacy outcome of stool consistency response by an absolute difference of 20.7% vs. placebo.
https://thefly.com/landingPageNews.php?id=2789079
Cigna announces launch of $250M Cigna Ventures fund
Cigna announced the launch of Cigna Ventures, a corporate venture fund focused on transformative and innovative health care companies. Cigna has committed $250M of capital to Cigna Ventures to invest in promising startups and growth-stage companies that are unlocking new growth possibilities in health care and will bring improved care quality, affordability, choice, and greater simplicity to customers and clients. Cigna Ventures is focused on companies across three strategic areas: insights and analytics; digital health and retail; and care delivery/management.
https://thefly.com/landingPageNews.php?id=2789087
Amneal Pharmaceuticals: FDA approves ANDA for chlorpromazine hydrochloride
Amneal Pharmaceuticals announced it has received U.S. FDA approval on its Abbreviated New Drug Application for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg and has immediately initiated commercialization activities. According to IQVIA, the U.S. market for chlorpromazine hydrochloride tablets USP is estimated to be approximately $207M in annual sales for the 12 months ended July 2018. The company also received approval for a generic version of Methergine Tablets USP, 0.2 mg, which it expects to launch shortly. According to IQVIA, methylergonovine maleate tablets had annual U.S. sales of approximately $73M for the 12 months ending July 2018.
https://thefly.com/landingPageNews.php?id=2789089
Allergan launches Spotlyte digital hub for asthetic treatment consumer education
Allergan launched Spotlyte, a digital hub of curated content that helps consumers discover how medical aesthetic treatments may fit into their routines through content, product reviews and insider profiles, beauty news and trends, and a team of trained specialists ready to offer real-time support and chat directly. Spotlyte is the first venture from the new Allergan-owned digital ventures unit, Project Moonwalker.
https://thefly.com/landingPageNews.php?id=2789095
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