Piper Jaffray analyst Christopher Raymond started Ardelyx with an Overweight rating and $15 price target. The analyst sees a “sizeable disconnect” between Wall Street’s view of tenapanor’s potential versus that of the nephrology community. While the drug is not fully de-risked, there is enough data to get a “strong sense” of tenapanor’s ultimate clinical profile, which confers $1B-plus revenue potential, Raymond tells investors in a research note. Nephrologists appear “fully aware of this drug’s potential with swift and dramatic uptake projected if approved,” adds the analyst. He thinks tenapanor’s launch is “poised to be one of biotech’s great product launches of 2021.”
Monday, April 8, 2019
United Therapeutics: esuberaprost study did not meet primary endpoint
United Therapeutics announced that the BEAT clinical study of esuberaprost tablets in patients suffering from pulmonary arterial hypertension did not meet its primary endpoint of delayed time to first clinical worsening event. Accordingly, United Therapeutics has decided to discontinue further esuberaprost development.
Madrigal Pharmaceuticals to present additional data from Phase 2 NASH study
Madrigal Pharmaceuticals announced that on Thursday, April 11, at the International Liver Congress 2019, European Association for the Study of the Liver in Vienna, further in depth analyses of the Phase 2 NASH study with MGL-3196 will be presented. Resmetirom is currently in Phase 3 development for the treatment of NASH patients with stage 2-3 fibrosis. MGL-3196-05 was a 36-week multicenter, randomized, double-blind, placebo- controlled serial MRI-PDFF, paired liver biopsy study in adults with biopsy-confirmed NASH and hepatic fat fraction greater than or equal to10%. In 12 week interim and 36 week final analyses, MGL-3196 treated patients had significantly more reduction of liver fat compared with placebo on MRI-PDFF and up to 77% of resmetirom-treated patients showed at least a 30% reduction of liver fat. NASH resolution was attained on biopsy in 39% of resmetirom patients who had a positive PDFF response. At 36 weeks 107 paired biopsies were assessed to examine the predictive power of PDFF response on histologic response of NAS, NASH resolution and reduction of ALT. In resmetirom-treated patients, a 12 week PDFF response versus non-response was predictive of NASH resolution at week 36 and correlated with improvements in steatosis, hepatocyte ballooning and inflammation as well as reduction in ALT. Placebo patients with weight loss greater than or equal to5% were likely PDFF responders, and a PDFF response in placebo patients also predicted reductions in inflammation and hepatocyte ballooning. Dr. Harrison stated, “These analyses show that positive MRI-PDFF responses correlate with reductions in hepatocyte ballooning, inflammation and NASH resolution on liver biopsy and are associated with decreases in ALT. The data suggest that reduction of hepatic fat is a critical component of NASH improvement and resolution.”
Baxter downgraded to In Line on valuation at Evercore ISI
Baxter downgraded to In Line on valuation at Evercore ISI. As previously reported, Evercore downgraded Baxter to In Line from Outperform with an $84 price target. Analyst Vijay Kumar views valuation as “fair at current levels” following multi-year outperformance.
Inspire Medical reports three new positive coverage policies issued by BCBS
Inspire Medical Systems announced that three new Blue Cross Blue Shield Association healthcare plans have issued positive coverage policies of Inspire therapy. These plans include: Highmark, Inc.; Blue Cross Blue Shield of Alabama; and BCBS of South Carolina, which, in the aggregate, provide coverage for approximately 8.3 million members. As to these positive coverage policies: Highmark, Inc., the sixth largest BCBS plan, covers approximately 4.6 million members across Pennsylvania, West Virginia, Delaware and took effect on April 5, 2019; BCBS of Alabama covers approximately 2.9 million members and took effect on April 2, 2019; and BCBS of South Carolina covers approximately 800,000 members and took effect on March 15, 2019. There have now been 16 positive coverage policies issued by BCBSA healthcare plans, currently covering approximately 33 million members, following BCBSA Evidence Street’s January 7, 2019 report, which stated that there is sufficient evidence to determine that Inspire therapy results in a meaningful improvement in net health outcomes for patients meeting specified criteria. In aggregate, there are a total of approximately 61 million members under all of the policies that cover Inspire therapy.
Neon Therapeutics completes enrollment of NT-002 trial
Neon Therapeutics announced the completion of enrollment in NT-002, its Phase 1b clinical trial evaluating NEO-PV-01 with Keytruda and chemotherapy in patients with untreated advanced or metastatic non-small cell lung cancer, or NSCLC. NEO-PV-01 is a personal neoantigen vaccine custom-designed and manufactured based on the neoantigens identified by Neon’s proprietary bioinformatics engine, Recon, as being the most therapeutically relevant for an individual patient.
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