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.
Monday, April 8, 2019
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.
Good time to take another look at Theravance, says Cantor Fitzgerald
Cantor Fitzgerald analyst Louise Chen believes it is a good time to take another look at Theravance Biopharma given its “inexpensive valuation” and “important catalysts” this year. The company’s cash and equivalents totaled $517.1M at the end of 2018 and it appears well positioned to receive over $1B in milestones and payments, Chen tells investors in a research note. However, its market capitalization is only $1.3B, says the analyst. She thinks the peak sales potential of Theravance’s organ-selective JAKs, Ampreloxetine, Yupelri and Trelegy, are all underappreciated and keeps an Overweight rating on the shares with a $55 price target.
Evolus announces publication of Jeuveau, Botox head-to-head trial
Evolus announced the publication of the European and Canadian Phase III head-to-head pivotal trial results in the April issue of Aesthetic Surgery Journal. “The results of this study are compelling and reinforce the clinical performance of Jeuveau, which is the first 900 kDa product to enter the U.S. market in nearly 30 years,” said David Moatazedi, president and CEO. “We look forward to launching Jeuveau in the coming weeks in the United States.
Cantor positive on HTG Molecular after hosting management meetings
Cantor Fitzgerald analyst Jordan Abrams reiterates an Overweight rating on HTG Molecular Diagnostics with a $6 price target. After hosting investor meetings with management, the analyst is positive on “increased visibility into the business” with a focus on longer-term product development. Product investment positions HTG well to be the leader in RNA molecular profiling, Abrams tells investors in a research note. Meanwhile, the analyst believes the company’s base profiling business “remains strong.” Although biopharma partnership data readouts are the most visible potential catalysts to the shares, consistent execution in the base profiling business “will also propel the shares higher,” Abrams writes.
Applied Genetic reaches enrollment milestones in two clinical trials
Applied Genetic announced that it has achieved enrollment milestones in two of its Phase 1/2 clinical trials. The company completed enrollment of the dose escalation portion of the achromatopsia, or ACHM, CNGB3 trial, which is evaluating the safety and efficacy of its product candidate, rAAV2tYF-PR1.7-hCNGB3, for the treatment of ACHM caused by mutations in the CNGB3 gene. The company also completed enrollment in the expansion group, which includes pediatric patients, of its product candidate, rAAV2tYF-GRK1-RPGR, for the treatment of X-linked retinitis pigmentosa, or XLRP, caused by mutations in the RPGR gene. Both investigational therapies utilize the company’s proprietary AAV delivery technology and are administered by subretinal injection. The company is enrolling patients in two parallel Phase 1/2 clinical trials of its product candidates for ACHM caused by mutations in the two most common ACHM genes, CNGB3 and CNGA3. To date, AGTC has enrolled 12 patients in the ACHM CNGB3 trial and six patients in the ACHM CNGA3 trial. AGTC plans to provide topline interim six-month data for the dose escalation portion of the CNGB3 study in the second half of the year. To date, AGTC has completed enrollment of 10 and six patients in the dose escalation and expansion portions of the XLRP trial, respectively. The company plans to provide topline interim six-month data for the dose escalation portion of the trial in Q3 and the expansion portion in Q4.
Axsome Therapeutics initiated at SVB Leerink
Axsome Therapeutics initiated with an Outperform at SVB Leerink. SVB Leerink analyst Marc Goodman initiated Axsome Therapeutics with an Outperform and $25 price target.
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