Thursday, November 8, 2018
Globus Medical raises FY18 EPS view to $1.62 from $1.55, consensus $1.55
Raises FY18 revenue to $705M from $700M, consensus $701.41M.
https://thefly.com/landingPageNews.php?id=2821093
Ascendis Pharma forms JV with investor syndicate
Ascendis Pharma announced the formation of Visen Pharmaceuticals, a joint venture, or JV, with an investor syndicate led by Vivo Capital, to develop, manufacture and commercialize the company’s endocrinology rare disease therapies in Greater China, which includes mainland China, Hong Kong, Macau and Taiwan. Ascendis has granted Visen exclusive rights to develop and commercialize TransCon hGH, TransCon PTH and TransCon CNP in Greater China, and has received 50% ownership of Visen. An investor syndicate led by Vivo, along with participation by Sofinnova Ventures, has invested $40M and has received 50% ownership of Visen. Visen will be responsible for all development, manufacturing and commercialization costs for TransCon hGH, TransCon PTH, and TransCon CNP in Greater China. Ascendis will be reimbursed for clinical trial material and technical support by Visen. Commercial supply will be negotiated for each product by Ascendis and Visen. Ascendis will collaborate with Visen to evaluate integration of Greater China into Ascendis Pharma’s global rare disease clinical development programs. Ascendis and Vivo have an option to participate in certain future investment rounds to maintain their pro rata ownership of the joint venture. Visen has a right of first negotiation on certain future Ascendis products within the endocrinology disease area limited to Greater China. Ascendis retains full rights to its TransCon technology products outside of Greater China.
https://thefly.com/landingPageNews.php?id=2821113
Veracyte says data shows ‘real world’ performance of Afirma GSC
Veracyte announced the publication of “real world” data showing that the Afirma(R) Genomic Sequencing Classifier (GSC) enables even more patients to avoid unnecessary surgery in thyroid cancer diagnosis compared to the company’s flagship, original Afirma Gene Expression Classifier (GEC). The findings are published online in Endocrine Practice, the journal of the American Association of Clinical Endocrinologists. In the study, researchers from Memorial Healthcare System in Hollywood, Fla., reviewed data from all patients in their practice whose thyroid nodules were deemed indeterminate (i.e., not clearly benign or cancerous) by cytopathology review and who subsequently received results from genomic testing with the Afirma GSC (n=139) or the Afirma GEC (n=481). They found that the Afirma GSC identified 47 percent more thyroid nodules as benign than the first-generation test (61.2 percent vs. 41.6 percent). Use of the next-generation test also reduced overall surgery rates among all patients with indeterminate thyroid nodules by 45 percent. The researchers determined that sensitivity for the Afirma GSC in their practice was 97 percent. The RNA sequencing-based Afirma GSC demonstrated especially strong performance in distinguishing benign from cancerous Hurthle cells – a category of thyroid cell that has historically been challenging to diagnose by cytopathology or molecular methods. The Afirma GSC identified 64.7 percent of Hurthle cell dominant biopsies as benign compared to 17.3 percent with the original test and dramatically reduced overall surgery referrals in this group by 57.3 percent. “Our data suggest that the Afirma GSC is helping us to further reduce unnecessary surgeries among our patients with indeterminate thyroid nodules by enhancing the original test’s specificity while maintaining its high sensitivity,” said R. Mack Harrell, M.D., cofounder of the Memorial Center for Integrative Endocrine Surgery and lead author of the new study. “A key reason for this change is the Afirma GSC’s ability to rule out cancer in Hurthle-dominant thyroid nodules. This is important because Hurthle-dominant cases comprise 22 percent of the indeterminate thyroid nodules we evaluate.”
https://thefly.com/landingPageNews.php?id=2820985
Subscribe to:
Posts (Atom)