Xencor (XNCR) announced it will regain rights to develop and commercialize XmAb13676, a CD20 x CD3 bispecific antibody, from Novartis (NVS) effective June 20, 2019, due to strategic pipeline reprioritization by Novartis. Xencor granted Novartis co-development and ex-U.S. commercial rights in June 2016 through a collaboration and license agreement to develop and commercialize novel bispecific antibodies, including XmAb13676 and XmAb14045, and to access Xencor’s XmAb bispecific Fc and other Fc technologies. Currently XmAb13676 is being evaluated in an open-label Phase 1, multiple-dose, dose-escalation study to assess its safety, tolerability and preliminary anti-tumor activity in patients with B-cell malignancies, and initial data are expected in 2019.
Monday, January 7, 2019
AtriCure sees FY19 revenue approx. $220M-$228M, consensus $222.8M
Management projects 2019 revenue of approximately $220M to $228M, reflecting growth of approximately 9% to 13% over full year 2018. Adjusted EBITDA, a non-GAAP measure, is projected to be positive for 2019.
SeaSpine sees FY19 revenue $152M-$156M, consensus $153.37M
https://thefly.com/landingPageNews.php?id=28445
OrthoPediatrics prelim Q4 revenue $14.5M-$14.7M, consensus $14.62M
https://thefly.com/landingPageNews.php?id=284460
Cerus reports Q4 prelim product revenue $16.5M; revenue consensus $19.9M
Cerus’ unaudited preliminary product revenue for the fourth quarter of 2018 totaled $16.5M compared to $16.2M during the same period the prior year. Preliminary fourth quarter product revenue would represent the highest quarterly product revenue ever reported by the Company.
AcelRx reports publication of pooled analysis analyzing sufentanil tablets
AcelRx Pharmaceuticals announced the publication of a pooled analysis in the peer reviewed journal, Pain Management, analyzing the results of AcelRx’s clinical studies to assess safety of sufentanil sublingual tablets for the short-term treatment of moderate-to-severe acute pain in medically supervised settings. The objective of the safety analysis was to evaluate the pooled data from AcelRx’s clinical studies of sufentanil sublingual tablets administered at 30 mcg dose equivalents over less than or equal to 72 hours for moderate-to-severe acute pain management in both postoperative and emergency room patients. Analysis included a subset of patients from SST 15 mcg studies where patients received the first two doses of SST 15 mcg within the first 20-25 min (representing a 30-mcg dose-equivalent). Overall, 804 patients were evaluated in the pooled safety analysis, including 646 that had received the active drug. Across all of the AcelRx studies, adverse events were experienced by 60.5% of patients in the SST group, and 61.4% in the placebo group. The most common treatment-related AEs experienced by patients treated with SST were nausea (28.5%), vomiting (6.5%) and headache (5.0%). Findings from the pooled analysis support that short-term (less than or equal to72 hours) administration of SST is well tolerated, with most adverse events considered mild or moderate in severity. The publication also noted the additional safety assessment measuring cognitive impairment, which AcelRx had performed in one open-label SST 30 mcg study in emergency room patients. A total of 75 patients were dosed with SST 30 mcg and evaluated predose and 1 hour postdose for cognitive impairment using the validated Six-item Screener tool. In 97.3% of the patients, the score stayed the same or improved following a dose of SST 30 mcg.
https://thefly.com/landingPageNews.php?id=2844607
Homology Medicines advances 1st gene editing development candidate to study
Homology Medicines announced that it has nominated an in vivo gene editing development candidate and initiated IND-enabling studies for the treatment of pediatric patients with phenylketonuria. Homology also completed its internal GMP manufacturing facility with capabilities to support both gene editing and gene therapy programs. “Starting IND-enabling studies with an in vivo, nuclease-free gene editing candidate is an important milestone for Homology and achieves a key 2018 corporate goal,” said Albert Seymour, Ph.D., Chief Scientific Officer of Homology Medicines. “Our dual platform has enabled us to progress specific genetic medicine programs for PKU that may address two distinct patient populations who require different therapeutic approaches based on human biology, with gene therapy for adults and gene editing for children. We look forward to continuing to move these one-time potentially curative treatments forward as rapidly as possible.”
https://thefly.com/landingPageNews.php?id=2844609
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