OrthoPediatrics prelim Q4 revenue $14.5M-$14.7M, consensus $14.62M

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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.

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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.
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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.”
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Baxter initiates U.S. clinical trial for on-demand PD solution generation system

Baxter International announced that the first patients have been enrolled in a U.S. clinical trial for the company’s on-demand peritoneal dialysis, or PD, solution generation system. The innovative system is designed to improve the patient experience by making PD solutions in small batches in the patient’s home. The FDA has indicated that the company may proceed with the prospective, multi-center clinical trial.
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Gamida Cell expects to present additional data from NAM-NK study in 1H19

Gamida Cell expects to achieve the following milestones this year: Present additional data from the Phase 1 study of NAM-NK in first half of 2019. Report early data from the Phase 1/2 study of NiCord in patients with severe aplastic anemia data in the first half of 2019. Complete patient enrollment in the Phase 3 study of NiCord in patients with high-risk hematologic malignancies in the second half of 2019.
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Eli Lilly sees no change to dividend policy as a result of Loxo deal

Eli Lilly (LLY), on its conference call discussing its proposed $8B acquisition of Loxo Oncology (LOXO), said that it sees no change to dividend policy as a result of the deal, though it will limit share repurchases in 1H. The company said it expects modest downward pressure on margins in the near-term.
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