OMER = Omeros announced that results of a prospective, controlled study showing that its FDA-approved ophthalmic drug Omidria reduces use of the opioid fentanyl during cataract surgery while also reducing surgical pain were published in the peer-reviewed journal Clinical Ophthalmology. Omidria is approved by FDA for prevention of miosis and for reduction in postoperative pain for adults and pediatric patients undergoing cataract or lens replacement surgery. The study objectives were to evaluate the effect of Omidria compared to epinephrine on perioperative fentanyl use and pain in patients undergoing cataract surgery. Sixty patients were prospectively assigned to have either Omidria or epinephrine added to the irrigation solution used during surgery. Patients in the Omidria group were 6.7 times more likely not to require fentanyl, with 9.8% of Omidria patients requiring fentanyl versus 42.1% of epinephrine patients. In addition, mean visual analog scale pain scores were significantly lower in the Omidria group than in the epinephrine group. The proportion of patients with VAS scores of 3 was significantly greater in the Omidria group than in the epinephrine group. Omidria patients also were 94% less likely to require fentanyl or to have moderate-to-severe pain than patients receiving epinephrine. Congress and CMS understand the public health risk associated with opioid exposure and CMS is required under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment, or SUPPORT, for Patients and Communities Act to review payments under its outpatient prospective payment system for opioids and evidence-based non-opioid alternatives for pain management with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives. In its 2020 OPPS final rule published on November 1, CMS did not add any products to the non-opioid exclusion from packaged payment. Although CMS had received an analysis of the Donnenfeld data, CMS specifically requested peer-reviewed published evidence and the Donnenfeld study had not yet been published at the time the final rule was issued. With the publication of the Donnenfeld opioid-sparing data, Omeros believes that Omidria meets all of CMS’ requirements for the non-opioid exclusion. CMS stated in the final rule that it will continue to analyze the evidence in support of the benefits of Omidria and monitor utilization of this drug, and Omeros intends to address CMS’ Omidria-related comments. Omeros also plans to continue its administrative and legislative efforts to secure ongoing separate payment for Omidria beyond the drug’s current pass-through extension. Omidria continues to receive separate payment from CMS under its pass-through extension until October 1, 2020.

PRIM = Reports Q3 revenue $865.1M, consensus $894.97M. Reports total Backlog of $3.2B at September 30 a 16.3% increase over December 31, 2018. The company commented, “”I am pleased to say that Primoris had another great quarter, with strong project execution and continued cost control leading to a record net income. The lack of major storm repair work and project delays created a slight headwind compared to last year, but it was more than offset by benefits from the partial resolution of outstanding claims. Over the past year we have seen our backlog grow 19%, growing both our Fixed and MSA backlog, thanks to the combined efforts of our dedicated sales and operations teams. As expected, we saw a significant positive swing in our operating cash flow in the Q3, allowing us to continue reducing our debt levels while maintaining a robust capital expenditure program, actively evaluating additional acquisition opportunities, and initiating a share repurchase program.”

USM = Raymond James analyst Ric Prentiss upgraded U.S. Cellular to Strong Buy from Outperform with a price target of $49, down from $53, following what he calls an overreaction on Friday to the Q3 results. In a research note to investors, Prentiss says he believes the brand refresh and new rate plans will continue to drive foot traffic into stores, helping postpaid phone subscriber growth and continues to believe the best option to maximize return on invested capital for U.S. Cellular would be to affiliate with, or sell to, a larger carrier, whether the T-Mobile (TMUS)-Sprint (S) merger is approved or not. The analyst views shares as “very attractive.”

XLNX = On October 31, 2019, Xilinx announced that SK Telecom has adopted Xilinx® Alveo™ Datacenter Accelerator cards to power a real-time AI-based physical intrusion and theft detection service. SK Telecom’s AI inference accelerator (AIX) implemented on Xilinx Alveo cards provides efficient and accurate physical intrusion detection using deep neural networks. ADT CAPS CO., LTD., South Korea’s second largest physical security company, licenses and commercially deploys the physical intrusion detection service.

IFMK = On September 13, 2019, iFresh announced that its Board of Directors has authorized a new share repurchase program of up to 2M shares of iFresh common stock between certain price range in the open market. The Company expects to put the program into place within the next twelve months and will issue a further release when the program has been established.

BLCM = On October 31, 2019, Bellicum Pharmaceuticals announced that an abstract for a preclinical investigation from its natural killer cell chimeric antigen receptor (CAR) program has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. The meeting is being held November 6-10, 2019 in National Harbor, Md.

Details of the poster presentation are as follows:

Title: Solid Tumor Cytotoxicity by Natural Killer Cells Expressing a HER2-Directed Chimeric Antigen Receptor Enhanced by MyD88/CD40 (MC)
Poster Board: #P151
Presenter: Henri Bayle, Ph.D.
Time/Location: Friday, November 8, 2019, 7 a.m. to 8 p.m. ET

USM = Raymond James analyst Ric Prentiss upgraded U.S. Cellular to Strong Buy from Outperform with a price target of $49, down from $53, following what he calls an overreaction on Friday to the Q3 results. In a research note to investors, Prentiss says he believes the brand refresh and new rate plans will continue to drive foot traffic into stores, helping postpaid phone subscriber growth and continues to believe the best option to maximize return on invested capital for U.S. Cellular would be to affiliate with, or sell to, a larger carrier, whether the T-Mobile (TMUS)-Sprint (S) merger is approved or not. The analyst views shares as “very attractive.”