Nabriva Therapeutics announced that the U.S. FDA has updated the PDUFA goal date for the completion of the FDA’s review of the CONTEPO New Drug Application from June 30, 2019 to April 30, 2019. The two-month acceleration is due to a clarification of the classification and subsequent expedited review period for the CONTEPO NDA submitted in October 2018. In addition to priority review, CONTEPO has been granted Qualified Infectious Disease Product and Fast Track designations by the FDA for the treatment of several serious infections, including cUTI.
Monday, January 14, 2019
Bio-Techne upgraded to Overweight on favorable backdrop at Stephens
Stephens analyst Drew Jones upgraded Bio-Techne to Overweight from Equal Weight, citing his view of the favorable backdrop for legacy reagents and its sustainable momentum with its protein platforms. The demand for GMP-grade products continues to increase amid an increasing focus on cell therapies and biologics, which Jones said is a great opportunity for Bio-Techne given he views it as well-positioned to gain market share from smaller players who will be unable to make the investments needed to provide high-quality, validated proteins and antibodies. Jones maintains a $180 price target on Bio-Techne shares.
Cantor highlights BioMarin, ProQR after JPMorgan Healthcare Conference
Cantor Fitzgerald analyst Eliana Merle found BioMarin’s (BMRN) gene therapy platform advances and “improved risk-reward” for ProQR Therapeutics’ (PRQR) USH2A program ahead of key data mid-2019 as most notable from the JPMorgan Healthcare Conference. The analyst left feeling more confident about BioMarin’s gene therapy platform, which she thinks could positively surprise over the next 12-24 months as new programs enter the clinic. Further, she thinks the safety events in question at this point are likely overdone in ProQR shares following the 15% selloff since the conference. Merle now sees an “even more” favorable risk/reward into the company’s mid-2019 proof-of-concept readout from a separate program.
Anthem initiated at Stephens
Anthem initiated with an Overweight at Stephens. Stephens analyst Scott Fidel initiated coverage of 11 Managed Care and Healthcare Facilities stocks, telling investors that overall he is constructive on managed care and selective on hospitals. He started Anthem with an Overweight rating and $310 price target, calling the $4B in gross savings it will realize from insourcing its pharmacy benefits management contract the “most powerful company-specific tailwind” in his coverage group. He also believes the 9% pullback in the stock over the past month has created an attractive entry point, Fidel added.
https://thefly.com/landingPageNews.php?id=2848035
Aslan target lowered to $8.50 from $12 at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju lowered his price target for Aslan Pharmaceuticals to $8.50 after varlitinib data in first-line gastric cancer didn’t show statistical significance. The analyst, however, reiterates a Buy rating on the shares.
https://thefly.com/landingPageNews.php?id=2848037
Omeros reports preliminary Q4 revenue $22M, consensus $13.94M
Omeros’ preliminary total and OMIDRIA 1% / 0.3% revenues for the fourth quarter of 2018 are expected to be a record high at approximately $22.0 million compared to $4.6 million in 3Q18 and $13.8 million in the prior year fourth quarter. The increase from the prior periods reflects strong demand for OMIDRIA from ambulatory surgery centers and hospitals following reinstatement of pass-through reimbursement for OMIDRIA on October 1, 2018. Consistent with Omeros’ strategy, growing revenues from OMIDRIA are increasingly funding the progress across the company’s pipeline, including the advancement of its OMS721 Phase 3 program in hematopoietic stem cell transplant-associated thrombotic microangiopathy, or HSCT-TMA. As reflected in an update recently submitted to clinicaltrials.gov, Omeros plans to keep the ongoing HSCT-TMA registration trial open through the submission, filing and review of the Biologics License Application, or BLA, and the Marketing Authorization Application, or MAA, in the U.S. and Europe, respectively, to collect additional data. These data are expected to help provide healthcare professionals and payers with additional supporting information on the clinical use and value of OMS721 once approved. The update submitted by Omeros to clinicaltrials.gov has no effect on the overall timing, content or requirements of the OMS721 HSCT-TMA program, including the BLA and MAA, and the program remains on track. “We are very pleased that demand for OMIDRIA, in its first quarter of restored separate payment, has not only returned quickly to the levels experienced prior to the expiration of pass-through reimbursement but that quarterly revenue and sell-through results are already setting new high-water marks,” said Gregory Demopulos, M.D., Omeros’ chairman and CEO. “We are also encouraged by the expanding coverage seen by commercial and Medicare Advantage payers and, with the addition of OMIDRIA to its national formulary, by the VA. All of these data underscore the importance both of improved outcomes with OMIDRIA and of separate payment to ensuring patient access to the drug’s benefits. As expected, revenues from sales of OMIDRIA ramped up throughout the fourth quarter, and we look forward to continued revenue growth in 2019 as we prepare to commercialize OMS721 for the treatment of stem cell transplant-associated TMA.”
https://thefly.com/landingPageNews.php?id=2848043
Microbot Medical announces data from independent lab study of SCS Microbot
Medical announced that it has “validated the operational effectiveness” of the company’s Self-Cleaning Shunt, or SCS, in a recent independent in-vitro laboratory study. The company also shared images of its SCS from the laboratory study that demonstrate the device prevented shunt occlusion. The study was conducted at Envigo CRS Israel, a provider of non-clinical contract research services and research models. Human brain glioblastoma cells were used in order to assess performance of the SCS in a test system with accelerated cell growth rate, accumulation and obstruction rates. The study commenced in October 2018 and after 30 days it demonstrated: gignificant cell growth and accumulation in a non-operating SCS and a significant inhibition in cell growth in the constantly operating SCS with very little to no cell attachment on the robotic brush, or ViRob, and on the opening where the robotic brush operates. The study also demonstrated that the company’s SCS has the ability to operate after cells had accumulated on the catheter holes and the robotic brush. Moreover, SCS activation demonstrated the potential to disintegrate existing occlusions formed on the robotic brush and on the opening where the robotic brush operates. In addition to this study, the company previously announced data from two pre-clinical studies that were performed at leading U.S. academic institutions. In-vitro study, which was performed at Wayne State University, supports the SCS’ potential as a viable technology for preventing occlusion in shunts used to treat hydrocephalus. In-vivo animal study, which was performed at Washington University School of Medicine, supports the safety profile of the company’s SCS as a CSF catheter. The follow up study, which is being conducted by the same academic institutions, commenced in October 2018 and includes a larger sample size compared to the initial studies. The primary and secondary endpoints will seek to validate the safety and efficacy of the SCS that will be activated in both in-vitro and in-vivo models. The company’s objective is to conclude the follow up study and announce the data in the second half of 2019. The company plans to use the findings either for its regulatory submissions in the US, Europe and other jurisdictions, or as part of a pre-submission meeting request, depending on the final results of the ongoing follow-up study.
https://thefly.com/landingPageNews.php?id=2848045
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