Apyx Medical’s decision to withdraw its 510k submission for dermal resurfacing following FDA pushback on various aspects of their study removes a source of upside and will “no doubt give legs to some of the theories floated in the short report,” Piper Jaffray analyst Matt O’Brien tells investors in a research note. However, the analyst continues to believe that once Apyx “irons out” some of its clinical hurdles, the company will receive this clearance. Additionally, O’Brien feels that the product’s use off-label for these procedures is likely reflective of J-Plasma’s “unique utility in these situations,” which allows him to remain constructive on the stock. He reiterates an Overweight rating on Apyx Medical with a $10 price target.
Tuesday, April 2, 2019
Evoke Gets CRL, Recommendations to Address Deficiencies from FDA for Gimoti
Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its 505(b)(2) New Drug Application (NDA) for Gimoti™ for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. The CRL, which cites fewer issues than the recent multidisciplinary review letter, states that FDA has determined it cannot approve the NDA in its present form and provides recommendations to address the two remaining approvability issues in an NDA resubmission. The issues are related to clinical pharmacology and product quality/device quality. The Agency did not request any new clinical data and did not raise any safety concerns. The clinical pharmacology issue was specific to a low Cmax in subjects representing less than 5% of the total administered Gimoti doses in the pivotal pharmacokinetic (PK) study. The Agency stated the overall lower mean Cmax was driven by the data from these few subjects. Without the aberrant doses, the Company’s analysis shows the data met the bioequivalence criteria for both men and women. The Agency recommended a root cause analysis to determine the origin of the PK variability and mitigation strategies to address the issue. Additionally, FDA requested data from previously planned registration batches of commercial product to be manufactured by the Company. These data were requested to provide additional support for the proposed acceptance criteria for droplet size distribution after actuation of the sprayer device.
UnitedHealthcare, AMA announce new collaboration
UnitedHealthcare and the American Medical Association announced a new collaboration that will better identify and address social determinants of health to improve access to care and patient outcomes. Building on work initiated by UnitedHealthcare, the two organizations are working together to standardize how data is collected, processed and integrated regarding critical social and environmental factors that contribute to patient well-being. Through this collaboration, UnitedHealthcare and the AMA are supporting the creation of nearly two dozen new ICD-10 codes related to SDOH. By combining traditional medical data with self-reported SDOH data, the codes trigger referrals to social and government services to address people’s unique needs, connecting them directly to local and national resources in their communities.
Piper ‘staying bullish’ on Bausch Health after headquarter visit
Piper Jaffray analyst David is “staying bullish” on Bausch Health Companies after bring an investor group to meet with management at the company’s headquarters. The analyst continues to believe that visibility into Bausch’s longer-term EBITDA growth of at least in the mid-single digits is high, with key drivers including Xifaxan growth and contribution from new products. That translates into an attractive risk/reward profile at current valuation levels, Amsellem tells investors in a research note. He reiterates an Overweight rating on Bausch Health with a $28 price target.
AtriCure upgraded to Buy from Neutral at BTIG
BTIG analyst Sean Lavin upgraded AtriCure to Buy from Neutral with a $35 price target following the recent share slide, telling investors in a research note that its valuation warrants a second look. Lavin says that at the current valuation, he believes investors can be rewarded through quarterly beats and “enthusiasm” ahead of Converge data and notes that fundamentals have improved as the open business has stabilized.
https://thefly.com/landingPageNews.php?id=2887153
https://thefly.com/landingPageNews.php?id=2887153
Monday, April 1, 2019
Amgen in New Phase 3 Outcomes Study for Cholesterol-Lowering Treatment
Amgen plans to conduct VESALIUS-CV, a multinational clinical outcomes study including at least 13,000 patients that will explore the potential of Repatha®(evolocumab) for the prevention of a first cardiovascular (CV) event in patients at high cardiovascular risk without a prior heart attack or stroke.1 The study will be the first to investigate long-term outcomes in this population with Repatha for a minimum of four years.1 The safety and efficacy of Repatha has not been established for this use. Named after the legendary scientist Andreas Vesalius, who was one of the first to accurately depict the anatomy and function of the heart,2 this study is an important addition to PROFICIO (Program to Reduce LDL-C and cardiovascular Outcomes Following Inhibition of PCSK9 In different pOpulations), the growing clinical program for Repatha.
Sangamo To Host April 2, 2019 Conference Call For Clinical Update
Sangamo Therapeutics Inc. (Nasdaq: SGMO), a genomic medicine company, announced today that management will host a conference call on Tuesday, April 2nd at 8:00 a.m. Eastern Time to provide a clinical development update.
The conference call will be webcast live and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.
The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 6063108. For those unable to listen in at the designated time, a conference call replay will be available for one week following the call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 6063108.
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