UBS analyst Michael Leuchten downgraded AstraZeneca to Sell from Neutral and lowered his price target for the shares to GBP 54 from GBP 59. Last week’s oncology deal with Japan’s Daiichi Sankyo suggests limited cash generation in the near term and is a sign of slow margin recovery, Leuchten tells investors in a research note. He believes AstraZeneca can’t generate enough cash flow to support its current enterprise value
Tuesday, April 2, 2019
LabCorp upgraded to Buy from Hold at Jefferies
Jefferies analyst Brian Tanquilut upgraded Quest Diagnostics to Buy from Hold.
Achieve Life Sciences completes second DSMB review of ORCA-1 trial
Achieve Life Sciences announced that the Data Safety Monitoring Committee, or DSMC, met on March 28, 2019 to conduct its second and final safety review of the ORCA-1 Trial. The DSMC is an independent committee that advises on continuation or stopping of clinical trials based upon safety and study conduct considerations. The ORCA-1 DSMC has had the responsibility for safeguarding the interests of trial subjects by assessing the safety of the interventions and monitoring the conduct of the ORCA-1 trial. The committee has reviewed the ORCA-1 data twice during the conduct of the study, and has concluded following each review that there are no safety concerns for subjects or study conduct issues, and the trial should continue for completion as planned. ORCA-1 topline efficacy and safety data are expected to be announced by end of the second quarter of 2019. “We are very pleased with the speed of enrollment and efficient conduct of the ORCA-1 trial, which is attributed to the commitment of the trial subjects, clinical investigators and their support teams,” said Dr. Cindy Jacobs, Chief Medical Officer at Achieve. “We look forward to sharing the data results in the near future.”
Piper continues to believe Apyx Medical will receive 510k clearance
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.
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.
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