CareDx in ‘early innings’ of sales growth acceleration, says Piper Jaffray. After traveling with management, Piper Jaffray analyst William Quirk continues to believe CareDx is in the “early innings” of a multiyear revenue acceleration story “that has several legs.” Management was upbeat about the pace of the AlloSure launch, with K-OAR center enrollment ahead of schedule, Quirk tells investors in a research note. The analyst encourages small cap growth funds to add to or establish positions in the stock and reiterates an Overweight rating on CareDx with a $14 price target.
Monday, May 21, 2018
Welltower upped to buy by Raymond James
Welltower upgraded to Outperform from Market Perform at Raymond James
MyoKardia sets design of Phase 3 cardiomyopathy therapy trial
MyoKardia announced the design of its pivotal Phase 3 EXPLORER-HCM clinical trial to evaluate the use of mavacamten for the potential treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy. The company has incorporated input on the study design from the Division of Cardiovascular and Renal Products of the U.S. Food and Drug Administration, and plans to conduct this single pivotal study along with a long-term extension study to support registration. MyoKardia expects to dose the first patient in the EXPLORER-HCM trial in the second quarter of 2018 and expects that data from the Phase 3 trial will be available in the second half of 2020.EXPLORER-HCM is a multi-national randomized double-blind study designed to assess the effects of a 30-week treatment of mavacamten versus placebo with a primary endpoint of clinical response. The clinical response endpoint is intended to broadly capture the potential benefits of treatment with mavacamten on how patients feel and function by utilizing both peak oxygen consumption and New York Heart Association functional classification. Clinical response can be achieved by meeting either of two definitions: 1) an improvement of at least 1.5 mL/kg/min in peak VO2 accompanied by a reduction from baseline of at least one NYHA functional class or 2) an improvement from baseline of 3.0 mL/kg/min or greater in peak VO2 without worsening in NYHA functional class. Approximately 220 patients will be enrolled and randomized on a 1:1 basis to receive either mavacamten or placebo. The EXPLORER-HCM trial design includes two opportunities for individualized dose adjustment throughout the 30-week treatment period. Patients in the active treatment arm will start on a once-daily 5mg dose of mavacamten. At Weeks 8 and 14, daily doses may be increased to 10mg or 15mg, or remain unchanged, based on measurements of provoked left ventricular outflow tract gradient conducted at Weeks 6 and 12. A reduction in provoked LVOT gradient under 50 mmHg has been shown in PIONEER to correlate to improvements in several clinical measurements, including NYHA class and peak VO2. All assessments and dose adjustments will be conducted in a blinded fashion. Patients will be allowed to maintain their HCM-related background medications for the duration of the EXPLORER-HCM Phase 3 trial, including beta blockers or calcium channel blockers. Secondary endpoints in the Phase 3 EXPLORER-HCM trial will include the average change from baseline in post-exercise peak LVOT gradient, NYHA functional class, peak VO2, the proportion of patients achieving post-exercise peak LVOT gradient below 50 mmHg or 30 mmHg at Week 30 and patient-reported outcome measures. Exploratory endpoints will include changes in echocardiographic indices of cardiac structure and function, N-terminal pro b-type natriuretic peptide concentrations, quality of life questionnaire scores and daily physical activity assessed using a wearable accelerometer. Throughout the EXPLORER-HCM study, patients will be monitored for adverse events and certain assessments will be performed. If at any time during the trial, a patient’s plasma concentration is above an upper target range or LVEF falls below the normal range, doses of mavacamten may be decreased. Following the 30-week treatment period and eight-week post-treatment wash-out period, patients will be able to participate in a long-term extension study of mavacamten
Arrowhead presents new data on treatment of Cystic Fibrosis
Arrowhead announced the presentation of new preclinical data on ARO-ENaC, formerly referred to as ARO-Lung1, for the treatment of cystic fibrosis, or CF, at the American Thoracic Society, or ATS 2018. ARO-ENaC is the first product candidate to leverage the Targeted RNAi Molecule, or TRiM, platform targeting the pulmonary epithelium to address diseases of the lung. ARO-ENaC is an inhaled RNA interference therapeutic targeting the epithelial sodium channel alpha subunit, or alphaENaC, for the treatment of CF, a rare disease caused by a genetic mutation that leads to mucus buildup in the lungs and pancreas. CF patients can have difficulty breathing and experience frequent and persistent lung infections. Increased ENaC activity contributes to drying mucus in the airway and a reduced ability of the lung to clear toxins and infectious agents. Inheritance of poorly functioning ENaC genes by CF patients leads to milder lung disease. Researchers have been interested in developing therapeutics that decrease ENaC activity in CF patients. However, the development of inhaled small molecule inhibitors has been limited by their short duration of action and unwanted effects resulting from ENaC inhibition in the kidney. ARO-ENaC is designed specifically to address those deficiencies by selectively reducing ENaC in the lung, while sparing the kidney, with a long duration of effect
Nabriva call on Phase 3 data
Conference call to discuss positive topline results from pivotal phase 3 clinical trial of Oral Lefamulin held on May 21 at 8:30 am. Weblink: https://investors.nabriva.com/events/event-details/nabriva-therapeutics-leap-2-phase-3-trial-topline-results-conference-call
Heska target upped by Benchmark after Zoetis-Abaxis deal
Heska price target raised to $120 following management meetings at Benchmark. After meeting with meetings with Heska (HSKA) management, Benchmark analyst Raymond Myers came away with a better understanding of how current investments are likely to accelerate future cash flows and how its new products and international expansion can accelerate revenue growth in 2019. He also said Zoetis’ (ZTS) deal to acquire Abaxis (ABAX) “puts a high price tag on Heska,” estimating that valuing Heska on the same terms as Abaxis would imply a valuation of $143 per Heska share. Myers raised his price target on Heska to $120 from $100 and keeps a Buy rating on the shares.
Teen phone monitoring app leaked thousands of user passwords
At least one server used by an app for parents to monitor their teenagers’ phone activity has leaked tens of thousands of accounts of both parents and children.
The mobile app, TeenSafe, bills itself as a “secure” monitoring app for iOS and Android, which lets parents view their child’s text messages and location, monitor who they’re calling and when, access their web browsing history, and find out which apps they have installed.
Although teen monitoring apps are controversial and privacy-invasive, the company says it doesn’t require parents to obtain the consent of their children.
But the Los Angeles, Calif.-based company left its servers, hosted on Amazon’s cloud, unprotected and accessible by anyone without a password.
Robert Wiggins, a UK-based security researcher who searches for public and exposed data, found two leaky servers.
Both of the servers was pulled offline after ZDNet alerted the company, including another that contains what appears to be only test data.
“We have taken action to close one of our servers to the public and begun alerting customers that could potentially be impacted,” said a TeenSafe spokesperson told ZDNet on Sunday.
The database stores the parent’s email address associated with TeenSafe, as well as their corresponding child’s Apple ID email address. It also includes the child’s device name — which is often just their name — and their device’s unique identifier. The data contains the plaintext passwords for the child’s Apple ID. Because the app requires that two-factor authentication is turned off, a malicious actor viewing this data only needs to use the credentials to break into the child’s account to access their personal content data.
None of the records contained content data, such as photos or messages, or the locations of either parents or children.
The data also contained error messages associated with a failed account action, such as if a parent looking up a child’s real-time location didn’t complete.
Shortly before the server went offline, there were at least 10,200 records from the past three months containing customers data — but some are duplicates.
One of the servers appeared to store test data, but it’s not known if there are other exposed servers with additional data.
TeenSafe claims to have over a million parents using the service.
We began verifying some of the data by reaching out to those whose email addresses were named in the leaking data.
We contacted a dozen people over iMessage, one by one, to confirm their passwords (you can learn more about how we verify data breaches here). Not everyone responded. But several people — parents of children who use the app — confirmed their email addresses and passwords, or that it had been recently changed within the past month or so.
The parents also confirmed their child’s email address, used as their Apple ID.
While we did not contact children for fear of causing alarm, some of the email addresses were associated with their high schools.
It’s not clear why the data, let alone passwords for teens’ Apple IDs, was stored in plaintext.
The company claims on its website that it’s “secure” and uses encryption to scramble the data, such as in the event of a data breach.
TeenSafe said it was continuing to assess the situation and “will provide additional information” as it becomes available.
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