Esperion’s experimental treatment for reducing cholesterol can impact millions of patients, according to CNBC, citing CEO Tim Mayleben. Esperion announced its treatment bempedoic acid reduced bad cholesterol, or LDL, by 18% in a clinical trial. The treatment was combined statins in the trial. Mayleben said the target is those who are taking a statin and not reaching their desired LDL goal.
Thursday, November 1, 2018
Karyopharm to present studies on selinexor anticancer therapies
Karyopharm Therapeutics announced that ten abstracts have been selected for presentation, including three oral presentations, at the upcoming American Society of Hematology 2018 Annual Meeting being held December 1-4, 2018 in San Diego. Four key abstracts to be presented at the meeting will feature clinical data for selinexor, the Company’s first in class, oral SINE compound, from Karyopharm-sponsored trials. The presentations will include: top-line results from the Phase 2b SADAL study in patients with relapsed or refractory diffuse large B-cell lymphoma, additional data from the pivotal Phase 2b STORM study in patients with penta-refractory multiple myeloma, and updated data from the Darzalex and Pomalyst arms of the Phase 1b/2 STOMP study of selinexor in combination with backbone therapies for the treatment of patients with relapsed or refractory multiple myeloma. In addition to top-line data from the SADAL study, this year’s ASH meeting will also feature updated data from the STORM study in an oral presentation. As part of this presentation, data from an independent database of patients with heavily pretreated myeloma will also be presented, further underscoring how poor the prognosis is for patients with penta-refractory multiple myeloma. In October 2018, the U.S. FDA accepted Karyopharm’s New Drug Application for selinexor seeking accelerated approval as a new treatment for patients with penta-refractory multiple myeloma. The FDA has assigned a Priority Review and given an action date of April 6, 2019 under the Prescription Drug User-Fee Act. Other key abstracts at the meeting include data from two arms of the Phase 1b/2 STOMP study. There will be an oral presentation with updated data from the arm evaluating selinexor in combination with Darzalex and low-dose dexamethasone. In previously reported data, the once weekly SDd combination without a proteasome inhibitor or immunomodulatory drug demonstrated high response rates in the patient population as a doublet regimen. Finally, a poster presentation will highlight updated data from the arm evaluating selinexor in combination with Pomalyst and low-dose dexamethasone. In data reported previously from these arms, selinexor demonstrated evidence of synergistic anti-myeloma activity when combined with these standard approved therapies.
ImmunoGen data give ‘very positive’ first look at IMGN632, says Piper Jaffray.
Piper Jaffray analyst Joseph Catanzaro said the abstract for IMGN632 to be presented by ImmunoGen at the ASH meeting on its Phase 1 trial of IMGN632 in relapsed/refractory acute myeloid leukemia gives a “very positive first look,” though he adds that he views the program as carrying significant clinical risk given the novel payload and prior failure of a similar drug. Catanzaro has an Overweight rating and $15 price target on ImmunoGen shares.
Teladoc/BetterHelp: Vulnerable Patients Exposed To ‘Growth At Any Cost’ Culture
The Street is not aware of how significant TDOC mental health play BetterHelp has become to TDOC organic growth; we estimate it now represents 70% of organic subscription revenue growth.
The Street is not following the recent YouTube/BetterHelp scandal which caused a massive defection of YouTubers who decided to stop promoting BetterHelp due to controversy around the unit’s sales practices.
We question BetterHelp’s vetting protocols – as of September 28, 2018, BetterHelp still offered appointments with a therapist who was indicted on rape allegations nine months earlier.
Our industry and credit card analysis suggests ~60% of BetterHelp patients churn off within the first month – with its YouTube lead engine now compromised, we expect rapid revenue erosion.
Teladoc owes investors and patients answers as to what the company is doing to curtail BetterHelp’s questionable sales practices – until this happens, the stock is, in our view, ‘uninvestible’
Executive Summary
Teladoc acquired BetterHelp in January 2015 in order to enter the mental health market. Since the acquisition, BetterHelp revenues have exploded from almost zero to a projected $60 million in FY18. Teladoc has provided investors with limited detail about BetterHelp. As a result, the Street does not realize how significant BetterHelp has become to Teladoc organic subscription revenue growth. Later in this report, we show that BetterHelp could be contributing as much as 70% of organic subscription revenue growth to Teladoc. Just a few weeks ago, BetterHelp found itself at the center of a major controversy regarding its economic arrangements with YouTube Influencers. Critics allege that BetterHelp has been profiting off individuals with mental health problems. Criticism of BetterHelp has revolved around its model of compensating YouTube influencers to push BetterHelp onto their followers. There has also been vocal criticism surrounding BetterHelp’s terms of services. We also found evidence that BetterHelp is not doing enough to vet its therapists – we found an example of BetterHelp offering appointments in September 2018 with an individual who was indicted on rape allegations nine months earlier. Hundreds of YouTube Influencers appear to be defecting from BetterHelp, ceasing their prior promotion of the service. As a result, we expect Teladoc revenues to materially suffer going forward. We also expect there will be significant regulatory and legal liability arising from the scandal that is just starting to develop. As a result, we believe Teladoc shares are ‘uninvestible’ until management addresses the BetterHelp situation head on.
Piper says Agios pull forward of Tibsovo sNDA ‘should be very well received’
Piper Jaffray analyst Tyler Van Buren noted that Agios Pharmaceuticals’ Q3 earnings and Idhifa and Tibsovo results were in-line with his expectations, but the more important updates were the announcement of an sNDA filing by the end of January in frontline AML patients who aren’t candidates for current standard-of-care and the AGILE trial enrollment completion being accelerated a year following conversations with the FDA. The analyst, who believes the pull forward of the frontline AML filing “should be very well received,” recommends investors buy Agios shares at current levels and keeps an Overweight rating on the stock.
Piper calls updated leukemia data from Argenx ‘striking’
In its American Society of Hematology abstract data release, Argenx updated Phase I dose escalation data for ARGX-110 combined with azacitidine in 12 newly diagnosed, unfit acute myeloid leukemia patients showing a “striking” 92% overall response rate and 82% were complete responses, Piper Jaffray analyst Edward Tenthoff tells investors in a research note. The analyst says this level of activity is “unprecedented” for acute myeloid leukemia. He has viewed ARGX-110 as an underappreciated asset in Argenx’s pipeline and believes these data support the ongoing Phase II dose expansion study that could offer an accelerated path to approval. Tenthoff reiterates an Overweight rating on Argenx with a $154 price target. The stock in late morning trading is up 14%, or $11.36, to $91.37.
Piper continues to recommend Abiomed shares after ‘strong’ Q2
Piper Jaffray analyst Matt O’Brien reiterates an Overweight rating on Abiomed with a $480 price target following this morning’s “strong” Q2 results. Although the back-half guidance implies a revenue growth deceleration, management is “sticking with its traditional conservative playbook here,” O’Brien tells investors in a post-earnings research note. With the number of domestic Impella sites ticking higher this quarter, coupled with better than expected Japanese performance, Abiomed is up to continue delivering the “best top-line growth in large-cap med tech,” says the analyst. As such, he continues to recommend investors purchase the stock.
https://thefly.com/landingPageNews.php?id=2815715
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