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Wednesday, February 6, 2019

Vertex downgraded to Hold at Maxim on valuation

Maxim analyst Jason McCarthy downgraded Vertex to Hold from Buy after its better than expected Q4 results. The analyst notes that 2018 marks another “great year” for the company’s CF business, with revenue of $868M topping consensus while rising 11% from last year. McCarthy adds that he still expects the franchise to grow amid Symdeko launch ramps in U.S. and Europe, but sees the valuation on the stock being potentially stretched.
https://thefly.com/landingPageNews.php?id=2859999

Jefferies highlights Karyopharm, Reata as stocks to focus on in 2019

Jefferies analyst Maury highlights Karyopharm Therapeutics (KPTI) and Reata Pharmaceuticals (RETA) as two stocks to focus on in 2019. Karyopharm has important regulatory updates upcoming with an expected FDA panel for selinexor in penta-refractory multiple myeloma and then an FDA action date scheduled for April 6, Raycroft tells investors in a research note. And Reata is expected to report initial, awaited focal segmental glomerulosclerosis data in the first half of 2019 and then two pivotal readouts in the second half in Alport syndrome and Friedreich’s ataxia, adds the analyst. He believes the current share weakness offers an “appealing entry point” for Karyopharm.

Illumina price target lowered to $340 from $372 at Argus

Argus analyst Jasper Hellweg lowered his price target on Illumina to $340 to reflect its recent Q4 earnings miss along with the company’s view of the product transition not having reached the halfway mark for the upgrade cycle. The analyst also kept his Buy rating on Illumina and raised his FY19 EPS view to $6.56 from $6.34, noting that any unevenness from pre-tariff stocking by customers which has recently impacted results “should dissipate over time.” Hellweg further justifies his positive view on the company based on “strong sales of consumables, continued progress on the company’s product transition, and gradual normalization in the timing of orders.”
https://thefly.com/landingPageNews.php?id=2860027

Corvus Pharmaceuticals announces presentation of CPI-444, CPI-006 data

Corvus Pharmaceuticals announced the presentation of updated biomarker and clinical results from its two lead programs that target the adenosine pathway, CPI-444, an adenosine A2A receptor antagonist, and CPI-006, an anti-CD73 antibody. The data were presented at the Immuno-Oncology 360 degrees Conference. The presentation reviewed gene expression data of an adenosine gene signature recently announced by Corvus, in patients with renal cell carcinoma, or RCC, who are participating in Corvus’ ongoing Phase 1/1b study of CPI-444, a selective and potent inhibitor of the adenosine A2A receptor. In particular, the data from the study showed a relationship of this novel biomarker to angiogenesis gene expression data. Such findings indicate that expression of AdenoSig was inversely related to the angiogenesis signature, which has been well studied by others and correlates with response to vascular endothelial growth factor receptor, or VEGFR, inhibitors such as Sutent and other tyrosine kinase inhibitors. Low expression of angiogenesis genes predicts a lack of response to VEGFR inhibition. These data suggest that patients with a high AdenoSig are potentially more likely to respond to treatment with CPI-444 and less likely to respond to VEGFR inhibitors. The company also presented updated clinical results from the ongoing Phase 1/1b dose-escalation study of CPI-006 in patients with a variety of advanced cancers, including non-small cell lung cancer, or NSCLC, RCC and other cancers who have failed standard therapies. The first arm of the study is evaluating CPI-006 as a monotherapy, a second arm is evaluating CPI-006 in combination with CPI-444, and a third arm is planned to evaluate CPI-006 in combination with pembrolizumab, an anti-PD-1 antibody. CPI-006 given as a monotherapy activated B cells and led to a redistribution of these cells along with changes in other immune cells. These data are consistent with immune stimulation induced by CPI-006. CPI-006 reacted with an epitope on CD73 that led to blockade of adenosine production and expression of lymphocyte activation antigens that are independent of adenosine.
https://thefly.com/landingPageNews.php?id=2860041

Perrigo Gets FDA OK for Generic Version of Zovirax

Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Zovirax® Cream, 5% (acyclovir cream, 5%) developed in collaboration with Sol-Gel Technologies Ltd. (NASDAQ: SLGL). The Company anticipates launching the product this month.
Annual market sales for the twelve months ending December 2018 were approximately $92 million as measured by IQVIA™.
Perrigo Executive Vice President and President Rx Pharmaceuticals Sharon Kochan stated, “This final approval and first to market launch is another example of our long-term investment in new products, the team’s impressive execution skills and our solid collaboration with SolGel. We stay committed to providing affordable treatment options for patients in important extended topical categories.”

GSK sees 2019 earnings hit from rival asthma treatments

Britain’s biggest drugmaker GlaxoSmithKline Plc on Wednesday said it expects full-year adjusted profit to be hurt by new competition for its blockbuster asthma drug Advair.
GSK reported adjusted earnings per share of 31.2 pence on sales of about 8.20 billion pounds ($10.62 billion) in the fourth quarter.
Analysts had expected earnings of 27.7 pence and sales of 7.95 billion pounds, according to a company-provided consensus here of 11 analysts.
The company said it expects adjusted earnings per share to decline 5 percent to 9 percent, reflecting recent approval of a generic competitor to Advair in the United States.

Alphabet’s Verily is building a high-tech rehab campus to combat opioid addiction

Verily, Alphabet’s life science division, is building a tech-focused rehab campus in Dayton, Ohio to combat the opioid crisis.
Verily will join two health networks, Kettering Health Network and Premier Health, to create a nonprofit named OneFifteen. The organization will deploy a tech-enabled system of care to treat substance abuse, including a behavioral health treatment center, rehabilitation housing and wrap-around services.
Verily’s technology will integrate the facility and use analytics to measure the effectiveness of various interventions.
Clinical care will be provided d by an operating partner of OneFifteen, Samaritan Behavioral Health, Inc., a subsidiary of Premier Health.
OneFifteen will begin seeing individuals for inpatient and outpatient care in the Spring of 2019. The full campus is expected to be completed in 2020.
“In Montgomery County, Ohio, healthcare providers and public services are at the front lines of what many have termed ‘ground zero’ for the opioid epidemic and are meeting success by taking action through thoughtful public alliances to stem the tide of overdoses in their communities,” Verily said in a press release announcing the new initiative.