AwesomeCapital

FDA seen taking action on tobacco

Tobacco stocks are on watch after Citi warns that the FDA is “closer” to taking regulatory action.

The FDA is also launching its first TV ads to fight teen vaping. The $60M FDA initiative called “The Real Cost” features new commercials featuring street magician Julius Dein using tricks to educate teens on the risks of e-cigarettes.

Related stocks: Altria (NYSE:MO), Philip Morris International (NYSE:PM), British American Tobacco (NYSE:BTI), Vector Group (NYSE:VGR), Imperial Brands (OTCQX:IMBBY).

https://seekingalpha.com/news/3480802-fda-seen-taking-action-tobacco

Amarin up on draft ICER report confirming Vascepa value

Amarin (NASDAQ:AMRN) perks up 3% premarket on light volume on the heels of a draft report from the non-profit Institute for Clinical and Economic Review (ICER) concluding that Vascepa (icosapent ethyl) and Johnson & Johnson’s (NYSE:JNJ) blood thinner Xarelto (rivaroxaban) provide clinical benefit, reduce cardiovascular risk and “fall below commonly cited thresholds for cost-effectiveness.” In other words, the products are priced appropriately for the value delivered.

JNJ is off a fraction premarket.

https://seekingalpha.com/news/3480799-amarin-3-percent-premarket-draft-icer-report-confirming-vascepa-value

Omeros up on reimbursement code for Omidria

Omeros (NASDAQ:OMER) is up on the heels of the establishment of a permanent U.S. reimbursement code for eye drop OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3%. The code will go into effect October 1.

https://seekingalpha.com/news/3480805-omeros-2-percent-premarket-reimbursement-code-omidria

BioTelemetry buys Swedish med tech ADEA Medical

Aimed at beefing up its international footprint, BioTelemetry (NASDAQ:BEAT) has acquired early-stage Swedish medical technology outfit ADEA Medical AB, a provider of diagnostic products and remote health services in the Nordic countries, for an undisclosed sum.

https://seekingalpha.com/news/3480812-biotelemetry-buys-swedish-med-tech-adea-medical

IQVIA beats Q2 consensus; 2019 guidance raised

IQVIA Holdings (IQV) Q2 results: Revenues: $2,740M (+6.7%).

Net Income: $60M (-1.6%); EPS: $0.30 (+3.4%); Non-GAAP Net Income: $306M (+13.3%); Non-GAAP EPS: $1.53 (+18.6%); CF Ops: $504M (+2.2%).

2019 Guidance: Revenue: $11,000M – 11,150M from $10,900M – 11,125M; non-GAAP EPS: $6.25 – 6.45 from $6.20 – 6.40.

https://seekingalpha.com/news/3480834-iqvia-beats-q2-consensus-2019-guidance-raised

DelMar up 57% on start of new arm of VAL-083 study

Thinly traded nano cap DelMar Pharmaceuticals (DMPI +56.9%) is up on a healthy 35x surge in volume following its announcement that the first patient has been dosed in the adjuvant arm (before maintenance treatment with chemo agent temozolomide) of its Phase 2 clinical trial evaluating lead drug VAL-083 in patients with MGMT-unmethylated glioblastoma multiforme (GBM), a type of brain cancer resistant to temozolomide.

The arm will enroll up to 24 newly diagnosed patients who have undergone surgery and chemoradiation with temozolomide (TMZ), but will receive VAL-083 instead of standard-of-care TMZ for adjuvant therapy.

Orphan Drug-tagged VAL-083 (dianhydrogalactitol) is a small molecule chemotherapeutic, specifically, a bifunctional alkylating agent.

https://seekingalpha.com/news/3480877-delmar-57-percent-start-new-arm-valminus-083-study