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Friday, August 2, 2019

Glaxo Nucala Receives EU Approval for Self-Administration by Asthma Patients

GlaxoSmithKline (LSE/NYSE: GSK) today announced that the European Commissionhas granted marketing authorisation for two new methods of administering Nucala (mepolizumab): a pre-filled pen and a pre-filled safety syringe. This is the only monthly* anti-IL5 biologic approved in Europe that people with severe eosinophilic asthma can take at home, after a healthcare professional decides it is appropriate.
Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: “Making Nucala available for patients to take in the convenience of their own home is an important advance that builds on its proven efficacy, reflecting our ongoing efforts to meet the needs of patients with complex diseases.”
Severe eosinophilic asthma can have a life-changing impact, with patients experiencing asthma symptoms that remain uncontrolled despite high-dose standard treatments. This can leave them struggling to breathe and at increased risk of a potentially fatal asthma attack./1,/2
The first European launches of the new administration options are expected to take place in August 2019. The original lyophilised version remains available, giving healthcare professionals a choice of three different administration options to best fit in with their patients’ lives.

Dentsply Sirona Q2 non-GAAP EPS up 10%; 2019 guidance raised

Dentsply Sirona (XRAYQ2 results: Revenues: $1,009.4M (-3.1%); Technologies & Equipment: $558.4M (+0.9%); Consumables: $451M (-7.8%).
Net Income: $36.4M (+103.2%); EPS: $0.16 (+103.2%); Non-GAAP Net Income: $147.9M (+8.1%); Non-GAAP EPS: $0.66 (+10.0%); CF Ops: $145.1M.
2019 Guidance: Non-GAAP EPS: $2.35 – 2.45 from $2.30 – 2.40.

Premarket analyst action

Stericycle (NASDAQ:SRCL) upgraded to Neutral with a $44 (flat) price target at Baird.
Myriad Genetics (NASDAQ:MYGN) upgraded to Neutral with a $46 (2% upside) price target at BofA Merrill Lynch. Shares down 2% premarket.
Ultragenyx (NASDAQ:RARE) resumed with Outperform rating and $75 (24% upside) price target at Wedbush.
Abiomed (NASDAQ:ABMD) downgraded to Equal Weight with a $215 (5% upside) price target at Morgan Stanley. Downgraded to Neutral at Guggenheim.
Adaptimmune (NASDAQ:ADAP) downgraded to Neutral at Guggenheim.
Biotelemetry (NASDAQ:BEAT) downgraded to Market Perform at Raymond James.
Clovis Oncology (NASDAQ:CLVS) downgraded to Neutral at Guggenheim.
Intersect ENT (NASDAQ:XENT) downgraded to Neutral at Guggenheim. Downgraded to Neutral with a $17 (16% downside risk) price target at Piper Jaffray.
Mirati Therapeutics (NASDAQ:MRTX) downgraded to Underweight with an $85 (19% downside risk) price target at JPMorgan.

Deciphera Pharmaceuticals EPS beats by $0.53, beats on revenue

Deciphera Pharmaceuticals (NASDAQ:DCPH): Q2 GAAP EPS of -$0.56 beats by $0.53.
Revenue of $25M beats by $22.78M.

Stemline up 3% premarket on Q2 beat

Stemline Therapeutics (STMLQ2 results: Elzonris sales: $13M.
Net Loss: ($16.8M) (+11.1%); Loss Per Share: ($0.42) (+36.4%); Quick Assets: $103.9M (+72.9%).
Shares are up 3% premarket.

Harrow Health nabs rights to microbial agent for eye and ear infections

Harrow Health (NASDAQ:HROW) subsidiary Stowe Pharmaceuticals in-licenses worldwide rights to TGV Health’s antimicrobial agent Zian for complex bacterial, fungal and viral infections in the eye and ear. The initial primary indication will be adenoviral conjunctivitis. Secondary indications include mixed bacterial-viral infections, keratitis, endophthalmitis and corneal ulcers.
Financial terms are not disclosed.

Regional Health sells 3 properties, extinguishes debt; up 55% premarket

Thinly traded nano cap Regional Health Properties (NYSEMKT:RHE) is up 55% premarket on light volume on the heels of its sale of three skilled nursing facilities to affiliates of MED Healthcare Partners LLC for $26.1M in cash. A fourth property will be sold by August 28.
RHE used the proceeds to repay $24.7M in debt secured by the four facilities.