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Wednesday, February 19, 2020

Tivity Health EPS misses by $0.15, misses on revenue

Tivity Health (NASDAQ:TVTY): Q4 Non-GAAP EPS of $0.40 misses by $0.15; GAAP EPS of -$6.69 misses by $7.07.
Revenue of $272.79M (+78.2% Y/Y) misses by $2.36M.
Shares -33.71%.

Community Health Q4 cash flow ops up 218%; shares up 9% after hours

Community Health Systems (NYSE:CYH) Q4 results:
Revenues: $3,286M (-4.8%).
Net loss: ($373M) (-13.7%); loss/share: ($3.27) (-12.4%).
Non-GAAP EBITDA: $447M (+6.7%).
Cash flow ops: $194M (+217.8%).
2020 guidance: Revenues: $12.4B – 12.8B; non-GAAP EBITDA: $1.65B – 1. 80B. Consensus revenue: $12.7B.
Shares up 9% after hours.

Invitae EPS misses by $0.07, misses on revenue

Invitae (NYSE:NVTA): Q4 Non-GAAP EPS of -$0.63; GAAP EPS of -$0.79 misses by $0.07.
Revenue of $66.29M (+46.1% Y/Y) misses by $0.33M.
Shares +1.82%.

Teva down 5% after hours on failed deutetrabenazine study

A Phase 2/3 clinical trial, ARTISTS 1, evaluating Teva Pharmaceutical Industries’ (NYSE:TEVA) deutetrabenazine for the treatment of tics in pediatric patients with moderate-to-severe Tourette syndrome failed to achieve the primary endpoint.
Deutetrabenazine to not sufficiently separate from placebo as measured by the change in Total Tic Score from baseline at week 12.
The company markets the drug as Austedo for the treatment of Huntington’s disease chorea and tardive dyskinesia.
Shares down 5% after hours.

Incyte’s ruxolitinib successful in second late-stage dermatitis study

Incyte (NASDAQ:INCY) perks up 2% premarket on light volume on the heels of its announcement of positive results from a second Phase 3 clinical trial, TRuE-AD1, evaluating ruxolitinib cream 0.75% or 1.5% in patients at least 12 years old with mild-to-moderate atopic dermatitis (AD).
The study met the primary endpoint of a statistically significant proportion of treated patients achieving clear or almost clear skin at week 8 compared to vehicle (placebo).
A sister Phase 3, TRuE-AD2, was also successful.
Marketing applications should be the next step.

FDA accepts Karyopharm application for expanded use of selinexor

Under Priority Review status, the FDA accepts Karyopharm Therapeutics’ (NASDAQ:KPTI) supplemental marketing application seeking approval to use Xpovio (selinexor) to treat adults with relapsed/refractory diffuse large B-cell lymphoma who have received at least two prior therapies.
The agency’s action date is June 23.
The FDA approved the nuclear export inhibitor in July 2019 for multiple myeloma.

FDA Ad Com set for mortality reduction claim for Glaxo’s Trelegy Ellipta

An FDA advisory committee will meet on Tuesday, April 21, to review and discuss GlaxoSmithKline’s (NYSE:GSK) application seeking a mortality risk reduction claim for COPD inhalation therapy Trelegy Ellipta (fluticasone furoate, umeclidinium, & vilanterol).
The company in-licensed the product from Innoviva (NASDAQ:INVA) (formerly Theravance).