Dosing underway in study of Mesoblast cell therapy in COVID-19

Mesoblast Limited (NASDAQ:MESO) is up 12% premarket on light volume in reaction to its announcement that the first participants have been dosed in a 300-subject Phase 2/3 clinical trial evaluating cell therapy remestemcel-L in COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS) on ventilator support.

The primary endpoint is all-cause mortality with 30 days of randomization compared to placebo plus standard-of-care treatment.

The company is developing remestemcel-L for various inflammatory conditions, including acute graft-versus-host disease. It works by downregulating production of pro-inflammatory proteins (cytokines) while increasing production of anti-inflammatory cytokines.

https://seekingalpha.com/news/3570022-dosing-underway-in-study-of-mesoblast-cell-therapy-in-covidminus-19

Heron Therapeutics EPS beats by $0.08, beats on revenue

Heron Therapeutics (NASDAQ:HRTX): Q1 GAAP EPS of -$0.57 beats by $0.08.

Revenue of $25.4M (-19.6% Y/Y) beats by $4.17M.

Press Release

https://seekingalpha.com/news/3570088-heron-therapeutics-eps-beats-0_08-beats-on-revenue

Axcella up 34% premarket on positive action of dietary supplement in NAFLD

Ultra-thinly traded micro cap Axcella (NASDAQ:AXLA) jumps 34% premarket on light volume in reaction to topline results from a study evaluating dietary supplements AXA1125 and AXA1957 in 102 people with nonalcoholic fatty liver disease (NAFLD).

The company says AXA1125 showed greater and more consistent reductions in clinically relevant biomarkers versus placebo than AXA1957.

Specifically, participants receiving AXA1125 experienced a 23% mean reduction in liver fat content compared to a 6% reduction for placebo. The mean reduction in the liver enzyme ALT (biomarker of liver stress/damage) was 22% versus a 7% reduction in the control arm.

On the safety front, both supplements were generally well-tolerated. The most common treatment-related adverse events (occurred in at least 10% of subjects) were gastrointestinal effects (diarrhea, nausea, reduced appetite) and upper respiratory infection. Most were mild and “transient” resolving in two-to-three weeks.

The company is going with AXA1125 for its candidate for NASH.

https://seekingalpha.com/news/3570048-axcella-up-34-premarket-on-positive-action-of-dietary-supplement-in-nafld

Ionis Pharma Q1 Spinraza Royalties up 10%

Ionis Pharmaceuticals (IONS) Q1 results:

Revenues: $133M (-55.2%); Spinraza Royalties: $66M (+10.0%).

Net loss: ($48M) (-157.1%); loss/share: ($0.35) (-156.5%); non-GAAP Net loss: ($15M) (-111.8%); non-GAAP loss/share: ($0.11).

Pipeline highlights: Initiated the CARDIO-TTRansform Phase 3 clinical trial for AKCEA-TTR-LRx in patients with TTR-mediated amyloid cardiomyopathy.

Two medicines granted Fast Track Designation by the FDA: AKCEA-APO(a)-LRx for the treatment of cardiovascular disease due to elevated Lp(a) levels;

IONIS-C9Rx for the treatment of C9orf72-ALS.

Ionis generated more than $20M as numerous partnered medicines advanced.

Initiated a Phase 1 study of ION224, an Ionis-owned medicine in development for the treatment of NASH.

Upcoming Catalysts: Initiate the Phase 3 study of AKCEA-APOCIII-LRx in patients with FCS.

Refile WAYLIVRA NDA for U.S. marketing authorization.

File for WAYLIVRA marketing approval in Brazil with PTC Therapeutics.

The company is reaffirming 2020 financial guidance, including ending 2020 meaningfully profitable.

Previously: Ionis Pharmaceuticals EPS beats by $0.01, misses on revenue (May 6)

https://seekingalpha.com/news/3570050-ionis-pharma-q1-spinraza-royalties-up-10

DarioHealth up on FDA nod on self-check glucose meter in hospitals

The FDA has approved the emergency use of DarioHealth’s (NASDAQ:DRIO) blood glucose testing strips and smartphone-connected device for hospitalized diabetics who have COVID-19.

Patients can self-test their blood sugar levels with their own device or the hospital can issue one to them upon admission.

https://seekingalpha.com/news/3570063-dariohealth-up-11-on-fda-nod-on-self-check-glucose-meter-in-hospitals

White House coronavirus task force to ‘continue indefinitely’ – Trump

The White House coronavirus task force will “continue indefinitely,” President Trump said via Twitter, adding that he may “add or subtract people to it, as appropriate.”

The task force’s focus will be on “SAFETY & OPENING UP OUR COUNTRY AGAIN.”

It will also be “very focused” on vaccines and therapeutics, Trump said.

https://seekingalpha.com/news/3570067-white-house-coronavirus-task-force-to-continue-indefinitely-trump-says

Amgen’s Otezla shows positive action in mild psoriasis

Amgen (AMGN +0.4%) announces positive results from a Phase 3 clinical trial, ADVANCE, evaluating Otezla (apremilast) in patients with mild-to-moderate plaque psoriasis.

The study met the primary endpoint demonstrating a statistically significant proportion of treated patients achieving clear or almost clear skin at week 16 versus placebo. Key secondary endpoints were also met.

Detailed results will be submitted for presentation at an upcoming medical conference.

The FDA approved the PDE4 inhibitor in September 2014 for patients with moderate-to-severe plaque psoriasis.

https://seekingalpha.com/news/3570077-amgens-otezla-shows-positive-action-in-mild-psoriasis