RedHill files for study of opaganib in COVID-19

RedHill Biopharma Ltd. (NASDAQ:RDHL) has filed an application with the Ministry of Health in Russia seeking sign-off for a Phase 2/3 clinical trial evaluating Yeliva (opaganib) in severely ill hospitalized COVID-19 patients.

The randomized, double-blind, parallel-arm, placebo-controlled study will enroll 270 subjects with severe COVID-19 pneumonia who are receiving supplemental oxygen. They will be randomized 1:1 to receive either opaganib or placebo on top of standard-of-care treatment.

The primary endpoint will be the proportion of patients requiring mechanical ventilation by day 14. Preliminary data should be available when ~100 participants have been evaluated for the primary objective.

The trial will include sites across Europe in addition to Russia and other countries.

Opaganib inhibits an enzyme called sphingosine kinase-2 (SK2) which blocks the synthesis of a lipid-signaling molecule called sphingosine 1-phosphate (S1P) that promotes cancer cell growth and pathological inflammation.

https://seekingalpha.com/news/3581843-redhill-files-for-study-of-opaganib-in-covidminus-19

Biogen’s Spinraza shows sustained benefit in presymptomatic SMA patients

Biogen (NASDAQ:BIIB) announces new positive data from its long-term NURTURE study evaluating Spinraza (nusinersen) in presymptomatic patients with spinal muscular atrophy (SMA).

At data cutoff in February which includes almost an additional year of follow-up, all treated patients (n=25; median age: 3.8 years) were alive and remained permanent ventilation-free. All children who have been able to walk independently have maintained their ability to do so.

No new safety signals have been reported.

The open-label study has been extended for another three years.

Related ticker: Ionis Pharmaceuticals (NASDAQ:IONS)

https://seekingalpha.com/news/3581849-biogens-spinraza-shows-sustained-benefit-in-presymptomatic-sma-patients

CVS stays the course with 2020 outlook

Ahead of meetings with investors, CVS Health (NYSE:CVS) discloses that its previously issued (May 6) earnings and cash flow guidance for the year will remain unchanged.

EPS: $5.47 – 5.60.

Non-GAAP EPS: $7.04 – 7.17.

Cash flow ops: $10.5B – 11.0B.

All other guidance withdrawn on May 6 remains so.

https://seekingalpha.com/news/3581856-cvs-stays-course-2020-outlook

Qualigen closes license deal for AS1411 in COVID-19

Qualigen (NASDAQ:QLGN) inks an agreement with the University of Louisville (UofL) that will facilitate the development of candidate AS1411 to the potential treatment of COVID-19.

It has owned exclusive rights to AS1411 for all uses since 2018 but the new deal provides a license under UofL’s pending U.S. patent for its use in preventing or treating COVID-19.

AS1411 is a DNA aptamer (short single-stranded DNA that can selectively bind to a target).

https://seekingalpha.com/news/3581893-qualigen-closes-license-deal-for-as1411-in-covidminus-19

Johnson & Johnson accelerates start of COVID-19 vaccine trial

Johnson & Johnson (JNJ +1.0%) unit Janssen Pharmaceutical Companies has moved the start of its Phase 1/2a clinical trial evaluating Ad26.COV2-S, its SARS-CoV-2 vaccine candidate, up to the second half of July from September.

The study will test the candidate’s safety and immunogenicity in 1,045 healthy adult volunteers in the U.S. and Belgium.

It is in talks with the National Institutes of Allergy and Infectious Diseases (NIAID) to accelerate the start of a Phase 3 study pending the outcome of Phase 1s and regulatory sign-off.

https://seekingalpha.com/news/3581918-johnson-johnson-accelerates-start-of-covidminus-19-vaccine-trial

Rite Aid expands COVID-19 sample collection sites

Rite Aid (RAD +1.7%) announces 21 new drive-through locations effective tomorrow, June 11, through its partnership with the U.S. Department of Health and Human Services (HHS).

Locations now total 92 and have the capacity to collect almost 47K swab specimens for COVID-19 testing each week. OPKO’s BioReference Lab unit is performing the actual diagnostic work.

https://seekingalpha.com/news/3581922-rite-aid-expands-covidminus-19-sample-collection-sites

Adial Pharma nabs order for 1,000 COVID-19 blood tests

Thinly traded nano cap Adial Pharmaceuticals (ADIL +14.1%) is up on more than a 7x surge in volume in reaction to its announcement that it has received a “firm order” for 1,000 Rapid Result COVID-19 antibody test kits.

The buyer plans to use the assays in the Phoenix, AZ area.

Adial owns exclusive distribution rights to the 10-minute test under an agreement with BioLab Sciences.

The company says the test detects IgG antibodies with 98.6% accuracy and IgM antibodies with 92.9% accuracy but does not specify whether this represents sensitivity only or includes specificity.

https://seekingalpha.com/news/3581935-adial-pharma-nabs-order-for-1000-covidminus-19-blood-tests