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Wednesday, July 1, 2020

OPKO NY nursing home results: 29% of staff positive for COVID-19 exposure

OPKO Health (NASDAQ:OPK) was up premarket on the heels of announcing the results of COVID-19 molecular PCR and antibody tests in nursing home and live-in facility employees in New York, performed by unit BioReference Labs.
Overall 29% of nursing home employees in the state tested positive for SARS-CoV-2 antibodies, with results ranging from 16.2%-55.1%, depending on the specific area.
2.9% of employees tested positive for active infection (positive PCR) in the state, ranging from 1.20% – 4.60%.
The majority of the nearly 3,500 antibody tests were performed within the first two weeks of May.

Johnson & Johnson Ebola vaccine OK’d in Europe

As expected, the European Commission has approved Johnson & Johnson (JNJ +0.3%) unit Janssen Pharmaceutical Companies’ two-dose Ebola vaccine regimen,  Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo).
In late May, the advisory group CHMP adopted a positive opinion recommending approval.
The event triggers a $10M milestone payment to licensor Bavarian Nordic A/S (OTCPK:BVNKF). Shares are up 3% in Europe.

Inovio under pressure as Pfizer vaccine data highlights its lack thereof

Inovio Pharmaceuticals (INO -15.4%) is down, albeit on average volume, pressured by a string of downgrades after it released “positive results” on COVID-19 vaccine candidate INO-4800 that was woefully light on data, a shortcoming that significantly contrasts with the data-heavy announcement from Pfizer and BioNTech on their candidate BNT162b1.

Citron pulls bearish Cytodyn report

Citron Research has removed its bearish report on Cytodyn (OTCQB:CYDY +7%) that it published yesterday. Shares have retraced over 39% since printing $10.01 early in Tuesday’s session.
Shares had rallied 186% before the selloff.

Kroger gets FDA OK for at-home COVID test

Kroger (KR-0.6%) says it received Emergency Use Authorization from the FDA for its COVID-19 Test Home Collection Kit.
“The home collection is performed under the supervision of a licensed healthcare professional,” the company says.
After entering details via website, people will receive a clinical assessment and will then be shipped the test.
The kit “includes a nasal swab, transport vial, instruction sheet, prepaid shipping label, and packing materials for return shipment of the sample to the laboratory.”

ISM manufacturing jumps back into expansion zone

June ISM Manufacturing Index: 52.6 vs. 49.0 consensus, 43.1 prior.
Overall read was propelled by a large jump in New Orders, up 24.6 points to 56.4 and Production, up 24.1 points to 57.3.
Supplier deliveries fell 11.1 points to 56.9 from 68.0.

Pfizer, BioNTech: Early Positive Data in Ongoing Phase 1/2 Covid Vaccine Trial

  • In an ongoing U.S. Phase 1/2 placebo-controlled, observer-blinded clinical trial, nucleoside-modified messenger RNA vaccine candidate (BNT162b1) expressing the SARS-CoV-2 receptor binding domain (RBD) is being evaluated in 45 subjects
  • At day 28 (7 days after dose 2), all subjects who received 10 or 30 mg of BNT162b1 had significantly elevated RBD-binding IgG antibodies with geometric mean concentrations (GMCs) of 4,813 and 27,872 units/ml which are 8- and 46.3-times, respectively, the GMC of 602 units/ml in a panel of 38 sera of convalescent patients who had contracted SARS-CoV-2
  • At day 28 (7 days after dose 2), all subjects who received 10 or 30 mg of BNT162b1 had SARS-CoV-2 neutralizing antibodies with geometric mean titers (GMTs) of 168 and 267, which are 1.8- and 2.8-times, respectively, the GMT of the convalescent serum panel
  • Local reactions and systemic events after immunization with 10 µg and 30 µg of BNT162b1 were dose-dependent, generally mild to moderate, and transient. No serious adverse events were reported
  • Further data from the ongoing Phase 1/2 clinical trial of four vaccine candidates will enable selection of a lead candidate and dose level for a large, global Phase 2b/3 safety and efficacy study that may begin as early as July 2020
  • Efforts to manufacture the leading candidates, at risk, are gearing up. In case the safety and efficacy study is successful, and the vaccine receives regulatory approval, the companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021