Healthcare Roundup – Stricter FDA standards make COVID-19 vaccine approval unlikely before election day, Adial commence sale of COVID-19 test kits

Published on: September 23, 2020
Author: Amy Liu

Stricter FDA standards make COVID-19 vaccine approval unlikely before election day

The Washington Post reports that tougher FDA standards for emergency use authorization (EUA) of a COVID-19 vaccine will extend the review timeline and make it unlikely that a nod could happen by election day on November 3.

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The agency is tightening the criteria to boost transparency and public trust amid perceptions that the review process is being politicized. President Trump has repeatedly stated that a vaccine will be approved by November 3, a tight timeline that may give Americans pause that the vaccine was fully vetted and is safe and effective. According to Pew Research Center, a bit more than 50% of people would get the vaccine if available today, down from 72% in May.

The new FDA guidance reportedly will require study participants to be followed for a median of two months after they receive the second dose. Reviewers will also be looking for at least five cases of severe COVID-19 cases in the control arm as well as some cases in older people, signals that the vaccine works. The 50% efficacy bar compared to control remains unchanged.

The two-month follow-up period makes it unlikely that Pfizer (PFE +0.7%) or Moderna (MRNA -0.8%) could prepare their respective applications in time for sufficient agency review before November 3. Pfizer has previously stated that it might have data by the end of next month but that was before the new guidance.

Selected tickers: Johnson & Johnson (JNJ -0.5%), Sanofi (SNY -1.8%), GlaxoSmithKline (GSK -0.6%), Dynavax (DVAX -3.4%), Novavax (NVAX +1.2%), Merck (MRK -0.1%)

Adial commence sale of COVID-19 test kits in the U.S.

Adial Pharmaceuticals (ADIL +4.7%) and iRemedy Healthcare have commenced sales of FaStep COVID-19 IgG/IgM rapid antibody test kits to healthcare providers and hospitals through the iRemedy network and ecommerce platform.

Antibody test kits distributed by Adial are FDA emergency use authorization registered, 10-minute, ‘instant’ point-of-care test devices.

Aurora Cannabis down 10% on soft revenue outlook

It’s the first earnings report for Aurora (NYSE:ACB) since Miguel Martin was named as the new CEO on September 8. For 2020 FQ4, the company lost $1.9B; for all of fiscal 2020, the company lost $3.3B.

Fiscal 2021 Q1 guidance sees net revenue of $60M-$64M vs. $67.5M in the just-reported 2020 FQ4. Adjusted gross margin before fair value adjustments on cannabis net revenue is seen at 46%-50%, with SG&A costs in the low-$40M range.

Adjusted gross margin before fair value adjustments on cannabis net revenue was 50% in FQ4 and 43% in FQ3. SG&A in FQ4 was $63.8M.

The company expects to achieve positive adjusted EBITDA in FQ2. That compares to adjusted EBITDA loss of $34.6M in FQ4 and loss of $50.4M in FQ3.

The conference call is underway. Webcast here.

Shares -10% after-hours. Falling in concert are Tilray (NASDAQ:TLRY) -2.9% and Cronos (NASDAQ:CRON) -1.7%.

COVID-19 test makers struggling to meet demand

Shortages of reagents, essential chemicals used in diagnostic assays, are the latest supply issue hampering U.S. health systems in their efforts to offer COVID-19 tests to all who need or request them. Some hospitals and other testing operations have returned to restricting tests to the most essential patients despite boosting capacity.

Morris Hospital and Healthcare Centers, located in the greater Chicago area, is now only conducting about 1/3 of the testing it was doing this summer because it is receiving only about 1/3 of Abbott’s (ABT -2.0%) rapid tests kits that its has been allocated. An Abbott spokesperson stated that the company was continuing to expand capacity to meet demand and is working with customers to supply as many tests as possible.

The overall number of COVID-19 tests distributed in the U.S. last month was 37.6M, up 138% from April’s 15.8M according to the Advanced Medical Technology Association, a medical device trade group.

Demand has spiked in certain regions experiencing rising infection rates coupled with school reopenings and increased testing in facilities such as nursing homes.

A recent survey by the American Association for Clinical Chemistry revealed that 67% of laboratories are having difficulties obtaining both reagents and test kits, the highest level since the group began canvassing labs in May.

Shortages are likely to persist due to the approaching flu season since those tests use the same components and equipment.

Last week, Abbott announced that it expected to ship “tens of millions” of its BinaxNow COVID-10 Ag Card rapid test this month and 50M/month starting next month.

Earlier this month, Roche (OTCQX:RHHBY -0.1%) announced that it expected to produce 40M units of its CE Mark’d SARS-CoV-2 Rapid Antigen Test in September and 80M/month by year-end.

Selected tickers: Danaher (DHR -0.7%), Thermo Fisher Scientific (TMO -0.3%), Quest Diagnostics (DGX -1.7%), LabCorp (LH -0.5%), OPKO Health (BioReference Labs) (OPK -1.7%), PerkinElmer (PKI +0.2%), Qiagen (QGEN +0.3%), Hologic (HOLX -1.6%), Bectin, Dickinson (BDX -1.2%)

Zai Lab prices Hong Kong listing at HK$562

Zai Lab Limited (NASDAQ:ZLAB) prices Hong Kong secondary listing of 10.56M ordinary shares at HK$562.00 per share for gross proceeds of HK$5.94B.

Based on the ratio of one ordinary share to ADS, the Offer Price translates to approximately US$72.52 per ADS.

Underwriters’ over-allotment is an additional ~1.58M shares.

Net proceeds will be used for R&D efforts, fund working capital and other general corporate purposes.

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