Biotech week ahead, Oct. 5

Biotech stocks made a steady recovery over the week ended Oct. 2, although Friday's weakness trimmed some of the gains of the week.

Companies working on anti-COVID-19 antibody treatments were in the news during the week. Sorrento Therapeutics Inc. SRNE 2.9% announced a second more potent preclinical antibody candidate, while Regeneron Pharmaceuticals Inc. REGN 0.59% released preliminary readout for its antibody cocktail in treating non-hospitalized COVID-19 patients.

On the FDA approval front, Eton Pharmaceuticals Inc. ETON 3.73% received the nod for its Alkindi Sprinkle as a hormone replacement therapy for treating adrenocortical insufficiency in children under 17 years of age. Mesoblast NASDAQMESO, however, was in for a disappointment. Its stem cell therapy for acute graft versus host disease was turned down by the regulatory agency.

Zosano Pharma Corp. ZSAN 5.7% shares wilted on a deficiency review letter for the NDA for its migraine patch. Selecta Biosciences Inc. SELB 1.83%, which reported an adverse clinical readout, was also among the biggest losers of the week

The week saw five biopharma companies debuting on Wall Street, raising a combined $582.18 million in gross proceeds.

Here are the key catalysts for the unfolding week.

Conferences

• Heart Failure Society of America, or HFSA, Virtual Annual Scientific Meeting 2020: Sept. 30–Oct. 6
• American Neurological Association, or ANA, 2020 Virtual Meeting: Oct. 4-9
• 7th Annual Jefferies Cell Therapy Summit: Oct. 5-6
• Chardan Virtual 4th Annual Genetic Medicines Conference: Oct. 5-6
• HIV Glasgow 2020: Oct. 5-8

PDUFA Dates

Avenue Therapeutics Inc. ATXI 0.45%, a Fortress Biotech FBIO 1.99% company, awaits FDA nod for intravenous tramadol as a potential alternative that could reduce the use of conventional opioids for treating acute pain. The PDUFA date is scheduled for Saturday, Oct. 10.

Adcom Calendar

A joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will review Alkermes Plc's ALKS 2.77% NDA for olanzapine/samidorphan oral tablets for the proposed indications of schizophrenia and bipolar I disorder. The committees will discuss the efficacy, safety, and benefit-risk profile of the combo treatment. The meeting is scheduled between 10 a.m. ET and 4 p.m. ET on Friday.

Clinical Readouts

Neurocrine Biosciences Inc. NBIX 2.93% will present at the ANA 2020 meeting new data from a post-hoc, sub-group analysis of Phase 3 data for Ongentys as an add-on to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes.

Merck & Co. Inc. MRK 1.08% will present at the HIV Glasgow 2020 96-week results from efficacy and safety analyses of data from the Phase 2b study of islatravir in adults with HIV-1 infection who had not previously received antiretroviral treatment. Additionally, Merck will share results from Phase 1/1b studies of MK-8507 for once-weekly oral administration in combination with islatravir.

IPOs

Silver Spring, Maryland-based Aziyo Biologics Inc. has filed with the SEC a preliminary prospectus for an initial public offering of 2.94 million shares at an estimated price range of $16-$18. The regenerative medicine company proposes to list its shares on the Nasdaq under the ticker symbol AZYO.

https://www.benzinga.com/general/biotech/20/10/17759230/the-week-ahead-in-biotech-avenues-fda-decision-alkermes-adcom-meeting-aziyo-biologics-ipo

Japan planning unprecedentedly quick approval of anti-viral drug Avigan

The government is planning to fast-track the approval of anti-viral drug Avigan as a COVID-19 treatment in November even before its developer has filed for a regulatory review, government sources said Saturday.

Under that plan, the review of the influenza drug Avigan as a new coronavirus treatment will be completed in an unprecedentedly short screening period of three weeks once Fujifilm Toyama Chemical Co. submits a new drug application, expected in mid-October, the sources said, raising concerns about whether its safety and efficacy will be thoroughly scrutinized.

Despite some concerns about the drug's side effects, including birth defects, the government has been eager to get the health ministry to approve it as a coronavirus treatment and offer it to other countries.

Former Prime Minister Shinzo Abe came under fire in May for promoting Avigan as a treatment for COVID-19, saying then the drug's approval was expected within that month.

According to the sources, the government had already mapped out the drug's approval process by the time Fujifilm Toyama Chemical, a subsidiary of Fujifilm Holdings Corp., disclosed data from clinical studies on Sept. 23.

Three weeks would be an unusually short period for a review of a new drug even if it receives a fast-track designation which is meant to speed up approval of orphan drugs and treatments for serious conditions. A new drug review typically takes about a year.

There have also been concerns about whether the developer can collect enough clinical data to confirm Avigan's safety and potential benefit, given the limited number of patients available in its domestic clinical trial.

According to data on 156 patients without severe symptoms released by Fujifilm Toyama Chemical in late September, those administered Avigan showed improvement in their conditions after 11.9 days, shorter than the 14.7 days for those in a placebo group.

On Saturday, nearly 600 new coronavirus cases were reported in Japan, bringing the cumulative total to over 86,000. The death toll stood at around 1,600.

https://www.japantimes.co.jp/news/2020/10/04/national/science-health/japanese-approval-coronavirus-drug-avigan/

Why A Negative Test Doesn't Rule Out COVID

Since the recent presidential debate, at least 11 people involved in the event have tested positive for COVID-19, raising questions about how the virus could have run rampant there despite precautions, which included testing for everyone who attended.

The Cleveland Clinic supervised the event. In a statement issued Friday, it said it had requirements to keep a safe environment that aligned with CDC guidelines -- including social distancing, hand sanitizing, temperature checks, and masking. “Most importantly, everyone permitted inside the debate all tested negative for COVID-19 prior to entry. Individuals traveling with both candidates, including the candidates themselves, had been tested and tested negative by their respective campaigns.”

It’s not clear what kind of tests were used by the candidates, but the White House has reportedly relied on the Abbott ID Now test in the past, which it uses to screen visitors and the president daily.

Rapid tests like ID Now are convenient, and they can return results in as little as 15 minutes, but they are not as accurate as the gold-standard PCR tests, which require lab processing and return results in 1-2 days.

The FDA warned in May that the test could return false negative results. Studies have found that the test misses between 1 in 3 and 1 in 7 of positive cases.

The FDA advised that anyone testing negative on the ID Now have their results confirmed with a different testing method. It’s unclear whether the White House has been doing this confirmatory testing.

Tests miss COVID cases for a variety of reasons, says Isaac Bogoch, MD, an infectious disease specialist at the Toronto General Hospital Research Institute.

“Sometimes the sample isn’t collected properly. Sometimes there’s a problem with the device, and someone might be positive but not shedding the virus yet. Those are some reasons that come to mind,” he says.

After the virus that causes COVID-19 enters the body, it has to penetrate our cells and corrupt their operating instructions so it can churn out more copies of itself to infect more cells and make more copies. It takes a few days for this copying to happen enough to be detected on a test.

For COVID, it takes about 3 to 5 days after infection for someone to make enough copies to be picked up by a test. There appears to be a small window, maybe as short as hours, when a person is shedding the virus and infectious, but doesn’t yet have enough virus in their body to be detected by a less sensitive rapid test. If a person is tested while they are in this window, their case would be missed.

That also means that more people who attended the debate may test positive in the coming days.

“They’re not out of the woods,” Bogoch says, even if they tested positive at first, as Biden has. For that reason, he says anyone who’s been exposed to COVID should follow CDC guidelines to quarantine themselves for at least 14 days.

https://www.webmd.com/lung/news/20201003/why-a-negative-test-doesnt-rule-out-covid