Biotech Investors: Mark Your Calendar For These November PDUFA Dates

The month of October could at best be termed as mixed from the perspective of drug approvals. Avenue Therapeutics Inc's ATXI 6.78% pain drug and Zosano Pharma Corp's ZSAN 3.07% migraine patch stumbled at the FDA altar.

The FDA announced a delay in deciding on Spectrum Pharmaceuticals, Inc.'s SPPI 2.58% treatment candidate for chemotherapy-induced neutropenia, citing COVID-19 that impaired its ability to conduct inspections. Regeneron Pharmaceuticals Inc REGN 1.57% succeeded in getting its antibody cocktail for Ebola past the finish line.

Two new molecular entities, including Gilead Sciences, Inc.'s GILD 0.51% Veklury were approved during the month, taking the total NME approvals for the year to 42.

PDUFA dates are binary events that invariably serve as make-or-break catalysts for stocks. These dates are deadlines by which the FDA reviews a new drug application before announcing its decision concerning the approvability/non-approvability of the drug.

Here are the key PDUFA dates for November.

Supernus Awaits Nod For ADHD Drug

• Company: Supernus Pharmaceuticals Inc SUPN 1.2%
• Type of Application: NDA
• Candidate: SPN-812 (vilaxazine hydrochloride)
• Indication: attention deficit hyperactivity disorder, or ADHD
• Date: Nov. 8

SPN-812 is a once-daily, serotonin norepinephrine modulating agent. The company announced FDA acceptance of the NDA on Jan. 21, 2020.

About 6.1 million children and adolescents in the U.S. are diagnosed with ADHD, Supernus said: "SPN-812, if approved by the FDA, will be the first truly new therapy to treat ADHD in a decade."

Following a survey of 26 pediatric and adolescent psychiatrists with the goal of gauging receptivity to SPN-812, Piper Sandler said there were a sufficiently high number of respondents who are open to prescribing SPN-812 as an alternative to Strattera, the only other serotonin norepinephrine modulating agent available for ADHD as well as an alternative to stimulants.

The product, the firm said, can attain some modicum of commercial success.

Assuming FDA approval by the PDUFA action date, the company said it expects to begin shipments in December.

Sanofi Seeks Approval For Biologic to Treat Autoimmune Hemolytic Anemia

• Company: Sanofi SA SNY 2.46%
• Type of Application: BLA
• Candidate: Sutimlimab
• Indication: hemolysis in adult patients with cold agglutinin disease
• Date: Nov. 13

Cold agglutinin disease is a chronic autoimmune hemolytic anemia that causes the body's immune system to mistakenly attack healthy red blood cells and cause their rupture, thereby causing chronic anemia, profound fatigue, acute hemolytic crisis etc.

Sanofi noted in a release an estimated 5,000 people in the U.S. live with the disease.

Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s.

The FDA accepted the application on May 14, granting it priority review.

Will FDA Go With Adcom Verdict For Alkermes' Antipsychotic Drug

• Company: Alkermes Plc ALKS 0.49%
• Type of Application: NDA
• Candidate: ALKS 3831
• Indication: schizophrenia and for the treatment of bipolar I disorder
• Date: Nov. 15

Alkermes is seeking approval of fixed dosage strengths of ALKS 3831 composed of 10 mg of samidorphan co-formulated with 5 mg, 10 mg, 15 mg or 20 mg of olanzapine. It's an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain.

The FDA accepted the NDA for ALKS 3831, an investigational, novel, once-daily, oral atypical antipsychotic drug, in late January.

The Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, which met in early October to review the NDA, jointly voted that samidorphan meaningfully mitigates olanzapine-associated weight gain and that the safety profile of ALKS 3831 has been adequately characterized.

Can Second Time Be Charm For Adamis?

• Company: Adamis Pharmaceuticals Corp ADMP 3.33%
• Type of Application: NDA
• Candidate: Zimhi (naloxone HCI Injection, USP) 5mg/0.5ml
• Indication: opioid overdose treatment
• Date: Nov. 15

The original NDA was handed down a complete response letter in November 2019. Subsequently, the company resubmitted the application in May 2020.

Naloxone is an opioid antagonist and is generally considered the drug of choice for immediate administration for opioid overdose. It works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.

Related Link: Why Biogen's Fortunes Hinge On Aducanumab Approval

Can Mylan's Copycat Version of Biogen's MS Drug Get The Nod?

• Company: Mylan NV MYL
• Type of Application: Abbreviated New Drug Application, or ANDA
• Candidate: dimethyl fumarate
• Indication: relapsing form of multiple sclerosis.
• Date: Nov. 16

Mylan's dimethyl fumarate is a generic version of Biogen Inc's BIIB 0.8% MS medication Tecfidera. The company said in a mid-July release it's one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for a dimethyl fumarate product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon approval.

Biogen's total IQVIA sales for Tecfidera in the U.S. for the 12 months ended April 30, were about $3.78 billion, Mylan said.

D-Day Around The Corner For Bristol-Myers Squibb's Lymphoma Cell Therapy

• Company: Bristol-Myers Squibb Co BMY 2.94%
• Type of Application: BLA
• Candidate: liso-cel
• Indication: Lymphoma
• Date: Nov. 16

Lisocabtagene maraleucel, or liso-cel, is a CD19-directed chimeric antigen receptor T cell therapy for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. It came into Bristol-Myers' stable through its Celgene acquisition.

Given the priority review accorded for the therapy, a decision was initially due mid-August. The FDA, however, extended the timeline by three months to review additional information submitted by the sponsor.

Can Eiger's Progeria Drug Pass The FDA Muster?

Company: Eiger Biopharmaceuticals Inc EIGR 5.59%

• Type of Application: NDA
• Candidate: Lonfarnib
• Indication: progeria and progeroid laminopathies
• Date: Nov. 20

The FDA accepted the NDA for accelerated review on May 19. Lonfarnib, which goes by the trade name Zokinvy, has rare pediatric disease designation.

Zokinvy is an orally active inhibitor of farnesyltransferase, an enzyme involved in modification of proteins through a process called prenylation.

Both progeria and progeroid laminopathies are genetic conditions caused by mutation in genes, and manifests as accelerated aging.

Roche Seeks Label Expansions For Flu Medication

• Company: Roche Holdings RHHBY 1.8%
• Type of Application: sNDA
• Candidate: Xofluza
• Indication: Influenza
• Date: Nov. 23

Roche's Xofluza was originally approved for acute uncomplicated influenza in October 2018, and later in October 2019 its label was panded to include people at high-risk of developing influenza-related complications.

The company now has two sBLAs pending before the FDA, one seeking approval for an additional formulation of Xofluza as granules for oral suspension for people one year of age and older with influenza, and another for post-exposure prophylaxis.

Liquidia Hopes For Relief With Hypertension Drug Approval

• Company: Liquidia Technologies Inc LQDA 5.39%
• Type of Application: NDA
• Candidate: LIQ861
• Indication: pulmonary arterial hypertension
• Date: Nov. 24

LIQ861 is an investigational, inhaled dry powder formulation of treprostinil designed using Liquidia's novel print technology and engineered with the goal of enhancing deep-lung delivery of treprostinil in PAH patients by means of a convenient, palm-sized dry powder inhaler.

Revance Seeks Clearance For Frown Lines Treatment

• Company: Revance Therapeutics Inc RVNC 2.85%
• Type of Application: BLA
• Candidate: Daxi
• Indication: treatment of moderate to severe glabellar, or frown, lines
• Date: Nov. 25

DAXI, or daxibotulinumtoxinA for injection, is a next-gen neuromodulator product.

Can Rhythm Win FDA Backing For Genetically-induced Obesity?

• Company: Rhythm Pharmaceuticals Inc RYTM 6.67%
• Type of Application: NDA
• Candidate: setmelanotide
• Indication: obesity
• Date: Nov. 27

Setmelanotide is an investigational, melanocortin-4 receptor agonist, for the treatment of pro-opiomelanocortin deficiency obesity and leptin receptor deficiency obesity, both of which are ultra-rare genetic disorders.

Keytruda Lined Up For Another Approval

Company: Merck & Co., Inc. MRK 0.3%

• Type of Application: sBLA
• Candidate: Keytruda
• Indication: triple-negative breast cancer
• Date: Nov. 28

The sBLA seeks approval for Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer, whose tumors express PD-L1. The application was based on the Phase 3 KEYNOTE-355 trial.

The FDA accepted the application on July 30 for priority review.

Y-mAbs Awaits Nod For In-licensed Antibody Treatment For Neuroblastoma

• Company: Y-mAbs Therapeutics, Inc YMAB 2.7%
• Type of Application: BLA
• Candidate: Naxitamab (trade name Danyelza)
• Indication: relapsed/refractory high-risk neuroblastoma
• Date: Nov. 30

Naxitamab is an investigational, humanized monoclonal antibody. Y-mAbs had licensed the drug from researchers at Memorial Sloan Kettering Cancer Center.

Adcom Calendar

FDA's Peripheral and Central Nervous System Drugs Advisory Committee will discuss Biogen Inc's BIIB 0.8% BLA for its Alzheimer's treatment candidate aducanumab. The meeting is scheduled for Nov. 6. Biogen has a lot riding on the successful clearance of aducanumab, given the pressure the company is experiencing in its marketed products such as Spinraza.

https://www.benzinga.com/general/biotech/20/11/18141414/attention-biotech-investors-mark-your-calendar-for-these-november-pdufa-dates

Drugs and vaccines may not swiftly end pandemic, says Merck & Co’s CEO

Merck & Co’s CEO Kenneth Frazier has warned that the drugs and vaccines in the pipeline to combat COVID-19 may not be enough to swiftly end the pandemic.

Speaking to CNBC, Frazier said that the drugs and vaccines to treat COVID-19 are not a “silver bullet” solution to the pandemic, meaning people are likely to be wearing masks and practicing social distancing measures well into 2021

He told CNBC’s Squawk Box: “I don’t see the therapeutics that we have – or the vaccines that are coming – as a silver bullet.

“I would say certainly well into 2021 we’ll still be trying to observe these public health measures.”

Frazier said he is “very optimistic that in the near future” there will be positive results coming from late-stage clinical trials for COVID-19 vaccines and therapeutics.

A potential vaccine is unlikely to be widely available for people until mid-2021, Frazier noted.

It’s expected that vaccines will only work in around 70% of cases and Dr Anthony Fauci, White House coronavirus adviser, said that the likelihood of a highly effective COVID-19 vaccine providing coverage in around 98% of people is slim.

Frazier added: “The natural history of viruses is that they don’t go away.

“I don’t think we should tell people that they can expect to give up on those public health measures anytime soon.”

US-based Merck & Co is developing two separate potential COVID-19 vaccines, one from the Australian vaccine manufacture Themis that it acquired in July and with scientific non-profit organisation IAVI.

However the company known as MSD outside North America is well behind the leaders in the COVID-19 vaccine race, which according to the World Health Organization are phase 3 candidates from China’s Sinovac and Sinopharm, followed by the UK’s AstraZeneca.

Frazier made his comments as the US sees a deadly surge of the coronavirus just as voters go to the polls to decide whether incumbent Republican president Donald Trump stays on for another four years, or is replaced by his Democrat rival Joe Biden.

Trump’s handling of the pandemic has been a focus point in the campaigns for the White House, with nearly 9.4 million confirmed cases and 231,000 deaths attributed to the disease.

https://pharmaphorum.com/news/drugs-and-vaccines-may-not-swiftly-end-pandemic-says-merck-cos-ceo/

Trials and tribulations in Biogen’s Alzheimer’s drug reviews

Regulatory reviews of Biogen’s Alzheimer’s drug aducanumab are now ongoing on both sides of the Atlantic, but debate is still ongoing about whether the data behind the drug is strong enough to support approval.

The EMA has just kicked off its review of the anti-amyloid therapy, following in the footsteps of the FDA in the US which has been looking at the drug since August, but a new analysis of the mixed phase 3 data for aducanumab argues that an additional trial should be carried out.

The paper in the journal Alzheimer’s & Dementia, led by Mayo Clinic neurologist David Knopman, says that efficacy of aducanumab “as a treatment for the cognitive dysfunction in Alzheimer’s disease cannot be proven by clinical trials with divergent outcomes.”

Meanwhile, the paper also notes that Knopman has been excluded from an FDA advisory committee meeting due to discuss the data on Friday, ahead of a decision on the marketing application due in March.

The expert – who was an investigator in the phase 3 trials of Biogen’s drug – told Reuters he was recused from the panel because of his involvement in conducting clinical trials of aducanumab.

Aducanumab – which Biogen is developing with Japanese drugmaker Eisai – was all but abandoned in 2019 after the partners decided that two phase 3 trials of the drug were unlikely to show an effect on cognitive decline in Alzheimer’s.

Shares in Biogen were hit hard, as investors lost hope that aducanumab might be rescue the almost defunct amyloid hypothesis of Alzheimer’s disease, which holds that blocking the formation of amyloid plaques in the brain could delay the onset of dementia.

Just a few months later however they said a fresh look at the results of the EMERGE and ENGAGE studies had revealed that the initial futility analysis was “incorrect.” In fact, the drug reduced clinical decline in patients with early, a chance was put down to more exposure to a higher dose in additional patient follow-up.

Some patients showed statistically significant improvements on symptoms like memory, orientation, and language, as well as being able to carry out day-to-day tasks more easily.

There’s a lot riding on the FDA and EMA reviews. If approved, aducanumab will become the first therapy to reduce the clinical decline of Alzheimer’s and to change the course of the disease, says Biogen. It would also be the first amyloid-targeting drug to reach the market, after dozens of others have failed in clinical development.

Meanwhile, aducanumab is the big hope in Biogen’s late-stage pipeline, which otherwise is looking fairly thin, at a time when the biotech is facing the loss of patent protection for its blockbuster multiple sclerosis therapy Tecfidera (dimethyl fumarate).

Knopman and fellow authors argue in the Alzheimer’s & Dementia paper that Biogen’s interpretation of data in the two trials might not be correct.

They write that they have found alternative explanations for the apparent drug benefits unrelated to the treatment, and say that while there is evidence that aducanumab was working on amyloid and other biomarkers like tau protein as expected, “no evidence was presented to correlate biomarker changes to cognitive benefits.”

They also say there were differences in the placebo responses between the two studies, which could have contributed to the divergent results.

“Our analysis supports the conduct of a third, definitive phase 3 trial with high‐dose aducanumab [that is] optimally designed and adequately powered to prove efficacy,” they conclude.

The FDA has not commented on the reasons for Knopman’s exclusion from the advisory committee meeting publicly, but in these cases there is usually a conflict of interest.

Along with his involvement in EMERGE and ENGAGE, Knopman also serves on a data safety monitoring board for a tau drug for Alzheimer’s developed by Biogen, and is an investigator in a trial sponsored by Eli Lilly and the University of Southern California.

He also performs unpaid consultancy work for Samus Therapeutics, Third Rock, Roche, and Alzeca Biosciences, according to the paper’s conflict of interest statement.

https://pharmaphorum.com/news/trials-and-tribulations-in-biogens-alzheimers-drug-reviews/

Will Novo’s pivotal push also include Alzheimer’s?

The pandemic might be holding back sales of Novo Nordisk’s obesity drug Saxenda, but the difficult environment is not deterring the company from making big bets in this disease. A priority review voucher is being deployed to speed up US review of its follow-on asset, semaglutide, it was revealed last week, while a novel combination will move into phase III next year.

These updates came alongside quarterly results, when the company also confirmed that pivotal trials would start with a newly acquired cardiovascular project, ziltivekimab, and semaglutide in Nash. This all signals a growing R&D bill for the Danish developer, although executives have yet to decide whether sema will be taken any further in Alzheimer’s disease; data due in the coming days could help determine the likelihood of this potentially costly strategic move.

The trial in question, called Elad, is being run by Imperial College London with Novo’s older GLP-1 analogue, liraglutide or Victoza, in 200 patients with mild Alzheimer's dementia. The study is by far the biggest to date to look at a diabetes drug in cognitive impairment; diabetes has been associated with dementia, and impaired insulin signalling has been suggested as the common mechanistic link (Novo Nordisk’s quiet entry into the year of Alzheimer’s, January 20, 2020).

Novo execs have been characteristically cautious in their comments about the potential here. Mads Krogsgaard Thomsen, the company’s chief scientific officer, stressed again last week that any decision would be made on much more than the Elad readout. “A multitude of data gatherings” will form the basis of any decision, he said, although he admitted that advisory board meetings had been held on the subject.

Mr Thomsen said Novo was not planning an announcement on the Elad data, which will be presented at the CTAD conference on Friday. However, a decision on whether to take sema into larger studies in this field is expected in the coming months, and any signals of efficacy will raise expectations.

Late-stage expansion

Alzheimer’s is of course a long way from Novo’s core area of expertise, which could arguably add to the risks of such a move. Still, the potential rewards have persuaded many companies that the risk is worth it; should the decision be made to push ahead, many investors would be reassured to see a cautious clinical development plan emerge.

This is particularly true at the moment considering the substantial expansion already on the cards for Novo’s phase III pipeline. Pivotal development for semaglutide in Nash has been well trailed, as has the obesity combination of sema and AM833.

But confirmation that ziltivekimab will move forward is notable; topline data from the phase IIb Rescue trial in chronic renal disease, revealed for the first time, showed impressive reductions in the inflammatory markers including hsCRP. Mr Thomsen said safety looked clean, and reductions in other cardiovascular inflammation biomarkers were seen, warranting the start of a cardiovascular outcome study.

Source: Company presentation.

This will be an expensive undertaking – and comes on top of the $725m Novo paid for the asset last year. The theory behind the move is that suppression of IL-6 in patients with kidney disease and atherosclerotic cardiovascular disease can prevent further heart problems and deaths.

Thus Novo is heading into 2021 with a growing R&D cost burden – just as the pandemic is making life hard in obesity, an area in which major sales growth is expected. Reimbursement is already considered a major headwind here, although news of Saxenda’s endorsement in the UK is encouraging.

The company hopes that semaglutide’s greater efficacy will make cost-effectiveness calculations easier – and the decision to use a priority review voucher shows that it is keen to get to market as soon as possible. A decision on approval is due mid-2021 in the US.

But it is far from clear that the pandemic will be under control next year. With Nash and now cardiovascular disease Novo at least has other potential growth areas, but next year will be all about spending.

https://www.evaluate.com/vantage/articles/news/trial-results/will-novos-pivotal-push-also-include-alzheimers

Germany readies exhibition halls, mobile teams for COVID-19 vaccination

Germany is scouting trade fair halls and airport terminals to use as potential mass vaccination centres, as it draws up plans to inoculate the nation as soon as the first coronavirus shot gains European approval, state health officials told Reuters.

Berlin expects the first COVID-19 vaccines to be available in early 2021 and has given the country’s 16 states a Nov. 10 deadline to detail the addresses of 60 facilities that could serve as delivery centres for manufacturers.

Under the national vaccine strategy, approved by its cabinet last week, Germany has asked the states to identify central vaccination centres which will be supplemented by mobile teams who go into care homes.

The centralised approach underscores the potential logistical challenges facing governments, including limited supplies, multi-dose vials and complex storage requirements.

Some of the most advanced vaccines in human testing are so-called mRNA vaccines being developed by Moderna and the team of BioNTech and Pfizer Inc.

The BioNTech/Pfizer candidate needs to be stored at temperatures as low as minus 80 degrees Celsius (-112 Fahrenheit). That may give a slight edge to Moderna, whose vaccine is stored at minus 20 degrees Celsius (-4 Fahrenheit), roughly the same as home freezer temperatures.

In smaller, city states such as Hamburg and Bremen, authorities are scouting for central locations that are easy to reach like exhibition halls, where vaccinations could be stockpiled.

“We are on the lookout for larger locations that are centrally located and spacious. This could well be the airport or trade fair,” a spokesman for Hamburg’s health ministry said, adding no final decision has been taken.

Bigger, more rural states like Baden-Wuerttemberg and Schleswig-Holstein plan to distribute shots from a centralised delivery site into districts and towns, spokespeople for the health authorities said.

Germany has asked the Robert Koch Institute’s vaccine committee to identify which vulnerable population groups should get the shots first, although front-line workers are expected to be a priority.

In a second phase, when more vaccines are widely available in single-dose vials, Germany hopes to administer shots for the broader population at doctors’ practices.

An electronic register will record who has been vaccinated, while an app is being developed to allow people to record potential side effects.

The scale of Germany’s planning contrasts with Italy where authorities intend to use existing infrastructure, including 50,000 general practitioners, 14,000 paediatricians and vaccination centres for local public health offices.

“With these channels we normally administer around 30 million vaccinations per year to both children and adults, so we believe that this is an adequate infrastructure for the future COVID vaccine as well,” a health ministry spokesman said.

France has also been mulling plans for nationwide storage and distribution of vaccines, but no firm details were yet available, a source close to the health ministry said.

https://www.reuters.com/article/us-health-coronavirus-germany-inoculatio/germany-readies-exhibition-halls-mobile-teams-for-covid-19-vaccination-idUSKBN27J16L

McKesson: States seek $21B from drug distributors in opioid settlement

McKesson Corp MCK.N on Tuesday said it and two other major U.S. drug distributors could be expected to pay up to $21 billion under a new proposal to resolve thousands of lawsuits alleging they helped fuel the U.S. opioid crisis.

McKesson and rivals AmerisourceBergen Corp ABC.N and Cardinal Health Inc CAH.N last year proposed paying a combined $18 billion to resolve the roughly 3,200 lawsuits, with drugmaker Johnson & Johnson JNJ.N paying another $4 billion.

That proposal, part of a settlement framework negotiated with four state attorneys general, met resistance from lawyers for local governments and several states, leading to further talks. J&J on Oct. 13 said it would now contribute $5 billion.

San Francisco-based McKesson in a quarterly report said under the new $21 billion settlement framework proposed by attorneys general, it would pay about $8 billion over 18 years.

The proposal is subject to further negotiations, and McKesson said it “has not reached a point where settlement is probable.”

“Communities are desperately in need of the relief this deal would provide,” said Laura Brewer, a spokeswoman for North Carolina Attorney General Josh Stein, who is involved in the settlement talks.

The lawsuits, largely filed by states, counties and cities, seek to hold drug companies responsible for an opioid addiction epidemic that according to U.S. government data resulted in 450,000 overdose deaths from 1999 to 2018.

The lawsuits accuse drugmakers of deceptively marketing opioids and distributors of ignoring red flags indicating the prescription painkillers were being diverted for improper uses. They deny wrongdoing.

McKesson said the proposed settlement also calls for the distributors to make changes to their anti-diversion programs.

OxyContin maker Purdue Pharma and generic painkiller manufacturer Mallinckrodt Plc MNK.N previously filed for bankruptcy protection in connection with their own multibillion-dollar proposals to resolve opioid lawsuits against them.

https://www.reuters.com/article/us-usa-opioids-litigation/mckesson-says-states-seek-21-billion-from-drug-distributors-in-opioid-settlement-idUSKBN27J1UC

FDA warns about false positive results from COVID-19 antigen tests

The U.S. Food and Drug Administration said on Tuesday it is alerting clinical laboratory staff and healthcare providers that false positive results can occur with COVID-19 antigen tests.

The decision was made following reports of false positive results associated with the tests used in nursing homes. [https://bit.ly/389ohyw ]

The U.S. agency said false positive results may occur when users do not follow the instructions for the use of antigen tests for rapid detection of SARS-CoV-2.

Antigen tests detect proteins on the surface of the virus. They require an uncomfortable nasal or throat swab, and can produce results more quickly than molecular tests - which detect genetic material in the virus - but are considered less accurate.

Countries straining to contain a second wave of COVID-19 are turning to faster, cheaper but less accurate tests to avoid the delays and shortages that have plagued efforts to diagnose and trace those infected quickly.

The FDA issued the first emergency use authorization (EUA) for a COVID-19 antigen test in May.

The U.S. government has signed agreements with several companies including Becton Dickinson and Quidel Corp to supply antigen tests to U.S. nursing homes in an attempt to identify outbreaks faster and stem the tide of the virus.

In September, Becton Dickinson, which is supplying 750,000 of its SARS-CoV-2 antigen test to the U.S. government, said it is investigating reports from U.S. nursing homes that its rapid coronavirus testing equipment is producing false-positive results.

https://www.marketscreener.com/quote/stock/QUIDEL-CORPORATION-10595/news/Quidel-U-S-FDA-warns-about-false-positive-results-from-COVID-19-antigen-tests-31682565/