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Inovio Pharma under pressure on bearish Citron call

COVID-19 vaccine developer Inovio Pharmaceuticals (INO -9.6%) slumps on average volume in apparent response to a post on social media by short seller Citron Research that the stock is heading back to $5 a share, 68% below the current price of $15.47.

Shares peaked at $33.79 on June 26 during the COVID-19 vaccine-stoked rally.

Roth Capital is another bear, believing the candidate INO-4800 has “virtually no chance” of coming out on top of its many competitors.

Muddy Waters is yet another pessimist.

https://seekingalpha.com/news/3616555-inovio-pharma-under-pressure-on-bearish-citron-call

Airlines look to COVID tests that give results in minutes

European airlines are pinning hopes on pre-flight COVID-19 tests that deliver results as fast as pregnancy tests to help restore passengers’ confidence in taking to the skies in confined spaces with shared air.

Germany’s Lufthansa, at the mercy of government bailouts for survival, is in talks with Swiss drugmaker Roche over deploying so-called antigen tests, according to two people familiar with the discussions, as the airline aims to make them available next month.

Italian operator Alitalia, meanwhile, told Reuters that from Wednesday it would add two flights from Milan to Rome, to the two it is already offering from Rome to Milan, exclusively for passengers with negative tests.

The tests are administered by health authorities at the airports and included in ticket prices. If they prove popular and safe, these antigen-tested flights will be expanded to more domestic, and later international, routes, the airline said.

Unlike laboratory-based molecular tests that have been the staple of health authorities in the pandemic, antigen tests do not require machines to process. Much like pregnancy tests, they can produce results in about 15 minutes.

However the tests require an uncomfortable nasal swab and are not as accurate as the molecular, or PCR, tests. They generally produce more “false negatives” which could mean sick people could slip through the cracks and onto planes.

An increasing number are hitting the market, from companies such as Abbott Laboratories, Becton Dickinson & Co and Quidel Corp and Roche, which is rebranding antigen tests from South Korea’s privately held SD Biosensor.

Airlines are pressing governments to embrace alternatives to blanket travel restrictions amid a resurgence of COVID-19 cases in Europe.

Rapid antigen tests that can be administered by non-medical staff are expected to become available in coming weeks for as little as $7 each, the head of industry body the International Air Transport Association said on Tuesday.

NEGATIVE-ONLY FLIGHTS

Despite the drawbacks of such antigen tests, carriers hope they could tip the balance in convincing people to fly.

“It is to give … confidence, at a specific point in time, that the result is positive or negative,” said Christian Paulus, a Roche research and development manager.

“The PCR remains the gold standard. Therefore if there are any questions open, or if the clinical appearance of the person who had a negative test, if the person has symptoms like a fever, then you would for sure do confirmatory testing.”

Alitalia launched its “COVID Tested Flights” programme from Rome to Milan last week, and will expand it from Wednesday. Only passengers with negative COVID-19 results can board.

“So far no positive passengers have been found,” said an Alitalia spokesman, adding that many chose to take the airline’s antigen tests the night before the flight. Travellers can access airport-testing facilities via a preferred lane with their tickets.

The airline plans to analyse findings around the middle of October, but already expects antigen-tested flights will be expanded to domestic and later international routes. “First, we have to see how this experiment goes,” the spokesman said.

The pre-flight antigen tests follow a scheme in Italy where such tests were used defensively.

SD Biosensor said its tests had been deployed at Italian airports for incoming tourists, to avoid a renewed COVID-19 wave imported from infection hotspots.

‘BETTER THAN QUARANTINE’

Lufthansa Chief Executive Carsten Spohr last week told employees during a townhall meeting that the airline was in talks with Roche. The drugmaker started selling the rapid tests this week, and said SD Biosensor could initially supply it with about 40 million tests per month.

The Lufthansa tests could initially go to cabin crews, a spokeswoman said, though Bjoern Becker, a senior director of product management, ground & digital services for the Lufthansa Group, said the tests could also be made available to first-class and business-class passengers.

https://www.reuters.com/article/us-health-coronavirus-airlines-testing-f/positive-about-flying-airlines-look-to-covid-tests-that-give-results-in-minutes-idUSKCN26E0RS

Pfizer inks deal with Vivet Therapeutics in liver disorder

Pfizer (NYSE:PFE) and Vivet Therapeutics, a privately held gene therapy biotech company have entered into a manufacturing agreement, under which Pfizer will provide clinical supply for a Phase 1/2 clinical trial evaluating Vivet’s investigational gene therapy, VTX-801, for the potential treatment of Wilson disease, a rare and life-threatening liver disorder.

Terms of the agreement were not disclosed. The trial is expected to commence in early 2021.

The Phase 1/2 clinical supply for VTX-801 will be manufactured in Pfizer’s facility in Chapel Hill, North Carolina.

In March 2019, Pfizer acquired 15% ownership stake in Vivet and collaborated for the development of VTX-801.

https://seekingalpha.com/news/3616370-pfizer-inks-deal-vivet-therapeutics-in-liver-disorder

Bluebird bio’s Lentiglobin nabs PRIME status in Europe

Bluebird bio’s (NASDAQ:BLUE) LentiGlobin, an investigational gene therapy (bb1111) for the treatment of sickle cell disease (SCD), was granted eligibility to the Priority Medicines (PRIME) program by the EMA.

PRIME, akin to Breakthrough Therapy status in the U.S., provides for more intensive guidance on development and accelerated review of the market application.

SCD is a progressive and debilitating genetic disease caused by a mutation in the β-globin gene that leads to the production of abnormal sickle hemoglobin (HbS), resulting in chronic hemolytic anemia and vasculopathy.

https://seekingalpha.com/news/3616385-bluebird-bio-s-lentiglobin-nabs-prime-status-in-europe

Illumina Analysts Question Grail Deal’s Commercial Opportunity, Hefty Price

Illumina, Inc. ILMN 0.6% announced Monday a deal to buy privately held Grail, which focuses on early detection of multiple cancers, for $8 billion in cash and stock. 

The Illumina Analysts: Baird analyst Catherine Ramsey Schulte maintained a Neutral rating on Illumina shares and lowered the price target from $335 to $281.

JPMorgan analyst Tycho Peterson downgraded Illumina shares from Overweight to Neutral and reduced the price target from $390 to $280.

Wells Fargo Securities analyst Dan Leonard maintained an Underweight rating and took the price target from $290 down to $250.

Baird Cautious On Grail Deal: Although the deal presents a large market opportunity, the reimbursement landscape remains uncertain, Ramsey Schulte said in a note.

Given the hefty price tag, the analyst said she is cautious on the patience that will be required in the years ahead before any potential meaningful adoption can be seen.

Baird said it is adding Grail to its model, assuming a December 2021 close, with $3.50 of EPS dilution in 2022 and what it views as an optimistic ramp scenario given the uncertain reimbursement landscape and fragmented market.

JPMorgan Finds It Hard To Get Excited: The deal will allow Illumina to participate in the early cancer detection market, estimated at $60 billion by 2023, Peterson said.

At launch, Grail’s Galleri cancer screening test will have an initial addressable market of 52 million lives prior to reimbursement, with test ASPs estimated to start at $1,200, the analyst said. 

The deal has uncertainty around the pace of market penetration and revenue generation, a lack of operational synergies, significant near-term dilution and potential distraction and dilution from the core business recovery next year, he said. 

Even without the deal, Illumina was already positioned to participate in Grail’s ramp through its 14.5% stake in the company, HSD royalties, supply arrangement and more, Peterson said. 

Grail’s Test Opportunity Unconvincing, Wells Fargo Says: Wells Fargo’s bearish stance on Illumina is based on the firm’s view that Street sales and earnings forecasts have more potential downside risk than upside potential, Leonard said in a note. 

Illumina’s proposed deal to buy Grail carries much higher-than-expected earnings dilution, the analyst said, adding that he doesn’t share the company’s conviction in the commercial opportunity for Grail’s cancer screening test.

https://www.benzinga.com/analyst-ratings/analyst-color/20/09/17606024/illumina-analysts-question-grail-deals-commercial-opportunity-hefty-price-tag

GoodRx Holdings IPO: What Investors Need To Know

Prescription pricing platform GoodRx Holdings will hit the public markets this week.

The Filing: Good Rx Holdings NASDAQGDRX plans to sell 34.6 million shares in a pricing range of $24 to $28. At a pricing of $26, the company will be valued at around $10 billion based on over 384 million shares out.

Silver Lake, which owns over 35% of the company, will invest another $100 at the IPO price along with the offering.

One of the items featured in the amended S-1 was “Founders Award” for co-founders Douglas Hirsch and Trevor Bezdek, who own around 1.3% of the company. The two will have the change to earn 25 million shares in the company through time-based and performance-based milestones.

About GoodRx Holdings: Launched in 2011, GoodRx has the mission to “help Americans get the healthcare they need at a price they can afford.” The company reports that 20%to 30% of prescriptions are left at pharmacy counters due to customers not being able to afford them.

The company had 15 million monthly visitors in the second quarter and 4.9 million monthly active users. Over 80% place repeat orders with the GoodRx platform.

GoodRx offers four items targeting prescriptions, subscriptions, manufacturer solutions and telehealth.

Financials: Revenue has also grown at a compound annual growth rate of 57% since 2016.

GoodRx reported revenue of $388 million in 2019. First half 2020 revenue grew 48% to $257 million. Revenue was under $100 million back in 2016.

GoodRx has been profitable since 2015, something highlighted in the offering.

Net income was $66 million in fiscal 2019. First half 2020 net income grew to $54.7 million.

Market Size: GoodRx lists a total addressable market size of $800 billion. This is broken down to market sizes of $524 billion for prescriptions, $30 billion for manufacturing solutions, and $250 billion for telehealth.

Growing Telehealth Market: GoodRx purchased telehealth provider HeyDoctor in 2019.

“We plan to significantly invest in our telehealth offerings, as we see this as an opportunity to add another key consumer entry point into our platform,” the filing reads.

The company announced in July that HeyDoctor by GoodRx was now available in all 50 states and Washington D.C. The telehealth platform was seeing 1000 patients per day last quarter with increased COVID-19 related demand. 

Since the March launch, 130,000 customers had started a telehealth visit with HeyDoctor. Services like pediatrics, prescription refills, online counseling and prescription mail delivery were added.

Teladoc Health TDOC 6.29% has been one of the hottest stay at home stocks in 2020, with shares up 142%. The company has seen increased visits and revenue due to the COVID-19 pandemic. The company now has a $16.5 billion valuation.

Telehealth company American Well AMWL 8.61% went public last week. Shares priced at $18 and traded as high as $25.90 on their first public day. Shares now trade at $23.46 and have a market capitalization of $5 billion.

Subscription Offerings: GoodRx has a partnership with The Kroger Co KR 0.81% that includes subscription offerings.

“The usage of Gold and Kroger Savings has increased significantly. We will continue to increase the value proposition for consumers by bundling various existing and new offerings in affordable and consumer-friendly subscription packages,” the filing reads.

Growth Plans: Along with growing telehealth and subscription offerings, the company is putting an emphasis on growing its customer base, increase the number of offerings used by each customer, build the GoodRx brand, offer additional solutions to pharmaceutical manufacturers, and pursue strategic partnerships and acquisitions.

https://www.benzinga.com/news/20/09/17609261/goodrx-holdings-ipo-what-investors-need-to-know

‘Stricter FDA standards make COVID-19 vaccine OK 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.

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%)

https://seekingalpha.com/news/3616286-stricter-fda-standards-make-covidminus-19-vaccine-approval-unlikely-election-day

CDC asks Americans to cancel Halloween

Americans should avoid door-to-door trick-or-treating, attending crowded and indoor parties, and wearing costume masks this Halloween to prevent the spread of COVID-19, according to the U.S. Centers for Disease Control and Prevention.

The U.S. health agency said that many traditional Halloween activities could be high-risk for spreading viruses and outlined several safer, alternative ways to participate in a note on holiday celebrations.

The guidance comes after new COVID-19 cases in the United States rose last week for the first time after falling for eight straight weeks, an increase that health experts attributed to schools reopening and parties over the Labor Day holiday.

The health agency also said activities like attending haunted house settings, consuming alcohol or drugs and attending the fall festival that is outside one’s community were high risk and should be avoided.

CDC advised one-way trick-or-treating where participants are six feet apart and wearing Halloween-themed cloth masks.

Other low-risk activities include carving pumpkins and decorating one’s home, outdoor scavenger hunts and parties, virtual costume contests and hosting a movie night with household members.

The health agency recommended tailoring all Halloween activities based on whether coronavirus infections were spiking in a given area, adding that the new guidelines are not meant to replace any local or state mandates on the pandemic.

For Thanksgiving, CDC advised against long distance travel, attending crowded parades and going shopping in crowded shops.

https://www.reuters.com/article/us-health-coronavirus-cdc-halloween/cdc-asks-americans-to-avoid-trick-or-treating-indoor-halloween-parties-idUSKCN26D29D

CDC sets October 16 deadline for states to submit vaccine plans

The U.S. Centers for Disease Control and Prevention (CDC) on Tuesday set an Oct. 16 deadline for states to submit plans for distributing COVID-19 vaccines – even before it becomes clear when any will be available – according to a presentation to a panel of experts who make recommendations on U.S. vaccines.

The plan is to take into account specific requirements, such as cold storage necessary for vaccines currently in late-stage clinical trials by Pfizer Inc and Moderna Inc, provided to the states on Sept. 16.

The Advisory Committee on Immunization Practices (ACIP), a group of external medical experts that advises the CDC, had been expected to vote on Tuesday on which population groups should get scarce initial doses of any vaccine that receives approval or emergency use authorization from U.S. regulators.

A CDC spokeswoman said on Tuesday the vote would not take place, without providing a reason. The next panel meeting is scheduled for Oct. 28 and 29.

Once the U.S. Food and Drug Administration authorizes a vaccine, ACIP will call an emergency meeting to make specific recommendations on distribution priorities, according to ACIP panel member Dr. Beth Bell of the University of Washington.

Bell said the recommendations could be narrower than guidance provided by the FDA for an emergency use authorization. ACIP’s recommendations will be delivered to CDC Director Dr. Robert Redfield, who is tasked with making the final decision on how the vaccines will be used.

When asked by a panel member how states could develop distribution plans by the October deadline, even before a specific vaccine is approved or authorized, Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said the aim was to be ready “on the first day we can actually distribute vaccines.”

Vaccine distribution is expected to occur in a phased manner, with healthcare personnel, essential workers, people with high-risk medical conditions and adults over age 65 likely to receive vaccines in the first phase, according to a meeting presentation here posted on the agency’s website.

In addition to Pfizer and Moderna, AstraZeneca Plc has a vaccine in the final stage of testing. The U.S. trial of that vaccine remains on hold as a potential safety issue is investigated.

https://www.reuters.com/article/us-health-coronavirus-vaccine-cdc/u-s-health-agency-sets-october-16-deadline-for-states-to-submit-vaccine-plans-idUSKCN26D1JD

RedHill Biopharma on go with Phase 2/3 Covid-19 study with opaganib in Brazil

The Brazilian Health Regulatory Agency has signed off the ongoing global Phase 2/3 study of RedHill Biopharma’ (RDHL +1.5%) opaganib, sphingosine kinase-2 selective inhibitor, in patients hospitalized with severe COVID-19 pneumonia.

The study has been in Brazil, Israel, U.K., Italy, Russia and Mexico, and is expected to enroll up to 270 patients requiring hospitalization and treatment with supplemental oxygen.

In parallel, U.S. Phase 2 study with opaganib in patients with severe COVID-19 pneumonia is ~75% enrolled, with enrollment set to be completed in the coming weeks. Recently, a pre-scheduled independent Safety Monitoring Committee recommended that the study continue without change.

https://seekingalpha.com/news/3616236-redhill-biopharma-on-go-phase-2-3-covidminus-19-study-opaganib-in-brazil