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Monday, February 1, 2021

BioNTech says back on schedule to deliver COVID-19 vaccine doses to EU

 BioNTech and Pfizer Inc are on-track to meet the delivery deadline for their coronavirus vaccine to the European Union, the Germany-based company said on Monday.

European countries are grappling with broad vaccine delays, at least temporarily, as all Western vaccine makers with approved shots - Moderna, Pfizer and partner BioNTech and AstraZeneca - fall behind their initial delivery targets.

BioNTech and Pfizer are working toward ramping up delivery to Europe beginning the week of Feb. 15, the German company said.

Pfizer has successfully modified production processes at its manufacturing plant in Puurs, Belgium, putting the companies back on the original schedule of vaccine dose deliveries to the European Union, BioNTech said.

BioNTech said its own manufacturing site in Marburg, Germany, will be able to start production for validation by the European Medicines Agency in February.

The company also said its European manufacturing network has continued to expand, from three partners in December 2020 when the companies' vaccine was first authorized, to 13 currently.

The companies expect to make 2 billion doses of the vaccine in 2021.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/BioNTech-says-back-on-schedule-to-deliver-COVID-19-vaccine-doses-to-EU-32328412/

Under Biden order, workers refusing unsafe work could stay on unemployment aid

 Many workers called back by employers resuming or expanding operations despite the ongoing coronavirus pandemic face a dilemma: return to jobs that put them at high risk of the virus, or say no, and risk going without pay or unemployment benefits.

President Joe Biden argues workers should not have to make that choice.

An executive order signed on his second full day in office could make it easier for people to still qualify for jobless benefits if they quit or refuse a job that puts them at undue risk of infection from the coronavirus.

More than 18 million Americans are drawing some form of government unemployment assistance.

The order asks the U.S. Department of Labor to clarify that workers who refuse jobs due to unsafe working conditions can still receive unemployment insurance. A department spokesman told Reuters the agency is developing an Unemployment Insurance Program Letter - the usual mechanism for issuing guidelines or clarifying policies - in response to the order.

The Labor Department also issued new guidance on Friday with recommendations on how employers can protect workers from the virus, which has infected more than 25 million Americans and led to more than 433,500 U.S. deaths since the pandemic began.

“In a period where lots of people have lost jobs and people are desperate for work, people will go and end up working under dangerous conditions and they will do so believing they have no other alternative,” said Ken Jacobs, chair of the UC Berkeley Labor Center.

Assuring them they have the right to refuse unsafe work, and paying them enough to afford not to work, is “vitally important,” Jacobs said. “You want people in the greatest risk groups to stay home.”

SEEKING CLARITY

It’s not clear how many workers have lost unemployment benefits after refusing jobs because of COVID-19 safety concerns, said Andrew Stettner, a senior fellow at The Century Foundation and an expert on unemployment insurance. Still, the new guidance should establish minimum protections for workers, replacing an approach that can vary by state, he said.

“It’s been very unclear for a claimant to understand whether they can refuse an offer to go back to work,” Stettner said.

Currently some states, including Texas, publish lists of the circumstances in which a worker might be able to keep receiving benefits after turning down a job. For instance, the state offers exceptions for workers age 65 and up, or those with health conditions that put them at high risk.

But other states advise workers of a narrower set of protections, and many make decisions on a case by case basis.

“The goal would be to have some clear standards,” Stettner said.

The new federal guidance, likely to be issued in the coming weeks, would be aimed at making both states and workers aware they should be able to qualify for unemployment benefits after refusing a job that puts them at greater risk because of their age, a health condition or lack of COVID-19 safety protocols, analysts say.

‘WE NEED A STANDARD’

That policy could make a big difference for people in jobs at restaurants or other businesses requiring workers to be in close proximity to others, two recent studies suggest.

Essential workers were 55% more likely to get infected with coronavirus than those who stayed at home, according to a study of the early months of the pandemic in Pennsylvania published this week by researchers at Independence Blue Cross and the Wharton School of Business.

“We all had a hunch that essential workers by the nature of their jobs are probably more exposed, which means they’re probably more likely to get infected – but what we didn’t know was by how much,” said Wharton’s Hummy Song, one of the paper’s authors.

A separate study out last week from the University of California found deaths of working-age Californians increased by 22% in 2020 from what would have been expected based on prior trends, and the deaths were concentrated in certain occupations.

Deaths among workers in food and agriculture, for instance, were 39% higher. Among healthcare workers, deaths were up 20%, the study noted.

The findings indicate there may be better protections in place in health care settings than in restaurants or other fields, said Yea-Hung Chen, one of the study’s authors.

https://www.reuters.com/article/us-usa-economy-unemployment/under-biden-order-workers-refusing-unsafe-work-could-stay-on-unemployment-aid-idUSKBN2A128L


Facebook Oversight Reverses Hydroxychloroquine Censorship Decision

 Facebook's independent Oversight Board has ruled against the social media giant's decision to remove an October 2020 post touting hydroxychloroquine (HCQ) - the antimalarial which Democrats and their media surrogates were cautiously optimistic about until former President Trump promoted it.

"In October 2020, a user posted a video and accompanying text in French in a public Facebook group related to COVID-19," explained the board on its website. "The post alleged a scandal at the Agence Nationale de Sécurité du Médicament (the French agency responsible for regulating health products), which refused to authorize hydroxychloroquine combined with azithromycin for use against COVID-19, but authorized and promoted remdesivir. The user criticized the lack of a health strategy in France and stated that “[Didier] Raoult’s cure” is being used elsewhere to save lives. The user’s post also questioned what society had to lose by allowing doctors to prescribe in an emergency a “harmless drug” when the first symptoms of COVID-19 appear."

The Oversight Board noted that the user's post did not encourage people to take HCQ without a prescription, and was instead "opposing a governmental policy and aimed to change that policy."

"The combination of medicines that the post claims constitute a cure are not available without a prescription in France and the content does not encourage people to buy or take drugs without a prescription. Considering these and other contextual factors, the Board noted that Facebook had not demonstrated the post would rise to the level of imminent harm, as required by its own rule in the Community Standards," the Board continued, adding that Facebook failed to satisfactorily explain why it removed the post, annd that their 'misinformation and imminent harm rule' is too vague - recommending that the company clarify its standards on health misinformation.

"The Board also found Facebook's misinformation and imminent harm rule, which this post is said to have violated, to be inappropriately vague and inconsistent with international human rights standards," wrote the panel. "A patchwork of policies found on different parts of Facebook's website make it difficult for users to understand what content is prohibited. Changes to Facebook's COVID-19 policies announced in the company's Newsroom have not always been reflected in its Community Standards, while some of these changes even appear to contradict them."

One can't help but wonder how many lives the left's politicization of HCQ may have cost, after several studies have concluded that when taken early into a COVID-19 infection, the antimalarial has been shown to reduce mortality.

The currently completed retrospective studies and randomized trials have generally shown these findings: 1) when started late in the hospital course and for short durations of time, antimalarials appear to be ineffective, 2) when started earlier in the hospital course, for progressively longer durations and in outpatients, antimalarials may reduce the progression of disease, prevent hospitalization, and are associated with reduced mortality. -American Journal of Medicine

One Brazilian study found 4.6x fewer hospitalizations in patients who took HCQ and azithromycin within seven days of infection, while a retrospective study of cases in Detroit showed a 71% reduction in mortality with early treatment using the HCQ / Azithromycin combination.
 
meta-analysis of 105,040 cases from 20 studies in 9 countries found a reduction in mortality by up to three times in groups treated early with Hydroxychloroquine and Azithromycin.
 
Unfortunately for those hoping to use HCQ, Trump made the mistake of endorsing it, setting off a cascade of anti-HCQ propaganda which has been largely disproven.

Concert misses primary endpoint in schizophrenia trial

 CTP-692 Did Not Achieve Primary Endpoint Assessing Positive and Negative Syndrome Scale (PANSS) Total Score at 12 Weeks

Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) today announced that its Phase 2 clinical trial to evaluate CTP-692 as an adjunctive treatment in patients with schizophrenia did not meet the primary endpoint or other secondary endpoints. CTP-692 is a deuterated form of D-serine, an endogenous amino acid that is a co-agonist of the NMDA receptor.

"The body of evidence in the field supporting D-serine as an adjunctive treatment for schizophrenia was compelling and led us to advance CTP-692 into a Phase 2 proof of concept study. Unfortunately, we didn’t see the results we hoped for to support continuation of this program. Going forward, we will focus our internal resources on the advancement of CTP-543, which is currently in Phase 3 evaluation for the treatment of alopecia areata, and evaluation of additional pipeline candidates," stated Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. "We believe that we conducted a well-designed, well-controlled study and extend our gratitude to the patients, caregivers and investigators for their participation in the CTP-692 Phase 2 study. It’s our hope that these learnings will support future research to address the important need to improve the symptom domains of schizophrenia."

https://finance.yahoo.com/news/concert-pharmaceuticals-announces-results-ctp-120000293.html

Stocks That Wall Street Hates but You May Like

 For good or bad, what Wall Street analysts think about a stock makes a big difference. One downgrade from an analyst can cause a stock to sink. On the other hand, an analyst's upgrade or price target increase usually provides a nice positive catalyst for a stock.

But -- you might need to sit down for this -- Wall Street analysts aren't always right. That's shocking, I know. And sometimes they can be flat-out wrong about a stock. With that in mind, here are two stocks that Wall Street hates but you'll probably like.

Fulgent Genetics: More than just COVID-19 testing

The Wall Street consensus price target for Fulgent Genetics (NASDAQ:FLGT) reflects a 41% discount to the current price for the healthcare stock. I think that analysts are being way too pessimistic about Fulgent's prospects.

As its name indicates, Fulgent Genetics focuses on genetic testing. Its stock quadrupled in value in 2020 thanks to surging demand for Fulgent's COVID-19 tests. Wall Street analysts apparently think that that demand will sharply decline this year. That might seem reasonable with the increasing availability of COVID-19 vaccines.

However, new coronavirus variants (especially the B.1.351 variant first identified in South Africa) appears to be more resistant to vaccines. Don't be surprised if COVID-19 testing volumes remain high for a longer period than analysts expect.

I also think that Wall Street is missing a more important long-term story for Fulgent. The company's opportunities go way beyond COVID-19 testing.

Fulgent estimates that its addressable market for genetic testing will top $10 billion by the end of 2022. Even with soaring sales last year, the company will probably report revenue of around $300 million. Fulgent's technology platform gives it the nimbleness and cost advantages that should enable it to capture a much greater chunk of the potential market over the next few years.

Can Fulgent Genetics double your money in 2021? I wouldn't go that far at this point, especially since the stock has basically doubled already year to date. However, my view is that it's more likely that Fulgent will continue to deliver solid returns this year than plunge more than 40% as many Wall Street analysts expect. 

Illumina: The 800-pound gorilla in genomics

Wall Street is also pretty pessimistic about Fulgent's gene-sequencing technology partner and 800-pound gorilla in the genomics market, Illumina (NASDAQ:ILMN). The average analyst price target is 24% below Illumina's current share price.

Unlike Fulgent, Illumina didn't deliver jaw-dropping returns last year. Its stock rose less than 12% while the S&P 500 index jumped 16%. Illumina is off to a better start this year with a double-digit gain. However, I don't think the stock is poised to sink as analysts seem to anticipate it will. Actually, my view is that 2021 will be a pretty good year for Illumina.

The company already announced guidance projecting revenue growth of up to 20% in 2021. Sure, increased COVID-19 testing one tailwind fueling this growth. But Illumina also has other growth drivers, including a major ramp-up in population genomics initiatives this year and its recent launch of Illumina Connected Analytics, a cloud-based platform supporting bioinformatics.

Illumina's NovaSeq system should also continue to enjoy solid momentum. It's already the most successful sequencing system in the company's history. The installed base for Novaseq currently tops 1,100. Illumina still has over 320 customers using its older HiSeq system that haven't converted to NovaSeq yet. 

While Illumina's near-term prospects look good, it's the company's long-term potential that is especially exciting. We've only begun to see what gene sequencing can achieve in helping detect cancer at early stages and develop therapies for genetic diseases.

Illumina still expects to lower the cost of sequencing a human genome to $100 from around $600 today. If it achieves that goal (and I think it will), there could be an explosion in the use of genomic sequencing. And this 800-pound gorilla will probably grow much larger.

https://www.fool.com/investing/2021/02/01/2-stocks-that-wall-street-hates-but-youll-probably/

'Popular Robinhood Stock That Could Be Better Than Bitcoin in 2021'

It's been a rollercoaster ride for bitcoin already in 2021, and the year is still young.

However, I wouldn't be surprised if bitcoin delivers solid returns over the next 11 months. On the other hand, I also think that Robinhood investors like several stocks that could generate even higher returns. Here's one popular stocks on the no-cost trading platform that could be better than bitcoin in 2021.

Inovio Pharmaceuticals

Perhaps the most critical milestone for the world this year will be the massive rollouts of COVID-19 vaccines. The vaccine developed by Inovio Pharmaceuticals (NASDAQ:INO) could be among those administered in 2021. 

Inovio turned in a tremendous performance last year, with its shares soaring 168%. That gain could be a drop in the bucket, though, if the biotech's INO-4800 COVID-19 vaccine proves safe and highly effective.

It will be later in the year before we know more about the real potential for INO-4800. Inovio is currently evaluating the experimental vaccine in a phase 2 clinical study. 

The biotech stock could have another major catalyst on the way, though. Inovio expects to report results from a late-stage study of VGX-3100 in treating precancerous cervical dysplasia in the first half of 2021. Positive results from this study could set the stage for a regulatory filing for VGX-3100.

https://www.fool.com/investing/2021/01/28/3-popular-robinhood-stocks-that-could-be-better-th/

COVID-19 test kit developer Lucira Health sets terms for $125 million IPO

 Lucira Health, which is developing single-use test kits for COVID-19 and other infectious diseases, announced terms for its IPO on Monday.


The Emeryville, CA-based company plans to raise $125 million by offering 7.8 million shares at a price range of $15 to $17. At the midpoint of the proposed range, Lucira Health would command a fully diluted market value of $644 million.

Lucira has developed a testing platform that produces centralized-laboratory-accurate molecular testing in a single-use and consumer-friendly test kit that is powered by two AA batteries and fits in the palm of a hand. The company's initial focus is within respiratory diseases, starting with COVID-19 and influenza A and B virus indications. Its LUCIRA COVID-19 All-In-One Test Kit is designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection. The company is pre-revenue.

Lucira Health was founded in 2013 and plans to list on the Nasdaq under the symbol LHDX. BofA Securities, William Blair and LifeSci Capital are the joint bookrunners on the deal.