2nd US Omicron Case Is Vaccinated Adult Male Whose 'Mild Symptoms' Fully Resolved

 Update 10:55am: Here is another reason to be optimistic - not suicidal - by the news that the Omicron variant is spreading. As we, Ackman and Kolanovic, all said, the Omicron variant could be the best thing that happened to the pandemic as it is much more "mild" than Delta, and because it is much more transmissible could soon become the dominant version.

As the Minnesota Dept of Health said in its press release on the second identified US covid case, the "Infected Minnesota resident recently returned from domestic travel; variant was found through MDH variant surveillance program, which is one of the strongest surveillance programs in the nation"

And the punchline:

"The person with the Omicron variant is an adult male, is a resident of Hennepin County, and had been vaccinated. The person developed mild symptoms on Nov. 22 and sought COVID-19 testing on Nov. 24. The person’s symptoms have resolved." 

In other words, just as we noted, Omicron continues to manifest itself in an extremely mild fashion, and its symptoms go away in days (it is unclear how it progresses in unvaccinated people so far).

We also know what happens next: according to the press release...

The person spoke with MDH case investigators and reported traveling to New York City and attended the Anime NYC 2021 convention at the Javits Center from Nov. 19-21. The person was advised to isolate from others. Minnesota epidemiologists will continue to investigate in collaboration with New York City and the U.S. Centers for Disease Control and Prevention.

Said otherwise, expect a cluster of Omicron cases in NYC in the next 24-48 hours. And more importantly, with physicians hoping to get an accurate picture of the symptoms of the new strain, we should have a clear picture of just how benign Omicron is within the next 72 or so hours.

* * *

Earlier

The first time that algos dumped everything on news that an Omicron case had been identified in the US in San Francisco, that was at least somewhat understandable even if virtually everyone knew it was just a matter of time before the "extremely transmissible" Omicron made its way to the US. However, when moments ago Reuters reported that a second Omicron cade had been identified in Minnesota...

• OMICRON COVID-19 VARIANT CASE IDENTIFIED IN MINNESOTA -STATE HEALTH DEPARTMENT

... for algos to pull off the same exact stunt was borderline stupid - after all, every incremental omicron case brings us closer to trillions in stimmies which as everyone by now knows send stocks soaring (inflation will be ignored by everyone if stonks are surging faster than prices are rising). And yet, the dump we just observed is precisely the same that took place yesterday, prompting some - such as us - to ask just what 13-year-olds are programming these algos, that trade the market in the dumbest possible way.

It wasn't just stocks: everything tumbled - yields, cryptos, you name it...

So for all those confused what they should be doing here, let us repeat, what we have been saying and what Rabobank said just moments ago - Omicron "will of course be used as an argument for more stimulus ahead."  Those selling stocks on this news clearly have not been paying any attention to what happened in the past year.

https://www.zerohedge.com/markets/everything-tumbles-after-second-us-omicron-case-identified-minnesota

Pfizer Jab & GSK's Antibody Drug Called Effective Against Omicron

 After teasing various aspects of his plan to protect Americans from the omciron variant (which is arriving at the start of the latest 'winter wave') while the CDC quietly collects names of travelers who recently visited southern Africa, President Joe Biden is preparing to share his plan, which will impose tighter restrictions on foreign travelers while extending a mask mandate and (potentially) double down on vaccine restrictions for American workers (even as multiple federal judges have rejected the mandate).

Biden's comments are expected later on Thursday, but during the early hours of the US session, Germany's outgoing Chancellor Angela Merkel and her successor, Olaf Scholz, agreed on a plan to effectively mandate vaccinations by imposing stringent restrictions on Germans who haven't voluntarily gotten the jab.

As governments scramble to use omicron as an excuse to crack down on the unvaccinated, makers of vaccines and COVID remedies have continued to share data about their products' efficacy at combating the omicron variant. And unsurprisingly, many of the big-name firms are saying they expect their jabs to "hold up" against the variant.

Despite Moderna CEO Stephane Bancel's market-rattling warnings that the first generation of mRNA vaccines - including Moderna's - might need to be retooled in order for them to protect against omicron, a senior Pfizer executive told Bloomberg that the company expects its jabs to offer significant protection against omicron, with more data expected in the coming weeks.

"We don’t expect that there will be a significant drop in effectiveness," Ralf Rene Reinert, vice president of vaccines for international developed markets, said in an interview with Bloomberg Television. "But again, this is speculation. We will check this. We will have the data in the next couple of weeks."

Pfizer has already started working on new versions of its vaccine twice, with the emergence of the beta and delta variants, and concluded both times that the original shot provided good protection, Reinert said. Now its scientists will evaluate whether that’s the case for omicron, Bloomberg reports.

"It’s not that we start from scratch," Reinert said. "We know what we have to do."

These reassurances have arrived at a critical time: on Wednesday afternoon, the US became the 29th country to identify a case of the omicron variant. A US traveler in the San Francisco area was identified as the first patient known to be infected with the new variant (though it's likely that many others have already been infected, since the variant has been detected in Europe more than two weeks ago).

The US has seen a slight uptick in new cases in recent weeks as the 'winter wave' appears to be starting.

Source: Reuters

The global trend is moving in the same direction as Europe and other continents see rising numbers of cases.

Source: Reuters

And on the medical front, Pfizer isn't alone: GlaxoSmithKline said Thursday that its COVID antibody treatment looks to be effective against the new omicron variant in early tests.

Lab tests of the mutations found in the variant showed the drug is still active against the virus, Glaxo said in a statement on Thursday. GSK is now conducting in vitro experiments to confirm the response against a combination of all the omicron mutations.

As a result, Sotrovimab, the GSK antibody treatment, has been approved by the UK's Medicines and Healthcare products Regulatory Agency following a "rigorous" review of its safety.

Meanwhile, back in South Africa, scientists are tweaking their initial warnings about the variant. One day after reporting a massive surge in new cases (which some dismissed as a quirk resulting from a change in how public health officials count positive cases), scientists for the Diseases Institute are saying that while they expect a surge in cases due to omicron, the intensity of infections should be markedly more mild. Above all, the scientists expect fewer active cases and hospitalizations during this wave.

Here are some additional omicron-related headlines from Thursday:

• Indian officials have seen mild cases in Omicron patients. India reported two cases of the variant.
• UK Health Secretary Sajid Javid announced the UK secured 54mln additional doses of the Pfizer (PFE) / BioNTech (BNTX) jabs and 60mln additional doses of the Moderna (MRNA) vaccine for the next two years which he said will help the UK to "buy time" with the new variant.
• South Korea's government is considering coronavirus measures including banning social gatherings and reducing business hours, while it was also reported that South Korea is considering halting its gradual return to normal life as COVID-19 infections rise and it also reported a fresh record daily increase in cases, as well as confirmed its first case of the Omicron variant.
• The Japanese government will temporarily invalidate special visas issued to foreign nationals who meet certain conditions in an effort to curb the spread of the Omicron variant.

Finally, President Biden is planning to include additional measures like forcing insurers to pay for at-home COVID tests as part of his plan for mitigating the 'winter wave' of COVID cases. Private insurers already cover COVID tests administered in doctor’s offices and other medical facilities, but there are now at least eight at-home tests on the US market that can be used by individuals at home. Biden is scheduled to deliver remarks on his 'winter plan' beginning just before 1400ET on Thursday. He will be speaking from Bethesda, Maryland.

https://www.zerohedge.com/markets/pfizer-jab-gsks-antibody-drug-are-effective-against-omicron

Terns Flirts with Milestones in Challenging NASH Space

 Today, treatment for non-alcoholic steatohepatitis (NASH), a severe form of fatty liver disease, consists mainly of lifestyle modification – specifically dieting and weight loss. There are no approved drugs that treat it directly, although many are in development.

“One of the key challenges is that multiple different pathways are at play,” Dr. Erin Quirk, M.D., president, CMO and head of R&D at Terns Pharmaceuticals told BioSpace. Inflammation, fibrosis creation and metabolic state of the patient, such as insulin resistance and abnormal signaling between tissues outside the liver, are all factors. “You can’t target one element and make a significant impact. We believe it takes multiple approaches to move the needle.”

Terns is developing a pipeline of single-agent and complementary small molecule therapeutics to address this challenge. TERN-501 is the latest to enter clinical development. It is a thyroid hormone receptor beta (THR-β) agonist that appears to significantly increase levels of sex hormone-binding globulin (SHBG), an important pharmacodynamic marker of THR-β engagement that is linked to NASH histologic efficacy.

TERN-501 could be important in NASH treatment because THR-β agonists can reverse steatosis – the accumulation of excess fat in the liver. “By targeting the beta ISA isoform of the thyroid hormone receptor, which is expressed in the liver, TERN-501 activates fat metabolism locally through upregulation of mitochondrial oxidation to remove fat from the liver. THR- β agonism also likely tones down liver inflammation,” Quirk said.

In a rodent model, low doses of TERN-501 resolved steatosis completely, and reduced serum lipids, hepatic inflammation and fibrosis.

Those improvements seen early on now show signs of being replicated in humans. Results from the recently-completed Phase I clinical trial showed a significant dose-dependent effect of TERN-501 on SHBG. At a 10 mg dosage, TERN-501 resulted in a mean 166% change from baseline in SHBG levels at day 15. The same study showed LDL cholesterol levels dropped a mean of 21%, and the 6 mg dose group achieved a maximum 28% decrease in LDL cholesterol versus an 8% decrease for the placebo group. Meanwhile, mean levels of triglycerides dropped 36% and apolipoprotein-B dropped 28% from baseline at a 10 mg dosage.

Additionally, Quirk added, “The TERN-501 safety profile – to date – is similar to that of placebo,” with no clinically meaningful differences in adverse events or safety laboratories. The drug is highly selective for THR-β. Company literature notes that TERN-501 is “23-fold more selective for THR-β than for THR-α activation in a cell-free assay,” thereby minimizing the risk of cardiotoxicity and other side effects.

Once-daily dosing is supported, and results suggest that TERN-501 eventually could be co-formulated with other small molecule NASH therapeutics, simplifying a daily drug regimen. The drug received Fast Track designation for NASH from the U.S. Food & Drug Administration this past summer.

Because Terns plans a multifactorial approach to NASH treatment, the Phase I study included a drug-drug interaction element in which TERN-501 was co-administered with TERN-101. “TERN-501 potentially addresses liver fat, while TERN-101 is a farnesoid X receptor (FXR) agonist, which may decrease liver scarring and inflammation,” Quirk noted. The results of this portion of the study showed a low potential for drug-to-drug interactions with these two compounds, suggesting their possible use as a combination therapy.

In a separate study, the controlled, 12-week, 100-person Phase IIa LIFT trial showed that TERN-101 began to reverse fibroinflammation and also had a good tolerability profile. In that study, mean corrected T1 (cT1) – a marker of liver inflammation and fibrosis – values showed a decrease of at least 80 milliseconds from baseline in a higher proportion of patients treated with TERN-101 than those treated with placebo. Those decreases indicate significant improvements in fibro-inflammation after treatment with TERN-101. This was the first FXR agonist trial to demonstrate zero discontinuations because of adverse events.

A Phase II combination trial of TERN-501 and TERN-101 is expected to begin in the first half of 2022. The company plans to study each of the two drugs alone and in combination.

“This is a potentially important study,” Quirk said. “It will be the first drug combination Terns will assess, and is likely to be the first time that THR-β and FXR agonists are co-administered to NASH patients. We want to reduce both liver fat and fibroinflammation, so if we can demonstrate a regimen has large effects on cT1 and MRI-PDFF, we may have a chance to see improvements in liver biopsies and in clinical outcomes for patients.”

If such an outcome occurs, it will be a major milestone for treatment advances and for Terns in particular. Quirk observed, “There are few examples of any drug or combination where a high proportion of patients have met those endpoints – resolution of NASH and improvement of fibrosis.”

https://www.biospace.com/article/terns-is-tilting-at-milestones-in-challenging-nash-space-/

Minnesota reports second U.S. omicron Covid case in resident who traveled to NYC

 Minnesota public health authorities confirmed Thursday what appears to be the second U.S. case of the omicron Covid variant in a resident who recently returned from New York City, the state’s department of health said.

The man, who was fully vaccinated and has since recovered, traveled to New York City to attend the Anime NYC 2021 convention at the Javits Center from Nov. 19-21, the department said in a statement. The first omicron case was confirmed in California by U.S. officials Wednesday in a person who recently returned to San Francisco from a trip to South Africa.

New York Gov. Kathy Hochul said they haven’t yet confirmed any cases in the state. “However, we are very cognizant of the fact that it’s very likely soon that someone is going to test positive for this,” she said at a press conference in Manhattan on Thursday.

She said conference attendees were required to get vaccinated, and she recommended that they all get tested.

The patient in California who first tested positive for omicron was also fully vaccinated, has mild symptoms and is improving, Gov. Gavin Newsom said on Wednesday. The person, who is between 18 and 49 years old, had not received a booster dose because they were not six months out from their original vaccination course, he said.

Dr. Mark Ghaly, California’s Health and Human Services secretary, said the fact that the California patient has mild symptoms and is improving underscores the importance of vaccines.

Health officials in the U.S. and around the world are concerned that omicron is more transmissible and may evade the protection provided by currently available vaccines to some degree. The variant has some 50 mutations, more than 30 of which are on the spike protein that the virus uses to attach to human cells.

“The molecular profile of the kinds of mutations that you see [in omicron] would suggest that it might be more transmissible and that it might elude some of the protection of vaccines,” White House chief medical advisor Dr. Anthony Fauci told reporters on Wednesday. “But we don’t know that now.”

The Biden administration on Thursday laid out a plan to combat omicron and a possible winter surge of the predominant delta variant of the virus. The White house is requiring all in-bound international travelers to test for Covid within 24 hours of their departure. The administration is extending mask requirements on domestic flights and public transit through March 18. It is also expanding access to free at-home Covid tests.

The World Health Organization on Wednesday said omicron has been confirmed in at least 23 countries worldwide. The variant was first identified in Botswana last month and brought to the attention of the WHO by public health officials in South Africa.

Maria Van Kerkhove, the WHO’s technical lead, said on Wednesday that hospitalizations are rising in South Africa, but more data is needed before drawing conclusions about whether omicron causes more severe disease.

The CEOs of Pfizer and Moderna say it will take about two weeks to gather enough data to determine what impact omicron’s mutations have on the effectiveness of the current vaccines. They have said it would take until early 2022 to develop a shot that specifically targets the variant. However, Moderna CEO Stephane Bancel said the company can roll out a higher dosage booster shot much quicker.

https://www.cnbc.com/2021/12/02/minnesota-reports-second-us-omicron-covid-case-in-resident-who-traveled-to-nyc.html

Novavax says it could start making Omicron-specific vaccine in January

  Novavax Inc said on Thursday it could begin commercial manufacturing of a COVID-19 vaccine tailored for the Omicron coronavirus variant in January next year, while it tests whether or not its current vaccine works against the variant.

Laboratory data expected in the coming weeks will show whether antibodies from individuals who have previously received Novavax's COVID-19 shot can neutralize the variant, according to the company.

Novavax also said it has started developing an Omicron-specific spike protein antigen and will begin laboratory tests of a new vaccine to target the variant in a few weeks.

The Omicron coronavirus variant has shaken up markets and caused global alarm over concerns about whether it could evade protection provided by widely used vaccines and prolong the public health crisis.

Other vaccine makers including Moderna and Pfizer have also begun working on Omicron-tailored COVID-19 shots.

Novavax's COVID-19 vaccine received its first emergency use approval in Indonesia in early November followed by the Philippines. 

https://finance.yahoo.com/news/novavax-says-could-start-making-153636271.html

Biofrontera gets notice of allowance for pain-reducing protocol patent

 Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the U.S. patent application number 17/234,490, titled “Illumination for Photodynamic Therapy,” that covers an innovative, pain-reducing illumination protocol for photodynamic therapy (PDT).

“This patented illumination protocol demonstrates Biofrontera’s commitment to the patients’ need for innovative treatments. The patent also strengthens Biofrontera’s competitiveness for our FDA-approved combination product, Ameluz® together with our PDT-lamp BF-RhodoLED® and its successor model RhodoLED® XL in the U.S. by providing an opportunity to pursue label expansion to include more patient-friendly protocols,” stated Erica Monaco, Chief Executive Officer of Biofrontera Inc.

The patent application claims a method for photodynamic therapy in which a dynamic and innovative illumination protocol is implemented. This protocol consists of changing illumination intensities combined in a predefined order with interruptions of the illumination to specifically modulate and reduce pain perception to the patient. The new illumination protocol aims at combining the high efficacy of Ameluz® with the flexibility of BF-RhodoLED® to modulate light for pain reduction to ultimately become a new standard-of-care in PDT.

Implementation of the protocol to Biofrontera’s medical devices requires a software installation and can be rolled-out to both the BF-RhodoLED® and BF-RhodoLED® XL lamps. To include this illumination protocol in the U.S. prescribing information, Biofrontera Group, in accordance with pipeline development under the license and supply agreement (LSA) between Biofrontera Inc. and Biofrontera AG, will start a Phase 3 trial for the treatment of actinic keratoses on the face and scalp with 3 tubes of Ameluz® and the RhodoLED® XL lamp involving the new protocol in 2022.

https://finance.yahoo.com/news/biofrontera-inc-announces-notice-allowance-141500790.html

BeyondSpring cut to Underperform from Buy by B of A

 Target to $5 from $45

https://finviz.com/quote.ashx?t=bysi&ty=c&ta=1&p=d