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Monday, January 10, 2022

Study suggests common cold may provide some protection against COVID-19

 A small study from the Imperial College London suggests that the body’s defense against common cold coronaviruses may provide some protection against COVID-19, providing a potential direction for upcoming vaccine development.

The research published in Nature Communications on Monday found that people with higher T cell levels from previous coronavirus infections like the common cold were less likely to contract COVID-19.

The virus that sparked the pandemic is a kind of coronavirus, while other coronaviruses spark other illnesses including some common colds. 

By analyzing blood samples from 52 participants who lived with someone with confirmed COVID-19 in September 2020, researchers determined that there were “significantly higher levels” of pre-existing T cells after common cold coronaviruses among the 26 people who did not contract COVID-19. 

Still, the researchers emphasized that vaccines still offer the best protection against the virus that’s killed millions worldwide.

"While this is an important discovery, it is only one form of protection, and I would stress that no one should rely on this alone,” lead author Rhia Kundu said. “Instead, the best way to protect yourself against COVID-19 is to be fully vaccinated, including getting your booster dose.”

But the results could help improve the shots’ effectiveness against current and future variants. The T cells researched in the study offer protection by focusing on internal proteins within the COVID-19 virus, instead of spike proteins. 

The current vaccines, while effective, target the spike proteins located on the surface of the virus that are more likely to mutate than internal proteins, including in the omicron strain. The data suggests the next step of COVID-19 vaccine development should focus on internal proteins.

"New vaccines that include these conserved, internal proteins would therefore induce broadly protective T cell responses that should protect against current and future SARS-CoV-2 variants,” senior author Ajit Lalvani said in a release. 

The researchers acknowledged that the study’s small sample size and lack of ethnic diversity, with the vast majority of participants being of white European ethnicity, present limitations for the research.

https://thehill.com/policy/healthcare/588985-study-suggests-common-cold-may-provide-some-protection-against-covid-19

Pfizer CEO predicts omicron vaccine will be ready in March

 Pfizer CEO Albert Bourla on Monday said that his company is aiming to have a vaccine that targets the omicron variant as well as other COVID-19 variants ready in March. 

“This vaccine will be ready in March,” Bourla said in an appearance on CNBC’s "Squawk Box."

“We [are] already starting manufacturing some of these quantities at risk,” he added. 

Pfizer will produce the doses to be ready in case countries want the shots, but Bourla noted that it was unclear if a vaccine targeting variants was necessary or how exactly it would be used.

“The hope is that we will achieve something that will have way, way better protection particularly against infections, because the protection against the hospitalizations and the severe disease — it is reasonable right now with the current vaccines as long as you are having let’s say the third dose,” Bourla said.

Last month, Anthony Fauci, the White House chief medical adviser, said that he did not see a need for an omicron-specific vaccine.

"Our booster vaccine regimens work against omicron," he said. "At this point there is no need for a variant-specific booster."

To combat the new variant, Fauci encouraged people to get their booster shots and their vaccines. 

"The message remains clear: If you are unvaccinated, get vaccinated, and particularly in the arena of omicron, if you are fully vaccinated, get your booster shot," he said.

More recently, the Centers for Disease Control and Prevention approved booster doses of Pfizer-BioNTech's COVID-19 vaccine for adolescents ages 12 to 15, making about 5 million children now eligible for the shot.

https://thehill.com/policy/healthcare/588988-pfizer-ceo-predicts-omicron-vaccine-will-be-ready-in-march

States turning to National Guard for COVID-19 help as omicron surges

 Several states are turning to their National Guards for help as they see spikes in demand for coronavirus testing and other pandemic needs during the omicron surge. 

Governors have been deploying their guards since the pandemic began to help with a variety of needs. But over the past year, the spread of the delta and omicron variants has spurred the need for backup personnel.

On Jan. 3, Ohio Gov. Mike DeWine (R) announced that about 300 members of his state’s National Guard will support state testing efforts in nine new cities. A week earlier he had mobilized an additional 1,250 members to support hospitals that critically needed the help.

Overall, over 2,300 members of the state’s National Guard are working with Ohio’s health care systems.

“The demand for COVID-19 testing increases, adding to the pressure our hospitals are facing, members of the Ohio National Guard will continue to play a critical role in the state’s response,” DeWine said in a statement last Monday. “I commend Guard members for their commitment to their fellow Ohioans as they answer the call to serve.”

Over the past week, several other states, including Minnesota and Rhode Island, also announced they would mobilize the National Guard to support testing capacity.

California Gov. Gavin Newsom (D) on Friday announced he’s mobilizing 200 members of the California National Guard to support testing facilities amid the omicron surge. 

The deployments come as the U.S. sees a rapid spike in COVID-19 infections largely fueled by the omicron variant, which was first detected in South Africa on Nov. 14.

The first confirmed case of omicron was identified in the U.S. on Dec. 1, and the spread of infections that has ensued has placed a new strain on testing and hospital capacity.

Maryland Gov. Larry Hogan (D) declared a state of emergency on Tuesday and mobilized as many as 1,000 National Guard soldiers and airmen to support the state for COVID-19 testing, to help local hospitals and to assist with patient transport. 

“The truth is that the next four to six weeks will be the most challenging of the entire pandemic,” Hogan said at the time. “All of the emergency actions we are taking today are to keep our hospitals from overflowing, to keep our kids in school, and to keep Maryland open for business, and we will continue to take whatever actions are necessary in the very difficult days and weeks ahead.”

In some states, troops are being deployed just as coronavirus-related missions were set to wind down.

Hawaii in mid-December was just about to mark the end of the Hawaii National Guard Joint Task Force that was supporting the state’s COVID-19 response but reversed the decision amid an increase in infections sparked by the omicron variant.

And on Jan. 3, the Oregon Air National Guard announced the end to a mission that began in August to support hospitals amid a COVID-19 surge, but said a small contingent of staff would continue the mission through the end of February. 

Days later, Gov. Kate Brown (D) announced that she will be mobilizing up to 500 Guard members to support health care workers amid the omicron surge. An initial 125 troops will be deployed this week.  

As governors mobilize their National Guard members, the Department of Defense is separately aiding states amid the surge.

President Biden announced last month that he instructed the Pentagon to mobilize an additional 1,000 active-duty service members to help at medical facilities. Thus far, it has sent active-duty medical personnel to several states over the past month specifically to alleviate hospitals.

In New Hampshire, for instance, 17 active-duty service members arrived last Monday and are set to depart in February.

“We are grateful to have this team here in New Hampshire, and we continue to press for all available resources as we combat this winter surge,” Gov. Chris Sununu (R) said in a statement announcing the service members’ arrival.

https://thehill.com/policy/defense/589022-states-turning-to-national-guard-for-covid-19-help

Neuronetics strengthens after prelims

 Neuronetics, Inc. (NASDAQ: STIM), a commercial stage medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, today announced certain preliminary unaudited fourth quarter and full year 2021 revenue results.

Fourth Quarter 2021
Preliminary unaudited total revenue for the fourth quarter of 2021 is expected to be in the range of approximately $14.5 to $15.0 million as compared to previously stated guidance of $13.0 to $14.0 million.

Full Year 2021
Preliminary unaudited total revenue for the full year 2021 is expected to be in the range of approximately $54.8 to $55.3 million as compared to previously stated guidance of $53.3 to $54.3 million.

“Despite the headwinds associated with COVID-19 that persisted in 2021, our team delivered strong performance in the fourth quarter, primarily as a result of increased treatment session volumes across our customer base and solid demand for new systems,” said Keith J. Sullivan, President and Chief Executive Officer of Neuronetics. “Throughout the year, we made significant progress on several of our strategic initiatives setting ourselves up to drive future growth, including entering into new, exclusive, commercial agreements with multiple national accounts. While the macro environment continues to be fluid, we are very excited about our prospects for 2022. We plan to capitalize on our strong momentum going into the year and are confident in our team’s ability to drive the widespread adoption of NeuroStar Advanced Therapy for Mental Health.”

https://finance.yahoo.com/news/neuronetics-reports-preliminary-fourth-quarter-133000407.html

Olink bounces on prelims

 Olink Holding AB (publ) (“Olink”) (Nasdaq: OLK) today announced preliminary unaudited revenue for the fourth quarter and year ended December 31, 2021, and additional select unaudited performance metrics.

Revenues for the fourth quarter 2021 are expected to be between $43.2 million and $43.7 million, versus $27.2 million in the corresponding quarter of last year. Full year 2021 revenues are expected to be between $94.5 million and $95.0 million, an increase of approximately 75% compared to the year ended December 31, 2020. In addition, Olink anticipates fourth quarter 2021 Kit share of total revenues will be roughly 35%, versus 18% reported during the third quarter of 2021. The Company also expects year-end Explore externalizations to reach a total of 25, consistent with its overall plan for 2021.

Olink intends to provide guidance for the full year 2022 when it reports fourth quarter and full year 2021 earnings on February 14, 2022.

“2021 was a transformational year for Olink, including our successful IPO, strong execution of the next phase of our corporate plan, and the achievement of numerous milestones,” said Jon Heimer, CEO. “This tremendous progress, and our strong competitive position, would not have been possible without the talent and determination of the entire Olink team.”

Fourth quarter and full year 2021 results conference call
Olink expects to report its full unaudited financial results for the full year 2021 before the market open on Monday, February 14, 2022. Company management will host a conference call to discuss financial results at 8:00 am ET. Investors interested in listening to the conference call may do so by dialing (833) 562-0120 for domestic callers or (661) 567-1096 for international callers, followed by Conference ID: 5159949. A live webcast of the conference call will be available on the “Investors” section of the Company's website at https://investors.olink.com/investor-relations. The webcast will be archived and available for replay for at least 90 days after the event.

Virtual presentation at the 40th Annual J.P. Morgan Healthcare Conference
Jon Heimer, CEO, will give a virtual presentation at 9:00 am ET on Wednesday, January 12, 2022, at the 40th annual J.P. Morgan Healthcare Conference. A live and archived webcast of the event will be available on the “Events” section of the Company’s website at https://investors.olink.com/news-events/events.

https://finance.yahoo.com/news/olink-announces-preliminary-unaudited-revenue-130000841.html

Biotechs weak despite JP Morgan focus

The bloodbath continued for biotech stocks Monday as the J.P. Morgan Healthcare Conference kicked off with massive deals for Pfizer (PFE) and Bayer (BAYRY).

Pfizer is teaming up with Beam Therapeutics (BEAM), Codex DNA (DNAY) and Acuitas Therapeutics. The partnerships are around base editing — a new form of gene editing — and messenger RNA. Meanwhile, Bayer said it would partner with Mammoth Biosciences to study gene-editing approaches to liver diseases.

But the deals didn't spark biotech stocks. The SPDR S&P Biotech ETF (XBI) slipped 1.3% near 101.70, continuing a five-day decline. In fact, the only day the exchange-traded fund has gained in 2022 was on the first day of trading, Jan. 3.

Some of the biggest dives came for biotech stocks that beat fourth-quarter expectations.

Biotech Stocks: Preannouncements Mixed

Exelixis (EXEL) stock toppled 6.5% near 17.50 after the company pre-reported about $300 million in sales of its cancer treatment, Cabometyx. That narrowly beat forecasts for $298 million, RBC Capital Markets analyst Kennen MacKay said in a report to clients.

Full-year guidance for $1.325 billion to $1.425 billion in Cabometyx sales "straddles Street estimates for $1.4 billion and adds confidence to Cabo's growth trajectory after a commercially disappointing third-quarter and surprising 6% quarter-over-quarter decline from the second quarter," he said.

Still, the biotech stock dropped below its 50-day moving average, according to MarketSmith.com.

At the same time, Novocure (NVCR) tumbled 4.4% near 63.30. Novocure sells a wearable treatment for brain and lung cancers. Fourth-quarter growth was flat, but beat expectations at $133.2 million, Wedbush analyst David Nierengarten said in his note to clients.

Blueprint Medicines (BPMC) disappointed biotech stock investors when it preannounced $20 million in quarterly sales of cancer drug Ayvakit. Leerink analyst Andrew Berens says the Street called for $27 million. The news put the biotech stock at its lowest point since August, down 5.6% near 86.30.

Allogene (ALLO) shares are fell 12% near 11.90 after the Food and Drug Administration gave it permission to restart its cancer studies. The company is editing donated cells, directing them to fight cancer, before infusing them into patients.

The news should have been bullish for the biotech stock, but shares hit a record low.

Biocryst Shares Rocket

One notable divergence in the biotech stock pattern was from Biocryst Pharmaceuticals (BCRX). Shares retook their 200-day line after sales of the company's drug, Orladeyo, beat expectations. Biocryst pre-reported $45.6 million in fourth quarter sales. Biocryst stock soared 21.2% near 14.

In 2022, the company expects "no less than $250 million" in sales of Orladeyo, a hereditary angioedema drug. Hereditary angioedema is a swelling disorder. Peak sales are now expected to be $1 billion, Piper Sandler analyst Christopher Raymond said in a report.

He has an overweight rating on the biotech stock.

https://www.investors.com/news/technology/biotech-stocks-the-bloodbath-continues-despite-gene-editing-deals-for-pfizer-bayer/

Alnylam prelims, update

 Achieved Full Year 2021 Preliminary Global Net Product Revenues of $662 Million, Representing 83% Annual Growth Compared to 2020 –

– Maintained Strong Balance Sheet with Year-End Cash and Investments Balance of Approximately $2.4 Billion –

-Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced its preliminary* fourth quarter and full year 2021 global net product revenues for ONPATTRO, GIVLAARI and OXLUMO and provided additional updates on the products’ commercial launches.

2021 Preliminary Commercial and Financial Performance*

ONPATTRO® (patisiran), a commercial-stage RNAi therapeutic targeting transthyretin (TTR) for the treatment of polyneuropathy in adult patients with hATTR amyloidosis.

  • Preliminary global net product revenues for the fourth quarter and full year 2021 were approximately $139 million and $475 million, respectively, representing quarterly and annual growth of 15% and 55% compared to Q3 2021 and full year 2020, respectively.

  • As of year-end 2021, over 2,050 patients worldwide were receiving commercial ONPATTRO.

GIVLAARI® (givosiran), a commercial-stage RNAi therapeutic for the treatment of adults with acute hepatic porphyria (AHP).

  • Preliminary global net product revenues for the fourth quarter and full year 2021 were approximately $41 million and $128 million, respectively, representing quarterly and annual growth of 28% and 132% compared to Q3 2021 and full year 2020, respectively.

  • As of year-end 2021, over 350 patients worldwide were receiving commercial GIVLAARI.

OXLUMO® (lumasiran), a commercial-stage RNAi therapeutic for the treatment of primary hyperoxaluria type 1 to lower urinary oxalate levels in pediatric and adult patients.

  • Preliminary global net product revenues for the fourth quarter and full year 2021 were approximately $19 million and $60 million, respectively, representing quarterly growth of 29% compared to Q3 2021.

  • As of year-end 2021, over 140 patients worldwide were receiving commercial OXLUMO.

Finally, the Company today reported that it expects its full year 2021 non-GAAP operating loss to be substantially improved relative to the prior year, as the Company continues to transition toward a self-sustainable financial profile.

Further, at December 31, 2021, Alnylam had preliminary cash, cash equivalents, and marketable securities of approximately $2.4 billion, as compared to $1.9 billion at December 31, 2020.

"We are pleased to have closed out 2021 on a very strong note with continued execution across our commercial portfolio, delivering top-line revenue at the upper end of our guidance range. These preliminary results reflect the dedication of our teams to deliver these important medicines to patients in need around the world, despite the variable dynamics posed by the ongoing pandemic. We’re also excited to have ended the year with Leqvio, partnered with Novartis, becoming the fourth RNAi therapeutic approved in the U.S., and the first indicated to treat a major risk factor for a highly prevalent disease," said Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam. "Furthermore, as we reflect upon the one year anniversary of the announcement of our Alnylam P5x25 strategy, we believe we are well on our way to achieving or potentially exceeding these ambitious goals, positioning Alnylam as a top-tier, global, multi-product commercial company with a broad pipeline and organic platform poised to deliver sustainable innovation well into the future, a profile rarely seen in our industry."

Alnylam management will discuss these preliminary selected financial results and commercial updates during a webcast presentation at the 40th Annual J.P. Morgan Healthcare Conference, being held virtually, tomorrow, Monday, January 10, 2022 at 9:45 am ET.

https://finance.yahoo.com/news/alnylam-announces-preliminary-fourth-quarter-180000610.html