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Monday, February 1, 2021

Robust spike antibody responses, increased reactogenicity in seropositive individuals after single dose of SARS-CoV-2 mRNA vax

 Florian Krammer1$, Komal Srivastava1 , the PARIS team1*, and Viviana Simon1,2,3

 doi: https://doi.org/10.1101/2021.01.29.21250653

Abstract 

An important question is arising as COVID-19 vaccines are getting rolled out: Should individuals who already had a SARS-CoV-2 infection receive one or two shots of the currently authorized mRNA vaccines. In this short report, we show that the antibody response to the first vaccine dose in individuals with pre-existing immunity is equal to or even exceeds the titers found in naïve individuals after the second dose. We also show that the reactogenicity is significantly higher in individuals who have been infected with SARS-CoV-2 in the past. Changing the policy to give these individuals only one dose of vaccine would not negatively impact on their antibody titers, spare them from unnecessary pain and free up many urgently needed vaccine doses.

https://www.medrxiv.org/content/10.1101/2021.01.29.21250653v1.full.pdf

Single Dose Vaccination in Healthcare Workers Previously Infected with SARS-CoV-2

 Saman Saadat, 

Zahra Rikhtegaran-TehraniJames LogueMichelle NewmanMatthew B FriemanAnthony D. HarrisMohammad M. Sajadi

Fresenius sees significant negative impact on 2021 net income due to Covid impact

 Fresenius Medical Care AG & Co. KGaA anticipates significant negative impact on 2021 net income due to accelerated

impact of Covid-19 related excess mortality on its patient population 
Based on preliminary numbers Fresenius Medical Care confirms achievement of its 2020 financial targets, with net income 
(attributable to shareholders of Fresenius Medical Care AG & Co. KGaA) slightly above the top end of the target range. 
Earnings development was impacted negatively in Q4 by an impairment in the Latin America segment of approximately EUR 
195 million, which is treated as a special item. 
Fresenius Medical Care hereby informs the market early on its indicative preliminary assumptions for the development of 
the net income in fiscal year 2021. 
The significant acceleration in November and December 2020 of Covid-19 related patient excess mortality is expected to 
continue into 2021. In addition, the Company anticipates the associated cost for safety measures for patients and 
employees to remain at a high level. Fresenius Medical Care continues to monitor the further development of mortality, 
the adoption and speed of roll out of vaccinations as well as government relief measures and to closely evaluate 
opportunities to adjust its cost base. 
Against this backdrop, Fresenius Medical Care anticipates, based on early indications and before special items, such as 
potential restructuring measures, and on a constant currency basis, revenue growth of up to mid-single digits and 
assumes net income (attributable to shareholders of Fresenius Medical Care AG & Co. KGaA) to decline by up to 25 
percent. 
https://www.marketscreener.com/quote/stock/FRESENIUS-MEDICAL-CARE-AG-436087/news/DGAP-Adhoc-Fresenius-Medical-Care-AG-Co-KGaA-anticipates-significant-negative-impact-on-2021-ne-32330261/

Vertex 4Q Results Beat Expectations, Driven by Cystic Fibrosis Business

 Vertex Pharmaceuticals Inc. reported higher profit and revenue for the quarter and year ended in December, driven by strong results from its cystic fibrosis business.

PROFIT: Net income for the quarter rose to $604.2 million from $583.2 million a year earlier. On a per-share basis, profit rose to $2.30 from $2.23. On an adjusted basis, the profit rose to $2.51 a share. Analysts surveyed by FactSet expected $2.21 a share, or $2.57 a share on an adjusted basis.

REVENUE: Total revenue for the quarter rose to $1.63 billion from $1.41 billion a year earlier.

YEAR: The company ended the year with a profit of $2.71 billion on $6.21 billion in revenue, compared with a profit of $1.18 billion on $4.16 billion in revenue a year earlier.

OUTLOOK: This year, it expects $6.7 billion to $6.9 billion in product revenue.

CEO: Chief Executive Reshma Kewalramani said the company's 2020 performance was "marked by a significant increase in the number of people treated with the triple combination in the U.S. and the EU."

"It was also a year marked by meaningful pipeline advancement," Dr. Kewalramani said. "We now have clinical programs in seven disease areas, spanning multiple modalities including small molecules for alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases, gene editing for sickle cell disease and beta thalassemia, and cell therapy for type 1 diabetes."

https://www.marketscreener.com/quote/stock/VERTEX-PHARMACEUTICALS-11321/news/Vertex-Pharmaceuticals-4Q-Results-Beat-Expectations-Driven-by-Cystic-Fibrosis-Business-Earnin-32330085/

Moderna Analyst: Unrealistic COVID Vax Expectations Shape Unfavorable Setup

 Coronavirus vaccine developer Moderna Inc's 

MRNA 9.06% stock was moving lower Monday after a downgrade from BofA Securities. 

The Moderna Analyst: Geoff Meacham downgraded Moderna shares from Neutral to Underperform and maintained a $150 price target.

The Moderna Thesis: Moderna shares have seen an extended rally, rising 425% in 2020 and an incremental 66% year-to-date, Meacham said in a Monday note.

The shares have now catapulted to levels that are increasingly difficult to justify on a fundamental basis, the analyst said. 

The gains have come despite rival vaccine candidates from Novavax, Inc. NVAX 21.44% and Johnson & Johnson JNJ 0.25% moving toward approval by the FDA in the near term, he said.

The Moderna and Pfizer Inc. PFE 0.24%-BioNTech SE – ADR BNTX 0.72% vaccines may have best-in-class efficacy, but the volume and lower price points from Novavax, J&J, AstraZeneca plc AZN 0.4% and others will likely affect cumulative sales expectations for Moderna, Meacham said. 


For supporting a valuation over $180, Moderna should generate more than $85 million in cumulative COVID-19 vaccine sales, the analyst said, adding that this is reflected in the share price at current levels.

BofA's $150 price target already implies significant mRNA-1273 upside at $47 billion over the next 10 years, concentrated primarily in 2021-2023, he said. 

Additionally, consensus expectations for Moderna's vaccine sales are unrealistic, Meacham said. 

"These factors, together with a pipeline that is still too early to compensate for declining vaccine sales (CMV launch in 2024e), creates an unfavorable setup for MRNA shares." 

https://www.benzinga.com/analyst-ratings/analyst-color/21/02/19423561/moderna-analyst-unrealistic-covid-19-vaccine-expectations-create-unfavorable-setup

Short squeeze fuels new stock-market services tracking Reddit messages

 Day traders are credited with sparking a revolution on Wall Street, helping to juice the shares of GameStop Corp. GME, -30.77% and AMC Entertainment Holdings AMC, +0.83% and rattling the foundation of segments of the hedge-fund industry in the process.

Now, a group of data providers are wagering that financial markets will never be the same again and that deep-pocketed investors will shell out big bucks to monitor discussions on message boards like Reddit’s r/wallstreetbets and social-media platforms like Discord for mentions of publicly traded companies.

“ We believe this is a kind of watershed moment and perhaps irreversible,” Boris Spiwak, director of marketing at alternative data company Thinknum told MarketWatch in a Monday interview. Thinknum’s plans were mentioned in a Barrron’s article over the weekend.

Spiwak said that he envisions clients that use the services of companies like Thinknum as a way to not only profit from chatter on social-media platforms but also as a form of crisis management, as klatches of individual investors gather on platforms to coalesce around investing ideas.

“This is very new and we see it as a crisis-management purchase, as an insurance policy, and a way to increase returns and minimize losses,” for clients he said.

Thinknum’s service, which kicked off last week, is one of the most expensive that it offers to clients, costing just under $25,000 a year, to track the number of times New York Stock Exchange-listed companies, and those on the Nasdaq, are called out on sites like r/wallstreetbets or other Reddit sub-reddits.

“Demand has been massive — we’ve received over 100 inbound requests from hedge funds in the last few days,” wrote the Thinknum marketing director.

Thus far the interest in these pricey products come from fund managers but the company says it also is fielding inquiries from institutional investors looking for “an insurance policy to protect themselves from Reddit.”

The moves by the alternative data company come as videogame retailer GameStop and other companies, like movie chain AMC Entertainment and headphone maker Koss Corp. KOSS, -45.31%, have experienced a parabolic run-up in share values over a short period as investors congregating on sites like Reddit’s r/wallstreetbets, poured millions into heavily shorted companies to spark a rally in those shares.

The recent advance in heavily shorted shares targeted by the army of individual investors appeared to be causing pain for hedge funds.

Melvin Capital Management, one of the hedge funds seen at the center of the kerfuffle over GameStop, lost 53% on its investments in January, The Wall Street Journal wrote, citing people familiar. WSJ also said that another hedge fund Maplelane Capital ended January with a roughly 45% loss.  

Meanwhile, Andrew Left, founder of Citron Research, last Friday, a famed short seller, altered his strategy, saying that his firm would no longer be publishing short selling reports. Left was seen drawing the ire of individual investors for his negative views on GameStop — a bricks-and-mortar retailer that he says was worth only around $20 in the midst of a growing shift of digital videogame sales.

“Young people want to buy stocks. That’s the zeitgeist,” said Left about his decision to exit the business of identifying companies that he thinks are overvalued and announcing publicly that he ‘s betting its shares will sink.

“They don’t want to short stocks, so I’m going to help them buy stocks,” Left said of his focus on long investing.

Other companies, including SimilarWeb are also trying to promote tools for investors to track investing and discussions on popular social-media sites and on some of popular trading platforms.

SimilarWeb says that it can track searches for stock ticker symbols among users of the mobile app and desktop users on Robinhood Markets platform, for example. SimilarWeb says that search activity can be indicative of actual trading and can help clients identify trends early, according to Ed Lavery, director of investor solutions at SimilarWeb.

“Demand for data on retail trading platforms has surged,” Lavery told MarketWatch in a phone interview Monday afternoon.

Lavery said the estimated data on search that SimilarWeb offers has been something that the company has been tracking for years but had only been solicited by clients in recent days. He said Similar has similar data on Charles Schwab SCHW, +3.53% and E-Trade Financial but Robinhood has drawn the most interest among its users.

“ Robinhood as a platform is making more noise,” he said.

SESAMm, which bills itself as one of the leading providers of analytics and artificial intelligence for investment professionals, also had either developed or was working on services that could help identify social-media trends, said Spiwak.

SESAMm, which recently scored some 7.5 million in venture-capital funding from NewAlpha Asset Management and global investment firm The Carlyle Group, didn’t immediately return an email for comment.

To be sure, other services attempt to offer such insights on investing trends on social media free. Those include poolsapp.com and Unbiastock.com.

Meanwhile, the liquidation of profitable long positions by hedge funds and other investors who needed cash to cover losses on losing short positions has been blamed for the Dow Jones Industrial Average DJIA, +0.76%, the S&P 500 index SPX, +1.61% and the Nasdaq Composite Index COMP, +2.55% registering their worst weekly losses since October last Friday.

Markets were attempting to claw back from those losses early Monday, kicking off what is likely to be a turbulent February.

https://www.marketwatch.com/story/gamestop-short-squeeze-fuels-new-stock-market-services-tracking-reddit-messages-11612203740

Adamas: FDA OKs 2nd indication for Gocovri in Parkinson's

- GOCOVRI is now the first and only medication approved to treat OFF and dyskinesia motor complications -

- Adamas to host webcast conference call today at 4:30 pm ET/1:30 pm PT -

Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced it has received marketing authorization from the U.S. Food and Drug Administration (FDA) for a supplemental New Drug Application for GOCOVRI® (amantadine) extended release capsules, gaining a second indication for the product. GOCOVRI is now approved as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes, in addition to its indication for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.

https://finance.yahoo.com/news/adamas-announces-fda-approval-second-190700002.html