FT : Sanofi to start human trials of mRNA vaccine against Covid-19

Sanofi to start human trials of mRNA vaccine against Covid-19
French group has fallen behind newcomers despite being one of the biggest jab makers in world


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Sanofi will start human trials for the second Covid-19 vaccine it has in development as it races to try to catch up with rival groups that have beaten it to market during the pandemic.

The French pharmaceuticals group, which was the third-biggest vaccine maker by sales in the world last year behind GlaxoSmithKline and Merck, has been working on the vaccine, based on so-called mRNA technology, in partnership with US group Translate Bio.

Sanofi said in a statement on Friday that its clinical study of 415 adults would evaluate the safety, side effects and best dose of the experimental vaccine. Initial results are expected in the third quarter.

Two mRNA vaccines are already on the market, made by upstart newcomers BioNTech and Moderna. Experts believe that the new technology could reshape the vaccine industry for years to come. 

The stakes are high for Sanofi, led by Paul Hudson, chief executive, as it seeks to claw itself back into the Covid-19 vaccine race. It wants to win a slice of a market that analysts expect will be lucrative given that Covid-19 vaccines will probably need to be taken every year, as with flu.

Sanofi had prioritised another Covid-19 vaccine last year that it had in the works with GSK and was based on a more traditional use of recombinant-protein.

But the companies are having to repeat an early-stage trial after a dosing mistake wrecked its original test. The setback meant they would not meet their original goal of producing 1bn doses of that vaccine in 2021. They now hope to secure approval by the fourth quarter.

Analysts have estimated that the Covid-19 vaccine market could be worth $10bn a year once the pandemic subsides. Sanofi could still seize a part of that even if it arrives later than competitors.

Pfizer has said it expects $15bn revenue from its Covid-19 jab this year, while Moderna predicted that it would bring in $18.4bn.

The arrival of variants of the virus is also likely to mean that people will need booster shots, which companies are already starting to work on.

Sanofi and Translate Bio said they were also beginning separate early-stage studies on other mRNA vaccine candidates against the new variants of Sars-Cov-2. BioNTech/Pfizer and Moderna are doing similar work.

In France, Sanofi’s inability to bring a jab to market as quickly as rivals has been cast by politicians and some academics as a national failure that shows how much its research and innovation have fallen behind other countries.

Another French effort came to nothing in January when a Covid-19 vaccine out of the Pasteur Institute, which was later licensed to Merck, also failed in clinical trials.

“Our mRNA vaccine candidate is the result of our expertise in infectious diseases coupled with the innovative technologies of our partner,” said Thomas Triomphe, Sanofi’s head of vaccines.

“Initiating the Phase 1/2 trial represents an important step forward in our goal of bringing another effective vaccine to the ongoing fight against the Covid-19 pandemic.”

>>> Denver Prepares For Biggest Snowstorm In More Than Century

Denver Prepares For Biggest Snowstorm In More Than Century

While much of the country has experienced warmer temperatures this week (something we outlined here & here), a much-needed change from last month's polar vortex blast that nearly collapsed Texas' power grid, a monster storm could strike Denver and surrounding areas this weekend.
AccuWeather meteorologists continue to track the weekend winter storm, making its rounds in southern California mid-week and set to arrive in southern Colorado late Friday and dump snow across the state through late Sunday or early Monday morning.
"The looming storm threatens to be a long-duration event that could result in snowfall totals that could reach 2 feet in Denver and pile as high as 3 feet in places west of Denver, such as Boulder and Fort Collins. Heavy snow will stretch north into Wyoming as well," meteorologists said.
AccuWeather Chief Meteorologist Bernie Rayno said the snowstorm could "eclipse the seasonal total in one storm." He said, "Denver has received 34.1 inches for the season to date. The storm has the potential to rank among the biggest on record in Denver."
Winter weather advisories have already been posted across Colorado.
While Southwest, Midwest, Southeast, Mid-Atlantic, and Northeast regions are experiencing warmer temperatures this week, cooler weather may arrive later this weekend into early next week.

FT : Renault to sell Daimler stake for €1.2bn

Renault to sell Daimler stake for €1.2bn
Carmakers will continue to work on vans and engines together

Renault is selling its entire stake in Germany’s Daimler as it looks to pay off debt and bolster its finances to weather the pandemic.

The French carmaker said on Thursday it would sell its 1.5 per cent stake in Stuttgart-based Daimler, bringing in close to €1.2bn, based on the closing share price.

With the pandemic slashing demand for cars and a global chip shortage hitting the sector, Renault fell to a record €8bn loss last year.

Renault said the cash would allow it “to accelerate the financial deleveraging of its automotive activity”. Prior to the sale, the company had €3.6bn of net debt, compared with €1.7bn of net cash in 2019.

But it stressed its industrial partnership with Daimler “remains unchanged and is not impacted”.

Earlier this year new chief executive Luca de Meo, who joined the business in July, cited selling the Daimler stake as one of the options for the company when looking to raise money, saying there were “no taboos”.

He told the FT in January he would only look to sell the stake “if I have the opportunity to allocate that money in a place with triple the benefit”.

The stake in Daimler was built up in 2010 under the leadership of Carlos Ghosn as part of a strategic partnership between Renault, Nissan and Daimler that involved swapping equity positions and some collaboration on vehicle development.

Currently, Renault and Daimler collaborate on some vans and engine projects.

Separately, as part of its alliance with Nissan, Renault holds a 43 per cent stake in the Japanese carmaker. Nissan holds a 15 per cent stake in the French group. 

That alliance remains intact but it came under intense strain since the arrest of alliance-boss Ghosn in Japan in 2018, which exposed tensions between the two carmakers and meant Renault entered the pandemic in a precarious state.

Renault took on a €5bn state-backed loan to get through the crisis. And in an effort to right the company, De Meo is reducing factory capacity by a quarter, deepening cost cuts to €3bn by 2025, including 15,000 job cuts, and overhauling its brands in a turnround plan aimed at reviving its fortunes.

>>> US After Hours Summary: FNKO +10%, MTN +10% gain while POSH -15% declines on

After Hours Summary: FNKO +10%, MTN +10% gain while POSH -15% declines on earnings/guidance

After Hours Gainers:

Companies trading higher in after hours in reaction to earnings/guidance: FNKO +9.8%, MTN +9.7%, DOMO +6.1%, MVIS +5.5%, TLYS +3.5%, MSP +1.9%

Companies trading higher in after hours in reaction to news: CFRX +43.3% (awarded BARDA contract for up to $86.8 mln), NVAX +21.6% (reported efficacy data for NVX-CoV2373 against original and variant COVID-19 strains), LSPD +6.9% (agreed to acquire Vend for approx. $350 mln), CLA +2.6% (closed combination with Ouster), TMUS +0.8% (provided Analyst Day highlights; updated mid- and long-term targets)

After Hours Losers:

Companies trading lower in after hours in reaction to earnings/guidance: POSH -14.8%, SLGG -9.8%, CMTL -6.7%, ULTA -6.6% (also announced CEO transition), PBPB -4.2%, GDRX -4.1%, DOCU -4.1%, STNE -3.8%, CHPT -3.1%, ZUO -2.0%, WPM -1.7% (also increased quarterly dividend)

Companies trading lower in after hours in reaction to news: MRKR -21.7% (stock offering), POWW -11.9% (stock offering), MANU -1.8% (announced offering of 5.0 mln Class A ordinary shares by selling shareholder)

>>> US Close Dow +0.58% S&P +1.04% Nasdaq +2.52% Russell +2.31%

Closing Stock Market Summary

The S&P 500 (+1.0%), Dow Jones Industrial Average (+0.6%), and Russell 2000 (+2.3%) set intraday and closing record highs on Thursday. The Nasdaq Composite (+2.5%) played catch-up with a 2.5% gain, as the mega-cap/growth stocks found renewed buying interest. 

The session started on a high note in a momentum trade, with the Dow quickly notching its fourth all-time high in four days and the broader market attracting follow through from buyers amid a fear of missing out on further gains. Today was the first closing record high for the S&P 500 since Feb. 12, thanks to an impressive 5.6% rally off last Friday's session low. 

The information technology (+2.1%), communication services (+1.8%), and consumer discretionary (+1.6%) sectors, which contain many of the recently-battered mega-caps and growth stocks, did the heavy lifting. The bullish bias, however, did lose steam in the afternoon, with selling interest leaking into the financials (-0.3%), utilities (-0.3%), and consumer staples (-0.2%) sectors. 

Nonetheless, there were some positive-sounding news events that supported risk sentiment.

Briefly, President Biden signed the $1.9 trillion stimulus bill one day earlier than expected, allowing some payments to reach bank accounts as soon as this weekend; weekly initial claims decreased by 42,000 to 712,000 (Briefing.com consensus 725,000); and the ECB said it expects to conduct asset purchases at a significantly higher pace over the next quarter than during the first months of this year.

Longer-dated Treasury yields continued to climb off overnight lows following the ECB statement before leveling off during the trading session, which included a $24 billion 30-yr bond reopening auction that was met with tepid demand. It was good enough for stocks, though, just like the 3-yr note and 10-yr note auctions earlier this week.

The 10-yr yield increased one basis point to 1.53% after touching 1.48% at its low and 1.55% at its high, while the 2-yr yield decreased two basis points to 0.13%. The U.S. Dollar Index decreased 0.5% to 91.37. WTI crude futures rose 2.4%, or $1.57, to $66.02/bbl.

Separately, Oracle (ORCL 67.44, -4.68, -6.5%) and General Electric (GE 12.27, -0.98, -7.4%) were eyesores on this record-setting day. Oracle underwhelmed investors with its earnings report and guidance. GE was downgraded to Perform from Outperform at Oppenheimer.

Reviewing Thursday's economic data:

  • Initial jobless claims for the week ending March 6 decreased by 42,000 to 712,000 ( consensus 725,000), which is the lowest level of claims since the first week of last November. Continuing claims for the week ending February 27 decreased by 193,000 to 4.144 million.
    • The key takeaway from the initial jobless claims data is that initial claims are still high, but at least they are moving in a direction that suggests the economy is finding its growth stride again. To wit, in the first week of January, initial jobless claims were 927,000.
  • Job openings increased to 6.917 million in January from a revised 6.752 million in December (from 6.646 million).

Looking ahead, investors will receive the Producer Price Index for February and the preliminary University of Michigan Index of Consumer Sentiment for March on Friday.

  • Russell 2000 +18.4% YTD
  • Dow Jones Industrial Average +6.1% YTD
  • S&P 500 +4.9% YTD
  • Nasdaq Composite +4.0% YTD

>>> US Gapping down

Gapping down
In reaction to earnings/guidance
:

  • ALTO -15.7%, CLDR -6.7%, SUMO -5.4%, BEST -5.1%, ORCL -5%, MYE -4.1%, TALO -3.9%, LC -3.5%, TTCF -3.1%, SCWX -3%, OPCH -1.9%, AVO -1%

Other news:

  • JE -13.1% (TSX and NYSE commence delisting proceedings)
  • NVEE -11.9% (stock offering)
  • KDMN -9.8% (FDA extends review period for belumosudil for the treatment of cGVHD)
  • HESM -7.4% (prices offering of 6 mln Class A shares at $21.00 per share)
  • IVC -7.1% (convertible senior notes offering)
  • GLSI -3.7% (provides updates on upcoming presentations)
  • OSH -3.3% (convertible senior notes offering)
  • MGP -2.6% (prices offering of 19 mln shares of common stock at $32.15 per share)

Analyst comments:

  • GE -2% (downgraded to Perform from Outperform at Oppenheimer)
  • QSR -1.1% (downgraded to Market Perform from Outperform at Cowen)
  • AVO -1% (downgraded to Neutral from Overweight at JP Morgan)

>>> US Gapping up

Gapping up
In reaction to earnings/guidance
:

  • BMBL +9.7%, JD +6.3%, AMC +6.1%, ASAN +5.9%, GOGO +5.8%, SKLZ +4.9%, FNV +4.4%, KRO +4.4%, FSM +3.3%, BLDP +3.2%, GCO +3.2%, KYMR +2.9%, DCBO +2.8%, DGX +1.7%, GDS +1.1%

Other news:

  • VIR +61.9% (Vir Biotechnology and GSK reports VIR-7831 reduces hospitalization and risk of death in early treatment of adults with COVID-19)
  • OGI +41.5% (OrganiGram and BAT form product development collaboration -- includes strategic investment from BAT for 19.9% equity interest)
  • SPPI +27.4% (announces that the U.S. Food and Drug Administration has granted Fast Track designation for poziotinib for the treatment of non-small cell lung cancer in previously treated patients with HER2 exon 20 mutations)
  • AVEO +22.8% (continued momentum after receiving FDA approval for FOTIVDA)
  • SLGG +15.5% (announces the acquisition of Mobcrush)
  • GOEV +7.7% (introduces fully-electric pickup truck )
  • ALKS +6.8% (FDA grants orphan drug designation to nemvaleukin alfa (nemvaleukin, formerly referred to as ALKS 4230), for the treatment of mucosal melanoma)
  • BTAI +6.3% (submits NDA to FDA for BXCL501; also reported earnings)
  • MSGN +5.6% (weighing merger with MSG Entertainment [MSGE], per Bloomberg)
  • SPFR +4.3% (following report that co is weighing merger with Velo3D)
  • AXON +4.2% (Axon and drone manufacturer Skydio announce strategic partnership for law enforcement and emergency responders)
  • PLTR +4% (Palantir Technologies and Faurecia (FURCF) announce six-year partnership)
  • VCVC +3.9% (REE Automotive files Registration Statement on Form F-4 in connection with its proposed business combination with 10x Capital Venture Acquisition Corp)
  • SCOR +3.6% (announced an agreement to provide Ovation with Comscore's video-on-demand audience measurement)
  • BAND +3.2% (convertible senior notes offering)
  • ENFA +2.9% (in talks for merger with BuzzFeed, according to Bloomberg)
  • NUVB +2.9% (FDA grants orphan drug designation to NUV-422 for the treatment of patients with malignant gliomas)
  • CRIS +2.5% (announced abstract for CA-4948 accepted for presentation at AACR Annual Meeting)
  • SURF +2.5% (announced presentations at AACR Annual Meeting)
  • BNTX +2.2% (Pfizer and BioNTech (BNTX) confirm 97% vaccine effectiveness; data suggests PFE/BNTX vaccine is 94% effective against asymptomatic SARS-CoV-2 infections) RIGL +1.8% (completed patient enrollment in a multi-center Phase 2 clinical trial to evaluate the safety of fostamatinib for the treatment of hospitalized COVID-19 patients)
  • FI +1.6% (Frank's International and Expro to combine to create a leading full-cycle service provider)
  • RWT +1.4% (increased dividend)

Analyst comments:

  • CATB +17.2% (upgraded to Outperform from Perform at Oppenheimer)
  • ADT +4.8% (upgraded to Buy from Hold at Deutsche Bank)
  • MELI +4.4% (upgraded to Buy from Neutral at BTIG Research)
  • AER +4.3% (upgraded to Overweight from Equal-Weight at Stephens)
  • CWH +4.3% (upgraded to Outperform from Market Perform at BMO Capital Markets)
  • QRVO +3.8% (upgraded to Overweight from Equal Weight at Barclays)
  • DHI +2.3% (upgraded to Overweight from Neutral at JP Morgan)
  • APA +1.8% (upgraded to Overweight from Equal-Weight at Morgan Stanley)
  • COST +1.5% (upgraded to Overweight from Equal Weight at Wells Fargo)
  • OXY +1.5% (upgraded to Peer Perform from Underperform at Wolfe Research)

>>> US Early premarket gappers

Early premarket gappers

  • Gapping up:
    • VIR +55.6%, OGI +34.9%, SLGG +20.5%, BMBL +10.3%, AVEO +9.8%, AMC +9.6%, ASAN +8.6%, FOSL +7%, SPFR +6.7%, SKLZ +6.6%, ENFA +6.4%, GOEV +6.4%, FSM +6.3%, JD +6.3%, MSGN +4.5%, BLDP +4.3%, SURF +3.5%, VLDR +3.3%, BAND +3.3%, DCBO +2.8%, RWT +2.7%, CRIS +2.3%, FI +2%, MRNA +1.9%, MSGE +0.9%, BA +0.9%, CPA +0.9%, GDS +0.9%
  • Gapping down:
    • ALTO -14.6%, HESM -11.8%, NVEE -11.8%, JE -9.2%, KDMN -8.3%, IVC -7.2%, CLDR -6.7%, SMSI -6.3%, BEST -6%, ORCL -5.6%, GLSI -4.3%, TALO -4%, SUMO -3.9%, LC -3.5%, OSH -3.3%, MGP -2.8%, AVO -0.8%