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Sanofi (SNY)

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  • M
    Metal Ox
    $tbio Surprised appointment of $sny Sanofi exec did not move the share price needle. A positive development. Could signal tbio needs addtl exec to get organized, focused, or could signal higher level of coordination with Sanofi, or could hint at eventual buyout. In all cases positive. Anyone buying lots more on the news or is it more prudent to wait for stock to bottom and build new base?
  • T
    Tommy
    $RGRX conversation
    Can you believe I almost missed RGRX?

    $nvax $nakd $sndl $sny $regn $bcrx $sava $cmg
  • s
    siggy
    $AGEN conversation
    $GSK $SNY covid19 vaccine #fails in #elderly group
    62.5% in the >60 age group
    will reformulate now
    they will need $AGEN #QS21 NOW FINALY for it too
    $GSK said back then they choose AS03 over #AS01 (QS21 adjuvant) due to missing manufacturing capabilities

    December 11, 2020 01:00 ET | Source: Sanofi
    multilang-release

    Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly

    Phase 1/2 interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years
    Insufficient response in older adults demonstrates the need to refine the concentration of antigen in order to provide high-level immune response across all age groups
    Companies plan a Phase 2b study with an improved antigen formulation
    With support from BARDA as part of Operation Warp Speed, study to start in February 2021, including a proposed comparison with an authorized COVID-19 vaccine
    Product availability now expected in Q4 2021 pending successful completion of the development plan

    PARIS and LONDON – December 11, 2020 – Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults. Phase 1/2 study interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen.

    A recent challenge study in non-human primates performed with an improved antigen formulation demonstrated that the vaccine candidate could protect against lung pathology and lead to rapid viral clearance from the nasal passages and lungs, within 2 to 4 days. These results increase the Companies confidence in the capacity of the adjuvanted recombinant platform to deliver a highly efficient vaccine for all adults.

    Sanofi’s recombinant technology and GSK’s pandemic adjuvant are established vaccine platforms that have proven successful against influenza. The recombinant technology offers the advantages of stability at temperatures used for routine vaccines, the ability to generate high and sustained immune responses, and the potential to prevent virus transmission.

    “We care greatly about public health which is why we are disappointed by the delay announced today, but all our decisions are and will always be driven by science and data. We have identified the path forward and remain confident and committed to bringing a safe and efficacious COVID-19 vaccine. Following these results and the latest encouraging new preclinical data, we will now work to further optimize our candidate to achieve this goal,” said Thomas Triomphe, Executive Vice President and Head of Sanofi Pasteur. “No single pharma company can make it alone; the world needs more than one vaccine to fight the pandemic.”

    Roger Connor, President of GSK Vaccines added: “The results of the study are not as we hoped. Based on previous experience and other collaborations, we are confident that GSK’s pandemic adjuvant system, when coupled with a COVID-19 antigen, can elicit a robust immune response with an acceptable reactogenicity profile. It is also clear that multiple vaccines will be needed to contain the pandemic. Our aim now is to work closely with our partner Sanofi to develop this vaccine, with an improved antigen formulation, for it to make a meaningful contribution to preventing COVID-19.”

    The Companies plan a Phase 2b study expected to start in February 2021 with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) under contract W15QKN-16-9-1002. The study will include a proposed comparison with an authorized COVID-19 vaccine. If data are positive, a global Phase 3 study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.

    Sanofi and GSK adjuvanted recombinant protein-based vaccine candidate was selected in July 2020 by U.S. government’s Operation Warp Speed in order to accelerate its development and manufacturing.

    The Companies have updated Governments and the European Commission where a contractual commitment to purchase the vaccine has been made.

    Phase 1/2 study

    The interim Phase 1/2 results showed a level of neutralizing antibody titers after two doses comparable to sera from patients who recovered from COVID-19, a balanced cellular response in adults aged 18 to 49 years, but insufficient neutralizing antibody titers in adults over the age of 50. The candidate showed transient but higher than expected levels of reactogenicity likely due to the suboptimal antigen formulation, with no serious adverse events related to the vaccine candidate.....
  • M
    Momo
    $DVAX conversation
    $GSK $SNY covid19 vaccine #fails in #elderly group
    62.5% in the >60 age group
    Based on AS03 adjuvant ;-)

    December 11, 2020 01:00 ET | Source: Sanofi
    multilang-release

    Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly

    Phase 1/2 interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years
    Insufficient response in older adults demonstrates the need to refine the concentration of antigen in order to provide high-level immune response across all age groups
    Companies plan a Phase 2b study with an improved antigen formulation
    With support from BARDA as part of Operation Warp Speed, study to start in February 2021, including a proposed comparison with an authorized COVID-19 vaccine
    Product availability now expected in Q4 2021 pending successful completion of the development plan

    PARIS and LONDON – December 11, 2020 – Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults. Phase 1/2 study interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen.

    A recent challenge study in non-human primates performed with an improved antigen formulation demonstrated that the vaccine candidate could protect against lung pathology and lead to rapid viral clearance from the nasal passages and lungs, within 2 to 4 days. These results increase the Companies confidence in the capacity of the adjuvanted recombinant platform to deliver a highly efficient vaccine for all adults.

    Sanofi’s recombinant technology and GSK’s pandemic adjuvant are established vaccine platforms that have proven successful against influenza. The recombinant technology offers the advantages of stability at temperatures used for routine vaccines, the ability to generate high and sustained immune responses, and the potential to prevent virus transmission.

    “We care greatly about public health which is why we are disappointed by the delay announced today, but all our decisions are and will always be driven by science and data. We have identified the path forward and remain confident and committed to bringing a safe and efficacious COVID-19 vaccine. Following these results and the latest encouraging new preclinical data, we will now work to further optimize our candidate to achieve this goal,” said Thomas Triomphe, Executive Vice President and Head of Sanofi Pasteur. “No single pharma company can make it alone; the world needs more than one vaccine to fight the pandemic.”

    Roger Connor, President of GSK Vaccines added: “The results of the study are not as we hoped. Based on previous experience and other collaborations, we are confident that GSK’s pandemic adjuvant system, when coupled with a COVID-19 antigen, can elicit a robust immune response with an acceptable reactogenicity profile. It is also clear that multiple vaccines will be needed to contain the pandemic. Our aim now is to work closely with our partner Sanofi to develop this vaccine, with an improved antigen formulation, for it to make a meaningful contribution to preventing COVID-19.”

    The Companies plan a Phase 2b study expected to start in February 2021 with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) under contract W15QKN-16-9-1002. The study will include a proposed comparison with an authorized COVID-19 vaccine. If data are positive, a global Phase 3 study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.

    Sanofi and GSK adjuvanted recombinant protein-based vaccine candidate was selected in July 2020 by U.S. government’s Operation Warp Speed in order to accelerate its development and manufacturing.

    The Companies have updated Governments and the European Commission where a contractual commitment to purchase the vaccine has been made.

    Phase 1/2 study

    The interim Phase 1/2 results showed a level of neutralizing antibody titers after two doses comparable to sera from patients who recovered from COVID-19, a balanced cellular response in adults aged 18 to 49 years, but insufficient neutralizing antibody titers in adults over the age of 50. The candidate showed transient but higher than expected levels of reactogenicity likely due to the suboptimal antigen formulation, with no serious adverse events related to the vaccine candidate.....
  • D
    DaveM
    $CODX conversation
    Please IGNORE the lawsuits posted on yahoo...they have no merit and should not have effect on CODX...been through all this with INO...do your due diligence and read up on INO message board
    THE MESSAGE
    Citron Research Analyst made a Short-Selling SEC 72 Hour news or subjective comment and brought huge block-trade short-selling traders, alert that the SEC should have halted all Short-Sellers, because of the Twitter Tweet can be considered a volatile statement, in that, the legal class action suits should have been filed against Citron Research for their false claims made against Inovio $INO, in a deliberate act of causing significant shareholder losses due to their Tweet sent, March 9, 2020.
    By James Gornick
    Wednesday, April 22, 2020 11:10 AM EDT
    Currently, we have price targets for $INO PT’s near-term and long-term. The near-term PT is $37-$48 dollars a share. The longer-term price-target is between $72 - $98 dollars a share in the 2020-2021 fiscal reporting quarters. We make these PT’s based on Inovio huge pipeline of candidates for FDA approvals over these next two years or less.
    FURTHER FACTS AGANIST CITRON AND FILED CLASS-ACTION EFFORTS
    Where are the Twitter Tweets of the law firms filing or that Citron subjective feelings on the GlaxoSmithKline and Sanofi? They are certainly missing their Tweets on $GSK and $SNY as maybe a short-selling candidate’s as Citron had chosen Inovio $INO in their development of a vaccine in a 3 hour start-up period. Remember, INO-4700 was already in active Phase 1 / 2 trials during Summer 2019. The tweaking and following FDA guidelines as well as W.H.O.guidlines with INO-4800 before applying for FDA approvals as clearly stated by Dr. Kim, CEO of Inovio Pharmaceuticals. Make no mistake, we still don't agree with the further delusion of shareholder value by the newest agreement by Inovio and Stifel Nicholas 150 million share offer but know they can use these proceeds for bringing their robust drug pipeline to final market with FDA approvals.
    WHAT'S THE FINAL TRADING MESSAGE
    Time to send the message for the Institutional Investors to run back into ownership--long positions, and bring the bullish goring of the short-selling bears on $INO to break their trading funds within their banks...
  • n
    nito
    $NVAX conversation
    Remarks by President Trump and Members of the Coronavirus Task Force in Meeting with Pharmaceutical Companies $PFE, $GILD, $MRNA, $REGN, $SNY, $GSK
    MR. ERCK: Mr. President, Mr. Vice President, thank you for saving the most exciting company for the last. (Laughter.) So we’re Novavax. We’re down the street in Maryland. We’re a vaccine company. We make the recombinant nanoparticles. We make respiratory vaccines. We have two in phase three trials. We have an RSV vaccine, where we vaccinated 4,600 pregnant women to protect infants from RSV disease and the youngest kids.

    We have a flu vaccine. We all know we need a better flu vaccine and we have one in phase three trials. We’re going to unblind in four weeks. It’s an exciting time for the company.

    But we actually — our company is focused on emerging infectious diseases. We’ve made two coronavirus vaccines. We made one for SARS. We made one for MERS. We tested MERS and — all the way through animal challenge trials and it showed 100 percent infection protection.

    We have an Ebola vaccine that what the NIH showed, in four different nonhuman primate studies, that we had 100 percent protection at extremely low doses.

    And we’ve made a pandemic flu vaccine for H7 and 9 and others. And we’ve twice now taken from the gene sequence to the first in human studies done in the 90 days and published it in the New England Journal. And we’re once again doing the same thing since the gene sequence was identified — I think it published on January 10th. We’ve taken the same recombinant nanoparticle platform and have been in animal studies for a couple of weeks. We expect data this week on — from one of them.

    THE PRESIDENT: On this? On corona?

    MR. ERCK: And on this — I’m sorry, on corona. Yes. And we’re going to the nonhuman primates this week with the coronavirus vaccine candidate.

    THE PRESIDENT: So what do you think in terms of timing? What do you do think?

    MR. ERCK: Timing is — what you hear around the table. As soon as we can get it to humans in the May-June timetable and in phase one study (inaudible) but we’ll have primate data.

    THE PRESIDENT: So those are unheard of speeds, I think. Right? Pretty much. We’ll make it very easy for you. Those are — and we have to be very safe. But those are unheard of speeds.

    Go ahead, please.

    MR. ERCK: No, and we’re trying to identify scale so that we can get to the billion (inaudible) scale both for — we have the vaccine antigen and adjuvant. And you put those together and you get the most promising result, we think. And so we desperately need and have good relationships with the FDA and to work with the FDA to see where, instead of waiting 30 days, for — to get to an IND, you get in 10 days or 21 — whatever the number is. But there are a lot of things that we can do with the FDA.

    And, frankly, we need money. We’re a biotech company, and not one of the larger pharma companies. And so we need money to get scale.

    THE PRESIDENT: But you work with the other companies also?

    MR. ERCK: And we have worked with the other companies and on this particular instance, we have not yet. But we can.
    https://www.whitehouse.gov/briefings-statements/remarks-president-trump-members-coronavirus-task-force-meeting-pharmaceutical-companies/
    Cabinet Room 3:20 P.M. EST THE PRESIDENT: Well, thank you very much. Today, we are meeting with the pharmaceutical and biotechnology companies — the biggest in the world, most prestigious, the ones that get down to the bottom line very quickly — to
    Cabinet Room 3:20 P.M. EST THE PRESIDENT: Well, thank you very much. Today, we are meeting with the pharmaceutical and biotechnology companies — the biggest in the world, most prestigious, the ones that get down to the bottom line very quickly — to
    www.whitehouse.gov
  • M
    Martin
    $CYDY conversation
    So, folks, what are your bets for tonight 6:00 pm ET?
    1. leronlimab by $CYDY
    2. remstemcell-L/Ryoncil by $MESO
    3. aviptadil/VIP by $RLFTF
    4. anti-spike antibodies by $REGN
    5. anti-spike antibodies by $LLY
    6. oleandrin
    7. some vaccine ($MRNA, $NVAX, $AZN, $INO, $JNJ, $PFE, $SNY, $GSK)
    8. novel disinfectant
    9. something else

    https://www.republicworld.com/world-news/us-news/trump-to-hold-press-conference-to-discuss-therapeutic-breakthrough.html
    Trump will hold a press conference at around 6:00 pm ET on August 23 to discuss "a major therapeutic breakthrough" regarding COVID-19.
    Trump will hold a press conference at around 6:00 pm ET on August 23 to discuss "a major therapeutic breakthrough" regarding COVID-19.
    www.republicworld.com
  • n
    nito
    $SNY conversation
    Novavax’ NanoFlu Achieves All Primary Endpoints In Phase 3 Clinical Trial. $SNY, $PFE, $JNJ, $EBS, $AZN, $NVS, $GSK
    Trial also achieves statistical significance in key secondary endpoints
    Novavax to submit a U.S. BLA under FDA’s accelerated approval pathway
    Company to host investor conference call today at 8:30 a.m. EDT
    GAITHERSBURG, Md., March 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced positive top-line results of its pivotal Phase 3 clinical trial of NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant, in adults aged 65 and older. Using the Food and Drug Administration’s (FDA) criteria for accelerated approval of seasonal influenza vaccines, the trial evaluated the immunogenicity and safety of NanoFlu compared to Fluzone® Quadrivalent, a U.S.-licensed quadrivalent influenza vaccine.
    https://finance.yahoo.com/news/novavax-nanoflu-achieves-primary-endpoints-100010015.html
  • n
    nito
    $NVAX conversation
    Trump to Declare National Emergency to Speed Virus Response
    (Bloomberg) -- President Donald Trump plans to declare a national emergency on Friday over the coronavirus outbreak, invoking the Stafford Act to open the door to more federal aid for states and municipalities, according to two people familiar with the matter.

    The president said he will hold a news conference at 3 p.m. in Washington. Trump spoke Friday with Emmanuel Macron, the French president tweeted, about the pandemic, and agreed to organize a video conference with world leaders on Monday to coordinate research efforts on a vaccine and treatments and work on how to respond to the economic fallout....
    $INO, $GILD, $REGN, $SNY, $PFE
    https://www.yahoo.com/finance/news/trump-declare-national-emergency-speed-151931686.html
  • k
    ken.
    $MNKD conversation
    $sny and $nvo Don't sweat this actors acting before the house special committee on aging discussing diabetes research funding. Likely helps you. This video was published by mnkd. Since released 10 mos ago sales of poor selling Afrezza, that's not a substitute for long acting insulin and hasn't yet started FDA mandated 8-10K patient FDA, have continued their downward spiral. Since it's a mnkd video one must wonder what actor received to give the brief Afrezza bleeb that had nothing to do with focus of committee.

    Underwater mnkd pumpers are desperate and afraid.
    House of Cards actor, Paul Sparks, speaks to Congress on diabetes funding and makes mention of his experience with inhaled insulin. JDRF Children’s Congress ...
    House of Cards actor, Paul Sparks, speaks to Congress on diabetes funding and makes mention of his experience with inhaled insulin. JDRF Children’s Congress ...
    www.youtube.com
  • n
    nito
    $EBS conversation
    Emergent BioSolutions Inc. (EBS) announced today that it has entered into an agreement with Novavax, Inc. (NVAX) whereby Emergent will collaborate with Novavax, utilizing its molecule-to-market contract development and manufacturing (CDMO) services to support bringing into the clinic Novavax’s novel experimental vaccine candidate to protect against coronavirus disease (COVID-19). Under the terms of the agreement, Emergent will produce the COVID-19 experimental vaccine candidate, which is based on the proprietary recombinant protein nanoparticle technology platform of Novavax and utilizing their proprietary Matrix-M™ adjuvant to enhance immune responses. Emergent has initiated work for this program anticipating that the COVID-19 experimental vaccine candidate will be used in a Phase 1 clinical study within the next four months
    https://finance.yahoo.com/news/emergent-biosolutions-signs-development-manufacturing-093010053.html

    $NVAX, $GILD, $REGN, $PFE, $GSK, $SNY
  • n
    nito
    $JNJ conversation
    Novavax’s influenza vaccine NanoFlu has outperformed Sanofi’s Fluzone Quadrivalent on measures of immunogenicity in a phase 3 trial. The trial hit its primary and key secondary endpoints, sending Novavax’s stock up 40% and sparking talk of an accelerated FDA approval.
    “With these data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine. We expect that both Fast Track designation and the accelerated approval pathway from the FDA will help Novavax bring NanoFlu to market as quickly as possible to address the serious public health threat of influenza,” Novavax CEO Stanley Erck said in a statement. $PFE, $SNY
    https://www.fiercebiotech.com/biotech/novavax-flu-vaccine-matches-and-beats-sanofi-rival-phase-3
    Novavax’s influenza vaccine NanoFlu has outperformed Sanofi’s Fluzone Quadrivalent on measures of immunogenicity in a phase 3 trial. The trial hit its primary and key secondary endpoints, sending Novavax’s stock up 40% and sparking talk of an acceler
    Novavax’s influenza vaccine NanoFlu has outperformed Sanofi’s Fluzone Quadrivalent on measures of immunogenicity in a phase 3 trial. The trial hit its primary and key secondary endpoints, sending Novavax’s stock up 40% and sparking talk of an acceler
    www.fiercebiotech.com
  • Z
    Ziming
    $AGEN conversation
    I see this from twitter

    $GSK $SNY covid19 vaccine #fails in #elderly group
    62.5% in the >60 age group
    will reformulate now
    they will need $AGEN #QS21 NOW FINALY for it too
    $GSK said back then they choose AS03 over #AS01 (QS21 adjuvant) due to missing manufacturing capabilities
  • K
    KenLongernow
    $MNKD conversation
    $nvo $sny for a great laugh and good short opportunity read mnkd 2Q18 10Q. Replete w/ mgmt statements of having doubts about remaining in business. At end of June had about 26M in cash left has major debt payments due. Check out a seeking alpha article about their only drug, afrezza a flop of historic proportions, being worthless. Individually, just 1 NVO diabetes med sells more in 4 days than mnkd has sold of afrezza in 4 years. Most recent script data for this flop is Nrx = 276 Refills = 298
  • c
    cuneyt
    $IMMR conversation
    $IMMR strong buy. Already cash flow positive w/ buybacks, before #PS5  royalties start adding. Haptics will be added to new products, including vehicles, appliances etc. $IMMR patents already won against $MSFT $SNY etc

    DD before the masses find it. Start here...
  • A
    Anonymous
    $JUNO conversation
    Two major pharma acquisitions today. $CELG buying $JUNO and $SNY buying $BIVV. Congrats to those who are long on Juno and Bioverative. Both Celgene and Sanofi are in red. http://alph.st/bce19e98
  • F
    Faust
    Let’s hope the part about Sanofi is BS , they are terrible cheap skates

    Cytodyn $CYDY confirming that French based Sanofi $SNY
    to partner on future clinical trials of Leronlimab following positive phase 2 clinical trials in the treatment of COVID-19
  • z
    zop
    $NVAX conversation
    $NVAX listen to minute 36 of the White House meeting. Novavax to release animal studies for corona candidates this week! $ino $mrna $gild $sny

    https://www.c-span.org/video/?469926-1/president-trump-meeting-pharmaceutical-executives-coronavirus
    President Trump meets with pharmaceutical executives at the White House during the global outbreak of the coronavirus.
    President Trump meets with pharmaceutical executives at the White House during the global outbreak of the coronavirus.
    www.c-span.org
  • A
    Anonymous
    $MNKD conversation
    JUST GOT DONE CLOSING A SUCCESSFUL SHORT OF #SNY AKA SNAKEOFFI . WILL BUY MORE MANNKIND SHARES.

    UBER
  • z
    zop
    $CLVS conversation
    Doing some channel checks. Rubraca doing well. Lots of interest in $clvs from $azn $mrk $bmy $sny