With U.S. policy toward North Korea in limbo as the new administration in Washington conducts a months-long policy review, former officials and experts are sparring over whether to shift focus from seeking the North's full denuclearisation. The administration of President Joe Biden says its review of North Korea policy will be finished in coming months, before announcing its plans for handling a rolling crisis that has bedevilled generations of U.S. presidents.
WASHINGTON — Cheered on by President Joe Biden, House Democrats hustled to pass the most ambitious effort in decades to overhaul policing nationwide, able to avoid clashing with moderates in their own party who are wary of reigniting a debate they say hurt them during last fall's election. The George Floyd Justice in Policing Act was approved 220-212 late Wednesday. The sweeping legislation, which was first approved last summer but stalled in the Senate, was named in honour of Floyd, whose killing by police in Minnesota last Memorial Day sparked protests nationwide. The bill would ban chokeholds and “qualified immunity” for law enforcement and create national standards for policing in a bid to bolster accountability. “My city is not an outlier, but rather an example of the inequalities our country has struggled with for centuries,” said Rep. Ilhan Omar, D-Minn., who represents the Minneapolis area near where Floyd died. She asked her colleagues if they would "have the moral courage to pursue justice and secure meaningful change?” Democrats say they were determined to pass the bill a second time, to combat police brutality and institutional racism after the deaths of Floyd, Breonna Taylor and other Black Americans following interactions with law enforcement — images of which were sometimes jarringly captured on video. Those killings drew a national and international outcry. Floyd’s family watched the emotional debate from a nearby House office building. But the debate over legislation has turned into a political liability for Democrats as Republicans seized on calls by some activists and progressives to “defund the police” to argue that Democrats were intent on slashing police force budgets. This bill doesn't do that. Former Democratic National Committee Chairman Tom Perez said it was a reason the party, after talking confidently of growing its majority in November, instead saw it shrink to just 10 seats, 221-211. “We played too much defence on ‘defund the police,’” Perez said. Moderate Democrats said the charge helped drive Democratic defeats in swing districts around the country. “No one ran on ‘defund the police,’ but all you have to do is make that a political weapon,” said Rep. Henry Cuellar, a moderate Texas Democrat who has pushed for more police funding in places like his city of Laredo, where the law enforcement presence is especially concentrated given the close proximity to the Mexican border. While Democrats used their then-larger majority to pass the police reform measure in the House last summer, it stalled in the then-Republican-controlled Senate, where GOP senators pushed an alternate plan that Democrats blocked from consideration, calling it inadequate. Democrats now control both chambers of Congress, but it seems unlikely the bill could pass the Senate without substantial changes to win GOP support. The bill had been set for a vote Thursday, but House leaders abruptly changed the schedule to wrap up their week's work after U.S. Capitol Police warned of threats of violence at the Capitol two months after the Jan. 6 siege. Senior Democratic congressional aides said Wednesday they were eager to get the bill to the Senate, where negotiations will take longer. Republicans quickly revived the “defund the police” criticisms. “Our law enforcement officers need more funding not less,” Rep. Scott Fitzgerald, R-Wis., said during Wednesday's debate. Despite the political attacks by Republicans, even the House's more centrist lawmakers, some representing more conservative districts, backed the bill. “Black Americans have endured generations of systemic racism and discrimination for too long, and this has been painfully evident in their treatment by law enforcement," said Rep. Suzan DelBene, D-Wash, who chairs the moderate New Democrat Coalition. That endorsement came despite the bill's prohibitions on so-called qualified immunity, which shields law enforcement from certain lawsuits and is one of the main provisions that will likely need to be negotiated in any compromise with the Senate. Police unions and other law enforcement groups have argued that, without such legal protections, fear of lawsuits will stop people from becoming police officers — even though the measure permits such suits only against law enforcement agencies, rather than all public employees. California Rep. Karen Bass, who authored the bill, understands the challenge some House members face in supporting it. “My colleagues, several of them, I do not make light of the difficulty they had getting reelected because of the lie around defunding the police,” Bass said. She called provisions limiting qualified immunity and easing standards for prosecution “the only measures that hold police accountable — that will actually decrease the number of times we have to see people killed on videotape.” Bass said she would not make concessions before the bill cleared the House. Changes would only serve to weaken it while failing to shield Democrats from the false “defund the police” narrative surrounding it, she said. “Even if they were to vote against the bill, even if they were to have a press conference denouncing the bill, they are still going to be hit with the same lie,” Bass said of Democrats. She also acknowledged the challenges Democrats faced last November — and may likely see again — when former President Donald Trump's reelection campaign and other leading Republicans crowded the airwaves with images of cities around the country burning. But Bass said those attacks, like much of the opposition to the bill, are built on racism, promoting fears about how “the scary Black people are going to attack you if you try to rein in the police.” “That's as old as apple pie in our history,” she said. “So do you not act because of that?” Still, she conceded that changes are likely to come if the measure is to win the minimum 60 votes it will need to advance in the Senate, which is now split 50-50. Bass said she'd been in contact with South Carolina Sen. Tim Scott, the only Black Republican in the chamber, and was confident he would help deliver some GOP support. Scott said this week that the legislation's sticking points were qualified immunity and prosecutorial standards and that in both areas, “We have to protect individual officers.” “That's a red line for me,” Scott said, adding, “Hopefully we'll come up with something that actually works.” That could prove a tall order, despite the White House's vocal support for police reform. Biden has promised to combat systemic racism and signed executive orders he says will begin doing that, though advocates are expecting the new administration to go further. Biden has tweeted that he hopes "to be able to sign into law a landmark police reform bill.” Will Weissert And Padmananda Rama, The Associated Press
Deutsche Lufthansa on Thursday posted a smaller-than-expected net loss in the fourth quarter and forecast an operating loss in 2021 below last year's level. The German carrier said its net loss came at 1.14 billion euros ($1.37 billion), above the company's analyst consensus for a loss off 1.24 billion euros in the October-to-December period.
WASHINGTON — House Democrats passed sweeping voting and ethics legislation over unanimous Republican opposition, advancing to the Senate what would be the largest overhaul of the U.S. election law in at least a generation. House Resolution 1, which touches on virtually every aspect of the electoral process, was approved Wednesday night on a near party-line 220-210 vote. It would restrict partisan gerrymandering of congressional districts, strike down hurdles to voting and bring transparency to a murky campaign finance system that allows wealthy donors to anonymously bankroll political causes. The bill is a powerful counterweight to voting rights restrictions advancing in Republican-controlled statehouses across the country in the wake of Donald Trump’s repeated false claims of a stolen 2020 election. Yet it faces an uncertain fate in the Democratic-controlled Senate, where it has little chance of passing without changes to procedural rules that currently allow Republicans to block it. The stakes in the outcome are monumental, cutting to the foundational idea that one person equals one vote, and carrying with it the potential to shape election outcomes for years to come. It also offers a test of how hard President Joe Biden and his party are willing to fight for their priorities, as well as those of their voters. This bill “will put a stop at the voter suppression that we’re seeing debated right now,” said Rep. Nikema Williams, a new congresswoman who represents the Georgia district that deceased voting rights champion John Lewis held for years. “This bill is the ‘Good Trouble’ he fought for his entire life.” To Republicans, however, it would give license to unwanted federal interference in states' authority to conduct their own elections — ultimately benefiting Democrats through higher turnout, most notably among minorities. “Democrats want to use their razor-thin majority not to pass bills to earn voters’ trust, but to ensure they don’t lose more seats in the next election,” House Minority Leader Kevin McCarthy said from the House floor Tuesday. The measure has been a priority for Democrats since they won their House majority in 2018. But it has taken on added urgency in the wake of Trump’s false claims, which incited the deadly storming of the U.S. Capitol in January. Courts and even Trump's last attorney general, William Barr, found his claims about the election to be without merit. But, spurred on by those lies, state lawmakers across the U.S. have filed more than 200 bills in 43 states that would limit ballot access, according to a tally kept by the Brennan Center for Justice at New York University. In Iowa, the legislature voted to cut absentee and in-person early voting, while preventing local elections officials from setting up additional locations to make early voting easier. In Georgia, the House on Monday voted for legislation requiring identification to vote by mail that would also allow counties to cancel early in-person voting on Sundays, when many Black voters cast ballots after church. On Tuesday, the Supreme Court appeared ready to uphold voting restrictions in Arizona, which could make it harder to challenge state election laws in the future. When asked why proponents sought to uphold the Arizona laws, which limit who can turn in absentee ballots and enable ballots to be thrown out if they are cast in the wrong precinct, a lawyer for the state's Republican Party was stunningly clear. “Because it puts us at a competitive disadvantage relative to Democrats,” said attorney Michael Carvin. “Politics is a zero-sum game." Battle lines are quickly being drawn by outside groups who plan to spend millions of dollars on advertising and outreach campaigns. Republicans “are not even being coy about it. They are saying the ‘quiet parts’ out loud,” said Tiffany Muller, the president of End Citizens United, a left-leaning group that aims to curtail the influence of corporate money in politics. Her organization has launched a $10 million effort supporting the bill. “For them, this isn’t about protecting our democracy or protecting our elections. This is about pure partisan political gain.” Conservatives, meanwhile, are mobilizing a $5 million pressure campaign, urging moderate Senate Democrats to oppose rule changes needed to pass the measure. “H.R. 1 is not about making elections better,” said Ken Cuccinelli, a former Trump administration Homeland Security official who is leading the effort. "It’s about the opposite. It’s intended to dirty up elections.” So what's actually in the bill? H.R. 1 would require states to automatically register eligible voters, as well as offer same-day registration. It would limit states' ability to purge registered voters from their rolls and restore former felons' voting rights. Among dozens of other provisions, it would also require states to offer 15 days of early voting and allow no-excuse absentee balloting. On the cusp of a once-in-a-decade redrawing of congressional district boundaries, typically a fiercely partisan affair, the bill would mandate that nonpartisan commissions handle the process instead of state legislatures. Many Republican opponents in Congress have focused on narrower aspects, like the creation of a public financing system for congressional campaigns that would be funded through fines and settlement proceeds raised from corporate bad actors. They've also attacked an effort to revamp the federal government's toothless elections cop. That agency, the Federal Election Commission, has been gripped by partisan deadlock for years, allowing campaign finance law violators to go mostly unchecked. Another section that's been a focus of Republican ire would force the disclosure of donors to “dark money” political groups, which are a magnet for wealthy interests looking to influence the political process while remaining anonymous. Still, the biggest obstacles lie ahead in the Senate, which is split 50-50 between Republicans and Democrats. On some legislation, it takes only 51 votes to pass, with Vice-President Kamala Harris as the tiebreaker. On a deeply divisive bill like this one, they would need 60 votes under the Senate’s rules to overcome a Republican filibuster — a tally they are unlikely to reach. Some Democrats have discussed options like lowering the threshold to break a filibuster, or creating a workaround that would allow priority legislation, including a separate John Lewis Voting Rights bill, to be exempt. Biden has been cool to filibuster reforms and Democratic congressional aides say the conversations are fluid but underway. Senate Majority Leader Chuck Schumer has not committed to a time frame but vowed “to figure out the best way to get big, bold action on a whole lot of fronts.” He said: “We’re not going to be the legislative graveyard. ... People are going to be forced to vote on them, yes or no, on a whole lot of very important and serious issues.” ___ AP Congressional Correspondent Lisa Mascaro contributed to this report. Brian Slodysko, The Associated Press
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But while investors will be closely watching the Fed chief, due to speak Thursday at a Wall Street Journal conference, for any hints of concern about last week's jump in bond yields, they see a high bar for the U.S. central bank to actually take action. Thursday's event will be Powell's last outing before the Fed's policy-making committee convenes March 16-17. Swiber said of particular interest will be whether the Fed addresses short-dated yields nearing zero as yields at the long end spike.
Sumit Nagal next faces fifth seed and veteran Spaniard Albert Ramos Vinolas in the Quarter-finals.
Florian Zeller on The Father: 'Anthony Hopkins took me in his arms. We knew the miracle had happened'. The French director and dramatist reveals how he pushed Hopkins into giving one of the most wrenching performances of his career in an unflinching dementia drama also starring Olivia Colman
Shopping is a whole new world now I have to wear a mask. I’ve been snubbed in the DIY store and pampered in the pet shop. And for once it has nothing to do with my being on TV
Europe's unusually warm week breaks temperature records . Mild end to February saw Germany record sharpest temperature rise in a week, going from -23.8C to 18.1C
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Westminster warned as poll shows record backing for Welsh independence. Survey for ITV News Tonight reported ‘dramatic uplift’ with 40% backing independence and most support amongst young people
'Families are struggling': Britons react to Rishi Sunak's 2021 budget. We ask people about what measures on furlough, universal credit, property and more will mean for them
Now, I would like to turn the call over to Red Robin's CEO, Paul Murphy. With me is Lynn Schweinfurth, our chief financial officer who will review our quarterly results after my prepared remarks. The material improvements we made to our business will enable us to resume our transformation strategy in an even stronger position, and deliver our brand promise, recapture the soul of Red Robin effectively, tell our story, and accelerate profitable growth.
The approach for Covid-19 jabs will be similar to that used for the modified flu vaccine to deal with new strains each year, the regulator said.
Geneva, Switzerland, March 4, 2021 - Addex Therapeutics Ltd (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, announced today that Tim Dyer, Chief Executive Officer, will present at the H.C. Wainwright Global Life Sciences Conference (March 9-10, 2021). In his presentation, which is scheduled for Tuesday, March 9, 2021 at 07:00 ET, Mr Dyer will provide a corporate update and discuss recent developments at Addex. The video presentation will be available for viewing on-demand by registered participants via this link from the time of the presentation and subsequently on the Events page the Company’s website (www.addextherapeutics.com). The video replay will be archived for 90 days following the event. Management will be available for virtual one-on-one meetings throughout the conference. For more information or to schedule a one-on-one meeting with management, please contact your conference representative or James@HaydenIR.com. About Addex Therapeutics:Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric modulators for neurological disorders. Allosteric modulators offer several potential advantages over conventional non-allosteric molecules and may offer an improved therapeutic approach to conventional "orthosteric" small molecule or biological drugs. Adder’s allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention. adder’s lead drug candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is poised to start a pivotal registration clinical trial for Parkinson’s disease levodopa induced dyskinesia (PD-LID) in H1 2021. Addex is also investigating dipraglurant's therapeutic use in blepharospasm (a type of dystonia), for which a clinical trial is expected to be initiated in H1 2021. Addex's third clinical program, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc, is scheduled to enter a phase 2a proof of concept clinical study for the treatment of epilepsy in Q2 2021. Addex’s GABAB PAM program has been licensed to Indivior PLC who are focused on development for the treatment of addiction. Preclinical programs include GABAB PAM for CMT1A, mGlu7 NAM for PTSD, mGlu2 NAM for mild neurocognitive disorders, mGlu4 PAM for Parkinson’s disease and mGlu3 PAM for neurodegenerative disorders. Addex is listed on the SIX Swiss Exchange and the NASDAQ Capital Market and trades under the ticker symbol "ADXN". Press Contacts: Tim DyerChief Executive Officer+41 22 884 15 55PR@addextherapeutics.comMike SinclairPartner, Halsin Partners+44 (0) 20 7318 firstname.lastname@example.orgJames Carbonara Hayden IR (646)-755-7412 email@example.com Forward Looking Statements:This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including in respect of the anticipated initiation of clinical trials. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Addex Therapeutics’ Annual Report on Form 20-F for the year ended December 31, 2019, as filed with the SEC on April 27, 2020, the prospectus related to the global offering and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements.
The Chancellor pledged to build a ‘fairer and more just’ country post Covid-19.
- Biologics License Application (BLA) for IV efgartigimod accepted for review by U.S. Food and Drug Administration (FDA) for generalized myasthenia gravis (gMG) - Pre-approval access program opened in U.S. and Europe for eligible gMG patients - Management to host conference call today at 2:30 pm CEST (8:30 am ET) - March 4, 2021 Breda, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today reported financial results for the full year 2020 and provided a fourth quarter business update. “2020 was an exceptional year for argenx, marked by execution across the organization and highlighted by the positive results of our pivotal Phase 3 ADAPT trial. We have started 2021 on strong footing with the FDA’s acceptance for review of the BLA for efgartigimod, bringing us one step closer to offering a new therapy option to people living with gMG. In preparation for our first commercial launch, we remain committed to a series of educational and engagement efforts with patients, physicians and payors on FcRn as a target and the unmet disease burden that gMG patients face,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “With proof-of-concept established for efgartigimod in four indications and enrollment on track to begin in the fifth and sixth indications this year, we are building out a broad development plan with our FcRn antagonist. In addition, we expect Phase 1 healthy volunteer data mid-year from our C2 antagonist ARGX-117, our second program in severe autoimmunity, solidifying our commitment to continued pipeline expansion with antibody-based medicines that have potential in multiple autoimmune indications,” concluded Mr. Van Hauwermeiren. FOURTH QUARTER 2020 AND RECENT BUSINESS UPDATE BLA for efgartigimod accepted for review by FDA; on track with commercial and regulatory preparations in the U.S., Japan, the EU and China. BLA for IV efgartigimod for treatment of gMG accepted for review by FDA with action date set for December 17, 2021 under Prescription Drug User Fee Act (PDUFA)Japanese Marketing Authorization Application (J-MAA) expected to be filed with Pharmaceuticals and Medical Devices Agency (PMDA) in first half of 2021 with anticipated Japan commercial launch in 2022MAA expected to be filed with European Medicines Agency (EMA) in second half of 2021Zai Lab Limited to discuss potential accelerated regulatory pathway for approval in China with National Medical Products Administration (NMPA)Commercial readiness activities on track, including: Build-out of supply chain to ensure ample commercial product available at launch to meet early demandHiring of experienced, neurology-focused sales team with aim to have approximately 70 sales representatives in place for launchOngoing education efforts with key stakeholder groups, including patients, physicians and payors Launched pre-approval access program (PAA) in the U.S. and Europe to open availability of efgartigimod to people living with gMG who have a high degree of unmet clinical need and are not able to participate in a clinical trial Seven global trials to be ongoing in 2021 of efgartigimod across IV and subcutaneous (SC) formulations; proof-of-concept now demonstrated in four indications, which strategically fit within growing commercial franchises. ADAPT-SC: Enrollment ongoing in registrational trial evaluating non-inferiority based on pharmacodynamic effect of SC efgartigimod compared to IV efgartigimod for treatment of gMG; trial expected to enroll approximately 50 patientsADHERE: Enrollment ongoing in registrational trial evaluating SC efgartigimod for treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) following interim analysis of safety data as well as efficacy assessments that surpassed pre-defined “GO” threshold; trial expected to enroll approximately 130 patientsADVANCE and ADVANCE-SC: Registrational trials ongoing of IV and SC efgartigimod for treatment of primary immune thrombocytopenia (ITP); trials expected to each enroll approximately 156 patientsADDRESS: Registrational trial ongoing of SC efgartigimod for treatment of pemphigus (vulgaris and foliaceus); trial expected to enroll approximately 150 patientsEnrollment in fifth and sixth indications to begin in 2021Agreement with Zai Lab Limited expected to expand and accelerate global development of efgartigimod, including into additional autoimmune indications Data expected mid-2021 from Phase 1 healthy volunteer trial of ARGX-117, a potential first-in-class C2 antagonist and second program with broad applicability in severe autoimmunity. -Trial to evaluate safety and tolerability of single and multiple ascending doses of IV and SC ARGX-117, and to identify dose to take forward into potential Phase 2 proof-of-concept trials, including for multifocal motor neuropathy (MMN) Combination trials of cusatuzumab remain ongoing for treatment of acute myeloid leukemia (AML) as part of global collaboration and licensing agreement with Cilag GmbH International, an affiliate of Janssen. Data update from Phase 2 CULMINATE trial evaluating cusatuzumab in combination with azacitidine for treatment of newly diagnosed AML to be presented in peer-reviewed forumDecision to initiate additional cusatuzumab studies under collaboration will be determined following review of all available data including ongoing Phase 1b ELEVATE trial (NCT04150887), which is evaluating cusatuzumab in combination with venetoclax and azacitidine for treatment of newly diagnosed AML Immunology Innovation Program (IIP) continues to drive pipeline expansion by identifying potential value-creation opportunities through collaboration with leading disease biologists. Preclinical work ongoing in early-stage pipeline, including ARGX-118, ARGX-119 and ARGX-12017 discovery programs under evaluation that emerged from IIP argenx continues its transition to a global, integrated, immunology organization. Geneva office opened to support commercial infrastructure ahead of expected EU launch of efgartigimodPlanned transition agreement in place for Chief Financial Officer Eric Castaldi as part of evolution to commercial-stage company; recruitment efforts ongoing for U.S.-based successorYvonne Greenstreet, President and Chief Operating Officer of Alnylam, has been nominated to Board of Directors to fill position of Dr. David Lacey, who intends to transition to an advisory role for the CompanyCompleted public offering of 3,593,750 ordinary shares in February 2021 with gross proceeds of $1.15 billion Q4 AND FY2020 FINANCIAL RESULTS Year Ended December 31,(in thousands of € except for shares and EPS) 2020 2019 VarianceRevenue €36,425 €69,783 €(33,358)Other operating income 18,109 12,801 5,308Total operating income 54,534 82,584 (28,050) Research and development expenses (325,479) (197,665) (127,814)Selling, general and administrative expenses (149,367) (64,569) (84,798)Total operating expenses (474,846) (262,234) (212,612) Change in fair value on non-current financial assets 2,544 1,096 1,448 Operating loss €(417,769) €(178,554) €(239,215) Financial income/(expense) (1,414) 14,275 (15,689)Exchange gains/(losses) (106,956) 6,066 (113,022) Loss before taxes €(526,139) €(158,213) €(367,926) Income tax expense €(2,784) €(4,752) €1,968 Loss for the year and total comprehensive loss €(528,923) €(162,965) €(365,958) Loss for the year and total comprehensive loss attributable to: Owners of the parent €(528,923) €(162,965) €(365,958)Weighted average number of shares outstanding 45,410,442 38,619,121 Basic and diluted loss per share (in €) (11.65) (4.22) Net increase in cash and cash equivalents and current financial assets compared to year-end 2019 and 2018 291,147 771,252 Cash and cash equivalents and current financial assets at the end of the period 1,626,968 1,335,821 DETAILS OF FINANCIAL RESULTS Cash and cash equivalents and current financial assets totaled €1,627.0 million on December 31, 2020, compared to €1,335.8 million on December 31, 2019. The increase in cash and cash equivalents and current financial assets resulted primarily from the closing of a global offering in May 2020, including a U.S. offering and a European private placement, which resulted in the receipt of €778.1 million in gross proceeds, decreased by €47.4 million of underwriter discounts and commissions, and offering expenses, partially offset by net cash flows used in operating activities. Revenue decreased by €33.4 million for the year ended December 31, 2020 to €36.4 million, compared to €69.8 million for the year ended December 31, 2019. The decrease was due to the milestone payments following the first-in-human clinical trial with ABBV-151 under the AbbVie collaboration which was achieved in the year ended December 31, 2019, partly offset by revenue recognition of the transaction price related to the Janssen collaboration. The increase in other income is primarily driven by increased research and development incentives and higher payroll tax rebates for employing certain highly qualified research and development personnel. Research and development expenses increased by €127.8 million for the year ended December 31, 2020 to €325.5 million, compared to €197.7 million for the year ended December 31, 2019. The increase resulted primarily from higher external research and development expenses, primarily related to the efgartigimod program in various indications, cusatuzumab program and other clinical and preclinical programs. Furthermore, the personnel expenses increased due to a planned increase in headcount. Selling, general and administrative expenses totaled €149.4 million for the year ended December 31, 2020, compared to €64.6 million for the year ended December 31, 2019. The increase primarily resulted from higher personnel expenses and consulting fees related to the preparation of a possible future commercialization of argenx’s lead product candidate efgartigimod. For the year ended December 31, 2020, financial expenses, which is the net of primarily interest received and changes in fair value of invested funds, amounted to €1.4 million, compared to a financial income of €14.3 million for the year ended December 31, 2020. Financial expenses correspond mainly to the decrease in net asset value of money invested funds following the impact of the COVID-19 outbreak on the financial markets. Exchange losses totaled €107.0 million for the year ended December 31, 2020, compared to an exchange gain of €6.1 million for the year ended December 31, 2019. The unfavorable change is mainly attributable to unrealized exchange rate losses on cash and cash equivalents and current financial asset position in U.S. dollars. FINANCIAL GUIDANCE Based on current plans to fund anticipated operating expenses and capital expenditures, argenx expects its cash burn to increase significantly in 2021, approximately doubling compared to 2020. The increased spend will support the Company’s transition to an integrated immunology company, including the build-out of global commercial infrastructure and drug product inventory ahead of the expected launch of efgartigimod in gMG in the U.S, the advancement of its clinical-stage pipeline, including seven expected global trials of efgartigimod, and the continued investment in its Immunology Innovation Program. EXPECTED 2021 FINANCIAL CALENDAR May 14, 2021: Q1 2021 financial results and business updateJuly 29, 2021: HY 2021 financial results and business updateOctober 28, 2021: Q3 2021 financial results and business update CONFERENCE CALL DETAILSThe full year 2020 results and fourth quarter business update will be discussed during a conference call and webcast presentation today at 2:30 pm CEST/8:30 am ET. A webcast of the live call may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website. Dial-in numbers:Please dial in 15 minutes prior to the live call. Belgium 0800 389 13 France 0805 102 319 Netherlands 0800 949 4506 United Kingdom 0800 279 9489 United States 1 844 808 7140International 1 412 902 0128 About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, and Japan. For more information, visit www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/ and Twitter at https://twitter.com/argenxglobal. For further information, please contact: Media:Kelsey KirkKKirk@argenx.com Investors:Beth DelGiaccobdelgiacco@argenx.com Joke Comijn (EU)firstname.lastname@example.org Forward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes concerning its 2021 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and argenx’s, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the effects of the COVID-19 pandemic, argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law. Attachment Q4FY20 Press Release - Financial Tables_FINAL
FDA accepts Dupixent® (dupilumab) for review in children with moderate-to-severe asthma Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to improve lung function in children aged 6 to 11 years with asthma in a randomized Phase 3 trial, while also further adding to the well-established safety profile of Dupixent Dupixent has the potential to be a best-in-class treatment option in this younger population of children aged 6 to 11 Acceptance represents another milestone in the development of Dupixent in addressing diseases driven by type 2 inflammation PARIS and TARRYTOWN, N.Y. – March 4, 2021 - The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma aged 12 and older with elevated eosinophils or oral corticosteroid dependent asthma. The target action date for the FDA decision is October 21, 2021 and the EU regulatory submission for children aged 6 to 11 years with asthma is planned for Q1 2021. In the U.S., approximately 75,000 children aged 6 to 11 years are living with uncontrolled moderate-to-severe asthma, which can carry a significant burden for children and their families. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, these children can still experience coughing, wheezing, and difficulty breathing. They are also at risk for life-threatening severe asthma attacks that can lead to hospitalization and emergency room visits, and may require the use of systemic corticosteroids which carry significant risks when used long term. Uncontrolled moderate-to-severe asthma can impair lung function, and can interfere with day-to-day activities, such as sleeping, attending school and playing sports. The sBLA is supported by data that include pivotal Phase 3 results evaluating the efficacy and safety of Dupixent in addition to standard-of-care maintenance therapy in children with moderate-to-severe asthma with type 2 inflammation, characterized by elevated blood eosinophil levels and/or raised fractional exhaled nitric oxide (FeNO) levels. In the trial, Dupixent significantly reduced severe asthma attacks and rapidly improved lung function within two weeks in children aged 6 to 11 years. Safety results were generally consistent with the well-established safety profile of Dupixent in the approved indication for patients aged 12 and older with moderate-to-severe asthma. Adverse events in the Phase 3 trial that were more commonly observed with Dupixent included injection site reactions, viral upper respiratory tract infections and eosinophilia. Detailed results from this Phase 3 trial will be published later this year. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), atopic dermatitis and eosinophilic esophagitis. About Dupixent Dupixent is approved in the U.S. to treat patients aged 6 years and older with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies; for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older whose asthma is not controlled with their current asthma medicines; and for use with other medicines for the maintenance treatment of CRSwNP in adults whose disease is not controlled. Outside of the U.S., Dupixent is approved for specific patients with moderate-to-severe atopic dermatitis and certain patients with asthma in a number of other countries around the world, including the EU and Japan. Dupixent is also approved in the EU and Japan to treat certain adults with severe CRSwNP. Across all approved indications globally, more than 200,000 patients have been treated with Dupixent. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver. Dupilumab development program To date, dupilumab has been studied in more than 10,000 patients across 50 clinical trials in various chronic diseases driven by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes, including pediatric asthma (6 to 11 years of age, Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3) and food allergies (Phase 2). These potential uses are under clinical investigation, and the safety and efficacy of dupilumab in these conditions have not been fully evaluated by any regulatory authority. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About Sanofi Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi, Empowering Life Sanofi Media Relations Contact Sally Bain Tel: +1 781-264-1091 Sally.Bain@sanofi.com Sanofi Investor Relations Contacts ParisEva Schaefer-JansenArnaud DelepineYvonne Naughton Sanofi Investor Relations Contacts North AmericaFelix LauscherFara BerkowitzSuzanne Greco Sanofi IR main line:Tel: +33 (0)1 53 77 45 email@example.com://www.sanofi.com/en/investors/contact Regeneron Media Relations Contact Sharon ChenTel: +1 914-847-1546Sharon.Chen@regeneron.com Regeneron Investor Relations Contact Mark HudsonTel: +1 914-847-3482Mark.Hudson@regeneron.com Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron’s business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron’s and its collaborators’ ability to continue to conduct research and clinical programs, Regeneron’s ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators (collectively, “Regeneron’s Products”), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron’s Products and product candidates being developed by Regeneron and/or its collaborators (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma characterized by raised blood eosinophil levels and/or raised fractional exhaled nitric oxide (FeNO) levels (“Pediatric Asthma”); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as dupilumab for the treatment of Pediatric Asthma, chronic obstructive pulmonary disease, pediatric atopic dermatitis, eosinophilic esophagitis, bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, food and environmental allergies, and other potential indications; uncertainty of market acceptance and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on the commercial success of Regeneron’s Products and Regeneron’s Product Candidates; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection, Dupixent, Praluent® (alirocumab), and REGEN-COVTM (casirivimab and imdevimab)), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2020. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). Attachment Press Release
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