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2021-12-06 08:41:03 LEGN Legend Biotech $44.36 / -4.465 (-9.15%) , JNJ Johnson & Johnson $159.37 / +2.25 (+1.43%) 08:41 12/06/21 12/06 08:41 12/06/21 08:41	Legend submits NDA to Japan regulator for BCMA CAR-T therapy Cilta-cel for RRMM Legend Biotech (LEGN) announces submission of a New Drug Application, NDA, to the Japanese Ministry of Health, Labour and Welfare, MHLW, for ciltacabtagene autoleucel by its collaboration partner, Janssen Pharmaceutical (JNJ) . Cilta-cel is an investigational B-cell maturation antigen -directed chimeric antigen receptor CAR-T cell therapy for the treatment of adults with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor , an immunomodulatory agent , and an anti-CD38 antibody. The submission is based on results from the Phase 1b/2 CARTITUDE-1 study conducted in the US and Japan, which evaluated the efficacy and safety of cilta-cel for patients with relapsed or refractory multiple myeloma.1 Cilta-cel is currently under regulatory review by several health authorities around the world, including the United States and Europe. "Today's submission is an encouraging step in our mission to provide a potentially transformative cell therapy option to patients with multiple myeloma," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "We look forward to closely collaborating with our partner Janssen and the MHLW in order to make cilta-cel available to patients living with relapsed or refractory multiple myeloma, who have exhausted several standard-of-care treatments and are facing poor prognoses." LEGN Legend Biotech $44.36 / -4.465 (-9.15%) JNJ Johnson & Johnson $159.37 / +2.25 (+1.43%)	07 Dec 25 Jan 28 Feb

2021-12-06 08:41:03

LEGN

Legend Biotech

$44.36 / -4.465 (-9.15%)

, JNJ

Johnson & Johnson

$159.37 / +2.25 (+1.43%)

08:41

12/06/21

12/06

08:41

12/06/21

08:41

Legend submits NDA to Japan regulator for BCMA CAR-T therapy Cilta-cel for RRMM

Legend Biotech (LEGN) announces submission of a New Drug Application, NDA, to the Japanese Ministry of Health, Labour and Welfare, MHLW, for ciltacabtagene autoleucel by its collaboration partner, Janssen Pharmaceutical (JNJ) . Cilta-cel is an investigational B-cell maturation antigen -directed chimeric antigen receptor CAR-T cell therapy for the treatment of adults with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor , an immunomodulatory agent , and an anti-CD38 antibody. The submission is based on results from the Phase 1b/2 CARTITUDE-1 study conducted in the US and Japan, which evaluated the efficacy and safety of cilta-cel for patients with relapsed or refractory multiple myeloma.1 Cilta-cel is currently under regulatory review by several health authorities around the world, including the United States and Europe. "Today's submission is an encouraging step in our mission to provide a potentially transformative cell therapy option to patients with multiple myeloma," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "We look forward to closely collaborating with our partner Janssen and the MHLW in order to make cilta-cel available to patients living with relapsed or refractory multiple myeloma, who have exhausted several standard-of-care treatments and are facing poor prognoses."

LEGN

Legend Biotech

$44.36 / -4.465 (-9.15%)

JNJ

Johnson & Johnson

$159.37 / +2.25 (+1.43%)

07
Dec
25
Jan
28
Feb

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Conference/Events	Knot Offshore Partners management to meet virtually with B. Riley » 04:55 01/18/22 01/18 04:55 01/18/22 04:55 KNOP Knot Offshore Partners $16.42 / +0.53 (+3.34%) Virtual Meetings to be… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return tomorrow Get Free Trial ShowHide Related Items >><< Company News Street Research Events KNOP Knot Offshore Partners $16.42 / +0.53 (+3.34%) 12/01/21 Knot Offshore Partners falls -10.2% KNOP Knot Offshore Partners $16.42 / +0.53 (+3.34%) 03/12/21 B. Riley Securities Knot Offshore Partners price target raised to $22 from $20 at B. Riley 01/20/21 Barclays Knot Offshore Partners downgraded to Underweight from Equal Weight at Barclays 00:00 Today Knot Offshore Partners 01/19/22 Knot Offshore Partners
Conference/Events	Mizuho telecom/media/tech analyst to hold analyst/industry conference call » 04:55 01/18/22 01/18 04:55 01/18/22 04:55 Telecom, Media &… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return tomorrow Get Free Trial
Conference/Events	Identiv management to meet virtually with Northland » 04:55 01/18/22 01/18 04:55 01/18/22 04:55 INVE Identiv $22.06 / +0.11 (+0.50%) Virtual Meeting to be… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return tomorrow Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings Syndicate Events INVE Identiv $22.06 / +0.11 (+0.50%) 01/05/22 Identiv partners with collectID to authenticate collectible Brazil soccer shirts 12/06/21 Identiv appoints Amir Khoshniyati as General Manager, VP, Transponder Business 12/02/21 Identiv names Justin Scarpulla as CFO, effective December 6 08/03/21 Identiv CFO Sandra Wallach to step down INVE Identiv $22.06 / +0.11 (+0.50%) 12/28/21 Lake Street Lake Street names 18 small cap best ideas for 2022 12/01/21 B. Riley Identiv shares not fully pricing in prescription pill program, says B. Riley 11/03/21 B. Riley Identiv price target raised to $31 from $26 at B. Riley 09/28/21 Lake Street Identiv price target raised to $24 from $20 at Lake Street INVE Identiv $22.06 / +0.11 (+0.50%) 08/03/21 Identiv sees FY21 revenue $100M-$106M, consensus $100.69M 08/03/21 Identiv reports Q2 EPS 9c, consensus (4c) 08 Apr 00:00 Today Identiv
Conference/Events	Semler Scientific management to meet virtually with B. Riley » 04:55 01/18/22 01/18 04:55 01/18/22 04:55 SMLR Semler Scientific $78.64 / -4.12 (-4.98%) Virtual Meeting to be… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return tomorrow Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings On The Fly Events SMLR Semler Scientific $78.64 / -4.12 (-4.98%) 09/27/21 Semler Scientific up 12% after saying Nasdaq approves listing 09/27/21 Semler Scientific to begin trading on Nasdaq on September 28 SMLR Semler Scientific $78.64 / -4.12 (-4.98%) 12/27/21 B. Riley B. Riley recommends LifeMD, OptimizeRx, Semler, Zynex into 2022 11/02/21 Lake Street Semler Scientific price target lowered to $175 from $200 at Lake Street 11/02/21 B. Riley Semler Scientific earnings selloff a buying opportunity, says B. Riley 10/26/21 B. Riley Semler Scientific price target raised to $175 from $151 at B. Riley SMLR Semler Scientific $78.64 / -4.12 (-4.98%) 11/01/21 Semler Scientific reports Q3 EPS 51c, consensus 64c SMLR Semler Scientific $78.64 / -4.12 (-4.98%) 11/01/21 Fly Intel: After-Hours Movers 00:00 Today Semler Scientific

Conference/Events	Cowen Internet/new media analyst to hold analyst/industry conference call » 04:55 01/18/22 01/18 04:55 01/18/22 04:55 Internet & New Media… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return tomorrow Get Free Trial
Conference/Events	FTC Solar to host business news update conference call » 04:55 01/18/22 01/18 04:55 01/18/22 04:55 FTCI FTC Solar $5.13 / -0.945 (-15.56%) CEO Hunkler holds a… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return in 8 minutes Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings Syndicate Periodicals On The Fly Events Options FTCI FTC Solar $5.13 / -0.945 (-15.56%) 11/26/21 USITC says tariffs on imported solar equipment continues to be necessary 11/04/21 FTC Solar awarded first solar project in Africa 09/14/21 FTC Solar CEO Tony Etnyre to step down, Sean Hunkler to succeed 08/11/21 FTC Solar sees 'sequential revenue growth ' for 2H21 FTCI FTC Solar $5.13 / -0.945 (-15.56%) 01/14/22 BofA FTC Solar downgraded to Underperform from Neutral at BofA 01/07/22 Piper Sandler FTC Solar price target lowered to $14 from $17 at Piper Sandler 11/16/21 Roth Capital Roth says court restoring solar 'bifi' exemption a 'major surprise' 11/15/21 Roth Capital Roth Capital not expecting A-SMACC to reveal petitioner to keep anti-circ case alive FTCI FTC Solar $5.13 / -0.945 (-15.56%) 11/10/21 FTC Solar sees Q4 revenue $70M-$80M, consensus $129M 11/10/21 FTC Solar reports Q3 adjusted EPS (17c), consensus (19c) 11/09/21 FTC Solar awarded 504 MW project in Arizona 08/11/21 FTC Solar expects FY21 revenue to exceed $310M, consensus $302.18M 28 Apr FTCI FTC Solar $5.13 / -0.945 (-15.56%) 12/13/21 CA regulators propose deep cut to rooftop solar incentives, Bloomberg reports 12/13/21 California proposes 'deep cut' in rooftop solar incentives, Bloomberg reports FTCI FTC Solar $5.13 / -0.945 (-15.56%) 01/14/22 Wall Street in Fives - Must Read Lists for Friday 01/14/22 Wall Street in Fives - Must Read Lists at Midday 11/11/21 Commerce bid rejection for solar tariffs seen as negative for First Solar 10/25/21 Charged: Xpeng planning to go beyond cars as Hertz places $4B Tesla order 08:30 Today FTC Solar - FTCI FTCI FTC Solar $5.13 / -0.945 (-15.56%) 01/12/22 Six new option listings on January 12th
Conference/Events	Jefferies software/Internet analyst to hold analyst/industry conference call » 04:55 01/18/22 01/18 04:55 01/18/22 04:55 TEAM Atlassian $297.39 / -0.99 (-0.33%) Software & Internet… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return tomorrow Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings On The Fly Events Options TEAM Atlassian $297.39 / -0.99 (-0.33%) 10/28/21 Atlassian names Bharadwaj as COO, says Beer to retire as CFO 09/09/21 Atlassian names Cloudflare COO to board of directors 08/16/21 Lone Pine takes stake in Moderna, exits Netflix in Q2 TEAM Atlassian $297.39 / -0.99 (-0.33%) 01/06/22 Jefferies Atlassian price target lowered to $355 from $460 at Jefferies 12/22/21 Fly Intel: Top five analyst initiations 12/22/21 KeyBanc Atlassian resumed with an Overweight at KeyBanc 12/16/21 Goldman Sachs Atlassian initiated with a Neutral at Goldman Sachs TEAM Atlassian $297.39 / -0.99 (-0.33%) 10/28/21 Atlassian sees Q2 EPS 35c-38c, consensus 44c 10/28/21 Atlassian reports Q1 EPS 46c, consensus 40c 07/29/21 Atlassian sees Q1 non-IFRS EPS 38c-39c, consensus 31c 07/29/21 Atlassian reports Q4 EPS (85c), consensus 18c TEAM Atlassian $297.39 / -0.99 (-0.33%) 10/29/21 Wall Street in Fives - Must Read Lists for Friday 10/29/21 Wall Street in Fives - Must Read Lists at Midday 10/28/21 Fly Intel: After-Hours Movers 07/30/21 Wall Street in Fives - Must Read Lists for Friday 11:00 Today Software & Internet TEAM Atlassian $297.39 / -0.99 (-0.33%) 12/06/21 Unusual call flow in option market yesterday 12/03/21 Calls lead puts 15:2 in Atlassian with shares down $6.6%
Upgrade	Vtex upgraded to Buy from Neutral at Goldman Sachs » 04:52 01/18/22 01/18 04:52 01/18/22 04:52 VTEX Vtex $7.55 / -0.175 (-2.27%) Goldman Sachs analyst… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return in 9 minutes Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings Syndicate On The Fly Options VTEX Vtex $7.55 / -0.175 (-2.27%) 11/17/21 Vtex falls -6.0% 11/15/21 Lone Pine boosts Twitter stake, reduces Meta Platforms stake 11/15/21 Tiger Global boosts stake in Snowflake, exits TAL Education Group 09/30/21 Vtex launches new global integration with Facebook VTEX Vtex $7.55 / -0.175 (-2.27%) 09/24/21 Morgan Stanley Vtex upgraded to Overweight from Equal Weight at Morgan Stanley 08/16/21 JPMorgan Vtex initiated with a Neutral at JPMorgan 08/16/21 Morgan Stanley Vtex initiated with an Equal Weight at Morgan Stanley 08/16/21 Itau BBA Vtex initiated with an Outperform at Itau BBA VTEX Vtex $7.55 / -0.175 (-2.27%) 11/17/21 Vtex backs FY21 revenue view $124M-$126M, consensus $124.59M 11/17/21 Vtex sees Q4 revenue $35.3M-$37.3M, consensus $36.93M 11/17/21 Vtex reports Q3 EPS (12c), consensus (10c) 21 Jul VTEX Vtex $7.55 / -0.175 (-2.27%) 12/03/21 The Five Stocks Billionaire Paul Singer Is Betting Big On 08/07/21 Opening Day: European Wax Center jumps in first trading day 07/24/21 Opening Day: Zoom Video rival Kaltura rises in market debut VTEX Vtex $7.55 / -0.175 (-2.27%) 11/24/21 Nine new option listings on November 24th
Upgrade	Brookfield Renewable Partners upgraded to Outperform at National Bank » 04:49 01/18/22 01/18 04:49 01/18/22 04:49 BEP Brookfield Renewable Partners $32.72 / -0.895 (-2.66%) National Bank analyst… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return tomorrow Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings Periodicals On The Fly Events BEP Brookfield Renewable Partners $32.72 / -0.895 (-2.66%) 12/14/21 Brookfield to renew its normal course issuer bid for its partnership units BEP Brookfield Renewable Partners $32.72 / -0.895 (-2.66%) 01/16/22 BMO Capital Brookfield Renewable Partners upgraded to Outperform at BMO Capital 01/11/22 CIBC Brookfield Renewable Partners upgraded with $40 target at CIBC 01/10/22 CIBC Brookfield Renewable Partners upgraded to Outperformer from Neutral at CIBC 01/07/22 Scotiabank Brookfield Renewable Partners upgraded at Scotiabank after December weakness BEP Brookfield Renewable Partners $32.72 / -0.895 (-2.66%) 11/05/21 Brookfield Renewable Partners reports Q3 normalized FFO 36c, consensus (4c) BEP Brookfield Renewable Partners $32.72 / -0.895 (-2.66%) 07/21/21 Infrastructure bill expected to flop in first test vote, AP reports BEP Brookfield Renewable Partners $32.72 / -0.895 (-2.66%) 01/10/22 Charged: Nikola drops suit against Tesla, Musk says FSD Beta 10.9 ready soon 12/13/21 Charged: Lucid receives SEC subpoena, Musk 'thinking of' quitting job 09/27/21 Charged: Analysts say sell Tesla and Lordstown, buy Fisker 02/27/22 27th Annual Energy Summit

Events

Earnings calls, analyst events, roadshows and more

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Empire State Manufacturing Index: January 2022 Government Event
FTCI
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FTC Solar - FTCI Conference Calls
PNC
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PNC Financial - PNC Conference Calls
GS
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Goldman Sachs - GS Conference Calls
Today at 10:00

Housing Market Index: January 2022 Government Event
MSFT ...
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Technology Industry Meetings
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Business & Information Services Industry Meetings
TFC
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Truist Financial - TFC Conference Calls
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4-Week Bill Announcement Government Event
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8-Week Bill Announcement Government Event

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Syndicate

This week’s upcoming IPOs and secondary offerings

Priced
Not Priced

Mon	No deals
Tues	No deals
Wed	No deals
Thurs	No deals
Fri	No deals

Mon	JUNS X JUNS Jupiter Neurosciences IPO Managers: Roth Capital & Desjardins $5.00-7.00 3.333M Shares
Tues	No deals
Wed	FSPR X FSPR Four Springs Capital IPO Managers: Morgan Stanley, Goldman Sachs & Wells Fargo, Mizuho, Scotiabank, Nomura, Berenberg $13.00-15.00 18M Shares RHDM X RHDM Rhodium Enterprises IPO Managers: B. Riley & Cowen, Needham, DA Davidson, Northland $12.00-14.00 7.692M Shares
Thurs	SMSA X SMSA Samsara Vision IPO Managers: ThinkEquity $5.00-7.00 28.75M Shares
Fri	No deals

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Legend submits NDA to Japan regulator for BCMA CAR-T therapy Cilta-cel for RRMM

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