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2022-07-25 07:02:37 MEDXF Medexus Pharmaceuticals $1.47 / + (+0.00%) 07:02 07/25/22 07/25 07:02 07/25/22 07:02	Medexus Pharmaceuticals announces resubmission of Treosulfan NDA Medexus Pharmaceuticals and medac announces that medac has resubmitted its New Drug Application for treosulfan with the U.S. Food and Drug Administration. The current submission was a response to the FDA request to submit information to complete medac's April 2022 NDA resubmission and initiate FDA review. The NDA requests approval of treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation. The current submission includes updates to data files and supporting information in response to the FDA's information request received with the FDA's acknowledgment of receipt of the NDA resubmission in May 2022. If the response is considered complete by the FDA, the review clock for the NDA resubmission will then start as of the date of submission of a complete response. "We remain excited about the prospect of a treosulfan approval in the United States and about treosulfan's significant potential in the U.S. market," commented Ken d'Entremont, Medexus's CEO. "We are encouraged by the recent publication of the final study results and analysis of the pivotal phase 3 clinical trial of treosulfan conducted by medac, which met its primary endpoint and key secondary endpoints. An FDA approval within a two- to six-month period from the acceptance date would then pave the way for a commercial launch of treosulfan in the United States in the first half of calendar year 2023."

2022-07-25 07:02:37

MEDXF

Medexus Pharmaceuticals

$1.47 / + (+0.00%)

07:02

07/25/22

07/25

07:02

07/25/22

07:02

Medexus Pharmaceuticals announces resubmission of Treosulfan NDA

Medexus Pharmaceuticals and medac announces that medac has resubmitted its New Drug Application for treosulfan with the U.S. Food and Drug Administration. The current submission was a response to the FDA request to submit information to complete medac's April 2022 NDA resubmission and initiate FDA review. The NDA requests approval of treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation. The current submission includes updates to data files and supporting information in response to the FDA's information request received with the FDA's acknowledgment of receipt of the NDA resubmission in May 2022. If the response is considered complete by the FDA, the review clock for the NDA resubmission will then start as of the date of submission of a complete response. "We remain excited about the prospect of a treosulfan approval in the United States and about treosulfan's significant potential in the U.S. market," commented Ken d'Entremont, Medexus's CEO. "We are encouraged by the recent publication of the final study results and analysis of the pivotal phase 3 clinical trial of treosulfan conducted by medac, which met its primary endpoint and key secondary endpoints. An FDA approval within a two- to six-month period from the acceptance date would then pave the way for a commercial launch of treosulfan in the United States in the first half of calendar year 2023."

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Recommendations	Warehouses De Pauw price target raised to EUR 27 from EUR 24 at RBC Capital » 15:24 02/08/23 02/08 15:24 02/08/23 15:24 WDPSF Warehouses De Pauw $32.35 / + (+0.00%) RBC Capital analyst… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return tomorrow Get Free Trial ShowHide Related Items >><< Street Research WDPSF Warehouses De Pauw $32.35 / + (+0.00%) 01/30/23 Kepler Cheuvreux Warehouses De Pauw downgraded to Hold from Buy at Kepler Cheuvreux 12/09/22 Barclays Warehouses De Pauw price target lowered to EUR 24 from EUR 25 at Barclays 12/09/22 JPMorgan Warehouses De Pauw downgraded to Neutral from Overweight at JPMorgan 10/25/22 JPMorgan Warehouses De Pauw price target lowered to EUR 31 from EUR 34.50 at JPMorgan
Recommendations	ams OSRAM price target raised to CHF 7.70 from CHF 7.30 at Credit Suisse » 15:20 02/08/23 02/08 15:20 02/08/23 15:20 AMSSY ams OSRAM $4.05 / -1.005 (-19.88%) Credit Suisse 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 AMSSY ams OSRAM $4.05 / -1.005 (-19.88%) 01/02/23 Energous, ams announce agriculture sensor application collaboration AMSSY ams OSRAM $4.05 / -1.005 (-19.88%) 01/18/23 Bernstein ams OSRAM initiated with a Market Perform at Bernstein 12/06/22 Oddo BHF ams OSRAM downgraded to Underperform from Neutral at Oddo BHF 11/22/22 Credit Suisse ams OSRAM price target lowered to CHF 7.30 from CHF 9.50 at Credit Suisse 11/03/22 Deutsche Bank ams OSRAM price target lowered to CHF 7.50 from CHF 8.50 at Deutsche Bank
Options	Tenet options imply 7.4% move in share price post-earnings » 15:19 02/08/23 02/08 15:19 02/08/23 15:19 THC Tenet Healthcare $54.12 / -0.395 (-0.72%) Pre-earnings options… 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 Options THC Tenet Healthcare $54.12 / -0.395 (-0.72%) 01/19/23 Tenet Healthcare CFO Daniel Cancelmi retiring at year-end 01/19/23 Tenet Healthcare now sees 2022 adjusted EBITDA above $3.425B guidance midpoint 01/17/23 Tenet Healthcare up 1% in early trading after Einhorn reveals long position 10/21/22 Tenet Healthcare falls -31.7% THC Tenet Healthcare $54.12 / -0.395 (-0.72%) 01/03/23 Truist Tenet Healthcare price target raised to $60 from $55 at Truist 12/06/22 Loop Capital Tenet Healthcare price target raised to $45 from $40 at Loop Capital 10/27/22 Raymond James Tenet Healthcare price target lowered to $80 from $135 at Raymond James 10/25/22 Citi Tenet Healthcare shares offer 'significant upside,' says Citi THC Tenet Healthcare $54.12 / -0.395 (-0.72%) 10/20/22 Tenet narrows FY22 EPS view to $5.88-$6.42 from $5.80-$7, consensus $6.46 10/20/22 Tenet Healthcare sees Q4 adjusted EPS $1.00-$1.54, consensus $1.80 10/20/22 Tenet Healthcare reports Q3 adjusted EPS $1.44, consensus $1.24 10/20/22 Notable companies reporting after market close THC Tenet Healthcare $54.12 / -0.395 (-0.72%) 01/17/23 Greenlight took 'medium-sized' Tenet Healthcare position in Q4, Bloomberg says THC Tenet Healthcare $54.12 / -0.395 (-0.72%) 01/17/23 What You Missed On Wall Street On Tuesday 01/17/23 What You Missed On Wall Street This Morning 10/21/22 What You Missed On Wall Street On Friday 10/21/22 What You Missed On Wall Street This Morning 02/09/23 Tenet Healthcare - THC 02/23/23 Tenet Healthcare THC Tenet Healthcare $54.12 / -0.395 (-0.72%) 01/27/23 Largest borrow rate increases among liquid names 11/21/22 Tenet put volume heavy and directionally bearish 11/09/22 Tenet call volume above normal and directionally bullish 11/08/22 Tenet call volume above normal and directionally bullish
Technical Analysis	NASDAQ market internals summary » 15:17 02/08/23 02/08 15:17 02/08/23 15:17 $NSD NASDAQ Market Internals / + Volume is above average… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return tomorrow Get Free Trial ShowHide Related Items >><< Technical Analysis $NSD NASDAQ Market Internals / + 14:17 Today NASDAQ market internals summary 13:17 Today NASDAQ market internals summary 12:17 Today NASDAQ market internals summary 11:17 Today NASDAQ market internals summary
Recommendations	BNP Paribas price target raised to EUR 78 from EUR 75 at Credit Suisse » 15:16 02/08/23 02/08 15:16 02/08/23 15:16 BNPQY BNP Paribas $33.59 / +1.09 (+3.35%) Credit Suisse analyst Jon… 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 Periodicals BNPQY BNP Paribas $33.59 / +1.09 (+3.35%) 01/17/23 Bank of Montreal gets regulatory approval to acquire Bank of the West 01/03/23 Kentucky lists BlackRock, Citi, JPMorgan as energy boycotters 12/16/22 FDIC identifies deficiencies in Credit Suisse, BNP Paribus 2021 plan submissions 12/08/22 Euronet appoints Torres to board of directors BNPQY BNP Paribas $33.59 / +1.09 (+3.35%) 01/30/23 Barclays Barclays upgrades European banks view to Positive from Neutral 01/13/23 JPMorgan BNP Paribas price target lowered to EUR 60 from EUR 61 at JPMorgan 11/28/22 Barclays BNP Paribas upgraded to Overweight from Equal Weight at Barclays 11/09/22 Morgan Stanley BNP Paribas price target raised to EUR 68 from EUR 67 at Morgan Stanley BNPQY BNP Paribas $33.59 / +1.09 (+3.35%) 11/25/22 Deutsche Bank, BNP to face higher capital requirements from ECB, Bloomberg says 08/25/22 Blackrock, UBS named energy industry boycotters by Texas, WSJ says
Technical Analysis	NYSE market internals summary » 15:16 02/08/23 02/08 15:16 02/08/23 15:16 $NYE NYSE Market Internals / + Volume is average for… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return tomorrow Get Free Trial ShowHide Related Items >><< Technical Analysis $NYE NYSE Market Internals / + 14:16 Today NYSE market internals summary 13:16 Today NYSE market internals summary 12:16 Today NYSE market internals summary 11:16 Today NYSE market internals summary

Recommendations	Idorsia price target lowered to CHF 12.50 from CHF 15 at Credit Suisse » 15:15 02/08/23 02/08 15:15 02/08/23 15:15 IDRSF Idorsia $13.51 / -1.165 (-7.94%) Credit Suisse analyst… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return tomorrow Get Free Trial ShowHide Related Items >><< Street Research IDRSF Idorsia $13.51 / -1.165 (-7.94%) 01/18/23 Jefferies Idorsia downgraded to Hold from Buy at Jefferies 01/03/23 JPMorgan Idorsia price target lowered to CHF 15 from CHF 17 at JPMorgan 11/10/22 Credit Suisse Idorsia downgraded to Neutral from Outperform at Credit Suisse 10/26/22 Credit Suisse Idorsia price target lowered to CHF 21 from CHF 25 at Credit Suisse
Recommendations	TeamViewer price target raised to EUR 15 from EUR 14 at Barclays » 15:12 02/08/23 02/08 15:12 02/08/23 15:12 TMVWY TeamViewer $7.73 / +1.19 (+18.20%) Barclays analyst James… 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 TMVWY TeamViewer $7.73 / +1.19 (+18.20%) 12/15/22 Manchester United, TeamViewer reach agreement on future partnership 11/30/22 Climb Channel Solutions selects TeamViewer as preferred partner TMVWY TeamViewer $7.73 / +1.19 (+18.20%) 14:31 Today Morgan Stanley TeamViewer price target raised to EUR 13 from EUR 12.50 at Morgan Stanley 02/01/23 JPMorgan TeamViewer downgraded to Underweight from Neutral at JPMorgan 01/12/23 Morgan Stanley TeamViewer price target raised to EUR 12.50 from EUR 12 at Morgan Stanley 12/12/22 Morgan Stanley TeamViewer downgraded to Underweight from Equal Weight at Morgan Stanley
Recommendations	Demant price target raised to DKK 180 from DKK 175 at Barclays » 15:12 02/08/23 02/08 15:12 02/08/23 15:12 WILYY Demant $15.26 / + (+0.00%) Barclays analyst Hassan… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return tomorrow Get Free Trial ShowHide Related Items >><< Street Research WILYY Demant $15.26 / + (+0.00%) 05:47 Today Danske Bank Demant upgraded to Buy from Hold at Danske Bank 01/30/23 Handelsbanken Demant upgraded to Outperform from Market Perform at Handelsbanken 01/25/23 Exane BNP Paribas Demant downgraded to Neutral from Outperform at Exane BNP Paribas 01/25/23 Jefferies Demant downgraded to Hold from Buy at Jefferies
Options	Lincoln National options imply 7.7% move in share price post-earnings » 15:11 02/08/23 02/08 15:11 02/08/23 15:11 LNC Lincoln National $35.23 / -0.19 (-0.54%) Pre-earnings options… 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 LNC Lincoln National $35.23 / -0.19 (-0.54%) 12/08/22 Lincoln National falls -7.3% 11/03/22 Lincoln National falls -31.1% 11/03/22 Lincoln National falls -28.3% 11/03/22 Lincoln National falls -25.3% LNC Lincoln National $35.23 / -0.19 (-0.54%) 01/09/23 Barclays Lincoln National cut to Underweight at Barclays amid ongoing capital strain 01/09/23 Barclays Lincoln National downgraded to Underweight from Equal Weight at Barclays 01/06/23 JPMorgan Lincoln National downgraded to Neutral from Overweight at JPMorgan 12/20/22 Piper Sandler Lincoln National price target lowered to $31 from $38 at Piper Sandler LNC Lincoln National $35.23 / -0.19 (-0.54%) 11/02/22 Lincoln National reports Q3 adjusted EPS with items ($10.23), consensus $1.64 LNC Lincoln National $35.23 / -0.19 (-0.54%) 11/16/22 Street Wrap: Today's Top 15 Upgrades, Downgrades, Initiations 11/04/22 Street Wrap: Today's Top 15 Upgrades, Downgrades, Initiations 11/03/22 What You Missed On Wall Street On Thursday 11/03/22 What You Missed On Wall Street This Morning 02/09/23 Lincoln National - LNC LNC Lincoln National $35.23 / -0.19 (-0.54%) 11/16/22 Early notable gainers among liquid option names on November 16th
Hot Stocks	California AG announces $215M settlement against Centene » 15:09 02/08/23 02/08 15:09 02/08/23 15:09 CNC Centene $73.40 / +2.51 (+3.54%) California Attorney… 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 Options CNC Centene $73.40 / +2.51 (+3.54%) 02/02/23 Managed care stocks pressured after CMS' preliminary Medicare Advantage rates 01/23/23 Centene completes divestiture of Magellan Specialty Health to Evolent Health 01/03/23 Centene's Health Net selected for new medi-cal direct contracts 12/16/22 Centene announces $2B increase to stock repurchase program CNC Centene $73.40 / +2.51 (+3.54%) 08:54 Today SVB Securities Cigna price target lowered to $309 from $335 at SVB Securities 07:51 Today Loop Capital Centene price target lowered to $95 from $110 at Loop Capital 05:26 Today Barclays Centene price target lowered to $93 from $100 at Barclays 01/31/23 JPMorgan Medicare Advantage final rule more favorable than feared, says JPMorgan CNC Centene $73.40 / +2.51 (+3.54%) 02/07/23 Centene backs FY23 adjusted EPS view $6.25-$6.40, consensus $6.36 02/07/23 Centene reports Q4 EPS 86c, consensus 85c 02/06/23 Notable companies reporting before tomorrow's open 02/06/23 Notable companies reporting before tomorrow's open CNC Centene $73.40 / +2.51 (+3.54%) 11/29/22 Managed care company returns will be tough to keep replicating, WSJ says 09/23/22 Nebraska picks two current, one new Medicaid health plan provider, OWH reports 09/23/22 UnitedHealth, Molina, Centene win Medicaid contracts in Nebraska, Bloomberg says 08/18/22 White House plans for end of COVID-19 vaccine coverage, WSJ reports CNC Centene $73.40 / +2.51 (+3.54%) 01/03/23 What You Missed On Wall Street On Tuesday 01/03/23 What You Missed On Wall Street This Morning 12/16/22 What You Missed On Wall Street On Friday 12/16/22 What You Missed On Wall Street This Morning 02/28/23 Centene CNC Centene $73.40 / +2.51 (+3.54%) 01/17/23 Centene call volume above normal and directionally bullish 01/09/23 Centene put volume heavy and directionally bearish 12/22/22 Early notable gainers among liquid option names on December 22nd 11/21/22 Centene put volume heavy and directionally bearish

Events

Earnings calls, analyst events, roadshows and more

WYNN
Today at 16:15

Wynn Resorts - WYNN Conference Calls
FORM
Today at 16:25

FormFactor - FORM Conference Calls
UTI
Today at 16:30

Universal Technical - UTI Conference Calls
ME
Today at 16:30

23andMe - ME Conference Calls
TTMI
Today at 16:30

TTM Technologies - TTMI Conference Calls
DIS
Today at 16:30

Disney - DIS Conference Calls
VKTX
Today at 16:30

Viking Therapeutics - VKTX Conference Calls
AEIS
Today at 16:30

Advanced Energy - AEIS Conference Calls
INFA
Today at 16:30

Informatica - INFA Conference Calls
VNDA
Today at 16:30

Vanda Pharmaceuticals - VNDA Conference Calls

View All Events »

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Syndicate

This week’s upcoming IPOs and secondary offerings

Priced
Not Priced

Mon	BLNK X BLNK Blink Charging Spot Secondary Managers: Barclays Priced at: $12.00 8.333M Shares Special Comments Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial
Tues	CVAC X CVAC CureVac Secondary Managers: Goldman Sachs, Jefferies, SVB Securities & Kempen Priced at: $9.25 27.027M Shares Special Comments Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial DT X DT Dynatrace Spot Secondary Managers: BofA Priced at: $45.55 15M Shares Special Comments Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial FRC X FRC First Republic Spot Secondary Managers: BofA, JPMorgan, Goldman Sachs & Morgan Stanley Priced at: $140.00 2.5M Shares Special Comments Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial LBPH X LBPH Longboard Pharmaceuticals Spot Secondary Managers: Evercore ISI & Cantor Fitzgerald Priced at: $4.00 5M Shares Special Comments Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial RXST X RXST RxSight Spot Secondary Managers: BofA Priced at: $12.50 4M Shares Special Comments Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial SINT X SINT Sintx Technologies Spot Secondary Managers: Maxim Priced at: $5.60 2.15M Shares Special Comments Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial STAF X STAF Staffing 360 Solutions Spot Secondary Managers: H.C. Wainwright Priced at: $2.65 1.88M Shares Special Comments Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial TMCI X TMCI Treace Medical Spot Secondary Managers: BTIG Priced at: $21.00 4.76M Shares Special Comments Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial XPOF X XPOF Xponential Fitness Spot Secondary Managers: BofA & Jefferies Priced at: $24.50 5M Shares Special Comments Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial
Wed	SONN X SONN Sonnet BioTherapeutics Secondary Managers: Chardan & EF Hutton Priced at: $1.08 13.89M Shares
Thurs	No deals
Fri	No deals

Mon	No deals
Tues	No deals
Wed	BFRG X BFRG Bullfrog AI IPO Managers: WallachBeth, Kingswood $6.50 1.32M Shares HSAI X HSAI Hesai IPO Managers: Goldman Sachs, Morgan Stanley & Credit Suisse, Huatai Securities $17.00 - 19.00 9M Shares INTS X INTS Intensity Therapeutics IPO Managers: Benchmark $4.00-4.50 1.778M Shares Special Comments Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial NRXS X NRXS Neuraxis IPO Managers: Alexander Capital $7.00-9.00 1.875M Shares NXT X NXT Nextracker IPO Managers: JPMorgan, BofA, Citi & Barclays, Truist, HSBC, BNP Paribas, Mizuho, Scotiabank, KeyBanc $20.00-23.00 23.26M Shares Special Comments Ratings Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial
Thurs	ENLT X ENLT Enlight Renewable Energy IPO Managers: JPMorgan, BofA & Barclays, Credit Suisse, Wolfe Research, Nomura, HSBC, Roth MKM $20.57 14M Shares Special Comments Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial LEWY X LEWY LeeWay Services IPO Managers: ThinkEquity $5.00 1M Shares MLYS X MLYS Mineralys Therapeutics IPO Managers: BofA, Ever Bank, Stifel, Credit Suisse, Guggenheim & Wells Fargo $14.00-16.00 10M Shares Special Comments Some content is locked. Log in above or sign up for a free trial to see this information. Get Free Trial
Fri	No deals

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Medexus Pharmaceuticals announces resubmission of Treosulfan NDA

OTHER BREAKING NEWS FROM THE FLY

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