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2023-01-19 09:08:52 PBLA Panbela Therapeutics $3.42 / +0.17 (+5.23%) 09:08 01/19/23 01/19 09:08 01/19/23 09:08	Panbela: EMA adopts decision for SBP-101 as orphan medicinal product Panbela Therapeutics announced that the European Medicines Agency EMA Committee for Orphan Medicinal Products has issued the Adoption of Commission Implementing Decision relating to the designation of ivospemin, SBP-101 as an orphan medicinal product in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma, PDA . The Commission adopted the decision on January 13, 2023 and it will be published for information in all official languages of the EU in the Community Register of Orphan Medicinal Products . Previously, the U.S. Food and Drug Administration granted orphan drug designation to SBP-101. "We are pleased to receive notice that the European Commission has adopted the positive decision for orphan drug designation from EMA's Committee for Orphan Medicinal Products," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "The designation of orphan drug status within the EU is an important achievement as we continue to advance the global ASPIRE trial with the potential that this may be an option for patients with first line metastatic pancreatic cancer in the future."

2023-01-19 09:08:52

PBLA

Panbela Therapeutics

$3.42 / +0.17 (+5.23%)

09:08

01/19/23

01/19

09:08

01/19/23

09:08

Panbela: EMA adopts decision for SBP-101 as orphan medicinal product

Panbela Therapeutics announced that the European Medicines Agency EMA Committee for Orphan Medicinal Products has issued the Adoption of Commission Implementing Decision relating to the designation of ivospemin, SBP-101 as an orphan medicinal product in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma, PDA . The Commission adopted the decision on January 13, 2023 and it will be published for information in all official languages of the EU in the Community Register of Orphan Medicinal Products . Previously, the U.S. Food and Drug Administration granted orphan drug designation to SBP-101. "We are pleased to receive notice that the European Commission has adopted the positive decision for orphan drug designation from EMA's Committee for Orphan Medicinal Products," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "The designation of orphan drug status within the EU is an important achievement as we continue to advance the global ASPIRE trial with the potential that this may be an option for patients with first line metastatic pancreatic cancer in the future."

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Initiation	Inari Medical assumed with an Overweight at Morgan Stanley » 06:59 05/30/23 05/30 06:59 05/30/23 06:59 NARI Inari Medical $59.00 / -0.49 (-0.82%) Morgan Stanley analyst… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return on Jun 2nd, 06:59 Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings NARI Inari Medical $59.00 / -0.49 (-0.82%) 05/22/23 Inari Medical announces planned enrollment of PEERLESS II trial 03/06/23 Inari Medical announces results from FLAME study 01/19/23 Inari Medical director sells $3.68M in common stock 01/12/23 Inari:1st patient enrolled in 'clinical outcomes' study of ClotTriever for DVT NARI Inari Medical $59.00 / -0.49 (-0.82%) 05/04/23 Canaccord Inari Medical price target raised to $84 from $80 at Canaccord 04/18/23 Truist Inari Medical price target raised to $70 from $68 at Truist 02/28/23 Canaccord Inari Medical price target raised to $80 from $77 at Canaccord 02/21/23 Canaccord Inari Medical price target raised to $77 from $76 at Canaccord NARI Inari Medical $59.00 / -0.49 (-0.82%) 05/03/23 Inari Medical raises FY23 revenue view to $478M-$488M from $470M-$480M 05/03/23 Inari Medical reports Q1 EPS (4c), consensus (23c) 02/27/23 Inari Medical sees FY23 revenue $470M-$480M, consensus $465.34M 02/27/23 Inari Medical reports Q4 EPS (11c), consensus (17c)
Initiation	iRhythm assumed with an Overweight at Morgan Stanley » 06:58 05/30/23 05/30 06:58 05/30/23 06:58 IRTC iRhythm $119.31 / -1.51 (-1.25%) Morgan Stanley analyst… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return on Jun 2nd, 06:58 Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings On The Fly IRTC iRhythm $119.31 / -1.51 (-1.25%) 05/22/23 iRhythm announces presentation of four new studies as Hearth Rythum 2023 03/15/23 iRhythm COO Douglas Devine steps down 03/10/23 iRhythm provides update on investments with SVB Financial 03/06/23 iRhythm announces results of multiple new studies at ACC.23/WCC IRTC iRhythm $119.31 / -1.51 (-1.25%) 05/05/23 Canaccord iRhythm price target raised to $153 from $143 at Canaccord 05/05/23 Needham iRhythm price target raised to $151 from $133 at Needham 05/05/23 Citi iRhythm price target raised to $135 from $130 at Citi 04/17/23 Truist iRhythm price target raised to $154 from $137 at Truist IRTC iRhythm $119.31 / -1.51 (-1.25%) 05/04/23 iRhythm reports Q1 EPS ($1.29), consensus (90c) 03/15/23 iRhythm affirms FY23 revenue view of $475M-$485M, consensus $482.2M 02/23/23 iRhythm Sees FY23 revenue $475M-$485M, consensus $485.6M 02/23/23 iRhythm reports Q4 EPS (67c), consensus (62c) IRTC iRhythm $119.31 / -1.51 (-1.25%) 02/07/23 Street Wrap: Today's Top 15 Upgrades, Downgrades, Initiations
Initiation	Axonics assumed with an Overweight at Morgan Stanley » 06:58 05/30/23 05/30 06:58 05/30/23 06:58 AXNX Axonics $48.52 / -1.03 (-2.08%) Morgan Stanley assumed… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return on Jun 2nd, 06:58 Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings Syndicate On The Fly Events AXNX Axonics $48.52 / -1.03 (-2.08%) 04/24/23 Axonics acquired assets of Radian, terms not disclosed 01/31/23 Axonics receives FDA approval for rechargeable sacral neuromodulation system 12/13/22 Axonics announces Health Canada approval of R20 neurostimulator AXNX Axonics $48.52 / -1.03 (-2.08%) 05/23/23 CL King Axonics initiated with Buy on 'underpenetrated markets' at CL King 05/23/23 CL King Axonics initiated with a Buy at CL King 05/02/23 Needham Axonics price target raised to $73 from $71 at Needham 04/17/23 Truist Axonics price target lowered to $73 from $82 at Truist AXNX Axonics $48.52 / -1.03 (-2.08%) 05/01/23 Axonics raises FY23 revenue view to $348M from $324M, consensus $347.8M 05/01/23 Axonics reports Q1 EPS (19c), consensus (29c) 03/01/23 Axonics backs FY23 revenue view of $342M, consensus $336.4M 03/01/23 Axonics reports Q4 EPS 1c, consensus (24c) 03 Aug AXNX Axonics $48.52 / -1.03 (-2.08%) 05/23/23 Street Wrap: Today's Top 15 Upgrades, Downgrades, Initiations 05/01/23 Fly Intel: After-Hours Movers 03/24/23 Street Wrap: Today's Top 15 Upgrades, Downgrades, Initiations 01/11/23 What You Missed On Wall Street On Wednesday 06/26/23 Axonics Inc
Recommendations	Insperity price target lowered to $120 from $131 at Baird » 06:57 05/30/23 05/30 06:57 05/30/23 06:57 NSP Insperity $110.43 / +0.2 (+0.18%) Baird analyst Mark Marcon… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return on Jun 2nd, 06:57 Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings On The Fly Events NSP Insperity $110.43 / +0.2 (+0.18%) 05/24/23 Insperity announces 10% dividend increase to 57c per share 04/24/23 Insperity falls -7.4% 02/16/23 Insperity VP Herinks ells 5,000 shares of company stock NSP Insperity $110.43 / +0.2 (+0.18%) 04/27/23 Roth MKM Insperity price target raised to $147 from $144 at Roth MKM 04/24/23 Truist Insperity cut to Hold at Truist amid softening white collar labor trends 04/24/23 Truist Insperity downgraded to Hold from Buy at Truist 04/24/23 Truist Insperity downgraded to Hold from Buy at Truist NSP Insperity $110.43 / +0.2 (+0.18%) 04/26/23 Insperity sees FY23 EPS $5.62 - $6.39, consensus $5.66 04/26/23 Insperity sees Q2 EPS $1.16- $1.32, consensus $1.17 04/26/23 Insperity reports Q1 EPS $2.67, consensus $2.48 02/09/23 Insperity sees FY23 EPS $5.24-$6.30, consensus $5.32 NSP Insperity $110.43 / +0.2 (+0.18%) 04/24/23 Street Wrap: Today's Top 15 Upgrades, Downgrades, Initiations 06/13/23 Business Services Bus Tour

Initiation	Sight Sciences assumed with an Overweight at Morgan Stanley » 06:57 05/30/23 05/30 06:57 05/30/23 06:57 SGHT Sight Sciences $9.26 / +0.24 (+2.66%) Morgan Stanley analyst… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return on Jun 2nd, 06:57 Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings On The Fly Events SGHT Sight Sciences $9.26 / +0.24 (+2.66%) 05/23/23 Sight Sciences announces publication of two-year results of ROMEO study 05/07/23 Sight Sciences announces 12-month results from MIGS comparative analysis of RWD 04/03/23 Sight Sciences appoints Alison Bauerlein CFO 03/30/23 Sight Sciences defeats invalidity challenges filed by Alcon, Ivantis SGHT Sight Sciences $9.26 / +0.24 (+2.66%) 01/06/23 Stifel Stifel upgrades Sight Sciences to Buy on potential 2023 upside 01/06/23 Stifel Sight Sciences upgraded to Buy from Hold at Stifel 12/12/22 Citi Sight Sciences price target raised to $15 from $10 at Citi 10/12/22 Piper Sandler CMS proposal a positive for Med Tech sector, says Piper Sandler SGHT Sight Sciences $9.26 / +0.24 (+2.66%) 03/13/23 Sight Sciences sees FY23 revenue $ $89M-$94M, consensus $91.22M 03/13/23 Sight Sciences reports Q4 EPS (35c), consensus (42c) 01/09/23 Sight Sciences sees FY22 revenue $71.2M-$71.4M, consensus $70.93M 01/09/23 Sight Sciences sees Q4 revenue $20.4M-$20.6M , consensus $20.12M SGHT Sight Sciences $9.26 / +0.24 (+2.66%) 01/09/23 Fly Intel: After-Hours Movers 06/08/23 Sight Sciences, Inc.
Initiation	Insulet assumed with an Equal Weight at Morgan Stanley » 06:56 05/30/23 05/30 06:56 05/30/23 06:56 PODD Insulet $272.56 / -4.225 (-1.53%) Morgan Stanley assumed… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return on Jun 2nd, 06:56 Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings Periodicals On The Fly PODD Insulet $272.56 / -4.225 (-1.53%) 05/04/23 Insulet names Eric Benjamin CPXO, Mark Field CTO 04/25/23 Insulet announces FDA approval of Omnipod GO 04/21/23 Tandem Diabetes down 5% after FDA approves Medtronic's MiniMed 780G 03/15/23 Insulet to replace SVB Financial in S&P 500 at open on 3/15 PODD Insulet $272.56 / -4.225 (-1.53%) 05/08/23 Barclays Insulet price target raised to $329 from $292 at Barclays 05/05/23 UBS Insulet price target raised to $360 from $328 at UBS 05/05/23 Piper Sandler Insulet price target raised to $360 from $340 at Piper Sandler 05/05/23 Baird Insulet price target raised to $370 from $350 at Baird PODD Insulet $272.56 / -4.225 (-1.53%) 05/04/23 Insulet raises FY23 revenue growth view to 18%-22% from 14%-19% 05/04/23 Insulet sees Q2 revenue growth of 27%-30% 05/04/23 Insulet reports Q1 EPS 34c, consensus 11c 02/23/23 Insulet sees FY23 revenue growth 14%-19%, consensus $1.47B PODD Insulet $272.56 / -4.225 (-1.53%) 02/22/23 Apple hits breakthroughs in glucose monitoring project, Bloomberg reports PODD Insulet $272.56 / -4.225 (-1.53%) 05/05/23 Street Wrap: Today's Top 15 Upgrades, Downgrades, Initiations 03/29/23 Street Wrap: Today's Top 15 Upgrades, Downgrades, Initiations 02/23/23 Fly Intel: After-Hours Movers 02/22/23 Diabetes management stocks slide on report of tech giant's breakthroughs
Initiation	DexCom assumed with an Equal Weight at Morgan Stanley » 06:56 05/30/23 05/30 06:56 05/30/23 06:56 DXCM DexCom $115.06 / +0.475 (+0.41%) Morgan Stanley analyst… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return on Jun 2nd, 06:56 Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings Periodicals On The Fly Events Options DXCM DexCom $115.06 / +0.475 (+0.41%) 04/17/23 DexCom commends expansion of CGM Medicare to diabetics using all insulin types 03/21/23 DexCom announces expanded coverage for G6 CGM System in Manitoba 03/13/23 DexCom has no material exposure to developments at Silicon Valley Bank 03/06/23 DexCom down more than 7% after FDA gives nod to Abbott CGM sensors DXCM DexCom $115.06 / +0.475 (+0.41%) 05/01/23 Barclays DexCom price target raised to $115 from $110 at Barclays 04/28/23 Stifel DexCom price target raised to $140 from $130 at Stifel 04/28/23 UBS DexCom price target raised to $150 from $142 at UBS 04/28/23 BTIG DexCom price target raised to $134 from $132 at BTIG DXCM DexCom $115.06 / +0.475 (+0.41%) 04/27/23 DexCom sees FY23 revenue $3.40B-$3.52B, consensus $3.47B 04/27/23 DexCom reports Q1 EPS 17c, consensus 15c 04/27/23 Notable companies reporting after market close 02/09/23 DexCom sees FY23 revenue of $3.35B-$3.49B, consensus $3.47B DXCM DexCom $115.06 / +0.475 (+0.41%) 02/22/23 Apple hits breakthroughs in glucose monitoring project, Bloomberg reports DXCM DexCom $115.06 / +0.475 (+0.41%) 04/27/23 Fly Intel: After-Hours Movers 04/03/23 Fly Insider: Kohl's, 89Bio among week's notable insider trades 03/29/23 Street Wrap: Today's Top 15 Upgrades, Downgrades, Initiations 02/22/23 Diabetes management stocks slide on report of tech giant's breakthroughs 00:00 Today DexCom DXCM DexCom $115.06 / +0.475 (+0.41%) 03/06/23 DexCom put volume heavy and directionally bearish 03/02/23 Early notable gainers among liquid option names on March 2nd 02/10/23 Early notable gainers among liquid option names on February 10th 02/09/23 DexCom options imply 6.0% move in share price post-earnings
Initiation	TransMedics assumed with an Equal Weight at Morgan Stanley » 06:55 05/30/23 05/30 06:55 05/30/23 06:55 TMDX TransMedics / + Morgan Stanley analyst… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return on Jun 2nd, 06:55 Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings Syndicate On The Fly TMDX TransMedics / + 02/22/23 TransMedics jumps 14% to $73.72 after Q4 results, above-consensus guidance 01/25/23 TransMedics CEO Hassanein sells $801K in company shares TMDX TransMedics / + 05/18/23 Canaccord TransMedics price target lowered to $86 from $91 at Canaccord 05/02/23 Oppenheimer TransMedics price target raised to $90 from $85 at Oppenheimer 05/01/23 Canaccord TransMedics price target raised to $91 from $78 at Canaccord 02/23/23 Canaccord TransMedics price target raised to $78 from $68 at Canaccord TMDX TransMedics / + 05/01/23 TransMedics raises FY23 revenue view to $160M-$170M from $138M-$145M 05/01/23 TransMedics reports Q1 EPS (8c), consensus (25c) 02/22/23 TransMedics sees 2023 revenue $$138M-$145M, consensus $134.71M 02/22/23 TransMedics reports Q4 EPS (21c), consensus (30c) 05 Aug TMDX TransMedics / + 02/22/23 Fly Intel: After-Hours Movers
Recommendations	Hibbett price target lowered to $50 from $70 at Baird » 06:55 05/30/23 05/30 06:55 05/30/23 06:55 HIBB Hibbett $39.20 / -4.9 (-11.11%) Baird lowered the… Story temporarily locked. To read stories as they happen please subscribe, Login above, or return on Jun 2nd, 06:55 Get Free Trial ShowHide Related Items >><< Company News Street Research Earnings On The Fly Events HIBB Hibbett $39.20 / -4.9 (-11.11%) 05/26/23 Hibbett CEO says 'our consumers are facing a number of headwinds' 03/03/23 Hibbett sees FY24 CapEx $60M-$70M 03/03/23 Hibbett sees FY24 gross margin down 20-30 bps vs. FY23 03/03/23 Hibbett CEO sees 'several headwinds' in FY24 HIBB Hibbett $39.20 / -4.9 (-11.11%) 05/26/23 Baird Hibbett price target lowered to $50 from $80 at Baird 05/26/23 BofA Hibbett downgraded to Underperform from Buy at BofA 05/26/23 Williams Trading Hibbett cut to Sell at Williams Trading after 'far worse' than expected outlook 05/26/23 Williams Trading Hibbett downgraded to Sell from Hold at Williams Trading HIBB Hibbett $39.20 / -4.9 (-11.11%) 05/26/23 Hibbett cuts FY24 EPS view to $7.00-$7.75 from $9.50-$10.0, consensus $9.14 05/26/23 Hibbett reports Q1 EPS $2.74, consensus $3.04 03/03/23 Hibbett sees FY24 EPS $9.50-$10.0, consensus $10.40 03/03/23 Hibbett reports Q4 EPS $2.91, consensus $2.94 HIBB Hibbett $39.20 / -4.9 (-11.11%) 05/26/23 What You Missed On Wall Street On Friday 05/26/23 What You Missed On Wall Street This Morning 05/26/23 Fly Intel: Pre-market Movers 03/14/23 Street Wrap: Today's Top 15 Upgrades, Downgrades, Initiations 05/31/23 Hibbett 06/07/23 Hibbett Inc

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