Toll

Takeda Receives Positive CHMP Opinion for Recombinant ADAMTS13 (rADAMTS13) in Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

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금요일, 5월 31, 2024

Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval, under exceptional circumstances, of recombinant ADAMTS13 (rADAMTS13) for the treatment of ADAMTS13 deficiency in children and adult patients with cTTP.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval, under exceptional circumstances, of recombinant ADAMTS13 (rADAMTS13) for the treatment of ADAMTS13 deficiency in children and adult patients with cTTP.
  • The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for rADAMTS13 throughout the European Union (EU).
  • “With this positive opinion for recombinant ADAMTS13, we are one step closer to offering patients in the EU the first treatment specifically indicated for cTTP.
  • Data from this trial ( NCT03393975 ) were published in The New England Journal of Medicine in May 2024. rADAMTS13 is also being investigated in adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP), the acquired form of TTP, in an ongoing Phase 2b trial ( NCT05714969 ).

Glass Lewis Joins ISS in Recommending Gildan Activewear Shareholders Vote “FOR” ALL EIGHT of Browning West’s Director Candidates, Including Former CEO Glenn Chamandy

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월요일, 5월 20, 2024

Notably, Glass Lewis and ISS both recommended shareholders WITHHOLD support for all 10 of Gildan’s nominees: Timothy Hodgson, Lewis Bird, III, Dhaval Buch, Marc Caira, Jane Craighead, Sharon Driscoll, Lynn Loewen, Anne Martin-Vachon, current CEO Vince Tyra, and Les Viner.

Key Points: 
  • Notably, Glass Lewis and ISS both recommended shareholders WITHHOLD support for all 10 of Gildan’s nominees: Timothy Hodgson, Lewis Bird, III, Dhaval Buch, Marc Caira, Jane Craighead, Sharon Driscoll, Lynn Loewen, Anne Martin-Vachon, current CEO Vince Tyra, and Les Viner.
  • Glass Lewis also recommended shareholders vote against Gildan’s proposed executive compensation because it does not align with shareholders’ interests.
  • Usman S. Nabi and Peter M. Lee of Browning West commented:
    “We appreciate the ringing endorsement both leading independent proxy advisory firms have given our entire slate of director candidates.
  • Visit SEDAR+ ( www.sedarplus.ca ) to review a copy of Browning West’s Circular and related proxy materials, including a GOLD Proxy Card or voting instruction form.

ISS Recommends Gildan Activewear Shareholders Vote the GOLD Proxy Card “FOR” ALL EIGHT of Browning West’s Director Candidates, Including Former CEO Glenn Chamandy

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금요일, 5월 17, 2024

Usman S. Nabi and Peter M. Lee of Browning West commented:

Key Points: 
  • Usman S. Nabi and Peter M. Lee of Browning West commented:
    “We are pleased ISS has recommended shareholders elect our entire slate of director candidates, including Gildan co-founder and proven value creator Glenn Chamandy.
  • The report from ISS is a resounding indictment of the incumbent Board, including directors new and old, which threw Gildan into chaos by terminating Mr. Chamandy late last year.
  • Visit SEDAR+ ( www.sedarplus.ca ) to review a copy of Browning West’s Circular and related proxy materials, including a GOLD Proxy Card or voting instruction form.
  • Longacre Square Partners is serving as strategic advisor and Pelican PR is serving as public relations advisor.

Goodness Growth Holdings Announces First Quarter 2024 Results

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화요일, 5월 7, 2024

MINNEAPOLIS, May 07, 2024 (GLOBE NEWSWIRE) -- Goodness Growth Holdings, Inc. ("Goodness Growth" or the "Company") (CSE: GDNS; OTCQX: GDNSF), a cannabis company committed to providing safe access, quality products and great value to its customers, today reported financial results for its first quarter ended March 31, 2024. Key financial results are presented below in summary form with supporting commentary and discussion from management of certain key operating metrics which the Company uses to judge its performance. All currency figures referenced herein are denominated in U.S. dollars.

Key Points: 
  • On April 1, 2024, the Company announced that it has executed a binding term sheet with ACE Venture Enterprises, Inc. (“Ace”), whereby Ace will acquire Goodness Growth Holdings subsidiary, Vireo Health of New York, pending regulatory approval.
  • The parties also committed to a collaborative advisory agreement that retains Goodness Growth’s management and compliance oversight in return for an approximate 15 percent share of net profits.
  • On May 1, 2024, the Company announced several leadership and corporate updates related to the day-to-day management of its business.
  • ET (3:30 p.m. CT) to discuss its financial results for its first quarter ended March 31, 2024.

Knowles Reports Q1 2024 Financial Results and Provides Outlook for Q2 2024

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수요일, 5월 1, 2024

Non-GAAP information should be considered a supplement to, and not a substitute for, financial statements prepared in accordance with GAAP.

Key Points: 
  • Non-GAAP information should be considered a supplement to, and not a substitute for, financial statements prepared in accordance with GAAP.
  • In addition, the non-GAAP financial measures included in this press release do not have standard meanings and may vary from similarly titled non-GAAP financial measures used by other companies.
  • Knowles believes that its presentation of these non-GAAP financial measures is useful because it provides investors and securities analysts with the same information that Knowles uses internally for purposes of assessing its core operating performance.
  • For a reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures, see the reconciliation table accompanying this release.

Goodness Growth Holdings Announces Fourth Quarter and Full Year 2023 Results

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월요일, 4월 1, 2024

MINNEAPOLIS, April 01, 2024 (GLOBE NEWSWIRE) -- Goodness Growth Holdings, Inc. ("Goodness Growth" or the "Company") (CSE: GDNS; OTCQX: GDNSF), a cannabis company committed to providing safe access, quality products and great value to its customers, today reported financial results for its fourth quarter and full year ended December 31, 2023. Key financial results are presented below in summary form with supporting commentary and discussion from management of certain key operating metrics which the Company uses to judge its performance. All currency figures referenced herein are denominated in U.S. dollars.

Key Points: 
  • 2"A Flower" refers to produced biomass that meet the Company's highest internal standards for flower quality, size, and appearance.
  • As of December 31, 2023, total current assets were $148.9 million, including cash on hand of $16.0 million.
  • As of December 31, 2023, the Company had a total of 232,799,343 shares outstanding on the treasury method basis.
  • ET (3:30 p.m. CT) to discuss its financial results for its fourth quarter and full year ended December 31, 2023.

Knowles to Release First Quarter 2024 Financial Results on May 1, 2024

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월요일, 4월 8, 2024

Knowles Corporation (NYSE: KN), a leading global supplier of high performance components and solutions, including ceramic capacitors and radio frequency (“RF”) filters, advanced medtech microphones and balanced armature speakers and MEMS microphones for the consumer electronic market, today announced the date for the release of its first quarter 2024 financial results.

Key Points: 
  • Knowles Corporation (NYSE: KN), a leading global supplier of high performance components and solutions, including ceramic capacitors and radio frequency (“RF”) filters, advanced medtech microphones and balanced armature speakers and MEMS microphones for the consumer electronic market, today announced the date for the release of its first quarter 2024 financial results.
  • Knowles will issue its first quarter 2024 financial results on May 1, 2024, immediately after market close followed by a conference call at 3:30 p.m. Central time (4:30 p.m. Eastern time) to discuss the results and company outlook.
  • The conference ID is 3966457 followed by # key.
  • A webcast replay will also be accessible via the Knowles website at http://investor.knowles.com for a limited time.

Goodness Growth Holdings Reschedules Fourth Quarter and Full Year 2023 Results Call to April 1, 2024

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월요일, 3월 25, 2024

MINNEAPOLIS, March 25, 2024 (GLOBE NEWSWIRE) -- Goodness Growth Holdings, Inc. ("Goodness Growth" or the "Company") (CSE: GDNS; OTCQX: GDNSF), a cannabis company committed to providing safe access, quality products and great value to its customers, today announced that, due to scheduling conflicts, it has rescheduled its fourth quarter and full year results conference call for the year ended December 31, 2023 to Monday, April 1, 2024 after the market closes.

Key Points: 
  • MINNEAPOLIS, March 25, 2024 (GLOBE NEWSWIRE) -- Goodness Growth Holdings, Inc. ("Goodness Growth" or the "Company") (CSE: GDNS; OTCQX: GDNSF), a cannabis company committed to providing safe access, quality products and great value to its customers, today announced that, due to scheduling conflicts, it has rescheduled its fourth quarter and full year results conference call for the year ended December 31, 2023 to Monday, April 1, 2024 after the market closes.
  • Goodness Growth management will host a conference call with the investment community that day, Monday, April 1, 2024 at 4:30 p.m.
  • ET (3:30 p.m. CT) to discuss its results.
  • Interested parties may attend the conference call by dialing 1-800-715-9871 (Toll-Free) (US and Canada) or 1-646-307-1963 (Toll) (International) and referencing conference ID number 3718174.

Goodness Growth Holdings to Release Fourth Quarter and Full Year 2023 Results on March 28, 2024

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목요일, 3월 14, 2024

MINNEAPOLIS, March 14, 2024 (GLOBE NEWSWIRE) -- Goodness Growth Holdings, Inc. ("Goodness Growth" or the "Company") (CSE: GDNS; OTCQX: GDNSF), a cannabis company committed to providing safe access, quality products and great value to its customers, today announced that it will release its financial results for its fourth quarter and full year ended December 31, 2023 on Thursday, March 28, 2024 after the market closes.

Key Points: 
  • MINNEAPOLIS, March 14, 2024 (GLOBE NEWSWIRE) -- Goodness Growth Holdings, Inc. ("Goodness Growth" or the "Company") (CSE: GDNS; OTCQX: GDNSF), a cannabis company committed to providing safe access, quality products and great value to its customers, today announced that it will release its financial results for its fourth quarter and full year ended December 31, 2023 on Thursday, March 28, 2024 after the market closes.
  • Goodness Growth management will host a conference call with the investment community that same day, Thursday, March 28, 2024 at 4:30 p.m.
  • ET (3:30 p.m. CT) to discuss its results.
  • Interested parties may attend the conference call by dialing 1-800-715-9871 (Toll-Free) (US and Canada) or 1-646-307-1963 (Toll) (International) and referencing conference ID number 3718174.

Takeda Announces Approval of ADZYNMA® Intravenous Injection 1500 (apadamtase alfa /cinaxadamtase alfa) in Japan for Patients with Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

Retrieved on: 
화요일, 3월 26, 2024

Takeda ( TSE: 4502/NYSE:TAK ) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of ADZYNMA (apadamtase alfa /cinaxadamtase alfa) for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP) for individuals 12 years of age and older.1 ADZYNMA is the first and only approved recombinant ADAMTS13 protein designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme.

Key Points: 
  • Takeda ( TSE: 4502/NYSE:TAK ) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of ADZYNMA (apadamtase alfa /cinaxadamtase alfa) for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP) for individuals 12 years of age and older.1 ADZYNMA is the first and only approved recombinant ADAMTS13 protein designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme.
  • cTTP is an ultra-rare, chronic blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme.2 It is associated with acute events and debilitating chronic symptoms or thrombotic thrombocytopenic purpura (TTP) manifestations, which can include thrombocytopenia, microangiopathic hemolytic anemia, headache and abdominal pain.2,3,4 When left untreated, acute TTP events have a mortality rate of >90%.2,4
    “The approval of ADZYNMA is an important milestone for people living with cTTP in Japan, who had limited treatment options and now have the first treatment option specifically approved to treat this ultra-rare condition,” said Yasushi Kajii, Head, R&D Japan Region at Takeda.
  • “Developing innovative treatments that make a difference in the lives of patients is at the heart of what we do.
  • In Period 3, the incidence of TEAEs was 2.8% (1/36) in this drug group: nausea and headache (1 subject each).6
    This approval does not result in any changes to Takeda’s consolidated forecast for the fiscal year ending March 31, 2024 (FY2023).