Committee

Axis Initiates a Strategic Review

Retrieved on: 
Tuesday, February 20, 2024

Axis Auto Finance Inc. (“Axis” or the “Company”) ( TSX: AXIS ), a fintech lender changing the way Canadians finance used vehicles, announces that it has initiated a review of strategic alternatives to maximize shareholder value and in connection therewith has formed a special committee of independent directors (the "Special Committee") to oversee this process.

Key Points: 
  • Axis Auto Finance Inc. (“Axis” or the “Company”) ( TSX: AXIS ), a fintech lender changing the way Canadians finance used vehicles, announces that it has initiated a review of strategic alternatives to maximize shareholder value and in connection therewith has formed a special committee of independent directors (the "Special Committee") to oversee this process.
  • In response to incoming expressions of interest, Axis through the Special Committee, will evaluate a range of alternatives to determine the best path forward to maximize value for shareholders.
  • The Board has not set a timetable to complete the strategic review process nor have any decisions been made relating to strategic alternatives at this time.
  • There can be no assurance that the strategic review and the preliminary non-binding discussions will result in any binding offer or any other transaction, or of the pricing of any such possible transaction.

NYSE American to Commence Delisting Proceedings Against Bite Acquisition Corp. (BITE)

Retrieved on: 
Tuesday, February 20, 2024

The Company has a right to a review of NYSE Regulation staff’s determination to delist the Securities by the Listings Qualifications Panel of the Committee for Review of the Board of Directors of the Exchange (the “Panel”).

Key Points: 
  • The Company has a right to a review of NYSE Regulation staff’s determination to delist the Securities by the Listings Qualifications Panel of the Committee for Review of the Board of Directors of the Exchange (the “Panel”).
  • Following such appeal and a decision by the Panel, NYSE American or the Company will make an announcement regarding either proceeding with suspension and delisting or continued trading in the Company’s Securities.
  • If the Company does not appeal this determination, NYSE American will announce the date that trading will be suspended.
  • The filing by the Exchange of an application with the Securities and Exchange Commission to delist the Securities is pending completion of all applicable procedures, including any appeal by the Company of the NYSE Regulation staff’s decision.

NYSE American to Commence Delisting Proceedings Against Catcha Investment Corp (CHAA)

Retrieved on: 
Tuesday, February 20, 2024

NYSE American LLC (“NYSE American” or the “Exchange”) announced today that the staff of NYSE Regulation has determined to commence proceedings to delist the Class A ordinary shares of Catcha Investment Corp (the “Company”) — ticker symbol CHAA — from NYSE American.

Key Points: 
  • NYSE American LLC (“NYSE American” or the “Exchange”) announced today that the staff of NYSE Regulation has determined to commence proceedings to delist the Class A ordinary shares of Catcha Investment Corp (the “Company”) — ticker symbol CHAA — from NYSE American.
  • The Company has a right to a review of NYSE Regulation staff’s determination to delist the Class A ordinary shares by the Listings Qualifications Panel of the Committee for Review of the Board of Directors of the Exchange (the “Panel”).
  • Following such appeal and a decision by the Panel, NYSE American or the Company will make an announcement regarding either proceeding with suspension and delisting or continued trading in the Company’s Class A ordinary shares.
  • If the Company does not appeal this determination, NYSE American will announce the date that trading will be suspended.

Global Social and Emotional Learning (SEL) Market Analysis Report 2023: Demand for New Learning Models with Advancement in Technologies to Present Growth Opportunities - Forecasts to 2028 - ResearchAndMarkets.com

Retrieved on: 
Monday, February 19, 2024

The "Social and Emotional Learning Market by Offering (Solution, Services), Solution (Social & Emotional Learning Platform, Social & Emotional Learning Assessment Tool), Service, End User, Core Competency, Type & Regions - Global Forecast to 2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Social and Emotional Learning Market by Offering (Solution, Services), Solution (Social & Emotional Learning Platform, Social & Emotional Learning Assessment Tool), Service, End User, Core Competency, Type & Regions - Global Forecast to 2028" report has been added to ResearchAndMarkets.com's offering.
  • The report would help stakeholders understand the market's pulse and provide them with information on the key market drivers, restraints, challenges, and opportunities.
  • The growing demand for SEL is increasing due to the usage and demand for various advanced technologies, such as wearable devices, mixed reality, and AI.
  • Emotional Learning (EL) involves developing an individual's ability to make positive life choices, achieve intellectual success, and build a promising career.

European Commission Approves Pfizer’s VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis

Retrieved on: 
Monday, February 19, 2024

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
  • “For the 2.6 million people in Europe living with UC, the unpredictable physical, mental, and emotional impacts of the condition can be debilitating.
  • This authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2023.
  • Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of VELSIPITY.

Summary of opinion: Xromi, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024

On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xromi.

Key Points: 
  • On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Xromi.
  • The marketing authorisation holder for this medicinal product is Nova Laboratories Ireland Limited.
  • The CHMP adopted an extension to the existing indication to include prevention of sickle cell disease complications in infants from 9 months of age.
  • 1New text in bold, removed text as strikethrough

Summary of opinion: Reblozyl, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024

On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Reblozyl.

Key Points: 
  • On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Reblozyl.
  • The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
  • For information, the full indications for Reblozyl will be as follows:
    Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) (see section 5.1).
  • Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non-transfusion dependent beta thalassaemia (see section 5.1).

Summary of opinion: Carvykti, 22/02/2024

Retrieved on: 
Sunday, March 10, 2024

On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Carvykti.

Key Points: 
  • On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Carvykti.
  • The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV.
  • The CHMP adopted an extension to the existing indication to include treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior therapy.
  • 1New text in bold, removed as strikethrough

Summary of opinion: Cibinqo, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024

On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Cibinqo.

Key Points: 
  • On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Cibinqo.
  • The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.
  • The CHMP adopted an extension to the existing indication to include treatment of adolescents aged 12 years and older.
  • For information, the full indication will therefore be as follows1:
    Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

Summary of opinion: Kalydeco, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024

On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Kalydeco.

Key Points: 
  • On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Kalydeco.
  • The marketing authorisation holder for this medicinal product is Vertex Pharmaceuticals (Ireland) Limited.
  • The CHMP recommended the approval of a new presentation of Kalydeco granules (13.4 mg granules in sachet) and an extension to the existing indication to allow use in children from 1 month of age.
  • For information, the indications for Kalydeco tablets remain unchanged and are provided in the summary of product characteristics (SmPC).