IRC

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer

Retrieved on: 
Sunday, April 7, 2024

Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.

Key Points: 
  • Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.
  • There were approximately 77,000 new cases of and 46,000 deaths due to renal carcinoma in China in 2022.
  • Distant metastasis occurred in about one-third of renal carcinoma patients at initial diagnosis, and in 20%-50% of localized patients after nephrectomy.
  • “The approval of toripalimab combined with axitinib addresses the gap in first-line immunotherapy for renal cancer in China.

HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status

Retrieved on: 
Tuesday, April 2, 2024

HONG KONG, SHANGHAI, China & FLORHAM PARK, N.J., April 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of fruquintinib and sintilimab for the treatment of patients with advanced endometrial cancer with pMMR1 or non-MSI-H2 tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”).

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase II study investigating fruquintinib in combination with sintilimab in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy.
  • Data from FRUSICA-1 will be submitted for presentation at an upcoming medical conference.
  • “This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab.
  • “Endometrial cancer remains one of the most common gynecological malignancies.

Right To Play and global partners successfully call on the United Nations to put play in the spotlight for two billion children worldwide

Retrieved on: 
Tuesday, March 26, 2024

Right To Play and global partners have successfully called on the United Nations to adopt an annual International Day of Play to champion and protect children’s right to play.

Key Points: 
  • Right To Play and global partners have successfully called on the United Nations to adopt an annual International Day of Play to champion and protect children’s right to play.
  • The need to support children’s right to play is more urgent now than ever, including for children who are experiencing crisis.
  • Right To Play is a global organisation that protects, educates and empowers millions of children to rise above adversity through the power of play.
  • Programming in 14 countries, Right To Play is the leading global development organisation focused on using the power of play to transform children’s lives.

Right To Play and global partners successfully call on the United Nations to put play in the spotlight for two billion children worldwide

Retrieved on: 
Tuesday, March 26, 2024

Right To Play and global partners have successfully called on the United Nations to adopt an annual International Day of Play to champion and protect children’s right to play.

Key Points: 
  • Right To Play and global partners have successfully called on the United Nations to adopt an annual International Day of Play to champion and protect children’s right to play.
  • The need to support children’s right to play is more urgent now than ever, including for children who are experiencing crisis.
  • Right To Play is a global organisation that protects, educates and empowers millions of children to rise above adversity through the power of play.
  • Programming in 14 countries, Right To Play is the leading global development organisation focused on using the power of play to transform children’s lives.

Bowman Announces Fiscal Year 2023 Financial Results

Retrieved on: 
Monday, March 11, 2024

Bowman Consulting Group Ltd. (Nasdaq: BWMN) (“Bowman” or the “Company”), a national engineering and infrastructure services firm supporting owners and developers of the built environment, today released financial results for the fiscal year ended December 31, 2023.

Key Points: 
  • Bowman Consulting Group Ltd. (Nasdaq: BWMN) (“Bowman” or the “Company”), a national engineering and infrastructure services firm supporting owners and developers of the built environment, today released financial results for the fiscal year ended December 31, 2023.
  • On November 17, 2023, the Company’s Board of Directors authorized a new $10.0 million repurchase program ("2023 Stock Repurchase Program").
  • Non-GAAP Adjusted Earnings per Share:
    In connection with the release of financial results for the three and nine months ended September 30, 2023, the Company introduced the new non-GAAP financial metric of adjusted earnings per share (“Adjusted EPS”).
  • 2 Non-GAAP financial metrics the Company believes offer valuable perspective on results of operations.

Innovent and HUTCHMED Jointly Announce NDA Acceptance in China for Sintilimab Combination with Fruquintinib for the Treatment of Advanced Endometrial Cancer with Priority Review Status

Retrieved on: 
Tuesday, April 2, 2024

The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity  with treatment on platinum-based doublet chemotherapy.

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity  with treatment on platinum-based doublet chemotherapy.
  • We are excited about the NDA acceptance and priority review designation, which increases our potential to bring a new treatment option to endometrial cancer patients, and concurrently strengthens the leadership position of TYVYT® in China."
  • We look forward to bringing this much-awaited treatment advancement to endometrial cancer patients to improve their treatment outcome."
  • The NMPA granted Breakthrough Therapy designation to the combination of sintilimab and fruquintinib for this potential indication in July 2023.

American Student Assistance Announces More Than $6 Million in Grants to Increase Access to Career Readiness Opportunities for Youth from Underserved Communities

Retrieved on: 
Monday, March 25, 2024

The grantees' initiatives are focused on improving career readiness outcomes for middle and high schoolers from under-resourced communities.

Key Points: 
  • The grantees' initiatives are focused on improving career readiness outcomes for middle and high schoolers from under-resourced communities.
  • The grant will fund the launch of a youth advisory board, paid internship program, and an alumni program to support mentees post-program.
  • Big Thought envisions a world in which young people in marginalized communities have the same opportunities and experiences as their peers.
  • High school students will move through three phases, including career exploration, career launch, and youth entrepreneurship launch.

As Colorado's Refugee Population Grows, Colorado Access Expands Support

Retrieved on: 
Thursday, March 21, 2024

In an effort to respond, Colorado Access has developed new strategic partnerships with the International Rescue Committee (IRC) and Project Worthmore to strengthen refugees' access to quality care.

Key Points: 
  • In an effort to respond, Colorado Access has developed new strategic partnerships with the International Rescue Committee (IRC) and Project Worthmore to strengthen refugees' access to quality care.
  • Colorado Access is now funding a health navigator position in partnership with the IRC.
  • Project Worthmore, is working with Colorado Access to expand its dental clinic services with additional, updated dental equipment.
  • "Dental health is a priority for Colorado Access because it is an important part of the overall health of our members," said Leah Pryor-Lease, director of community and external relations at Colorado Access.

Xometry Appoints James Miln as New Chief Financial Officer

Retrieved on: 
Thursday, February 29, 2024

A veteran of big-name tech and consumer brands, Miln brings considerable financial planning, operational and investor relations expertise to Xometry.

Key Points: 
  • A veteran of big-name tech and consumer brands, Miln brings considerable financial planning, operational and investor relations expertise to Xometry.
  • Miln succeeds retiring CFO Jim Rallo, who will remain as an advisor with Xometry through April.
  • Rallo will work closely with Miln and the rest of the leadership team to ensure a smooth transition.
  • “James’ significant experience across marketplaces, search and advertising will help us capitalize on our leadership position in digitizing manufacturing,” said Randy Altschuler, Chief Executive Officer of Xometry.

Armada Hoffler Announces Income Tax Treatment of Its 2023 Dividend Distributions

Retrieved on: 
Friday, February 23, 2024

Line 2b - These amounts are a subset of, and included in, the 2023 Capital Gain amounts (Line 2a).

Key Points: 
  • Line 2b - These amounts are a subset of, and included in, the 2023 Capital Gain amounts (Line 2a).
  • Box 2e is a subset of, and included in, the 2023 Taxable Ordinary Dividend amounts (Line 1a).
  • Box 2f is a subset of, and included in, the 2023 Capital Gain amounts (Line 2a).
  • Line 5 - These amounts are a subset of, and included in, the 2023 Taxable Ordinary Dividend amounts (Line 1a).