Spiroplasma mirum

CANbridge Pharmaceuticals CAN108 New Drug Application (NDA) for Alagille Syndrome Accepted by China’s National Medical Products Administration

Retrieved on: 
Tuesday, January 18, 2022

CANbridge anticipates that the application will be granted priority review, upon the close of the publicity period of the priority review process, on January 17th.

Key Points: 
  • CANbridge anticipates that the application will be granted priority review, upon the close of the publicity period of the priority review process, on January 17th.
  • CANbridge and Mirum Pharmaceuticals signed an exclusive license agreement for the development and commercialization of maralixibat (CAN108) in Greater China last year.
  • Under the terms of the agreement, CANbridge has the right to develop and commercialize CAN108 for three indications: Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC) and biliary atresia (BA) in Greater China.
  • Alagille syndrome (ALGS) is a rare autosomal dominant disorder that affects multiple organs, including the liver, heart, bones and eyes.

Mirum Pharmaceuticals Provides Business Update and Highlights Key 2022 Corporate Milestones

Retrieved on: 
Tuesday, January 11, 2022

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today provided a corporate update and highlighted key 2022 milestones in conjunction with its presentation at the 40th Annual J.P. Morgan Virtual Healthcare Conference.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today provided a corporate update and highlighted key 2022 milestones in conjunction with its presentation at the 40th Annual J.P. Morgan Virtual Healthcare Conference.
  • As of December 31, 2021 Mirum had preliminary unaudited cash, cash equivalents, and short-term investments of approximately $261.5 million.
  • Recent achievements and corporate updates:
    Successful first quarter of LIVMARLI commercialization with approximately $3.0 million in net product revenue.
  • Anticipated milestones for Mirum include:
    Launch commercial early access programs in international markets for LIVMARLI in the first half of 2022.

Mirum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Tuesday, January 11, 2022

The Compensation Committee of Mirums Board of Directors approved the awards as an inducement material to the new employees employment in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The Compensation Committee of Mirums Board of Directors approved the awards as an inducement material to the new employees employment in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The awards are subject to the terms and conditions of Mirums 2020 Inducement Plan and the terms and conditions of an applicable award agreement covering the grant.
  • Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases.
  • In addition, Mirum has an expanded access program open in Canada, Australia, the UK and several countries in Europe for eligible patients with Alagille syndrome.

Mirum Pharmaceuticals to Present at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022

Retrieved on: 
Tuesday, January 4, 2022

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that it will present at the annual J.P. Morgan Healthcare Conference taking place virtually January 10-13, 2022.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that it will present at the annual J.P. Morgan Healthcare Conference taking place virtually January 10-13, 2022.
  • Mr. Peetz and members of Mirums leadership team will be available for one-on-one meetings during the conference.
  • Additionally, the company will participate in a fireside chat at the upcoming H.C. Wainwright Virtual BIOCONNECT 2022 Conference.
  • A webcast of the presentation will be accessible from the Investors & Media section of Mirums website beginning January 10, 2022, at 7:00 a.m.

The Chinese Red Cross Foundation Rare Disease Mutual Assistance Fund Officially Launches

Retrieved on: 
Monday, December 20, 2021

December 18, 2021 marked the opening of China Rare Disease Conference 2021, organized by the China Alliance for Rare Diseases (CHARD), the Chinese Red Cross Foundation (CRCF), the China Pharmaceutical Innovation and Research Development Association (PhIRDA) and the Chinese Hospital Association (CHA).

Key Points: 
  • December 18, 2021 marked the opening of China Rare Disease Conference 2021, organized by the China Alliance for Rare Diseases (CHARD), the Chinese Red Cross Foundation (CRCF), the China Pharmaceutical Innovation and Research Development Association (PhIRDA) and the Chinese Hospital Association (CHA).
  • At the CRCF Rare Disease Mutual Assistance Fund launch ceremony, CRCF President, Changjiang Guo, acknowledged the first corporate sponsors with certificates.
  • The ceremony shared the stage with the launch ceremony for the central governments Lottery Charity Fund, dedicated to the development of rare disease diagnosis and treatment capabilities nationwide.
  • We are honored to participate in the launch of the CRCF Rare Disease Mutual Assistance Fund, said James Xue, Ph.D., CANbridge Founder, Chairman and CEO.

Mirum Pharmaceuticals Added to NASDAQ Biotechnology Index

Retrieved on: 
Wednesday, December 15, 2021

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that it has been selected for addition to the NASDAQ Biotechnology Index.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that it has been selected for addition to the NASDAQ Biotechnology Index.
  • The NASDAQ Biotechnology Index contains securities of NASDAQ-listed companies classified according to the Industry Classification Benchmark as either Biotechnology or Pharmaceuticals which also meet other eligibility criteria.
  • The NASDAQ Biotechnology Index is re-ranked annually and all securities in the index are listed on the NASDAQ Global Market or the NASDAQ Global Select Market and meet minimum market value and share volume requirements among other criteria.
  • For more information, please visit the NASDAQ Biotechnology Index information page on the NASDAQ website.

LIVMARLI (maralixibat) Presentations Show Improvements in Quality of Life Measures in Alagille Syndrome and PFIC2 at NASPGHAN Annual Meeting 2021

Retrieved on: 
Monday, December 13, 2021

Treatment response to LIVMARLI was defined as a 1 point reduction in caregiver Itch-Reported Outcome (ItchRO) instrument score from baseline to Week 48.

Key Points: 
  • Treatment response to LIVMARLI was defined as a 1 point reduction in caregiver Itch-Reported Outcome (ItchRO) instrument score from baseline to Week 48.
  • These data demonstrate that the significant improvements in pruritus seen with LIVMARLI at Week 48 of the ICONIC study are clinically meaningful and are associated with improvements in patients quality of life.
  • The analysis examined 22 patients with BSEP deficiency, or PFIC2, following treatment with LIVMARLI as part of the INDIGO study.
  • Changes in certain liver tests are common in patients with Alagille syndrome and can worsen during treatment with LIVMARLI.

CANbridge Pharmaceuticals Ltd Listed on Main Board of Hong Kong Stock Exchange

Retrieved on: 
Friday, December 10, 2021

CANbridge Pharmaceuticals, Inc. (Canbridge or the company, stock code 1228.HK), a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development, and commercialization of transformative therapies, was officially listed on the Main Board of the Stock Exchange of Hong Kong Limited (SEHK) today.

Key Points: 
  • CANbridge Pharmaceuticals, Inc. (Canbridge or the company, stock code 1228.HK), a leading China-based global rare disease-focused biopharmaceutical company committed to the research, development, and commercialization of transformative therapies, was officially listed on the Main Board of the Stock Exchange of Hong Kong Limited (SEHK) today.
  • Morgan Stanley Asia Limited and Jefferies Hong Kong Limited are the Joint Sponsors of the offering.
  • CANbridge is a China-based, rare disease-focused biopharmaceutical company, founded in 2012, that is committed to the research, development, and commercialization of biotech therapies.
  • CANbridge Pharmaceuticals Inc. (CANbridge, stock code: 1228.HK) is a China-based global rare disease-focused biopharmaceutical company committed to the research, development and commercialization of transformative therapies.

Mirum Pharmaceuticals to Present LIVMARLI™ (maralixibat) Analyses at NASPGHAN 2021 Annual Meeting

Retrieved on: 
Monday, December 6, 2021

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that five posters featuring data on LIVMARLI (maralixibat) oral solution will be presented at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Annual Meeting taking place virtually December 12-18, 2021.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that five posters featuring data on LIVMARLI (maralixibat) oral solution will be presented at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Annual Meeting taking place virtually December 12-18, 2021.
  • LIVMARLI is currently being evaluated in late-stage clinical studies in other rare cholestatic liver diseases including progressive familial intrahepatic cholestasis (PFIC) and biliary atresia.
  • LIVMARLI has received Breakthrough Therapy designation for ALGS and PFIC type 2 and orphan designation for ALGS, PFIC and biliary atresia.
  • To learn more about ongoing clinical trials with LIVMARLI, please visit Mirums clinical trials section on the companys website.

Mirum Pharmaceuticals to Participate in Upcoming Investor Conferences

Retrieved on: 
Monday, November 22, 2021

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that it will participate in the following upcoming virtual investor conferences:

Key Points: 
  • Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that it will participate in the following upcoming virtual investor conferences:
    Format: Fireside Chat (available today, November 22, at 10:00 a.m.
  • Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare liver diseases.
  • In addition, Mirum has an expanded access program open in Canada, Australia, the UK and several countries in Europe for eligible patients with Alagille syndrome.
  • Mirum is planning to launch a Phase 2b study in primary biliary cholangitis later this year.