financetom
Business
financetom
/
Business
/
BridgeBio's Acoramidis Recommended by EU Panel for Transthyretin Amyloid Cardiomyopathy
News World Market Environment Technology Personal Finance Politics Retail Business Economy Cryptocurrency Forex Stocks Market Commodities
BridgeBio's Acoramidis Recommended by EU Panel for Transthyretin Amyloid Cardiomyopathy
Dec 13, 2024 5:59 AM

08:37 AM EST, 12/13/2024 (MT Newswires) -- BridgeBio Pharma's ( BBIO ) acoramidis has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, which recommended granting a marketing authorization for the drug to treat wild-type or variant transthyretin amyloidosis in adults with cardiomyopathy, the regulator said Friday.

The CHMP cited a pivotal study that showed treatment with acoramidis, or Beyonttra, reduced cardiovascular hospitalizations over a 30-month period, according to the regulator.

BridgeBio said it expects a final decision from the European Commission "in the coming months" and plans to launch the drug in Europe in H1 2025.

Acoramidis was approved by the US Food and Drug Administration last month as Attruby, BridgeBio added.

Comments
Welcome to financetom comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
Related Articles >
Zura Bio Begins Phase 2 Study to Evaluate Tibulizumab in Adults With Systemic Sclerosis
Zura Bio Begins Phase 2 Study to Evaluate Tibulizumab in Adults With Systemic Sclerosis
Dec 23, 2024
09:51 AM EST, 12/23/2024 (MT Newswires) -- Zura Bio ( ZURA ) said Monday that it has begun a phase 2 study evaluating tibulizumab as a treatment for adult patients with systemic sclerosis. The immunology company said the study includes a 24-week efficacy period and a 28-week open-label extension. It also said the primary endpoint of the trial is the...
Update: Rumble Shares Soar After Agreeing to $775 Million Strategic Investment From Tether
Update: Rumble Shares Soar After Agreeing to $775 Million Strategic Investment From Tether
Dec 23, 2024
09:55 AM EST, 12/23/2024 (MT Newswires) -- (Updates with recent stock movement in the headline and first paragraph.) Rumble (RUM) shares were up almost 61% Monday morning after the companies said late Friday that Rumble agreed to a $775 million strategic investment from cryptocurrency firm Tether. Under the terms, Tether will purchase 103.3 million of Rumble's shares for $7.50 apiece....
NeuroSense Signs Term Sheet for Phase 3 PrimeC Trial in Amyotrophic Lateral Sclerosis
NeuroSense Signs Term Sheet for Phase 3 PrimeC Trial in Amyotrophic Lateral Sclerosis
Dec 23, 2024
09:44 AM EST, 12/23/2024 (MT Newswires) -- NeuroSense Therapeutics ( NRSN ) said Monday it has signed a binding term sheet with an unnamed pharmaceutical company to further develop PrimeC as potential treatment for amyotrophic lateral sclerosis in some key markets. NeuroSense said it would keep full rights to PrimeC in other key territories. The term sheet includes a substantial...
Iamgold Amends, Upsizes Credit Facility
Iamgold Amends, Upsizes Credit Facility
Dec 23, 2024
09:55 AM EST, 12/23/2024 (MT Newswires) -- Iamgold ( IAG ) said Monday that the company and its group of lenders have amended its existing secured revolving credit facility, extending its term to four years through Dec. 20, 2028. The facility size has also been increased to $650 million from $425 million, the company said, adding that the facility will...
Copyright 2023-2026 - www.financetom.com All Rights Reserved