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JPM: Ionis Looks Past Kynamro To Profitability

 
• By Lisa LaMotta

Despite significant progress on its late-stage programs and the promise of profitability, Ionis Pharmaceuticals Inc. can't seem to please investors who can only focus on the a failed partnership.

The biotech, which changed its name from ISIS pharmaceuticals in December due to its negative associations, made several small announcements...

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More from Musculoskeletal

Stealth Bio Bags Elamipretide FDA Win After Multiple Setbacks

 
• By Sushmita Panda

Stealth won FDA accelerated approval for Forzinity, the first Barth syndrome therapy, after multiple regulatory setbacks. The decision sets the stage for confirmatory trials and expanded patient access.

Regeneron’s Garetosmab May Become Second Drug For Rare Bone Disease FOP

 
• By Alaric DeArment

The company announced positive Phase III data for the drug in fibrodysplasia ossificans progressiva, as well as Phase II combination data among patients with obesity.

More Pressure on Elevidys As The EU’s CHMP Says ‘No’

 
• By Alexandra Shimmings

Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.

Capricor Gets Complete Response For DMD Cell Therapy

 
• By Joseph Haas

Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.

More from Therapy Areas

Roche’s evERA Giredestrant Study Hits In All-Comer Breast Cancer Population

 
• By Alexandra Shimmings

The Phase III trial of the SERD has shown a significant benefit in the intent-to-treat and ESR1-mutated populations in post-CDK ER+/HER2- metastatic breast cancer but whether the data will be enough to support an equally broad approval remains to be seen.

Sanofi’s Pipeline Pressure Continues As Tolebrutinib Trips Near Finish Line

 
• By Manas Mishra

Sanofi’s MS hopeful tolebrutinib hits a regulatory hurdle in the US, renewing pressure on the firm’s pipeline. Analysts hope the delay won’t prove material.

Why India Revoked The Entresto Patent And Novartis Abstained From Proceedings

 
• By Anju Ghangurde

India revokes Novartis's patent pertaining to Entresto, upholding the objections of opponents including the Indian Pharmaceutical Alliance on lack of novelty and prior claiming, among others. Novartis decided against participating in the hearings.