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Where Next For Biologics In COPD After Roche’s Astegolimab Phase III Missfire?

 

The Phase III failure could dent Roche’s hopes of entering the COPD market with its novel therapy, despite its success in a large Phase IIb trial. It also marks another disappointment for the anti-IL33/ST2 approach.

Abivax Over The Moon As Obefazimod Storms Phase III

 
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Stock shoots up over 460% on positive results in two ulcerative colitis trials of the oral first-in-class candidate.

The Duchenne Gene Therapies Lining Up To Take Elevidys’ Place

 

Regenxbio and Solid Biosciences believe they have a next-generation approach to AAV-based gene therapies – but must distance themselves from Sarepta’s safety and efficacy problems.

Replimune CRL Could Hold Warning For Accelerated Approvals

 

FDA issued a complete response letter to Replimune’s BLA for a novel oncolytic immunotherapy for melanoma in a surprise to management and investors.

Business


Abivax Over The Moon As Obefazimod Storms Phase III

 
• By 

Stock shoots up over 460% on positive results in two ulcerative colitis trials of the oral first-in-class candidate.

Scrip M&A Podcast: Is Biopharma M&A In A Holding Pattern Or A ‘New Normal’

 
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Scrip discusses the latest M&A activity and trends with CEO Shawn Titcomb of Allele Capital and Cheryl Reicin, a partner focused on international life sciences activity at Mintz.

Finance Watch: Sarepta’s Debt Woes Grow With Elevidys Shipment Pause

 
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Public Company Edition: Sarepta restructured after stopping shipments of its Elevidys for some patients to ease future debt pressures, but now it has stopped shipments to all patients. Also, Madrigal secured up to $500m in new debt, Cogent closed a $230m offering and other financings.

Avalyn Raises $100m Series D To Advance Inhaled Pulmonary Fibrosis Candidates

 
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Looking to improve on the efficacy and safety of Roche’s Esbriet and BI’s Ofev, Avalyn has inhalable formulations of those drugs in Phase IIb and Phase I, respectively.

Scrip Originals


Finance Watch: Sarepta’s Debt Woes Grow With Elevidys Shipment Pause

 
• By 

Public Company Edition: Sarepta restructured after stopping shipments of its Elevidys for some patients to ease future debt pressures, but now it has stopped shipments to all patients. Also, Madrigal secured up to $500m in new debt, Cogent closed a $230m offering and other financings.

Stock Watch: Q2 Sales Growth Sparks Diverging Reactions To J&J And Novartis

 
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With drug sector indexes underperforming the broad market in the first half of 2025, investors may have been anticipating tariff-related and other headwinds. But impending loss of exclusivity on key products may be provoking more anxiety at this point.

Pipeline Watch: Five Approvals And Twelve Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Executives On The Move: Five New CEOs Among This Week’s Changes

Recent moves in the industry include changes at the top at Ascentage Pharma, Inventiva and Brenig Therapeutics, plus five companies get new CFOs.