Clinical Trials

Pipeline Watch: Nine Approvals And Nine 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.

Regenxbio Rises After Duchenne Update And Sarepta Safety Scare

 

Encouraging results in younger children with Duchenne is keeping Regenxbio on track for a potential mid-2026 filing for its gene therapy, RGX-202.

Roivant Phase III Batoclimab Trial Is Positive, But No Filing Planned

 

The company’s Immunovant announced positive data from a Phase III trial in myasthenia gravis but the focus is on next-generation drug IMVT-1402.

After Securing Biogen Pact, Stoke’s CEO Edward Kaye Bows Out

 

The 75-year-old veteran of rare disease drug development is handing over the reins to a successor, but will stay to help Stoke Therapeutics expand its pipeline.


Almirall Looks To Dominate Across Derma Spectrum

 
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CEO Carlos Gallardo tells Scrip the Barcelona-based group has laid the foundations to advance four promising assets that have considerable potential for a variety of dermatological diseases.

Amgen’s Research VP On Goldilocks Viscosity, AI’s Hinge Moment

 
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Amgen’s AI model to predict proteins in the “bright Goldilocks zone of viscosity” with over 80% accuracy minus a wet lab experiment holds immense potential, VP Research Haldar said at an event as he spoke about a “hinge moment” for AI in pharma

New Duchenne Results Put Avidity On Course For Filing

 

The potential first-in-class antibody oligonucleotide conjugate could treat a form of the muscle wasting disease, and could be the first of Avidity’s trio of rare disease drugs to gain approval.

Incyte’s Povorcitinib Looks Approvable In HS, But How Competitive?

 
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Incyte’s JAK1 inhibitor meets the primary endpoint in two Phase III hidradenitis suppurativa trials, but the drug may not be able to supplant established biologic therapies.


AstraZeneca Buys Into In Vivo Cell Therapy Potential With EsoBiotec

 

The acquisition is worth up to $1bn and adds to AstraZeneca’s broad array of cell therapy technologies.

Pipeline Watch: Ten Approvals And Eighteen 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.

Altimmune Outlines Pemvidutide Plans In MASH And Beyond

 
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The company sees potential for the GLP-1/glucagon receptor dual agonist in MASH as well as alcohol-related liver disease as hopes to move pemvidutide into Phase III in obesity with a partner.

Amgen Bullish On Uplizna As ‘New Standard Of Care’ In Myasthenia Gravis

 

In the crowded and competitive field of generalized myasthenia gravis, Amgen has faith that Uplizna’s twice-yearly administration will make it the treatment of choice.


Unpartnered Obesity Assets Are Becoming Slim Pickings For Pharma

 

Evaluate Pharma’s top 10 list of unpartnered mid-stage obesity assets shows that few credible challengers to Novo’s Wegovy and Lilly’s Zepbound remain available.

Kelun Wins World’s First TROP2 ADC Approval In Lung Cancer

 

While diverging from partner Merck & Co. in its study dosage of sacituzumab tirumotecan, Kelun has garnered the world’s first approval, in China, for a TROP2-targeting antibody-drug conjugate, for the treatment of lung cancer.

Roche Means Business With Biggest Ever Obesity Pact

 
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The Swiss giant has inked a deal potentially worth $5.30bn with Zealand to access the Danish biotech's long-acting amylin analog petrelintide.

Arvinas/Pfizer’s Vepdegestrant Misses Best Case In Phase III

 

A Phase III trial testing the protein degrader in breast cancer met the primary endpoint and showed an efficacy benefit only in the subgroup of ESR1 mutant patients, not the full population.


Novo Nordisk’s CagriSema Disappoints Again

 

The REDEFINE 2 study saw CagriSema fail to outshine Lilly’s tirzepatide in weight loss for overweight patients with diabetes, leaving its rival still in the driving seat.

Mineralys Seeks First-To-Market Edge In Uncontrolled Hypertension

 
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Battling AstraZeneca in the aldosterone inhibitor space, Mineralys reports Phase III data showing lorundrostat can significantly decrease uncontrolled/resistant blood pressure at six weeks.

Trevi Gets A Clap On The Back For Chronic Cough Data

 

A Phase IIa trial studying Haduvio for the treatment of refractory chronic cough showed a benefit for patients, opening the door to a broad market and impressing investors.

BioNTech Seeks New Partners To Boost PD-L1xVEGF Competitor

 

Increasingly focused on maximizing and accelerating the progress of its PD-L1 x VEGF inhibitor BNT357, the company expects new partnerships to be announced this year.