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Rhythm Eyes Bigger Market For Imcivree Following Phase II Hypothalamic Obesity Promise

 
• By Ayisha Sharma

The US firm’s Imcivree has impressed with interim mid-stage data from a hypothalamic obesity study, paving the way for pivotal success that could open up a much larger market.  

Children With Hypothalamic Obesity Experience A False Sense Of Uncontrollable Hunger • Source: Shutterstock

Rhythm Pharmaceuticals, Inc.’s Imcivree has shown strong efficacy in a Phase II hypothalamic obesity trial, helping expand its potential market far beyond obesity caused by rare genetic problems.

Imcivree (setmelanotide) is on the US market for patients aged six years or older with obesity due to deficiencies in pro-opiomelanocortin (POMC), proprotein convertase subtilisin or the leptin receptor since last year. It also received a US Food and Drug Administration thumbs up for the additional indication of obesity due to Bardet-Biedl syndrome last month. However, Rhythm plans to expand its label to hypothalamic obesity, which could open the door to 5,000 to 10,000 new patients

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Insilico Fast-Tracks First AI-Designed TNIK Inhibitor Into Phase III For IPF

 
• By Dexter Jie Yan

InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.

Pipeline Watch: Six Approvals And Thirteen 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.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

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Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.