Aligos' MASH readout doesn't satisfy investors

Today’s Big News

Sep 20, 2024

Novo obesity prospect linked to ‘mild to moderate neuropsychiatric side effects’ in phase 2


Sanofi lifts lid on MS data behind tolebrutinib’s mixed phase 3 scorecard, plans ‘24 approval filings


Aligos' MASH prospect slashes liver fat in phase 2, but stock drops anyway


Edgewise's stock jumps 50% on the back of safety data for potential heart disease rival to Camzyos


Genfit moves to jump-start enrollment in slow-going phase 2 liver failure trial


In 2 papers, researchers describe potential new neurodegenerative disease treatment approach


Chutes & Ladders—2 Kite vets fly over to Kyverna Therapeutics 

The Top Line Podcast: Don’t miss out on the newest episode. Listen now.

 

Featured

Novo obesity prospect linked to ‘mild to moderate neuropsychiatric side effects’ in phase 2

Novo Nordisk’s $1 billion bet that it had found a cannabinoid CB1 receptor blocker that could reduce weight while avoiding the psychiatric effects that capsized Sanofi’s Acomplia faces new questions after the company revealed mid-stage headline results.
 

Top Stories

Sanofi lifts lid on MS data behind tolebrutinib’s mixed phase 3 scorecard, plans ‘24 approval filings

Sanofi has shared data from the phase 3 HERCULES trial that could rescue its multiple sclerosis (MS) drug candidate tolebrutinib, linking the BTK inhibitor to a 31% delay in time to onset of confirmed disability progression. The drugmaker plans to seek approval this year.

Aligos' MASH prospect slashes liver fat in phase 2, but stock drops anyway

Aligos Therapeutics is heralding a midstage win in metabolic-dysfunction associated steatohepatitis after three different doses of its drug candidate significantly slashed liver fat at 12 weeks. Despite the company's enthusiasm, the results failed to impress investors.

Beyond data: Humanizing clinical research with Avacare

With intricate protocols and shifting regulatory demands, it’s more difficult than ever to find and keep participants, as well as gather reliable data.

Edgewise's stock jumps 50% on the back of safety data for potential heart disease rival to Camzyos

Edgewise tested its drug, dubbed EDG-7500, separately in healthy subjects and in patients with obstructive HCM.

Genfit moves to jump-start enrollment in slow-going phase 2 liver failure trial

Slow enrollment in a key clinical trial has driven Genfit to rework the protocol to try to keep the study on track. The biotech said the changes reflect the comorbidities of people with acute on-chronic liver failure (ACLF) and the logistics of caring for the patients.

In 2 papers, researchers describe potential new neurodegenerative disease treatment approach

Two new papers show how TRIM21 techniques can remove tau tangles inside of mouse neurons and improve mobility in a mouse model of Alzheimer’s disease.

Chutes & Ladders—2 Kite vets fly over to Kyverna Therapeutics

Warren Biddle hit the exit from his role as SVP, global head of commercial at Gilead’s CAR-T unit Kite Pharma to take on the CEO gig at fellow CAR-T maker Kyverna, effective immediately.

Fierce Pharma Asia—Merck's collabs with Daiichi, Eisai deliver readouts; Granules hit with FDA manufacturing observations

Merck and Daiichi Sankyo's HER3 antibody-drug conjugate reported a positive phase 3 result in EGFR-mutated lung cancer. Merck and Eisai's Keytruda-Lenvima combo delivered a win in liver cancer. An FDA document details shortfalls at a Granules plant in India. Plus more.

Gilead's Kite exits China cell therapy joint venture with Fosun Pharma

Gilead Sciences’ Kite Pharma will sell its stake in China’s Fosun Kite Biotechnology nearly eight years after forming the cell therapy-focused joint venture with Fosun Pharma.

Texas attorney general, Pieces Technologies settle allegations of inaccurate generative AI advertising

Pieces Technologies agreed to more clearly disclose how it is describing its tools’ performance and to provide more explicit disclosures to its hospital customers covering how the products are to be used and could potentially lead to patient harm.
 
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Pharma Recapping Digital Pharma East 2024

In this week's episode of "The Top Line," we’re recapping and discussing the major trends from Digitial Pharma East.

 

Resources

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Why Biotech Sponsors Need Outside Support: IRB, IBC, DMCs, and EACs

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Overcoming drug development hurdles with phase-appropriate technology transfers

Facing roadblocks in drug development? Uncover how phase-appropriate technology transfers can help you navigate challenges and speed up your journey to market.

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Building a “Best Practice” Commercial Organization in Biopharma

We interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned.
 

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On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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