1. Scrip
  2. >>New Products

Four Major Approval Decisions To Watch Out For In Q2

 
• By Ayisha Sharma

Having looked at four prominent drug candidates which are expecting important top-line data this quarter, with the help of Biomedtracker's Q2 Outlook Report, we take a look at four other assets that could soon break into the US market, from infectious diseases to diabetes.

Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medication.
These Four Drug Candidates Have A PDUFA Date Set By The FDA • Source: Alamy

Amylyx Pharmaceuticals, Inc.’s AMX0035 for the rare neurodegenerative disorder amyotrophic lateral sclerosis (ALS) is set for a US Food and Drug Administration decision on 29 June. The candidate is a proprietary combination of tauroursodeoxycholic acid and sodium phenylbutyrate designed to reduce mitochondrial and endoplasmic reticulum stress.

The filing was based on data from the pivotal CENTAUR trial, which enrolled 137 ALS patients and measured the co-primary endpoint of change in the slope of the Amyotrophic Lateral...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from New Products

Sanofi Bid For Second COPD Approval Hurt By Mixed Itepekimab Data

 
• By Kevin Grogan

One Phase III trial hits but a second study misses by a mile.

Bayer Has BI In Its Sights With Priority Review For HER2 Lung Cancer Drug

 
• By Kevin Grogan

Sevabertinib gets onto the FDA's approval fast track three months after zongertinib.

Pipeline Watch: 12 Approvals And 26 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.

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

 
• By Alexandra Shimmings

The German company has big plans for the next five years or so. Scrip speaks to its chief medical officer Lykke Hinsch Gylvin about how it is using AI and other innovative approaches to make good on its ambitions.

More from Scrip

Quotables: Pharma Leaders On The Month’s Hot Topics

 
• By Anabel Costa-Ferreira

The highlights of recent comments and insights from industry executives on the key issues covered in Scrip.

In Brief: Neurocrine Details New Data For Schizophrenia Drug Moving To Phase III

 
• By Sushmita Panda

Neurocrine reports new details of positive Phase II results in schizophrenia and a favorable safety and cardiovascular profile for its first-in-class oral M4 agonist, now moving to Phase III trials.

Astellas Gets CLDN.18.2-Targeted ADC From China’s Evopoint

 
• By Joseph Haas

Astellas will pay $130m up front for near-global rights to a Phase I/II antibody-drug conjugate that will add to its portfolio of CLDN.18.2-targeted drugs, including Vyloy.