Chelsea skyrockets 147% after FDA panel backs Northera

After a daylong detailed discussion on 14 January, the verdict from the FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) for Chelsea Therapeutics' investigational drug Northera (droxidopa) was as it was two years ago: Approve the drug.

After a daylong detailed discussion on 14 January, the verdict from the FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) for Chelsea Therapeutics' investigational drug Northera (droxidopa) was as it was two years ago: Approve the drug.

The 16-1 vote had investors clamoring for Chelsea's shares, which skyrocketed 147% in after-hours trading on 14 January – a...

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

More from Cardiovascular

Mineralys Eyes NDA As Lorundrostat Scores CKD Win In Race With AstraZeneca

 

As it races AstraZeneca’s baxdrostat to market, Mineralys plans to file an NDA later this year, backed by strong efficacy and safety data across four trials.

Merck & Co.’s Winrevair Positioned For Expansion On HYPERION Results

 

The Phase III trial met the primary endpoint of time to clinical worsening in patients newly diagnosed with pulmonary arterial hypertension.

Obesity Treatment Could Go Global With Lilly’s Orforglipron

 

The company’s oral GLP-1 candidate has reassured on its safety at the American Diabetes Association meeting, convincing analysts it will open up new global markets.

Lilly Agrees To Acquire PCSK9 Base-Editing Partner Verve

 
• By 

Instead of opting in on Phase II-ready PCSK9-targeted VERVE-102, Lilly will buy its partner for up to $1.3bn. Analysts call the deal a bargain for Lilly, but fair to Verve.

More from Therapy Areas

Veru’s Enobosarm Market Potential Enhanced By New Obesity Data

 
• By 

The late-stage biotech posted results from the maintenance extension portion of its Phase IIb QUALITY trial in which enobosarm reduced weight regain and helped preserve lean mass in patients who discontinued their semaglutide weight-loss treatment.

GSK, Bharat On Shigella Vaccine Phase II Data Timelines, Malaria Vaccine Price Halving

 
• By 

GSK tells Scrip about timelines for data expected from two Phase II trials for its Bharat Biotech-partnered shigella vaccine candidate, which puts it ahead of Limmatech/Valneva. Meanwhile, a global-first malaria vaccine, also partnered with Bharat, sees an over 50% price cut

Pfizer’s Hympavzi Poised For Broader Hemophilia Label

 

The drugmaker announced positive topline results for the drug in hemophilia A and B patients with inhibitors, on top of the existing approval for patients without inhibitors.