In Brief: US FDA Delay Sends Biohaven Shares Down

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Biohaven

Biohaven’s share price has fallen by nearly 20% since the US Food and Drug Administration unexpectedly announced a three-month delay to its review of the firm’s troriluzole for spinal cerebellar ataxia.

The change pushes the decision date into the fourth quarter, and the regulator will now also convene an advisory committee,...

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 Scrip

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By 

Wales-based group launches with $140m series A.

BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

 

Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.

Immuneering Could Partner Atebimetinib Or Go It Alone After Phase IIa Success

 

CEO Ben Zeskind said all options are on the table after atebimetinib showed impressive results in pancreatic cancer.

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

Sarepta Market Dynamics For Elevidys Imperiled By Second Patient Death

 
• By 

With two deaths in non-ambulatory DMD patients, Sarepta is attempting damage control and will ask the US FDA to advise, setting up a possible confrontation with CBER director Prasad.

Supernus Secures Sage With CVR-Supported Deal

 

Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.

BMS’s Breyanzi Stands To Further Expand Broad Lymphoma Coverage

 

The drugmaker presented data at a lymphoma meeting showing strong efficacy for the CAR-T in marginal zone lymphoma, the second most common indolent lymphoma.