Advaxis Sinks On Delayed Disclosure Of Clinical Hold

Advaxis Inc. fell 25.8% in after-hours trading on Oct. 6 when the company said the US FDA placed a clinical hold on its investigational new drug (IND) application for axalimogene filolisbac (ADXS-HPV) – a disclosure that was made five days after Advaxis received word from the agency.

Advaxis Inc. fell 25.8% in after-hours trading on Oct. 6 when the company said the US FDA placed a clinical hold on its investigational new drug (IND) application for axalimogene filolisbac (ADXS-HPV) – a disclosure that was made five days after Advaxis received word from the agency.

The clinical hold affects four ongoing clinical trials for the Princeton, New Jersey-based company's therapeutic vaccine for cancers caused by...

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

Merck & Co.’s Enlicitide Poised To Be First Oral PCSK9 Inhibitor To Market

 

The company announced positive data from two Phase III trials testing the cholesterol-lowering medicine.

In Brief: Tourmaline Reports Positive Topline Phase II Results for Pacibekitug In CKD

 

Based on first positive results for any quarterly IL-6 inhibitor, company plans to initiate Phase III cardiovascular outcomes trial.

In Brief: Essence Raises Ionis Tryngolza Hypertriglyceridemia Filing Hopes

 

Tryngolza has met endpoints in a moderate hypertriglyceridemia trial. Positive results in severe disease in Q3 could allow for a filing for a broader patient population than its currently approved indication of familial chylomicronemia syndrome.

Regeneron Wins PCSK9 Court Battle Against Amgen

 

A federal court jury found Amgen liable for violating antitrust laws in allegedly preventing Praluent from competing against Repatha.

More from Therapy Areas

Nuvation Set For First Launch With Ibtrozi In Lung Cancer

 

The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.

In Brief: Gilead HIV Trials On Hold Over Safety Signal

 

The FDA has paused Gilead’s HIV trials of GS-1720 and GS-4182 over safety concerns. The company’s upcoming PrEP PDUFA looks to be unaffected.

Spain’s SpliceBio Secures Sanofi and Roche Support In $135m Financing

 
• By 

Series B cash will be used to advance its Stargardt disease gene therapy.