Avedel Pharmaceuticals is rebounding after sharp losses on Thursday.

The pharma stock plunged 68.3% yesterday after the company announced the US Food & Drug Administration responded to its new drug application for its narcolepsy therapy FT218 by deeming it "inappropriate."

 

Regulators have requested that Avedel add a certification to the Risk Evaluation and Mitigation Strategies, or REMS, patent for the new drug application. The company said it now expects to receive tentative approval for the drug by June 2023.

 

Shares plunged on the news, but the selloff may have been overdone because the stock is rebounding in today's premarket.

 

Shares of AVDL are up 45.8% on active trading volume following yesterday's big selloff.  

 

Upbeat clinical data is rallying shares of Adicet Bio ahead of today's open.

 

The company released a clinical update from Phase 1 trials of its ADI-001 treatment for relapsed/refractory Non-Hodgkin's Lymphoma (NHL) as of its Feb. 14th, 202, ASCO abstract data-cut date.

 

Studies found the drug demonstrated a 67% complete response rate with positive preliminary durability data. It also had a favorable safety and tolerability profile.

 

Adicet also said it will present updated data from a May 31st data-cut date at ASCO Annual Meeting on June 6th, 2922, at 9 a.m. ET.

 

"We look forward to presenting updated data on safety, efficacy, pharmacokinetics and longer follow up, including available data from patients enrolled in dose level 3," said Adicet President & CEO Chen Schor.

 

ACET is up 9.9% in today's premarket.