The Daily Biotech Pulse: Valneva's COVID-19 Vaccine Filing Accepted By EMA, Enanta's RSV Candidate Fails, Orphan Drug Tag For Mersana's Gastric Cancer Candidate

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Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

Enanta's RSV Candidate Fails In Low-Risk Patient Population 

Enanta Pharmaceuticals Inc's (NASDAQ: ENTA) EDP-938 failed to reduce the total symptom score compared to placebo in healthy adults with community-acquired Respiratory Syncytial Virus (RSV). 

In this low-risk patient population, a statistically significant difference in the number of subjects achieving undetectable RSV RNA at the end of treatment at day five was observed.

Recruitment is ongoing in pediatric and hematopoietic cell transplant RSV patients. Enanta expects to initiate an additional Phase 2b study in a high-risk adult population by the end of 2022.

Shares moved 17.3% lower to $38 during after-hours trading.

Valneva's COVID-19 Vaccine Filing Accepted By EMA

The European Medicines Agency (EMA) has accepted Valneva SE's (NASDAQ: VALN) marketing application seeking approval for its COVID-19 vaccine candidate, VLA2001. 

VLA2001 is advancing from the rolling review process and beginning the formal review process by the EMA's Committee for Human Medicinal Products (CHMP). 

If the CHMP accepts Valneva's conditional marketing authorization application, Valneva confirms it would expect to receive a positive CHMP opinion in June 2022.

Adamis Announces CEO Transition

Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has <a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/05/g27291369/adamis-pharmaceuticals-announces-leadership-transition-to-support-new-phase-of-innovation-and-grow" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; …

Full story available on Benzinga.com

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