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Novavax Takes Accelerated Approval Pathway For Flu Vaccine Development

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Novavax Takes Accelerated Approval Pathway For Flu Vaccine Development

Novavax, Inc. (NASDAQ: NVAX) shares were seeing strong upward momentum Thursday in reaction to announcements from the company tied to the development of its NanoFlu vaccine candidate and the lease of product development and manufacturing facilities. 

In late February, the stock re-entered penny stock territory in the wake of a failed late-stage trial for its respiratory syncytial vaccine candidate ResVax. The company subsequently enacted a 1-for-20 reverse stock split in early May.

Nano Flu To Follow Accelerated Approval Pathway

Novavax said Thursday that it will use the FDA's accelerated approval pathway for the licensure of NanoFlu, its nanoparticle seasonal influenza vaccine candidate. 

An accelerated pathway would help the company conduct a non-inferiority immunogenicity trial against a licensed quadrivalent comparator, while making a commitment to confirm its efficacy post-licensure.

The company said it will start a Phase 3 trial for NanoFlu by the fall of 2019 and expects to release top-line data from the trial in the first quarter of 2020.

The immunogenicity data from the trial will support a BLA filing, according to Novavax. 

Novavax plans to have an end-of-Phase 2 meeting with the FDA in the third quarter to discuss the clinical trial design of the Phase 3 trial and other topics to support a future BLA filing.

Facility Sale To Fund Clinical Development

Novavax also announced Thursday that it entered into an agreement with Catalent Inc (NYSE: CTLT)'s Paragon Gene Therapy unit to lease out two of its product development and manufacturing facilities on a long-term basis.

The deal provides Novavax with a cash payment of about $18 million at closing and helps reduce the biotech's operating costs, according to the company. 

Novavax said it will use the cash savings and infusion to advance NanoFlu and ResVax through the next phases of clinical development and regulatory review.

Novavax is concurrently entering  into an agreement with Paragon that calls for the latter company to provide process development and manufacturing services for Novavax programs.

The transactions are expected to close in July 2019.

Novavax shares were up 10.86% at $6.14 at the time of publication Thursday. 

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