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Novavax (NVAX) Seeks Accelerated Approval Pathway for NanoFlu

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Novavax, Inc. (NVAX - Free Report) announced plans of using the accelerated approval pathway for its influenza vaccine candidate, NanoFlu. The FDA has also acknowledged that the company can use the pathway for the vaccine candidate.

In the fall of 2019, the company expects to initiate a phase III study for immunogenicity data to support a biologics license application (“BLA”) for NanoFLu. Top-line data from the study is expected in the first quarter of 2020.

In a separate press release, Novavax also announced the sale of its manufacturing equipment and related assets to Catalent Biologics’ Paragon Gene Therapy unit for $18 million. The transaction is expected to close in July 2019. Novavax can use the additional fund from the sale of assets to support clinical development of its vaccine candidates — NanoFlu and ResVax.

Following the announcements, shares of the company surged more than 11% on Jun 27. However, the stock has plunged 83.3% so far this year against the industry’s 2.7% increase.

In January 2019, the company released top-line phase II results for NanoFlu, its nanoparticle seasonal influenza vaccine candidate. The study showed that NanoFlu improved immune responses in adults aged 65 years or older compared with Sanofi’s (SNY - Free Report) vaccine division’s Fluzone High-Dose, the leading influenza vaccine in older adults, in a phase II study.

In the third quarter of 2019, Novavax is planning an End-of-Phase II meeting with the FDA for discussing the proposed phase III clinical study design and other topics that will support the future BLA.

Meanwhile, the company’s lead candidate ResVax — a respiratory syncytial virus (“RSV”) vaccine — is being developed to protect infants by immunizing mothers against the disease. The candidate has failed to meet the primary endpoint of a phase III study of prevention from medically significant RSV and lower respiratory tract infection. However, the study did show efficacy against a secondary objective of preventing hospitalization, and is the first RSV vaccine to show phase III efficacy. Earlier this month, the FDA has recommended an additional study to confirm the efficacy against medically significant RSV disease in infants born to mothers vaccinated with ResVax. Aforementioned news had significant, unfavorable impact on the company’s share price.

Zacks Rank and Key Picks

Novavax has a Zacks Rank #2 (Buy). A couple of other top-ranked stocks in the biotech sector are Anika Therapeutics Inc. (ANIK - Free Report) and Applied Genetics Technologies Corp. (AGTC - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings per share estimates have moved up from $1.21 to $1.31 for 2019 and from $1.21 to $1.33 for 2020 over the past 60 days. The stock has gained 17.3% so far this year.

Applied Genetics’ earnings per share estimates have changed from a loss of $1.25 to a gain of 1 cent for 2019 and loss per share estimates narrowed from $2.39 to $2.15 for 2020 over the past 60 days. The stock has rallied 50.6% so far this year.

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