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Dynavax Closes Enrollment in Renal Disease Study on Heplisav-B

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Dynavax Technologies Corporation (DVAX - Free Report) announced that it has reached the enrollment target in a phase I study evaluating hepatitis B vaccine, Heplisav-B in patients with end-stage renal disease undergoing hemodialysis.

The study is evaluating a four-dose regimen of Heplisav-B in patients who have previously not received any hepatitis B vaccine. The company expects final immunogenicity data from the study in the fourth quarter of 2020.

Please note that Heplisav-B is approved for prevention of infection caused by all known subtypes of hepatitis B virus in adults. Dynavax generates revenues primarily from the sale of Heplisav-B, its only marketed product. The vaccine generated sales of $10.5 million in the first quarter of 2020, representing growth of almost 87% year over year.

Shares of Dynavax have increased 2.8% year to date compared with the industry’s rally of 7.9%.

The company had announced a strategic restructuring in May last year to prioritize the vaccine business by focusing on Heplisav-B. The company reduced workforce and streamlined operations to focus on Heplisav-B’s commercialization. The company’s decision to focus on Heplisav-B seems to be benefiting its sales.

It is also exploring alternatives for its immuno-oncology portfolio.

Following its restructuring initiatives, the company’s near-term focus is on Heplisav-B sales execution, while it is assessing additional opportunities to leverage its proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG1018, and evaluating other opportunities for growth.

Meanwhile, the company has established multiple research collaborations leveraging CpG 1018 to support the development of coronavirus vaccines. Dynavax has filed patent applications for the use of CpG-1018 in the COVID-19 vaccine. Several of its collaboration partners have announced clinical studies to evaluate a potential COVID-19 vaccine, which uses CpG-1018 adjuvant. A successful development of any vaccine will likely boost Dynavax revenues through milestone payments.

Zacks Rank and Stocks to Consider

Dynavax currently has a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Geron Corporation (GERN - Free Report) , Applied Genetics Technologies Corp. and Axovant Sciences Ltd. . All of them carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Geron’s loss per share estimates have narrowed from 48 cents to 28 cents for 2020 and from 38 cents to 29 cents for 2021 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average beat of 11.41%.        

Applied Genetics’ loss per share estimates have narrowed from $2.32 to $2.05 for 2020 and from $2.01 to $1.80 for 2021 in the past 60 days. The company delivered a positive earnings surprise in two of trailing four quarters, with an average beat of 1.34%.        

Axovant’s loss per share estimates have narrowed from $2.74 to $2.59 for 2020 and from $2.40 to $2.30 for 2021 in the past 60 days. The company delivered a positive earnings surprise in all trailing four quarters, with average beat of 34.22%.

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