Monday, August 01, 2016 5:55:42 AM
Dynavax Technologies Corporation is a small clinical-stage biopharmaceutical company with multiple product candidates in development for the prevention of infectious disease, the treatment of autoimmune and inflammatory diseases, and the treatment of cancer. The company currently has a market capitalization of just under $600 million, a stock price of near $15.50 a share. Dynavax is developing what it hopes will be cutting edge immunotherapies based on Toll-Like Receptor ('TLR') biology and its ability to modulate the immune system.
The key date for Dynavax shareholders is December 15th as that is when the FDA will decide to approve its hepatitis B vaccine Heplisav - B. Approval is highly likely. Hepatitis B is not nearly as dangerous as hepatitis C but it is 10 times more virulent. Hepatitis B virus causes chronic liver disease, liver cirrhosis and potentially liver cancer and over two million individuals in the United States have the disease.
In a large scale (> 10,000 subject) phase 3 trial, Heplisav - B provided greater protection than the current standard on the market "Engerix-B" (~95% to ~81%). In addition, Heplisav - B can be administered effectively in two dosages over a month instead of three dosages over six months like Engerix-B. This should greatly improve on the current ~55% compliance rate with the current regime. Engerix-B does some $150 million to $200 million in sales in an average quarter so this is an addressable market.
Dynavax Technologies is also working a promising ashtma compound currently in Phase II testing led by development partner AstraZeneca (NYSE:AZN). Finally, SD-101 is an early stage but intriguing oncology compound. The company had over $150 million in cash on the balance sheet as of the last completed quarter. Dynavax gets little analyst coverage. The latest analyst commentary was from Cowen & Co. on April 28th with a reiteration of a Buy rating and $30 price target. I like Dynavax as a standalone entity, but it also make a small logical acquisition target given its pipeline and low market capitalization. GlaxoSmithKline (NYSE:GSK), owner of Engerix-B would be one possible suitor in my opinion.
Recent DVAX News
- Form SC 13D - General Statement of Acquisition of Beneficial Ownership • Edgar (US Regulatory) • 09/16/2024 08:05:57 PM
- Form SC 13G/A - Statement of Beneficial Ownership by Certain Investors: [Amend] • Edgar (US Regulatory) • 09/09/2024 03:31:14 PM
- Lantheus Appoints Julie Eastland as New Board Member • GlobeNewswire Inc. • 09/05/2024 12:30:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/06/2024 09:01:38 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/06/2024 08:10:29 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/06/2024 08:05:11 PM
- Dynavax Reports Second Quarter 2024 Financial Results and Provides Business Updates • PR Newswire (US) • 08/06/2024 08:01:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/02/2024 08:05:10 PM
- Dynavax to Report Second Quarter 2024 Financial Results and Host Conference Call on August 6, 2024 • PR Newswire (US) • 07/23/2024 08:00:00 PM
- Dynavax Initiates Phase 1/2 Study of Novel Shingles Vaccine Program • PR Newswire (US) • 06/27/2024 08:09:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/03/2024 09:37:54 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/29/2024 12:32:55 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/29/2024 12:30:49 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/29/2024 12:28:17 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/29/2024 12:26:33 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/29/2024 12:23:47 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/29/2024 12:21:48 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/29/2024 12:19:28 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/29/2024 12:18:05 AM
- Dynavax to Present at Upcoming Investor Conferences • PR Newswire (US) • 05/28/2024 08:18:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/24/2024 08:05:18 PM
- Dynavax Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B® Regimen for Adults on Hemodialysis in the U.S. • PR Newswire (US) • 05/14/2024 12:30:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/08/2024 08:10:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/08/2024 08:05:25 PM
- Dynavax Reports First Quarter 2024 Financial Results and Provides Business Updates • PR Newswire (US) • 05/08/2024 08:01:00 PM
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