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Dynavax Shares Plunge 70% Amid Complete Response Letter For Hepatitis B Drug

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Dynavax Shares Plunge 70% Amid Complete Response Letter For Hepatitis B Drug

Shares of Dynavax Technologies Corporation (NASDAQ: DVAX) plunged more than 70 percent after the disclosure of a Complete Response Letter (CRL) from the FDA on its Biologics License Application for HEPLISAV-B. The drug candidate is meant for immunization of adults 18 years and older affected by hepatitis B infection.

Acknowledgement

The company indicated that the regulator acknowledged the completion of its response reviews received early in October. This included those related to AESI, as well as the numerical imbalance in cardiac events apart from extensive analysis including independent expert consultation.

Dynavax pointed out that there was no request for any additional clinical studies and that there were no concerns with rare serious autoimmune events.

CEO Eddie Gray said, "The CRL is consistent with our opinion that HEPLISAV-B is approvable and we are seeking to meet with the FDA as soon as possible. However, the time and resources that will be required to gain approval leads us to consider that we may not be able to advance this program on our own and we are moving swiftly to identify a potential pharmaceutical or financial partner.”

Complete Response Letter

According to accessdata.fda.gov., the FDA would issue the applicant a CRL if the regulator found that the data is not sufficient to approve the application or abbreviated application in the form submitted by the applicant company.

Secondly, the CRL would list the specific deficiencies that the FDA has identified for not according approval. The regulator would issue CRL after a complete review of the applicant’s data submitted to it in an original application or abbreviated application or with any amendments.

While inadequate would lead to a CRL, the FDA would recommend actions for the applicant to take. For its part, the applicant should follow the actions suggested by the agency.

Following the news, the stock plummeted 74 percent to $3.00 in the pre-market session.

Posted-In: Complete Response Letter FDA Complete Response LetterBiotech News FDA Movers General Best of Benzinga

 

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