On Tuesday, Goldman Sachs (NYSE:GS) reiterated a Neutral rating for Dynavax (NASDAQ:DVAX) Technologies (NASDAQ:DVAX), maintaining a price target of $20.00. The decision follows the recent announcement from Dynavax that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the use of Heplisav-B in adult patients undergoing hemodialysis treatment.
The commentary from the analyst at Goldman Sachs acknowledged the FDA's negative response as a setback for the Heplisav-B program. However, it was also noted that the impact of the CRL is likely to be insignificant. The rationale behind this assessment is that the growth in market share among the healthy adult population and the company's path to profitability are the primary objectives for Dynavax.
Dynavax disclosed the FDA's decision on the sBLA for Heplisav-B on Tuesday. The CRL is a formal communication from the FDA indicating that the review process of a new drug application is complete, but the application cannot be approved in its present form.
Goldman Sachs expressed the view that while the CRL is certainly a disappointment for the Heplisav-B hemodialysis program, the potential market expansion into the hemodialysis patient population would have only provided a marginal increase to the asset's commercial prospects.
The investment firm concluded that Dynavax's investment appeal will continue to be based on the company's ability to expand its margins and achieve profitability. This outlook remains unchanged until Dynavax makes further advancements in its early-stage pipeline.
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