ADMA Biologics Reports First Quarter 2018 Financial Results

- May 15th, 2018

ADMA Biologics (NASDAQ:ADMA) announced its financial results for the quarter ended March 31, 2018 and provided an update on its operations and corporate objectives. As quoted in the press release: “During the first quarter, we achieved several internal goals regarding the improvement of our quality systems and manufacturing processes, including a significant regulatory milestone with … Continued

ADMA Biologics (NASDAQ:ADMA) announced its financial results for the quarter ended March 31, 2018 and provided an update on its operations and corporate objectives.

As quoted in the press release:

“During the first quarter, we achieved several internal goals regarding the improvement of our quality systems and manufacturing processes, including a significant regulatory milestone with the commercial product release of Nabi-HB®,” stated Adam Grossman, President and Chief Executive Officer. “The recently commercialized batch of Nabi-HB® was sourced and manufactured under our ownership, resulting in increased quarter-over-quarter revenues.”

Mr. Grossman continued, “Also during the quarter, we successfully qualified the filling and packaging process for Bivigam®, our Intravenous Immunoglobulin (“IVIG”) product, and filled three conformance batches, along with the production and filling of three RI-002 conformance batches.  The filled Bivigam® and RI-002 batches are currently undergoing stability testing, as required by the U.S. Food and Drug Administration (“FDA”), and results are planned to be used to support our anticipated Prior Approval Supplement (“PAS”) for Bivigam® and Biologics License Application (“BLA”) for RI-002. These batches are the first conformance lots manufactured using our improved, optimized IVIG production process. We anticipate that upon FDA approval of the regulatory filings, we will have the ability to use these conformance batches as commercial product.  We continue to believe that our regulatory timelines established at the beginning of 2018 remain on track, and we look forward to providing further updates as they occur.”

Click here to read the full press release.

Are You Aware of the FDA's Plans for 2018?

Find out what's going on in our new report
 

Get the latest Biotech Investing stock information

Get the latest information about companies associated with Biotech Investing Delivered directly to your inbox.

Biotech Investing

Select All
Select None

By selecting company or companies above, you are giving consent to receive email from those companies. And remember you can unsubscribe at any time

Tags

Leave a Reply

Your email address will not be published. Required fields are marked *