ADMA Biologics Inc (NASDAQ: ADMA) is making a run for the top in the market this morning, and for good reason. The company announced that it has received an FDA approval, meaning that it can now market its product in the United States.
As you could imagine, the news excited investors, sending the stock screaming for the top. Today, we’ll talk about:
- The FDA approval;
- what we’re seeing from ADMA stock as a result; and
- what we’ll be watching for ahead.
ADMA Announces FDA Approval
As mentioned above, ADMA Biologics is having a great day in the market today after announcing an FDA approval. The announcement came by way of press release early this morning.
In the release, the company said that the United States Food and Drug Administration had approved ASCENIV. The treatment is an Immune Globulin Intravenous, Human-sira 10% liquid that has previously been referred to as RI-002. The product has been approved for the treatment of Primary Humoral Immunodeficiency Disease (PIDD or PI) in adults and adolescents 12 years of age and older.
In the pivotal Phase III study surrounding the treatment, ADMA showed that the treatment improved the rate of Serious Bacterial Infections. Moreover, the treatment decreased the amount of Serious Bacterial Infections, serious infections, days on antibiotics, and days off of school or work due to infections.
In a statement, Adam Grossman, President and CEO at ADMA, had the following to offer:
We are excited about this significant achievement in receiving FDA approval for ASCENIV™ a novel, patented IVIG product that we feel is a necessary addition to existing available therapies for patients who suffer from PI. We hope availability of ASCENIV™ will help ameliorate a portion of the current shortages facing U.S. IVIG supply.
There are approximately 250,000 PI patients diagnosed and living in the U.S., and we believe there is an opportunity to treat meaningful segments of this patient population with ASCENIV™. As previously disclosed, ASCENIV™ is manufactured using our unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using our proprietary microneutralization assay.
Going forward, we believe this FDA approval better positions ADMA to further its mission to evaluate ASCENIV™ in immune-compromised patients infected with or at-risk for Respiratory Syncytial Virus (“RSV”) infection. We look forward to working with the FDA and the immunology and infectious disease community on developing a clinical investigation to evaluate use of ASCENIV™ in this patient population in the near future.”
We are grateful to the clinical trial subjects, investigators, and health care workers who participated in our Phase III trial and thank them for their extraordinary efforts. We are also thankful to our dedicated and loyal employees who relentlessly contributed to the approval of ASCENIV™ and exemplify our corporate mission of working tirelessly because patients are counting on us.
With the receipt of ASCENIV’s™ FDA approval, ADMA, at its sole option, can elect to access up to an additional $27.5M of available funding from Perceptive Advisors under ADMA’s existing credit facility. This option remains available to the Company through June 2020, and such funds could be used to support the launch of ASCENIV™, procure plasma raw material inventory, and begin construction on potential new plasma centers, as well as for general corporate activities.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to ADMA biologics, the news proved to be overwhelmingly positive.
After all, the FDA approval means that the company can start marketing the product in the United States. This pushes the company out of clinical stages and into commercial stages, opening the door to revenue.
Considering this, it’s not surprising to see that excited investors are pushing the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Current’y (10:59), ADMA is trading at $5.54 per share after a gain of $1.47 per share or 36.12% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on ADMA. In particular, we’re interested in following the company’s commercialization efforts with regard to ASCENIV. Nonetheless, we’ll keep a close eye on the story and bring the news to you as it breaks!
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