ADMA Biologics (ADMA) announced Monday that it received approval from the U.S. Food and Drug Administration (FDA) for its plasma yield enhancement production process.
The technology is designed to extract more medication from each plasma donation. The company claims it can boost production yields by about 20%.
“This approval represents a pivotal milestone for ADMA, unlocking the opportunity for meaningful acceleration in our revenue and earnings trajectory beginning in late 2025 and accelerating further into 2026 and beyond,” ADMA President and CEO Adam Grossman said in a statement.
Shares of ADMA jumped 12.1% on Monday. The stock is now up 42.9% year to date and 274.2% over the past year.
Grossman added that ADMA is the first U.S. producer of plasma-derived products to receive FDA approval for a yield enhancement process.
This move, he says, cements the company’s leadership in modernizing plasma fractionation through “agile, forward-thinking scientific development and execution.”
The FDA win adds to a strong stretch for the company. In March, ADMA reported $426.5 million in total revenue for FY2024, up 65% from the prior year.
Adjusted EBITDA soared 309% to $164.6 million. Earnings per share (EPS) came in at $0.46, easily beating forecasts for $0.15.For 2025, ADMA is targeting $490 million in revenue.
After the FDA news, Mizuho Securities raised its price target to $32 while keeping an Outperform rating. Cantor Fitzgerald also reiterated an Overweight rating with a $25 target.
The stock closed Monday at $24.51.
U.S. operations offer immunity from tariffs
The FDA approval comes as broader concerns grow around potential pharmaceutical tariffs.
A report by Ernst & Young last week warned that a 25% tariff on pharmaceutical imports, floated by President Trump, would add roughly $51 billion a year to U.S. drug costs.
The U.S. imported $203 billion in pharmaceutical goods in 2023, according to the report.
Earlier this month, the Trump administration launched national security probes into both pharmaceutical and semiconductor imports seen as a prelude to new tariffs.
ADMA isn't particularly worried about the prospect of pharma tariffs because its operations are fully U.S.-based.
In a statement earlier this month, the company said its “manufacturing operations, end-market sales, and customer engagements” are all conducted domestically.
“The tariffs that have been implemented on foreign goods, services and manufacturing should have no impact on ADMA and its supply chain or production operations,” Grossman said.
“The company’s vertically integrated supply chain is fully domiciled in the U.S., providing end-to-end domestic control over sourcing, manufacturing, and distribution.”
Grossman added that ADMA’s U.S. footprint “not only ensures enhanced supply chain robustness, resilience, and regulatory compliance, but also aligns with increasing federal and private sector preferences for U.S.-made products and services” under the Trump administration.
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