ADMA Biologics (ADMA) recently announced that the FDA has approved a supplemental biologics license application for its lead drug Asceniv.
Asceniv (immune globulin intravenous, human – slra 10% liquid), a plasma-derived, polyclonal, intravenous immune globulin (IVIG), was initially approved by the FDA in April 2019.
It was earlier indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age).
The regulatory body recently expanded Asceniv’s label to include pediatric immune compromised patients two years of age and older.
The label expansion meaningfully broadens Asceniv’s addressable market, enabling earlier-line use in younger PI patients. This should support incremental volume growth and strengthen ADMA’s competitive positioning within the IVIG market, particularly given Asceniv’s differentiated, patent-protected plasma sourcing and formulation.
The pediatric approval also removes a regulatory overhang tied to post-marketing commitments, improving the product’s lifecycle visibility. Management’s focus now shifts to driving adoption in the newly eligible patient population, which could serve as a near- to medium-term revenue catalyst.
Total revenues of $510.2 million in 2025 were up 20% from 2024, driven by higher Asceniv sales due to continued growth in physician, payer and patient adoption. Asceniv delivered record utilization in 2025, with revenues climbing 51% year over year to $363 million on strong demand and growing prescriber adoption. The trend is likely to have continued in the first quarter (results are expected later in the week).
Third-party suppliers outperformed expectations in 2025, and newly executed agreements now provide access to more than 280 plasma collection centers, significantly strengthening Asceniv’s long-term supply outlook.
ADMA expects 2026 revenues to exceed $635 million.
The company is positioned to benefit in 2026 from a continued shift in product mix toward higher-margin IVIG therapies, supporting further gross margin expansion. Hence, margins have likely improved in the first quarter.
Competition in the Plasma Therapy Market
ADMA Biologics competes with Grifols GRFS and Takeda TAK for plasma-derived products.
GRFS is a leading producer of plasma derivatives globally, ranking among the three largest producers in the industry in terms of total sales, alongside Takeda and CSL Group. The main plasma products that Grifols manufactures are IG, Factor VIII, Alpha 1 (A1PI) and albumin. Grifols also manufactures intramuscular (hyperimmune) immunoglobulins (IGs), ATIII, Factor IX and plasma thromboplastin component.
GRFS has a strong presence across key segments of the plasma derivatives industry, including A1PI, IG, and albumin, supported by its leading position in plasma collection centers and robust fractionation capacity.
Takeda’s broad immunoglobulin portfolio includes Hyqvia, Cuvitru, Gammagard Liquid and Gammagard Liquid ECR. The company is developing next-generation IG products with 20% facilitated SCIG (TAK-881). It is also pursuing other early-stage opportunities (e.g., hypersialylated Immunoglobulin [hsIgG]) that would diversify its portfolio further.
ADMA’s Price Performance, Valuation & Estimates
ADMA shares have plunged 43.5% year to date compared with the industry’s decline of 3.2%.
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From a valuation perspective, ADMA is expensive at this moment. ADMA’s shares currently trade at 3.70x forward sales, lower than its mean of 3.73x but higher than the industry’s 2.05x.
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Earnings estimates for 2026 have decreased to 93 cents per share from 96 cents over the past 60 days, while those for 2027 have declined to $1.34 from $1.38.
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ADMA currently has a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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This article originally published on Zacks Investment Research (zacks.com).