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ADMA Biologics posts $141.1M Q3 revenue; FDA gives constructive pre-IND feedback on SG-001

🇺🇸 Adma Biologics, Inc. (ADMA) · Wed 04 Nov 2026

The US plasma company reported 31% year-on-year ASCENIV sales growth and kept its full-year revenue guidance, while the FDA responded positively to its pre-IND package for a pneumococcal candidate.

ADMA Biologics reported third-quarter 2026 results on 4 November, with total revenue of $141.1m and net income of $49.9m. Sales of ASCENIV, its immune globulin product, rose 31% compared with the same quarter a year earlier.

The company left its full-year revenue guidance unchanged at $530m or more. It did, however, raise the minimum of its adjusted earnings outlook for the year. The summary available does not give the new figure.

ADMA also said the US Food and Drug Administration had given constructive feedback on its pre-IND package for SG-001, a pneumococcal hyperimmune globulin candidate. The agency accepted in principle the proposed assay for product testing, subject to validation.

Pre-IND meetings and written feedback let sponsors gauge FDA expectations before filing an investigational new drug application. Feedback of this kind is not an approval and does not guarantee the outcome of a later submission. No further details on timelines or clinical plans for SG-001 were available.

What it means for your team

  • For quality and CMC teams, the FDA's in-principle acceptance of the SG-001 testing assay is conditional on validation, so assay validation data will be central to the next regulatory step.
  • For market-access teams, ASCENIV's 31% growth and the maintained revenue guidance point to continued demand in the immune globulin segment.
  • For regulatory teams, the pre-IND feedback is an early development milestone for SG-001, not a marketing authorisation or an IND clearance.

Company's press release (SEC filing): Adma Biologics, Inc. ↗

Article written by VigiEye from the official source (Adma Biologics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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