Armata Pharmaceuticals (ARMP) secures FDA pediatric study plan for AP-SA02
Rhea-AI Filing Summary
Armata Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has agreed to an Initial Pediatric Study Plan (Agreed iPSP) for AP‑SA02, a bacteriophage therapy being developed as an adjunct treatment for complicated Staphylococcus aureus bacteremia in pediatric patients.
The Agreed iPSP is a regulatory requirement before submitting a Biologics License Application and sets a framework for evaluating patients up to 17 years of age, aligned with the adult indication. Under FDA requirements and the Pediatric Research Equity Act, pediatric studies will be deferred until safety and efficacy data are generated in adults in a planned Phase 3 program expected to start in the second half of 2026. After completion of the adult Phase 3 study, Armata plans a single multicenter, open‑label pediatric study to assess safety, tolerability and clinical response.
AP‑SA02, a fixed multi‑phage cocktail targeting methicillin‑sensitive and methicillin‑resistant S. aureus, has Qualified Infectious Disease Product and Fast Track designations. Positive Phase 1b/2a diSArm study results were previously presented, and Armata plans a Phase 3 superiority study in complicated bacteremia, anticipated to initiate in the second half of 2026.
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8-K Event Classification
Key Figures
Key Terms
Initial Pediatric Study Plan regulatory
Biologics License Application regulatory
Pediatric Research Equity Act (PREA) regulatory
Qualified Infectious Disease Product regulatory
Fast Track designations regulatory
bacteriophage therapeutics medical
FAQ
What FDA milestone did Armata Pharmaceuticals (ARMP) report for AP-SA02?
How will the pediatric program for AP-SA02 at Armata (ARMP) be structured?
When does Armata Pharmaceuticals (ARMP) plan to start the adult Phase 3 trial of AP-SA02?
What prior clinical data support AP-SA02 at Armata (ARMP)?
What regulatory designations has AP-SA02 received according to Armata (ARMP)?
Which infections is AP-SA02 from Armata (ARMP) intended to treat?
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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| Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered | ||
| Item 7.01 | Regulation FD Disclosure. |
On July 13, 2026, Armata Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it has received agreement from the U.S. Food and Drug Administration (the “FDA”) on an Agreed Initial Pediatric Study Plan (“Agreed iPSP”), which establishes the agreed regulatory framework for the future evaluation of AP-SA02 for the adjunct treatment of complicated Staphylococcus aureus bacteremia (“SAB”) in pediatric patients. The full text of the press release issued in connection with this announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 and the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 7.01 and the attached Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated July 13, 2026. | |
| 104 | Cover Page Interactive Data File (embedded within Inline XBRL document). |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: July 13, 2026 | Armata Pharmaceuticals, Inc. | |
| By: | /s/ David House | |
| Name: | David House | |
| Title: | Senior Vice President, Finance and Principal Financial Officer | |
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Exhibit 99.1
Armata
Pharmaceuticals Receives Agreement from FDA on Initial Pediatric Study Plan for AP-SA02 for the
Treatment of Complicated Staphylococcus
aureus Bacteremia
Fulfills important regulatory milestone for AP-SA02 on the path toward a future BLA and supports expansion into pediatric patients
LOS ANGELES, Calif., July 13, 2026 - Armata Pharmaceuticals, Inc. (NYSE American: ARMP) (“Armata” or the “Company”), a late clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced that it has received agreement from the U.S. Food and Drug Administration (the “FDA”) on an Agreed Initial Pediatric Study Plan (“Agreed iPSP”), which establishes the agreed regulatory framework for the future evaluation of AP-SA02 for the adjunct treatment of complicated Staphylococcus aureus bacteremia (“SAB”) in pediatric patients. Agreement with the FDA on an iPSP is a regulatory requirement that must be met prior to submitting a Biologics License Application (“BLA”).
“Reaching agreement with the FDA on our Agreed iPSP for AP-SA02 is an important regulatory milestone that reflects our commitment to addressing the needs of both adult and pediatric patients with complicated SAB,” said Dr. Deborah Birx, Chief Executive Officer of Armata. “Pediatric patients, especially very young premature babies and newborns, represent a particularly vulnerable population with limited treatment options for serious S. aureus infections, and we are pleased to have an aligned, FDA-endorsed pediatric development framework in place. This agreement positions us to work towards efficiently expanding development beyond adults while continuing to advance AP-SA02 toward potential registration.”
The Agreed iPSP outlines a proposed pediatric development program targeting patients up to 17 years of age with complicated SAB, the same indication that Armata is pursuing in adults. Consistent with FDA requirements under the Pediatric Research Equity Act (PREA) and with established FDA and European Medicines Agency regulatory frameworks, the FDA agreed that because the disease pathophysiology and treatment response in SAB are consistent across all age groups, pediatric studies should be deferred until safety and efficacy data are generated in adults in the planned Phase 3 program. Following completion of the adult Phase 3 study which is expected to initiate in the second half of 2026, the proposed program will comprise a single, multicenter, open-label, pediatric study to assess safety, tolerability, and clinical response outcomes. This strategy establishes a pathway for potential future expansion of AP-SA02 into the pediatric population while prioritizing patient safety and efficient clinical development.
About AP-SA02
Armata is developing AP-SA02, a fixed multi-phage cocktail, for the adjunct treatment of complicated Staphylococcus aureus bacteremia caused by methicillin-sensitive S. aureus (MSSA) or methicillin-resistant S. aureus (MRSA). AP-SA02 has received Qualified Infectious Disease Product (QIDP), and Fast Track designations from the FDA. The diSArm study (NCT05184764) was a Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to best available antibiotic therapy (“BAT”) compared to BAT alone (placebo) for the treatment of adults with complicated S. aureus bacteremia. Positive results from the Phase 2a diSArm study were highlighted in a late-breaking oral presentation at IDWeek 2025™ in October 2025. The Company plans to advance AP-SA02 into a Phase 3 superiority study in complicated S. aureus bacteremia, anticipated to initiate in the second half of 2026.
About Armata Pharmaceuticals, Inc.
Armata is a late clinical-stage biotechnology company focused on the development of high-purity pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, S. aureus, and other important pathogens. Armata is committed to advancing phage therapy with drug development expertise that spans bench to clinic including in-house phage-specific current Good Manufacturing Practices (“cGMP”) manufacturing to support full commercialization.
Forward Looking Statements
This communication contains “forward-looking” statements as defined by the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to Armata’s future financial performance and involve known and unknown risks, uncertainties and other factors which may cause Armata’s actual results, performance or events to be materially different from any future results, performance or events expressed or implied by the forward-looking statements. In some cases, you can identify these statements by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions. These forward-looking statements reflect management’s beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this communication and are subject to risks and uncertainties including risks related to Armata’s development of bacteriophage-based therapies; Armata's planned clinical trials; ability to staff and maintain its production facilities under fully compliant cGMP; ability to meet anticipated milestones in the development and testing of the relevant product; ability to be a leader in the development of phage-based therapeutics; ability to achieve its vision, including improvements through engineering and success of clinical trials; ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of its product candidates and commercialize any approved products on its expected timeframes or at all; and Armata’s estimates regarding anticipated operating losses, capital requirements and needs for additional funds. Additional risks and uncertainties relating to Armata and its business can be found under the caption “Risk Factors” and elsewhere in Armata’s filings and reports with the U.S. Securities and Exchange Commission (the “SEC”), including in Armata’s Annual Report on Form 10-K, filed with the SEC on March 25, 2026, and in its subsequent filings with the SEC.
Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Media Contacts:
At Armata:
Pierre Kyme
ir@armatapharma.com
310-665-2928
Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
212-915-2569