Armata Pharmaceuticals Announces End-of-Phase 2 Meeting with FDA and Plans to Advance AP-SA02 to a Phase 3 Superiority Study in Complicated BacteremiaStaphylococcusaureus

Rhea-AI Summary

Armata Pharmaceuticals (NYSE: ARMP) received an End-of-Phase 2 written response from the FDA confirming that safety and efficacy data from its Phase 2a diSArm study support advancing IV AP-SA02 into a Phase 3 superiority study for complicated Staphylococcus aureus bacteremia. The Phase 3 trial is anticipated to initiate in the second half of 2026 and will test AP-SA02’s superiority versus standard of care, with primary endpoints at end of best available antibiotic therapy and at Day 28. The FDA provided guidance on study design, CMC, BLA expectations, and encouraged a QIDP request; Armata has submitted a QIDP request and is addressing FDA comments.

Positive

• FDA confirmed Phase 2a data support advancement to Phase 3
• Phase 3 will be a superiority trial versus standard of care
• Phase 3 anticipated to start in H2 2026
• QIDP request for AP-SA02 submitted

Negative

• Outstanding CMC and FDA comments must be resolved before Phase 3/BLA
• Phase 3 start date is anticipated, subject to regulatory and operational clearance

News Market Reaction

-4.94% 3.8x vol

16 alerts

-4.94% News Effect

+10.1% Peak Tracked

-24.1% Trough Tracked

-$13M Valuation Impact

$243M Market Cap

3.8x Rel. Volume

On the day this news was published, ARMP declined 4.94%, reflecting a moderate negative market reaction. Argus tracked a peak move of +10.1% during that session. Argus tracked a trough of -24.1% from its starting point during tracking. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $13M from the company's valuation, bringing the market cap to $243M at that time. Trading volume was very high at 3.8x the daily average, suggesting heavy selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Phase: Phase 2a Planned phase: Phase 3 Study timing: Second half of 2026 +5 more

8 metrics

Phase Phase 2a diSArm study supporting Phase 3 advancement

Planned phase Phase 3 Superiority study in complicated S. aureus bacteremia

Study timing Second half of 2026 Phase 3 study initiation anticipated

Primary endpoint window 28 days Clinical response at end of BAT and 28 days later

EOP2 meeting End-of-Phase 2 FDA written response supporting Phase 3 advancement

QIDP request Qualified Infectious Disease Product FDA amenable; company has submitted request for AP-SA02

Price move -5.25% 24h move on FDA Phase 3 advancement news

Relative volume 2.14x Today’s volume vs 20-day average before news

Market Reality Check

Price: $7.82 Vol: Volume 78,587 is above th...

high vol

$7.82 Last Close

Volume Volume 78,587 is above the 20-day average of 36,774, indicating elevated trading interest. high

Technical Shares at $6.68 are trading above the 200-day MA of $3.34, reflecting a pre-news uptrend.

Peers on Argus

Biotech peers in momentum scan such as PYXS (-7.77%) and ZNTL (-4.01%) also move...

2 Down

Biotech peers in momentum scan such as PYXS (-7.77%) and ZNTL (-4.01%) also moved down, suggesting broader sector pressure alongside ARMP’s -5.25% move.

Historical Context

5 past events · Latest: Nov 18 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 18	KOL webinar	Positive	+2.5%	KOL webinar highlighting positive AP-SA02 Phase 1b/2a diSArm data.
Nov 12	Earnings & update	Positive	-0.9%	Q3 2025 results with positive AP-SA02 data and new loan financing.
Nov 10	Facility commissioning	Positive	+7.4%	Commissioning of new cGMP phage manufacturing facility in Los Angeles.
Oct 22	Phase 2a results	Positive	+103.2%	Positive Phase 2a diSArm efficacy and safety results for AP-SA02 at IDWeek.
Oct 14	Conference preview	Neutral	-0.6%	Announcement of upcoming late-breaking AP-SA02 clinical data presentation.

Pattern Detected

ARMP has shown strong positive alignment to clinical and manufacturing milestones, with occasional divergence on broader corporate/earnings updates.

Recent Company History

Over the last few months, Armata has steadily advanced AP-SA02. Positive Phase 2a diSArm data and the IDWeek 2025 presentation on Oct 22, 2025 drove a 103.17% move. Commissioning of a new cGMP phage facility on Nov 10, 2025 preceded a 7.44% gain, while a KOL webinar on Nov 18, 2025 also saw shares up. Today’s FDA End-of-Phase 2 feedback and Phase 3 planning build directly on these earlier clinical and manufacturing milestones.

Regulatory & Risk Context

Active S-3 Shelf · $100,000,000

Shelf Active

Active S-3 Shelf Registration 2025-08-13

$100,000,000 registered capacity

Armata has an effective Form S-3 shelf filed on Aug 13, 2025 to sell up to $100,000,000 of securities, already tapped via a $100,000,000 at-the-market equity program. This structure provides flexible access to capital for Phase 3 and beyond but also introduces ongoing dilution risk, particularly given disclosed going-concern uncertainties and substantial additional financing needs.

Market Pulse Summary

This announcement confirms FDA support to advance AP-SA02 into a Phase 3 superiority trial in compli...

Analysis

This announcement confirms FDA support to advance AP-SA02 into a Phase 3 superiority trial in complicated S. aureus bacteremia, following positive Phase 2a diSArm data. Investors may track the final Phase 3 design, timing relative to the second half of 2026, and progress on QIDP status. Regulatory filings detail a $100,000,000 shelf and ATM program plus going-concern risks, making future financing terms and dilution key variables to monitor.

Key Terms

bacteriophage, end-of-phase 2, chemistry, manufacturing, and controls, biologics license application, +4 more

8 terms

bacteriophage medical

"bacteriophage product candidate, AP-SA02, into a Phase 3 clinical study"

A bacteriophage is a virus that infects and kills specific bacteria, acting like a precision tool that targets only certain bacterial strains. For investors, bacteriophage-based products matter because they represent an alternative to traditional antibiotics, potentially addressing drug-resistant infections and creating new markets in healthcare and agriculture; success or failure in development and regulation can sharply affect the value of companies working in this field.

end-of-phase 2 regulatory

"announced the conclusion of an End-of-Phase 2 ("EOP2") written response"

End-of-phase 2 is the development milestone when a drug or medical treatment completes its mid-stage human testing and the sponsor and regulators review the results to decide whether and how to proceed to larger late-stage trials. It matters to investors because this review signals whether the product showed enough benefit and acceptable safety to justify expensive Phase 3 studies, much like passing a major exam before committing to the final, costly year of a degree, and can materially affect a company’s value and funding needs.

chemistry, manufacturing, and controls regulatory

"addressing FDA comments, including on Chemistry, Manufacturing, and Controls ("CMC")"

Chemistry, manufacturing, and controls (CMC) is the detailed documentation of how a drug or medical product is made, tested, and kept consistent — like a recipe, factory checklist, and quality-control plan combined. Investors care because strong CMC means regulators are more likely to approve the product and the company can reliably scale production, while weak or incomplete CMC raises the risk of approval delays, production problems, extra costs, or recalls.

biologics license application regulatory

"The FDA also included recommendations for the future Biologics License Application"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

qualified infectious disease product designation regulatory

"request for Qualified Infectious Disease Product Designation ("QIDP") for AP-SA02"

A qualified infectious disease product (QIDP) designation is a regulatory label given to certain antibiotics or antifungal drugs that target serious or life-threatening infections, which makes those treatments eligible for faster review and added market protections from regulators. For investors it matters because the designation can shorten development time and grant extra exclusivity—like giving a new product a head start and a temporary no-competition period—potentially increasing the drug’s commercial value and reducing development risk.

best available antibiotic therapy medical

"clinical response at end of best available antibiotic therapy ("BAT")"

The best available antibiotic therapy is the most appropriate existing antibiotic or combination of antibiotics that a treating doctor would use for a patient, based on current medical guidelines, local bacterial patterns, and the patient’s condition. Investors care because it sets the practical benchmark for clinical trials and real‑world comparisons: a new drug must show clear advantage or comparable safety versus this “best current tool,” which influences regulatory approval, market demand, and commercial adoption.

superiority study clinical

"Phase 3 clinical study design, which will assess the superiority of AP-SA02"

A superiority study is a clinical test designed to show that one medical treatment works better than another (such as an existing drug or a placebo). For investors, its importance lies in proving a product’s advantage: clear positive results can increase the odds of regulatory approval, market adoption, and higher sales, much like a head‑to‑head taste test that proves one recipe is preferred and therefore more valuable commercially.

bacteremia medical

"Phase 3 clinical study in complicated S. aureus bacteremia"

Bacteremia is the presence of bacteria in the bloodstream, which can be a transient event or the start of a serious infection. For investors, it matters because it influences demand for diagnostics, antibiotics, medical devices and hospital care, can change clinical trial outcomes or regulatory decisions, and may affect healthcare costs and company revenues much like a leak in a building’s pipes signals the need for immediate repairs and long‑term maintenance.

AI-generated analysis. Not financial advice.

In the news release, Armata Pharmaceuticals Announces End-of-Phase 2 Meeting with FDA and Plans to Advance AP-SA02 to a Phase 3 Superiority Study in Complicated BacteremiaStaphylococcusaureus, issued Jan. 13, 2026 by Armata Pharmaceuticals, Inc. over PR Newswire, we are advised by the company that the original version contained incorrect information introduced by PR Newswire during transmission. The complete, corrected release follows, with additional details at the end:

Armata Pharmaceuticals Announces End-of-Phase 2 Meeting with FDA and Plans to Advance AP-SA02 to a Phase 3 Superiority Study in Complicated Staphylococcus aureus Bacteremia

FDA agreed that data from the Phase 2a diSArm study support advancement of AP-SA02 to a Phase 3
study

First bacteriophage company to advance a clinical candidate to Phase 3

LOS ANGELES, Jan. 13, 2026 /PRNewswire/ -- 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 the conclusion of an End-of-Phase 2 ("EOP2") written response from the U.S. Food and Drug Administration ("FDA") and plans to advance the Company's intravenously-administered Staphylococcus aureus bacteriophage product candidate, AP-SA02, into a Phase 3 clinical study in complicated S. aureus bacteremia. The Phase 3 study is anticipated to initiate in the second half of 2026.

FDA's Center for Biologics Evaluation and Research division, upon reviewing Armata's detailed EOP2 background package, confirmed that the safety and efficacy data from Armata's Phase 2a diSArm study support advancement to Phase 3. The FDA provided critical guidance on key elements of the Phase 3 study design, which will assess the superiority of AP-SA02 over the current standard of care for the treatment of complicated S. aureus bacteremia. Armata is addressing FDA comments, including on Chemistry, Manufacturing, and Controls ("CMC") and aligning them with the Company's existing Phase 3 manufacturing and quality strategy. The FDA also included recommendations for the future Biologics License Application and is amenable to Armata submitting a request for Qualified Infectious Disease Product Designation ("QIDP") for AP-SA02. The Company is already addressing many of the clinical and CMC comments from FDA and has submitted the request for QIDP.

"The completion of our Phase 2a diSArm was the first evidence of the efficacy of phage therapy in a randomized controlled study and a momentous achievement for Armata," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "Following the End-of-Phase 2 meeting written response from FDA, in which the FDA provided recommendations on key study elements, we can finalize the design of the pivotal superiority study of AP-SA02. Armata intends to initiate the study later this year. If successful, this would be the first superiority-based pivotal trial for an antibacterial drug candidate in several decades and usher in a new era in the treatment of deadly bacterial infections such as complicated bacteremia due to S. aureus."

"I would like to acknowledge the participants and investigators from the diSArm study who were critical in getting us to this point. The Company anticipates robust enrollment in the Phase 3 study in light of the Phase 2 data, and many sites that participated in the Phase 2 study are enthusiastic to continue to be involved. We remain grateful for our partnership with the U.S. Department of Defense, and our significant shareholder, Innoviva, who continue to support this important program," Dr. Birx concluded.

The results of the Phase 2a diSArm study were announced in May 2025 and further highlighted in a late-breaking oral presentation at IDWeek 2025™ in October 2025. The primary study endpoint for the Phase 3 superiority study is expected to be clinical response at end of best available antibiotic therapy ("BAT") and 28 days later at End of Study. Safety and healthcare resource impact analyses will be included.

About AP-SA02 and diSArm Study
Armata is developing AP-SA02, a fixed multi-phage phage cocktail, for the treatment of complicated bacteremia caused by Staphylococcus aureus, including methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA) strains.

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 BAT compared to BAT alone (placebo) for the treatment of adults with complicated S. aureus bacteremia. The results from the diSArm study are an important step forward in Armata's effort to confirm the potent antimicrobial activity of phage therapy and the completion of the study represents a significant milestone in the development of AP-SA02, moving Armata one step closer to introducing an effective new treatment option to patients suffering from complicated S. aureus bacteremia.

The Phase 1b/2a clinical development of AP-SA02 was partially supported by a $26.2 million Department of Defense (DoD) award, received through the Medical Technology Enterprise Consortium (MTEC) and managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program.

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, Staphylococcus 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 21, 2025, 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

Correction: An earlier version of this release incorrectly had the headline as "Complicated BacteremiaStaphylococcusaureus" instead of "Complicated Staphylococcus aureus Bacteremia."

FAQ

What did Armata (ARMP) announce on January 13, 2026 about AP-SA02?

Armata announced an FDA End-of-Phase 2 written response supporting advancement of AP-SA02 to a Phase 3 superiority study for complicated S. aureus bacteremia.

When is Armata planning to start the AP-SA02 Phase 3 study (ARMP)?

The company anticipates initiating the Phase 3 study in the second half of 2026, subject to resolving FDA comments.

What primary endpoints will Armata use in the AP-SA02 Phase 3 trial (ARMP)?

The primary endpoints are clinical response at end of best available antibiotic therapy and at Day 28 (end of study).

Did the FDA provide guidance to Armata (ARMP) on AP-SA02 development?

Yes; the FDA provided recommendations on Phase 3 study design, CMC, BLA expectations, and indicated amenability to a QIDP request.

Has Armata (ARMP) applied for QIDP for AP-SA02?

Armata has submitted a request for Qualified Infectious Disease Product (QIDP) designation for AP-SA02.