U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with ENHANZE® for the Treatment of Advanced EGFR-mutated Non-Small Cell Lung Cancer

Rhea-AI Summary

Halozyme (NASDAQ: HALO) announced that the U.S. FDA approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) co-formulated with ENHANZE for patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer on Dec 18, 2025. RYBREVANT FASPRO™ is approved across all RYBREVANT indications and is the first and only subcutaneous targeted therapy for EGFR+ mNSCLC.

Compared with IV delivery, administration time fell to ~5 minutes and administration-related reactions declined ~fivefold (13% SC vs 66% IV). The product met both co-primary PK endpoints in Phase 3 PALOMA-3 (Ctrough at C2D1 or C4D1 and C2 AUC D1-D15). Johnson & Johnson issued related press details on Dec 17, 2025.

Positive

• U.S. FDA approval received on Dec 18, 2025
• First and only subcutaneous targeted therapy for EGFR+ mNSCLC
• Administration time reduced to ~5 minutes
• Administration-related reactions reduced to 13% vs 66%
• Met co-primary PK endpoints in Phase 3 PALOMA-3

Negative

• None.

Key Figures

Administration time approximately five minutes Subcutaneous RYBREVANT FASPRO™ vs several hours IV

ARR rate (SC) 13 percent Administration-related reactions in SC arm

ARR rate (IV) 66 percent Administration-related reactions in IV arm

ARR reduction approximately fivefold SC vs IV administration-related reactions

Phase Phase 3 PALOMA-3 study supporting approval

Market Reality Check

$70.29 Last Close

Volume Volume 1,338,430 is below the 2,549,410 share 20-day average, indicating muted pre-news activity. low

Technical Price 65.77 is trading above the 200-day MA at 63.33, reflecting a pre-existing uptrend.

Peers on Argus

HALO was up 2.02% pre-news, while peers showed mixed, mostly modest moves: MRNA +1.67%, VRNA +0.06%, ROIV -1.33%, MDGL -1.03%, RVMD -0.93%, suggesting a company-specific driver.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 08	Board appointment	Neutral	-1.6%	New director with extensive healthcare and analytics experience joined the board.
Dec 04	Legal injunction	Positive	-2.4%	Preliminary injunction in Germany restricting Merck’s Keytruda SC launch activities.
Nov 25	Conference participation	Neutral	-1.6%	CEO presentation and investor meetings at Evercore healthcare conference.
Nov 18	Acquisition deal	Positive	-0.7%	Completed Elektrofi acquisition adding Hypercon™ ultra‑high concentration platform.
Nov 17	Drug delivery deal	Positive	+0.8%	Global ENHANZE® collaboration to develop subcutaneous petosemtamab formulation.

Pattern Detected

Recent news, including legal and strategic updates, often saw modest negative reactions, even on arguably positive developments.

Recent Company History

Over the last two months, Halozyme reported stronger Q3 results with total revenues of $354.264M and net income of $175.225M, executed a large convertible note financing, and expanded its drug delivery portfolio via the Elektrofi acquisition with up to $900M consideration. It also entered a new ENHANZE® collaboration with Merus and obtained a German injunction related to Keytruda SC. Against this backdrop, today’s FDA approval for an ENHANZE‑enabled lung cancer therapy continues the theme of partner-driven ENHANZE® adoption.

Market Pulse Summary

This announcement highlights another FDA approval for an ENHANZE®-enabled therapy, extending use into advanced EGFR-mutated non-small cell lung cancer and offering subcutaneous dosing in about five minutes with reduced administration-related reactions (13% vs 66% IV). Historically, Halozyme has seen multiple ENHANZE®-based approvals across partners and tumor types. Investors may watch future partner uptake, royalty trends, and additional regulatory milestones to gauge the long-term impact of this approval.

Key Terms

epidermal growth factor receptor medical

"for patients with epidermal growth factor receptor (EGFR)-mutated locally advanced"

A protein on the surface of many cells that acts like an antenna or switch controlling cell growth and repair; certain changes (mutations) can make it stuck in the “on” position, driving uncontrolled cell division. Investors watch it because drugs or tests that target this receptor can become valuable therapies or diagnostic tools, shaping clinical trial outcomes, regulatory approvals, and potential revenue for companies in the healthcare sector.

non-small cell lung cancer medical

"metastatic non-small cell lung cancer (NSCLC).1 RYBREVANT FASPRO™ is approved"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

subcutaneously medical

"only subcutaneously (SC) administered targeted therapy for patients with EGFR+ mNSCLC"

Given or delivered beneath the skin into the fatty layer just under the surface, usually by injection or a small device. For investors, whether a medicine is given subcutaneously affects how easy it is for patients to use, how often doses are needed, and the cost and complexity of manufacturing and regulation—think of it like placing a slow-release patch under a carpet instead of pouring medicine on top of it, which changes convenience and ongoing demand.

intravenous medical

"Compared to intravenous (IV) delivery, RYBREVANT FASPRO™ significantly reduced"

Intravenous means delivering a drug, fluid or substance directly into a vein so it goes straight into the bloodstream. For investors, that matters because intravenous products often act faster, require different manufacturing, regulatory steps and healthcare settings (like hospitals or clinics), and can affect pricing, adoption and revenue profiles in ways that differ from pills or topical treatments — like turning a slow-release delivery into a direct tap to the system.

pharmacokinetic medical

"meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

area under the curve medical

"1 or C4D1 and C2 area under the curve (AUCD1-D15)].1,2For more information"

Area under the curve (AUC) is a measure of total exposure to a drug over time, calculated by summing the concentration of the drug in the blood at each point after dosing. For investors, AUC matters because it helps regulators and doctors judge how much of a medicine reaches the body and for how long—information that influences dosing, safety, regulatory approval, and ultimately a drug’s market potential, much like measuring total rainfall tells you how wet a season was.

subcutaneous medical

"first and only subcutaneously (SC) administered targeted therapy for patients"

Subcutaneous means situated or applied just beneath the skin. In finance, the term can describe processes or investments that are hidden or not immediately visible, much like something placed under the skin that isn't easily seen from the outside. Recognizing subcutaneous activities helps investors understand underlying factors that may influence markets or asset values over time.

U.S. Food and Drug Administration regulatory

"has received approval from the U.S. Food and Drug Administration (FDA) for"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

AI-generated analysis. Not financial advice.

RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw)

SAN DIEGO, Dec. 18, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), which is co-formulated with ENHANZE® for patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).¹ RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw) and represents the first and only subcutaneously (SC) administered targeted therapy for patients with EGFR+ mNSCLC.

Compared to intravenous (IV) delivery, RYBREVANT FASPRO™ significantly reduced administration time from several hours to approximately five minutes and demonstrated an approximately fivefold reduction in administration-related reactions (ARRs) (13 percent in SC vs 66 percent in IV arm).

"Formulated with our leading ENHANZE drug delivery technology, RYBREVANT FASPRO™ has the potential to make administration faster and more convenient for patients and their families compared to intravenous administration," said Dr. Helen Torley, president and chief executive officer of Halozyme. "By reducing administration times and simplifying the treatment experience, ENHANZE-formulated products could also support efficiencies for healthcare providers and lower costs for the healthcare system. This approval underscores ENHANZE's role in delivering meaningful clinical and economical value for patients, providers and payers."

Based on the results from the Phase 3 PALOMA-3 study (NCT05388669), RYBREVANT FASPRO™ delivered consistent results to RYBREVANT®, meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab levels in the blood [Ctrough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve (AUCD1-D15)].^1,2

For more information on this approval, please view Johnson & Johnson's press release issued on December 17, 2025.

References

^1.RYBREVANT FASPRO™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.

^2.Yang J et al. Amivantamab Plus Lazertinib vs Osimertinib in First-line EGFR-mutant Advanced NSCLC – Final Overall Survival from MARIPOSA [ELCC abstract #40]. Presented at: 2025 European Lung Cancer Congress (ELCC); March 26-29, 2025; Paris, France.

About Halozyme

Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies.

As the innovators of ENHANZE^® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE^® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, and Merus N.V.

Halozyme is also developing Hypercon™ to expand the breadth of its drug delivery technology portfolio. Hypercon™ is an innovative microparticle technology that is expected to set a new standard in hyper concentration of drugs and biologics that can reduce the injection volume for the same dosage and expands opportunities for at-home and health care provider administration. The addition of Hypercon™ enhances our ability to transform the patient treatment experience by enabling the creation and delivery of highly concentrated biologics, substantially broadening the scope of therapeutics that can be delivered subcutaneously. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Johnson & Johnson, Eli Lilly, and argenx.

Halozyme also develops, manufactures, and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability, and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex^® and XYOSTED^®, partnered commercial products, and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.

Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility.

For more information, visit www.halozyme.com and connect with us on LinkedIn and Twitter.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and administration-related reactions, broadening the treatment options for the indications referred to in this press release, support efficiencies for healthcare providers and potentially lower healthcare system costs. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results or delays in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Contacts:

Tram Bui
VP, Investor Relations and Corporate Communications
609-333-7668
tbui@halozyme.com

Sydney Charlton
Teneo
917-972-8407
sydney.charlton@teneo.com

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What did Halozyme announce about RYBREVANT FASPRO on Dec 18, 2025 (HALO)?

Halozyme announced FDA approval of RYBREVANT FASPRO co-formulated with ENHANZE for EGFR-mutated advanced NSCLC on Dec 18, 2025.

How does RYBREVANT FASPRO (HALO) differ from IV RYBREVANT in administration?

Subcutaneous delivery cuts administration to ~5 minutes and lowers ARRs to 13% vs 66% for IV.

Did RYBREVANT FASPRO meet clinical endpoints in PALOMA-3 relevant to HALO investors?

Yes; RYBREVANT FASPRO met both co-primary pharmacokinetic endpoints in Phase 3 PALOMA-3 (Ctrough and C2 AUC measures).

Which company holds the FDA approval and where can I find more details dated Dec 17–18, 2025?

Johnson & Johnson received the FDA approval; investors can review Johnson & Johnson's press information published on Dec 17, 2025.

What benefit could ENHANZE-formulated RYBREVANT FASPRO bring to healthcare providers?

ENHANZE-formulation may shorten administration time and potentially support provider efficiencies and lower system costs.