U.S. FDA Approves TECVAYLI® in Combination with DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma

Q: What did Halozyme announce about FDA approval for TECVAYLI plus DARZALEX FASPRO (HALO) on March 6, 2026?

Halozyme announced that Johnson & Johnson received FDA approval for TECVAYLI with DARZALEX FASPRO for adults with RRMM after at least one prior therapy. According to Halozyme, approval is supported by Phase 3 MajesTEC-3 results showing significant PFS and OS benefit.

Q: What were the MajesTEC-3 Phase 3 trial results that led to FDA approval for TECVAYLI plus DARZALEX FASPRO (HALO)?

MajesTEC-3 reported a hazard ratio of 0.17 for progression or death versus standard regimens (95% CI 0.12–0.23; P<0.0001). According to Halozyme, the three-year PFS rate was 83% after a median three-year follow-up.

Q: Which patients are eligible for the TECVAYLI plus DARZALEX FASPRO indication in the FDA approval tied to HALO?

The approval covers adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. According to Halozyme, the regimen is subcutaneously administered and intended across treatment settings.

Q: How does the TECVAYLI plus DARZALEX FASPRO regimen relate to Halozyme's ENHANZE technology (HALO)?

DARZALEX FASPRO incorporates ENHANZE technology to enable subcutaneous delivery of daratumumab with hyaluronidase. According to Halozyme, the approved combo uses subcutaneous administration for both agents, supporting broader outpatient use.

Q: When were the MajesTEC-3 trial results presented that support the FDA approval for TECVAYLI plus DARZALEX FASPRO (HALO)?

Key MajesTEC-3 results supporting approval were presented at the 2025 American Society of Hematology meeting and accessed December 2025. According to Halozyme, these Phase 3 data underpin the FDA decision announced March 6, 2026.

Rhea-AI Impact

(Moderate)

Rhea-AI Sentiment

(Neutral)

Rhea-AI Summary

Halozyme (NASDAQ: HALO) announced that Johnson & Johnson received U.S. FDA approval (March 6, 2026) for TECVAYLI (teclistamab) combined with DARZALEX FASPRO for adults with relapsed/refractory multiple myeloma after ≥1 prior therapy. The approval followed Phase 3 MajesTEC-3 data showing statistically significant PFS and OS benefits.

Key trial results: hazard ratio 0.17 for progression or death (95% CI 0.12–0.23; P<0.0001) and a three-year PFS rate of 83% after median three-year follow-up.

Positive

FDA approval for TECVAYLI plus DARZALEX FASPRO in RRMM after ≥1 prior therapy
Phase 3 MajesTEC-3: HR 0.17 (95% CI 0.12–0.23; P<0.0001) indicating 83% risk reduction
Three-year PFS rate of 83% after median three-year follow-up

Negative

None.

News Market Reaction – HALO

+0.01%

1 alert

+0.01% News Effect

On the day this news was published, HALO gained 0.01%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Risk reduction: 83% reduction in risk of progression or death Hazard ratio: HR 0.17 95% CI: 0.12–0.23 +2 more

5 metrics

Risk reduction 83% reduction in risk of progression or death MajesTEC-3 Phase 3 RRMM study vs standard regimens

Hazard ratio HR 0.17 Progression or death risk vs standard of care in RRMM

95% CI 0.12–0.23 Confidence interval for hazard ratio in MajesTEC-3

P-value P<0.0001 Statistical significance for PFS/OS improvements in MajesTEC-3

Three-year PFS rate 83% TECVAYLI + DARZALEX FASPRO regimen in RRMM

Market Reality Check

Price: $65.40 Vol: Volume 1,822,603 vs 20-da...

normal vol

$65.40 Last Close

Volume Volume 1,822,603 vs 20-day avg 2,082,936 (relative 0.88x) ahead of this FDA approval. normal

Technical Price $67.36 trades above 200-day MA at $66.29, sitting 18.07% below the 52-week high and 41.81% above the 52-week low.

Peers on Argus

HALO was down 3.8% while close peers showed mixed moves: MRNA -5.49%, MDGL +1.11...

HALO was down 3.8% while close peers showed mixed moves: MRNA -5.49%, MDGL +1.11%, ROIV +0.32%, VRNA +0.06%, RVMD -0.8%, indicating stock-specific trading rather than a broad biotech move.

Previous Fda approval Reports

5 past events · Latest: Dec 18 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 18	FDA approval update	Positive	-1.0%	FDA approval of RYBREVANT FASPRO co-formulated with ENHANZE for EGFR+ NSCLC.
Nov 07	FDA approval update	Positive	-0.2%	FDA approval of DARZALEX Faspro with ENHANZE for high-risk smoldering myeloma.
Apr 10	FDA approval update	Positive	+4.4%	FDA approval of VYVGART Hytrulo prefilled syringe with ENHANZE for gMG and CIDP.
Dec 30	FDA approval update	Positive	-0.3%	FDA approval of Opdivo Qvantig subcutaneous formulation with ENHANZE technology.
Sep 13	FDA approval update	Positive	+2.9%	FDA approval of OCREVUS ZUNOVO subcutaneous ENHANZE-enabled therapy for MS.

Pattern Detected

Across five prior FDA approval headlines, HALO often saw modest or even negative next-day moves, with 3 of 5 events showing price declines despite positive regulatory outcomes.

Recent Company History

Recent FDA approvals tied to Halozyme’s ENHANZE® collaborations span oncology and neurology, including Opdivo Qvantig™ for solid tumors, OCREVUS ZUNOVO™ for multiple sclerosis, VYVGART® Hytrulo for gMG and CIDP, and DARZALEX Faspro for high‑risk smoldering multiple myeloma. These deals highlight ENHANZE’s use in subcutaneous formulations and faster administration. Price reactions around these approvals were mixed, so today’s TECVAYLI plus DARZALEX FASPRO approval fits an ongoing pattern of strong clinical/regulatory progress not always mirrored in immediate share performance.

Historical Comparison

+1.1% avg move · Past FDA-approval headlines for ENHANZE® partners moved HALO an average of +1.15%. Today’s -3.8% pre...

fda approval

+1.1%

Average Historical Move fda approval

Past FDA-approval headlines for ENHANZE® partners moved HALO an average of +1.15%. Today’s -3.8% pre-news level sits below that norm, implying more cautious positioning.

FDA approvals show a widening ENHANZE® footprint, from multiple sclerosis and solid tumors to myasthenia gravis, CIDP, lung cancer, and now earlier-line multiple myeloma.

Market Pulse Summary

This announcement highlights a significant FDA approval for TECVAYLI plus DARZALEX FASPRO in earlier...

Analysis

This announcement highlights a significant FDA approval for TECVAYLI plus DARZALEX FASPRO in earlier-line relapsed or refractory multiple myeloma, backed by Phase 3 data showing an 83% risk reduction and 83% three‑year PFS. It extends Halozyme’s pattern of ENHANZE®-enabled subcutaneous partnerships driving new indications across oncology and neurology. Investors may watch how this translates into royalty trends alongside previously issued 2026 revenue and EBITDA guidance, and monitor future regulatory or partner updates tied to ENHANZE-based products.

Key Terms

progression-free survival, overall survival, subcutaneously, relapsed or refractory multiple myeloma, +4 more

8 terms

progression-free survival medical

"data demonstrating statistically significant improvements in progression‑free survival and overall survival"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"statistically significant improvements in progression‑free survival and overall survival versus standard"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

subcutaneously medical

"both drugs are administered subcutaneously, offers patients with relapsed or refractory multiple myeloma"

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.

relapsed or refractory multiple myeloma medical

"for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received"

A form of multiple myeloma that either returns after an initial response to treatment (relapsed) or does not respond to standard therapies from the start (refractory). Investors care because these patients represent a clear medical need and a defined market for new drugs or therapies; successful treatments can drive clinical trial value, regulatory approval chances, and potential sales, much like a solution that works where existing approaches fail.

Phase 3 medical

"approval is based on data from the Phase 3 MajesTEC-3 study, an ongoing, Phase 3 randomized"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

hazard ratio medical

"risk of disease progression or death compared to standard regimens (hazard ratio [HR], 0.17;"

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

confidence interval medical

"0.17; 95 percent confidence interval [CI], 0.12-0.23; P<0.0001).2 The three-year PFS"

An interval estimate that shows a range of values within which a true number (like a company’s expected earnings, a projected return, or a model input) is likely to lie, together with a stated level of confidence in that range. For investors it turns a single point forecast into a band—like a weather forecast saying 60–70°F instead of just 65°F—making uncertainty explicit so you can judge risk and size positions more sensibly.

subcutaneous medical

"treatment regimen, in which both drugs are administered subcutaneously, offers patients with relapsed"

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.

AI-generated analysis. Not financial advice.

03/06/2026 - 08:00 AM

FDA approval based on Phase 3 data demonstrating statistically significant improvements in progression‑free survival and overall survival versus standard of care regimens

SAN DIEGO, March 6, 2026 /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 TECVAYLI® (teclistamab-cqyv) in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy.¹

"The newly approved TECVAYLI plus DARZALEX FASPRO treatment regimen, in which both drugs are administered subcutaneously, offers patients with relapsed or refractory multiple myeloma a new, effective treatment option that can be administered across all treatment settings. DARZALEX FASPRO, incorporating the ENHANZE technology, continues to set new standards in multiple myeloma treatment and outcomes," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme

The approval is based on data from the Phase 3 MajesTEC-3 study, an ongoing, Phase 3 randomized study evaluating the safety and efficacy of teclistamab plus daratumumab versus investigator's choice of daratumumab and dexamethasone with either pomalidomide or bortezomib in patients with RRMM who have received at least one prior line of therapy. TECVAYLI® in combination with DARZALEX FASPRO® demonstrated statistically significant improvements in PFS and OS in patients with RRMM compared to standard treatment after a median follow-up of three years in patients with RRMM. Results show an 83% reduction in the risk of disease progression or death compared to standard regimens (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P<0.0001).² The three-year PFS rate was 83%,² underscoring a durable benefit.

For more information on this approval, please view Johnson & Johnson's press release issued on March 5, 2026.

References

^1. TECVAYLI® U.S. Prescribing Information

^2. Maria-Victoria Mateos, et. al., Phase 3 Randomized Study of Teclistamab Plus Daratumumab Versus Investigator's Choice of Daratumumab and Dexamethasone With Either Pomalidomide or Bortezomib (DPd/DVd) in Patients With Relapsed Refractory Multiple Myeloma (RRMM): Results of MajesTEC-3, 2025 American Society of Hematology Annual Meeting. Accessed December 2025.

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, Merus N.V. and Skye Bioscience.

Halozyme expanded its drug delivery technology portfolio to develop partner products using Hypercon™ and Surf Bio's hyperconcentration technology. Hypercon™ is an innovative microparticle technology expected to set a new standard in hyperconcentration of drugs and biologics by reducing injection volume for the same dosage and enabling administration in at‑home and healthcare‑provider settings. The addition of Surf Bio's polymer‑based hyperconcentration technology further broadens the range of biologics that can be delivered subcutaneously, meaningfully expanding the scope of opportunities across therapeutic modalities. Together, Hypercon™ and Surf Bio's technology complement ENHANZE® by enabling creation and delivery of highly concentrated biologics. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Janssen, 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.

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 and broadening the treatment options for the indication referred to in this press release. 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

View original content to download multimedia:https://www.prnewswire.com/news-releases/us-fda-approves-tecvayli-in-combination-with-darzalex-faspro-for-relapsedrefractory-multiple-myeloma-302706257.html

SOURCE Halozyme Therapeutics, Inc.

FAQ

What did Halozyme announce about FDA approval for TECVAYLI plus DARZALEX FASPRO (HALO) on March 6, 2026?

Halozyme announced that Johnson & Johnson received FDA approval for TECVAYLI with DARZALEX FASPRO for adults with RRMM after at least one prior therapy. According to Halozyme, approval is supported by Phase 3 MajesTEC-3 results showing significant PFS and OS benefit.

What were the MajesTEC-3 Phase 3 trial results that led to FDA approval for TECVAYLI plus DARZALEX FASPRO (HALO)?

MajesTEC-3 reported a hazard ratio of 0.17 for progression or death versus standard regimens (95% CI 0.12–0.23; P<0.0001). According to Halozyme, the three-year PFS rate was 83% after a median three-year follow-up.

Which patients are eligible for the TECVAYLI plus DARZALEX FASPRO indication in the FDA approval tied to HALO?

The approval covers adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. According to Halozyme, the regimen is subcutaneously administered and intended across treatment settings.

How does the TECVAYLI plus DARZALEX FASPRO regimen relate to Halozyme's ENHANZE technology (HALO)?

DARZALEX FASPRO incorporates ENHANZE technology to enable subcutaneous delivery of daratumumab with hyaluronidase. According to Halozyme, the approved combo uses subcutaneous administration for both agents, supporting broader outpatient use.

When were the MajesTEC-3 trial results presented that support the FDA approval for TECVAYLI plus DARZALEX FASPRO (HALO)?

Key MajesTEC-3 results supporting approval were presented at the 2025 American Society of Hematology meeting and accessed December 2025. According to Halozyme, these Phase 3 data underpin the FDA decision announced March 6, 2026.

U.S. FDA Approves TECVAYLI® in Combination with DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma