Anixa Biosciences Secures United States Adopted Names Council Approval of Non-Proprietary Name for its CAR-T Therapy, a Key Step Toward Future Commercialization

Rhea-AI Summary

Anixa (NASDAQ: ANIX) announced that the United States Adopted Names (USAN) Council approved liraltagene autoleucel as the non-proprietary name for its FSHR-targeted CAR-T therapy for recurrent ovarian cancer.

This follows prior International Nonproprietary Names (INN) approval by WHO and supports a universally recognized drug name ahead of potential commercialization and ongoing Phase 1 trial collaboration with Moffitt Cancer Center.

News Market Reaction

-3.29%

1 alert

-3.29% News Effect

On the day this news was published, ANIX declined 3.29%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Share price: $3.04 52-week high: $5.4566 52-week low: $2.331 +5 more

8 metrics

Share price $3.04 Pre-news trading price for ANIX

52-week high $5.4566 52-week high price level

52-week low $2.331 52-week low price level

Cash & investments $15,174,000 As of October 31, 2025 (10-K)

Fiscal 2025 net loss $11,028,000 Loss for fiscal year 2025 (10-K)

Accumulated deficit $251,677,000 As of October 31, 2025 (10-K)

ATM equity program $100,000,000 Maximum common stock sales permitted under ATM program (10-K)

Net tangible book value/share $0.46 As of July 31, 2025 in S-3 shelf

Market Reality Check

Price: $2.96 Vol: Volume 175,106 is 0.74x t...

normal vol

$2.96 Last Close

Volume Volume 175,106 is 0.74x the 20-day average of 235,042, showing subdued trading ahead of this news. normal

Technical Shares at $3.04 trade below the $3.40 200-day MA and sit 44.29% under the 52-week high, despite this constructive regulatory naming step.

Peers on Argus

ANIX was down 1.94% while key biotech peers like SRZN (-1.44%), STTK (-4.21%), T...

ANIX was down 1.94% while key biotech peers like SRZN (-1.44%), STTK (-4.21%), TCRX (-0.97%), ADAG (-5.17%) and PYXS (-5.23%) also declined, but no peers appeared in the momentum scanner, suggesting a stock-specific catalyst rather than a coordinated sector move.

Historical Context

5 past events · Latest: Jan 27 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 27	Patent allowance	Positive	-0.3%	Mexican patent allowance expanding IP for breast cancer vaccine technology.
Dec 15	Clinical program update	Positive	-8.9%	Transfer of IND and plans to advance breast cancer vaccine to Phase 2.
Dec 11	Phase 1 data	Positive	-6.4%	Final Phase 1 data showed safety and 74% immune response in vaccine trial.
Dec 10	Investor event	Positive	+1.4%	Announcement of investor fireside chat to discuss final breast cancer data.
Dec 09	Data presentation notice	Positive	-3.1%	Notice of upcoming SABCS presentation of final Phase 1 breast cancer data.

Pattern Detected

Recent history shows a tendency for ANIX shares to trade lower on otherwise positive development and IP news, with multiple favorable clinical and patent updates followed by negative next-day moves.

Recent Company History

Over the past few months, ANIX has highlighted progress across its oncology pipeline. Positive Phase 1 breast cancer vaccine data in Dec 2025 (meeting primary endpoints in 35 participants with 74% showing immune responses) and related conference communications were followed by share price declines. Likewise, a Jan 27, 2026 Mexican patent allowance for its breast cancer vaccine saw a slight negative reaction. Against this backdrop, today’s USAN/INN naming for liraltagene autoleucel fits a pattern of constructive, non-revenue milestones arriving while the stock trades below long-term averages.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-09-10

Anixa has an active Form S-3 shelf filed on 2025-09-10, allowing it to register and offer various securities, including common and preferred stock, warrants, and units. The filing details estimated offering expenses of $96,146 but shows no usage to date, with 0 prospectus supplements filed and the shelf not yet effective.

Market Pulse Summary

This announcement highlights an important regulatory naming step for Anixa’s FSHR-targeted CAR-T, li...

Analysis

This announcement highlights an important regulatory naming step for Anixa’s FSHR-targeted CAR-T, liraltagene autoleucel, supporting future global commercialization efforts. It comes as ANIX trades below its $3.40 200-day MA and remains significantly under its 52-week high. Historically, the company has reported positive early-stage data and IP expansion while still posting a $11,028,000 fiscal 2025 loss and an accumulated deficit of $251,677,000, making upcoming clinical readouts and funding decisions key metrics to monitor.

Key Terms

car-t, fshr, usan, inn, +2 more

6 terms

car-t medical

"the Company's novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer."

CAR-T is a type of cancer therapy that reprograms a patient’s own immune cells to seek and destroy specific cancer cells, like teaching guard dogs a new scent to track intruders. It matters to investors because CAR-T treatments can command high prices, drive strong revenue for successful developers, and carry regulatory and manufacturing risks that can sharply affect a company’s valuation and long-term growth prospects.

fshr medical

"the Company's novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer."

FSHR is the protein on cell surfaces that binds follicle-stimulating hormone, a natural chemical that controls reproductive processes like egg and sperm development. Investors watch FSHR because drugs or diagnostics that target this receptor can affect fertility treatments, hormone-related disorders, and certain cancers; think of it as a lock that, when a new key is developed, can open markets for therapies or tests. Advances around FSHR can change a company’s product potential and regulatory risk.

usan regulatory

"the United States Adopted Names (USAN) Council approved "liraltagene autoleucel""

USAN (United States Adopted Names) is the official system that assigns the standard generic names for medicines in the United States, similar to giving every drug a universal first and last name so healthcare providers and regulators can identify it clearly. For investors, a granted USAN signals a drug has reached a recognized stage in development and helps with marketing, labeling and prescribing clarity—factors that can affect regulatory progress, commercial adoption and valuation.

inn regulatory

"approval for international use of the name by the International Nonproprietary Names (INN) Expert Committee"

An INN (International Nonproprietary Name) is the official generic name assigned to a pharmaceutical substance so it can be recognized worldwide, like a common name for a chemical compound rather than a brand label. Investors use INNs to spot when different companies are selling the same drug under different brands, assess competition and generic substitution risks, and evaluate whether a product is likely to face patent-free market pressure once proprietary protection ends.

phase 1 medical

"successful execution of our ongoing Phase 1 trial of liraltagene autoleucel"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

active pharmaceutical ingredients medical

"Each USAN is unique and is used to identify active pharmaceutical ingredients and ensures"

The active pharmaceutical ingredient (API) is the specific chemical or biological substance in a medicine that produces the intended health effect — the ‘engine’ that treats, prevents or diagnoses a condition. Investors watch APIs because they determine a drug’s cost, quality, regulatory approval and patent protection; shortages, manufacturing problems or competition at the API level can directly affect a drug maker’s sales and valuation.

AI-generated analysis. Not financial advice.

SAN JOSE, Calif., Feb. 2, 2026 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that the United States Adopted Names (USAN) Council approved "liraltagene autoleucel" for the non-proprietary name of the Company's novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer. This U.S. approval follows the earlier approval for international use of the name by the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO). The USAN and INN nomenclature schemes for CAR-T cell therapies follow a two-word structure describing the gene and cell component.

"The assignment of the non-proprietary name in the U.S. represents an important step in the development and potential future commercialization of our CAR-T therapy. With this approval, and the prior approval by the INN Expert Committee of the WHO, we have the ability to establish a universally recognized and conflict-free non-proprietary drug name for our CAR-T therapy on a world-wide basis," said Dr. Amit Kumar, Chairman and CEO of Anixa. "We remain focused on the successful execution of our ongoing Phase 1 trial of liraltagene autoleucel, or lira-cel, for the treatment of ovarian cancer. The Phase 1 study is being conducted in partnership with Moffitt Cancer Center."

A USAN is a non-proprietary name selected by the USAN Council to ensure safety, consistency and logic in the choice of names of U.S. medications. The USAN Council is co-sponsored by the American Medical Association, the United States Pharmacopeial Convention, and the American Pharmacists Association. Each USAN is unique and is used to identify active pharmaceutical ingredients and ensures the clear identification, safe prescription and dispensing of medicines to patients.

About liraltagene autoleucel
Liraltagene autoleucel, or lira-cel, is a follicle stimulating hormone receptor (FSHR)-mediated chimeric antigen receptor-T cell (CAR-T) technology that targets FSHR, which is exclusively expressed on normal ovarian cells, tumor vasculature, and certain cancer cells. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is also known as CER-T (chimeric endocrine receptor-T cell) therapy, a new type of CAR-T. Liraltagene autoleucel is currently being evaluated in a first-in-human trial (NCT05316129) that is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor clinical activity. Lira-cel is based on technology exclusively licensed to Anixa by The Wistar Institute.

About Anixa Biosciences, Inc.
Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology. This technology is differentiated from other cell therapies as the natural ligand of the FSHR receptor, FSH, binds to the FSHR receptor on the tumor cell instead of an antibody fragment. Moffitt is a world leader in cancer immunotherapy treatments, pioneering next-generation cell therapies such as CAR-T, and tumor infiltrating lymphocytes (TILs) to harness the power of the immune system. The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. The breast and ovarian cancer vaccines were developed at Cleveland Clinic and exclusively licensed to Anixa. Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company related to these vaccine technologies. Anixa's unique business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit www.anixa.com or follow Anixa on LinkedIn, X, Facebook and YouTube.

Forward-Looking Statements
Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.

Contact:
Mike Catelani
President, COO & CFO
mcatelani@anixa.com
408-708-9808

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SOURCE Anixa Biosciences, Inc.

FAQ

What is liraltagene autoleucel and why did USAN approve it for Anixa (ANIX)?

Liraltagene autoleucel is the non-proprietary name for Anixa's FSHR-targeted CAR-T therapy. According to the company, USAN approval creates a standardized, conflict-free name in the U.S., aligning with prior WHO INN approval to enable consistent global identification of the therapy.

How does the USAN approval of liraltagene autoleucel affect Anixa's (ANIX) commercialization plans?

USAN approval removes a naming obstacle for future commercialization in the U.S. According to the company, having both USAN and INN names allows a universally recognized drug name, which supports regulatory filings, labeling, and international market preparedness.

What clinical development is ongoing for liraltagene autoleucel at Anixa (ANIX)?

Anixa is conducting a Phase 1 trial of liraltagene autoleucel for recurrent ovarian cancer. According to the company, the study is ongoing in partnership with Moffitt Cancer Center and aims to evaluate safety and early clinical activity prior to later-stage development.

Does USAN approval mean liraltagene autoleucel is an approved therapy for patients of Anixa (ANIX)?

No, USAN approval is a non-proprietary name assignment, not a regulatory marketing approval. According to the company, the designation ensures consistent naming for safety and prescribing but does not indicate regulatory clearance for clinical use.

What is the significance of WHO INN approval alongside USAN for Anixa's (ANIX) CAR-T therapy?

Dual INN and USAN approvals provide a globally consistent non-proprietary name for the therapy. According to the company, this combination helps avoid naming conflicts and supports worldwide identification, labeling, and future international commercialization efforts.