---
title: "Avenue Therapeutics ends AJ201 license and transfers program back to AnnJi"
url: "https://aibio.space/news/avenue-therapeutics-ends-aj201-license-transfers-program-back-annji/"
publisher: "aibio.space (Biotech Investor Relations News)"
date: "2025-04-30"
section: "Mergers"
tickers: "OTC:ATXI"
source: "https://www.sec.gov/Archives/edgar/data/1644963/000110465925042570/tm2513615d1_8k.htm"
summary: "AnnJi will pay Avenue $2.0 million over 90 days, plus possible milestones and a 1.75% royalty."
---

By the aibio.space news desk.

Sources

- [Avenue Therapeutics, Inc. 8-K (2025-04-30)](https://www.sec.gov/Archives/edgar/data/1644963/000110465925042570/tm2513615d1_8k.htm)

[ATXI](https://aibio.space/companies/avenue-therapeutics/)

2025-04-30

# Avenue Therapeutics ends AJ201 license and transfers program back to AnnJi

Tickers [ATXI](https://aibio.space/companies/avenue-therapeutics/)

AnnJi will pay Avenue $2.0 million over 90 days, plus possible milestones and a 1.75% royalty.

## Key facts

- **Company**: Avenue Therapeutics, Inc. (OTC: ATXI)

- **News type**: Mergers

- **Primary source**: [Avenue Therapeutics, Inc. 8-K (2025-04-30)](https://www.sec.gov/Archives/edgar/data/1644963/000110465925042570/tm2513615d1_8k.htm)

*A financial district skyline and bay. Photo: Carol M Highsmith, CC0, via rawpixel. The picture shows the field, not the companies named.*

## The termination

Avenue Therapeutics, Inc. and AnnJi Pharmaceutical Co., Ltd., a Taiwanese company, signed a License Termination and Program Transfer Agreement on April 24, 2025, according to an 8-K filed April 30, 2025. The agreement ends the license under which Avenue held rights to AJ201, a clinical candidate in a Phase 1b/2a trial in the United States for spinal and bulbar muscular atrophy, also called Kennedy's Disease. The license dates from February 28, 2023.

The termination takes effect immediately, along with the related subscription and registration rights agreements. The parties dismissed all pending dispute resolution proceedings and exchanged mutual releases of claims. Avenue transferred to AnnJi all of its rights to the assets arising under the license and related to AJ201.

On March 3, 2025, AnnJi had given notice that it intended to terminate the license. The company's annual report, filed March 31, 2025, says AnnJi cited failure to use commercially reasonable efforts to develop and commercialize AJ201, failure to negotiate a clinical supply agreement by March 31, 2024, and an anticipated failure to meet a first-patient-dosing milestone in a Phase 2/3 trial by February 28, 2027.

## What Avenue pays and receives

Avenue will repurchase all 14,777 of its shares held by AnnJi for an aggregate payment of $1.00. It also paid AnnJi $0.2 million as consideration for legal expenses.

AnnJi agreed to pay Avenue $2.0 million in total over 90 days, with $1.0 million due within 30 days of the April 24 effective date and $1.0 million within 90 days.

Avenue is also eligible for up to $5 million in development and regulatory milestone payments for AJ201, and up to $17 million in sales milestone payments. It will receive a 1.75% royalty on net sales of AJ201, which the 8-K says is subject to potential diminution in certain circumstances. If AnnJi later licenses AJ201 to a third party, Avenue gets 15% of what AnnJi receives from that licensee, up to $7.5 million. The 8-K also refers to a minimum of $4 million owed if the FDA approves a new drug application for AJ201.

Avenue has agreed not to develop, commercialize, manufacture or sell any competing product for 48 months in the United States, Canada, the European Union, Great Britain or Israel.

## The dispute the deal ends

The annual report said Avenue believed AnnJi's purported termination was invalid, that the license remained binding, and that the grounds for termination were without merit. It said Avenue had filed a Request for Arbitration with the International Court of Arbitration and intended to pursue mediation under the license. Within weeks, the parties dismissed those proceedings. The 8-K does not describe the grounds for the settlement or say whether either side conceded any point.

## What remains at Avenue

The annual report listed three product candidates: AJ201, intravenous tramadol for post-operative acute pain, and BAER-101 for epilepsy and panic disorders. BAER-101 is being developed by Baergic Bio, Inc., a majority-controlled subsidiary that Avenue acquired through a stock contribution agreement with Fortress Biotech, Inc. The report says Avenue is itself a majority-controlled subsidiary of Fortress. The April 8-K does not mention intravenous tramadol or BAER-101.

The AJ201 trial enrolled 25 patients in a 12-week, randomized, double-blind study of 600 mg a day against placebo. The primary endpoint was safety and tolerability. The annual report says enrollment was completed in January 2024 and the last patient's last visit was in May 2024. Neither document reports trial results.

## Trading

Nasdaq suspended trading in Avenue's common stock at the open on March 19, 2025, and the shares have traded over the counter since then under the symbol ATXI. The 8-K says Nasdaq will file a Form 25 with the SEC to remove the stock from listing.

## What is left open

Neither document gives a cash balance or a runway estimate. The 8-K does not say what the $2.0 million will mean for the company's cash, or what Avenue will do with its remaining programs now that AJ201 has moved back to AnnJi.

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## Companies in this story

ATXI

Avenue Therapeutics, Inc.

OTC · United States

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Source page: https://aibio.space/news/avenue-therapeutics-ends-aj201-license-transfers-program-back-annji/. Facts in aibio.space stories are checked against company filings and releases; opinion is labelled. Cite as: aibio.space, "Avenue Therapeutics ends AJ201 license and transfers program back to AnnJi", 2025-04-30, https://aibio.space/news/avenue-therapeutics-ends-aj201-license-transfers-program-back-annji/
