Ayala Pharmaceuticals, Inc. - ADXS STOCK NEWS

Welcome to our dedicated page for Ayala Pharmaceuticals news (Ticker: ADXS), a resource for investors and traders seeking the latest updates and insights on Ayala Pharmaceuticals stock.

Ayala Pharmaceuticals, Inc. (OTCQX: ADXS) is a publicly traded, clinical-stage oncology company that focuses on the development and commercialization of small molecule therapeutics. The company primarily targets rare tumors and aggressive cancers through its innovative treatments. Ayala's leading candidate, AL102, is an investigational small molecule gamma secretase inhibitor currently in the Phase 3 RINGSIDE study for the treatment of desmoid tumors. The promising data from Phase 2 shows significant anti-tumor activity and high overall response rates.

Ayala's strategic vision was further enhanced by its merger with Biosight Ltd., which brought aspacytarabine (BST-236), a novel proprietary anti-metabolite for first-line treatment in unfit acute myeloid leukemia (AML), into its portfolio. AL102 has received FDA Fast Track and Orphan Drug Designations for the treatment of desmoid tumors, highlighting its potential impact in oncology.

Recently, Ayala entered into a definitive asset purchase agreement with Immunome, Inc. to sell AL102 and related drug candidate AL101. This agreement, valued at over $50 million, will allow Immunome to advance AL102 through clinical trials and towards potential commercialization. The transaction is expected to be completed by the end of Q3 2024, pending regulatory approvals.

Ayala is committed to advancing its remaining pipeline, which includes aspacytarabine (BST-236) for AML. Despite the sale of its key assets, Ayala continues to focus on developing impactful treatments within oncology, leveraging its expertise and the clinical data it has gathered.

For more information, please visit www.ayalapharma.com.

05/09/2024 04:10 PM

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Ayala Pharmaceuticals Files Form 15 to Voluntarily Deregister and Suspend its Reporting Obligations

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Ayala Pharmaceuticals, a clinical-stage oncology company, has filed a Form 15 with the SEC to deregister its common stock under the Exchange Act and suspend reporting obligations. This move will make the company no longer a public reporting entity once the Form 15 is effective.

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03/26/2024 08:00 AM

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Ayala Pharmaceuticals Announces Completion of Sale of AL102 to Immunome

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Ayala Pharmaceuticals, Inc. completes the sale of AL102 and AL101 to Immunome, Inc. for $20 million in cash, 2,175,489 shares of Immunome common stock, and potential milestone payments of up to $37.5 million. The sale includes the transfer of specified liabilities related to AL102. Ayala expresses satisfaction with the transaction, highlighting the expertise of Immunome in advancing AL102.

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02/20/2024 08:00 AM

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Ayala Pharmaceuticals Announces Completion of Enrollment in Phase 3 RINGSIDE Study Evaluating AL102 in Desmoid Tumors

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Ayala Pharmaceuticals Completes Patient Enrollment in Phase 3 RINGSIDE Study for AL102 in Desmoid Tumors

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02/06/2024 08:00 AM

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Immunome To Acquire AL102, A Phase 3 Asset for the Treatment of Desmoid Tumors, From Ayala Pharmaceuticals

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Immunome, Inc. has entered into a definitive asset purchase agreement with Ayala Pharmaceuticals, Inc. to acquire AL102 and related drug candidate AL101. The agreement includes a $20 million cash payment and $30 million in Immunome common stock, with up to an additional $37.5 million in milestone payments. AL102 is a small molecule gamma secretase inhibitor currently being evaluated in a Phase 3 trial for the treatment of desmoid tumors, showing promising results in terms of tumor reduction and anti-tumor activity.

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11/06/2023 08:00 AM

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Ayala Pharmaceuticals Announces AL102 Receives Orphan Drug Designation for Desmoid Tumors

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Ayala Pharmaceuticals receives FDA Orphan Drug Designation for AL102, a Gamma Secretase Inhibitor (GSI), for the treatment of desmoid tumors (DT). Desmoid tumors are rare connective tissue tumors that affect approximately 1,700 patients in the US annually. AL102 is currently being evaluated in the Phase 3 RINGSIDE study.

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10/23/2023 07:00 AM

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Ayala Pharmaceuticals Presents Updated AL102 Results from Phase 2 Clinical Trial in Desmoid Tumors at ESMO Congress 2023

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Ayala Pharmaceuticals announces positive results from the RINGSIDE study evaluating AL102 for the treatment of desmoid tumors. The treatment achieved an Overall Response Rate of 83% in the evaluable population, with an 88% reduction in tumor volume and 85% reduction in T2W signal intensity. Phase 3 registration segment of RINGSIDE is enrolling patients globally.

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10/19/2023 08:00 AM

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Ayala Pharmaceuticals Announces Closing of Merger with Biosight

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Ayala Pharmaceuticals completes merger with Biosight, expands product pipeline

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08/10/2023 04:30 PM

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Ayala Pharmaceuticals Announces Second Quarter 2023 Financial Results and Provides Corporate Update

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Ayala Pharmaceuticals announces successful End-of-Phase 2 meeting with FDA regarding AL102 for desmoid tumors. Enrollment in Phase 3 of RINGSIDE trial continuing as planned. Definitive merger agreement with Biosight expected to close in Q3 2023.

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08/01/2023 08:00 AM

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Ayala Pharmaceuticals Announces Abstracts on AL102 and AL101 Accepted for Presentation at ESMO Congress 2023

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Ayala Pharmaceuticals, Inc. will present posters on its gamma secretase inhibitors AL102 and AL101 at the European Society for Molecular Oncology (ESMO) Congress 2023. The Phase 2 results of AL102 for the treatment of Desmoid Tumors and the final results of the ACCURACY trial for AL101 therapy in patients with recurrent/metastatic adenoid cystic carcinoma (ACC) will be presented.

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07/27/2023 08:10 AM

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Ayala Pharmaceuticals and Biosight Enter into Definitive Merger Agreement

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Ayala Pharmaceuticals, Inc. and Biosight Ltd. have entered into a definitive merger agreement. The combined company will operate as Ayala Pharmaceuticals, Inc. and will focus on advancing a portfolio of oncology assets. Ayala's AL102 and Biosight's Aspacytarabine will be the primary focus. AL102 has shown promising results in the treatment of desmoid tumors, with a 50% partial response rate and 100% disease control rate in Phase 2. The merger aims to create sustainable value for patients and shareholders.

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FAQ

What is the primary focus of Ayala Pharmaceuticals?

Ayala Pharmaceuticals focuses on developing and commercializing small molecule therapeutics for rare tumors and aggressive cancers.

What are Ayala’s leading candidates under development?

Ayala’s leading candidates are AL102 for desmoid tumors and aspacytarabine (BST-236) for acute myeloid leukemia (AML).

What significant recent transaction has Ayala Pharmaceuticals entered into?

Ayala has entered into a definitive asset purchase agreement with Immunome, Inc. to sell AL102 and AL101 for over $50 million.

What is AL102 and what phase is it currently in?

AL102 is an investigational small molecule gamma secretase inhibitor currently in the Phase 3 segment of the RINGSIDE study for desmoid tumors.

What are the FDA designations achieved by AL102?

AL102 has received FDA Fast Track Designation and Orphan Drug Designation for the treatment of desmoid tumors.

What was the result of Ayala's merger with Biosight Ltd.?

The merger added aspacytarabine (BST-236) to Ayala’s portfolio, expanding its focus on therapeutics for hematological malignancies and disorders.

What is aspacytarabine (BST-236) used for?

Aspacytarabine (BST-236) is used for first-line treatment in unfit acute myeloid leukemia (AML) and has shown promising clinical data.

What recent clinical milestone has Ayala achieved?

Ayala recently completed patient enrollment in the Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors.

What is the significance of the sale of AL102 to Immunome?

The sale allows for the continued development and potential commercialization of AL102 by a team experienced in advancing oncology therapeutics.

What will Ayala focus on after the sale of AL102?

After the sale, Ayala will focus on its remaining pipeline, including aspacytarabine (BST-236) for AML, and continue its mission in developing cancer therapies.