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AYALA PHARMACEUTICALS INC - ADXS STOCK NEWS

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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.

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Advaxis, Inc. announced a partnership with Columbia University to initiate a Phase 1 clinical study of ADXS-504 in patients with biochemically recurrent prostate cancer, anticipated to begin in Q2 2021. The trial will evaluate the safety and tolerability of this novel neoantigen immunotherapy targeting multiple tumor antigens in 9-18 patients. Given the rising prostate cancer diagnoses in 2021, this study aims to explore new immune-based treatment options. Notably, previous studies showed promise for ADXS-PSA in advanced prostate cancer, indicating potential for ADXS-504.

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Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotech firm, will have its CEO, Kenneth A. Berlin, present at the Benzinga Biotech Small Cap Conference on March 24-25, 2021. Berlin's presentation is scheduled for 2:30 PM ET on March 24. Interested investors can view the presentation and request meetings via registration at the conference's website. Advaxis specializes in immunotherapy products utilizing bioengineered Listeria monocytogenes for enhanced anti-tumor T-cell immunity. For more details, visit advaxis.com.

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Advaxis, Inc. (Nasdaq: ADXS) reported promising results from its ongoing Phase 1/2 trial of ADXS-503 in non-small cell lung cancer (NSCLC), with a disease control rate of 67% and an overall response rate of 17% among the first six patients who had prior progression on KEYTRUDA®. The company recently closed a $9.2 million public offering, strengthening its balance sheet to support continued clinical development. Research and development expenses were reduced to $2.6 million, allowing the company to maintain a solid cash position of $33.3 million through May 2022.

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Advaxis (Nasdaq: ADXS) announced a collaboration with Precision for Medicine to present data at the AACR Annual Meeting 2021, scheduled from April 10-15. The presentation will focus on a novel flow immunophenotyping assay for evaluating PD-1 expression during pembrolizumab treatment and its correlation with T cell populations in the ongoing ADXS-503 trial. The poster, titled Evaluation of total PD-1 expression using multi-color flow cytometry, highlights immunotherapy advancements in metastatic non-small cell lung cancer. Full details will be available on the AACR website starting April 10.

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Advaxis, a biotechnology company focused on immunotherapy, is advancing its ADXS-503 program in non-small cell lung cancer (NSCLC). Recent clinical data showed a 67% disease control rate and 17% overall response rate in patients previously treated with KEYTRUDA®. The company strengthened its financial position with a $9.2 million public offering and initiated new clinical arms for ADXS-503. For the fiscal year ending October 31, 2020, Advaxis reported a net loss of $26.5 million and reduced R&D expenses by $11.1 million.

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Advaxis, Inc. (NASDAQ: ADXS) announced a milestone payment for its licensing agreement with OS Therapies for ADXS31-164 (OST-HER2) aimed at treating osteosarcoma. OS Therapies, in collaboration with the Children’s Oncology Group, will conduct a clinical study funded through secured financing. Advaxis will receive additional milestone payments and royalties on future sales. The treatment has potential benefits for children with limited options, building on prior successful trials in canines and humans. Advaxis continues to focus on its ADXS-HOT neoantigen program.

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Advaxis, Inc. (Nasdaq: ADXS) has received approval to transfer its listing from the Nasdaq Global Select Market to the Nasdaq Capital Market, effective December 24, 2020. This decision follows the company's stock trading below the minimum bid price required. Advaxis has been granted an additional 180-day period to meet the $1.00 bid price requirement, expiring June 21, 2021. If the stock does not regain compliance, it may face delisting, although an appeal option is available. Notably, the company plans to consider a reverse stock split if necessary, to meet the bid price requirement.

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Advaxis, Inc. (ADXS) has successfully closed an underwritten public offering of 26,666,666 common shares and warrants for 13,333,333 shares, raising approximately $9.2 million at $0.30 per share. This includes an overallotment of 3,999,999 shares and 1,999,999 warrants. The funds will support ongoing R&D, particularly the ADXS-HOT program, and may also be used for potential acquisitions or investments. The offering was executed under an effective shelf registration statement.

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Advaxis, Inc. (Nasdaq: ADXS) has announced a public offering of 26,666,666 shares of common stock and warrants to purchase 13,333,333 shares at $0.30 per unit. The warrants are exercisable at $0.35 each and will expire in five years. The underwriters have a 30-day option to purchase additional shares to cover over-allotments. Proceeds will support R&D initiatives, including the ADXS-HOT program, and may also fund acquisitions of new businesses or technologies. A.G.P./Alliance Global Partners is the book-running manager for this offering.

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Advaxis, Inc. (Nasdaq: ADXS) has announced plans for an underwritten public offering of its common stock and warrants to purchase common stock. The company intends to grant underwriters a 30-day option to purchase an additional 15% of the offered shares. Proceeds will support research and development efforts, particularly the ADXS-HOT program, and potential investments in other businesses or technologies. The offering is subject to market conditions, and further details will be provided in a prospectus supplement.

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FAQ

What is the current stock price of AYALA PHARMACEUTICALS (ADXS)?

The current stock price of AYALA PHARMACEUTICALS (ADXS) is $0.027 as of October 9, 2024.

What is the market cap of AYALA PHARMACEUTICALS (ADXS)?

The market cap of AYALA PHARMACEUTICALS (ADXS) is approximately 2.4M.

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.

AYALA PHARMACEUTICALS INC

Nasdaq:ADXS

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