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Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA) announced a poster presentation on interim results from the Phase 2 segment of its RINGSIDE clinical trial at the CTOS 2022 Annual Meeting. This trial evaluates AL102, a selective gamma-secretase inhibitor, for treating desmoid tumors. Interim results indicated positive efficacy at the 1.2 mg dose with responses beginning at 16 weeks, and AL102 showed a manageable safety profile. The Phase 3 enrollment has begun, targeting up to 156 patients for further evaluation of AL102's effectiveness.

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Ayala Pharmaceuticals (Nasdaq: AYLA) has announced the dosing of the first patient in Part B of the RINGSIDE trial, a pivotal Phase 3 study evaluating AL102 for desmoid tumors. This milestone follows promising results from the Phase 2 segment, which indicated early efficacy and safety. AL102, an oral gamma-secretase inhibitor, has received Fast Track designation from the FDA. The Phase 3 trial aims to enroll 156 patients to assess progression-free survival as the primary endpoint.

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Ayala Pharmaceuticals (Nasdaq: AYLA) announced a merger agreement with Advaxis, expected to close by end of Q1 2023, pending shareholder approval. Interim data from the RINGSIDE study showed strong efficacy of AL102 for desmoid tumors, with Fast Track designation granted by the FDA. Financially, Ayala reported a net loss of $10.2 million for Q3 2022, with cash reserves of $11.2 million. Collaboration revenue fell to $91 thousand, while R&D expenses were $7.2 million. The merger aims to enhance Ayala's pipeline and expand its U.S. presence.

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Ayala Pharmaceuticals and Advaxis have announced a definitive merger agreement to create a new entity focused on oncology. Ayala's lead candidate AL102 is in Phase 2/3 trials for desmoid tumors, while Advaxis's ADXS-504 targets prostate cancer. Following the merger, Ayala shareholders will own approximately 62.5% of the combined company. The merger is expected to enhance operational capabilities and financial resources to advance product development and seek a Nasdaq listing. A conference call was held to discuss the details of the merger.

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Ayala Pharmaceuticals (Nasdaq: AYLA) announced a KOL webinar on October 6, 2022, at 8:00 AM ET, to discuss desmoid tumors and the treatment landscape. Key presentations will be made by Professors Bernd Kasper and Robin Jones, focusing on positive interim data from the Phase 2/3 RINGSIDE trial of AL102. The RINGSIDE study has shown efficacy in patients with desmoid tumors and is currently progressing to Phase 3. The event aims to address unmet medical needs and will include a Q&A session. Registration details are available online.

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Ayala Pharmaceuticals (Nasdaq: AYLA) has announced that the FDA granted Fast Track designation for its investigational drug, AL102, aimed at treating progressing desmoid tumors. This designation may accelerate the development and review process, addressing a significant unmet medical need in patients suffering from this rare tumor type. The company is currently conducting the RINGSIDE Phase 2/3 clinical trial, which has shown positive interim results, indicating efficacy and good tolerability of AL102 in early patient cohorts.

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Ayala Pharmaceuticals (Nasdaq: AYLA) announced positive interim results from Part A of the RINGSIDE Phase 2/3 trial for AL102, a treatment for desmoid tumors. A confirmed partial response (PR) was achieved at week 16, with three additional unconfirmed PRs during follow-up. The drug demonstrated consistent tumor shrinkage and was well-tolerated at all doses. Moving forward, the company is initiating Part B of the trial with a selected dose of 1.2 mg daily. Results were presented at the ESMO Congress, highlighting AL102's potential to improve patient outcomes in this unmet medical need.

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Ayala Pharmaceuticals (Nasdaq: AYLA) has announced an upcoming oral presentation featuring results from Part A of the Phase 2/3 RINGSIDE clinical study. This presentation will occur at the European Society for Medical Oncology (ESMO) Congress from September 8-13, 2022, in Paris. The study evaluates the efficacy and safety of AL102 for treating desmoid tumors, with 42 patients enrolled. The primary endpoint is progression-free survival, while secondary endpoints include response rates and quality of life measures. For further details, visit ClinicalTrials.gov.

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Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA) announced promising interim results from the Phase 2/3 RINGSIDE trial of AL102 in desmoid tumors, showing significant anti-tumor activity and well-tolerated dosing. With a cash position of $20.1 million, the company's second-quarter 2022 financial results revealed a net loss of $8.2 million, improved from $10.8 million in Q2 2021. Collaboration revenue was $38,000, down from $761,000 year-over-year. Upcoming milestones include detailed RINGSIDE data presentation at ESMO and initiation of a Phase 2 trial for AL102 in T-ALL by year-end.

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Ayala Pharmaceuticals announced positive interim results from Part A of the RINGSIDE Phase 2/3 clinical trial evaluating AL102 for desmoid tumors. Tumor shrinkage was observed in nearly all evaluable patients at 16 weeks, with favorable safety results as AL102 was well tolerated across various doses. The study involved 42 patients and showed promising efficacy with no severe adverse events. Ayala plans to present additional data at a medical conference in the second half of 2022 and is set to initiate Part B of the trial in Q3 2022.

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FAQ

What is the market cap of AYLA (AYLA)?

The market cap of AYLA (AYLA) is approximately 7.9M.
AYLA

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7.91M
10.41M
Biological Product (except Diagnostic) Manufacturing
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