Ayala Pharmaceuticals Inc (NASDAQ: AYLA) stock price surged 160% today, right off our early premarket VipLiveAlerts-Pro watchlist! With some research we were able to identify a few catalysts, before most market participants even knew what was happening. Our team was first alerted of this essential stock news early premarket with shares at $1.50, opening off our member’s exclusive watchlist at $1.62 and with the stock seeing a high of the day of $2.42 for the highly lucerative 160% upside.
Ayala Pharmaceuticals announced on July 5, 2022, the interim data from part A of its Phase 2/3 RINGSIDE clinical trial evaluating its AL102 drug candidate in desmoid tumors. The company noted that AL102 demonstrated substantial anti-tumor activity in the early trial days.
However, the market reaction was non-existent as AYALA shares had kept falling until early premarket today when they reversed course and moved higher. A quick glance at the company’s Twitter page shows that it tweeted about the initial study results yesterday. At VipLiveAlerts-Pro, we follow hundreds of comapanies that are listed on the major stock exchanges as it helps us to keep up with news catalysts and social media sentiment.
The tweet from Ayala Pharma sparked investor interest in the company and its AL102 desmoid tumor cancer, triggering today’s early premarket action. Along with the company filing a request for the withdrawal of the Registration Statement on Form S-1.
We are excited to announce the interim data from Part A of our Phase 2/3 RINGSIDE trial of AL102 in desmoid tumors, demonstrating initial substantial anti-tumor activity. AL102 was well tolerated among this patient population. https://t.co/6niRmwikSE pic.twitter.com/IsyC9kUSQX— Ayala Pharmaceuticals (@AyalaPharma) July 25, 2022
In today’s trading session we’re seeing over 100 million shares traded, as of the time of this writing as trader’s pushed the share price higher.
The share price action on AYLA stock is significant as the company’s shares are now above the $1.00 mark set by the SEC as the cutoff point for stocks listed on U.S. stock exchanges. Shares closed at $1.56 or up 94.25% with the daily RSI at 64.20, (over 70 indicating overbought) just above the 50-day simple moving average with a clear up-gap.
“RINGSIDE is the first study to investigate AL102 exclusively in desmoid tumor patients, and it has been designed to evaluate a range of different doses and dose schedules. Successful management of this disease will likely require chronic treatment, and one of the key goals of our development program is to understand the optimal balance between efficacy, safety, and patient acceptability. We are encouraged by the early, but very promising efficacy data and emerging favorable side effect profile for AL102 reported in these interim results.”
“We are very excited with the interim data from Part A of the RINGSIDE study, although early, demonstrating initial substantial anti-tumor activity for AL102 as a single agent as measured by MRI scans,” – “We are also encouraged with the safety data showing that AL102 appears to be well tolerated. We look forward to presenting a more advanced and comprehensive data set at a medical meeting later in the year. The results from Part A will be used to determine the dose of AL102 to be evaluated in Part B of RINGSIDE, the randomized portion of the study, which Ayala is on track to initiate in the third quarter of 2022.”
The RINGSIDE pivotal Phase 2/3 study is a randomized multi-center trial. Part A of the study is evaluating the efficacy, safety, tolerability, and tumor volume by MRI after 16 weeks of AL102 in adult and adolescent patients with desmoid tumors. It enrolled 42 patients and is evaluating 3 doses of AL102. Patients who participated in Part A will be eligible to enroll into an open-label extension study at the selected dose, and long-term efficacy and safety will be monitored. Part B of the study will be double-blind, placebo-controlled, and will start immediately after dose selection from part A, enrolling up to 156 patients with progressive disease, randomized between AL102 or placebo. The study’s primary endpoint will be progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR) and patient-reported Quality of Life (QOL) measures.
For more information on the RINGSIDE Phase 2/3 study with AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).
Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers. Ayala’s approach is focused on predicating, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors including desmoid tumors, adenoid cystic carcinoma and T-cell acute lymphoblastic leukemia (T-ALL). AL101, has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC (ACCURACY) bearing Notch activating mutations. AL102 is currently in a Pivotal Phase 2/3 clinical trials for patients with desmoid tumors (RINGSIDE). For more information, visit www.ayalapharma.com.
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