Grab Sources And More Here: Company Website.
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As mentioned above, MAIA has several explosive potential catalysts to pay close attention to right now. Here they are:
No. 1 MAIA Potential Catalyst - FDA Grants ODD For THIO (Massive Development - Huge Company Milestone)
FDA Grants Orphan Drug Designation to MAIA Biotechnology for THIO as a Treatment for Glioblastoma
CHICAGO, November 10, 2023--(BUSINESS WIRE)--MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA" or the "Company"), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, announced today that the U.S. Food and Drug Administration ("FDA") has granted orphan drug designation to its lead asset THIO, a cancer telomere-targeting agent, for the treatment of glioblastoma. This is the third orphan drug designation granted to THIO, following the receipt of orphan drug designations for hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC) in 2022.
"We are pleased to receive a third orphan drug designation for THIO, further highlighting FDA’s recognition of THIO’s potential in the treatment of multiple cancer indications, including rare ones such as glioblastoma," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "Each year, globally, more than 300,000 people are diagnosed with brain tumors, of which, 25,000 are in the United States. Glioblastoma represents the majority of these cases in the U.S., with 15,000 new patients diagnosed and more than 10,000 deaths yearly, making it an orphan indication. Given this prevalence there is significant room for growth in the $2.2Bn glioblastoma market, which is expected to reach $3.2Bn globally in the next three years.1 We consider this ODD an important milestone for our development strategy and for glioblastoma patients who could benefit from a potentially revolutionary therapy."
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Read the full article here.
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No. 2 MAIA Potential Catalyst - Analyst's Target Suggests Over 550% Potential Upside From MAIA's Current Chart Levels
Back in July, Robert LeBoyer, Senior Vice President and equity research analyst with Noble Life Science Partners, reiterated a $14.00 target on MAIA.
From Friday's opening valuation, that provides MAIA with upside potential well over 550%!
Check out some key report highlights:
Survival Data From The First Two Patients Announced. MAIA Biotechnology announced updated survival data from the first two patients treated in its Phase 2 THIO-101 trial. The patients remain alive without disease progression for 12.2 and 11.5 months from treatment initiation and 10.2 months and 8.5 months after completing THIO treatment. These results compare with expected survival of about 3 months to 4 months after disease progression or about 6 months if a third line of therapy is given. We see these positive results as consistent with the preclinical data.
Patients Were From The Safety Lead-In Stage. The THIO-101 trial enrolls patients with recurrent or metastatic Stage 4 non-small cell lung cancer that have failed 2 lines of therapy. These prior therapies include an immune checkpoint inhibitor and a platinum-based (standard) chemotherapy regimen. The two patients were from the Part A safety verification stage. The patients were treated with 360 mg of THIO followed by a standard regimen of Libtayo (cemiplimab, an immune checkpoint inhibitor from Regeneron). The patients have not received any new cancer therapies.
The Part A Data Showed Safety and Tolerability. The safety data from Part A was announced in April 2023, followed by the start of the Part B dose-finding stage. This stage tests three doses (90 mg, 180 mg, and 360 mg) in combination with Libtayo. The 90 mg low dose is the human equivalent of the curative dose in animal models, while the 360 mg high dose was shown to be safe in Part A. One of the doses will be selected for the Part C registration stage.
Conclusion. Although survival was only reported from two patients, it has exceeded expectations for advanced NSCLC. Additional data from Part B is expected in late 3Q/4Q, to be followed by the start of the Part C registration stage. This fundamental progress has not been reflected in MAIA's stock price. We attribute its depressed valuation to the current environment for small-cap biotechnology, which has been down to flat for the past several months. ... We are reiterating our Outperform rating and $14 price target.
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No. 3 MAIA Potential Catalyst - Volatility Could Be In Full Force Based On MAIA's Low Float
According to the Yahoo Finance website, MAIA has a low float.
The website reports this profile to have roughly 9.02Mn shares in its float.
Why is that important? It's important on one crucial level. Volatility.
Could even more positive company news towards the end of 2023 provide a breakout spark?
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No. 4 MAIA Potential Catalyst - Positive Phase 2 Clinical Trial Data Exhibit Promising Potential Efficacy
MAIA Biotechnology Reports Positive Phase 2 Clinical Trial Data On Its Treatment For Non-Small Cell Lung Cancer
From the article:
On Oct. 24, MAIA Biotechnology reported a 100% Disease Control Rate (DCR) in second-line treatment for NSCLC in its ongoing phase 2 trial, THIO-101.
Read the full article here.
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MAIA Recap - NYSE American Breakout Idea Has 4 Explosive Potential Catalysts
No. 1 - FDA Grants ODD For THIO (Massive Development - Huge Company Milestone)
No. 2 - Analyst's Target Suggests Over 550% Potential Upside From MAIA's Current Chart Levels
No. 3 - Volatility Could Be In Full Force Based On MAIA's Low Float
No. 4 - Positive Phase 2 Clinical Trial Data Exhibit Promising Potential Efficacy
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Coverage is officially reinitiated on MAIA. When time allows, do this:
