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Wire

MAIA Biotechnology Says Ateganosine Shows 90.5% Disease Control Rate in Phase 2 Expansion Trial

MAIA Biotechnology (MAIA) said Wednesday initial efficacy data from its phase 2 part C expansion trial of ateganosine showed a 90.5% interim disease control rate in patients with advanced non-small cell lung cancer.The company said 21 patients received ateganosine followed by Regeneron Pharmaceuticals' (REGN) Libtayo in 21-day treatment cycles.MAIA added that the initial efficacy results were consistent with the results of the part A and part B studies, despite the part C trial enrolling a more heavily pre-treated patient population.MAIA Biotechnology shares were down 2.4% in Wednesday trading.Price: $1.44, Change: $-0.03, Percent Change: -2.11%

$MAIA$REGN
Wire

MAIA Biotechnology Says 29 Patients Dosed in Phase 3 Trial for Advanced Non-Small Cell Lung Cancer Treatment

MAIA Biotechnology (MAIA) said Thursday that 29 patients have been dosed in its phase 3 trial evaluating its novel telomere-targeting therapy as a third-line treatment for advanced non-small cell lung cancer.Vlad Vitoc, MAIA chief executive, said the company is expecting to dose up to 100 patients by year-end and to have sufficient survival data to conduct an interim analysis in 2027.The trial involves 34 activated trial sites in six countries, the company said.MAIA shares were more than 3% higher in Thursday trading.Price: $1.48, Change: $+0.06, Percent Change: +4.00%

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Sectors

Sector Update: Healthcare Stocks Higher Late Afternoon

Healthcare stocks rose late Wednesday afternoon, with the NYSE Healthcare Index increasing 0.6% and the State Street Health Care Select Sector SPDR ETF (XLV) adding 0.8%.The iShares Biotechnology ETF (IBB) advanced 1.7%.In corporate news, Medtronic (MDT) reported better-than-expected fiscal Q4 results on Wednesday, while the medical-device maker projected earnings and organic revenue growth for the current year. Its shares gained 5.8%.BioNTech (BNTX) cautioned that proposed healthcare reforms in Germany, due for a vote this summer, may put future investments in the country at risk, Bloomberg reported, citing Chief Commercial Officer Annemarie Hanekamp. BioNTech shares fell 0.8%.TG Therapeutics (TGTX) said its subcutaneous formulation of ublituximab showed "positive" results from a phase 1 trial comparing the multiple sclerosis therapy to the drug's intravenous version. Shares jumped past 10%.Maia Biotechnology (MAIA) shares rose 4.4% after the firm said Wednesday it has received clearance from the US Food and Drug Administration to open enrollment for the expansion of a phase 2 trial of ateganosine for advanced non-small cell lung cancer.

$BNTX$MAIA$MDT$TGTX
Sectors

Sector Update: Healthcare Stocks Higher in Afternoon Trading

Healthcare stocks rose Wednesday afternoon, with the NYSE Healthcare Index increasing 0.7% and the State Street Health Care Select Sector SPDR ETF (XLV) adding 1%.The iShares Biotechnology ETF (IBB) advanced 1.4%.In corporate news, Medtronic (MDT) reported better-than-expected fiscal Q4 results on Wednesday, while the medical-device maker projected earnings and organic revenue growth for the current year. Its shares gained 5.4%.TG Therapeutics (TGTX) said its subcutaneous formulation of ublituximab showed "positive" results from a phase 1 trial comparing the multiple sclerosis therapy to the drug's intravenous version. Shares jumped past 11%.Maia Biotechnology (MAIA) shares rose 3.7% after the firm said Wednesday it has received clearance from the US Food and Drug Administration to open enrollment for the expansion of a phase 2 trial of ateganosine for advanced non-small cell lung cancer.

$MAIA$MDT$TGTX
Wire

MAIA Gets FDA Clearance for Enrollment in Expanded Phase 2 Cancer Study

MAIA Biotechnology (MAIA) said Wednesday it has received clearance from the US Food and Drug Administration to open enrollment for the expansion of the phase 2 THIO-101 trial of ateganosine for advanced non-small cell lung cancer.The firm said it obtained clearance of its updated investigational new drug application highlighting improved manufacturing capabilities, including new manufacturers and formulation.In addition to the US, the THIO-101 study is ongoing at 44 clinical sites in six countries, it added.The additional data from the expansion studies may further support a filing for an accelerated approval, MAIA said.Shares were up over 4% in morning trading.Price: $1.41, Change: $+0.06, Percent Change: +4.44%

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