GlaxoSmithKline

GSK plc received EMA's PRIME designation for its B7-H3 targeted antibody-drug conjugate, GSK’227, for extensive stage small-cell lung cancer. The FDA also awarded breakthrough therapy designation. The decision is based on early clinical outcomes from the ARTEMIS-001 study, a Phase I trial assessing safety and anti-tumour efficacy. GSK aims to accelerate development of GSK’227 for limited treatments in other tumour types.

Margaret Keegan, former operating partner at Linden Capital Partners, is now CEO of Precision Medicine Group, a specialized services provider in drug development and commercialization. Keegan aims to elevate Precision's profile, leveraging her extensive experience in the industry to guide the company from being a 'best-kept secret' to an industry leader. She highlights Precision's broad operations and expertise in precision medicine, emphasizing the importance of AI in transforming drug development and commercialization.

Deutsche Bank's Emmanuel Papadakis maintains a Hold rating on GlaxoSmithKline (GSK) with a £13.50 price target. GSK shares opened at £1,304.00. Papadakis, a 4-star analyst with a 5.5% average return and 56.09% success rate, focuses on Healthcare stocks. GSK also received a Hold from Barclays and a Sell from Bank of America Securities. GSK's market cap is £53.84B with a P/E ratio of 21.56. Insider sentiment is positive, with increased insider buying. GSK is a major pharmaceutical company with significant presence in respiratory, oncology, antiviral, vaccines, and consumer healthcare sectors.

The RH5.1/Matrix-M malaria vaccine, studied in a Phase IIb trial, shows 55% efficacy against clinical malaria and over 80% against severe disease, with favorable safety and tolerability. It could complement existing pre-erythrocytic vaccines, offering a second line of defense against malaria.

GSK plc announced EMA's PRIME Designation for GSK5764227, a B7-H3-targeted ADC for relapsed extensive-stage small-cell lung cancer, supported by preliminary ARTEMIS-001 study data. This is GSK'227's second regulatory designation, following FDA's Breakthrough Therapy Designation in August 2024.

GSK's B7-H3-targeted ADC, GSK’227, received PRIME designation from EMA for relapsed ES-SCLC, following FDA's breakthrough therapy designation in 2024. The decision is based on ARTEMIS-0001 study outcomes. GSK aims to accelerate GSK’227's development in extensive-stage small-cell lung cancer and other tumor types.

GSK's Jemperli (dostarlimab) received FDA Breakthrough Therapy Designation for locally advanced dMMR/MSI-H rectal cancer, showing a 100% clinical complete response in a phase II trial. The designation aims to expedite development and review of drugs potentially improving serious condition treatments. Jemperli, a PD-1 blocking antibody, is part of GSK's immuno-oncology research.

GSK received EMA PRIME Designation for GSK5764227 (GSK’227), a B7-H3-targeted ADC for relapsed ES-SCLC. GSK acquired global rights from Hansoh Pharma, except in China regions. EMA based its decision on ARTEMIS-001 Phase 1 study data. GSK’227 also holds FDA Breakthrough Therapy Designation. Separately, GSK secured FDA Breakthrough Therapy Designation for Jemperli for rectal cancer and EMA CHMP recommendation for Jemperli plus chemotherapy for endometrial cancer.

GSK announced CHMP of EMA recommended expanding Jemperli approval for first-line treatment of all adult patients with primary advanced or recurrent endometrial cancer, including those with mismatch repair proficient/microsatellite stable tumours, pending European Commission decision expected Q1 2025.

The ZEST trial, evaluating niraparib for breast cancer recurrence prevention in ctDNA-positive patients, failed due to insufficient enrollment. Lessons include starting ctDNA testing during treatment and focusing on high-risk patients. Median recurrence-free intervals were 11.4 months with niraparib vs. 5.4 months with placebo, though conclusions on efficacy are limited.