GSK plc GSK announced that the FDA has granted a Breakthrough Therapy Designation to its investigational B7-H3-targeted antibody-drug conjugate (ADC), GSK5764227 (GSK’227), for the treatment of relapsed or refractory osteosarcoma in adult patients whose disease progressed on at least two prior lines of therapy.
The FDA grants Breakthrough Therapy designation to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that the therapy may provide substantial improvements over available treatments.
Osteosarcoma is a rare type of bone cancer. Currently, there are no FDA-approved treatments for treating patients with osteosarcoma who have progressed on two prior lines of therapy.
In the past year, shares of GSK have declined 14.3% compared with the industry’s decrease of 15.7%.
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More on the Latest FDA Tag for GSK's ADC Drug
The latest Breakthrough Therapy tag was based on data from the phase II ARTEMIS-002 study, which evaluated the safety and efficacy of GSK’227 for treating relapsed or refractory osteosarcoma and other unresectable bone and soft tissue sarcomas.
GSK in-licensed exclusive worldwide rights to develop and commercialize GSK’227 from Chinese biopharmaceutical company Hansoh Pharma in December 2023. The ARTEMIS-002 study is being conducted by Hansoh Pharma.
Hansoh Pharma retains exclusive rights to the candidate in China’s mainland, Hong Kong, Macau and Taiwan.
As part of the development plan, GSK recently started a global phase I study to support a registrational pathway for GSK’227.
Other Regulatory Status for GSK'227
Besides osteosarcoma, GSK is also developing GSK’227 for treating extensive-stage small-cell lung cancer (ES-SCLC), an aggressive and difficult-to-treat cancer.
Last month, the European Medicines Agency (EMA) granted Priority Medicines (PRIME) designation to GSK’227 for the treatment of relapsed ES-SCLC.
The EMA grants the PRIME designation to support the development of medicines that target an unmet need.
The FDA granted Breakthrough Therapy designation to GSK’227 for treating relapsed or refractory ES-SCLC in August 2024. This designation was granted based on data from the phase I ARTEMIS-001 study.
Data from the ARTEMIS-001 study showed that treatment with GSK’227 demonstrated promising early clinical evidence in ES-SCLC.
GSK's Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks from the biotech sector are Puma Biotechnology, Inc. PBYI, CytomX Therapeutics, Inc. CTMX and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Puma Biotechnology’s 2025 earnings per share have increased from 42 cents to 54 cents. In the past year, shares of PBYI have declined 26.3%.
PBYI’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.78%.
In the past 60 days, estimates for CytomX Therapeutics’ loss per share have narrowed from 56 cents to 35 cents for 2025. In the past year, shares of CTMX have plunged 28.3%.
CTMX’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 115.70%.
In the past 60 days, estimates for Castle Biosciences’ loss per share have narrowed from $1.88 to $1.84 for 2025. In the past year, shares of CSTL have surged 34.3%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
5 Stocks Set to Double
Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.
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Today, See These 5 Potential Home Runs >>GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report
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CytomX Therapeutics, Inc. (CTMX) : Free Stock Analysis Report
Castle Biosciences, Inc. (CSTL) : Free Stock Analysis Report
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