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GSK's ADC Drug for Lung Cancer Gets FDA's Breakthrough Tag
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GSK plc (GSK - Free Report) 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/refractory extensive-stage small-cell lung cancer (ES-SCLC).
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 therapy may provide substantial improvements over available treatments.
The above Breakthrough Therapy tag was based on data from the phase I ARTEMIS-001 study, which is evaluating the safety, tolerability and preliminary anti-tumor activity of GSK5764227 for treating locally advanced or metastatic solid tumors, including relapsed or refractory ES-SCLC, which is an aggressive and difficult-to-treat cancer.
GSK in-licensed exclusive worldwide rights to develop and commercialize GSK5764227 from Chinese biopharmaceutical company Hansoh Pharma in December 2023.
Hansoh Pharma retains exclusive rights to the candidate in China’s mainland, Hong Kong, Macau and Taiwan. The phase I ARTEMIS-001 study is being conducted by Hansoh Pharma.
Data from the early-stage study showed that treatment with GSK5764227 demonstrated promising early clinical evidence in ES-SCLC.
Shares of GSK have gained 12% so far this year against the industry’s decline of 1.7%.
Image Source: Zacks Investment Research
GSK plans to begin a global phase I/II study for GSK5764227 to treat relapsed/refractory ES-SCLC later in the second half of 2024, which is likely to pave the registrational pathway for the candidate.
In October 2023, GSK bought the first ADC from Hansoh Pharma, HS-20089, a B7-H4 targeted ADC, which is currently being developed in China in mid-stage studies.
ADCs are being considered a disruptive innovation in the pharmaceutical industry as these will enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
GSK has a strong portfolio of marketed drugs for oncology indications, including Jemperli (dostarlimab), Zejula (niraparib) and Ojjaara, which are approved for various cancer indications. In the first six months of 2024, GSK’s oncology drugs together recorded revenues of £629 million, reflecting significant year-over-year growth at constant exchange rate.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.49. Year to date, shares of ILMN have lost 2.4%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have surged 38.4%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share have moved up from 27 cents to 40 cents. Earnings per share estimates for 2025 have improved from 43 cents to 45 cents. Year to date, shares of BVS have rallied 51.2%.
BVS’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 102.86%.
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GSK's ADC Drug for Lung Cancer Gets FDA's Breakthrough Tag
GSK plc (GSK - Free Report) 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/refractory extensive-stage small-cell lung cancer (ES-SCLC).
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 therapy may provide substantial improvements over available treatments.
The above Breakthrough Therapy tag was based on data from the phase I ARTEMIS-001 study, which is evaluating the safety, tolerability and preliminary anti-tumor activity of GSK5764227 for treating locally advanced or metastatic solid tumors, including relapsed or refractory ES-SCLC, which is an aggressive and difficult-to-treat cancer.
GSK in-licensed exclusive worldwide rights to develop and commercialize GSK5764227 from Chinese biopharmaceutical company Hansoh Pharma in December 2023.
Hansoh Pharma retains exclusive rights to the candidate in China’s mainland, Hong Kong, Macau and Taiwan. The phase I ARTEMIS-001 study is being conducted by Hansoh Pharma.
Data from the early-stage study showed that treatment with GSK5764227 demonstrated promising early clinical evidence in ES-SCLC.
Shares of GSK have gained 12% so far this year against the industry’s decline of 1.7%.
Image Source: Zacks Investment Research
GSK plans to begin a global phase I/II study for GSK5764227 to treat relapsed/refractory ES-SCLC later in the second half of 2024, which is likely to pave the registrational pathway for the candidate.
In October 2023, GSK bought the first ADC from Hansoh Pharma, HS-20089, a B7-H4 targeted ADC, which is currently being developed in China in mid-stage studies.
ADCs are being considered a disruptive innovation in the pharmaceutical industry as these will enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
GSK has a strong portfolio of marketed drugs for oncology indications, including Jemperli (dostarlimab), Zejula (niraparib) and Ojjaara, which are approved for various cancer indications. In the first six months of 2024, GSK’s oncology drugs together recorded revenues of £629 million, reflecting significant year-over-year growth at constant exchange rate.
Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Illumina, Inc. (ILMN - Free Report) , Fulcrum Therapeutics, Inc. (FULC - Free Report) and Bioventus Inc. (BVS - Free Report) , 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 Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.49. Year to date, shares of ILMN have lost 2.4%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have surged 38.4%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share have moved up from 27 cents to 40 cents. Earnings per share estimates for 2025 have improved from 43 cents to 45 cents. Year to date, shares of BVS have rallied 51.2%.
BVS’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, the average surprise being 102.86%.