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GSK's sBLA for Jemperli Gets FDA Priority Tag in Rectal Cancer
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Key Takeaways
GSK's Jemperli sBLA for dMMR/MSI-H rectal cancer gets FDA priority review, with decision due in February 2027.
The AZUR-1 study showed durable 12-month complete responses with Jemperli monotherapy.
GSK's Hibsago won Japan's approval as the first functional cure for chronic hepatitis B in adults.
GSK plc (GSK - Free Report) announced that the FDA has accepted for review its supplemental biologics license application (sBLA) seeking approval for its oncology drug, Jemperli (dostarlimab), for a new cancer indication.
The sBLA is seeking approval of Jemperli for the treatment of patients with previously untreated stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected in February 2027.
Importantly, the above sBLA qualifies for an expedited FDA review under the National Priority Voucher program, potentially allowing the company to receive an earlier regulatory decision.
Jemperli is currently approved for the treatment of certain endometrial cancers and certain mismatch repair-deficient (dMMR) solid tumors.
GSK Price Performance
Year to date, shares of GSK have risen 9.7% compared with the industry’s 12.3% growth.
Image Source: Zacks Investment Research
GSK’s Latest sBLA Based on AZUR-1 Study
The sBLA for Jemperli in rectal cancer was based on the registrational phase II AZUR-1 study.
The AZUR-1 study met its primary endpoint by demonstrating that Jemperli monotherapy achieved a meaningful and durable 12-month clinical complete response in patients with stage II/III dMMR/MSI-H locally advanced rectal cancer. The treatment also exhibited a safety profile consistent with its established and manageable profile across solid tumors.
Jemperli received Breakthrough Therapy and Fast Track designations from the FDA for treating patients with stage II/III dMMR/MSI-H locally advanced rectal cancer. If approved, the therapy could become the first immunotherapy to potentially eliminate or delay the need for chemotherapy, radiation and surgery in some selected patients with this type of cancer, potentially transforming the current treatment paradigm.
Jemperli, a PD-1 inhibitor, was developed by GSK in collaboration with AnaptysBio (ANAB - Free Report) .
GSK and ANAB have an agreement to develop therapies targeting immuno-oncology indications. Per the terms of the agreement, GSK is responsible for the development and commercialization of Jemperli, while AnaptysBio is entitled to receive milestone payments and tiered royalties on annual net sales of the drug.
GSK’s Hibsago Gets Nod in Japan
In a separate press release, GSK announced that Japan’s Ministry of Health, Labour and Welfare has approved Hibsago (bepirovirsen), a potential first-in-class antisense oligonucleotide (ASO), as a functional cure for chronic hepatitis B (CHB) in certain eligible adult patients.
The approval was supported by data from the phase III B-Well study.
The approval marks the first global approval for Hibsago, as well as the first and only functional cure treatment for CHB approved in Japan.
A regulatory filing seeking approval for bepirovirsen in CHB is currently under review in the United States. A final decision from the FDA is expected by Oct. 26, 2026.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 10.6% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 126.7% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
View the Zacks #1 Rank List
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GSK's sBLA for Jemperli Gets FDA Priority Tag in Rectal Cancer
Key Takeaways
GSK plc (GSK - Free Report) announced that the FDA has accepted for review its supplemental biologics license application (sBLA) seeking approval for its oncology drug, Jemperli (dostarlimab), for a new cancer indication.
The sBLA is seeking approval of Jemperli for the treatment of patients with previously untreated stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected in February 2027.
Importantly, the above sBLA qualifies for an expedited FDA review under the National Priority Voucher program, potentially allowing the company to receive an earlier regulatory decision.
Jemperli is currently approved for the treatment of certain endometrial cancers and certain mismatch repair-deficient (dMMR) solid tumors.
GSK Price Performance
Year to date, shares of GSK have risen 9.7% compared with the industry’s 12.3% growth.
Image Source: Zacks Investment Research
GSK’s Latest sBLA Based on AZUR-1 Study
The sBLA for Jemperli in rectal cancer was based on the registrational phase II AZUR-1 study.
The AZUR-1 study met its primary endpoint by demonstrating that Jemperli monotherapy achieved a meaningful and durable 12-month clinical complete response in patients with stage II/III dMMR/MSI-H locally advanced rectal cancer. The treatment also exhibited a safety profile consistent with its established and manageable profile across solid tumors.
Jemperli received Breakthrough Therapy and Fast Track designations from the FDA for treating patients with stage II/III dMMR/MSI-H locally advanced rectal cancer. If approved, the therapy could become the first immunotherapy to potentially eliminate or delay the need for chemotherapy, radiation and surgery in some selected patients with this type of cancer, potentially transforming the current treatment paradigm.
Jemperli, a PD-1 inhibitor, was developed by GSK in collaboration with AnaptysBio (ANAB - Free Report) .
GSK and ANAB have an agreement to develop therapies targeting immuno-oncology indications. Per the terms of the agreement, GSK is responsible for the development and commercialization of Jemperli, while AnaptysBio is entitled to receive milestone payments and tiered royalties on annual net sales of the drug.
GSK’s Hibsago Gets Nod in Japan
In a separate press release, GSK announced that Japan’s Ministry of Health, Labour and Welfare has approved Hibsago (bepirovirsen), a potential first-in-class antisense oligonucleotide (ASO), as a functional cure for chronic hepatitis B (CHB) in certain eligible adult patients.
The approval was supported by data from the phase III B-Well study.
The approval marks the first global approval for Hibsago, as well as the first and only functional cure treatment for CHB approved in Japan.
A regulatory filing seeking approval for bepirovirsen in CHB is currently under review in the United States. A final decision from the FDA is expected by Oct. 26, 2026.
GSK’s Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) and Anika Therapeutics (ANIK - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have gained 10.6% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 earnings per share have risen from 41 cents to $1.05, while estimates for 2027 have increased from 46 cents to 95 cents during the same time. ANIK’s shares have surged 126.7% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.