StreetInsider.com News Articles

Hibsago (bepirovirsen) Approved in the US for the Treatment of Chronic Hepatitis B (CHB)

Tue, 20 Oct 2026 19:58:00 -0400

Approval based on phase III data showing unprecedented functional cure rates compared to standard of care
Six-month treatment with option of self-administration after first dose
CHB affects approximately 1.7 million people in the US1

PHILADELPHIA--(BUSINESS WIRE)-- GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving NrtI therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid (DNA), and with hepatitis B virus

Hibsago (bepirovirsen) Approved in the US for the Treatment of Chronic Hepatitis B (CHB)

Tue, 20 Oct 2026 19:58:00 -0400

Approval based on phase III data showing unprecedented functional cure rates compared to standard of care
Six-month treatment with option of self-administration after first dose
CHB affects approximately 1.7 million people in the US1

FDA approves GSK's Jemperli for a specific rectal cancer type

Mon, 19 Oct 2026 18:19:23 -0400

GSK plc (NYSE: GSK) announced that the U.S. Food and Drug Administration has approved Jemperli (dostarlimab-gxly) as a monotherapy for adults with stage II and III microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) locally advanced rectal cancer, under the accelerated approval pathway.

GSK claims the drug is the first and only immunotherapy approved for this indication. The MSI-H/dMMR biomarker is found in approximately 5% to 10% of rectal cancers. Approval was based on data from the phase II AZUR-1 trial, which assessed whether the drug could enable patients to forgo chemotherapy, radiation and surgery — the current standard of care.

Jemperli (dostarlimab-gxly) approved in US as first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer

Mon, 19 Oct 2026 18:18:00 -0400

Approval based on AZUR-1 data showing clinically significant proportion of participants with no detectable signs of cancer one year or more after treatment
No disease recurrences reported among responders after median follow up of more than two years
Jemperli monotherapy could help eligible patients avoid chemotherapy, radiation and surgery

PHILADELPHIA--(BUSINESS WIRE)-- GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) as the first and only immunotherapy for adults with stage II and III microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) locally advanced rectal cancer under the accelerated approval pathway.

Current standard of treatment

Jemperli (dostarlimab-gxly) approved in US as first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer

Mon, 19 Oct 2026 18:18:00 -0400

Approval based on AZUR-1 data showing clinically significant proportion of participants with no detectable signs of cancer one year or more after treatment
No disease recurrences reported among responders after median follow up of more than two years
Jemperli monotherapy could help eligible patients avoid chemotherapy, radiation and surgery

Current standard of treatment

Form 6-K GSK plc For: Oct 19

Mon, 19 Oct 2026 13:07:00 -0400

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Form 6-K GSK plc For: Oct 19

Mon, 19 Oct 2026 07:26:00 -0400

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Form 6-K GSK plc For: Oct 15

Thu, 15 Oct 2026 10:47:00 -0400

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Form 6-K GSK plc For: Oct 14

Wed, 14 Oct 2026 11:43:00 -0400

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Form S-8 GSK plc

Tue, 13 Oct 2026 11:36:00 -0400

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Form 6-K GSK plc For: Oct 13

Tue, 13 Oct 2026 11:13:00 -0400

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Form 6-K GSK plc For: Oct 13

Tue, 13 Oct 2026 06:28:00 -0400

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Wolfe Research Starts GlaxoSmithKline (GSK) at Outperform

Fri, 09 Oct 2026 05:37:19 -0400

Wolfe Research analyst Alexandria Hammond initiates coverage on GlaxoSmithKline (NYSE: GSK) with a Outperform rating and a price target of $70.00.

For an analyst ratings summary and ratings history on GlaxoSmithKline click here. For more ratings news on GlaxoSmithKline click here.

Shares of GlaxoSmithKline closed at $46.54 yesterday.

Form 6-K GSK plc For: Oct 08

Thu, 08 Oct 2026 11:42:00 -0400

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Viola Davis partners with GSK to educate adults 50 and older about their shingles risk

Thu, 08 Oct 2026 07:38:00 -0400

For the first time, Viola Davis shares her experience with shingles
Viola encourages adults 50 years and older to prioritize their health and have candid conversations about increased risks that come with aging

Viola Davis partners with GSK to educate adults 50 and older about their shingles risk

Thu, 08 Oct 2026 07:38:00 -0400

For the first time, Viola Davis shares her experience with shingles
Viola encourages adults 50 years and older to prioritize their health and have candid conversations about increased risks that come with aging

Form 6-K GSK plc For: Oct 06

Tue, 06 Oct 2026 10:44:00 -0400

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Form 6-K GSK plc For: Oct 01

Thu, 01 Oct 2026 10:57:00 -0400

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Form 6-K GSK plc For: Sep 24

Thu, 24 Sep 2026 10:44:00 -0400

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Form CERT GSK plc

Tue, 22 Sep 2026 11:05:00 -0400

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Form 6-K GSK plc For: Sep 22

Tue, 22 Sep 2026 10:52:00 -0400

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Form 8-A12B GSK plc

Tue, 15 Sep 2026 12:31:00 -0400

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Form 6-K GSK plc For: Sep 15

Tue, 15 Sep 2026 06:06:00 -0400

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Berenberg Upgrades GlaxoSmithKline (GSK) to Buy

Tue, 15 Sep 2026 01:56:58 -0400

Berenberg analyst Kerry Holford upgraded GlaxoSmithKline (NYSE: GSK) from Hold to Buy with a price target of $60.00 (from $54.00).

For an analyst ratings summary and ratings history on GlaxoSmithKline click here. For more ratings news on GlaxoSmithKline click here.

Shares of GlaxoSmithKline closed at $50.05 yesterday.

Berenberg Upgrades GlaxoSmithKline (GSK:LN) (GSK) to Buy

Tue, 15 Sep 2026 01:17:55 -0400

Berenberg analyst Kerry Holford upgraded GlaxoSmithKline (GSK:LN) (NYSE: GSK) from Hold to Buy with a price target of GBP22.00 (from GBP20.00).

The analyst comments: “Following the spin-off of the consumer business (now Haleon) in 2022, GSK management de-levered the remaining balance sheet and reset the dividend. The financial flexibility this afforded allowed the pace of business development in the pharma and vaccines units to accelerate. Deal cadence has stepped up another gear since Luke Miels became CEO. Business development is helping to refill the pipeline and many of the acquired assets have the potential to generate multi-billion-dollar peak sales. GSK has