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GSK 06:01

GSK plc

Exdensur approved in Japan

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GSKs Exdensur (depemokimab) has been approved in Japan for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). This marks the third regulatory approval for the drug, following previous approvals in the US and UK. Exdensur is the first and only ultra-long-acting biologic in Japan for these conditions, requiring only two doses per year.

The approval is based on positive results from the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy in reducing asthma exacerbations and improving nasal polyp size and nasal obstruction compared to placebo. Exdensur targets type 2 inflammation, a key driver of both severe asthma and CRSwNP, by inhibiting interleukin-5 (IL-5).

This approval addresses significant unmet needs in Japan, where patients with severe asthma face frequent exacerbations and hospitalizations, and those with CRSwNP experience debilitating symptoms. Exdensurs twice-yearly dosing regimen offers a convenient and potentially transformative treatment option for these patients.

GSK is also investigating depemokimab in other type 2 inflammation-driven diseases, including eosinophilic granulomatosis with polyangiitis (EGPA), hyper eosinophilic syndrome (HES), and chronic obstructive pulmonary disease (COPD).

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GSK 06:01

GSK plc

Exdensur approved in Japan

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GSKs Exdensur (depemokimab) has been approved in Japan for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). This marks the third regulatory approval for the drug, following previous approvals in the US and UK. Exdensur is the first and only ultra-long-acting biologic in Japan for these conditions, requiring only two doses per year.

The approval is based on positive results from the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy in reducing asthma exacerbations and improving nasal polyp size and nasal obstruction compared to placebo. Exdensur targets type 2 inflammation, a key driver of both severe asthma and CRSwNP, by inhibiting interleukin-5 (IL-5).

This approval addresses significant unmet needs in Japan, where patients with severe asthma face frequent exacerbations and hospitalizations, and those with CRSwNP experience debilitating symptoms. Exdensurs twice-yearly dosing regimen offers a convenient and potentially transformative treatment option for these patients.

GSK is also investigating depemokimab in other type 2 inflammation-driven diseases, including eosinophilic granulomatosis with polyangiitis (EGPA), hyper eosinophilic syndrome (HES), and chronic obstructive pulmonary disease (COPD).

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GSK 06:01

GSK plc

Nucala for adults with COPD approved in China

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**Summary**

GSK plc announced on January 5, 2026, that Chinas National Medical Products Administration (NMPA) has approved **Nucala (mepolizumab)** as an add-on maintenance treatment for adults with **chronic obstructive pulmonary disease (COPD)** characterized by elevated blood eosinophils (≥150 cells/µL). This approval makes Nucala the **first and only monthly biologic** in China studied in a broad COPD population with this eosinophilic phenotype.

The approval is based on positive results from the **MATINEE** and **METREX** phase III trials, which demonstrated a **clinically meaningful reduction in moderate/severe exacerbations** compared to placebo, including fewer hospitalizations and emergency department visits. Approximately **67% of COPD patients inadequately controlled on inhaled triple therapy** have blood eosinophil counts above 150 cells/µL, highlighting the significant unmet need addressed by this approval.

With **over 100 million COPD patients in China** and a mortality rate exceeding the global average, Nucala offers a novel treatment option to reduce exacerbations and associated healthcare costs. Nucala is already approved in China for severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic granulomatosis with polyangiitis, and is also approved for COPD in the US. Regulatory reviews are ongoing in other regions, including Europe.

Nucala is a monoclonal antibody targeting interleukin-5 (IL-5), a key driver of type 2 inflammation, and is part of GSK’s broader respiratory portfolio aimed at improving outcomes for patients with asthma, COPD, and other respiratory conditions.

**Key Points**

Nucala approved in China for COPD with elevated blood eosinophils (≥150 cells/µL).

First and only monthly biologic for this indication in China.

Reduces exacerbations, hospitalizations, and emergency visits based on MATINEE and METREX trials.

Addresses significant unmet need in China’s large COPD population.

Part of GSK’s expanding respiratory portfolio.

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GSK 06:01

GSK plc

Exdensur (depemokimab ulla) approved by US FDA

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**Summary**

GSK plc announced on December 17, 2025, that the US FDA has approved **Exdensur (depemokimab-ulaa)** as an add-on maintenance treatment for **severe asthma** with an **eosinophilic phenotype** in adults and adolescents aged 12 and older. Exdensur is the **first and only ultra-long-acting biologic** requiring **twice-yearly dosing**, offering sustained protection from asthma exacerbations. The approval is based on positive results from the **SWIFT-1 and SWIFT-2 phase III trials**, which demonstrated a **58% and 48% reduction** in annualized asthma exacerbations compared to placebo, respectively. The trials also showed fewer hospitalizations and emergency department visits in patients treated with Exdensur.

With an estimated **2 million Americans** living with severe asthma, half of whom continue to experience frequent exacerbations, Exdensur addresses a significant unmet need. The drug’s extended half-life and reduced dosing frequency aim to improve patient adherence and outcomes while reducing healthcare system burden. Exdensur has also received regulatory approvals in the UK and a positive opinion in Europe, with decisions pending in other regions, including China and Japan. GSK is further evaluating depemokimab in other type 2 inflammation-driven diseases, such as chronic rhinosinusitis with nasal polyps, COPD, and hypereosinophilic syndrome.

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GSK 06:01

GSK plc

Exdensur (depemokimab) UK MHRA approval

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**GSK’s Exdensur (Depemokimab) Receives UK MHRA Approval for Asthma and Chronic Rhinosinusitis with Nasal Polyps**

GSK plc announced on December 16, 2025, that the UKs Medicines and Healthcare products Regulatory Agency (MHRA) has approved Exdensur (depemokimab) for two indications

1. **Add-on maintenance treatment** for asthma in adults and adolescents (aged 12+) with type 2 inflammation and eosinophilic phenotype, inadequately controlled by inhaled corticosteroids and other controllers.

2. **Add-on therapy** for severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults not adequately managed by systemic corticosteroids or surgery.

**Key Highlights**

**First ultra-long-acting biologic** with **twice-yearly dosing** for respiratory diseases, offering sustained efficacy and convenience.

Approval based on positive results from **SWIFT** (asthma) and **ANCHOR** (CRSwNP) phase III trials, demonstrating

**54% reduction** in asthma exacerbations over 52 weeks.

**72% reduction** in exacerbations requiring hospitalization.

**Improved nasal polyp scores** and symptom control in CRSwNP patients.

**Well-tolerated** with a safety profile similar to placebo.

**First global approval**, with regulatory decisions pending in the US, EU, Japan, and China by H1 2026.

**Impact**

Exdensur addresses unmet needs for the **260+ million global asthma patients** and those with CRSwNP, reducing exacerbations, hospitalizations, and symptom burden. It also aims to lower healthcare costs associated with asthma, projected to rise by **22% in the NHS by 2031**.

**Future Prospects**

GSK is evaluating depemokimab in additional phase III trials for conditions like eosinophilic granulomatosis with polyangiitis (EGPA), hyper eosinophilic syndrome (HES), and uncontrolled COPD with type 2 inflammation.

This approval marks a **significant advancement** in respiratory care, offering a transformative treatment option for patients with type 2 inflammation-driven diseases.

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GSK 16:55

GSK plc

Blujepa approved in US for gonorrhoea indication

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**Summary**

GSK plc announced on December 11, 2025, that the U.S. Food and Drug Administration (FDA) has approved **Blujepa (gepotidacin)**, a first-in-class oral antibiotic, for the treatment of **uncomplicated urogenital gonorrhoea (uGC)** in adults and adolescents aged 12 and older weighing at least 45 kg. This approval marks the first new antibiotic class for gonorrhoea in over three decades, offering a much-needed alternative to injectable treatments.

**Key Highlights**

**Innovation** Blujepa is the first new class of antibiotics for gonorrhoea since 1987, addressing the urgent need for new treatments due to rising antimicrobial resistance.

**Indication** Approved for patients with limited or no alternative treatment options, such as those intolerant to or unwilling to use first-line injectable therapies.

**Clinical Evidence** Positive results from the **EAGLE-1 Phase III trial** demonstrated non-inferiority to the standard of care (ceftriaxone + azithromycin) with a favorable safety profile.

**Public Health Impact** Gonorrhoea, caused by *Neisseria gonorrhoeae*, is a priority pathogen for the WHO and an urgent public health threat in the U.S., with over 600,000 cases reported in 2023.

**Mechanism** Gepotidacin inhibits bacterial DNA replication through a novel mechanism, providing activity against resistant strains.

**Funding** Development was partially funded by the U.S. Department of Health and Human Services and the Department of Defense.

This approval underscores GSK’s commitment to addressing infectious diseases and combating antimicrobial resistance (AMR), with gepotidacin also approved earlier in 2025 for uncomplicated urinary tract infections (uUTI).

**Media and Investor Contacts**

GSK provided contact details for media and investor relations inquiries, emphasizing the significance of this milestone in infectious disease treatment.

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GSK 06:01

GSK plc

GSK'227 US FDA Orphan Drug Designation in SCLC

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GSK plc announced that its investigational antibody-drug conjugate, risvutatug rezetecan (GSK227), has received Orphan Drug Designation (ODD) from the US FDA for treating small-cell lung cancer (SCLC). This designation is supported by early clinical data showing durable responses in patients with extensive-stage SCLC (ES-SCLC), a particularly aggressive form of the disease with limited treatment options and poor prognosis.

Risvutatug rezetecan targets B7-H3, a protein overexpressed in various solid tumors, and is being developed for multiple cancer types, including lung, prostate, and colorectal cancers. This ODD marks the fifth regulatory designation for the drug, highlighting its potential as a transformative treatment. GSK has initiated a global Phase III trial for risvutatug rezetecan in relapsed ES-SCLC, further accelerating its development.

SCLC accounts for approximately 13% of all lung cancers in the US, with an estimated 29,500 new cases in 2025. ES-SCLC, representing 70% of SCLC cases, has a 5-year survival rate of only 3%, underscoring the urgent need for effective therapies. GSK’s progress with risvutatug rezetecan offers hope for patients with this challenging disease.

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GSK 06:01

GSK plc

Exdensur approved in Japan

Open AI Digest

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Return to today’s catalyst cards, chart beacons and AI charts.

GSKs Exdensur (depemokimab) has been approved in Japan for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). This marks the third regulatory approval for the drug, following previous approvals in the US and UK. Exdensur is the first and only ultra-long-acting biologic in Japan for these conditions, requiring only two doses per year.

The approval is based on positive results from the SWIFT and ANCHOR phase III trials, which demonstrated sustained efficacy in reducing asthma exacerbations and improving nasal polyp size and nasal obstruction compared to placebo. Exdensur targets type 2 inflammation, a key driver of both severe asthma and CRSwNP, by inhibiting interleukin-5 (IL-5).

This approval addresses significant unmet needs in Japan, where patients with severe asthma face frequent exacerbations and hospitalizations, and those with CRSwNP experience debilitating symptoms. Exdensurs twice-yearly dosing regimen offers a convenient and potentially transformative treatment option for these patients.

GSK is also investigating depemokimab in other type 2 inflammation-driven diseases, including eosinophilic granulomatosis with polyangiitis (EGPA), hyper eosinophilic syndrome (HES), and chronic obstructive pulmonary disease (COPD).

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GSK 06:01

GSK plc

Nucala for adults with COPD approved in China

Open AI Digest

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**Summary**

GSK plc announced on January 5, 2026, that Chinas National Medical Products Administration (NMPA) has approved **Nucala (mepolizumab)** as an add-on maintenance treatment for adults with **chronic obstructive pulmonary disease (COPD)** characterized by elevated blood eosinophils (≥150 cells/µL). This approval makes Nucala the **first and only monthly biologic** in China studied in a broad COPD population with this eosinophilic phenotype.

The approval is based on positive results from the **MATINEE** and **METREX** phase III trials, which demonstrated a **clinically meaningful reduction in moderate/severe exacerbations** compared to placebo, including fewer hospitalizations and emergency department visits. Approximately **67% of COPD patients inadequately controlled on inhaled triple therapy** have blood eosinophil counts above 150 cells/µL, highlighting the significant unmet need addressed by this approval.

With **over 100 million COPD patients in China** and a mortality rate exceeding the global average, Nucala offers a novel treatment option to reduce exacerbations and associated healthcare costs. Nucala is already approved in China for severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic granulomatosis with polyangiitis, and is also approved for COPD in the US. Regulatory reviews are ongoing in other regions, including Europe.

Nucala is a monoclonal antibody targeting interleukin-5 (IL-5), a key driver of type 2 inflammation, and is part of GSK’s broader respiratory portfolio aimed at improving outcomes for patients with asthma, COPD, and other respiratory conditions.

**Key Points**

Nucala approved in China for COPD with elevated blood eosinophils (≥150 cells/µL).

First and only monthly biologic for this indication in China.

Reduces exacerbations, hospitalizations, and emergency visits based on MATINEE and METREX trials.

Addresses significant unmet need in China’s large COPD population.

Part of GSK’s expanding respiratory portfolio.

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GSK 06:01

GSK plc

Exdensur (depemokimab ulla) approved by US FDA

Open AI Digest

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Return to today’s catalyst cards, chart beacons and AI charts.

**Summary**

GSK plc announced on December 17, 2025, that the US FDA has approved **Exdensur (depemokimab-ulaa)** as an add-on maintenance treatment for **severe asthma** with an **eosinophilic phenotype** in adults and adolescents aged 12 and older. Exdensur is the **first and only ultra-long-acting biologic** requiring **twice-yearly dosing**, offering sustained protection from asthma exacerbations. The approval is based on positive results from the **SWIFT-1 and SWIFT-2 phase III trials**, which demonstrated a **58% and 48% reduction** in annualized asthma exacerbations compared to placebo, respectively. The trials also showed fewer hospitalizations and emergency department visits in patients treated with Exdensur.

With an estimated **2 million Americans** living with severe asthma, half of whom continue to experience frequent exacerbations, Exdensur addresses a significant unmet need. The drug’s extended half-life and reduced dosing frequency aim to improve patient adherence and outcomes while reducing healthcare system burden. Exdensur has also received regulatory approvals in the UK and a positive opinion in Europe, with decisions pending in other regions, including China and Japan. GSK is further evaluating depemokimab in other type 2 inflammation-driven diseases, such as chronic rhinosinusitis with nasal polyps, COPD, and hypereosinophilic syndrome.

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GSK 06:01

GSK plc

Exdensur (depemokimab) UK MHRA approval

Open AI Digest

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Return to today’s catalyst cards, chart beacons and AI charts.

**GSK’s Exdensur (Depemokimab) Receives UK MHRA Approval for Asthma and Chronic Rhinosinusitis with Nasal Polyps**

GSK plc announced on December 16, 2025, that the UKs Medicines and Healthcare products Regulatory Agency (MHRA) has approved Exdensur (depemokimab) for two indications

1. **Add-on maintenance treatment** for asthma in adults and adolescents (aged 12+) with type 2 inflammation and eosinophilic phenotype, inadequately controlled by inhaled corticosteroids and other controllers.

2. **Add-on therapy** for severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults not adequately managed by systemic corticosteroids or surgery.

**Key Highlights**

**First ultra-long-acting biologic** with **twice-yearly dosing** for respiratory diseases, offering sustained efficacy and convenience.

Approval based on positive results from **SWIFT** (asthma) and **ANCHOR** (CRSwNP) phase III trials, demonstrating

**54% reduction** in asthma exacerbations over 52 weeks.

**72% reduction** in exacerbations requiring hospitalization.

**Improved nasal polyp scores** and symptom control in CRSwNP patients.

**Well-tolerated** with a safety profile similar to placebo.

**First global approval**, with regulatory decisions pending in the US, EU, Japan, and China by H1 2026.

**Impact**

Exdensur addresses unmet needs for the **260+ million global asthma patients** and those with CRSwNP, reducing exacerbations, hospitalizations, and symptom burden. It also aims to lower healthcare costs associated with asthma, projected to rise by **22% in the NHS by 2031**.

**Future Prospects**

GSK is evaluating depemokimab in additional phase III trials for conditions like eosinophilic granulomatosis with polyangiitis (EGPA), hyper eosinophilic syndrome (HES), and uncontrolled COPD with type 2 inflammation.

This approval marks a **significant advancement** in respiratory care, offering a transformative treatment option for patients with type 2 inflammation-driven diseases.

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GSK 16:55

GSK plc

Blujepa approved in US for gonorrhoea indication

Open AI Digest

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Return to today’s catalyst cards, chart beacons and AI charts.

**Summary**

GSK plc announced on December 11, 2025, that the U.S. Food and Drug Administration (FDA) has approved **Blujepa (gepotidacin)**, a first-in-class oral antibiotic, for the treatment of **uncomplicated urogenital gonorrhoea (uGC)** in adults and adolescents aged 12 and older weighing at least 45 kg. This approval marks the first new antibiotic class for gonorrhoea in over three decades, offering a much-needed alternative to injectable treatments.

**Key Highlights**

**Innovation** Blujepa is the first new class of antibiotics for gonorrhoea since 1987, addressing the urgent need for new treatments due to rising antimicrobial resistance.

**Indication** Approved for patients with limited or no alternative treatment options, such as those intolerant to or unwilling to use first-line injectable therapies.

**Clinical Evidence** Positive results from the **EAGLE-1 Phase III trial** demonstrated non-inferiority to the standard of care (ceftriaxone + azithromycin) with a favorable safety profile.

**Public Health Impact** Gonorrhoea, caused by *Neisseria gonorrhoeae*, is a priority pathogen for the WHO and an urgent public health threat in the U.S., with over 600,000 cases reported in 2023.

**Mechanism** Gepotidacin inhibits bacterial DNA replication through a novel mechanism, providing activity against resistant strains.

**Funding** Development was partially funded by the U.S. Department of Health and Human Services and the Department of Defense.

This approval underscores GSK’s commitment to addressing infectious diseases and combating antimicrobial resistance (AMR), with gepotidacin also approved earlier in 2025 for uncomplicated urinary tract infections (uUTI).

**Media and Investor Contacts**

GSK provided contact details for media and investor relations inquiries, emphasizing the significance of this milestone in infectious disease treatment.

Go Back To AI Charts

GSK 06:01

GSK plc

GSK'227 US FDA Orphan Drug Designation in SCLC

Open AI Digest

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Return to today’s catalyst cards, chart beacons and AI charts.

GSK plc announced that its investigational antibody-drug conjugate, risvutatug rezetecan (GSK227), has received Orphan Drug Designation (ODD) from the US FDA for treating small-cell lung cancer (SCLC). This designation is supported by early clinical data showing durable responses in patients with extensive-stage SCLC (ES-SCLC), a particularly aggressive form of the disease with limited treatment options and poor prognosis.

Risvutatug rezetecan targets B7-H3, a protein overexpressed in various solid tumors, and is being developed for multiple cancer types, including lung, prostate, and colorectal cancers. This ODD marks the fifth regulatory designation for the drug, highlighting its potential as a transformative treatment. GSK has initiated a global Phase III trial for risvutatug rezetecan in relapsed ES-SCLC, further accelerating its development.

SCLC accounts for approximately 13% of all lung cancers in the US, with an estimated 29,500 new cases in 2025. ES-SCLC, representing 70% of SCLC cases, has a 5-year survival rate of only 3%, underscoring the urgent need for effective therapies. GSK’s progress with risvutatug rezetecan offers hope for patients with this challenging disease.

Go Back To AI Charts