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GSK (GSK)

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Recent press releases and 8-K filings for GSK.

GSK Announces U.S. Drug Pricing Agreement and Major Investments
GSK
New Projects/Investments
  • GSK has entered into an agreement with the U.S. Administration to lower drug prices and expand access to respiratory medicines for millions of Americans, fulfilling President Trump's four requests.
  • As part of this agreement, GSK will reduce prices for certain medicines in Medicaid, implement a balanced pricing approach for new products, and offer up to 66% savings on its inhaled respiratory portfolio through a direct purchasing platform.
  • The agreement also includes securing a U.S. reserve of albuterol and exempts GSK and ViiV Healthcare from s232 tariffs for three years.
  • Separately, GSK announced in September 2025 plans to invest over $30 billion in U.S. R&D and manufacturing over the next five years, including $2 billion in new investment commitments made in the past 12 months.
3 days ago
GSK plc announces share repurchase
GSK
Share Buyback
  • GSK plc repurchased 232,912 ordinary shares on December 19, 2025, through BNP Paribas SA.
  • The shares were acquired at a volume-weighted average price of 1,807.58p (GBp), with prices ranging from a low of 1,798.50p to a high of 1,818.00p per share.
  • This transaction is part of an existing buyback program, bringing the total ordinary shares repurchased since September 30, 2025, to 14,554,645.
  • Following this purchase, the company holds 240,019,489 ordinary shares in treasury, which represents 5.89% of the total voting rights.
4 days ago
GSK Sells Rockville Facility to Samsung Biologics
GSK
M&A
New Projects/Investments
  • GSK is selling its Human Genome Sciences facility in Rockville, Maryland, to Samsung Biologics America for $280 million.
  • The acquisition, which includes two cGMP manufacturing plants with a combined drug-substance capacity of approximately 60,000 liters, is expected to close in the first quarter of 2026.
  • The deal also involves reported contract manufacturing organization (CMO) contracts valued at about 1.22 trillion won.
4 days ago
GSK Announces Share Buyback
GSK
Share Buyback
  • GSK plc purchased 235,000 of its ordinary shares on December 17, 2025, as part of its existing buyback program.
  • The purchase prices ranged from a low of 1,824.00p to a high of 1,850.00p per share, with a volume-weighted average price of 1,841.56p.
  • These newly acquired shares will be held as treasury shares, increasing the total number of ordinary shares held in treasury to 239,551,577.
  • Since September 30, 2025, GSK has repurchased a total of 14,086,733 ordinary shares.
  • Following this transaction, the company has 4,075,889,506 ordinary shares in issue (excluding treasury shares), and the percentage of voting rights attributable to treasury shares is 5.88%.
8 days ago
GSK announces US FDA approval for Exdensur
GSK
Product Launch
New Projects/Investments
  • GSK plc announced on December 16, 2025, that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older.
  • Exdensur is notable as the first and only ultra-long-acting biologic with twice-yearly dosing approved for this patient population.
  • The approval is based on data from the SWIFT-1 and SWIFT-2 phase III trials, which showed a significant 58% and 48% reduction in the rate of annualised asthma exacerbations over 52 weeks, respectively. A pre-specified pooled analysis also demonstrated a 72% reduction in the annualised rate of clinically significant exacerbations requiring hospitalisation and/or emergency department visits.
  • Exdensur has also recently received marketing authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and a positive CHMP opinion in Europe, with an approval decision expected in Q1 2026.
Dec 17, 2025, 12:10 PM
GSK plc Announces Share Buyback on December 16, 2025
GSK
Share Buyback
  • GSK plc purchased 230,000 ordinary shares of 31¼ pence each on December 16, 2025, through BNP Paribas SA.
  • The volume-weighted average price paid per share for this transaction was 1,834.71p.
  • These newly purchased shares will be held as treasury shares, increasing the total number of ordinary shares held in treasury to 239,316,577.
  • This transaction is part of an existing buyback programme, under which the company has purchased a total of 13,851,733 ordinary shares since September 30, 2025.
  • Following this purchase, the percentage of voting rights attributable to the ordinary shares held in treasury is 5.87%.
Dec 17, 2025, 11:31 AM
GSK's Exdensur (depemokimab) receives US FDA approval for severe asthma
GSK
Product Launch
New Projects/Investments
  • GSK announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older.
  • Exdensur is the first and only ultra-long-acting biologic with twice-yearly dosing approved for patients with severe asthma with an eosinophilic phenotype.
  • The FDA approval is based on data from the SWIFT-1 and SWIFT-2 phase III trials, which demonstrated a significant 58% and 48% reduction in the rate of annualized asthma exacerbations over 52 weeks, respectively, compared to placebo.
  • A pre-specified pooled analysis of the SWIFT trials showed a 72% reduction in the annualized rate of clinically significant exacerbations requiring hospitalization and/or emergency department visits for depemokimab compared with placebo.
  • Depemokimab recently received a positive CHMP opinion in Europe, with an approval decision expected in Q1 2026, and regulatory submissions are also under review in China and Japan.
Dec 17, 2025, 2:55 AM
GSK's Exdensur Receives UK MHRA Approval
GSK
Product Launch
  • GSK announced that its ultra-long-acting biologic, Exdensur (depemokimab), received marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) on December 15, 2025, marking its first global approval.
  • Exdensur is approved in the UK for two indications: as an add-on maintenance treatment for asthma with type 2 inflammation and as an add-on therapy for severe chronic rhinosinusitis with nasal polyps (CRSwNP).
  • The approval is based on data from the SWIFT and ANCHOR phase III trials, which showed sustained efficacy with twice-yearly dosing and a 54% reduction in clinically significant asthma exacerbations.
  • Further regulatory decisions for Exdensur are anticipated in the US, Japan, EU, and China, with approvals expected starting in December 2025 and continuing through H1 2026.
Dec 16, 2025, 1:51 PM
GSK plc Announces Share Repurchase on December 15, 2025
GSK
Share Buyback
  • GSK plc repurchased 230,000 ordinary shares on December 15, 2025, as part of its existing buyback programme.
  • The shares were acquired at a volume-weighted average price of 1,825.73p, with prices ranging from a lowest of 1,810.50p to a highest of 1,838.00p.
  • These shares will be held as Treasury shares, bringing the total number of ordinary shares held in treasury to 239,086,577.
  • Since the buyback programme was announced on September 30, 2025, GSK has purchased a total of 13,621,733 ordinary shares.
  • Following this purchase, the percentage of voting rights attributable to the ordinary shares held in treasury is 5.87%.
Dec 16, 2025, 1:02 PM
GSK plc Announces Share Buyback on December 12, 2025
GSK
Share Buyback
  • On December 12, 2025, GSK plc purchased 230,000 ordinary shares of 31¼ pence each through BNP Paribas SA, as part of its existing buyback programme.
  • The volume-weighted average price paid per share for this transaction was 1,827.59p.
  • Since September 30, 2025, GSK plc has repurchased a total of 13,391,733 ordinary shares.
  • Following this purchase, the company will hold 238,856,577 ordinary shares in treasury, representing 5.86% of the total voting rights.
Dec 15, 2025, 12:02 PM
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