GSK plc (GSK) news: FDA approves twice‑yearly asthma biologic Exdensur on Dec. 17, 2025

GSK plc (GSK) announced today that the FDA approved Exdensur (depemokimab‑ulaa) for severe eosinophilic asthma in patients 12+. Here’s what it means for GSK’s respiratory pipeline, competition, and shareholders on 17.12.2025.

GSK plc (LSE/NYSE: GSK) is in the spotlight on Wednesday, 17 December 2025, after the company confirmed US FDA approval for Exdensur (depemokimab‑ulaa)—a new twice‑yearly biologic for severe asthma—while also releasing its latest share buyback update through a regulatory filing. ^[1]

Below is a full, reader-friendly rundown of all current GSK news items dated 17.12.2025, plus what they signal for patients, clinicians, and investors.

Today’s GSK headlines (17.12.2025)

1) FDA clears Exdensur (depemokimab‑ulaa) for severe eosinophilic asthma (ages 12+)

GSK said the US Food and Drug Administration approved Exdensur as an add‑on maintenance treatment for severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older—positioning the drug as the first and only ultra‑long‑acting biologic in this setting with twice‑yearly dosing. ^[2]

2) GSK updates investors on “Transaction in Own Shares” (buyback)

In a separate 17 December 2025 regulatory announcement, GSK reported it purchased 230,000 ordinary shares on 16 December 2025 (via BNP Paribas) under its buyback programme, disclosing the day’s price range and average price and updating total treasury shares. ^[3]

1) FDA approval: What GSK’s Exdensur green light actually means

A new dosing schedule in a crowded asthma biologics market

For years, severe asthma biologics have generally meant frequent injections—often every few weeks. GSK’s key differentiator here is convenience: two doses a year.

GSK’s announcement emphasizes that Exdensur is an “ultra‑long‑acting” biologic designed for twice‑yearly dosing, aimed at maintaining suppression of the type 2 inflammation that drives disease in many severe asthma patients. ^[4]

That dosing profile matters because access and adherence remain real-world hurdles in severe asthma care—especially when patients feel well between flare-ups and struggle to maintain frequent injection schedules.

The clinical data GSK highlighted today

GSK said the FDA approval is based on the SWIFT‑1 and SWIFT‑2 Phase III trials, where depemokimab showed significant reductions in annualized asthma exacerbation rates versus placebo (both on top of standard of care). ^[5]

Key results disclosed by GSK include:

58% reduction in annualized exacerbations in SWIFT‑1
48% reduction in annualized exacerbations in SWIFT‑2
A pooled analysis indicating a 72% reduction in the annualized rate of clinically significant exacerbations requiring hospitalization and/or emergency department visits (Exdensur vs placebo) ^[6]

GSK also stated depemokimab was well tolerated, with side effects similar in rate and severity to placebo across these trials. ^[7]

Why GSK believes there’s significant unmet need

In its announcement, GSK pointed to the scale of the target population, citing ~2 million Americans living with severe asthma, and asserting that about half still experience frequent exacerbations and hospitalisations—suggesting a sizable pool of patients for whom better control (and easier dosing) could be meaningful. ^[8]

GSK also argued that biologics are underused in eligible patients in the US—framing longer intervals as potentially improving willingness to start and stay on therapy. ^[9]

A key caveat: Reuters reports FDA did not approve Exdensur for nasal polyps

While the asthma win is clear, today’s coverage also includes an important limiter on the near-term label.

Reuters reported that the FDA did not approve Exdensur for chronic rhinosinusitis with nasal polyps (CRSwNP) at this time, and quoted a GSK spokesperson saying the company remains confident in the benefit for CRSwNP and is continuing discussions with the FDA. ^[10]

That matters because CRSwNP is a commercially meaningful inflammatory condition—and label breadth often influences how quickly a new biologic becomes a “must have” option for specialists managing overlapping respiratory disease.

2) GSK’s share buyback update (Transaction in Own Shares) — what was disclosed today

Alongside the FDA approval headline, GSK also issued a standard but still market-relevant update on its ongoing repurchase activity.

In the 17 December 2025 announcement, GSK said it purchased:

230,000 ordinary shares on 16 December 2025
Lowest price paid:1,816.50p
Highest price paid:1,850.00p
Volume‑weighted average price:1,834.71p
Shares will be held as treasury shares ^[11]

GSK also disclosed cumulative and capital structure figures:

Since 30 September 2025, it has purchased 13,851,733 ordinary shares under the programme
Following this purchase, GSK will hold 239,316,577 shares in treasury
Ordinary shares in issue (excluding treasury): 4,076,124,506
Treasury shares represent 5.87% of voting rights (per the filing) ^[12]

While buyback updates are routine, the steady cadence can be interpreted as management signaling confidence in cash generation and shareholder returns—especially when paired with pipeline/regulatory momentum like today’s FDA approval.

Where Exdensur fits in GSK’s 2025–2026 respiratory strategy

A pipeline “platform” drug, not a single‑indication bet

GSK described depemokimab as a novel therapy engineered with an extended half‑life, enabling sustained suppression of disease-driving inflammation with twice‑yearly dosing—and pointed to broader development programs beyond asthma. ^[13]

In the same 17.12.2025 announcement, GSK referenced continued regulatory activity globally, including:

UK MHRA marketing authorisation already granted (referenced by GSK)
A positive CHMP opinion in Europe, with an approval decision expected in Q1 2026
Submissions under review in other markets including China and Japan ^[14]

Competitive landscape: convenience vs entrenched brands

The severe asthma biologics market is highly competitive, with multiple established players. Reuters’ earlier reporting on the European review process for depemokimab highlighted the broader competitive set, including Dupixent, Xolair, Tezspire, and others. ^[15]

The bet for GSK is that dosing frequency (twice-yearly) becomes a meaningful differentiator for both clinicians and patients—enough to drive switching or earlier biologic adoption.

Leadership context investors are watching heading into 2026

Today’s Reuters coverage also framed the approval as arriving during a leadership transition period. ^[16]

Separately, GSK has already announced that Luke Miels (currently Chief Commercial Officer) is CEO Designate and is set to assume full CEO responsibilities and join the Board on 1 January 2026, succeeding Dame Emma Walmsley. ^[17]

That timeline matters because 2026 is expected to be a high‑stakes year for large pharma: execution (launch excellence, pricing/access negotiations, lifecycle management, and late-stage pipeline readouts) often matters as much as scientific novelty.

What happens next: the near-term milestones to watch

Based on what GSK and major newswires have reported around Exdensur/depemokimab in December:

FDA–GSK next steps on CRSwNP: Reuters says the nasal polyps use was not approved today; any follow‑on filings, label changes, or new clinical/regulatory actions could become the next catalyst. ^[18]
Europe decision timing: GSK noted a European decision is expected in Q1 2026 (following the positive CHMP opinion it referenced). ^[19]
Global rollout path: GSK referenced reviews underway in Japan and China, implying further regulatory headlines could land through early 2026. ^[20]
Commercial execution: The real test will be uptake—whether “twice yearly” changes prescribing behavior amid strong competitors. ^[21]

Bottom line

For 17.12.2025, GSK’s news flow is unusually concentrated and consequential:

A major FDA approval for Exdensur (depemokimab‑ulaa) in severe eosinophilic asthma—offering a twice‑yearly biologic dosing schedule that could reshape adherence and adoption dynamics in a large market. ^[22]
A fresh share buyback disclosure, showing continued repurchases and updated treasury share totals. ^[23]

For patients and clinicians, the headline is straightforward: a new, longer‑interval option is now available in the US for a difficult‑to‑control severe asthma phenotype. For investors, the focus now shifts from approval to label breadth (CRSwNP), launch traction, and whether Exdensur becomes a durable growth driver as GSK heads into its CEO transition on January 1, 2026. ^[24]