GSK Stock News & Forecast (Week Ahead): CHMP Endorsements, FDA Label Expansion, Buyback Updates

Updated: Sunday, December 14, 2025 (markets closed; prices reflect the most recent close).

GSK plc (LSE: GSK / NYSE: GSK) heads into mid‑December with a rare “cluster catalyst” setup: multiple fresh European regulator panel endorsements, a new U.S. label expansion for an antibiotic, and steady buyback activity. That combination doesn’t guarantee a breakout (stocks are fickle creatures), but it does give investors a clearer map of what could move GSK shares in the days ahead.

As of the latest available trading data, GSK’s U.S. ADR last traded around $48.81. In London, the most recent close was 1,824.5p (Dec. 12, 2025). ^[1]

GSK stock performance this week: what the tape is saying

On the London Stock Exchange, GSK finished the week near 1,824.5p (Friday close). ^[2] Using last Friday to this Friday, that’s roughly a ~1% weekly gain based on published closes (Dec. 5 to Dec. 12). ^[3]

One notable hiccup: earlier in the week, GSK fell about 2% on Dec. 9 and lagged the broader FTSE 100 that day—useful context for anyone wondering why the chart has a little “step down, then recover” look. ^[4]

The big story: three new European CHMP nods (and why markets care)

In Europe, the key gatekeeper step before an EU-wide approval is often a CHMP opinion (CHMP = the EMA’s Committee for Medicinal Products for Human Use). A positive CHMP opinion is not final approval, but it’s a meaningful de‑risking milestone—especially when multiple products are involved.

1) Depemokimab (severe asthma + nasal polyps): a “twice‑yearly dosing” bet

GSK disclosed that depemokimab received a positive CHMP opinion in two indications: severe asthma with type 2 inflammation (age 12+) and chronic rhinosinusitis with nasal polyps (CRSwNP). ^[5]

Why investors care:

Depemokimab is being positioned as an ultra‑long‑acting IL‑5 (interleukin‑5) targeting biologic, aiming for two doses per year—a potential adherence/competition lever in a crowded biologics market. ^[6]
GSK said the positive opinion was supported by four Phase III trials across the indications. ^[7]
Timing: the European Commission decision is expected in Q1 2026, while the U.S. FDA decision is expected later this month (December 2025), according to reporting. ^[8]

Competitive landscape matters here: Reuters flagged the obvious heavyweights—Dupixent (Sanofi/Regeneron), Xolair (Roche/Novartis), Tezspire (Amgen/AstraZeneca), plus GSK’s own Nucala—so “good drug” isn’t enough; commercial differentiation will be the game. ^[9]

2) Arexvy (RSV vaccine): recommended expansion to adults 18+

GSK said the CHMP recommended expanding Arexvy to all adults 18+. ^[10]

Why this matters:

If finalised, it widens the eligible population and potentially strengthens GSK’s competitive posture versus Pfizer’s Abrysvo and Moderna’s mResvia in RSV. ^[11]
GSK expects an EU decision by February 2026. ^[12]

3) Nucala (mepolizumab): COPD label expansion moves closer in Europe

GSK also announced a positive CHMP opinion for Nucala as an add‑on maintenance treatment for certain adults with uncontrolled COPD characterised by raised blood eosinophils, on top of inhaled triple therapy. ^[13]

What’s notable here:

The opinion was based on the MATINEE Phase III trial, with GSK highlighting a significant reduction in COPD exacerbations versus placebo (in addition to triple therapy). ^[14]
This is strategically relevant because COPD is a large, established market—so even “incremental” label expansions can matter more than flashy early‑stage pipeline headlines.

U.S. FDA update: Blujepa (gepotidacin) expands into gonorrhea treatment

On the U.S. front, Reuters reported that the FDA expanded approval for GSK’s antibiotic Blujepa (gepotidacin) as an oral treatment option for uncomplicated urogenital gonorrhea in patients 12+ with limited or no alternative options. ^[15]

Why it matters (beyond the headline):

Gonorrhea treatment faces ongoing resistance pressures, and this decision was described as a meaningful step because it represents a new antibiotic class for gonorrhea after decades. ^[16]
Commercially, infectious disease products don’t always move the revenue needle like oncology megablockbusters—but they can improve portfolio durability and scientific credibility (and sometimes become surprisingly important when resistance trends worsen).

Oncology pipeline pulse: FDA Orphan Drug Designation for GSK’227 (risvutatug rezetecan)

GSK also announced that its B7‑H3 antibody‑drug conjugate GSK’227 (risvutatug rezetecan) received U.S. FDA Orphan Drug Designation for small‑cell lung cancer (SCLC), supported by preliminary Phase I data (ARTEMIS‑001). ^[17]

This is earlier‑stage than the CHMP items above, but it contributes to the broader investor narrative: GSK wants the market to price it as a pipeline‑driven biopharma, not just a “steady dividend pharma.”

Capital returns & share count: buyback activity stays steady

GSK continues to execute share repurchases under its existing buyback program. Recent disclosed purchases include:

220,000 shares repurchased (purchase date: Dec. 10, 2025) at a disclosed price range and VWAP in the announcement. ^[18]
217,000 shares repurchased (purchase date: Dec. 11, 2025), also with disclosed price details, to be held in treasury. ^[19]

In addition, GSK filed a block listing application for 250,000 shares reserved under its Sharesave plan (a routine employee plan mechanics item, but still share‑count relevant). ^[20]

Dividend calendar: nothing imminent this week, but 2026 dates are on the board

For income‑focused investors: GSK previously published provisional 2026 dividend dates, with the Q1 2026 ex‑dividend date indicated as May 14, 2026 (ordinary shares), followed by August 13 and November 12 for later quarters (and February 18, 2027 for Q4 2026). ^[21]

That means the coming week (mid‑December 2025) looks more “catalysts and sentiment” than “dividend-triggered flow.”

Forecasts: what analyst consensus implies for GSK through 2031

GSK publishes an analyst consensus table compiled from covering brokerage firms (with the dataset shown as at 26/11/2025). ^[22]

Key consensus figures (GBP, unless stated):

2025 turnover (revenue): £32,515m; 2026: £34,100m ^[23]
Operating margin: ~29.8% (2025) rising to ~30.4% (2026) in the consensus view ^[24]
Earnings per share (EPS): 170.1p (2025); 184.1p (2026) ^[25]
Dividend per share:63.6p (2025); 66.2p (2026) ^[26]
Free cash flow:£3,351m (2025); £5,831m (2026) ^[27]
Net debt:£14,232m (2025) trending down materially by 2026 (£11,254m) and further in later years ^[28]

How to read that as an investor (interpretation, not prophecy):

Consensus expects moderate top‑line growth into 2026, paired with incremental margin improvement. ^[29]
The cash flow ramp is particularly notable—if realised, it supports both dividends and buybacks (and selective deal‑making) without forcing the balance sheet into awkward gymnastics. ^[30]

Week-ahead outlook: what could move GSK stock next (Dec. 15–19, 2025)

Here are the most realistic near‑term drivers based on what’s already in motion:

1) U.S. FDA decision timing for depemokimab
Reuters reported the FDA is expected to decide later this month. If the decision lands in the coming week, it’s likely to be the loudest single‑day catalyst—positive or negative. ^[31]

2) Market digestion of the CHMP “triple headline”
Three separate CHMP positives (depemokimab, Arexvy expansion, Nucala in COPD) can create a “portfolio momentum” narrative. The market may still debate how much is already priced in—especially given year‑end liquidity and broad healthcare sector rotation. ^[32]

3) Buyback flow as a volatility dampener
Daily buybacks rarely launch rallies, but they can reduce free‑float pressure and slightly cushion dips—particularly in quieter holiday weeks. ^[33]

4) Macro/policy sentiment around UK pharma and US investment
GSK’s CEO recently reiterated the U.S. as the most attractive place for pharma investment, while UK policy changes (including NHS rebate/clawback adjustments reported in the same coverage) remain part of the background debate for UK‑listed pharma valuations. ^[34]

Technical take: practical levels traders tend to watch (no mysticism required)

With the London close around 1,824.5p, two obvious reference zones emerge:

Potential support: the ~1,800p area, which has shown up repeatedly in recent trading as prices swung between roughly the high‑1700s and low‑1800s on down days. ^[35]
Potential resistance: the ~1,850p area, close to the recently referenced 52‑week high region (MarketWatch cited a 52‑week high around £18.54 earlier in December). ^[36]

This is less “the oracle spoke” and more “humans love round numbers and recent highs/lows.”

Risks to keep on the radar (because markets enjoy plot twists)

Competition & pricing pressure in respiratory biologics and RSV vaccines could limit upside even with regulatory wins. ^[37]
Execution risk: CHMP positives still require final EU Commission decisions (Q1 2026 / Feb 2026 timelines mentioned), and launches require payer and physician uptake. ^[38]
Leadership transition: CEO Emma Walmsley is set to step down at year‑end 2025, with Luke Miels expected to succeed her from Jan. 1, 2026—usually not a crisis, but always a narrative risk (strategy tone, capital allocation style, etc.). ^[39]
Litigation overhang (Zantac) remains a topic investors track; GSK has a dedicated litigation page including its prior statement about settlement agreements for a large portion of U.S. state court cases. ^[40]

Bottom line: GSK stock setup into the week ahead

GSK enters the new week with fresh regulatory momentum (Europe and the U.S.), ongoing buybacks, and a consensus forecast profile that points to gradual growth and improving cash generation into 2026. ^[41]

The biggest near‑term swing factor is simple: whether the depemokimab FDA decision drops this week and how it’s framed (label scope, eligible population, commercial expectations). ^[42]