 GSK plc (LSE/NYSE: GSK), a global biopharmaceutical company, announced today that the European Medicines Agency (EMA) has granted its investigational drug, GSK'227, the Priority Medicines (PRIME) designation for the treatment of relapsed extensive-stage small-cell lung cancer (ES-SCLC). This regulatory acknowledgment is based on early clinical data suggesting potential therapeutic benefits in a disease marked by limited treatment options and poor patient outcomes.
The PRIME designation is designed to expedite the development and review of drugs targeting unmet medical needs. GSK'227, an antibody-drug conjugate (ADC) targeting B7-H3, has shown promise in preliminary trials. It is the second major regulatory milestone for GSK'227, following the Breakthrough Therapy Designation it received from the US Food and Drug Administration in August 2024.
Senior Vice President of Global Head Oncology at GSK, Hesham Abdullah, remarked on the significance of this development, noting the potential of GSK'227 to improve treatment for ES-SCLC and other tumor types with limited therapeutic options. The PRIME designation was supported by data from the ARTEMIS-001 study, an ongoing phase I trial conducted by Hansoh Pharma, which assessed the drug's safety and efficacy in over 200 patients with various advanced solid tumors.
Lung cancer remains one of the leading causes of cancer-related deaths globally. In Europe alone, lung cancer accounted for an estimated 484,554 new cases and 375,784 deaths in 2022. ES-SCLC, a particularly aggressive form of lung cancer, often presents with widespread disease at diagnosis and has a high rate of relapse after initial treatment. |
More tax, more wasted, more then needed as growth craters further.Most inept government in history |
Good time to invest in large uk headquartered multi national companies.Gsk is a great buy. |
Confidence in the UK markets is so low that nobody wants to invest here.
And now there is talk of an emergency tax raising budget in the spring.
God help us.
Suet |
And back below 1300 we go |
No Santa rally here lol ? |
https://fortune.com/europe/2024/12/16/gsk-silicon-valley-veteran-shobie-ramakrishnan-pharma-giant-tech-powerhouse/ |
Unfortunately Emma does not seem to inspire IIs in the same way as Mr Soirot at AZN or the turnaround bloke at RR, despite the good news of late. The CEO's profile and vision are important for a formerly significant UK Pls such as GSK. Her public profile and engagement are too low key imo. |
A red wash day all over, FED/BOE rate decisions pending Wednesday/Thursday this week weighing heavy until those are out of the way.. |
Post 33826...same VOD...should I say Lloy also... |
Spacecake that is most of the UK mkt and that's why we own almost nothing. Everything sold off on the cheap |
I have no idea why I bought this, continue to hold since 2007, even after the Haleon split there seems little direction. |
Hesham Abdullah, Senior Vice President, Global Head Oncology,R&D,GSK is a busy man signing off on RNS 's covering 3 different products within a week. |
I've been steadily increasing my position here based on that theory. Nevertheless frustrating when bad news sends shares plummeting but good news doesn't result in any uplift. At some point there will be a reversal, due to M&A activity or whatever. In the meantime we just have to grin and bear it. |
It takes a long time for mkts to work out they are wrong, and that is where the opportunity lies |
Two bits of good news but the share price continues to fall. Seems to be a bit of a disconnect. Longer term this could be a blockbuster for these indications. It’s a longer term hold for me. |
GSK plc (LSE/NYSE: GSK) announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Jemperli (dostarlimab) for the treatment of patients with locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer. The Breakthrough Therapy Designation aims to expedite the development and review of drugs with the potential to treat a serious condition and where preliminary clinical evidence may indicate substantial improvement over currently available therapy. This is the second regulatory designation for dostarlimab in locally advanced dMMR/MSI-H rectal cancer, following Fast Track designation for the same patient population in January 2023 |
Seven analysts have rated GSK with a hold rating and four have assigned a strong buy rating to the stock. |
She's doing fine |
Yep 1300 on the cards again |
Every chart for this horrific, prob a buy to trade again around 12.80, rinse and repeat. U.K. shares known as “ the bug zapper trade “ for a reason. |
 Two stocks to buy in a cheap sector
There are a couple of companies in this sector that have been oversold and are being tipped to do well. Another remains one to avoid, writes Graeme Evans.
AstraZeneca and Novo Nordisk are the leading picks and GSK is still one to avoid after a City bank revealed its 2025 forecasts for an “inexpensive” European pharma sector.
Bank of America said the industry’s fundamentals remain strong, with the European majors set to deliver another year of market-beating earnings growth in the region of 14%.
However, this has been offset by stock-specific issues and the potential for uncertainty over healthcare policy in the sector’s single largest and most profitable market of the US.
As a result, European pharma trades on 12 times forecast 2026 earnings. That’s a slim 3% premium to the wider market, whereas the long-term average is 12%.
The bank believes the weakness since September has been overdone and that valuations are too focused on risks rather than growth and the potential of pipelines. Its target multiple of 16 times implies a 30% total return potential if overhangs are removed.
Despite its multiple of seven times 2026 earnings making GSK
GSK
0.34%
one of the lowest-rated stocks in the sector, the bank continues to have an Underperform recommendation.
This reflects headwinds for vaccines Arexvy and Shingrix, as well as GSK having the worst post-2026 growth outlook in the sector due to the loss of exclusivity on key products.
The shares are down 9% this year, despite the company recently ending two years of uncertainty by setting aside $2.2 billion to settle 93% of Zantac litigation claims.
Third-quarter results in late October showed vaccine sales fell 15%, impacted by a tough comparative and the prioritisation of Covid vaccinations in the United States.
Shingles product Shingrix dropped 7% as lower demand in the US more than offset stronger international uptake. And the respiratory syncytial virus vaccine Arexvy also missed City targets by some distance, with a 72% decline to £188 million.
The pressure on GSK shares and other European pharma stocks continued at the end of November after president-elect Donald Trump nominated vaccine-sceptic Robert F. Kennedy Jr as health secretary.
While this brings the prospect of four years of uncertainty over healthcare policy, Bank of America believes this is already reflected in the sector's discounted P/E multiple. |
Customisable watchlists with full streaming quotes from leading exchanges, such as LSE, NASDAQ, NYSE, AMEX, Bovespa, BIT and more.
Hot Features
Premium
