Latest news with #Blenrep
Yahoo
24-05-2025
- Business
- Yahoo
GSK plc (GSK) Stock Rises as FDA Approves Nucala for COPD, CHMP Backs Blenrep for Cancer Treatment
GSK plc (NYSE:GSK) has strengthened its market outlook following major regulatory milestones. The U.S. FDA's recent approval of Nucala for chronic obstructive pulmonary disease (COPD) and a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) for Blenrep in multiple myeloma signal significant expansion in GSK's high-demand therapeutic portfolio. These advances are expected to boost the company's Specialty Medicines segment, which already reported a robust 17% sales increase, and are central to analyst projections of 4.6% annual revenue growth over the next three years. Despite broader market volatility and renewed trade tensions, GSK plc (NYSE:GSK) shares have climbed 4.9% in the past month, outperforming a market that saw a 2.5% weekly decline. This surge reflects growing investor confidence in GSK's innovation pipeline and future earnings potential. The company's fair value is estimated at £16.72 per share, suggesting an 18.6% upside from current levels. Over five years, GSK plc (NYSE:GSK) delivered a 5.42% total shareholder return, underscoring steady long-term growth amid industry challenges. While the stock underperformed the UK Pharmaceuticals sector over the past year, recent product approvals could reinforce GSK's competitive position and drive further gains. While we acknowledge the potential of GSK to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than GSK and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
23-05-2025
- Business
- Yahoo
GSK (LSE:GSK) Secures FDA Approval For COPD Treatment, Eyes European Nod For Blenrep
GSK recently received FDA approval for Nucala for COPD treatment, potentially enhancing its market presence. Meanwhile, the Committee for Medicinal Products for Human Use recommended Blenrep for multiple myeloma, adding momentum to the company's oncology portfolio. Despite broader market volatility driven by renewed trade tensions sparked by President Trump, GSK's shares rose 4.9% over the last month. This increase, amid a market experiencing a 2.5% weekly drop, suggests that the company's positive product news may have overshadowed broader market concerns, highlighting investor confidence in GSK's future earnings potential. You should learn about the 4 risks we've spotted with GSK. Trump's oil boom is here — pipelines are primed to profit. Discover the 22 US stocks riding the wave. The recent FDA approval for GSK's Nucala in COPD treatment and the positive recommendation for Blenrep could significantly enhance the company's revenue and earnings forecasts by expanding its product offerings in high-demand therapeutic areas. The approval is projected to strengthen its Specialty Medicines segment, which already experienced a 17% sales increase. The company's ongoing innovation and pipeline launches are central to analysts' expectations of 4.6% annual revenue growth over the next three years. These developments might improve investor sentiment, as reflected in the company's fair value estimation of £16.72 per share, indicating an 18.6% potential upside from the current share price of £13.6. Over a five-year period, GSK experienced a total shareholder return of 5.42%, highlighting steady albeit modest growth in a volatile market environment. In the past year, however, GSK's stock underperformed compared to the UK Pharmaceuticals industry, which recorded a 13% decline, and the broader UK market with a 2.2% increase. Despite short-term challenges, the company's long-term performance and the potential impact of recent product approvals could further consolidate its market position. The fair valuation underscores the need for investors to assess how GSK's operational enhancements will influence its growth trajectory amid competitive pressures and sector-specific risks. Upon reviewing our latest valuation report, GSK's share price might be too pessimistic. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include LSE:GSK. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Medscape
23-05-2025
- Health
- Medscape
Blenrep Gets European Nod to Treat Multiple Myeloma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion for Blenrep (belantamab mafodotin) for the treatment of relapsed or refractory multiple myeloma. The drug is an antibody drug conjugate comprising a humanized IgG1κ monoclonal antibody targeting the B-cell maturation antigen (BCMA), conjugated with a cytotoxic agent, maleimidocaproyl monomethylauristatin F (mcMMAF). Belantamab mafodotin binds to BCMA on the surface of myeloma cells, causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity. According to the manufacturer, GSK, it is the first such conjugate to be approved and represents a new mechanism of action compared with existing agents. Generally Poor Prognosis Multiple myeloma is a rare and incurable disease of the plasma cells, typically affecting adults older than 60 years of age. First-line therapy is usually with targeted cancer drugs such as lenalidomide or bortezomib in combination with a steroid, sometimes with chemotherapy and a stem cell transplant. Relapses are treated similarly. The disease has a generally poor prognosis and there is a need for novel effective therapies. Blenrep had been designated as an orphan medicine, and the EMA will now review the information to determine whether this can be maintained. CHMP said that two phase 3, randomized, open-label studies had shown that adding Blenrep to standard therapy of either bortezomib and dexamethasone in patients who have received at least one prior therapy, or pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide, prolonged progression-free survival in patients with relapsed or refractory multiple myeloma. Ocular Side Effects Common The safety and tolerability profiles of the Blenrep combinations were broadly consistent with those of the individual agents. The most common side effects with Blenrep include reduced visual acuity, corneal examination abnormalities (including keratopathy), thrombocytopenia, blurred vision, dry eye, foreign-body sensation in eyes, eye pain, photophobia, eye irritation, neutropenia, anemia, and diarrhea. Patients should have an ophthalmic examination, including visual acuity and slit-lamp examination, by an eye care professional before each of the first four doses of Blenrep, and as clinically indicated thereafter. Patients should be encouraged to inform their physicians of any ocular symptoms. The drug will be available as 70 mg or 100 mg powder for concentrate for solution for infusion. It is administered as a 30-minute infusion every 3 or 4 weeks. Treatment should be prescribed by physicians experienced in the treatment of multiple myeloma. Detailed recommendations will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorization has been granted by the European Commission.
Times
14-05-2025
- Business
- Times
GSK wins approval in the UK for blood cancer drug
A potential blockbuster blood cancer drug developed by GSK has been approved by the UK's medicines regulator. Blenrep, which was partly discovered by scientists at the FTSE 100 company's research hub in Stevenage, Hertfordshire, has been authorised by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of adults with multiple myeloma in combination with an existing drug for patients who have received at least one prior therapy. The UK approval is the first globally, with submissions under review in ten other markets. • Which British sectors will be hardest hit by Trump's tariffs Blenrep is one of five new significant regulatory approvals expected across GSK's overall portfolio this year and is also one of 14 pipeline assets the company expects to launch
Yahoo
30-04-2025
- Business
- Yahoo
GSK (LSE:GSK) Sees First Quarter Sales of £7.5 Billion and Net Income Surge
GSK reported a significant improvement in its first-quarter earnings, with sales, net income, and earnings per share all showing promising growth. This announcement coincided with a 5.14% rise in GSK's shares over the past week. Meanwhile, broader market trends have been characterized by volatility, with the major indexes seeing declines following a weak GDP report. Despite these fluctuations, GSK's positive earnings report likely bolstered investor sentiment, helping the company to outperform amidst a generally more turbulent economic backdrop. We've identified 4 warning signs with GSK and understanding the impact should be part of your investment process. Trump has pledged to "unleash" American oil and gas and these 22 US stocks have developments that are poised to benefit. The recent earnings improvement reported by GSK appears to have positively influenced investor sentiment, contributing to a 5.14% rise in its share price over the past week. This development could bolster GSK's narrative of focusing on specialty medicines and vaccines, potentially accelerating revenue and earnings growth consistent with their strategic goals. The anticipated approvals of Blenrep and depemokimab could further enhance growth. Over the past five years, GSK's total return, including share price and dividends, was 6.58%, highlighting modest long-term growth. Comparatively, GSK underperformed the UK Pharmaceuticals industry, which had a 10% decline over the past year. This contrast underscores the challenges faced by GSK, including competitive pressures and external market conditions. With regard to revenue and earnings forecasts, GSK's robust clinical pipeline and strategic focus may lead to improved financial performance. However, challenges like vaccine sales pressures and competitive environment risks may temper expectations. Analysts estimate GSK's earnings to rise to £7.0 billion by April 2028, an increase from the current £2.58 billion, with projected annual revenue growth of 4.5% over the next three years. The share price currently trades at £13.79, positioning it at a discount to the consensus analyst price target of £16.84. This suggests potential upside based on projected growth, although market dynamics and risk factors remain influential. Our expertly prepared valuation report GSK implies its share price may be lower than expected. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include LSE:GSK. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
