GlaxoSmithKline

Moderna acknowledges slower-than-expected uptake of its RSV vaccine, mResvia, amid competition from GSK and Pfizer. The company adjusts its market expectations and financial guidance, cutting R&D spending and discontinuing several pipeline projects. Moderna plans to focus more on oncology and respiratory disease vaccines, aiming to launch five new products by 2027.

Moderna delays break-even goal to 2028, predicting 2025 sales below current year forecast, due to extended regulatory timelines for flu and cancer vaccines. Shares drop 17.1% to $65.88. Expects $2.5B-$3.5B in 2025 sales, below analyst forecast of $3.74B. Plans to submit FDA applications for RSV and COVID-influenza combo shots.

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GSK's Blenrep receives Breakthrough Therapy Designation in China for relapsed or refractory multiple myeloma treatment based on DREAMM-7 trial results, showing significant PFS improvements over standard care.

GSK's phase II trial for mRNA seasonal flu vaccine met success criteria in both younger and older adults, showing acceptable safety and reactogenicity. The mRNA platform elicited strong antibody responses, prompting progression to late-stage development. GSK aims to create a best-in-class vaccine for greater flu protection.

The 'Migraine: Seven-Market Drug Forecast and Market Analysis' report, added to ResearchAndMarkets.com's offering, forecasts the migraine market in the US, France, Germany, Italy, Spain, the UK, and Japan to grow from $9.2 billion in 2023 to $16.4 billion by 2033, driven by a 6.0% CAGR. The report covers epidemiology, treatment options, unmet needs, pipeline analysis, and market competition.

Fulcrum Therapeutics' stock dropped >60% after its Phase 3 REACH trial for losmapimod, a potential FSHD treatment, missed its primary endpoint, leading to the suspension of the program.

A.A. (UCSF, NIH T32 grant, past consulting income from LeMaitre and MIS Technologies) and D.R. (FDA) have no conflicts of interest. L.H.C. (Duke, FDA, past consulting income from Regeneron, NFLPA, Boehringer, institutional grants from GSK, Novartis) also has no conflicts. R.M.C. (FDA, former Verily Life Sciences, Google Health employee, held equity, served on boards of Cytokinetics, Centessa, Clinetic, Keystone Symposia, C-Path, Clinical Research Forum, One Fifteen) discloses no conflicts related to this manuscript.

GSK's Blenrep granted Breakthrough Therapy Designation in China for relapsed or refractory multiple myeloma treatment, based on DREAMM-7 trial results.