Sotatercept

WINREVAIR met primary endpoint in Phase 3 ZENITH study for PAH, reducing risk of morbidity or mortality events. Study stopped early; participants offered WINREVAIR. Second positive phase 3 trial supports WINREVAIR as an activin signaling inhibitor therapy for PAH.

Piper Sandler maintains Overweight rating on Keros Therapeutics (NASDAQ:KROS) with $105.00 price target, anticipating Phase II PAH readout for cibotercept in Q2 2025. Insights from PAH specialists on competitor Winrevair's complex administration and risks suggest cibotercept's potential advantage. Keros' financial profile shows strong revenue growth and liquidity, supporting its drug pipeline advancement.

Merck's subcutaneous Keytruda, paired with Alteogen's berahyaluronidase alfa, performed as well as the IV version in a Phase III trial for first-line metastatic NSCLC, meeting primary and additional endpoints. This could delay biosimilar competition and expand access, with up to 50% of patients potentially eligible for the subcutaneous formula. Merck is also testing the subcutaneous version in other cancer types and signed a licensing deal with LaNova Medicines to advance a next-generation PD-1/VEGF therapy.

Healthcare stocks Merck and Medtronic offer reliable passive income due to their resilience in economic downturns and consistent dividend growth. Merck faces competition for Keytruda but has a robust pipeline and a solid dividend record. Medtronic, with 47 consecutive years of dividend increases, benefits from innovations like the MiniMed 780G insulin pump and the Hugo robotic surgery system.

Merck's Q3 revenue and adjusted earnings exceeded expectations, driven by strong sales of Keytruda, new treatments, and animal health products. However, Gardasil sales fell 11%, missing forecasts. The company narrowed its full-year sales forecast and lowered adjusted profit guidance, reflecting a one-time charge. Merck's pharmaceutical division revenue rose 5%, with Keytruda sales up 17%. Despite challenges, Merck anticipates significant drug launches over the next five years.

The article reviews the evolution of clinical trial endpoints for pulmonary arterial hypertension (PAH), highlighting the shift from traditional measures like 6-minute walk distance to composite endpoints such as time to clinical worsening. It discusses the challenges in validating biomarkers as surrogate endpoints and the potential of novel trial designs, including platform trials, to improve efficiency. The importance of patient-reported outcomes, diversity in trial participation, and the use of artificial intelligence in trial design are also emphasized.

In 2024, the FDA approved 34 new drugs, including treatments like Bristol Myers Squibb's Cobenfy, Eli Lilly's Kisunla, and Merck's Winrevair. In 2025, expect more breakthroughs, such as a non-opioid pain medication and a long-acting HIV prevention treatment.

Bio-pharma advances in endocrinology, dermatology, cardiovascular, oncology, rare diseases, pulmonology, gastroenterology, and neurology highlight promising therapies like Eli Lilly’s orforglipron, Amgen’s MariTide, Novo Nordisk’s oral semaglutide, Johnson & Johnson’s JNJ-2113, Sanofi’s amlitelimab, Ionis’s olezarsen, BridgeBio’s acoramidis, NewAmsterdam Pharma’s obicetrapib, Jazz Pharmaceuticals’ zanidatamab, Syndax’s revumenib, Merus’ zenocutuzumab, Johnson & Johnson’s nipocalimab, Novo Nordisk’s Mim8, Solid Biosciences’ SGT-003, Merck’s sotatercept, Johnson & Johnson’s Tremfya, and Crossject’s Zepizure, with analyses including clinical data, revenue forecasts, and expected launch dates.