FDA Approves First Alzheimer’s Blood Test for Primary Care
Summary:
The FDA has authorized Roche and Eli Lilly’s Elecsys pTau181 blood test – the first Alzheimer’s diagnostic approved for primary care settings. The test measures phosphorylated Tau 181 protein levels in patients 55+ showing cognitive decline, achieving 97.9% accuracy in ruling out Alzheimer’s pathology.
Kailera Secures $600M Series B for Global Obesity Drug Development
Summary:
Kailera Therapeutics has closed a $600 million Series B round to launch global Phase III trials for KAI-9531, a dual GLP-1/GIP receptor agonist that achieved 17.7% average weight loss in Chinese late-stage studies. The biotech plans to initiate three Phase III studies by year-end and will also develop an oral formulation and advance two additional obesity assets licensed from Jiangsu Hengrui Pharmaceuticals.
AstraZeneca Signs White House Drug Pricing Deal; FDA Flags Novo Plant
Summary:
AstraZeneca became the second pharma company to strike a U.S. drug pricing deal with the Trump Administration, agreeing to Medicaid discounts and a government cash-price website in exchange for delaying tariffs by three years. Meanwhile, the FDA issued an “official action indicated” letter for a Novo Nordisk Indiana plant, placing it out of compliance and impacting drug approvals for Scholar Rock and Regeneron, with Regeneron’s high-dose Eylea label expansions now unlikely to meet their deadlines.
BioCryst Acquires Astria for $700M, Doubling Down on Rare Swelling Disease
Summary:
BioCryst Pharmaceuticals is acquiring Astria Therapeutics for approximately $700 million to gain navenibart, a long-acting injectable for hereditary angioedema that can be dosed every 3-6 months and complements BioCryst’s daily pill Orladeyo ($438M in 2024 sales). The deal, valued at $13 per share representing a 53% premium, reflects BioCryst going “all in” on the competitive hereditary angioedema market, with analysts projecting the combined portfolio could reach $1.8 billion in revenue by 2033 pending Phase 3 data expected in 2027.
Pelage Raises $120M for Regenerative Hair Loss Therapy
Summary:
Pelage Pharmaceuticals closed a $120 million Series B round led by Arch Venture Partners and GV to advance PP405, a first-of-its-kind topical gel that activates dormant hair follicle stem cells for hair regrowth. In a mid-stage trial of 78 participants with androgenetic alopecia, the gel demonstrated safety and early efficacy, with nearly one-third of men showing >20% increased hair density at eight weeks versus none in the placebo group, and notably stimulated growth from previously dormant follicles – suggesting faster results than current treatments like Rogaine and Propecia.
