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  • Novartis Drops ALS for Lifonebart After Astrals Misses Every Endpoint — but Keeps the Molecule in Alzheimer’s
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Novartis Drops ALS for Lifonebart After Astrals Misses Every Endpoint — but Keeps the Molecule in Alzheimer’s

Novartis abandoned an ALS target the same day it paid $125 million for a way into the brain, and Eli Lilly licensed a second nervous-system delivery platform hours later — while the FDA's first-ever radioligand equivalent approval opened a parallel front in radiopharma.
pharminent September 16, 2026 (Last updated: September 16, 2026)

STRATEGIC NEWS WATCH — September 16, 2026

Today’s top developments:

  • The FDA approved Curium’s Bexlutry as the first product cleared under a new “radioligand equivalent” designation — an equivalent to Novartis’s Lutathera, both lutetium Lu 177 dotatate, in a product that generated $816 million in 2025 — opening generic-style competition in a modality long insulated by isotope supply and manufacturing complexity rather than patent (Pharmaphorum)
  • Novartis discontinued lifonebart (VHB937), a TREM2 stabilizer, in amyotrophic lateral sclerosis after the 251-patient Phase 2 Astrals trial missed both its primary and secondary endpoints, while keeping the molecule in its continuing Alzheimer’s trial (Fierce Biotech)
  • Novartis exercised its option on Sironax’s blood-brain barrier platform for large molecules, paying $125 million on closing under an agreement worth up to $175 million in total upfront and near-term payments (Fierce Biotech)
  • Eli Lilly licensed QurCan’s Target-Engineered Responsive Polymer platform for non-viral delivery of mRNA, DNA and oligonucleotide payloads to the nervous system, with milestones of up to $237 million per program plus an undisclosed upfront and a strategic equity investment (Pharmaceutical Technology)
  • Sling Therapeutics closed a $123 million Series C led by Forbion to fund Phase 3 (ORBIT) of linsitinib, an oral IGF-1R inhibitor for thyroid eye disease, with initial data expected in mid-2028 (BioSpace)

What to Watch

  • What “radioligand equivalent” actually means — The designation is new and the available coverage does not define its regulatory basis. The FDA’s own description of the pathway and its evidentiary requirements, not the Bexlutry approval itself, will decide whether Pluvicto and the rest of the isotope-based radioligand field are now exposed to the same treatment.
  • Lifonebart’s Alzheimer’s readout — The TREM2 thesis now rests entirely on the continuing Phase 2 in Alzheimer’s. Novartis argues target validation is stronger there; watch whether the trial’s design or endpoints were adjusted after Astrals, which would say more than the stated rationale does.
  • The Curium-Lantheus close — Curium’s $8 billion acquisition would create a roughly $2.1 billion-revenue radiopharma business at the moment the first equivalent approval lands in the category. Watch for antitrust review and closing timing; no date has been announced.
  • Delivery over targets as a neuroscience bet — Novartis paid $125 million for antibody transport across the blood-brain barrier and Lilly licensed nucleic-acid delivery into the nervous system on the same day a CNS target failed. The test is which named asset each platform is first paired with — the only way to judge them against Roche’s Brainshuttle and its peers.
  • Sling’s committed capital against a 2028 readout — $123 million funds a 130-patient Phase 3 reading out in mid-2028, into a thyroid eye disease market where Tepezza and Viridian’s Lumvoa are already approved. Watch enrolment pace; recruiting against two approved options, not the money, is the binding constraint.

This brief highlights the edition’s top stories. Read the full September 16, 2026 edition → for all stories and analysis — or browse the Strategic News Watch archive.

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