Editor’s Briefing: September 16, 2026

In Short. FDA cleared Telix’s Pixclara as the first U.S. FET-PET imaging drug for glioma recurrence versus treatment change, a day after the free calendar still carried the September 11 line as unresolved, and opened Operation Trial Blazer’s expedited IND pilot to pair sponsors with qualified research institutions through October 30; Curium’s Bexlutry became the first radioligand equivalent referencing Novartis’ Lutathera; GSK doubled down on China’s Chimagen with a trispecific myeloma wager worth up to $750 million; Connect’s Dupixent-class IL-4Rα antibody missed its asthma primary while Sionna cut nearly half its staff after a cystic fibrosis add-on miss; and capital kept rotating toward oral TED (Sling’s $123 million series C), CNS genetic delivery (Lilly–QurCan), and CDMO fill (Samsung’s $262 million Songdo contract).

---

Pixclara: FET-PET finally on a U.S. label

Telix’s Pixclara (floretyrosine F-18 / 18F-FET) won FDA approval for amino-acid PET imaging to distinguish recurrent or progressive glioma from treatment-related change in adults and children one month and older. Roughly four-fifths of malignant brain tumors are gliomas (~24,000 U.S. cases a year). FET-PET is already in international glioma imaging guidelines, but the U.S. lacked an approved drug that met those criteria. Clearance was not clean: the agency rejected the application last April, citing a need for additional confirmatory clinical evidence. Telix Precision Medicine CEO Kevin Richardson framed the label as giving U.S. physicians “more certainty in their diagnoses and greater confidence in their treatment planning.” Cross-check: pdufa.bio (data through September 15) still shows recent Approved rows for the September 11 cluster, while today’s regulatory packet still lists TLX101-Px (Pixclara) as Awaiting with a negative days-to-decision flag. Treat free-press approval as the live status and the packet as lagging. (Fierce Biotech)

Trial Blazer: reshoring first-in-human on a rolling IND

The FDA formally opened the Expedited Investigational New Drug pilot under Operation Trial Blazer, pairing drug sponsors with selected “qualified research institutions” (CROs, academic centers, regulatory advisors, and related entities) for rolling IND review. Staff will pick about eight to ten pairs; applications close October 30. Priority goes to novel products for severe unmet need with enough preclinical data for the agency to judge IND prospects. Acting Commissioner Kyle Diamantas and CDER’s Mike Davis pitched the pilot as a response to U.S. phase 1 timelines that can stretch toward two years while Australia and China start trials far faster, with China-run studies cited as rising past a stagnant U.S. annual count. Diamantas has previously said the broader effort aims to shave six months to a year off phase 1. BIO’s August feedback welcomed rolling review in principle but worried that QRI gatekeeping could add a layer rather than remove one. Separately, BioSpace flagged Wednesday’s PDUFA VIII stakeholder meeting as a venue for rare-disease endpoint flexibility, CMC risk, and U.S.-trial fee incentives that Ovid’s Jeremy Levin has already argued will not by themselves reverse offshore early development. (Fierce Biotech; BioPharma Dive; BioSpace; BioSpace)

First radioligand “equivalent,” and a trispecific myeloma bet

Curium’s lutetium Lu 177 dotatate injection Bexlutry won FDA approval as the industry’s first radioligand equivalent, referencing Novartis’ Lutathera for SSTR-positive gastroenteropancreatic neuroendocrine tumors via the 505(b)(2) pathway. Approval followed a June court decision clearing Curium of Novartis patent claims after a July 2024 filing. Lutathera itself did $436 million in first-half 2026 sales; Novartis CEO Vas Narasimhan has told investors that radioligand copycats will not behave like ordinary generics because of delivery logistics. Curium is separately pursuing Lantheus (up to about $8 billion), which already holds a tentative ANDA approval for another Lutathera copycat (PNT2003). Parallel to that manufacturing-and-supply story, GSK licensed a preclinical Chimagen trispecific T-cell engager for multiple myeloma (undisclosed upfront; up to $750 million in milestones) designed to hit two tumor antigens plus T cells, aiming for deeper responses and better tolerability than BCMA×CD3 and GPRC5D×CD3 bispecifics that all carry CRS and neurologic boxed warnings. The pact follows GSK’s 2024 Chimagen deal ($300 million upfront) on a separate lupus/B-cell TCE and sits beside AbbVie’s and J&J’s own trispecific myeloma bets. (Fierce Pharma; BioPharma Dive; Fierce Biotech; BioSpace)

Pipeline pruning: Connect’s asthma miss, Sionna’s 46% cut, BioMarin’s Noonan exit

Connect Biopharma’s rademikibart, an IL-4Rα antibody positioned against Dupixent, missed the primary endpoint in a 160-patient phase 2 asthma study with type 2 inflammation: a 66% reduction in treatment failure over 28 days versus placebo was not statistically significant, which the company blamed on a lower-than-projected event rate. A secondary FEV1 gain was significant; China partner Simcere already has a phase 3 atopic dermatitis win; COPD phase 2 topline is due at month-end. Shares fell about 35% in the first hour. Sionna, still digesting last month’s PreciSION CF miss of NBD1 stabilizer SION-719 on top of Trikafta (stock then −90%), is cutting about 46% of staff (including its CBO), taking a near-term ~$6.4 million restructuring charge, and advancing dual combination SION-451 plus corrector SION-2222 into phase 2a with cash said to reach 2H 2029 from a June $268.3 million balance. BioMarin discontinued Voxzogo development in Noonan syndrome on feasibility and treatment-landscape grounds (not a stated safety/efficacy stop), after earlier spring cuts in Turner, SHOX, and ACAN programs, while still pressing a hypochondroplasia sNDA and living with Ascendis’ weekly Yuviwel competition plus the royalty settlement that followed. (Fierce Biotech; Fierce Biotech; Fierce Pharma)

Capital and platforms: oral TED, CNS delivery, mature-asset sheds, CDMO fill

Sling closed a $123 million series C led by Forbion (TPG Life Sciences Innovations and Sectoral joining) to fund oral IGF-1R TKI linsitinib through an ongoing phase 3 TED study (target ~120 patients; proptosis at 24 weeks). Phase 2b/3 already showed a high-dose response rate of 52% on eye-bulging criteria; the pitch is oral convenience versus infused antibodies Tepezza and Lumvoa. Lilly pledged undisclosed upfront plus a strategic stake and up to $237 million in milestones per program to QurCan for TERP polymer-lipid nanoparticle delivery of genetic medicines into CNS and PNS, with QurCan optimizing cargos and Lilly owning later development. Sanofi will transfer 20 older medicines and three manufacturing sites (including Lovenox plants and 565 employees) to Germany’s Cheplapharm for a 26.4% equity stake, with portfolio moves starting 1Q 2027 and close targeted by 3Q 2027 under CEO Belén Garijo’s innovation pivot. On the plant floor, Samsung Biologics signed a $262 million Songdo manufacturing contract with an unnamed European pharma (cumulative contract value above $21.9 billion), while its PolyPeptide tender offer window runs September 15 to October 12; French supplier VERDOT opened a 4,200 m² Saint-Beauzire HQ/plant that it says lifts chromatography and TFF capacity 150%. Newly formed Jaguar LAA (Santé-backed; not Jaguar Gene Therapy) bought J&J’s Laminar catheter-based left-atrial-appendage closure assets (J&J had paid ~$400 million for Laminar in 2023). (Fierce Biotech; Fierce Biotech; Fierce Pharma; BioProcess International; BioProcess International; Fierce Biotech)

Public-health sidebar

Pennsylvania reported a fourth measles-associated death (an unvaccinated 18-year-old in Mifflin County; acute disseminated encephalomyelitis), after a 40-year-old and two infants earlier; none of the four were vaccinated, and the state has logged nearly 700 illnesses across 38 counties this year in the worst U.S. measles year since 1991. (STAT News)

What to watch

pdufa.bio (through September 15) and today’s regulatory packet still list Ultragenyx UX111 (ABO-102, Sanfilippo A) for September 19, Merck Winrevair HYPERION label work for September 21, Mirum/Incyte zilurgisertib (FOP) for September 26, Biofrontera Ameluz for basal cell carcinoma for September 28, and a September 30 cluster with Novo Mim8 (denecimig) plus Scholar Rock apitegromab still marked Upcoming despite free-press confirmation of the Isembyld approval. Roche Tecentriq adjuvant MSI-H colon follows October 9; Merck/Daiichi I-DXd in extensive-stage SCLC is October 10; Roche Enspryng in thyroid eye disease is October 15. Free press now treats Telix Pixclara as approved; the packet’s Awaiting flag looks stale. Wednesday’s PDUFA VIII public meeting is the process watch alongside Trial Blazer applications through October 30. Connect’s COPD rademikibart readout remains a month-end clinical gate. STAT+ headlines flagged Vera’s Trutakna IgAN phase 3 finals; free body not opened here.

Open mechanism and franchise questions from this tape: whether FET-PET adoption changes glioma re-treatment rates once U.S. reimbursement and site readiness catch the label; whether Trial Blazer’s QRI pairing actually shortens IND clocks or just reorders paperwork; whether radioligand “equivalents” erode Lutathera on price or stall on logistics as Novartis expects; whether trispecific myeloma TCEs can move earlier than today’s fourth-line bispecifics without multiplying CRS/neuro risk; whether oral IGF-1R can take TED share from infused antibodies; and whether QurCan-class non-viral CNS delivery is a real BBB path or another platform option on Lilly’s genetic-medicine shelf.