Director – Therapeutic Area Strategy - Neuroscience

Nuvectis' in-licensed cancer drug earned breakthrough designation in China, and it's not even their lead asset. FinanceWire Sep. 25, 2026, 08:00 AM WSW, NY, September 25th, 2026, FinanceWire Three months ago, Nuvectis Pharma (NASDAQ: NVCT) was an oncology developer anchored by a single early-stage program. Today it holds ex-China rights to the world's first approved once-daily oral Factor B inhibitor and, as of this morning, to a breakthrough-designated cancer drug. NXP200, the company's oral, brain-penetrant BRAF inhibitor, has been granted Breakthrough Therapy Designation for BRAF V600-mutant, recurrent or progressive high-grade glioma, an aggressive brain cancer with few effective options once it returns. The designation, granted by China's Center for Drug Evaluation to Nuvectis's partner Haisco Pharmaceutical Group, is reserved for drugs treating serious conditions where early data point to a meaningful advantage over existing therapy, and it brings closer regulator guidance and potentially a faster review once an application is filed. It follows a completed dose-escalation study in which the drug, on its own, produced responses in more than 40% of adult low- and high-grade glioma patients, including one complete response, in a heavily pretreated group. NXP200 is designed as a "paradox-breaker," shutting down the BRAF pathway without the paradoxical reactivation that limits first-generation BRAF drugs and drives resistance to them. CEO Ron Bentsur said the designation "underscores the compelling clinical activity observed to date," and the company still expects to file a U.S. IND for NXP200 in the fourth quarter. The designation also lands in a corner of oncology that regulators are clearly prioritizing. In April, the FDA granted its own Breakthrough Therapy Designation to FORE Biotherapeutics' plixorafenib, another brain-penetrant, paradox-breaking BRAF inhibitor, for adults with BRAF V600E-mutated high-grade glioma. Two regulators on two continents have now granted breakthrough status to the same drug class, for closely overlapping patient populations, within six months of each other. That may make NXP200 the most overlooked asset Nuvectis owns. The company describes it as having best-in-class potential, and the case rests on a specific gap. First-generation BRAF drugs are already a large business, with Novartis's Tafinlar and Mekinist combination alone generating $2.2 billion in sales last year, but they eventually stop working in many patients, and those who relapse on them are left with few targeted options. NXP200 has already shown single-agent activity in patients previously treated with BRAF inhibitors, precisely the group where the older drugs run out of road, and it is being developed across V600 mutations and the non-V600 BRAF mutations that first-generation drugs were not designed to address. If further data from the ongoing Phase 1b, including in BRAF-mutant tumor types beyond the brain, support that differentiation, NXP200 could begin to look less like a pipeline add-on and more like a franchise in its own right. And NXP200 is just one part of the Nuvectis pipeline. The asset anchoring the company today is ciprocopan (NXP100). Licensed from Haisco in the same June deal that brought in NXP200, ciprocopan won its first marketing approval in China in July for patients with paroxysmal nocturnal hemoglobinuria (PNH) who had not previously received a complement inhibitor, the first approval anywhere for a once-daily oral Factor B inhibitor. That approval rested on a head-to-head Phase 3 trial against AstraZeneca's Soliris, the long-time standard of care, in which 59.5% of ciprocopan patients reached hemoglobin of 12 g/dL or higher, compared with 8.3% on Soliris. A second application, for patients who have already failed C5-inhibitor therapy, is under review, and Nuvectis plans to meet with the FDA ahead of a U.S. IND submission targeted for the fourth quarter. The market ciprocopan is entering is moving quickly toward oral therapy. Novartis's Fabhalta, the first oral Factor B inhibitor on the U.S. market, grew sales from $169 million in the first quarter of 2026 to $225 million in the second, and Novartis places it in its $3 billion to $10 billion peak-sales tier. Fabhalta is taken twice a day. Ciprocopan is designed to be taken once, in a disease that requires treatment for life. Against that backdrop, Nuvectis's market value of roughly $700 million sits below what Fabhalta is now selling in a single year at its current quarterly pace, and at a fraction of the $2.5 billion Servier paid in April for Day One Biopharmaceuticals, whose lone approved BRAF inhibitor is projected to generate $225 million to $250 million in sales this year. Nuvectis holds rights to an approved once-daily Factor B inhibitor aimed at Fabhalta's market and a breakthrough-designated BRAF inhibitor aimed at adult cancers well beyond the pediatric population Day One's drug is approved for. Cantor Fitzgerald initiated coverage in August with an Overweight rating. The next few months are packed: NXP200's oral presentation at the European Society for Medical Oncology meeting in October, U.S. IND submissions for both ciprocopan and NXP200 targeted for the fourth quarter, and an expected update on NXP900's combination with osimertinib by year-end. As with any clinical-stage program, timelines can shift, and a breakthrough designation speeds review rather than guaranteeing approval. Nuvectis goes into that stretch holding rights to an approved drug and a breakthrough-designated one, with a third program in combination trials and, per company guidance, cash into the first half of 2029 following a $115 million raise in July. It is valued at about $700 million.

Lantheus Holdings wins FDA approval for Bravnetsa before Curium vote. The adult GEP-NET radiopharmaceutical is therapeutically equivalent to Lutathera, but Lantheus has not announced its launch date or price. The U.S. list of approved treatments for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours grew on Tuesday after Lantheus Holdings, Inc. NASDAQLNTH said the FDA granted final approval to Bravnetsa, a radiopharmaceutical equivalent to Lutathera. The decision moves abbreviated application 217060 beyond tentative approval, giving Lantheus an approved adult cancer therapy as it prepares for a vote on its sale to privately held Curium. The company's release says Bravnetsa, previously called PNT2003, was approved under an abbreviated new drug application after the FDA found it bioequivalent and therapeutically equivalent to the reference product Lutathera. Lantheus did not announce a launch date or price. Lantheus is a Bedford, Massachusetts, developer and seller of radiopharmaceutical imaging agents and cancer treatments, with a pending sale to Curium. Lantheus shares NASDAQLNTH closed unchanged at US$100.00 on Nasdaq at 4 p.m. EDT on Sept. 22, the day of the announcement. A Sept. 8 merger proxy says Curium would pay US$102.50 a share in cash at closing, with additional contingent payments possible if specified sales targets are met. Adult label leaves launch timing open. The FDA's Feb. 27, 2026, tentative-approval letter identified the application as ANDA 217060 and found Bravnetsa equivalent to the reference product. The September final decision authorizes marketing for adults with receptor-positive tumours of the pancreas or gastrointestinal tract, including foregut, midgut and hindgut disease. It is an equivalence finding, not evidence that Bravnetsa outperforms Lutathera. The adult-only label has a boundary: Lutathera also carries a pediatric indication, but Bravnetsa's prescribing information omits that use because of the reference maker's pediatric marketing exclusivity. The approval therefore gives Lantheus access to the adult market without extending its label to children. Bravnetsa's safety information warns of cumulative radiation exposure, bone-marrow suppression and kidney injury. Those are labeling warnings for lutetium Lu 177 dotatate treatment; the release presented no new clinical comparison with Lutathera. "We are focused on a thoughtful launch and ensuring the right commercial and operational capabilities are in place to support reliable supply and broad patient access," Lantheus executive chair and chief executive Mary Anne Heino said in the release. The incumbent, Novartis AG SWXNOVN NYSENVS, reported US$225 million in Lutathera sales for the second quarter of 2026. That July 21 figure gives a measure of the existing market, though Lantheus has not disclosed a revenue forecast for Bravnetsa. Mugglehead previously covered a separate Novartis actinium-based cancer drug trial. Curium received FDA approval on Sept. 14 for Bexlutry, another adult GEP-NET treatment using lutetium Lu 177 dotatate, and said it was already available. Curium's product came through a separate 505(b)(2) application supported by bridging data, while Bravnetsa has the agency's explicit therapeutic-equivalence determination under an abbreviated application. Among listed developers, Perspective Therapeutics, Inc. NYSEAMERICANCATX is testing a different radioactive medicine against somatostatin receptor-positive neuroendocrine tumours. The company scheduled updated VMT-alpha-NET data for Oct. 23 at the ESMO Congress; that program remains investigational. The iShares Biotechnology ETF NASDAQIBB closed at US$210.81 on Sept. 22 at 4 p.m. EDT, up 1.76 per cent that day. The benchmark's movement provides sector context for the Sept. 22 session. The Curium vote is next. The merger proxy sets US$102.50 per share as the cash consideration and up to US$12 more through contingent value rights. Its specified sales milestones cover prostate cancer diagnostics, neurology diagnostics and the DEFINITY ultrasound product. Bravnetsa is outside those defined groups, so this approval does not itself trigger a contingent payment. Curium's own Bexlutry approval means the proposed buyer and Lantheus now hold separate U.S. authorizations for treatments aimed at the same adult GEP-NET population. The companies have not said how they would position the two products together if the transaction closes, which is expected in the first half of 2027 subject to conditions. Lantheus shareholders are scheduled to vote on the Curium merger on Oct. 14. That vote will decide whether the agreed cash-and-contingent-rights transaction can proceed while the timing and terms of Bravnetsa's launch remain undisclosed.

Wednesday newspaper round-up: state pension, pharmaceutical companies, BMW. Share Search You are here: 23rd Sep 2026 07:05 (Sharecast News) - A thinktank linked to Reform UK has called for the abolition of the state pension and £75bn worth of sweeping tax cuts in a "radical" report likely to influence the party's platform for the next election. The Centre for a Better Britain's (CFABB) report - which also calls for weaker rules for UK banks and Trump-style investment accounts offering £1,000 to newborns - will be formally launched at a private event with City executives on Wednesday. - Guardian Motorists buying a secondhand car with a lot of miles on the clock are likely to find an electric vehicle (EV) ultimately more reliable than a petrol vehicle, according to a study. An analysis of 47.4m MOT tests found that after cars were driven 90,000 to 120,000 miles, EVs were about 25% less likely to fail than petrol models of the same age (based on a failure rate of 16.5% versus 22.1%). Beyond 120,000 miles, 16% of EVs failed, compared with 23.5% of petrol cars. The study found relatively little difference between the two fuel types at lower mileages. - Guardian Britain's biggest pharmaceutical companies have warned the future of the industry is at risk as Europe loses ground to the US and China in medical research. AstraZeneca and GSK, along with European rivals Novo Nordisk, Sanofi, Roche and Novartis, wrote an open letter warning that they were "losing ground to global competition". The letter warned that "without urgent action, strategic sectors like pharmaceuticals face a 'slow agony' of decline" as rivals increasingly dominate research-and-development spending and investment. - Telegraph BMW is facing a bill of more than £600m from the motor finance mis-selling scandal, marking one of the biggest hits faced by any lender. In newly filed accounts, the German carmaker's British finance arm increased its provision to cover mis-selling claims from £206m in 2024 to £612m in 2025. BMW's liability is more than the £430m that Barclays expects to pay and the £320m set aside by Close Brothers, another major car finance lender. However, it is still dwarfed by the worst affected lender, Lloyds Banking Group, which has provisioned £1.95bn. - Telegraph The state-backed British Business Bank and NatWest have agreed a "watershed" deal to invest in Phoenix Court, one of the UK's leading venture capital firms. The investment is the latest stage in efforts to get British capital into promising businesses to help them grow. The British Business Bank and NatWest will invest in Phoenix Court funds alongside HSBC and M&G. It is the first time that NatWest has invested in a venture capital fund. HSBC and M&G have invested in previous Phoenix Court funds. - The Times