Celcuity on June 2–3 disclosed Phase 3 VIKTORIA-1 results showing its experimental drug gedatolisib cut the risk of disease progression or death by roughly half in HR-positive, HER2-negative advanced breast cancer driven by PIK3CA mutations. In the trial, gedatolisib combined with AstraZeneca’s Faslodex and Pfizer’s Ibrance produced median progression-free survival (PFS) of about 11.1 months versus 5.6 months for the control arm of Faslodex plus Novartis’ Piqray; a gedatolisib-plus-hormone doublet achieved similar PFS. Safety signals included low white blood cell counts and stomatitis, with one treatment-related death attributed to Ibrance. Investors had higher expectations from an earlier small study that reported longer PFS, and Celcuity shares fell about 20–25%, trading near the low $90s. Gedatolisib is already under FDA review for patients without PIK3CA mutations, with a U.S. decision expected July 17; Celcuity plans to submit VIKTORIA-1 data as a label expansion. Analysts differ on commercial positioning because the triplet showed limited PFS advantage over the doublet, though some call the magnitude of benefit practice-changing for this hard-to-treat subgroup.

NHS England has approved mirvetuximab soravtansine (Elahere) for use in patients with folate receptor‑alpha (FRα) positive, platinum‑resistant epithelial ovarian, peritoneal and fallopian tube cancers. NICE recommended the antibody‑drug conjugate after clinical trials showed an average overall survival gain of about four months (from roughly 12.8 to 16.5 months), higher response rates (tumour shrinkage in 37% versus 16% with chemotherapy) and more manageable side‑effects. The treatment, developed by AbbVie and given by infusion once every three weeks, targets cancer cells expressing FRα and delivers cytotoxic therapy directly into tumours, improving quality of life for many patients and reducing common chemotherapy side‑effects. NHS England estimates up to 400 patients in England could benefit each year; Wales and Northern Ireland usually follow NICE guidance while Scotland makes independent decisions. Patient groups and clinical leads described the decision as the first major NHS advance for this hard‑to‑treat group in more than two decades, enabled by a new commercial arrangement with the manufacturer.

NewLimit, a South San Francisco longevity biotech cofounded by Coinbase CEO Brian Armstrong, announced a $435 million Series C that lifts its valuation to about $3.1 billion. The financing, led by Founders Fund and joined by Thrive Capital, Greenoaks, Quiet Capital and returning backers including Kleiner Perkins and Eli Lilly Ventures, is the third round for the company within roughly 12 months. Executives said the cash will accelerate plans to begin the company’s first human clinical trial next year of an epigenetic cell‑reprogramming therapy targeting the liver. Preclinical work reportedly showed reversal of ageing markers in human liver cells and improved recovery from injury in models; the initial Phase 1 programme will focus on patients with fatty liver disease with Phase 2 aiming at alcohol‑related liver disease. NewLimit also said it is developing reprogramming approaches for vascular endothelial cells and T cells to address chronic kidney disease and autoimmune conditions. Company CEO Jacob Kimmel credited a promising candidate and compelling data for the accelerated timeline, which contrasts with earlier projections that clinical testing could be years away.

Two researchers employed at the National Institutes of Health’s Rocky Mountain Laboratories have been federally charged after authorities say they attempted to bring vials of deactivated mpox into the United States without proper authorization and lied to investigators. Vincent Munster, chief of the Virus Ecology Section, and research fellow Claude Kwe were stopped at Detroit Metropolitan Airport on Jan. 25 after arriving from Brazzaville, Republic of Congo, via Paris. Customs and Border Protection and FBI agents say they discovered a large black case containing 113 vials in Styrofoam coolers; laboratory testing on a subset found 17 vials contained inactivated mpox virus, one contained chickenpox virus and two contained human DNA. Prosecutors have charged the pair with conspiracy to smuggle biological materials and making false statements; each faces up to five years in prison if convicted. The NIH said it is cooperating with investigators and that the matter is under investigation. Authorities have not publicly explained why the samples were transported without required permits or declarations.

Legend Biotech reported early clinical data showing its in vivo dual‑targeting CAR‑T candidate, LB2501, produced rapid responses in patients with relapsed or refractory B‑cell non‑Hodgkin lymphoma. As of an April 1 cutoff, 12 patients had been treated across two dose cohorts in a first‑in‑human study conducted in China; at the higher dose all six evaluable patients responded and five achieved complete responses. Legend said there were no dose‑limiting toxicities, deaths or serious adverse events; infusion‑related reactions occurred in nine patients and resolved quickly. LB2501 uses a modified viral delivery to generate CAR‑T cells inside the patient after a single infusion and targets CD19 and CD20, potentially removing the need for ex‑vivo manufacturing and lymphodepleting chemotherapy. The company plans to present further data at a medical meeting later in June. Analysts hailed the readout as potentially “best‑in‑class” in the emerging in‑vivo CAR‑T field and noted the results lifted Legend’s stock sharply and could increase acquisition interest from larger pharma groups. Longer follow‑up and broader cohorts are needed to confirm durability and safety.

An experimental oral drug, daraxonrasib, nearly doubled median survival for patients with previously treated metastatic pancreatic ductal adenocarcinoma in a randomized Phase 3 trial, researchers reported at the American Society of Clinical Oncology (ASCO) meeting in Chicago. The 500-patient RASolute-302 study found median overall survival of about 13.2 months on daraxonrasib versus roughly 6.6–6.7 months for investigator‑choice chemotherapy (hazard ratio ~0.40). Daraxonrasib also improved progression‑free survival and objective response rates and was associated with fewer treatment discontinuations; common adverse effects included rash and mucositis. The data were published in the New England Journal of Medicine. The drug, developed by Revolution Medicines, targets RAS/KRAS by locking the active protein and has received FDA Breakthrough and Orphan designations; the company has applied to U.S. regulators and the FDA is allowing expanded access while reviewing the filing. Canadian specialists at Princess Margaret Cancer Centre said they plan to open local clinical trials because Health Canada has not yet received a licensing application. Researchers are testing daraxonrasib earlier in treatment and in other RAS‑driven tumours, but questions remain about the durability of benefit as resistance eventually emerges.