Curated news and analysis on clinical trials, drug approvals, and medical research.
Senti Biosciences completed enrolment in its Phase I SENTI-202 trial in relapsed or refractory AML and said recent data showed deep, MRD-negative durable complete remissions. The company plans FDA talks in the first half of 2026 on a pivotal registration programme.
Vanguard and Goldman Sachs forecasts pointed to stronger long-term returns for international stocks than for U.S. equities. The articles highlighted broad international, European and emerging-market ETFs with low expense ratios and large exposure to non-U.S. markets.
South Africa will begin providing lenacapavir on June 5 after delays tied to postimportation testing, while Uganda has launched rollout of the twice-yearly HIV prevention injection in Lira.
Lilly said a Phase IIIb trial of ixekizumab plus tirzepatide in psoriasis and obesity or overweight beat ixekizumab alone on complete skin clearance plus at least 10% weight loss at 36 weeks.
Alnylam Pharmaceuticals entered a $1.23 billion discovery collaboration with Tenaya Therapeutics to identify up to 15 novel genetic targets for heart disease. The agreement includes $10 million upfront and up to $1.13 billion in milestone payments.
U.S. insulin glargine and biosimilar developments in 2026 included CivicaScript's low-cost launch and California's CalRx rollout. The global insulin biosimilars market reached US$2.5 billion in 2025 and is projected to reach US$6.0 billion by 2033.
CEL-SCI said it expects to begin summer 2026 enrollment in a 212-patient U.S. confirmatory registration study of Multikine in head and neck cancer. The company also said it submitted a Breakthrough Medicine Designation application in Saudi Arabia and reported quarterly net loss of $5.5 million.
The European Commission expanded Hympavzi approval to patients 12 and older with hemophilia A or B with inhibitors. Phase 3 data showed a 93% reduction in mean treated annualized bleeding rate versus on-demand therapy.
The FDA cleared neuromodulation devices from Epineuron, Aneuvo and Encora Therapeutics. The products address peripheral nerve surgery, spinal cord injury neurorehabilitation and essential tremor.
Biotech M&A is shifting toward late-stage CNS and oncology assets with human clinical validation. Oncotelic Therapeutics said it advanced global IP protection for OT-101 and CNS drug delivery.
A U.S. appeals court revived Regenxbio’s patent suit against Sarepta, holding the asserted gene-therapy host cell claims are markedly different from anything occurring in nature.
The FDA approved oral decitabine and cedazuridine tablets plus venetoclax for newly diagnosed AML in patients 75 and older or those ineligible for intensive induction chemotherapy. The approval was supported by phase 1/2 ASTX727-07 data showing a 41.6% complete response rate.
ABL111 received FDA agreement on an accelerated approval pathway for metastatic gastric cancer as the first patient was dosed in a global phase 2 trial. The companies said ORR will support accelerated approval and phase 2 is evaluating ABL111 with nivolumab and mFOLFOX6.
Microgravity drug research is expanding from ISS crystal studies to commercial manufacturing efforts. New experiments and a Varda-United Therapeutics collaboration target improved drug stability, delivery and production.
An ISS National Laboratory-sponsored project will send six extremophile microbes from Antarctica and Chile to the space station for about six months of exposure. Researchers will analyze genetic, structural, and protein-level changes after return to Earth.
Tumour-infiltrating lymphocyte therapy has shown durable responses in refractory melanoma, including a 31.4% objective response rate in phase II data. The 2024 FDA approval of Lifileucel marked a milestone as regulators in other markets continue reviews.
Moleculin said its MIRACLE Phase 2B/3 AML trial is nearing first unblinding, with blinded CRc above 40% and CR around 30%. The first 45-subject readout is expected before June 30, 2026.
Immunic reported first-quarter 2026 results and said a $200 million upfront private placement is expected to fund phase 3 ENSURE trials in relapsing MS. The financing could provide up to $400 million in gross proceeds.
A post hoc STAMPEDE analysis found lower on-treatment PSA levels were strongly associated with improved long-term survival in advanced prostate cancer, but disease burden still affected outcomes.
Takeda shares came under valuation scrutiny after recent gains and mixed pipeline news, including a DNL593 collaboration exit and positive Phase 3 data for zasocitinib. The analyses said the stock was trading close to or above widely followed fair value estimates, while DCF assumptions pointed to much higher implied value.
