Positive results from the second of two phase III trials set Compass Pathways plc’s synthetic psilocybin candidate COMP-360 on track for a potential U.S. FDA approval next year as the first classic psychedelic cleared for treatment-resistant depression. Shares of the company (NASDAQ:CMPS) shot up by 42% to $8.26 in early trading Feb. 17. The phase III trial known as COMP006 evaluated the change from baseline in the Montgomery-Åsberg Depression Rating Scale score, hitting statistical significance at week six. A second phase III, the COMP005 trial, which achieved the primary endpoint at six weeks last June, showed the effect was maintained through week 26. Compass Pathways plans to complete a rolling NDA submission in the fourth quarter for COMP-360, which has breakthrough therapy designation. Psilocybin, a hallucinogen, is the active ingredient in magic mushrooms.

Positive phase III AMD data with Apaxli sink Ocular

Shares of Ocular Therapeutix Inc. (NASDAQ:OCUL) were trading at $6.88, down 22.52% on what one expert characterized as “truly transformative” top-line results from the Sol-1 phase III superiority trial with Axpaxli (also known as OTX-TKI) for wet age-related macular degeneration (AMD). After a loading phase, Sol-1 compared a single dose of Axpaxli (0.45 mg) to a single dose of VEGF therapy Eylea (aflibercept, Regeneron Pharmaceuticals Inc., 2 mg) in wet AMD patients. Under the prespecified statistical analysis plan, which is aligned with the U.S. FDA by way of a special protocol assessment setup, the superiority primary endpoint at week 36 was met with high statistical significance (p=0.0006). Axpaxli, a bioresorbable, intravitreal hydrogel, showed either statistical significance or numerical superiority to Eylea in key secondary and prespecified exploratory endpoints, Ocular said. The hydrogel incorporates axitinib, a small-molecule, multitarget, tyrosine kinase inhibitor with anti-angiogenic properties. Axitinib was first approved in January 2012 as a tablet developed by Pfizer Inc. for advanced renal cell carcinoma.

Danaher to buy Masimo for $9.9B

Danaher Corp. has agreed to acquire Masimo Corp. for $9.9 billion in a move to strengthen its diagnostics business. Under the terms of the agreement, Danaher will acquire all the outstanding shares of Masimo for $180 per share in cash, representing a 38.3% premium to Masimo’s last closing price.

Vesalic targeting toxic muscle exosomes in motor neuron diseases

Newco Vesalic Ltd. has formed to take forward research indicating extracellular vesicles secreted by skeletal muscle cells carry toxic payloads that are key drivers of motor neuron diseases, including amyotrophic lateral sclerosis. The discovery of this process, which is largely external to the brain and the central nervous system, has opened up new targeting possibilities, and Vesalic is now working on in vivo studies to demonstrate preclinical proof of concept.

Omnigeniq’s journey from space science to drug design

A project that started as a bioreactor to assist astronauts in deep space to keep medications safe in a microgravity environment could help pharma companies model how drugs behave in the human body. Omnigeniq unveiled at the J.P. Morgan Healthcare conference the first computer model of a human protein as it exists in the body, confirming that native protein topology can be calculated directly from physics. Omnigeniq co-founder and Chief Scientific Officer Tiffanwy Klippel-Cooper told BioWorld she was building a bioreactor for astronauts so they would have a ready supply of drugs like insulin, and she needed to understand the physics of how microgravitational environments affect cell cultures.

Delay for Disc as CNPV-designated bitopertin earns CRL in EPP

Though it’s largely viewed by analysts as a simple delay rather than a setback, Disc Medicine Inc.’s unexpected complete response letter (CRL) for bitopertin in the rare genetic disorder erythropoietic protoporphyria (EPP) raises more questions regarding consistency and stability at the U.S. FDA. The NDA had sought an accelerated nod in EPP, a potentially life-threatening disease caused by mutations affecting heme biosynthesis, leading to an accumulation of protoporphyrin IX, a compound that plays critical roles in small amounts, but in large amounts can become toxic, causing severe photosensitivity

Human organoid mimics cancer-induced cachexia

The variety of organoids that can be developed in vitro is enabling major advances. Depending on the type of tissues and the research goals, these small 3D cell-based structures that mimic real tissue offer certain advantages over animal models. Scientists at the University of Padova in Italy have created human neuromuscular organoids to reproduce cancer-induced muscle cachexia, a condition that murine models do not accurately replicate.

HRSA taking another look at 340B rebates

A 340B rebate pilot program may have been enjoined last year, but that doesn’t necessarily mean it’s dead. The U.S. Health Resources and Services Administration (HRSA), which oversees the prescription drug discount program for the Department of Health and Human Services, published a request for information today to get input on the standards and procedures that should govern the approval of manufacturer rebate plans and the impacts on all stakeholders, including the hospitals and others that benefit from the steep discounts that have been given upfront in the past.

Med-tech deals and M&As start 2026 below last year’s norms

Med-tech M&A activity opened 2026 at a slower pace, with January deal value totaling $665.33 million, coming in well below the 2025 monthly average of $3.51 billion and trailing most individual months last year. The largest med-tech M&A deal in January saw Smith+Nephew plc agree to acquire Integrity Orthopaedics Inc. for up to $450 million to bolster its shoulder repair portfolio.

Holiday notice

BioWorld's offices were closed in observance of Presidents Day in the U.S. No issue was published Monday, Feb. 16.

Also in the news

Amicus, Applied Medical Technology, Astrazeneca, Biomarin, Coherus, Convai, Evommune, Eye Pcr, Galecto, Genfit, H. Lundbeck, Hanchorbio, HCW, Immunic, Invera Medical, Ipsen, Kandu, Magnolia, Median, Medicenna, Medtronic, Nasus, Novartis, Nxera, Okyo, Opus, PTC, Siemens, Sumitomo, Tempus AI, Ultragenyx, WY