Helus Pharma finished Phase 3 enrolment early, but HLP003’s decisive test is still ahead
Helus Pharma completes APPROACH enrolment as HLP003 heads toward a pivotal Phase 3 depression data readout in the fourth quarter of 2026.
Pharma & Biotech
Pharma & Biotech
IZCARGO has moved beyond Japan, but JCR Pharmaceuticals’ real test begins after the UAE authorization
JCR Pharmaceuticals’ UAE authorization for IZCARGO opens a new market, but reimbursement, supply and Phase III evidence will shape its impact.
Pharma & Biotech
TP101 drove near-complete tumor regression in mice. What must Tract Bio prove next?
Tract Bio's AACR posters link TP101 and stemECHO to drug-resistant cancer stem cells, while IND work and clinical validation remain the key hurdles ahead.
Medical Devices & Diagnostics
Rapid Medical’s steerable guidewire has FDA clearance, but can it shorten stroke access time?
Rapid Medical's DRIVEWIRE 35 gains FDA clearance for steerable vascular access, with stroke adoption now hinging on real-world workflow evidence.
Pharma & Biotech
Can Parhelia Biosciences and Sirona Dx solve the scale problem holding spatial biology back?
Parhelia and Sirona Dx are tackling spatial biology’s scale problem with automated workflows, but multisite validation remains the decisive test ahead.
Medical Devices & Diagnostics
i-Lumen Scientific begins U.S. pivotal trial of microcurrent therapy for dry AMD
i-Lumen Scientific, Inc. has randomized the first United States patient in its pivotal i-SIGHT2 study, beginning the domestic phase of a multinational trial evaluating whether low-level electrical stimulation delivered through a closed eyelid can improve visual function in people with intermediate-to-advanced dry age-related macular degeneration. The first U.S. randomization occurred at Texas Retina Associates in
Pharma & Biotech
Nektar Therapeutics starts Phase 3 ZENITH-AD trials of rezpegaldesleukin for atopic dermatitis
Nektar Therapeutics has initiated the first two studies in a 1,530-patient Phase 3 programme evaluating rezpegaldesleukin in adolescents and adults with moderate-to-severe atopic dermatitis, beginning the pivotal test of whether regulatory T-cell stimulation can compete with established eczema biologics and oral medicines. ZENITH AD-1 and ZENITH AD-2 will each enroll approximately 510 patients who have
Medical Devices & Diagnostics
Bluejay Diagnostics advances Symphony IL-6 test as SYMON-II enrollment concludes
Bluejay Diagnostics, Inc. has completed enrollment in its 750-patient SYMON-II clinical validation study, moving the investigational Symphony IL-6 test into the data-cleaning, sample-testing and statistical-analysis phase that will determine whether the company has a credible basis for a U.S. regulatory submission. The Nasdaq-listed diagnostics developer said enrollment finished earlier than originally anticipated across participating healthcare
Pharma & Biotech
Agios Pharmaceuticals stops tebapivat sickle cell development after mixed Phase 2 results
Agios Pharmaceuticals, Inc. has decided not to advance tebapivat in sickle cell disease after a randomized Phase 2 trial involving 59 participants failed to establish the differentiated clinical profile required for further investment. The Nasdaq-listed rare-disease drug developer said the once-daily pyruvate kinase activator improved haemoglobin and markers of haemolysis, but the response pattern did
Pharma & Biotech
PolyPid signs Azurity partnership for D-PLEX100 commercialization in the U.S. and Canada
PolyPid’s Azurity partnership gives D-PLEX100 a U.S. and Canada launch path after Phase 3 SHIELD II surgical site infection data