✨ Onyx Summary Lexicon Pharmaceuticals submitted new clinical data to the FDA from three investigator-initiated studies supporting a potential resubmission of its New Drug Application for Zynquista® (sotagliflozin) as an adjunct to insulin therapy for adults with type 1 diabetes. The submission follows a 2024 FDA complete response letter citing safety
✨ Onyx Summary Keros Therapeutics presented additional Phase 1 data for KER-065 showing strong bone anabolic activity and increased bone mineral density in healthy volunteers, with the treatment well-tolerated across all dose levels. The results reinforce KER-065’s dual potential in Duchenne muscular dystrophy and bone disorders, supporting its continued clinical
✨ Onyx Summary Belite Bio entered an upsized PIPE financing led by RA Capital with participation from Eventide, Marshall Wace, RTW, Soleus, and Vestal Point, raising ~$125M upfront and issuing two-year warrants exercisable at a 20% premium ($76.80) for up to an additional ~$150M. The company will sell 1,953,
✨ Onyx Summary ImmunityBio reported Phase 2 data showing that ANKTIVA® (nogapendekin alfa inbakicept) can reverse therapy-induced lymphopenia in patients with checkpoint inhibitor–resistant advanced non-small cell lung cancer, with reversal linked to longer median overall survival (15.8 vs. 11.5 months; p=0.0057). The study suggests that restoring
✨ Onyx Summary Guardant Health announced a strategic partnership with PathGroup to expand access to its FDA-approved Shield™ blood test for colorectal cancer screening across 250+ hospitals, 15,000 physicians, and millions of patients in 25 states. By integrating Shield into PathGroup’s vast network and workflows, the collaboration represents a
✨ Onyx Summary Adverum Biotechnologies granted inducement equity awards to two new employees, consisting of stock options to purchase 16,860 shares and 8,430 restricted stock units under its 2017 Inducement Plan. The awards, made in accordance with Nasdaq Listing Rule 5635(c)(4), align new hires’ incentives with shareholder
✨ Onyx Summary Lexicon Pharmaceuticals will present preclinical data at NeuPSIG 2025 showing pilavapadin (AAK1 inhibitor) reduced neuropathic pain in models of chemotherapy-induced peripheral neuropathy and multiple sclerosis, with a separate poster on the Phase 2b PROGRESS study design. The update broadens pilavapadin’s potential beyond diabetic peripheral neuropathic pain, aligning
✨ Onyx Summary Perspective Therapeutics has appointed Joel Sendek as Chief Financial Officer, effective immediately. Sendek, a veteran biotech finance executive with over $2.5 billion raised across prior CFO roles and a top-ranked equity research background, succeeds Juan Graham and is expected to strengthen the company’s financial and strategic
✨ Onyx Summary Guardant Health reported that its updated Shield™ colorectal cancer screening algorithm (V2) achieved 84% sensitivity and 90% specificity in a clinical validation study, including 62% sensitivity for detecting stage I disease. These results, alongside Shield’s status as the first FDA-approved blood test for CRC screening, underscore its
✨ Onyx Summary Lexicon Pharmaceuticals will present patient-reported outcomes on the impact of diabetic peripheral neuropathic pain at PAINWeek 2025 (Poster #53, Sept. 4, 4:00–5:30 p.m. PT, Las Vegas) led by Belinda Hardin, PharmD, BCPS, and Suma Gopinathan, Ph.D. The findings are intended to inform late-stage
✨ Onyx Summary ✨ Onyx Summary enGene Holdings announced it has reached target enrollment of 100 patients in the pivotal cohort of its Phase 2 LEGEND trial evaluating detalimogene voraplasmid in high-risk, BCG-unresponsive non-muscle invasive bladder cancer. The company plans to overenroll the cohort and now anticipates submitting a Biologics License Application
✨ Onyx Summary Perspective Therapeutics has appointed Maya Martinez-Davis, President of GSK’s U.S. Commercial business, to its Board of Directors as an independent director. Martinez-Davis brings over two decades of biopharma leadership across GSK, Merck KGaA, and Pfizer, strengthening the company’s strategic and commercial expertise as it advances
✨ Onyx Summary Allucent expanded its executive team, appointing Patrick Phillips as COO, Rachel Page as CCO, and Nate Thompson as CIO to strengthen operations, commercial execution, and technology/AI strategy. The hires aim to scale delivery for small and mid-sized biopharma clients, accelerating program execution and reinforcing Allucent’s position
✨ Onyx Summary Lexicon reported a pooled post-hoc analysis of the SCORED and SOLOIST-WHF trials presented at ESC 2025 showing sotagliflozin reduced total CV death and HF events and lowered total MACE versus placebo consistently across age, including ≥65 and ≥75 years. The dataset (~12,000 participants; median age 69) supports
✨ Onyx Summary Ocugen announced that CEO Dr. Shankar Musunuri will present at the H.C. Wainwright Global Investment Conference in New York (Sept. 8–10, 2025) and participate in a regulatory strategy panel at Biotech on Tap in Munich (Sept. 24–26, 2025). The company will also hold one-on-one investor
✨ Onyx Summary MassBio and SCbio announced the 10 startups selected for this fall’s Drive accelerator, which will run parallel biotech and techbio cohorts to support pre-seed companies tackling challenges in immunology, neuroscience, oncology, AI-driven drug discovery, and more. By equipping founders with mentorship, business tools, and investor exposure, the
