Valerii Vasylevskyi

Co-founder and COO @AllClinicalTrials, AI-powered patient recruitment for challenging clinical trials

[Valerii Vasylevskyi @Valerii_KE]

The noticeable effects of psychedelics often allow trial participants to guess which treatment they received, potentially biasing results through their expectations. Researchers are testing and proposing new approaches to make these studies more reliable.

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[Valerii Vasylevskyi @Valerii_KE]

Varda Space Industries has raised $251 million in a Series D round at a reported $1.6 billion valuation to scale pharmaceutical processing in microgravity. The round was led by Lux Capital and Natural Capital.

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[Valerii Vasylevskyi @Valerii_KE]

The FDA now allows osteoporosis drugmakers to use gains in total hip bone mineral density as a primary efficacy endpoint in trials of postmenopausal women at risk of fractures. The change could reduce reliance on large fracture trials that have enrolled nearly 8,000 patients, potentially making development faster and less costly. STAT reports renewed interest from venture investors and pharma companies in next-generation osteoporosis treatments.

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[Valerii Vasylevskyi @Valerii_KE]

Merck’s remigromig met the primary endpoint in the Phase 2b/3 BRUNELLO trial in 984 adults with diabetic macular edema. Both doses were non-inferior to ranibizumab for improvement in vision at week 52, supporting a potential new approach that targets the Wnt pathway. However, proliferative diabetic retinopathy, vitreous hemorrhage and discontinuations due to adverse events were more frequent with remigromig. Detailed results are still pending.

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[Valerii Vasylevskyi @Valerii_KE]

Kyverna reported sustained one-year results for miv-cel, its CD19 CAR-T therapy, in 26 patients with stiff person syndrome. At 12 months, 92% remained free of chronic immunotherapy for the condition, while the median time needed to walk 25 feet was 49% lower than at baseline. Among 12 patients who needed a walking aid before treatment, 67% no longer required one. Kyverna plans to include the one-year data in its rolling BLA submission, which it expects to complete in Q4 2026.

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[Valerii Vasylevskyi @Valerii_KE]

Enveda raised $311 million in a Series E round, valuing the AI drug discovery company at about $2 billion—double its valuation a year ago, according to TechCrunch. It now has three drug candidates in human clinical trials.

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[Valerii Vasylevskyi @Valerii_KE]

An FDA advisory panel voted 7–2, with one abstention, that the benefits of GRAIL’s Galleri multi-cancer blood test outweigh its risks for adults aged 50 and older. Panel members unanimously supported its safety but split 6–4 on its effectiveness. The vote is a recommendation, not FDA approval; the agency is still reviewing the application and has not announced a final decision date.

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[Valerii Vasylevskyi @Valerii_KE]

Iambic Therapeutics filed for a Nasdaq IPO on Monday, Sept 21. AI drug discovery biotech backed by Nvidia and Qatar's QIA. Lead candidate IAM1363 is in an early stage solid tumor trial.

Reporteise since inception is about $461.8M, proposed ticker IAM. Filing details not independently confirmed.

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[Valerii Vasylevskyi @Valerii_KE]

Definium's LSD-based therapy DT120 hit its primary endpoint in a second Phase 3 trial for generalized anxiety disorder (GAD).
At Week 12, HAM-A scores fell 9.8 points with the 100 µg dose vs 4.7 points with placebo, a placebo-adjusted difference of 5.1 points (p<0.0001).
This is a separate trial from the first positive Phase 3 GAD readout in August and the Phase 3 depression readout in June. Two pivotal Phase 3 GAD trials have now read out positive, strengthening the efficacy package ahead of a planned NDA filing in 1H 2027.

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[Valerii Vasylevskyi @Valerii_KE]

The FDA launched its Expedited IND Pilot on September 15, aiming to shorten the path from preclinical development to first-in-human trials in the U.S.
Under the program, drug sponsors will partner with qualified research institutions — including academic centers, CROs and other organizations with regulatory and scientific expertise — to prepare IND applications. Instead of waiting for a complete IND package, the FDA will be able to review individual components on a rolling basis during the pre-IND phase, allowing potential issues to be identified earlier.
The pilot also encourages IRB review and clinical site activation to begin in parallel with IND development, potentially reducing delays after FDA clearance.
The first cohort will include 8–10 sponsor–institution pairs. Applications are open through October 30, with FDA planning to notify selected participants by December 18.
The program is part of HHS's Operation TrialBlazer and could eventually inform a formal accreditation system for research institutions supporting early-stage drug development.

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[Valerii Vasylevskyi @Valerii_KE]

Ifosfamide and other generic chemo drugs remain short in the US. FDA expects the shortage to run until at least Oct 2026. Substitutes can cost patients more.

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[Valerii Vasylevskyi @Valerii_KE]

The FDA expanded accelerated approval for Bayer's sevabertinib, brand name Hyrnuo, to first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with HER2 (ERBB2) tyrosine kinase domain activating mutations. Patients no longer need to have received another systemic therapy first.
HER2 is a receptor encoded by the ERBB2 gene, and activating HER2 mutations drive roughly 2–4% of advanced NSCLC. Sevabertinib was already approved for these patients after prior systemic therapy. The expanded indication means doctors can now use it as an initial treatment rather than waiting for another therapy to fail.
The approval is based on objective response rate and duration of response from the Phase 1/2 SOHO-01 trial. Among 69 treatment-naïve patients, the response rate was 75%. Because this is an accelerated approval, continued approval may depend on confirmation of clinical benefit in the ongoing Phase 3 SOHO-02 trial.
Moving a targeted therapy into the first-line setting can substantially expand its use by allowing eligible patients to receive it earlier in their disease course.

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[Valerii Vasylevskyi @Valerii_KE]

NVIDIA says its BioNeMo Inference Runtime made Boltz-2 protein structure prediction 2.9× faster than the open-source version in its benchmark, reaching 58.5K residues per GPU-hour on eight H100 GPUs. It completed all 1,000 test targets, while the open-source implementation ran out of memory on 29.

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[Valerii Vasylevskyi @Valerii_KE]

FDA placed a partial clinical hold on Biohaven's epilepsy drug opakalim (BHV-7000), the company disclosed September 10. New enrollment in the pivotal RISE-2 trial is paused.
The FDA hold itself dates to September 4 and stems from insufficient data to assess the potential human risk of a metabolite identified in rodent studies. Biohaven's disclosure came September 10, when its shares fell more than 13% in premarket trading.
RISE-3, already fully enrolled, is unaffected by the enrollment hold and remains on track to read out in 2H 2026. Biohaven recently agreed to license its Kv7 platform, led by opakalim, to SK Biopharmaceuticals in a deal valued at up to $795 million plus royalties.

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[Valerii Vasylevskyi @Valerii_KE]

Insilico's AI-designed IPF drug rentosertib lowered predicted biological age across all six proteomic aging clocks in a Phase 2a analysis published in Nature Biotechnology on Sep. 7.

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[Valerii Vasylevskyi @Valerii_KE]

UCB (Euronext Brussels: UCB) has presented new long-term data for Rystiggo (rozanolixizumab) and Zilbrysq (zilucoplan), reinforcing its growing position in generalized myasthenia gravis, a rare autoimmune neuromuscular disease where targeted therapies are reshaping treatment.

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[Valerii Vasylevskyi @Valerii_KE]

Novartis paused 8 autoimmune and neurological trials of its CAR-T therapy rap-cel after three patients died following severe IEC-HS, a rare but potentially fatal hyperinflammatory reaction. The company’s oncology trials are continuing.
BMS has also paused its autoimmune CAR-T program with zola-cel after inflammatory and neurological safety events, although no treatment-related deaths have been reported there.
The cases highlight how different the risk-benefit calculation becomes when CAR-T moves beyond cancer. In severe, treatment-refractory autoimmune disease, substantial toxicity may still be acceptable, but fatal complications set a much higher bar for demonstrating durable benefit and identifying which patients are appropriate for treatment.

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[Valerii Vasylevskyi @Valerii_KE]

Newly released FDA memos show that senior CBER and oncology officials overruled the agency's primary review team to grant accelerated approval to Replimune's Tudriqev (RP1) for melanoma. The review team had recommended a third rejection, after Complete Response Letters in July 2025 and April 2026. The documents also flag trial-conduct and data-integrity concerns, including inconsistencies between Replimune's statements to FDA and the agency's review findings.

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[Valerii Vasylevskyi @Valerii_KE]

Anthropic's new Model Hardware Standard let Claude run a proof-of-concept lab assay at Genentech, with expert oversight and guidance — an early step toward autonomous labs, not full automation.

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[Valerii Vasylevskyi @Valerii_KE]

The FDA approved Rasonque (daraxonrasib) on August 26, 2026, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. It is the first broad RAS-targeted medicine approved for metastatic pancreatic cancer, taking on a signaling pathway that drug developers struggled for decades to target directly.
RAS signaling drives the large majority of pancreatic adenocarcinomas, and pancreatic cancer is often diagnosed late and progresses aggressively, making it one of the hardest cancers to treat. In the Phase 3 RASolute 302 trial, median overall survival was 13.2 months with daraxonrasib versus 6.7 months with standard chemotherapy, reducing the risk of death by 60%. The drug's wholesale acquisition cost is $39,800 for a 30-day supply.
That is a meaningful survival improvement in a cancer with historically limited treatment options. It also raises the familiar question of access, since even an effective therapy only helps patients who are identified and reach treatment in time.
Faster identification and enrollment of eligible patients matters especially in cancers like this one, where the disease can progress quickly.

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