Biopharmaceuticals

Tel Aviv, Israel – September 18, 2026 -- Lutris Pharma will present updated phase 2 clinical data for its topical B-Raf inhibitor LUT014 at the 35th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria, running September 30 through October 3.

Oral presentation scheduled for October 2 at EADV Congress in Vienna

The randomized, double-blind, placebo-controlled trial results will be delivered in an oral presentation titled 'Acneiform Rash from EGFR Inhibitor Therapy: Durable, Mechanism-Directed Reduction with Topical LUT014 (B-Raf Inhibitor) in a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial.' The session, Free Communication 6: Pruritus/Adverse Drug Reactions, is set for Friday, October 2, 2026, from 11:25 to 11:35 am CET in Hall N. Anisha Patel, MD, professor of Dermatology at The University of Texas MD Anderson Cancer Center in Houston, will present the data under Abstract ID AS-1328.

Cambridge – September 18, 2026 -- Nona Biosciences has developed HCAbLM, the first language model trained specifically on fully human heavy-chain-only antibodies (HCAbs), built from a dataset of 31.8 million HCAb sequences drawn from 73 independently immunized transgenic mice. The findings were detailed in a study titled "A foundation model learns the sequence and functional grammar of fully human heavy-chain-only antibodies," published on bioRxiv.

Nona targets the developability bottleneck in AI antibody design

Current AI antibody discovery is limited less by target-binding design than by manufacturability at scale, aggregation risk and stability -- collectively known as developability. HCAbLM was built to learn the underlying sequence grammar that determines whether an HCAb can fold correctly and progress into a viable drug candidate. General-purpose protein models lack this capability because their training data contain almost no HCAb sequences.

Valby, Denmark – – September 18, 2026 -- H. Lundbeck A/S has secured marketing authorization from Japan's Ministry of Health, Labour and Welfare for eptinezumab, branded Vyepti, as a preventive treatment for migraine attacks in adults, opening the company's first independent product launch in the country.

MHLW clears the only IV CGRP-targeted migraine preventive on the market

Eptinezumab remains the sole intravenous CGRP-targeted therapy approved for migraine prevention, now available in more than 30 markets worldwide following the Japanese clearance. The drug was first approved by the U.S. FDA in February 2020, followed by the European Commission in January 2022 and, most recently, South Korea.

Washington, D.C. – – September 18, 2026 -- Advocates for limb-girdle muscular dystrophy (LGMD) held more than 60 meetings with congressional offices this week, representing patients from over 20 states, as part of The Speak Foundation's LGMD Day on the Hill.

No FDA-approved treatment exists for LGMD despite scientific progress

LGMD is a group of rare genetic diseases causing progressive muscle weakness, and no FDA-approved treatment currently targets the condition. Advocates urged lawmakers to increase federal investment in LGMD research, expand access to Department of Defense research funding, and push for clearer, more consistent regulatory pathways for rare-disease treatments.

Pittsburgh – September 18, 2026 -- PhaseWell Research has acquired Community Clinical Research (CCR), an Austin, Texas-based inpatient-capable CNS clinical trial site, in a deal advised exclusively by The Braff Group. The transaction gives PhaseWell, a Shore Capital Partners portfolio company headquartered in Nashville, its first inpatient neuropsychiatric research capability.

CCR brings a 20-bed psychiatric research unit staffed around the clock

The site operates a purpose-built, 24/7-staffed, 20-bed psychiatric research unit designed for complex central nervous system (CNS) studies requiring intensive patient monitoring. CCR's clinical team is led by Dr. Brown, with Dr. Samuel Collier serving as Principal Investigator, alongside Sub-Investigator Reid Luedecke, PMHNP-BC, and Mark Embry.

Edina, Minn. – September 18, 2026 -- ReEmerge, Inc. has closed an oversubscribed $37 million Series A financing and exited stealth mode to advance a novel therapy targeting chronic cognitive impairment caused by traumatic brain injury (TBI).

Investor syndicate backs first-of-its-kind neural stimulation approach

U.S. Venture Partners (USVP) and Santé co-led the round, joined by Oxford Science Enterprises, 415 Capital, IAG Capital Partners, The Vertical Group, and Dendrion Ventures. The capital will fund an upcoming clinical study, technology development, and expansion of clinical and regulatory operations.

Dallas – September 18, 2026 -- Nanoscope Therapeutics will unveil four-year follow-up data showing sustained visual acuity gains from its gene therapy MOGENRY® in retinitis pigmentosa patients, with the FDA already having accepted and filed the company's Biologics License Application.

Christine Kay to present long-term durability data at Retina Society meeting

Dr. Christine Kay, Director of Clinical Research and Retinal Genetics at Vitreoretinal Associates in Gainesville, will present the data on September 23, 2026, at the 59th Annual Scientific Meeting of the Retina Society in Los Angeles. The presentation, titled "Lasting Vision Improvement With MCO-010 Optogenetic Therapy," draws on the REMAIN 4-year extension of the RESTORE Phase 2b/3 trial (NCT04945772) and is scheduled for 3:15 PM PT at the Fairmont Century Plaza Hotel.

Boston – September 17, 2026 -- Xylo Bio has dosed the first participants in a Phase 1 clinical trial of XYL-1001, a selective 5-HT2A receptor agonist targeting major depressive disorder (MDD), marking the company's transition to a clinical-stage biotechnology organization.

Phase 1 trial spans single and multiple ascending dose cohorts in Australia

The randomized, double-blind, placebo-controlled study is evaluating safety, tolerability, pharmacokinetics, and pharmacodynamic activity of XYL-1001 in healthy volunteers. The trial design incorporates translational biomarkers intended to characterize pharmacodynamic engagement and inform future clinical development decisions.

Stockholm – September 17, 2026 -- SciBase Holding AB has pushed back the first day of trading in subscription rights and paid subscribed shares (BTA) tied to its ongoing rights issue by one day, moving the start date from September 15, 2026 to September 16, 2026 on Nasdaq First North Growth Market.

The subscription period itself remains unchanged, running from September 15 through September 29, 2026.

Timetable shift leaves subscription window intact

The Swedish medtech company confirmed the updated timetable applies only to the trading commencement of subscription rights and BTAs, not to the underlying subscription mechanics of the capital raise.

Michael Colérus, Chief Financial Officer of SciBase, is the designated contact for investor inquiries related to the adjustment.

Evanston, Illinois – September 17, 2026 -- ZS has been named a Leader in the IDC MarketScape: Worldwide Life Science R&D RWD/Real-World Evidence for Data Platforms, Technology Solutions, and Consulting Services 2026 Vendor Assessment (IDC #US54122226, August 2026).

The recognition marks ZS's second IDC MarketScape Leader designation in 2026, following its May 2026 placement as a Leader in the Worldwide Life Sciences R&D Strategic Consulting Services assessment (IDC #US53009826).

ZS reports 90% NPS and 97% retention across its real-world data and evidence engagements

IDC's assessment cited ZS's integrated Medical & Evidence practice, which links medical, real-world evidence and health economics and outcomes research (HEOR) strategies to speed decision-making. The firm connects evidence generation directly to downstream dissemination, supporting publications, congress strategies and field medical execution for life sciences clients.