Biopharmaceuticals

Viva-Thera, XtalPi Nominate HIV Drug Candidate in Seven Months

Boston – September 22, 2026 -- Viva-Thera has nominated a preclinical candidate targeting the membrane-proximal external region (MPER) of HIV-1 gp41, completing discovery and optimization in seven months through a partnership with AI drug-design firm XtalPi (HKEX: 2228). The biotech, incubated and backed by XtalPi as a strategic shareholder, made its public debut disclosing progress across four HIV modalities: vaccines, long-acting small molecules, gene therapy and cell therapy.

XtalPi's AI screened 10 million compounds to isolate five validated hits

Using generative AI, XtalPi navigated a chemical space of approximately 10 million compounds to identify five hits with strong antiviral activity and favorable drug properties. Continuous optimization of these leads drove the program to preclinical candidate nomination within seven months, according to the companies.

Health Union, DTC Perspectives Launch Rare Disease Marketing Summit

Philadelphia – September 22, 2026 -- Health Union and DTC Perspectives have launched a strategic partnership to stage an invitation-only executive summit focused on redefining commercial models for rare disease and niche oncology marketing.

Summit convenes senior biopharma marketers in Boston on November 5, 2026

The Rare Marketing Summit: Redefining the Commercial Model for Rare Disease will run from 10:00 AM to 4:00 PM at The Westin Copley Place in Boston, MA, followed by a cocktail reception. Attendance is capped to preserve intimate peer exchange among senior-level biopharma marketing leaders.

PulsePoint Launches DTC Explorer to Speed Up Pharma Audience Building

New York – September 22, 2026 -- PulsePoint has launched DTC Explorer, a self-service workspace that lets pharma marketers build and publish clinically-informed consumer audiences in hours instead of the longer timelines previously required for custom segment creation.

New tool cuts audience-building time by connecting clinical claims data to consumer targeting

DTC Explorer draws on PulsePoint's proprietary Bespoke Audiences, which are built from de-identified diagnosis, drug, and treatment claims. Users can filter by consumer demographics, clinical signals, prescribed drugs, insurance provider, geography, or NPI list, reviewing real-time aggregate device and consumer counts as they refine selections before publishing directly to the PulsePoint platform for activation.

IntegriChain Execs to Address 340B, Gross-to-Net at Fall Summits

Philadelphia – September 22, 2026 -- IntegriChain will send five senior advisors to three Informa Connect industry conferences this fall, addressing government pricing, 340B compliance, and gross-to-net forecasting for biopharma manufacturers navigating tightening reimbursement rules.

Government pricing experts present at Chicago's MDRP Summit in October

At the Medicaid Drug Rebate Program (MDRP) Summit 2026, running October 5-7 at the Fairmont Chicago Millennium Park, Jeff Baab, Partner of Advisory Services at IntegriChain, will present "Updates on Landscape of Government Pricing and Contracting" on October 7 at 9:40 AM. The same day at 10:50 AM, Clay Willis, also Partner of Advisory Services, will deliver "340B Movement to Have All 340B Claims in One System of Record," covering the rebate model pilot program #2 and updated patient-definition and contract-pharmacy policies.

Oracle Named Leader in IDC MarketScape for Real-World Data Platforms

Austin, Texas – September 22, 2026 -- Oracle has been named a Leader in the IDC MarketScape: Worldwide Life Sciences R&D RWD/RWE for Data Platforms, Technology Solutions, and Consulting Services 2026 Vendor Assessment, according to a report published by IDC in August 2026 (Doc #US54122226).

IDC cites Oracle's four-decade track record in real-world data and evidence solutions

The MarketScape credits Oracle with delivering RWD/RWE solutions for over 40 years and aggregating real-world electronic health record data for nearly two decades through its health system network. Oracle expanded its RWD platform following its 2022 acquisition of Cerner and launched a next-generation AI-powered life sciences platform in 2026. The report states Oracle works with every major pharmaceutical company.

Circular Genomics, Altoida Combine Blood and Digital Biomarkers for Alzheimer's

San Diego – September 22, 2026 -- Circular Genomics and Altoida have entered a collaboration pairing blood-based circular RNA (circRNA) biomarkers with AI-powered digital cognitive testing to accelerate Alzheimer's drug development and build a scalable frontline diagnostic pathway.

Companies design a two-step diagnostic workflow combining digital and molecular data

The alliance links Circular Genomics' CircPathTM circRNA biomarker platform with Altoida's Digital NeuroMarkerTM platform. The proposed workflow starts with a 10-minute, self-administered digital cognitive assessment, followed by a confirmatory circRNA blood test to validate underlying disease biology. The companies say this sequence could reduce dependence on hours-long, specialist-administered neuropsychological batteries and extend Alzheimer's screening into primary care settings.

Compugen to Detail COM701 Ovarian Cancer Trial Data at Oct. 5 KOL Event

Holon, Israel – September 22, 2026 -- Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) will host a virtual key opinion leader event on October 5, 2026 at 8:00 AM ET, presenting new detail on COM701, its anti-PVRIG antibody candidate for relapsed platinum-sensitive ovarian cancer (PSOC).

Harvard oncologist to preview MAIA-ovarian trial design and timeline

Oladapo Yeku, M.D., Ph.D., FACP, of Harvard Medical School and Massachusetts General Hospital, will join Compugen management to discuss the randomized MAIA-ovarian adaptive platform trial. The study evaluates COM701 as a maintenance therapy in relapsed PSOC patients, with median progression-free survival data from the interim analysis expected by Q1 2027. COM701 has already shown initial anti-tumor activity and a favorable safety and tolerability profile in Phase 1 studies as monotherapy and in combination regimens.

Edgewise Reveals EDG-7500 Data Targeting Novel Cardiac Muscle Protein

Boulder, Colorado – September 22, 2026 -- Edgewise Therapeutics (Nasdaq: EWTX) disclosed preclinical data showing its lead cardiac drug candidate EDG-7500 improves heart relaxation while preserving systolic function, a mechanism the company says addresses a core driver of hypertrophic cardiomyopathy (HCM) that current therapies do not fully target.

Edgewise screened over 7,000 candidates to isolate a first-in-class RLC modulator

The company's Chief Scientific Officer, Alan Russell, said Edgewise screened more than 7,000 pharmacologically diverse compounds targeting the Regulatory Light Chain (RLC) before selecting molecules exhibiting positive lusitropic properties without compromising systolic performance. "EDG-7500's diastolic-biased profile has the potential to address a central pathologic driver of both symptomatic obstructive and nonobstructive HCM," Russell said.

SystImmune Wins FDA IND Clearance Using Non-Animal Test Methods

Redmond – September 22, 2026 -- SystImmune Inc. has secured U.S. Food and Drug Administration clearance for its Investigational New Drug application for SI-B037, a bispecific antibody, marking the first time the company has built a regulatory submission entirely on New Approach Methodologies (NAMs) rather than traditional animal toxicology studies.

SystImmune replaces animal testing with human organ-on-chip models

The IND package for SI-B037 relied on human organ-on-chip systems and primary human tissue models instead of conventional animal studies to assess nonclinical safety. Dr. Jahan Khalili, Senior Vice President of Research at SystImmune, said the human-relevant models provided a more direct read on a molecule engineered to engage multiple human pathways simultaneously.

Beactica Starts IND-Enabling Studies for Glioblastoma Drug BEA-17

Uppsala, Sweden – September 22, 2026 -- Beactica Therapeutics AB has initiated IND-enabling studies for BEA-17, a first-in-class oral degrader targeting the epigenetic regulators LSD1 and CoREST, moving the glioblastoma therapy toward first-in-human trials.

Beactica targets a cancer with 15-month median survival and no new treatment in over two decades

Glioblastoma remains the most common and aggressive primary brain tumour, with a median overall survival of approximately 15 months. Standard of care has stayed essentially unchanged for more than 20 years, and immunotherapies successful against other cancers have consistently failed against GBM's immunosuppressive tumour microenvironment.