Pharmaceuticals & Biopharmaceuticals

Ascletis' Oral GLP-1 ASC30 Cuts HbA1c 1.7% in Phase II Diabetes Trial

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Ascletis' Oral GLP-1 ASC30 Cuts HbA1c 1.7% in Phase II Diabetes Trial

HONG KONG – October 29, 2026 -- Ascletis Pharma (HKEX: 1672) reported that its oral small molecule GLP-1 receptor agonist ASC30 cut HbA1c by a placebo-adjusted 1.7% at the 40 mg dose, 1.6% at 60 mg and 1.7% at 80 mg in a U.S. Phase II study in type 2 diabetes. The 13-week trial (NCT07321678) met its primary endpoint and all secondary endpoints, the company said.

ASC30 delivers placebo-adjusted weight loss of up to 4.4% with no plateau

Placebo-adjusted body weight reductions at 13 weeks were 4.4% (40 mg, n=20), 3.8% (60 mg, n=29) and 4.0% (80 mg, n=28). No weight plateau was observed. Baseline average body weight was 93.7 kg. The weight results were statistically significant versus placebo (p = 0.001 to 0.003).

Sobi's Pozdeutinurad Hits Phase 3 Gout Endpoint, 69.2% Reach Target

STOCKHOLM – October 29, 2026 -- Sobi's investigational gout drug pozdeutinurad (AR882) met the primary endpoint of the Phase 3 REDUCE-2 study, with 69.2% of patients on the 75 mg dose reaching serum urate (SU) below 6 mg/dL at month 6, against 8.1% on placebo. The company is presenting the late-breaking data at ACR Convergence 2026.

Both pozdeutinurad doses beat placebo on the primary endpoint at month 6

REDUCE-2 randomised 811 gout patients to pozdeutinurad 75 mg, pozdeutinurad 50 mg or placebo. In the 50 mg arm, 56.6% of patients achieved SU below 6 mg/dL at month 6. Both doses were significant versus placebo (p<0.0001).

Pozdeutinurad is a once-daily oral, highly selective URAT1 inhibitor. Sobi is developing it for uncontrolled gout, defined as SU above 6 mg/dL with persistent flares and/or tophi despite oral urate-lowering therapy.

Amphastar to Report Q3 2026 Results After Close on November 5

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Amphastar to Report Q3 2026 Results After Close on November 5

RANCHO CUCAMONGA – October 29, 2026 -- Amphastar Pharmaceuticals (NASDAQ: AMPH) will publish results for the third quarter ended September 30, 2026, after the market closes on Thursday, November 5, 2026.

Amphastar schedules a 2:00 p.m. Pacific call to discuss the quarter

Management will hold a conference call at 2:00 p.m. Pacific Time on the same day. Participants can dial 877-407-0989 toll-free or 201-389-0921 from outside the United States, ten minutes before the start. A webcast of the call will run on the Investors page of the company website, and a replay will be posted within 24 hours of the call's end.

BAQSIMI sales sustainability is a named risk factor

In its forward-looking statements, Amphastar states there is no guarantee that its sales strategies will succeed or that it will continue to see significant sales of BAQSIMI. The company's trademarked portfolio also includes Primatene MIST, Amphadase and Cortrosyn.

Genedata Launches Platform-Native ELN for Biopharma R&D

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Genedata Launches Platform-Native ELN for Biopharma R&D

Basel – October 29, 2026 -- Genedata, a Danaher company, launched an electronic lab notebook (ELN) built natively into its biopharma R&D software platform, replacing standalone notebook tools with a single scientific record spanning discovery and development.

Genedata embeds the ELN in its existing platform data model

The ELN links directly to molecules, samples, process parameters, and assay and analytics results already managed in the platform. This cuts manual data transfers and inconsistencies between applications. It supports workflows for biologics and complex modalities including ADCs, bispecifics, cell and gene therapies, and peptides.

Experiment documentation stays tied to a candidate's full development history. That history runs from design and molecular biology through screening, engineering, expression, purification, and analytics to upstream and downstream process development, formulation, and analytical development.

HDF Awards $2M to Two Huntington's Disease Research Teams

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HDF Awards $2M to Two Huntington's Disease Research Teams

NEW YORK – October 29, 2026 -- The Huntington's Disease Foundation (HDF) has awarded $2 million across two 2026 Transformative Research Awards (TRAs), giving $1 million each to teams targeting the toxic huntingtin protein behind Huntington's disease (HD).

HDF typically funds one TRA a year. CEO Meghan Donaldson said the "extraordinary potential" of both proposals warranted funding each. The foundation attributes the expanded round to new major donors.

Harding team pursues small molecules to clear huntingtin

Dr. Rachel Harding of the Structural Genomics Consortium and the University of Toronto leads one funded collaboration. Her project, "Structure-Guided Development of Small Molecule Therapeutics Targeting the Huntingtin Protein," builds on a small molecule that binds directly and selectively to huntingtin.

Cadrenal Targets $1B CSA-AKI Market With 12-LOX Drug CAD-1005

PONTE VEDRA, Fla. – October 29, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) is seeking out-licensing or co-development partners for CAD-1005, a 12-LOX inhibitor it describes as Phase 3-ready, after a competitor's late-stage trial in cardiac surgery-associated acute kidney injury (CSA-AKI) was discontinued for lack of efficacy.

Cadrenal extends CAD-1005 from HIT to a $1 billion-plus U.S. CSA-AKI market

The company is consolidating its Cardiac Acute Critical Care franchise around a dual-indication plan. CAD-1005 will be developed for heparin-induced thrombocytopenia (HIT) and for CSA-AKI, which Cadrenal sizes at more than $1 billion in the U.S. It claims first-in-class positioning in CSA-AKI following the competitor's Phase 3 discontinuation. The source does not name the competitor or the failed mechanism.

Cadrenal Seeks Partners for 3 Cardiac Assets as Cash Lasts to Q1 2027

PONTE VEDRA – October 29, 2026 -- Cadrenal Therapeutics (Nasdaq: CVKD) has launched a structured partnering process for three cardiovascular assets while holding about $4.2 million in cash, enough to fund operations only through the first quarter of 2027.

The company is exploring development, licensing and commercialization deals for CAD-1005, frunexian and tecarfarin. It is pursuing out-licensing, portfolio monetization and commercial co-development rather than funding large late-stage trials on its own. Cadrenal said it will not start a clinical trial unless funding to complete that trial is in place.

Second-quarter net loss narrows to $3.3 million on lower R&D spending

Research and development expenses fell to $0.7 million in the quarter ended June 30, 2026, from $1.1 million a year earlier. General and administrative expenses were $2.6 million, against $2.7 million in the prior-year period.

Nektar Sets Nov. 12 Date for Q3 2026 Earnings and Investor Call

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Nektar Sets Nov. 12 Date for Q3 2026 Earnings and Investor Call

SAN FRANCISCO – October 29, 2026 -- Nektar Therapeutics (Nasdaq: NKTR) will report third-quarter 2026 financial results for the period ended September 30 on Thursday, November 12, 2026, after U.S. markets close.

CEO Howard Robin to host 5:00 p.m. ET results call

President and Chief Executive Officer Howard Robin will lead a conference call at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to review the quarter.

Lead candidate REZPEG is being evaluated in three indications

Nektar describes itself as a clinical-stage biotechnology company focused on the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Its lead candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a first-in-class regulatory T cell stimulator being evaluated in atopic dermatitis, alopecia areata and Type 1 diabetes mellitus.

EVERSANA Acquires AI-Driven HEOR Firm Estima Scientific

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EVERSANA Acquires AI-Driven HEOR Firm Estima Scientific

Chicago – October 29, 2026 -- EVERSANA has acquired London-based health economics and outcomes research (HEOR) technology company Estima Scientific, adding generative-AI tools for economic modeling, systematic literature reviews and network meta-analysis to its market access offering. Financial terms were not disclosed.

Estima's web-based generative-AI applications integrate proprietary code. Its consulting expertise and software will be folded into EVERSANA's market access and value & evidence solutions. The aim is to help pharmaceutical companies show a drug's clinical and economic value to payers more efficiently and transparently.

Formation Bio Launches $600M Fund to Acquire 10-15 Drug Programs

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Formation Bio Launches $600M Fund to Acquire 10-15 Drug Programs

New York – October 29, 2026 -- Formation Bio, an AI-native pharmaceutical company, has launched the Formation Bio Drug Development Accelerator Fund with $600 million in capital commitments to expand its portfolio of clinical-stage medicines. The company aims to acquire 10-15 drug programs over the next 3-5 years and advance them through key clinical milestones.

Fund draws research foundations, endowments and hospitals as limited partners

The Fund's limited partners include research foundations, institutional endowments, hospitals and philanthropic organizations. Formation Bio acts as general partner through a wholly owned subsidiary and has committed its own capital alongside them. The amount of that commitment was not disclosed.

The Fund exclusively finances the acquisition and development of programs within Formation Bio's portfolio, scaling the company's hub-and-spoke model.