Pharmaceuticals & Biopharmaceuticals

Cambrex Breaks Ground on $120M Iowa Expansion Adding 160,000 Liters

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Cambrex Breaks Ground on $120M Iowa Expansion Adding 160,000 Liters

East Rutherford – October 30, 2026 -- Cambrex has started construction on a $120 million expansion at its Charles City, Iowa, facility, adding 160,000 liters of manufacturing capacity for small molecule active pharmaceutical ingredients (APIs) and synthetic peptides.

Expansion lifts Charles City capacity by about 25% to nearly one million liters

The contract development and manufacturing organization (CDMO) expects to complete the project in the fourth quarter of 2028. The added volume raises the site's total capacity by approximately 25%, to nearly one million liters.

Cambrex held a groundbreaking ceremony on October 29 with company leaders, employees, state and local officials and members of the Charles City community. The start of construction coincides with the site's 100th anniversary.

FDA Clears Sun Pharma's ILUMYA for Psoriatic Arthritis in Adults

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FDA Clears Sun Pharma's ILUMYA for Psoriatic Arthritis in Adults

Mumbai – October 30, 2026 -- The U.S. Food and Drug Administration has approved Sun Pharma's supplemental Biologics License Application for ILUMYA (tildrakizumab-asmn) in adults with active psoriatic arthritis (PsA), the first expansion of the IL-23 inhibitor beyond plaque psoriasis since its 2018 U.S. approval.

Approval addresses a U.S. patient pool of about 2.4 million

Approximately 2.4 million Americans live with PsA, according to Sun Pharma. The company states that roughly 1 in 3 people with psoriasis also have PsA, and that more than 15% of psoriasis patients may have undiagnosed PsA.

ILUMYA was previously cleared only for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Avid Bioservices Wins Tustin Life Sciences Manufacturing Award

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Avid Bioservices Wins Tustin Life Sciences Manufacturing Award

Tustin – October 30, 2026 -- Avid Bioservices, a U.S. mid-scale biologics contract development and manufacturing organization (CDMO), has received the City of Tustin's Business Recognition Award in the Industrial & Manufacturing – Life Sciences category.

Tustin council member presents award to Avid CEO Kenneth Bilenberg in October 2026

Council Member Ryan Gallagher presented the award to Bilenberg, Group President and CEO of Avid, in the city where the company was founded. Avid describes the recognition as affirmation of its role in strengthening domestic biologics supply and setting the standard for flexible capacity.

Avid's local teams advance biologics from process development through commercial supply. The company provides integrated cell line development, process development, analytical development and CGMP manufacturing, from DNA to IND through commercial supply.

Amgen to Report Q3 2026 Results on November 3 After Market Close

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Amgen to Report Q3 2026 Results on November 3 After Market Close

Thousand Oaks – – October 29, 2026 -- Amgen (NASDAQ:AMGN) will report its third quarter 2026 financial results on Tuesday, November 3, 2026, after the close of U.S. financial markets.

Amgen schedules investor call for 4:30 p.m. ET with CEO Bradway

The earnings release will be followed by a conference call with the investment community at 4:30 p.m. ET. Robert A. Bradway, chairman and chief executive officer, will participate alongside other members of Amgen's senior management team.

Amgen streams the call live and archives the webcast for at least 90 days

Live audio of the call will be broadcast over the internet and is open to news media, investors and the general public. The webcast is available through the Investors section of Amgen's website, where the Investor Relations Events Calendar lists presentation times, webcast availability and links.

Astrosalva Launches With Unravel as Founding Partner for Rare Brain Diseases

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Astrosalva Launches With Unravel as Founding Partner for Rare Brain Diseases

SAN MATEO – October 29, 2026 -- Astrosalva Therapeutics, a privately held preclinical biotech, has launched with Unravel Biosciences as its founding development partner to pursue treatments for Alexander disease and the cerebral form of adrenoleukodystrophy (cALD). Unravel co-founder and CEO Richard Novak, PhD, has joined Astrosalva's board of directors.

Astrosalva widens its focus from Alexander disease to cALD

Both conditions are rare genetic diseases affecting the brain's white matter. In children, cALD can progress rapidly and often leads to total disability within a few years. MedlinePlus puts the prevalence of X-linked adrenoleukodystrophy, the genetic condition behind cALD, at 1 in 15,000 people worldwide. Ionis Pharmaceuticals estimates that Alexander disease affects about 1 in 1 to 3 million people worldwide.

Kazia CEO to Present at Guggenheim Healthcare Conference Nov. 9

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Kazia CEO to Present at Guggenheim Healthcare Conference Nov. 9

SYDNEY – October 29, 2026 -- Kazia Therapeutics (NASDAQ: KZIA) will put its CEO and its head of corporate strategy in front of investors at the Guggenheim 3rd Annual Healthcare Innovation Conference in Boston on November 9, 2026, at 8:30 a.m. EST.

Fireside chat features CEO John Friend and strategy head Jeffrey Kraws

John Friend, MD, Chief Executive Officer, and Jeffrey Kraws, Head of Corporate Strategy & Development, will take part in a fireside chat on the conference's opening day. The conference runs November 9 to 11, 2026, in Boston, Massachusetts. A live webcast of the session will be available.

Paxalisib carries multiple FDA designations across brain tumor indications

Kazia's lead asset, paxalisib, is an investigational oral, brain-penetrant dual PI3K/mTOR inhibitor. It is in development for central nervous system cancers, advanced breast cancer and colorectal cancer. In the U.S., it holds the following FDA designations:

HERVolution Data: HERV-K Expressed Across 43 Cancer Types

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HERVolution Data: HERV-K Expressed Across 43 Cancer Types

COPENHAGEN – October 29, 2026 -- HERVolution Therapeutics ApS published peer-reviewed data in the Journal of Translational Medicine showing HERV-K expression across the majority of 43 cancer types in RNA sequencing data from 1,353 patients, backing the target rationale for its lead program, IPT-001.

HERV-K expression spans nearly all cancer types examined

The analysis used data from the Copenhagen Prospective Personalized Oncology study (CoPPO, NCT02290522), which enrolled patients with advanced, predominantly pre-treated cancer. Most patients showed more than 100 HML-2 reads per million total reads across the 43 cancer types, cancers of unknown primary and unclassified tumors. The authors say this extends earlier indication-specific reports.

TransCode Launches Strategic Review of Oncology Portfolio

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TransCode Launches Strategic Review of Oncology Portfolio

BOSTON – October 29, 2026 -- TransCode Therapeutics (Nasdaq: RNAZ) has opened a formal strategic process that could end in a sale or licensing of its oncology assets, a partnership or a business combination, with lead candidate TTX-MC138 now in Phase 2a development.

Tungsten Advisors to run the process as exclusive financial advisor

The Board of Directors initiated the review to maximize the value of the company and its oncology portfolio. Options include licensing or selling individual assets, development and commercialization partnerships, portfolio transactions and business combinations. TransCode has engaged Tungsten Advisors as exclusive strategic financial advisor.

CEO and Chairman Philippe P. Calais said the process is meant to support continued development of TTX-MC138 while seeking to maximize value for stockholders.

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.