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Biopharmaceuticals

Implantica's RefluxStop Draws Overflow Crowd at U.S. Launch Event

Washington D.C. – September 29, 2026 -- Implantica AG launched its FDA-approved RefluxStop device in the U.S. market at the American Foregut Society (AFS) 2026 Annual Meeting, drawing an over-capacity crowd of more than 120 surgeons and gastroenterologists that forced organizers to turn away additional attendees.

FDA approval opens U.S. market for non-encircling GERD device

Following its recent Premarket Approval (PMA) from the U.S. Food and Drug Administration, RefluxStop entered a U.S. GERD treatment market estimated at 78 million patients. Unlike conventional anti-reflux surgeries that wrap around the esophagus, RefluxStop is designed to restore natural anatomy without encircling the food passageway, aiming to reduce side effects such as dysphagia and inability to belch or vomit.

Lilly's Foundayo Outperforms Oral Semaglutide 25 mg in New Diabetes Data

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Lilly's Foundayo Outperforms Oral Semaglutide 25 mg in New Diabetes Data

Indianapolis – September 29, 2026 -- Eli Lilly and Company (NYSE: LLY) reported that its oral GLP-1 drug Foundayo (orforglipron) at 17.2 mg produced 1.5% greater weight loss and 0.3% greater A1C reduction than oral semaglutide 25 mg over 52 weeks in adults with type 2 diabetes, based on an indirect treatment comparison presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes in Milan.

Indirect analysis draws on ACHIEVE-3 and PIONEER PLUS trial data

The comparison, covariate-adjusted for gender, age, baseline A1C and baseline weight, found weight-loss differences ranging from 1.5% to 2.4% and A1C reductions of 0.3% to 0.6% in favor of Foundayo 17.2 mg across multiple statistical methods. The 95% confidence interval for weight loss was -2.7% to -0.2%, and for A1C reduction was -0.6% to -0.1%.

Arthex Biotech Names Ex-IVERIC bio CEO Glenn Sblendorio Chairman

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Arthex Biotech Names Ex-IVERIC bio CEO Glenn Sblendorio Chairman

Valencia – – September 29, 2026 -- Arthex Biotech has appointed Glenn Sblendorio, former CEO of IVERIC bio, as Chairman of its Board of Directors as the clinical-stage RNA therapeutics company advances its lead program ATX-01 through Phase I/IIa trials for myotonic dystrophy type 1 (DM1).

Sblendorio brings three decades of biotech exit experience to Arthex's board

Sblendorio most recently led IVERIC bio, Inc. as CEO until its acquisition by Astellas Pharma, Inc. He previously served as President and Chief Financial Officer of The Medicines Company through its acquisition by Novartis, and as Executive Vice President and CFO of Eyetech Pharmaceuticals, Inc. until it was acquired by OSI Pharmaceuticals, Inc. Earlier in his career he was a Managing Director at MPM Capital Advisors.

Hengrui Licenses Oral GLP-1/GIP Drug to Novo in $2.6B Deal

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Hengrui Licenses Oral GLP-1/GIP Drug to Novo in $2.6B Deal

Shanghai – – September 29, 2026 -- Hengrui Pharma has licensed its investigational obesity and diabetes drug HRS-1596 to Novo Nordisk in a deal worth up to 2.6 billion US dollars, including a 300 million dollar upfront payment.

Novo secures global rights excluding Greater China

Under the agreement, Novo obtains exclusive rights to develop, manufacture and commercialise HRS-1596 worldwide, excluding the Chinese mainland, Hong Kong SAR, Macao SAR and Taiwan Region. Hengrui Pharma retains eligibility for royalties on net sales of the drug within Novo's licensed territory, on top of the milestone-based payments tied to development, regulatory and commercial targets.

iRegene's NouvSight001 Cleared for RP Trials in US and China

Chengdu, China – September 29, 2026 -- iRegene Therapeutics has secured clinical trial clearances in both China and the United States for NouvSight001, an off-the-shelf cell therapy targeting retinitis pigmentosa (RP), a retinal disease affecting roughly 1.5 million people worldwide.

China's NMPA clears Phase I/III trial while FDA grants Phase I/II clearance with special exemption

China's National Medical Products Administration authorized a Phase I/III trial to assess safety, tolerability and preliminary efficacy of NouvSight001 in RP patients. The U.S. FDA separately cleared a Phase I/II trial for the same indication and granted a special exemption, building on the Orphan Drug Designation the agency awarded the program in 2024.

IASO Bio's In Vivo CAR-T IASO206 Hits 90% Response Rate in Myeloma Trial

Shanghai – September 26, 2026 -- IASO Biotechnology reported a 90% objective response rate and 90% minimal residual disease (MRD) negativity rate for its BCMA-targeted in vivo CAR-T therapy IASO206, generated via a single intravenous infusion without lymphodepleting chemotherapy, in first-in-human Phase 1 data presented as a late-breaking oral session (LBA-11) at the 2026 International Myeloma Society Annual Meeting.

Ascletis' Oral ASC50 Cuts Psoriasis Severity 48.9% in Phase I Trial

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Ascletis' Oral ASC50 Cuts Psoriasis Severity 48.9% in Phase I Trial

Hong Kong – – September 28, 2026 -- Ascletis Pharma Inc. (HKEX: 1672) reported a 48.9% placebo-adjusted reduction in psoriasis area and severity index (PASI) scores from a 28-day U.S. proof-of-concept trial of ASC50, an oral small molecule IL-17A inhibitor positioned as a needle-free alternative to injectable antibody therapies for plaque psoriasis.

Once-daily 200 mg dosing matched published efficacy benchmarks for injectable IL-17A antibody secukinumab

The randomized, double-blind, placebo-controlled Phase I study (NCT07024602) enrolled mild-to-moderate plaque psoriasis patients who received once-daily 200 mg oral ASC50 for 28 days. Ascletis said the PASI reduction was comparable to published secukinumab data, though the comparison was not conducted head-to-head.

Viking Therapeutics Closes Upsized $575M Stock and Convertible Note Offering

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Viking Therapeutics Closes Upsized $575M Stock and Convertible Note Offering

San Diego – September 28, 2026 -- Viking Therapeutics, Inc. (Nasdaq: VKTX) has closed concurrent upsized public offerings totaling approximately $575.0 million in gross proceeds, funding to accelerate its late-stage obesity drug pipeline.

Viking raises $575 million through combined stock and convertible note sale

The clinical-stage biopharmaceutical company sold 9,035,714 shares of common stock at $35.00 per share, alongside $258.75 million in aggregate principal amount of 2.00% convertible senior notes due 2032. Both tranches were upsized after underwriters fully exercised their options, adding 1,178,571 shares to the equity offering and $33.75 million to the note offering.

TJP Acquires Evolution Consulting, Building End-to-End Life Sciences Platform

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TJP Acquires Evolution Consulting, Building End-to-End Life Sciences Platform

Conshohocken, Pa. – September 28, 2026 -- TJP, an independent agency focused on value and patient access for life sciences, has acquired Evolution Consulting & Research, a market research organization serving global pharmaceutical and biotech clients.

Acquisition completes TJP's end-to-end commercial platform for life sciences brands

The deal integrates Research, Strategy, Creative, Pull-Through, and Analytics into a single operating model. It follows TJP's earlier addition of FX2 Virtual, which brought Virtual Sales Professionals, Virtual Key Account Managers, reimbursement specialists, and omnichannel data analytics into the agency's portfolio.

Kye Pharmaceuticals Ranks No. 105 on Canada's Top Growing Companies List

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Kye Pharmaceuticals Ranks No. 105 on Canada's Top Growing Companies List

Mississauga, ON – September 25, 2026 -- Kye Pharmaceuticals ranked No. 105 on Report on Business magazine's 2026 list of Canada's Top Growing Companies, posting three-year revenue growth of 264%.

Kye secures second consecutive year on the Globe and Mail growth ranking

The Mississauga, Ontario-based specialty pharmaceutical company previously appeared on the 2025 edition of the list, marking its second straight year of recognition. The 2026 ranking included 376 companies in total, each qualifying through a voluntary application process and targeted revenue thresholds based on three-year growth performance.