HUTCHMED Announces NMPA Approval for ATLED® (Fanregratinib) for the Treatment of Patients with FGFR2-Fusion/Rearrangement Intrahepatic Cholangiocarcinoma

On August 28, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that the New Drug Application (NDA) for fanregratinib (HMPL-453), a novel, selective, oral inhibitor targeting FGFR 1/2/3, has been granted conditional approval by the China National Medical Products Administration ("NMPA") for the treatment of adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma ("ICC") with fibroblast growth factor receptor ("FGFR") 2 fusion or rearrangement who have previously received systemic therapy. Fanregratinib will be marketed in China under the brand name ATLED.

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ICC is a highly aggressive malignancy arising from the intrahepatic biliary epithelium. It accounts for 8.2-15.0% of primary liver cancers, and consequently it is the second most common type after hepatocellular carcinoma. In recent years, the incidence of ICC has continued to rise, with a 5-year overall survival rate of approximately 9%.[1] Approximately 10-15% of ICC patients globally have tumors harboring FGFR2 fusions or rearrangements.[2],[3]

The approval is supported by data from the Phase II registration cohort of the single-arm, multi-center, open‑label, pivotal Phase II/IIIb clinical trial of ATLED in China (NCT04353375). The results were recently presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2026. The study met its primary endpoint, demonstrating an Independent Review Committee (IRC)-assessed objective response rate (ORR) of 42.5% (95% CI: 30.0%–53.6%) in pretreated advanced ICC patients harboring FGFR2‑fusions/rearrangements, representing a strong, clinically meaningful response.

Key secondary endpoints showed consistent clinical activity and a rapid onset of action, with a median time to response of 1.4 months. Median duration of response (DoR) was 6.9 months (95% CI: 5.6–8.5) and disease control rate (DCR) reached 83.9% (95% CI: 74.5%–90.9%). Furthermore, the median progression-free survival (PFS) was 6.9 months (95% CI: 4.1–8.2), while the median overall survival (OS) was 16.6 months (95% CI: 12.4–16.6).

"As a major and with historically limited targeted options. We are thrilled by the NMPA approval of ATLED, which directly addresses this critical therapeutic gap in China," said Mr Johnny Cheng, Acting Chief Executive Officer and Chief Financial Officer of HUTCHMED. "This approval unlocks an important new treatment alternative for a substantial population of pretreated advanced ICC patients. We are fully prepared to leverage our established commercial infrastructure to bring this precision medicine to patients as rapidly as possible."

The Phase IIIb portion of the trial will serve as the confirmatory study to further validate the clinical benefits and safety of ATLED in this setting. Enrollment for this confirmatory cohort was initiated in January 2026.

About ATLED
ATLED (fanregratinib, HMPL‑453) is a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis and resistance to anti-tumor therapies. Abnormal FGFR gene alterations are believed to be the drivers of tumor cell proliferation in several solid tumor settings. HUTCHMED currently retain all rights to fanregratinib worldwide.

(Press release, Hutchison China MediTech, AUG 28, 2026, View Source [SID1234670387])

Redx Announces Close of Series A Financing of $36 Million and Strengthened Board Composition

On August 27, 2026 Redx Pharma Ltd ("Redx") the clinical-stage, biotechnology company focused on developing novel, small molecule, targeted medicines for fibrotic disease reported completion of its Series A financing of $36 million. The Company is also pleased to confirm a new Board composition, with Andrew Sinclair, Managing Director of Abingworth joining as Investor Director and Bernard Coulie, M.D, joining as an Independent Director.

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The Series A financing was led by Abingworth, with participation from other new investors including British Business Bank1 , as well as the Company’s current major shareholder, Redmile. As detailed in the Company’s joint announcement with Skye Bioscience, Inc. ("Skye") (Nasdaq: SKYE) on 14 August, 2026, this Series A financing was announced as part of a larger financing and transaction between the companies. In connection with the transaction, it is proposed that Skye will acquire the entire issued share capital of Redx via a scheme of arrangement under Part 26 of the U.K. Companies Act 2006 (the "Transaction"). Upon completion of the Transaction, the combined company will be led by Redx’s current management team and Board and plans to operate under the name Fibrx Therapeutics, Inc. and trade on Nasdaq.

The British Business Bank is helping to anchor Redx and its world-class drug discovery and talent to the UK’s leading scientific ecosystem. While the Nasdaq listing will provide access to a deep pool of global capital, the company will retain its UK roots, and its headquarters and research will continue to be led from its base in Alderley Park, Cheshire, the UK’s largest single-site life sciences campus.

The Series A financing, together with the concurrent private placement ("PIPE financing") entered into by Skye with Abingworth, British Business Bank and Redmile, each of whom invested in both the Series A and PIPE financing, as well as a syndicate of new investors, including NEXTBio and 5AM Ventures, will provide the combined company with an aggregate total financing of approximately $125 million in gross proceeds. The proceeds of the financing will support the advancement of Redx’s lead asset, RXC008, a gut-restricted pan-ROCK inhibitor for fibrostenotic Crohn’s disease (FSCD) into a Phase 2 clinical study.

Andrew Sinclair, Managing Director, Abingworth commented: "At Abingworth, we look to back exceptional teams and truly differentiated biology that can fundamentally reshape patient care. Fibrostenotic Crohn’s disease is one of the largest areas of unmet need in IBD. The data generated by Redx with RXC008 to date, suggest that this novel pan-ROCK inhibitor could have a significant impact in mitigating FSCD pathology and we are delighted to partner with the Company and the other members of the investment syndicate to fully explore this drug candidate’s potential."

Charlotte Lawrence, Managing Director and Head of Direct Equity at the British Business Bank, said: "Redx is an example of the pioneering science emerging from North West England. With RXC008, the company has the potential to develop an entirely new category of treatment for a patient population that today has limited options. This investment will support Redx as it advances a potentially transformative treatment, while helping ensure that the company’s innovation, talent and intellectual property remain rooted in the UK."

As a result of the Series A financing closing and following approval by Redx’s shareholders on 14 August 2026, the convertible loan notes issued pursuant to a note purchase agreement entered into on 29 June 2020 and the A1 ordinary shares in Redx were converted into ordinary shares. The convertible bridging loan notes issued on 16 April 2026 were converted into Series A shares. Following the conversion, the current number of Redx shares in issue and the number of total voting rights count is 707,228,330. Redx shareholders should use this number as the denominator for any calculations relating to their holding in Redx.

Changes in Board Composition Reflect Investor Base and Increase Fibrosis Expertise

As the Series A financing has now closed, the following changes to the Redx board of directors (the "Board") have become effective: Andrew Sinclair joins the Board as the Investor Director representing Abingworth, with Natalie Berner of Redmile retaining her seat as an Investor Director. Jeremy Green of Redmile remains as chair of the Board. Claire Catherinet, previously an Investor Director representing Sofinnova, has stepped down from the Board. Bernard Coulie M.D, PhD, the current CEO of Pliant Therapeutics, Inc. joins the Board as an Independent Director, bringing clinical experience as a gastroenterologist together with a wealth of knowledge in clinical development of novel anti-fibrotic therapies. Peter Presland and Dr Bernard Kirschbaum will remain on the Board as Independent Directors, together with Lisa Anson, CEO, who is an Executive Director.

"We are thrilled to have completed this Series A financing and to welcome new investors including Abingworth and British Business Bank as shareholders. We also appreciate the continued strong support from our major shareholder, Redmile. Importantly, the appointment of Bernard Coulie to the Board will provide invaluable clinical and strategic insights as we progress our pipeline of novel anti-fibrotic drug candidates through development" commented Lisa Anson, CEO, Redx. "This financing is an important catalyst for the Company and will allow us to commence our Phase 2 programme for our lead asset, RXC008 for patients living with FSCD, enabling us to drive the next phase of the Company’s growth."

RXC008, A Novel Gut-restricted pan-ROCK Inhibitor

Rho-associated coiled-coil forming protein kinase (ROCK) is well established as an antifibrotic target and is known to consist of two isoforms ROCK 1 and 2. RXC008 is a potent, oral, small molecule non-systemic ROCK1/2 inhibitor that avoids the significant cardiovascular side effects of systemic pan-ROCK inhibitors, including tachycardia and hypotension, by being restricted to the GI-tract via high efflux and low permeability. This results in virtually no systemic breakthrough, with the molecule being rapidly metabolised by paraoxonase enzymes in the plasma should any breakthrough occur. Data from the Phase 1 study showed good tolerability and tissue exposure with no clinically relevant breakthrough or hypotension observed, and a good safety profile with no serious adverse events. RXC008 has an open IND in the US and was granted FDA fast track designation in January 2026. RXC008 is now ready to commence a Phase 2 clinical study, with topline data expected in mid-2028.

About Fibrostenotic Crohn’s Disease (FSCD)

Crohn’s disease affects 1.7m2 people globally and >70,000 new cases are diagnosed each year. More than 50% of patients with Crohn’s disease can develop significant fibrosis and stricture formation within ten years after diagnosis3 ; this fibrosis associated with Crohn’s disease is known as fibrostenotic Crohn’s disease. The current management of fibrotic strictures of the gastrointestinal tract is primarily surgical as no drugs are specifically approved to tackle fibrosis, which can progress despite intervention with current standard of care anti-inflammatory therapies. Once a patient is suffering from FSCD, healthcare costs increase by an additional >$80k4 per patient per year due to additional hospitalizations and treatment versus Crohn’s disease, creating a health economic burden in this area of high unmet need.

(Press release, Redx Pharma, AUG 27, 2026, View Source [SID1234670413])

argenx Completes Acquisition of Forte Biosciences, Inc.

On August 27, 2026 argenx (Euronext & Nasdaq: ARGX), a global immunology innovation company reported the successful completion of the acquisition of Forte Biosciences, Inc. ("Forte") (Nasdaq: FBRX).

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The acquisition expands argenx’s portfolio of differentiated immunology medicines, adding FB102, a first-in-class anti-CD122 antibody with clinical proof-of-concept in vitiligo and celiac disease and potential to address multiple autoimmune diseases. The acquisition reflects argenx’s disciplined approach to identifying and advancing breakthrough science for patients with the potential to redefine standards of care in diseases that have lacked meaningful innovation for decades.

"At argenx, we measure our progress through patient impact, and the Forte acquisition deepens that impact," said Karen Massey, Chief Executive Officer of argenx. "As we advance toward Vision 2030, our ambition is to build a pipeline that extends our reach for patients across immunology. FB102 does exactly that with a potential first-in-class molecule targeting diseases with few treatment options today. This acquisition marks an important step in our long-term strategy to be the leading immunology innovation company."

FB102 complements argenx’s existing portfolio of antibody-based programs, including efgartigimod, empasiprubart, adimanebart, and ARGX-121, as well as several additional early-stage molecules, by adding a mechanism focused on pathogenic T-cell and NK-cell activity, broadening the company’s ability to pursue diseases driven by different dimensions of the immune system.

Transaction details

argenx completed the cash tender offer, through a subsidiary, for all the outstanding shares of common stock of Forte at a purchase price of $77.00 per share, without interest and subject to any applicable tax withholding. As of the tender offer expiration at one minute after 11:59 p.m., Eastern Time, on August 26, 2026, 19,894,879 shares of Forte common stock were validly tendered and not validly withdrawn, representing, together with the shares owned by argenx and its affiliates, approximately 87.13% of the total number of Forte’s issued and outstanding shares of common stock as of such date and time. All such shares have been accepted for payment in accordance with the terms of the tender offer, and argenx, on behalf of its subsidiary, will promptly pay for such shares.

Following the completion of the tender offer, argenx completed the acquisition of Forte through a merger of argenx’s wholly owned subsidiary with and into Forte, with Forte being the surviving corporation, in which all shares of Forte common stock issued and outstanding at the effective time of the merger were converted into the right to receive cash equal to the $77.00 offer price per share, without interest and subject to any applicable tax withholding. At the completion of the merger, Forte became a wholly owned subsidiary of argenx and Forte’s common stock will no longer be listed or traded on the Nasdaq Capital Market.

About FB102

FB102 is a proprietary molecule with potentially broad autoimmune and autoimmune-related applications. In June 2025, Forte announced positive data from the FB102 celiac disease study. A Phase 2 celiac disease study has been initiated with data expected in the second half of 2026. Data from a vitiligo trial were reported in July 2026. A Phase 1b alopecia areata trial is ongoing with data expected in the second half of 2026.

(Press release, argenx, AUG 27, 2026, View Source [SID1234670410])

Alvotech to present at upcoming investor conferences in September

On August 27, 2026 Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, reported that Robert Wessman, Founder and Chairman, and Dr. Balaji V. Prasad, Chief Strategy Officer, will participate in the upcoming investor conferences in September as follows:

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Morgan Stanley 24th Annual Global Healthcare Conference in New York – Fireside chat on Tuesday, September 15, 2026 at 12:20 pm ET (16:20 GMT)
Deutsche Bank’s 2026 Healthcare Summit in New York – Hosting investor meetings on Thursday, September 17, 2026.

A live webcast of the fireside chat will be available to the general public and can be accessed in the Investors Section of Alvotech’s website under Events and Presentations. After the event, a recording will be available for replay for 90 days.

(Press release, Alvotech, AUG 27, 2026, View Source [SID1234670404])

Ernexa Therapeutics Participates in the Virtual Investor "Why Now" On-Demand Conference

On August 27, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported that it participated in the Virtual Investor "Why Now" on-demand conference.

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During the webcast, Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics, presented the Company’s investment thesis and highlighted why he believes now is a pivotal time for Ernexa. The pitch discusses the Company’s planned transition into a clinical-stage biotechnology company, with lead candidate ERNA-101 advancing toward a planned Investigational New Drug (IND) submission and, importantly, the start of its first-in-human Phase 1 clinical study.

The discussion also highlights ERNA-101’s differentiated, off-the-shelf iMSC platform, encouraging preclinical results in ovarian cancer models and the Company’s continued execution across manufacturing, regulatory and clinical activities supporting its advancement into the clinic.

JTC Team and Virtual Investor Co. are paid consultants to Ernexa Therapeutics. JTC Team and Virtual Investor Co. are investor relations and corporate communications firms. Any content included in this release shall not be construed as an offer to purchase securities of Ernexa Therapeutics. Interested parties are responsible for conducting their own due diligence and are encouraged to review the Company’s website and the SEC website for the latest information and filings on the Company.

(Press release, Ernexa Therapeutics, AUG 27, 2026, View Source [SID1234670403])