Daily Snap - 29. August 2025

Author

Joachim Eeckhout
August 29, 2025

Good morning! On Tuesday, we told you how the LB Pharmaceuticals IPO could signal a revival of the public biotech market this year. Now, German generic drug manufacturer Stada is also considering an IPO this year, which could be a significant event. Acquired in 2017 for €5.32B by equity firms Bain Capital and Cinven, the company recently reported 6% year-on-year revenue growth, launched a biosimilar to J&J’s immunology blockbuster Stelara, and also signed 50 new business development and licensing deals. One thing is sure: we'll be watching this topic closely in the coming months.

Enjoy today’s read!

—Joachim E.

SNIPPETS

What’s happening in biotech today?

🎯Tumor targeting: Akiram Therapeutics has reported progress in its phase 1 clinical trial of AKIR001, a radiopharmaceutical designed to treat aggressive solid tumors, following the successful completion of the first patient cohort without safety concerns. Conducted at Karolinska University Hospital in Stockholm, the trial aims to assess the safety, tolerability, and pharmacokinetics of AKIR001 in patients with hard-to-treat cancers, such as thyroid, head and neck, gynecological, and lung cancers. AKIR001 uses an antibody targeting CD44v6 linked to radioactive lutetium-177 to deliver radiation directly to tumor cells. The trial will now advance to further stages to evaluate dosage and early indicators of efficacy.

🧠ARIA overload: Prothena's anti-amyloid beta antibody PRX012, aimed at treating early symptomatic Alzheimer’s disease, showed a significantly higher rate of amyloid-related imaging abnormalities with edema (ARIA-E) in a phase 1 trial compared to approved drugs like Leqembi and Kisunla, with up to 41.7% of patients affected at higher doses. While PRX012’s subcutaneous monthly dosing is a potential advantage, the elevated ARIA-E risk has led Prothena to deem its safety profile “non-competitive.” The company plans to seek partnerships to continue the development of PRX012 and a preclinical variant, PRX012-TfR, which has shown promise in reducing ARIA risk in animal studies.

🕵️‍♂️SMARCA2 hunter: Plexium, a biotech focused on protein degradation, has raised $60.1M following a period of restructuring and layoffs, marking a new chapter after its standout year in 2022 when it secured deals with Amgen and AbbVie and raised $102 million. The funding will support development of its pipeline, which includes PLX-4545, a CRBN molecular glue degrader shown to safely reprogram regulatory T cells in a phase 1 trial and PLX-61639, a SMARCA2 degrader targeting cancers with SMARCA4 mutations, currently in IND-enabling studies. Despite recent setbacks, including the end of its Amgen partnership, Plexium aims to advance its drug discovery and development efforts.

🚫FDA nope: Outlook Therapeutics suffered a major setback after the FDA issued a second complete response letter rejecting its application for ONS-5010, an ophthalmic formulation of bevacizumab (Avastin) intended for treating wet age-related macular degeneration (AMD). The agency cited insufficient evidence of effectiveness, particularly from the Phase III NORSE EIGHT trial, where ONS-5010 underperformed compared to Roche's Lucentis in visual acuity improvements. Despite no other deficiencies in the biologics license application, the FDA recommended additional confirmatory efficacy data. This follows a previous CRL in 2023 and adds to the company’s financial pressures, though the product has recently launched in Europe as Lytenava.

👎PSP flop: Amylyx Pharmaceuticals has discontinued its Phase IIb ORION trial evaluating AMX0035 for progressive supranuclear palsy (PSP) after the drug failed to show a difference from placebo in both primary and secondary endpoints. The oral therapy, a combination of sodium phenylbutyrate and taurursodiol, was intended to slow disease progression over a year, but interim 24-week data showed no measurable benefit, prompting the company to halt further development, including a planned Phase III trial. Despite previous approval for ALS, AMX0035 has since been withdrawn due to a lack of efficacy. Amylyx will now focus on other programs, including the Phase III LUCIDITY trial for avexitide in post-bariatric hypoglycaemia.

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