In this Week 40 edition of the Monday Pharma Briefing, we cover the latest pharma and biotech updates. Key highlights include MoonLake’s Phase Three hidradenitis suppurativa results, Novartis’ ESMO oncology data preview, and CRISPR’s first patient dosed in a European trial. Additional news includes milestones from AC Immune, Basilea, Roche, Synendos Therapeutics, Mainz Biomed, Santhera, and more.

MoonLake Immunotherapeutics has announced results from its VELA Phase Three trials evaluating the nanobody sonelokimab in patients with moderate to severe hidradenitis suppurativa. The company reported that the trials met their primary endpoints at week sixteen, demonstrating statistically significant improvements in clinical response. However, while both VELA One and VELA Two showed promising outcomes overall, one of the two study arms did not reach statistical significance individually. The trials included over five hundred patients and will continue through a fifty-two-week treatment period.

Moving to oncology developments, Novartis has confirmed it will present thirty-four abstracts at the upcoming European Society for Medical Oncology Congress in twenty twenty-five. Key highlights will include new data for Pluvicto in metastatic castration-resistant prostate cancer, as well as updated results for Kisqali in early-stage hormone receptor-positive, HER2-negative breast cancer. The presentations reflect Novartis’ focus on delivering transformative treatment options across multiple advanced cancer indications.

Addex Therapeutics has announced it will release its financial results for the first half and second quarter of twenty twenty-five on Tuesday, September thirtieth. The company will also host a conference call the following day, Wednesday, October first, to discuss the results and provide operational updates.

Numab Therapeutics has achieved a development milestone under its collaboration agreement with Boehringer Ingelheim. This achievement triggers a milestone payment from Boehringer, although the amount was not disclosed. The partnership focuses on the development of multi-specific antibodies for use in immuno-oncology and other therapeutic areas, supporting Numab’s broader biologics platform strategy.

In Alzheimer’s research, AC Immune has published peer-reviewed results from its Phase One B and Phase Two A trial of an anti-phospho tau active immunotherapy. The data, now available in the journal eBioMedicine, highlight a favorable safety profile and evidence of immune response. The vaccine is designed to target abnormal tau proteins associated with the progression of Alzheimer’s disease.

Basilea Pharmaceutica has been awarded a major contract by the Biomedical Advanced Research and Development Authority, or BARDA, to support the late-stage development of its novel oral antibiotic ceftibuten-ledaborbactam. The agreement provides for up to one hundred fifty-nine million dollars in funding, which will support Phase Three clinical trials and regulatory activities.

In the field of nuclear medicine, ITM Isotope Technologies Munich has signed a supply agreement with TerThera for the medical radioisotope terbium one sixty-one. The deal aims to support the availability of targeted radiopharmaceuticals used in precision oncology. Terbium one sixty-one is considered a promising isotope for therapeutic applications due to its dual emission profile.

Roche has presented new data at the twenty twenty-five European Committee for Treatment and Research in Multiple Sclerosis, or ECTRIMS, focused on its two key therapies, OCREVUS and fenebrutinib. The data span broad patient populations across various forms of multiple sclerosis, including relapsing and primary progressive types. Findings highlight long-term efficacy and safety of OCREVUS, along with promising early results for the investigational Bruton’s tyrosine kinase inhibitor fenebrutinib.

Synendos Therapeutics has reported positive topline results from its Phase One trials of SYT-five-ten, a first-in-class endocannabinoid system modulator aimed at mental health disorders. The compound demonstrated favorable safety and pharmacokinetic profiles, supporting advancement to Phase Two studies. Synendos is targeting stress-related neuropsychiatric conditions, with plans to initiate further trials in the near future.

Mainz Biomed has launched its colorectal cancer screening test ColoAlert commercially in Switzerland. ColoAlert is a non-invasive, polymerase chain reaction-based diagnostic that detects tumor DNA in stool samples. The Swiss launch marks a key step in the company’s broader European commercial rollout and follows earlier market entries in Germany and select EU countries.

atai Life Sciences, in collaboration with Beckley Psytech, has announced positive data from its Phase Two A study evaluating BPL-zero-zero-three, a fast-acting intranasal formulation of 5-MeO-DMT. The study demonstrated improved clinical outcomes using a two-dose induction regimen in patients with treatment-resistant depression.

Santhera Pharmaceuticals has reported financial results for the first half of twenty twenty-five, with total revenue reaching twenty-one point six million Swiss francs. The performance was driven primarily by sales of AGAMREE, its recently approved therapy for Duchenne muscular dystrophy. Santhera also provided updates on regulatory activities and commercialization plans in Europe and the United States.

CRISPR Therapeutics, in partnership with Sirius Therapeutics, has dosed the first patient in its Phase Two clinical trial of SRSD-one-zero-seven in Europe. The investigational therapy is a long-acting small interfering RNA that targets Factor Eleven to prevent venous thromboembolism in patients undergoing knee replacement surgery. The trial is designed to evaluate both safety and efficacy compared to standard anticoagulant therapies.

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