CureVac, Nyxoah, and BioNTech with powerful upward momentum

CureVac - Share price soars

The past trading week ended with a bang for the biopharmaceutical company, which specializes in the research and development of drugs based on the messenger molecule mRNA. With a daily gain of 11.33% to USD 3.44, the CureVac share not only went through the EMA 50 like butter on Friday but also broke through the short-term downward trend at USD 2.88 that has been in place since June 2024 on a weekly basis. The next hurdle is the horizontal resistance at USD 3.87, after which the annual high of currently USD 5.28 beckons.

At the current congress of the European Society for Medical Oncology (ESMO) in Barcelona, the Tübingen-based company with legal domicile in the Netherlands presented promising initial results from its ongoing Phase 1 study of the cancer vaccine CVGBM. This study is testing a novel messenger ribonucleic acid (mRNA)-based vaccine that has been developed to specifically target glioblastoma, a particularly aggressive form of brain cancer.

The results presented from the first part of the study include data on the safety and tolerability of the vaccine as well as initial findings on immunogenicity in patients treated with doses of 12 to 100 μg. The results are promising: 77% of patients showed a specific T-cell response against cancer antigens after treatment with the CVGBM vaccine alone and subsequent radiochemotherapy. Even more remarkable is that in 84% of these patients, these immune responses were newly induced, despite no measurable T-cell activity against the relevant antigens being detected prior to treatment.

Nyxoah - Textbook development

The Belgian medtech company Nyxoah, which focuses on the treatment of obstructive sleep apnea, or dangerous breathing interruptions during sleep, could also see a strong upward impulse soon, considering the technical chart situation. After a strong upward movement from USD 4.00 to USD 20.00, the shares of the innovator, which is listed on Nasdaq as well as on Euronext, corrected in textbook fashion and has been trading sideways for weeks after returning to the 78.6% Fibonacci retracement level. This is also the horizontal support zone from last year. The relative strength index, RSI, and the trend-following indicator MACD have been forming positive divergences for months, which could result in a sustainable trend reversal and new long-term highs above the USD 20 area.

In line with the technical chart situation, Nyxoah is on the brink of some landmark months that could lift the Company into higher valuation territory. The current market capitalization is EUR 245.01 million. The reason for this is that the Company’s CE-certified product Genio, which has been available in Europe since 2020 and is already used for treatment in ear, nose and throat clinics in the key market Germany, could also be approved in the US by the end of the current year. In Germany alone, over 14 million people suffer from obstructive sleep apnea, although only a quarter of them are diagnosed. In the United States, with 39 million sufferers, there is a much higher sales potential, which is likely to result in a re-evaluation of Nyxoah.

The basis for the submission for FDA approval was the US study "DREAM", which was successfully completed in spring. It enrolled 115 patients who were treated with Genio over a period of 12 months. All primary and secondary endpoints were met, and the results demonstrated a high level of efficacy regardless of the individual sleeping position. On this basis, the fourth module of the approval application was completed in the summer months and submitted to the FDA. According to management, the go-ahead is expected at the end of 2024 if the review is successful. The market launch and commercialization of Genio in the US is already planned for the first quarter of 2025.

BioNTech - Strong rebound

The stock of the moment is Mainz-based biotech company BioNTech, which shot to stock market stardom during the COVID-19 era. After a tough, dry spell - BioNTech shares lost over 80% of their value since their highs in August 2021 and hit a temporary low of USD 76.53 at the beginning of August - they have since staged a recovery rally and have posted a performance of around 60% to USD 123.40.

In recent days, both the upward momentum and the volume of the share have increased significantly. Experts are also waiting for positive statements on several product candidates at the European Society for Medical Oncology. BioNTech plans to present information on various compounds in development, paying particular attention to the antibody BNT327, which will be used to treat various types of cancer.

However, it is likely to be some time before various cancer drugs receive marketing authorization. BioNTech is aiming for the first approval for a cancer drug in 2026, after which annual market approvals in oncology are planned. Meanwhile, the Mainz-based company is suffering increasing losses due to the declining willingness to vaccinate its coronavirus vaccine. The net loss in the first half of the year was minus EUR 1.12 billion.

Due to the announcement of positive study results at the ESMO, CureVac was able to exit its downward trend amid high volumes. BioNTech also aims to shine with positive headlines at this conference. Nyxoah has a good chance of receiving FDA approval for its product Genio by the end of the year.