Germany-based Affimed NV has closed its previously announced offering of shares on the US Nasdaq market following the full exercise by underwriters of their option to purchase additional stock. A total of 13.8 million shares were sold at $2.50 per share raising $34.5 million. The closing was announced on 13 November.
The first vaccine for the active immunisation of individuals at risk of infection from the Ebola virus has been cleared by the World Health Organization for procurement by the United Nations and included in a stockpile for use in countries affected by the disease. These countries include the Democratic Republic of Congo where a public health emergency has been declared by the WHO.
Buoyed by strong demand for its drug discovery services, Evotec SE expects both revenue and profit to increase by 15% this year while spending on research and development rises. In a conference call with analysts on 12 November, Werner Lanthaler, the chief executive, said the forecast reflected a strong order book extending well into 2020.
In the first nine months, revenue rose by 16% to €321.4 million and adjusted earnings before interest, taxes, depreciation and amortisations (EBITDA) was up by 36% at €93.2 million.
H. Lundbeck A/S ended the first nine months of 2019 with two acquisitions under its belt and an increase in revenue from four key medicines for neurological disorders. Total revenue for the period was DKK 12.6 billion (€1.7 billion) of which 53% was attributed to the four medicines. However group revenue was down by 9% from a year earlier due to loss of patent protection for Onfi, a treatment for Lennox-Gastaut syndrome. Onfi lost exclusivity in 2018 and sales of the product were DKK 840 million, a decline of 69%.
A new drug for anaemia in patients with beta thalassaemia, a rare blood disorder, has been approved for marketing in the US following clinical testing which showed that patients receiving the treatment needed fewer blood transfusions than those on a placebo. The drug, Reblozyl (luspatercept-aamt), was authorised by the Food and Drug Administration on 8 November.
Germany-based Affimed NV has priced its previously announced US offering of 12 million shares at $2.50 per common share. After deducting underwriting discounts, the net proceeds are expected to be about $28.2 million. The offering is expected to close on or about 13 November.
Based in Heidelberg, Affimed is a clinical-stage company with three ongoing trials in lymphoma. On 7 November, it announced US Food and Drug Administration approval for the start of a fourth trial in patients with advanced cancers expressing the epidermal growth factor receptor (EGFR).
A new UK-based company has been launched to explore the dark matter of the genome with the goal of identifying antigens for the development of off-the-shelf cancer vaccines and T cell receptor based immunotherapies. Ervaxx Ltd was founded on original research by scientists at the Francis Crick Institute in London and launched on 6 November with $17.5 million in seed and Series A funding from SV Health Investors and an undisclosed global pharmaceutical company.
The US Food and Drug Administration has approved a new diagnostic capable of detecting antiretroviral drug resistance mutations in people living with the human immunodeficiency virus (HIV) Type 1. The test is able to detect mutations from a simple blood test that uses next generation sequencing to identify the genetic alterations.
The immunosuppressant Cosentyx (secukinumab) narrowly missed statistical significance for superiority in a head-to-head trial against Humira in patients with active psoriatic arthritis, Novartis announced on 1 November. The 52-week trial, called EXCEED, evaluated the two drugs in more than 800 patients who were naïve to a biologic therapy.
Novo Nordisk A/S has raised its sales forecast for 2019 following the strong performance of its glucagon-like peptide-1 (GLP-1) analog, Ozempic (semaglutide) for diabetes in the first nine months of the year. Group sales are expected to increase by 5% to 6% at constant exchange rates compared with earlier expectations for a rise of 4% to 6%. In the first nine months, Ozempic sales reached DKK 6.9 billion (€920 million), bringing its US market share for patients starting a drug for the first time up to 37%.