The picture keeps getting brighter for Argenx SE which, having targeted $750 million in a financing after positive phase II data, priced a global public offering of $1.1 billion, one of history’s larger rounds. Amsterdam-based Argenx capitalized on positive top-line data from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy.
Argenx SE’s top-line results from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy (CIDP) sparked buzz about other developers in the space with similar mechanisms of action to Vyvgart Hytrulo, such as Immunovant Inc.
Raya Therapeutic Inc. has entered into an early-stage R&D collaboration with Argenx SE to evaluate combinations of Raya’s pipeline of targeted small molecules with a potentially complementary product from Argenx.
Adults with generalized myasthenia gravis (gMG) have yet another therapeutic option, this time from UCB SA, with the U.S. FDA’s approval of orphan drug Rystiggo (rozanolixizumab-noli), a humanized IgG4 monoclonal antibody that binds to the neonatal Fc receptor.
The $60.8 billion collected by biopharma companies throughout 2022 is a sharp drop from each of the two prior years, down by 48.6% from 2021 and 54.8% from 2020. Each were standout years by any measure and a direct result of the investment fervor for the industry brought on by the COVID-19 pandemic. That exuberance diminished in the last year as investors tightened their grips due to economic uncertainties.
For European biotechnology, 2022 was a year of contraction. Disclosed equity investments in European firms engaged in the discovery and development of therapeutics totaled $6.782 billion, down 55% on the previous year’s record-breaking tally of $15.193 billion. Last year’s tally is the worst performance since 2017 and is well below the totals achieved during the two years immediately preceding the onset of the COVID-19 pandemic, which triggered a boom in biotech investing.
The first gene therapy to treat severe hemophilia A was among the drugs recommended for European approval by regulators from the EMA’s CHMP at its monthly meeting. Manufactured by Biomarin Pharmaceutical Inc., Roctavian (valoctocogene roxaparvovec) was recommended for conditional marketing authorization in the EU for severe hemophilia A in adults who do not have factor VIII inhibitors and no antibodies to adeno-associated virus serotype 5.
DUBLIN – A strong performance in the final quarter of 2021 pushed equity investment in European biotech firms engaged in discovering and developing therapeutics to a new record of $15.193 billion, a 19.8% increase on last year’s total of $12.682 billion. European biotech firms have now set a new investment benchmark for each of the past five years.
DUBLIN – Agomab Therapeutics NV raised $74 million in a series B round that attracted two heavyweight U.S. crossover investors, Redmile Group, which led the financing, and Cormorant Asset Management.