Covid-19 vaccine news may dominate the headlines in 2021, but a high-profile decision from the FDA is also expected on Biogen's aducanumab, an Alzheimer's disease hopeful. Alexion, Gilead and Regeneron will produce data on potential Covid-19 therapies. Within the EU peer group, key approvals are expected for Argenx and UCB, while 2021 is an important newsflow year for Galapagos.
Biogen's aducanumab may set tone for U.S. Biotech
The FDA's decision on aducanumab for Alzheimer's disease, expected in 1Q, may have significant implications for Biogen's growth prospects as well as affecting how the broader biotech industry is viewed. Updates on Regeneron's Covid-19 antibody cocktail and efforts by Gilead to potentially expand Veklury therapy to Covid-19 outpatients will be closely watched, especially given current virus trends. Regulatory approvals for new drugs at Bluebird, Incyte and Regeneron, among others, are expected and would lead to another batch of virtual pandemic-era launches. Potentially proof-of-concept data from two Vertex programs may rekindle interest in that company's pipeline.
EU Biotech 2021 approvals mostly carry limited risk
Key regulatory catalysts for European biotech in 2021 include the expected approvals of UCB's bimekizumab and Argenx's efgartigimod. Galapagos could win supplemental approval in Europe for Jyseleca in ulcerative colitis, where its efficacy underwhelmed, in our view. Label expansion for Genmab's Darzalex in amyloidosis and for the subcutaneous formulation are anticipated, with the biotech also likely to benefit from an expected EU win for Novartis' Kesimpta, and the possible launch of Seagen's tisotumab vedotin. EU approval for Cabometyx in combination with Opdivo in front-line renal cancer is key for Ipsen.
Morphosys could get the European regulator's nod for Monjuvi, and Merck KGaA for Tepmetko in the U.S. Regulatory risks for Cabometyx, Monjuvi and Tepmetko are low, given they're already approved in other regions.
Plethora of EU clinical news; Onus on Galapagos
Galapagos has several key clinical readouts in 2021, with positive results needed to restore pipeline confidence. These include safety data from the Manta studies, which are imperative for re-filing Jyseleca in the U.S., and readouts for potential game-changer ziritaxestat, and from its Toledo program. Genmab has a wave of early to mid-stage data, with attention particularly on GEN1046. UCB will report results in supplemental indications for bimekizumab and data for rare-disease drugs rozanolixizumab and zilucoplan. All three are key to the UCB's long-term growth prospects, given pending patent expirations. For Argenx, we expect readouts from its cancer pipeline, while data in neurological diseases for Rexulti are the focus of Lundbeck's newsflow. Merck KGaA could report key cancer readouts for bintrafusp alfa and Bavencio.
