European listed biotech landscape: 2021 review and outlook for 2022

2022 outlook

Overall, the mood for 2022 was rather optimistic at the end of last year, with an expected rebound of the sector, or at least an outperformance (see the investor interviews by Evaluate, at the end of last year). The new year is not really off for a good start for the bios in the US, but one can hardly say that it will set the tone for the whole year. More generally, several macro factors are to be factored in concerning the stock markets this year, like the sky-high inflation forcing a hawkish monetary policy, the Fed accelerated tapering, as well as the midterm elections in the US at the end of this year. Historically, the midterm years increase the market volatility… but usually there’s no pandemic on top of that. Moreover, it seems that geopolitics was also invited to the list of concerns for 2022.These may also play on the overall market sentiment, as well on the prices of energy, and thus on inflation. Given the usual impact of rates on the tech sector, and thus also on the biotech subsector, it seems one may expect a lot of volatility in 2022 on tech and biotech.

To end on what it would take in 2022 for funds to rotate back to biotech, one may wonder if an increase in M&A activity alone is susceptible to restore a positive sentiment on the sector. Of course, there are the news flow (e.g. it does not help when you see one clinical hold or one CRL/NDA withdrawal every day), the usual deliverables like clinical results or the approvals of new therapies, and the commercial performances, but has the biotech sector everything in its hands at the moment? Perhaps that what biotech investors want to see now is just a “back to normal” situation, potentially more favoring growth stocks than other transient recovery plays. In that case, maybe one should more expect a strong 2023 rather than a strong 2022, at least in the US, which is also what the historical impact of the midterm elections implies. In Europe, one will have to see if Sweden can recover from the hangover of 2021, or if the UK will keep up the pace of the post-Woodford recovery, for a third year in a raw. It also seems that Switzerland can have a particularly good year, so this will also be part of the main items in Europe, in terms of regional trends to follow.

Selected key events in 2022

A selection of 35 key clinical readouts for 2022 are listed below. The timelines are obviously not guaranteed. The list is not comprehensive (data to our best knowledge, at the date of publication of this post).

Date *Product CandidtaeIndicationCompanyClinical Event
10/01/2022ensovibepCOVID-19/SARS-CoV-2 Infection (Mild; Moderate; Ambulatory)Molecular Partnerspositive topline in Phase 2b (part of ph2b/3)
14/01/2022DonestaVMS; Hot FlushesMithra Pharma.1 positive (4/4 co-primary endpoints reached) & 1 negative (3/4 co-primary endpoints reached) Phase 3
early'22SNG001Pneumonia (linked to COVID-19/SARS-CoV-2 Infection; Hospitalized; Not Under Mech. Vent.)SynairgenPhase 3 topline
Q1'22ABX464UC (Maintenance)ABIVAXPhase 2b topline
Q1'22efgartigimodMyasthenia Gravis (generalized)argenxbridging phase 3 of SC-ENHANZE formulation vs IV
Q1'22SarconeosPneumonia (linked to COVID-19/SARS-CoV-2 Infection; Hospitalized; Not Under Mech. Vent.)BiophytisPhase 3 topline (phase 3 part of ph2/3)
end Q1'22temelimabMS (Relapsing/Remitting)GeNeuroPhase 2b topline, IIS by Karolinska Instituet
H1'22C21Pneumonia (linked to COVID-19/SARS-CoV-2 Infection; Hospitalized; Not Under Mech. Vent.)Vicore PharmaPhase 3 topline
Q2'22efgartigimodITP (Primary)argenxPhase 3 topline
Q2'22firibastatHBP; Hypertension ("Difficult-to-treat" Pts)Quantum GenomicsPhase 3 topline
H1'22Mangoral (Orviglance)Liver Mets (Pts w/ Reduced Renal Functions)Ascelia PharmaPhase 3 topline
H1'22arfolitixorin (Modufolin)CRC (1L; Adv.; Metastatic)Isofol MedicalPhase 3 topline
mid'22LYS-SAF302MPS (Type III-A); SanFilippo ALysogenePhase 3 topline (phase 3 part of ph2/3)
mid'22FYB202; Stelara biosimilarPsoriasis (Moderate; Severe)FormyconPhase 1/3-bioequivalence topline
mid'22aprocitentanHBP; Hypertension (Resistant)IdorsiaPhase 3 topline
pot. mid'22masitinibPneumonia (linked to COVID-19/SARS-CoV-2 Infection; Mild-Moderate Outpts; Hospitalized But Not Under Mech. Vent.)AB SciencePhase 2 topline
mid'22/Q3'22lecanemabAD (Early; MCI; Mild Dementia)BioArcticPhase 3 topline (by partners Eisai/Biogen)
Q3'22PXL-065NASHPoxelPhase 2b topline
Q3'22BI 456906Obesity; T2DZealand PharmaP2b topline (by partner BI)
Q3'22glepaglutideShort Bowel SyndromeZealand PharmaPhase 3 topline
H2'22mesdopetamPD-LIDIRLAB TherapeuticsPhase 2b/3 topline
H2'22OSE-127UC (Moderate; Severe)OSE Immunother.Phase 2 topline
H2'22gantenerumabAD (Early; Prodromal; Mild)Morphosystopline data of 2x phase 3 (by partner Roche)
H2'22felzartamabMembranous Nephropathy (Anti-PLA2R Antibody Positive); aMNMorphosysP1b/2a topline
H2'22felzartamabMembranous Nephropathy (Anti-PLA2R Ab-Pos)MorphosysPhase 2a topline
H2'22BetalutinFL (3L)Nordic Nanovector(registrational) Phase 2b topline
Q4'22efgartigimodPemphigus Vulgaris; Pemphigus FoliaceusargenxPhase 3 topline
Q4'22PXL 770; PXL-065AMN/ALS (X-linked)Poxeltopline data of 2x Phase 2a - pick the winner (between PXL 770 & 065)
Q4'22felzartamabIgANMorphosysPhase 2a topline
Q4'22evenamideSchizophrenia (Pts w/ Worsening of Psychosis on Atypical Antipsychotics)Newron Pharma.Phase 3 topline
end Q4'22Dipraglurant-IRPD-LIDAddex TherapeuticsPhase 2b/3 topline
YE'22clazosentan (PIVLAZ)Vasospasm (Associated with aSAH)IdorsiaPhase 3 topline
pot. H2'22Dasiglucagon DHPT1DZealand PharmaPhase 3 topline (by partner Beta Bionics)
pot. YE'22 (delay likely?)IBP-9414Necrotizing Enterocolitis (Preterm Infants; 500-1500g at Birth); NECInfant Bacterial Ther.Phase 3 topline
pot. YE'22vafidemstatAgressivity (BPD)Oryzon GenomicsPhase 2b topline
* Timings might differ materially from those planned as of today.

Finally, you can find below a selected list of key approvals expected in 2022 in the main territories. The same warnings as above apply.

Date *ProductIndication(s)CompanyApplicantTerritory
10/01/2022 (Approved)daridorexant (QUVIVIQ)InsomniaIdorsiaIdorsiaUS
20/01/2022 (Approved)efgartigimod (VYVGART)Myasthenia Gravis (generalized)argenxargenxJP
20/01/2022 (Approved)clazosentan (PIVLAZ)Vasospasm (Associated with aSAH)IdorsiaIdorsiaJP
March'22AP101 (FILSUVEZ)Epidermolysis BullosaAmryt PharmaAmryt PharmaEU
28/02/2022AP101 (FILSUVEZ)Epidermolysis BullosaAmryt PharmaAmryt PharmaUS
Q1'22daridorexant (QUVIVIQ)InsomniaIdorsiaIdorsiaEU
Q1'22VLA 2001SARS-CoV-2 Infection (Prophylactic Vaccine)ValnevaValnevaEU
Q1'22filgotinib (Jyseleca)UC (Moderate; Severe)GalapagosGileadJP
Q1'22Nefecon (Tarpeyo)IgANCalliditas Ther.Calliditas Ther.EU
Q2'22melflufen (PEPAXTO)MM (Relapsed; Refractory; Later Lines)OncopeptidesOncopeptidesEU
Q2'22octreotide (MYCAPSSA)Acromegaly (Maintenance)Amryt PharmaChiasmaEU
Q2'22FYB201; Lucentis biosimilarARMD (Wet)FormyconBioeq IPEU
Q2'22efgartigimod (VYVGART)Myasthenia Gravis (generalized)argenxargenxEU
Q3'22mdc-IRM; TV-46000Schizophrenia (Maintenance)MedinCellTevaUS
Q3'22FYB201; Lucentis biosimilarARMD (Wet)FormyconBioeq IPUS
Q3'22linzagolix (Yselty)Uterine Fibroids; Heavy Menstrual Bleeding (Premenopausal)ObsEvaObsEvaUS
Q3'22Xlucane; Lucentis biosimilarARMD (Wet)XBrane BiopharmaSTADA ArzneimittelEU
Q4'22teclistamabMM (Relapsed; Refractory)GenmabJanssen/JNJUS
Q4'22GS010 (LUMEVOQ)LHON (ND4 gene mutation)GenSight BiologicsGensight BiologicsEU
Q4'22remimazolam (ByFavo)Anesthesia (General)PaionPaionEU
Q4'22Dasynoc; HyNap-Dasa 505(b)(2)CMLXSpray PharmaXSpray PharmaUS
* Timings might differ materially from those planned as of today.

Disclosure: This post is not a market research. Bertrand Delsuc, publishing director on, discloses owning shares in some of the companies in this post, at the time of the publication. This article mainly includes factual data, but some comments might be subjective. These personal views are those from the owner's only, who declares no other conflict of interest, other than the ownership of shares in some biotech companies (no significant ownership in any companies, no short position).

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