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 Candidtae | Indication | Company | Clinical Event |
|---|---|---|---|---|
| 10/01/2022 | ensovibep | COVID-19/SARS-CoV-2 Infection (Mild; Moderate; Ambulatory) | Molecular Partners | positive topline in Phase 2b (part of ph2b/3) |
| 14/01/2022 | Donesta | VMS; Hot Flushes | Mithra Pharma. | 1 positive (4/4 co-primary endpoints reached) & 1 negative (3/4 co-primary endpoints reached) Phase 3 |
| early'22 | SNG001 | Pneumonia (linked to COVID-19/SARS-CoV-2 Infection; Hospitalized; Not Under Mech. Vent.) | Synairgen | Phase 3 topline |
| Q1'22 | ABX464 | UC (Maintenance) | ABIVAX | Phase 2b topline |
| Q1'22 | efgartigimod | Myasthenia Gravis (generalized) | argenx | bridging phase 3 of SC-ENHANZE formulation vs IV |
| Q1'22 | Sarconeos | Pneumonia (linked to COVID-19/SARS-CoV-2 Infection; Hospitalized; Not Under Mech. Vent.) | Biophytis | Phase 3 topline (phase 3 part of ph2/3) |
| end Q1'22 | temelimab | MS (Relapsing/Remitting) | GeNeuro | Phase 2b topline, IIS by Karolinska Instituet |
| H1'22 | C21 | Pneumonia (linked to COVID-19/SARS-CoV-2 Infection; Hospitalized; Not Under Mech. Vent.) | Vicore Pharma | Phase 3 topline |
| Q2'22 | efgartigimod | ITP (Primary) | argenx | Phase 3 topline |
| Q2'22 | firibastat | HBP; Hypertension ("Difficult-to-treat" Pts) | Quantum Genomics | Phase 3 topline |
| H1'22 | Mangoral (Orviglance) | Liver Mets (Pts w/ Reduced Renal Functions) | Ascelia Pharma | Phase 3 topline |
| H1'22 | arfolitixorin (Modufolin) | CRC (1L; Adv.; Metastatic) | Isofol Medical | Phase 3 topline |
| mid'22 | LYS-SAF302 | MPS (Type III-A); SanFilippo A | Lysogene | Phase 3 topline (phase 3 part of ph2/3) |
| mid'22 | FYB202; Stelara biosimilar | Psoriasis (Moderate; Severe) | Formycon | Phase 1/3-bioequivalence topline |
| mid'22 | aprocitentan | HBP; Hypertension (Resistant) | Idorsia | Phase 3 topline |
| pot. mid'22 | masitinib | Pneumonia (linked to COVID-19/SARS-CoV-2 Infection; Mild-Moderate Outpts; Hospitalized But Not Under Mech. Vent.) | AB Science | Phase 2 topline |
| mid'22/Q3'22 | lecanemab | AD (Early; MCI; Mild Dementia) | BioArctic | Phase 3 topline (by partners Eisai/Biogen) |
| Q3'22 | PXL-065 | NASH | Poxel | Phase 2b topline |
| Q3'22 | BI 456906 | Obesity; T2D | Zealand Pharma | P2b topline (by partner BI) |
| Q3'22 | glepaglutide | Short Bowel Syndrome | Zealand Pharma | Phase 3 topline |
| H2'22 | mesdopetam | PD-LID | IRLAB Therapeutics | Phase 2b/3 topline |
| H2'22 | OSE-127 | UC (Moderate; Severe) | OSE Immunother. | Phase 2 topline |
| H2'22 | gantenerumab | AD (Early; Prodromal; Mild) | Morphosys | topline data of 2x phase 3 (by partner Roche) |
| H2'22 | felzartamab | Membranous Nephropathy (Anti-PLA2R Antibody Positive); aMN | Morphosys | P1b/2a topline |
| H2'22 | felzartamab | Membranous Nephropathy (Anti-PLA2R Ab-Pos) | Morphosys | Phase 2a topline |
| H2'22 | Betalutin | FL (3L) | Nordic Nanovector | (registrational) Phase 2b topline |
| Q4'22 | efgartigimod | Pemphigus Vulgaris; Pemphigus Foliaceus | argenx | Phase 3 topline |
| Q4'22 | PXL 770; PXL-065 | AMN/ALS (X-linked) | Poxel | topline data of 2x Phase 2a - pick the winner (between PXL 770 & 065) |
| Q4'22 | felzartamab | IgAN | Morphosys | Phase 2a topline |
| Q4'22 | evenamide | Schizophrenia (Pts w/ Worsening of Psychosis on Atypical Antipsychotics) | Newron Pharma. | Phase 3 topline |
| end Q4'22 | Dipraglurant-IR | PD-LID | Addex Therapeutics | Phase 2b/3 topline |
| YE'22 | clazosentan (PIVLAZ) | Vasospasm (Associated with aSAH) | Idorsia | Phase 3 topline |
| pot. H2'22 | Dasiglucagon DHP | T1D | Zealand Pharma | Phase 3 topline (by partner Beta Bionics) |
| pot. YE'22 (delay likely?) | IBP-9414 | Necrotizing Enterocolitis (Preterm Infants; 500-1500g at Birth); NEC | Infant Bacterial Ther. | Phase 3 topline |
| pot. YE'22 | vafidemstat | Agressivity (BPD) | Oryzon Genomics | Phase 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 * | Product | Indication(s) | Company | Applicant | Territory |
|---|---|---|---|---|---|
| 10/01/2022 (Approved) | daridorexant (QUVIVIQ) | Insomnia | Idorsia | Idorsia | US |
| 20/01/2022 (Approved) | efgartigimod (VYVGART) | Myasthenia Gravis (generalized) | argenx | argenx | JP |
| 20/01/2022 (Approved) | clazosentan (PIVLAZ) | Vasospasm (Associated with aSAH) | Idorsia | Idorsia | JP |
| March'22 | AP101 (FILSUVEZ) | Epidermolysis Bullosa | Amryt Pharma | Amryt Pharma | EU |
| 28/02/2022 | AP101 (FILSUVEZ) | Epidermolysis Bullosa | Amryt Pharma | Amryt Pharma | US |
| Q1'22 | daridorexant (QUVIVIQ) | Insomnia | Idorsia | Idorsia | EU |
| Q1'22 | VLA 2001 | SARS-CoV-2 Infection (Prophylactic Vaccine) | Valneva | Valneva | EU |
| Q1'22 | filgotinib (Jyseleca) | UC (Moderate; Severe) | Galapagos | Gilead | JP |
| Q1'22 | Nefecon (Tarpeyo) | IgAN | Calliditas Ther. | Calliditas Ther. | EU |
| Q2'22 | melflufen (PEPAXTO) | MM (Relapsed; Refractory; Later Lines) | Oncopeptides | Oncopeptides | EU |
| Q2'22 | octreotide (MYCAPSSA) | Acromegaly (Maintenance) | Amryt Pharma | Chiasma | EU |
| Q2'22 | FYB201; Lucentis biosimilar | ARMD (Wet) | Formycon | Bioeq IP | EU |
| Q2'22 | efgartigimod (VYVGART) | Myasthenia Gravis (generalized) | argenx | argenx | EU |
| Q3'22 | mdc-IRM; TV-46000 | Schizophrenia (Maintenance) | MedinCell | Teva | US |
| Q3'22 | FYB201; Lucentis biosimilar | ARMD (Wet) | Formycon | Bioeq IP | US |
| Q3'22 | linzagolix (Yselty) | Uterine Fibroids; Heavy Menstrual Bleeding (Premenopausal) | ObsEva | ObsEva | US |
| Q3'22 | Xlucane; Lucentis biosimilar | ARMD (Wet) | XBrane Biopharma | STADA Arzneimittel | EU |
| Q4'22 | teclistamab | MM (Relapsed; Refractory) | Genmab | Janssen/JNJ | US |
| Q4'22 | GS010 (LUMEVOQ) | LHON (ND4 gene mutation) | GenSight Biologics | Gensight Biologics | EU |
| Q4'22 | remimazolam (ByFavo) | Anesthesia (General) | Paion | Paion | EU |
| Q4'22 | Dasynoc; HyNap-Dasa 505(b)(2) | CML | XSpray Pharma | XSpray Pharma | US |
| * Timings might differ materially from those planned as of today. | |||||
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