FDA approves Cosentyx for adolescents 12+ with hidradenitis suppurativa
The FDA approved Novartis’ Cosentyx (secukinumab) for Moderate to severe hidradenitis suppurativa, patients 12+ on Mar 13, 2026. The company can now sell it in that market.
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- Company
- Novartis AG NVS
- Drug
- Cosentyx (secukinumab)
- For
- Moderate to severe hidradenitis suppurativa, patients 12+
- Stage
- Approved / registrational · a study designed to support approval
- When
- Mar 13, 2026
- Source note
- Novartis said the FDA cleared Cosentyx for moderate-to-severe HS in patients aged 12 and older, making it the only IL-17A inhibitor approved in that pediatric population.
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- Source: novartis.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- NVS headlines on this site
Novartis expects to report results from its Phase 3 study of Pelacarsen (Lp(a)-lowering antisense; with Ionis) for Cardiovascular outcomes in patients with elevated Lp(a) and CVD in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
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- Entry
- Phase 3 Lp(a) HORIZON topline for pelacarsen · Clinical trial results (readout / topline data)
- Drug
- Pelacarsen (Lp(a)-lowering antisense; with Ionis)
- For
- Cardiovascular outcomes in patients with elevated Lp(a) and CVD
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Reuters (July 20, 2026) lists pelacarsen among three major Novartis readouts due in H2 2026. Novartis had guided to mid-2026 (Ionis relayed Q2 2026 timing in February 2026) and data are now considered overdue/imminent. One of the most-watched cardiology catalysts of 2026.
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- Source: kelo.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- NVS headlines on this site
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Novartis expects to report results from its Phase 3 study of Remibrutinib (oral BTK inhibitor, Rhapsido) for Relapsing multiple sclerosis in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
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- Entry
- Phase 3 remibrutinib multiple sclerosis readout · Clinical trial results (readout / topline data)
- Drug
- Remibrutinib (oral BTK inhibitor, Rhapsido)
- For
- Relapsing multiple sclerosis
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Reuters (July 20, 2026) reports the remibrutinib MS Phase 3 readout is due in H2 2026 — one of three pivotal Novartis readouts analysts flag as critical to the stock's valuation premium.
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- Source: kelo.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- NVS headlines on this site
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Novartis expects to report results from its Phase 3 study of Del-desiran (delpacibart etedesiran; Avidity Biosciences, being acquired by Novartis) for Myotonic dystrophy type 1 (DM1) in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- Pivotal del-desiran data in myotonic dystrophy type 1 (via Avidity) · Clinical trial results (readout / topline data)
- Drug
- Del-desiran (delpacibart etedesiran; Avidity Biosciences, being acquired by Novartis)
- For
- Myotonic dystrophy type 1 (DM1)
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Reuters (July 20, 2026) lists del-desiran pivotal data among the H2 2026 readouts that matter for Novartis, which agreed to acquire Avidity Biosciences. Multibillion-dollar peak sales potential per the report.
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- Source: kelo.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- NVS headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Novartis expects the FDA to decide on Cosentyx (secukinumab) for Polymyalgia rheumatica in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.
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- Entry
- FDA approval expected for Cosentyx in polymyalgia rheumatica (PMR) · Regulatory approval
- Drug
- Cosentyx (secukinumab)
- For
- Polymyalgia rheumatica
- Stage
- sBLA under FDA review
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Novartis Q2 2026 investor presentation (Jul 21, 2026) lists Cosentyx PMR under H2 2026 regulatory decisions (US); CEO on the call said they are 'anticipating FDA approval for that indication in the second half'. US/EU/JP submissions were made in Q1 2026.
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- Source: novartis.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- NVS headlines on this site
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Novartis expects the FDA to decide on Rhapsido (remibrutinib) for Chronic inducible urticaria (symptomatic dermographism) in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.
More details
- Entry
- FDA decision on Rhapsido (remibrutinib) in CIndU symptomatic dermographism · Regulatory approval
- Drug
- Rhapsido (remibrutinib)
- For
- Chronic inducible urticaria (symptomatic dermographism)
- Stage
- sNDA under FDA review
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Q2 2026 slides list Rhapsido CIndU US decision in H2 2026 (US filing for SD cohort made in 2025). Global filings across all three CIndU subtypes (EU, JP, CN) also planned 'later this year'.
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- Source: novartis.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- NVS headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Rhapsido (remibrutinib) global filings across three CIndU subtypes (EU, JP, CN), expected in the second half of 2026 (no exact date yet). A company milestone for Novartis (Rhapsido (remibrutinib) for Chronic inducible urticaria (SD, cold, cholinergic)): a step in the program rather than a decision or a data readout.
More details
- Entry
- Rhapsido (remibrutinib) global filings across three CIndU subtypes (EU, JP, CN) · Company milestone
- Drug
- Rhapsido (remibrutinib)
- For
- Chronic inducible urticaria (SD, cold, cholinergic)
- Stage
- Phase III RemIND
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Q2 2026 call (Jul 21, 2026): RemIND met primary endpoint in cold and cholinergic urticaria in Q1; slides list Rhapsido CIndU EU/JP/CN submissions in H2 2026.
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- Source: fool.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- NVS headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page