ITCI
Intra-Cellular Therapies Inc.
stock NASDAQ

# Hey everyone,
Back with the monthly catalyst briefing.
For those who don't know me, I'm the dev behind [CatalystAlert.io](https://catalystalert.io) \- I build tools to track biotech catalysts. Some month I pull the data from our calendar and put together a summary of what's coming up. Not investment advice, just laying out the facts so you can do your own research.
March is shaping up to be one of the busiest months in a while. Here's the breakdown.
# This week (Mar 1-6) - Heavy right out of the gate
Lot of Phase 3 data expected early in the month.
**VRDN (Viridian Therapeutics)** \- VRDN-003 Phase 3 results for Thyroid Eye Disease. This is a notable one for the TED space, where Horizon's Tepezza is currently the standard. Viridian is at \~$730M market cap.
**AZN (AstraZeneca)** \-Two Phase 3 readouts this week. Tozorakimab in COPD (around Mar 2) and Capivasertib in triple-negative breast cancer (around Mar 4). TNBC is a tough indication with significant unmet need.
**MRK (Merck)** \- Pembrolizumab Phase 3 data in NSCLC expected around Mar 5. This is a label expansion / combo data readout for Keytruda.
**ADCT (ADC Therapeutics)** \- Loncastuximab Tesirine Phase 3 in relapsed DLBCL. Small cap (\~$540M) in the ADC space, and DLBCL is a competitive indication.
**SNY (Sanofi)** \- Avalglucosidase alfa Phase 3 in Pompe disease (Glycogen Storage Disease Type II) around Mar 6.
# Week 2 (Mar 7-14) - Oncology-heavy
**ARGX (argenx)** \- Efgartigimod Phase 3 data in POTS (Postural Orthostatic Tachycardia Syndrome), expected around Mar 11. argenx is a $50B company and Efgartigimod (Vyvgart) is already approved for MG. POTS would be a significant new indication - currently an underserved condition affecting millions.
**PFE (Pfizer)** \- Sigvotatug Vedotin Phase 3 in NSCLC expected around Mar 12. This ADC is a key piece of Pfizer's oncology rebuild post-Seagen acquisition.
**BMY (Bristol Myers)** \- Repotrectinib Phase 3 in NSCLC around Mar 13.
**INSM (Insmed)** \- Treprostinil Palmitil Inhalation Powder Phase 3 in pulmonary hypertension, expected around Mar 14. Insmed is an $11B company and this is a major pipeline asset.
**AdCom** \- FDA Advisory Committee meeting scheduled for March 12 regarding an influenza vaccine.
# Mid-March (Mar 15-20) - Lots of big names
**REGN (Regeneron)** \- Three Phase 3 readouts expected around Mar 16: Fianlimab in melanoma, Pembrolizumab in melanoma, and Dupilumab in atopic dermatitis. Dupilumab (Dupixent) is their main revenue driver — any label expansion data is relevant. Fianlimab melanoma data is notable from a pipeline standpoint.
**INCY (Incyte)** \- Povorcitinib Phase 3 in nonsegmental vitiligo, around Mar 17. The vitiligo space has gotten competitive with Opzelura already on the market.
**IPSEY (Ipsen)** \- Elafibranor Phase 3 in primary biliary cholangitis, around Mar 19. PBC still has meaningful unmet need despite ursodiol.
# Expected sometime in March (dates not confirmed)
These are expected in March but no specific date has been announced. Timing could shift.
**MDGL (Madrigal Pharma)** \- Resmetirom Phase 3 data in NASH. $5.1B company, Rezdiffra is already conditionally approved. Additional Phase 3 data is significant for the NASH space.
**ABBV (AbbVie)** \- Venetoclax Phase 3 in AML. Two trials running.
**ITCI (Intra-Cellular Therapies)** \- Lumateperone Phase 3 in major depressive disorder. Caplyta is already approved for schizophrenia and bipolar depression - MDD would be a major label expansion.
**NBIX (Neurocrine)** \- Valbenazine Phase 3 in tardive dyskinesia. Ingrezza is already a $2B+ drug, likely lifecycle management data.
**IMVT (Immunovant)** \- Batoclimab Phase 3 in thyroid eye disease. Another TED readout in the same month as VRDN-003 above - the comparison between these two will be interesting.
**RNA (Avidity Biosciences)** \- AOC 1001 (del-desiran) Phase 3 in DM1 (myotonic dystrophy type 1). $10.8B company, lead program, potential first-in-class for this indication.
**KRYS (Krystal Biotech)** \- Two Phase 3 readouts expected: KB803 in dystrophic epidermolysis bullosa and KB801 in neurotrophic keratitis. Krystal ($4.6B) already has Vyjuvek approved.
# Late March (Mar 21-31)
**PFE (Pfizer)** \- Ritlecitinib Phase 3 in nonsegmental vitiligo, around Mar 22. Already approved for alopecia areata.
**OTSKF (Otsuka)** \- Centanafadine Phase 3 in ADHD, expected around Mar 25. Novel non-stimulant mechanism in a massive market.
**MLTX (MoonLake Immunotherapeutics)** \- Sonelokimab Phase 3 in hidradenitis suppurativa, around Mar 27. \~$1.1B company, lead program, novel nanobody format targeting an underserved condition.
**NVS (Novartis)** \- Remibrutinib Phase 3 in relapsing multiple sclerosis, around Mar 30. BTK inhibitors in MS are getting a lot of attention across the industry.
**URGN (UroGen Pharma)** \- UGN-104 Phase 3 in upper tract urothelial carcinoma, around Mar 31.
**RHHBY (Roche)** \- Multiple Phase 3 readouts at end of month: Giredestrant in endometrial cancer, Lenvatinib in HCC, and endocrine therapy data in early breast cancer.
# PDUFA dates - Looking ahead
No PDUFA dates in March (quiet month on the FDA decision front), but the queue is building fast for late Q2:
|Expected|Company|Drug|Review|
|:-|:-|:-|:-|
|May 31|**TNXP** (Tonix)|TNX-1800|Priority|
|May 31|**CORT** (Corcept)|Relacorilant|Standard|
|Jun 3|**REPL** (Replimune)|\-|Standard|
|Jun 6|**AGIO** (Agios)|\-|Standard|
|Jun 7|**ARGX** (argenx)|Efgartigimod|Priority|
|Jun 9|**RARE** (Ultragenyx)|\-|Priority|
|Jun 12|**KURA** (Kura Oncology)|Tipifarnib|Priority|
|Jun 15|**IRON** (Disc Medicine)|DISC-0123|Priority|
|Jun \~15|**REGN** (Regeneron)|MM therapy|Priority|
|Jun 15|**PHAR** (Pharming)|Leniolisib|Priority|
|Jun 16|**SNY** (Sanofi)|Fitusiran|Priority|
|Jun 16|**BIIB** (Biogen)|\-|Priority|
|Jun 18|**IMCR** (Immunocore)|Tebentafusp|Priority|
|Jun 20|**VNDA** (Vanda)|Tradipitant|Standard|
|Jun 20|**ARQT** (Arcutis)|ARQ-154|Standard|
|Jun 30|**RYTM** (Rhythm)|Setmelanotide|Priority|
|Jun 30|**CRNX** (Crinetics)|Paltusotine|Standard|
That's a lot of PDUFAs stacked in June.
# Notable themes this month
* **ARGX efgartigimod in POTS** \- Probably the highest-profile readout of March. POTS is a large underserved population with no approved treatment. Also worth noting ARGX has a PDUFA coming in June.
* **Two TED readouts** \- VRDN and IMVT both have Phase 3 data in thyroid eye disease expected this month. The market will likely compare these head-to-head.
* **RNA's AOC 1001 in DM1** \- First-in-class potential in myotonic dystrophy with a novel RNA-targeting approach.
* **MLTX sonelokimab in HS** \- Smaller name, but HS is genuinely underserved and the nanobody format is differentiated.
* **The June PDUFA wave** \- Worth getting familiar with these names now. ARGX, KURA, IRON, RYTM, CRNX, BIIB, SNY all have decisions coming.
**Disclaimer:** This is informational only, not investment advice. Dates can shift, trials get delayed, and outcomes are uncertain. Always do your own due diligence.
All data pulled from [CatalystAlert.io](https://catalystalert.io) \- I built it to track exactly this kind of stuff. If you have feedback or want features added, hit me up.

# Hey everyone,
Back with the monthly catalyst briefing.
For those who don't know me, I'm the dev behind [CatalystAlert.io](https://catalystalert.io) \- I build tools to track biotech catalysts. Some month I pull the data from our calendar and put together a summary of what's coming up. Not investment advice, just laying out the facts so you can do your own research.
March is shaping up to be one of the busiest months in a while. Here's the breakdown.
# This week (Mar 1-6) - Heavy right out of the gate
Lot of Phase 3 data expected early in the month.
**VRDN (Viridian Therapeutics)** \- VRDN-003 Phase 3 results for Thyroid Eye Disease. This is a notable one for the TED space, where Horizon's Tepezza is currently the standard. Viridian is at \~$730M market cap.
**AZN (AstraZeneca)** \-Two Phase 3 readouts this week. Tozorakimab in COPD (around Mar 2) and Capivasertib in triple-negative breast cancer (around Mar 4). TNBC is a tough indication with significant unmet need.
**MRK (Merck)** \- Pembrolizumab Phase 3 data in NSCLC expected around Mar 5. This is a label expansion / combo data readout for Keytruda.
**ADCT (ADC Therapeutics)** \- Loncastuximab Tesirine Phase 3 in relapsed DLBCL. Small cap (\~$540M) in the ADC space, and DLBCL is a competitive indication.
**SNY (Sanofi)** \- Avalglucosidase alfa Phase 3 in Pompe disease (Glycogen Storage Disease Type II) around Mar 6.
# Week 2 (Mar 7-14) - Oncology-heavy
**ARGX (argenx)** \- Efgartigimod Phase 3 data in POTS (Postural Orthostatic Tachycardia Syndrome), expected around Mar 11. argenx is a $50B company and Efgartigimod (Vyvgart) is already approved for MG. POTS would be a significant new indication - currently an underserved condition affecting millions.
**PFE (Pfizer)** \- Sigvotatug Vedotin Phase 3 in NSCLC expected around Mar 12. This ADC is a key piece of Pfizer's oncology rebuild post-Seagen acquisition.
**BMY (Bristol Myers)** \- Repotrectinib Phase 3 in NSCLC around Mar 13.
**INSM (Insmed)** \- Treprostinil Palmitil Inhalation Powder Phase 3 in pulmonary hypertension, expected around Mar 14. Insmed is an $11B company and this is a major pipeline asset.
**AdCom** \- FDA Advisory Committee meeting scheduled for March 12 regarding an influenza vaccine.
# Mid-March (Mar 15-20) - Lots of big names
**REGN (Regeneron)** \- Three Phase 3 readouts expected around Mar 16: Fianlimab in melanoma, Pembrolizumab in melanoma, and Dupilumab in atopic dermatitis. Dupilumab (Dupixent) is their main revenue driver — any label expansion data is relevant. Fianlimab melanoma data is notable from a pipeline standpoint.
**INCY (Incyte)** \- Povorcitinib Phase 3 in nonsegmental vitiligo, around Mar 17. The vitiligo space has gotten competitive with Opzelura already on the market.
**IPSEY (Ipsen)** \- Elafibranor Phase 3 in primary biliary cholangitis, around Mar 19. PBC still has meaningful unmet need despite ursodiol.
# Expected sometime in March (dates not confirmed)
These are expected in March but no specific date has been announced. Timing could shift.
**MDGL (Madrigal Pharma)** \- Resmetirom Phase 3 data in NASH. $5.1B company, Rezdiffra is already conditionally approved. Additional Phase 3 data is significant for the NASH space.
**ABBV (AbbVie)** \- Venetoclax Phase 3 in AML. Two trials running.
**ITCI (Intra-Cellular Therapies)** \- Lumateperone Phase 3 in major depressive disorder. Caplyta is already approved for schizophrenia and bipolar depression - MDD would be a major label expansion.
**NBIX (Neurocrine)** \- Valbenazine Phase 3 in tardive dyskinesia. Ingrezza is already a $2B+ drug, likely lifecycle management data.
**IMVT (Immunovant)** \- Batoclimab Phase 3 in thyroid eye disease. Another TED readout in the same month as VRDN-003 above - the comparison between these two will be interesting.
**RNA (Avidity Biosciences)** \- AOC 1001 (del-desiran) Phase 3 in DM1 (myotonic dystrophy type 1). $10.8B company, lead program, potential first-in-class for this indication.
**KRYS (Krystal Biotech)** \- Two Phase 3 readouts expected: KB803 in dystrophic epidermolysis bullosa and KB801 in neurotrophic keratitis. Krystal ($4.6B) already has Vyjuvek approved.
# Late March (Mar 21-31)
**PFE (Pfizer)** \- Ritlecitinib Phase 3 in nonsegmental vitiligo, around Mar 22. Already approved for alopecia areata.
**OTSKF (Otsuka)** \- Centanafadine Phase 3 in ADHD, expected around Mar 25. Novel non-stimulant mechanism in a massive market.
**MLTX (MoonLake Immunotherapeutics)** \- Sonelokimab Phase 3 in hidradenitis suppurativa, around Mar 27. \~$1.1B company, lead program, novel nanobody format targeting an underserved condition.
**NVS (Novartis)** \- Remibrutinib Phase 3 in relapsing multiple sclerosis, around Mar 30. BTK inhibitors in MS are getting a lot of attention across the industry.
**URGN (UroGen Pharma)** \- UGN-104 Phase 3 in upper tract urothelial carcinoma, around Mar 31.
**RHHBY (Roche)** \- Multiple Phase 3 readouts at end of month: Giredestrant in endometrial cancer, Lenvatinib in HCC, and endocrine therapy data in early breast cancer.
# PDUFA dates - Looking ahead
No PDUFA dates in March (quiet month on the FDA decision front), but the queue is building fast for late Q2:
|Expected|Company|Drug|Review|
|:-|:-|:-|:-|
|May 31|**TNXP** (Tonix)|TNX-1800|Priority|
|May 31|**CORT** (Corcept)|Relacorilant|Standard|
|Jun 3|**REPL** (Replimune)|\-|Standard|
|Jun 6|**AGIO** (Agios)|\-|Standard|
|Jun 7|**ARGX** (argenx)|Efgartigimod|Priority|
|Jun 9|**RARE** (Ultragenyx)|\-|Priority|
|Jun 12|**KURA** (Kura Oncology)|Tipifarnib|Priority|
|Jun 15|**IRON** (Disc Medicine)|DISC-0123|Priority|
|Jun \~15|**REGN** (Regeneron)|MM therapy|Priority|
|Jun 15|**PHAR** (Pharming)|Leniolisib|Priority|
|Jun 16|**SNY** (Sanofi)|Fitusiran|Priority|
|Jun 16|**BIIB** (Biogen)|\-|Priority|
|Jun 18|**IMCR** (Immunocore)|Tebentafusp|Priority|
|Jun 20|**VNDA** (Vanda)|Tradipitant|Standard|
|Jun 20|**ARQT** (Arcutis)|ARQ-154|Standard|
|Jun 30|**RYTM** (Rhythm)|Setmelanotide|Priority|
|Jun 30|**CRNX** (Crinetics)|Paltusotine|Standard|
That's a lot of PDUFAs stacked in June.
# Notable themes this month
* **ARGX efgartigimod in POTS** \- Probably the highest-profile readout of March. POTS is a large underserved population with no approved treatment. Also worth noting ARGX has a PDUFA coming in June.
* **Two TED readouts** \- VRDN and IMVT both have Phase 3 data in thyroid eye disease expected this month. The market will likely compare these head-to-head.
* **RNA's AOC 1001 in DM1** \- First-in-class potential in myotonic dystrophy with a novel RNA-targeting approach.
* **MLTX sonelokimab in HS** \- Smaller name, but HS is genuinely underserved and the nanobody format is differentiated.
* **The June PDUFA wave** \- Worth getting familiar with these names now. ARGX, KURA, IRON, RYTM, CRNX, BIIB, SNY all have decisions coming.
**Disclaimer:** This is informational only, not investment advice. Dates can shift, trials get delayed, and outcomes are uncertain. Always do your own due diligence.
All data pulled from [CatalystAlert.io](https://catalystalert.io) \- I built it to track exactly this kind of stuff. If you have feedback or want features added, hit me up.