RHYTHM PHARMACEUTICALS, INC.

RYTM

$7.40B

Mid Cap

NASDAQBiotechnology🇺🇸North America283 employees

Drugs in Pipeline

Phase 3 Programs

Upcoming Catalysts

Next Catalyst

Jan 31, 2026

Market Overview

Stock performance and market intelligence

Catalyst Timeline

5 upcoming, 0 past

Phase 2Next

LB54640 Phase 2 Results Expected

Jan 31, 2026LB5464028

Primary completion for LB54640 trial (NCT06046443) in Hypothalamic Obesity

Source

🎯PDUFA

✅Approved

FDA PDUFA Date IMCIVREE (priority)

3/14/2026

For obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. NDA filing. Extracted from SEC filing: 8-K

Source

🎯PDUFA

FDA PDUFA Date setmelanotide (priority)

6/30/2026

For Bardet-Biedl syndrome and other rare genetic diseases of obesity. NDA filing. Extracted from SEC filing: 8-K

Source

⭐Phase 3

Setmelanotide Phase 3 Results Expected

Sep 30, 2026Setmelanotide39

Primary completion for Setmelanotide trial (NCT06760546) in Hypothalamic Obesity

Source

Phase 2

Setmelanotide Phase 2 Results Expected

Oct 31, 2026Setmelanotide20

Primary completion for Setmelanotide trial (NCT06772597) in Prader-Willi Syndrome

Source

AI Predictions & Institutional Flow

Machine learning insights and smart money movement

FDA Submissions

Pending NDA/BLA submissions with predicted PDUFA dates

Drug Pipeline

Clinical development programs and drug candidates

Drug Pipeline

Class I or III Antiarrhythmic Medications

Phase 3

Atrial Fibrillation

Setmelanotide

Phase 3

Genetic Obesity

Flecainide or Sotalol or Propafenone

Phase 3

Paroxysmal Atrial Fibrillation

Setmelanotide 2 mg

Phase 3

Bardet-Biedl Syndrome

Part C: RM-718

Phase 2

Hypothalamic Obesity

LB54640

Phase 2

Hypothalamic Obesity

Diuretics

Phase 2

Heart Failure

Drug Name	Phase	Indication	Designations
Class I or III Antiarrhythmic Medications	Phase 3	Atrial Fibrillation	-
Setmelanotide	Phase 3	Genetic Obesity	-
Flecainide or Sotalol or Propafenone	Phase 3	Paroxysmal Atrial Fibrillation	-
Setmelanotide 2 mg	Phase 3	Bardet-Biedl Syndrome	-
Part C: RM-718	Phase 2	Hypothalamic Obesity	-
LB54640	Phase 2	Hypothalamic Obesity	-
Diuretics	Phase 2	Heart Failure	-

Regulatory & News

Approvals, filings, and latest developments

Regulatory Approvals

RYTM News

RHYTHM PHARMACEUTICALS, INC.

RYTM

$7.40B

Mid Cap

NASDAQBiotechnology🇺🇸North America283 employees

Drugs in Pipeline

Phase 3 Programs

Upcoming Catalysts

Next Catalyst

Jan 31, 2026

Market Overview

Stock performance and market intelligence

Catalyst Timeline

5 upcoming, 0 past

Phase 2Next

LB54640 Phase 2 Results Expected

Jan 31, 2026LB5464028

Primary completion for LB54640 trial (NCT06046443) in Hypothalamic Obesity

Source

🎯PDUFA

✅Approved

FDA PDUFA Date IMCIVREE (priority)

3/14/2026

For obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. NDA filing. Extracted from SEC filing: 8-K

Source

🎯PDUFA

FDA PDUFA Date setmelanotide (priority)

6/30/2026

For Bardet-Biedl syndrome and other rare genetic diseases of obesity. NDA filing. Extracted from SEC filing: 8-K

Source

⭐Phase 3

Setmelanotide Phase 3 Results Expected

Sep 30, 2026Setmelanotide39

Primary completion for Setmelanotide trial (NCT06760546) in Hypothalamic Obesity

Source

Phase 2

Setmelanotide Phase 2 Results Expected

Oct 31, 2026Setmelanotide20

Primary completion for Setmelanotide trial (NCT06772597) in Prader-Willi Syndrome

Source

AI Predictions & Institutional Flow

Machine learning insights and smart money movement

FDA Submissions

Pending NDA/BLA submissions with predicted PDUFA dates

Drug Pipeline

Clinical development programs and drug candidates

Drug Pipeline

Class I or III Antiarrhythmic Medications

Phase 3

Atrial Fibrillation

Setmelanotide

Phase 3

Genetic Obesity

Flecainide or Sotalol or Propafenone

Phase 3

Paroxysmal Atrial Fibrillation

Setmelanotide 2 mg

Phase 3

Bardet-Biedl Syndrome

Part C: RM-718

Phase 2

Hypothalamic Obesity

LB54640

Phase 2

Hypothalamic Obesity

Diuretics

Phase 2

Heart Failure

Drug Name	Phase	Indication	Designations
Class I or III Antiarrhythmic Medications	Phase 3	Atrial Fibrillation	-
Setmelanotide	Phase 3	Genetic Obesity	-
Flecainide or Sotalol or Propafenone	Phase 3	Paroxysmal Atrial Fibrillation	-
Setmelanotide 2 mg	Phase 3	Bardet-Biedl Syndrome	-
Part C: RM-718	Phase 2	Hypothalamic Obesity	-
LB54640	Phase 2	Hypothalamic Obesity	-
Diuretics	Phase 2	Heart Failure	-

Regulatory & News

Approvals, filings, and latest developments

Regulatory Approvals

RYTM News