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Catalyst Database

Chronological list of catalyst events. Click "See Drug Details" to view detailed info in our AmpCard. Use the Sort options or search box below (e.g. "Phase 2") to filter the catalyst results.

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Ticker

Drug | Disease (links)

Stage (next event)

Catalyst Date

Meeting

Biomedical meeting

ObesityWeek

Obesity

November 4, 2025

Obesity Week 2025 abstract release date: Embargoed until November 4, 2025

Abstract Release

THTX

PDUFA

Tesamorelin (F8 Formulation)

HIV-Associated Excess Abdominal Fat

March 25, 2025

Original PDUFA date 1/22/24. 1/24/24- Received CRL; FDA requested clarifications around CMC and add'l info related to immunogenicity. 11/26/24- Resubmitted sBLA. 12/10/24- FDA assigned PDUFA goal date of March 25, 2025.

Approval decision

Meeting

Biomedical meeting

American Association for Cancer Research (AACR)

Cancer

March 25, 2025

AACR abstract release date: Regular & Late-breaking Abstract title release on March 25th, 2025, and Regular Abstract text release on 3/25. Late-breaking texts are embargoed until April 25, 2025.

Abstract Release

GSK

PDUFA

Gepotidacin

Uncomplicated Urinary Tract Infection (uUTI)

March 26, 2025

10/17/24- NDA acceptance. PDUFA action date March 26, 2025.

Approval decision

SLNO

PDUFA

DCCR (Diazoxide Choline Controlled-Release) (K ATP agonist)

PWS (Prader-Willi syndrome)

March 27, 2025

Suspected Mover: 4/29/24- FDA BTD. Presentation at ENDO '24. 6/28/24- NDA submission. 8/27/28- NDA accepted w/ PDUFA date set 12/27/24. 10/8/24- FDA confirmed Adcom meeting not needed. 11/26/24- Extended review with new PDUFA date March 27, 2025.

Approval decision

MIST

PDUFA

Etripamil (CARDAMYST) (calcium channel blocker)

(PSVT) Paroxysmal Supraventricular Tachycardia

March 27, 2025

Big Mover: RAPID/RAPID Ext./NODE-303/NODE-301 studies. 5/29/24- NDA accepted. 8/26/24- NODE-303 data presentation at ESC '24 on 8/30/24. 11/12/24- PDUFA goal date of March 27, 2025.

Approval decision

SNY

PDUFA

Fitusiran

Hemophilia A or B

March 28, 2025

ATLAS-OLE & ATLAS-NEO trials. Regulatory decision on approval on 3/28/25

Approval decision

ALNY

PDUFA

FITUSIRAN

Hemophilia A/B

March 28, 2025

ATLAS-OLE Ph3 trial: Partnered with Sanofi. Reported positive topline results. 2/19/24 Expect to submit BLA in 2024. 8/1/24 Accepted BLA, FDA target action date of March 28, 2025

Approval decision

Meeting

Biomedical meeting

American College of Cardiology (ACC) Annual Scientific Session

Cardiology

March 29-31, 2025

ACC.25 meeting dates: March 29-31, 2025. https://accscientificsession.acc.org/

Meeting dates

PTN

Phase 2

PL8177 oral formulation

Ulcerative colitis

Q1 2025

Big Mover: 11/25/24- Completed enrollment. 2/13/25- Topline data in Q1 2025.

Data readout

Amp Volatility is calculated based off of options pricing with expiration after event.
Last Calculated: 03/13/20

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