Big Biotech Moves to Watch in January 2025: FDA Calendar
As we kick off 2025, there are plenty of exciting FDA catalysts just around the corner that you should have on your radar. I’ve been scrolling through BiopharmaWatch’s FDA Calendar, and here’s a quic
🚨 Shuttle Pharmaceuticals Holdings (Ticker: SHPH)
Catalyst Date: January 13, 2025
Event Type: Biodistribution and PK data
Drug: Ropidoxuridine
Stage: Phase 2
Indication: Glioblastoma
Why it matters: Glioblastoma is a tough-to-treat brain cancer, and any advancement here could bring attention to SHPH. Keep an eye on this one!
🧬 Anavex Life Sciences Corp (Ticker: AVXL)
Catalyst Date: January 13, 2025
Event Type: ANAVEX2-73 data readout
Drug: ANAVEX2-73 (blarcamesine)
Stage: Phase 2/3
Indication: Alzheimer’s disease
Why it matters: Alzheimer’s is a hot area in biotech, with several companies racing for a breakthrough. AVXL’s data could be a major catalyst if it shows promising results.
💊 Cardiol Therapeutics Inc. (Ticker: CRDL)
Catalyst Date: January 14, 2025
Event Type: Clinical readout from LANCER trial
Drug: CardiolRx
Stage: Phase 2/3
Indication: Anticoagulation for warfarin-treated cardiovascular patients
Why it matters: Cardiovascular diseases remain one of the leading causes of death. Positive data could push CRDL’s stock higher.
🧪 Edesa Biotech, Inc. (Ticker: EDSA)
Catalyst Date: January 13, 2025
Event Type: IND submission
Drug: EB06 (anti-TLR4 mAb)
Stage: Pre-clinical
Indication: Vitiligo
Why it matters: While it’s still early days for this treatment, an IND submission is a big step forward. Keep an eye on future clinical updates.
👩⚕️ Olema Pharmaceuticals, Inc. (Ticker: OLMA)
Catalyst Date: January 14, 2025
Event Type: Phase 3 data readout
Drug: OP-1250
Stage: Phase 3
Indication: Breast cancer
Why it matters: Breast cancer is a massive market. If OLMA reports strong efficacy, expect a big move.
🧠 Neumora Therapeutics, Inc. (Ticker: NMRA)
Catalyst Date: January 14, 2025
Event Type: Nasacerfont data readout
Drug: Nasacerfont
Stage: Phase 2
Indication: Major depressive disorder
Why it matters: Mental health treatments are in high demand. Positive results here could generate buzz.
💉 Atara Biotherapeutics, Inc. (Ticker: ATRA)
Catalyst Date: January 15, 2025
Event Type: Tableted Ebvallo data
Drug: Ebvallo
Stage: PDUFA
Indication: Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disorder
Why it matters: This is a PDUFA date, meaning the FDA will decide on approval. High stakes here!
🔬 Seres Therapeutics, Inc. (Ticker: MCRB)
Catalyst Date: January 16, 2025
Event Type: SER-155 data readout
Drug: SER-155
Stage: Phase 1/2
Indication: Reduction of bloodstream infections in allogeneic hematopoietic stem cell transplant recipients
Why it matters: Seres has been making waves with microbiome-based therapies. Could this be another hit?
🧬 MINK Therapeutics, Inc. (Ticker: INKT)
Catalyst Date: January 22, 2025
Event Type: gpm271 Phase 2 data readout
Drug: gpm271
Stage: Phase 2
Indication: Refractory gastric cancer
Why it matters: Gastric cancer is a challenging cancer to treat, and any positive data could be a game-changer.
🧪 Xilio Therapeutics, Inc. (Ticker: XLO)
Catalyst Date: January 23, 2025
Event Type: Phase 2 trial update
Drug: XTX101
Stage: Phase 2
Indication: Metastatic microsatellite stable colorectal cancer (MSS CRC)
Why it matters: Xilio is working on next-gen immune-oncology therapies. Keep a close watch on this one.
Other Notable Catalysts to Keep an Eye On:
ALXO: HER2-positive gastric/esophageal cancer (January 24)
ONCY: Phase 3 readout (January 24)
DRTS: Recurrent glioblastoma (January 24)
CHRS: NDA submission for a new drug (January 24)
BIIB: Early Alzheimer’s Disease data (January 25)
AGEN: Colorectal gastric cancer readout (January 25)
Final Thoughts 💭
The start of the year is packed with potential market-moving biotech events. Whether you're a trader or just a curious investor, keeping an eye on these catalysts can be rewarding. Remember, biotech is a high-risk, high-reward space. Make sure to do your due diligence before making any moves!
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Happy investing! 💰