Where i can see the next fda approval

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3/22/2025 11:13am

Aime

The deep research logic is organized as follows: 

Okay, the user is asking where they can see the next FDA approvals. Let me start by recalling the references provided. The user's background mentions sectors like Chiplet, US Tech, Semiconductor, China, and Apple, but their current question is about FDA approvals, so I need to focus on the relevant references.

Looking at the references, numbers 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28 are related to FDA approvals or regulatory updates. 

First, I should identify the key upcoming FDA events. Reference 4 mentions the FDA Calendar with PDUFA dates. For example, Telix Pharmaceuticals' Gozellix® has an approval date in March 2025 (Ref 5), Abeona Therapeutics' pz-cel has a PDUFA date of April 29, 2025 (Ref 6,7), and Milestone Pharmaceuticals' CARDAMYST™ has a PDUFA date of March 27, 2025 (Ref 10). 

I need to structure the answer by listing these upcoming approvals with their respective dates and companies. Also, the user might be interested in how to track these events. The references mention the FDA's website (Ref 3,15) and RTTNews (Ref 4) as sources. 

I should also include the visualization requirement. Each query from the references that the user can check should be highlighted. For example, the FDA's News & Events page (Ref 3) and the PDUFA calendar (Ref 4) are key resources. 

Additionally, the user's profile shows interest in tech sectors, but FDA approvals are more biotech/pharma. However, the answer should still be relevant to their query. 

I need to ensure that each citation is correctly numbered and placed at the end of the relevant sentence. Also, the visualizations should be inserted immediately after mentioning the query. 

Let me outline the structure: start with a conclusion, then list the key upcoming approvals with dates, companies, and references. Then explain where to track them, citing the relevant references. Include visualizations for each query mentioned. 

Check if all the PDUFA dates are covered. For example, Stealth BioTherapeutics' elamipretide has a PDUFA date of April 29, 2025 (Ref 9), and Foresee Pharmaceuticals' CAMCEVI has August 29, 2025 (Ref 8). Also, Biogen's LEQEMBI has August 31, 2025 (Ref 22,23). 

Make sure to mention the FDA's official channels and third-party trackers like RTTNews. Highlight the importance of these dates for investors in biotech/pharma sectors. 

Finally, ensure the language is clear and adheres to the user's preference for technical analysis and news-driven strategies. Since the user is interested in growth-oriented investments, emphasizing the potential impact of these approvals on stock performance could be beneficial.

Conclusion: The next FDA approvals are critical catalysts for biotech/pharma stocks, with key events clustered in Q2-Q3 2025. Below is a prioritized list of upcoming milestones and actionable insights for investors.

1. Key FDA Approval Dates to Watch

Q2 2025 Approvals

Abeona Therapeutics (ABEO): pz-cel for RDEB
- PDUFA Date: April 29, 2025 ¹²
- Impact: First gene therapy for recessive dystrophic epidermolysis bullosa (RDEB), addressing a $1.2B+ rare disease market.
- Commercialization: Targeting first patient treatment by Q3 2025, with $98.1M cash runway ¹.
Milestone Pharmaceuticals (MIST): CARDAMYST™ for PSVT
- PDUFA Date: March 27, 2025 ³
- Impact: Nasal spray for paroxysmal supraventricular tachycardia (PSVT), targeting a $1.5B+ market.
- Pipeline Expansion: Phase 3 trial for AFib-RVR planned for H1 2025 ³.
Stealth BioTherapeutics (SRTX): Elamipretide for Barth Syndrome
- PDUFA Date: April 29, 2025 ⁴
- Impact: Mitochondrial-targeted therapy for Barth syndrome, a rare genetic disorder.
- Clinical Validation: Positive FDA Advisory Committee vote (9-0) in October 2024 ⁴.

Q3 2025 Approvals

Telix Pharmaceuticals (TLX): Gozellix® for Prostate Cancer Imaging
- Approval Date: March 21, 2025 ⁵
- Impact: Next-gen PSMA-PET imaging agent with longer shelf life and broader distribution.
- Market Potential: Full reimbursement eligibility reduces patient costs ⁵.
Foresee Pharmaceuticals (6576.TW): CAMCEVI 21 mg for Prostate Cancer
- PDUFA Date: August 29, 2025 ⁶
- Impact: 3-month LAI formulation for advanced prostate cancer, complementing its 6-month version.
- Clinical Data: 97.9% efficacy in Phase 3 trials ⁶.

2. How to Track FDA Approvals

Official Channels

FDA News & Events Page
- Real-time updates on approvals and advisory committee meetings ⁷.
- Query: "FDA News & Events" ⁷.

FDA Drug Approvals Database
- Search for PDUFA dates and regulatory milestones ⁸.
- Query: "Drug Approvals and Databases" ⁸.

Third-Party Trackers

RTTNews FDA Calendar
- Aggregates PDUFA dates, advisory committee meetings, and catalysts ⁹.
- Query: "FDA Calendar, FDA Drug Approval, PDUFA Calendar" ⁹.

3. Strategic Implications for Investors

Near-Term Catalysts: Companies with April/March 2025 PDUFA dates (ABEO, MIST, SRTX) are likely to experience volatility ahead of decisions.
Long-Term Growth: Approvals for rare disease therapies (ABEO, SRTX) and imaging agents (TLX) could drive sustained revenue growth.
Risk Management: Monitor FDA advisory committee votes (e.g., SRTX’s Barth Syndrome vote ⁴) and post-approval commitments (e.g., ABEO’s labeling discussions ²).

Actionable Insight: Investors should prioritize ABEO (RDEB gene therapy) and MIST (PSVT nasal spray) for Q2 2025 catalysts. Track the FDA’s official channels and RTTNews for real-time updates.

Source:

1. Abeona Therapeutics Inc. Advances pz-cel BLA Review with FDA, Anticipates Commercial Launch for RDEB Treatment by Q3 2025