FDA Delays Review of Fast-Track Drugs Under Trump Administration, Impacting Multiple New Treatments
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 15 2026
0mins
Source: Benzinga
- Review Delays: The FDA has postponed the review of several drugs, notably Disc Medicine's bitopertin, due to safety and efficacy concerns, extending the review period to February 10, which may impact its market launch.
- New Drug Selection: Merck's cholesterol treatment and cancer therapy have been selected for the CNPV program, and if finalized, they will become the 17th and 18th drugs in the program, significantly shortening review times to one to two months.
- Adverse Event Concerns: The FDA delayed its review of Sanofi's Tzield by over a month due to reports of adverse events including seizures and blood clotting, potentially affecting its expanded-use application progress.
- Market Reaction: The review delays have led to declines in premarket trading for Disc Medicine, Eli Lilly, and Sanofi, reflecting market uncertainty regarding drug approvals.
Analyst Views on IRON
Wall Street analysts forecast IRON stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for IRON is 120.20 USD with a low forecast of 100.00 USD and a high forecast of 154.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
13 Analyst Rating
13 Buy
0 Hold
0 Sell
Strong Buy
Current: 77.540
Low
100.00
Averages
120.20
High
154.00
Current: 77.540
Low
100.00
Averages
120.20
High
154.00
About IRON
Disc Medicine, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases. The Company's pipeline includes bitopertin for the treatment of erythropoietic porphyrias (Eps), including erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), and Diamond-Blackfan Anemia (DBA); DISC-0974 for the treatment of anemia of myelofibrosis (MF), and anemia of chronic kidney disease (CKD), and DISC-3405 (formerly MWTX-003) for the treatment of polycythemia vera (PV) and other hematologic disorders. In addition, its preclinical programs also include DISC-0998, for the treatment of anemia associated with inflammatory diseases. Bitopertin is the lead product candidate in the Company's heme biosynthesis modulation portfolio. It is developing DISC-3405, a monoclonal antibody against Transmembrane Serine Protease 6 that it licensed from Mabwell Therapeutics, Inc.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
