Disc Medicine (IRON) and Sanofi (SNY) Drug Review Delays Exceed 12 Months

Written by Emily J. Thompson, Senior Investment Analyst

IRON+5.93%

SNY+0.34%

Source: seekingalpha

Updated: Jan 15 2026

0mins

Source: seekingalpha

Review Delays: Disc Medicine's rare disease therapy bitopertin faces a two-month delay in its review due to concerns over potential abuse and trial data issues, which could postpone its market launch and impact revenue generation.
Safety Concerns: Sanofi's Tzield (teplizumab-mzwv) is experiencing over a 12-month delay in its U.S. expansion bid due to adverse event reports, including seizures, blood clotting, and mortality, potentially undermining its competitive position in the diabetes market.
FDA Priority Review Program: The FDA's National Priority Review voucher program, launched last year to expedite review times from 10-12 months to just 1-2 months, is currently hindered by these delays, reflecting the agency's heightened scrutiny on safety and efficacy, which may affect future drug development strategies.
Industry Impact: As early recipients of the priority review vouchers, Disc Medicine and Sanofi's delays could lead to decreased investor confidence in their R&D pipelines, potentially impacting stock performance and market expectations.

IRON

$82.14+Infinity%1D

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

Morgan Stanley

Overweight

maintain

$115 -> $120

2026-01-08

Reason

Morgan Stanley

Price Target

$115 -> $120

AI Analysis

2026-01-08

maintain

Overweight

Reason

Morgan Stanley raised the firm's price target on Disc Medicine to $120 from $115 and keeps an Overweight rating on the shares. The firm sees a continuation of U.S. small-to-mid cap biotech's outperformance in 2026 as commercial names transition from "capital consumers to producers" and Large Cap Biopharma faces a looming patent cliff, the analyst tells investors in an outlook note for the group.

TD Cowen

Buy

maintain

2025-12-19

Reason

TD Cowen

Price Target

2025-12-19

maintain

Buy

Reason

Keeping a Buy rating on Disc Medicine, TD Cowen says the firm believes skepticism on the CNPV path is overblown. Disc's management remains confident, and TD Cowen's Prevision Policy experts suggest that "transactional" approvals - while likely a risk for the broader regulatory landscape should indeed benefit therapies/sponsors that the Agency is clearly excited about. FDA resources are shifting to programs like bitopertin, and the firm's confidence in accelerated approval remains high. Of note, a recent article on the FDA's CNPV program framed Disc's bitopertin as part of broader concerns around the compressed review timelines and governance structure.

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BMO Capital

Outperform

maintain

$120

2025-12-19

Reason

BMO Capital

Price Target

$120

2025-12-19

maintain

Outperform

Reason

BMO Capital notes that a STAT article appeared to raise concerns about the feasibility of FDA's Commissioner's National Priority Voucher approval timelines. The same article indicated that CBER director Vinay Prasad had indicated concerns about bitopertin's efficacy. The firm says that discussion with Disc Medicine's management post-STAT article highlights lack of interactions with Prasad but robust active dialogue with FDA. While Prasad may have speculated efficacy concerns related to bitopertin, these have not been communicated to Disc, no adcom has been noted as necessary, and no clear concerning questions around efficacy have been raised, BMO adds. Some procedural questions have been asked by FDA in trying to understand the bitopertin data package and how it may translate to clinical benefit. The firm has an Outperform rating on the shares with a price target of $120.

Jefferies

Roger Song

Buy

maintain

$154

2025-12-19

Reason

Jefferies

Roger Song

Price Target

$154

2025-12-19

maintain

Buy

Reason

After attending Disc Medicine's analyst call in response to the media article that expressed concerns regarding CNPV program and mentioned potential timeline extension on the company's Bitopertin/Erythropoietic Protoporphyria approval and skepticism on efficacy by FDA leader, Jefferies analyst Roger Song says that while the CNPV program's timeline may be under pressure with increasing demand, the firm remains confident on Bitopertin's approval in EPP under CNPV, based on robust efficacy/safety, significant unmet needs, and to-date review experience. The firm sees today's movement as a stock overreaction. Jefferies has a Buy rating on the shares with a price target of $154.

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.