On Monday, Raymond James made a significant adjustment to its stance on shares of Disc Medicine (NASDAQ:IRON), elevating the biopharmaceutical company's stock from Outperform to Strong Buy. Alongside the upgrade, the firm set a new price target of $110.00, a notable increase from the previous $66.00.
The upgrade followed an announcement from Disc Medicine that it had concluded a successful end of Phase 2 meeting with the FDA regarding its drug candidate bitopertin, aimed at treating erythropoietic porphyrias (EPP).
The FDA indicated a willingness to consider an accelerated approval filing based on PPIX reduction as a surrogate biomarker of efficacy for bitopertin in EPP. This development is particularly significant as it allows Disc to proceed with the data it has already gathered.
While the exact date for the New Drug Application (NDA) submission remains to be announced, with expectations set for the first quarter of 2025, the analyst anticipates that the filing will indeed occur next year. Approval and commercial launch of the drug are now expected in 2026, according to the firm's revised model.
The analyst cited these positive developments as the reason for the upgrade and the substantial increase in the price target. The accelerated timeline for the drug's launch and the probability of success were key factors in Raymond James' revised outlook for Disc Medicine.
In other recent news, Disc Medicine, a biopharmaceutical company, has made significant strides in its operations and clinical trials. The company received positive feedback from the FDA for its upcoming APOLLO study, which is set to begin by mid-2025 and focuses on the treatment of Erythropoietic Protoporphyria (EPP) using bitopertin. The FDA also recognized the potential for accelerated approval based on existing data.
Disc Medicine reported promising results from its Phase 1b study of DISC-0974, which showed significant reduction in hepcidin levels and improvement in iron mobilization and hemoglobin levels in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and anemia.
On the analyst front, Disc Medicine received a Buy rating from Jefferies and an Overweight rating from Wells Fargo. H.C. Wainwright maintained its Buy rating and $70.00 stock target for Disc Medicine, while BMO Capital Markets revised its outlook, raising the price target to $70 from $50.
In addition to these developments, Disc Medicine has made key appointments, welcoming Dr. Rahul Rajan Kaushik as Chief Technical Officer and Dr. Steve Caffé as Chief Regulatory Officer, both bringing over two decades of experience in the pharmaceutical industry.
Lastly, Disc Medicine announced a public stock offering of approximately $178 million, led by Frazier Life Sciences and Logos Capital, to advance research and clinical development of its product candidates.
InvestingPro Insights
The recent upgrade by Raymond James aligns with several key metrics and insights from InvestingPro. Disc Medicine (NASDAQ:IRON) has shown a strong performance over the past six months, with InvestingPro data indicating a 58.21% price total return. This significant uptick supports the analyst's bullish stance on the stock.
InvestingPro Tips highlight that two analysts have revised their earnings upwards for the upcoming period, which could be influenced by the positive FDA meeting outcome for bitopertin. Additionally, the company holds more cash than debt on its balance sheet, suggesting financial stability as it moves towards potential drug approval and commercialization.
However, investors should note that Disc Medicine is not currently profitable, with a negative EBITDA of -110.8M USD for the last twelve months as of Q2 2024. This aligns with the InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year.
For those seeking a more comprehensive analysis, InvestingPro offers 7 additional tips that could provide further insights into Disc Medicine's financial health and market position.
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