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Oppenheimer sees upside in Dianthus as CIDP study gains FDA support

EditorEmilio Ghigini
Published 11/12/2024, 04:32 AM
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On Monday, Oppenheimer maintained an Outperform rating on Dianthus Therapeutics (NASDAQ: DNTH) stock and raised the price target to $52.00 from the previous $48.00.

The adjustment follows Dianthus Therapeutics' third-quarter financial report, which showed a net loss of $25.2 million, surpassing the $17.2 million loss anticipated by analysts. The increased loss was attributed to an acceleration in research and development spending.

The company's announcement of its plan to initiate a pivotal trial for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) by the end of the year was highlighted as significant news.

Management sees this as a promising opportunity following positive interactions with the FDA, which appear supportive of a Biologics License Application (BLA) filing.

The design of the upcoming CIDP trial is expected to be similar to that of ARGX's Adhere trial, with a focus on preventing relapse and evaluating safety and tolerability. Notably, the trial design for Dianthus's DNTH103/riliprubart is expected to exclude a lead-in washout period, aiming to improve patient enrollment adherence.

This design choice is considered beneficial as enrollment challenges were observed in batoclimab's Phase 2b trial due to the now-commercially available Vyvgart, which could further complicate lead-in/washout enrollment.

Dianthus Therapeutics is awaiting further clarity by the end of the year regarding trial endpoint comparisons for DNTH103/riliprubart. In response to the recent developments and the company's commercial estimates for CIDP, Oppenheimer has revised its spending projections and consequently increased the price target for Dianthus Therapeutics' shares.

In other recent news, Dianthus Therapeutics continues to make significant strides in drug development. The company's developmental drug, DNTH103, is in the spotlight as it is being developed for larger indications such as generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CIDP), and multifocal motor neuropathy (MMN). Several analyst firms including Baird, Guggenheim, and H.C. Wainwright have maintained positive ratings for Dianthus, citing the potential of DNTH103.

Baird reaffirmed its Outperform rating on Dianthus shares amid a recent transaction where Sanofi (NASDAQ:SNY) sold Enjaymo to Recordati (BIT:RECI) for an $825 million upfront payment, with the potential for an additional $250 million based on commercial milestones. This deal is seen to have a favorable implication for Dianthus, as its leading drug DNTH-103 belongs to the same C1s inhibitor class as Enjaymo.

Guggenheim and H.C. Wainwright have also maintained their Buy ratings for Dianthus, highlighting the potential of DNTH103 to achieve over $1 billion in global peak sales for CIDP alone. Dianthus has also strengthened its leadership with the appointment of Steven Romano, M.D. to its Board of Directors.

The company has received FDA clearance for a Phase 2 trial of DNTH103 for Multifocal Motor Neuropathy patients, with initial results expected in 2026. As the company advances in its clinical trials and leadership enhancements, these are the recent developments that investors should keep an eye on.

InvestingPro Insights

Dianthus Therapeutics' recent financial performance and strategic moves align with several key metrics and insights from InvestingPro. The company's market capitalization stands at $860.09 million, reflecting investor interest in its potential despite current financial losses.

InvestingPro data shows that Dianthus has experienced significant revenue growth, with a 135.06% increase in quarterly revenue as of Q3 2024. This growth trajectory supports the company's aggressive research and development spending, which led to the higher-than-expected net loss mentioned in the article.

Two relevant InvestingPro Tips highlight the company's financial position. Firstly, Dianthus "holds more cash than debt on its balance sheet," which is crucial for a biotech company investing heavily in R&D and preparing for pivotal trials. Secondly, the company has shown a "high return over the last year," with a one-year price total return of 152.7% as of the latest data.

These insights suggest that while Dianthus is not currently profitable, investors are optimistic about its future prospects, particularly in light of the upcoming CIDP trial. For readers interested in a deeper analysis, InvestingPro offers 5 additional tips that could provide further context to Dianthus's financial health and market position.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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