On Monday, TD Cowen, through its analyst Joseph Thome, outlined ten anticipated catalysts for the year 2025 that are expected to generate significant investor interest and potentially influence stock movements. The forecast includes a range of clinical trial data releases and regulatory milestones across the firm’s coverage universe.
ANAB is expected to release Phase II rheumatoid arthritis data for Rosnilimab in February 2025. UTHR is looking to extend the success of its Tyvaso treatment to a Phase III idiopathic pulmonary fibrosis program.
Meanwhile, QURE, which has seen its stock surge 173% over the past year and is currently trading near its 52-week high of $18.49, is working towards submitting an accelerated approval application for AMT-130 in Huntington’s disease. According to InvestingPro data, the company maintains a healthy liquidity position with a current ratio of 6.51, though it faces profitability challenges.
ALKS is preparing to release Phase II datasets for its orexin candidate ‘2680 in the first half of 2025. JAZZ is concurrently anticipating Phase III gastric-esophageal junction adenocarcinoma readouts for Zanidatamab in the second quarter of the year, alongside its search for a new CEO.
PRME is set to announce initial prime editing clinical data this year with PM359 in chronic granulomatous disease. In the second half of the year, XENE plans to publish Phase III functional outcome score data for Azetukalner. PTCT is gearing up for several regulatory catalysts involving Vatiquinone, Sepiapterin, and Translarna.
Moreover, RAPP is testing a new Phase II approach for RNS-associated conditions with RAP-219, expecting functional outcome score data by mid-year. Lastly, CMRX has submitted Dordaviprone for accelerated approval and is currently awaiting a decision from the FDA.
To complement these insights, TD Cowen also provided a supplementary list of other potential catalysts to monitor, which includes readouts from THRD, AXSM, VRDN, ALLK, among others. For QURE specifically, analysts maintain a bullish stance with price targets ranging from $19.83 to $57.12.
This comprehensive overview by the firm aims to guide investors on key developments to watch in the biotech sector for 2025. For deeper insights into biotech companies’ valuations and financial health metrics, consider exploring InvestingPro, which offers 14 additional investment tips for QURE.
In other recent news, biotechnology firm uniQure (NASDAQ:) BV has made significant strides with its gene therapy product, AMT-130, for the treatment of Huntington’s Disease.
The U.S. Food and Drug Administration (FDA) has agreed to an accelerated approval process for AMT-130, a development that has been positively received by financial services companies like Mizuho (NYSE:) Securities, RBC Capital Markets, and Stifel. Furthermore, Raymond (NS:) James has upgraded the company’s stock from Outperform to Strong Buy.
The FDA’s approval pathway agreement is based on the company’s ongoing Phase I/II clinical trial data, potentially eliminating the need for additional studies. This development simplifies the approval process for uniQure’s treatment. The company has also initiated a Phase I/II clinical trial for its investigational treatment AMT-162, aimed at addressing ALS caused by SOD1 mutations.
While Goldman Sachs has maintained its Neutral rating on uniQure, other firms such as H.C. Wainwright and Stifel have maintained a positive rating on the company. These recent developments reflect uniQure’s progress in gene therapy, particularly with AMT-130 for Huntington’s disease and AMT-162 for ALS.
Further discussions with the FDA are anticipated in the first half of 2025 to discuss the statistical analysis plan and technical requirements for the Biologics License Application submission for AMT-130.
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