TD Cowen analyst Joseph Thome has maintained their bullish stance on DNLI stock, giving a Buy rating on August 7.
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Joseph Thome has given his Buy rating due to a combination of factors surrounding Denali Therapeutics’ promising pipeline and regulatory progress. The company has reported a significant advancement with its lead product, DNL310, which is under priority review by the FDA with a PDUFA date set for January 5, 2026. The clinical data from the Phase I/II study of DNL310 has been encouraging, showing substantial decreases in HS levels in the CSF and improvements in clinical measures, supporting the potential for approval with a broad label.
Additionally, Denali has reached an agreement with the FDA on an Accelerated Approval path for DNL126, targeting MPS IIIA, with promising preliminary data from its Phase I/II study. The alignment with the FDA and the similarities in the development programs of DNL310 and DNL126 enhance the prospects for DNL126’s approval. These developments, coupled with Denali’s strong cash position, suggest that the company’s shares are undervalued, justifying the Buy rating.
Thome covers the Healthcare sector, focusing on stocks such as Jazz Pharmaceuticals, PTC Therapeutics, and Axsome Therapeutics. According to TipRanks, Thome has an average return of -5.3% and a 38.89% success rate on recommended stocks.
In another report released on August 7, BTIG also reiterated a Buy rating on the stock with a $32.00 price target.