tiprankstipranks
Trending News
More News >
Advertisement
Advertisement

Inhibikase Therapeutics: Late-Stage IKT-001 PAH Program and De-Risked 505(b)(2) Pathway Support Buy Rating and $8 Target

Inhibikase Therapeutics: Late-Stage IKT-001 PAH Program and De-Risked 505(b)(2) Pathway Support Buy Rating and $8 Target

Ram Selvaraju, an analyst from H.C. Wainwright, has initiated a new Buy rating on Inhibikase Therapeutics (IKT).

Claim 70% Off TipRanks This Holiday Season

Ram Selvaraju has given his Buy rating due to a combination of factors related to Inhibikase Therapeutics’ lead asset, IKT-001, and its late-stage development pathway in pulmonary arterial hypertension (PAH). He highlights the company’s plan to move IKT-001 directly into a global, pivotal Phase 3 trial (IMPROVE-PAH) starting in early 2026, reflecting confidence from both management and regulators in the strength of the program. The drug is a novel prodrug form of imatinib mesylate, designed to capture the prior efficacy signals seen with imatinib in PAH—such as improvements in pulmonary vascular resistance and exercise capacity—while addressing tolerability issues that previously led to high discontinuation rates. Selvaraju expects that the reformulated agent should significantly reduce gastrointestinal side effects and thereby improve overall safety and adherence.

Ram Selvaraju also emphasizes that the FDA has already provided guidance supporting a two-part adaptive Phase 3 design, which he views as strategically favorable. The design allows for dose optimization, seamless transition from Part A to Part B, and the option to refine sample size based on interim findings, all of which can enhance statistical power and development efficiency. Additionally, the company’s work on differentiated dosage forms, optimized manufacturing, and pursuit of a 505(b)(2) regulatory pathway positions IKT-001 as a potentially new molecular entity with an accelerated and de-risked route to market. Taken together, these clinical, regulatory, and manufacturing advantages underpin his conviction that Inhibikase shares offer attractive upside, supporting his Buy rating and $8 price target.

In another report released on December 11, Cantor Fitzgerald also initiated coverage with a Buy rating on the stock with a $4.00 price target.

Disclaimer & DisclosureReport an Issue

1