RHHBY to Advance Parkinson's Disease Drug to Late-Stage Development

Roche RHHBY announced that it will advance pipeline candidate prasinezumab into phase III development for early-stage Parkinson’s disease.

Roche has a licensing agreement with Prothena PRTA for prasinezumab.

The decision to advance prasinezumab to late-stage development was based on data from the phase IIb PADOVA study and ongoing open-label extensions (OLEs) of PADOVA and phase II PASADENA studies.

Year to date, shares of Roche have risen 20.9% compared to the industry’s 4% growth.

More on RHHBY’s Prasinezumab

Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody, targeting a known biological driver of Parkinson’s disease progression.

The ongoing PASADENA and PADOVA OLE studies are evaluating the long-term safety and efficacy of prasinezumab in over 750 people with early-stage Parkinson’s disease.

Multiple endpoints from the PADOVA and OLE studies indicate a potential clinical benefit of prasinezumab when added to effective symptomatic treatment in early-stage Parkinson’s disease.

The phase IIb PADOVA study evaluated the safety and efficacy of prasinezumab versus placebo in 586 randomized patients with early-stage Parkinson’s disease who were on stable symptomatic treatment.

The study missed the primary endpoint. While the candidate showed potential clinical efficacy in the primary endpoint of time to confirmed motor progression, it missed statistical significance.

Nonetheless, positive trends toward reduced motor progression at 104 weeks (two years) were observed and these effects are expected to remain over longer treatment periods based on additional OLE data.

Data from the PADOVA study also provided the first biomarker evidence of prasinezumab affecting the underlying disease biology.

Hence, Roche believes that the totality of data hints at prasinezumab’s potential to become the first disease-modifying treatment for people with Parkinson’s disease.

In December 2013, Roche entered into a licensing agreement with Prothena for the development and commercialization of selected antibodies targeting alpha-synuclein, including prasinezumab.

Per the terms, Roche has the sole responsibility for developing and commercializing prasinezumab and will pay double-digit teen royalties on net sales of the candidate to Prothena.

To date, Prothena has earned $135 million with up to $620 million in additional milestone payments that include regulatory and sales milestones. In addition, Prothena has an option to co-promote prasinezumab in the United States.

Challenges in Developing Treatments for Parkinson's Disease

Parkinson’s disease is a chronic, progressive and debilitating neurodegenerative disease. Developing a treatment for this complex disease associated with both motor and non-motor symptoms is challenging.

Many companies are making efforts to develop a treatment for the disease. Earlier, in December 2024, UCB announced that the ORCHESTRA proof-of-concept study on minzasolmin, an investigational, oral small molecule, alpha-synuclein misfolding inhibitor, did not meet its primary and secondary clinical endpoints.

Minzasolmin was being developed in partnership with Swiss pharma giant Novartis NVS.

The successful development of prasinezumab will be a significant achievement for Roche.

RHHBY's Zacks Rank & Key Picks

Roche currently carries a Zacks Rank #3 (Hold).

A couple of better-ranked large-cap pharma stocks are Novartis and Bayer BAYRY, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Zacks Consensus Estimate for Novartis’ 2025 earnings per share (EPS) has risen from $8.46 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 35 cents to $9.02 during this timeframe. The stock has risen 25.6% so far this year.

BAYRY’s 2025 EPS estimate has increased from $1.19 to $1.25 for 2025 over the past 60 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 61.9%.

BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
 

 

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