Biogen (BIIB) will complete one of two Parkinson’s studies of BIIB122

Biogenic BIIB has announced it is discontinuing one of two studies on its partner Denali Therapeutics DNLI small molecule LRRK2 inhibitor, BIIB122, for Parkinson’s disease.

Biogens’ BIIB122 clinical development program initially comprised two late-stage studies. The first study was a Phase IIb LUMA study in participants with early stage Parkinson’s disease, and the second study was a Phase III LIGHTHOUSE study in patients with Parkinson’s disease associated with pathogenic LRRK2 mutations. LRRK2 mutations are one of the most common genetic drivers of Parkinson’s disease. While the LUMA study started in May 2022, the LIGHTHOUSE study started in September 2022.

Biogen has now decided to discontinue the LIGHTHOUSE study as it believes the study is complicated and will take several years to complete. The LIGHTHOUSE study is expected to be completed in 2031, when the competitive landscape could also become intense. The LUMA study protocol will be modified to now include only certain eligible patients with an LRRK2 gene mutation in addition to continuing to enroll eligible patients with early stage idiopathic Parkinson’s disease. Biogen will now focus on the LUMA study of BIIB122. Participants currently enrolled in the LIGHTHOUSE study can now join the LUMA study.

Biogen said these changes to BIIB122’s clinical program were not based on safety or efficacy data from studies of the candidate.

Biogens stock is up 9.1% this year so far versus a 7.6% decline for the industry.

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Biogen partnered with Denali Therapeutics in August 2020 to co-develop and co-commercialize BIIB122 for Parkinson’s disease. In 2023, Biogen licensed the Denalis ATV-enabled amyloid beta program.

Biogen has decided to realign its Parkinson’s disease program on BIIB122 as part of its ongoing research and development prioritization initiative. Biogen is focusing on research and development activities with the highest likelihood of success. It may accelerate, terminate, divest, or partner with certain programs by continuing to evaluate new internal and external opportunities within its major therapeutic areas of interest and adjacencies, as part of its R&D initiative.

Zacks ranking and actions to consider

Biogen currently has a Zacks Rank #3 (Hold).

Some better ranked big drug makers are Novo Nordisk NVO and Novartis NV extension. While Novo Nordisk has a Zacks rank of 1 (strong buy), Novartis has a Zacks rank of no. 2 (purchase). You can see the full list of today’s Zacks #1 Rank stock here.

Estimates for Novo Nordisks 2023 earnings per share increased from $4.51 to $5.07 over the past 30 days. Estimates for 2024 have gone from $5.26 per share to $5.91 in the same time frame. Novo Nordisks shares are up 16.2% this year so far.

Novo Nordisk beat earnings expectations in two of the previous four quarters, met estimates in one and missed the other. The company posted a four-quarter earnings surprise of 0.35%, on average.

Novartis earnings-per-share estimates have risen from $6.56 to $6.67 over the past 60 days, while those for 2024 have risen from $7.05 to $7.22 per share. Novartis shares are up 9.5% this year so far.

Novartis beat earnings expectations in each of the final four quarters. The company posted a four-quarter earnings surprise of 5.15%, on average.

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