Sangamo Therapeutics SGMO stock crashed 60.4% after hours on Monday after it announced that its partner, Pfizer PFE, terminated its global collaboration and license agreement for giroctocogene fitelparvovec, a one-time gene therapy candidate for treating moderately severe to severe hemophilia A.

Following Pfizer’s decision to end the collaboration, Sangamo regained development and commercialization rights to giroctocogene fitelparvovec. The company is considering all options to continue the program, which includes looking for a new collaboration partner for the candidate.

In the year so far, Sangamo’s shares have gained 330.7% against the industry’s 13.1% decline.

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PFE Returns Rights to SGMO Despite Pivotal Study Meeting Goal

A rare genetic blood disorder, hemophilia is caused by a missing clotting protein Factor VIII (FVIII) in hemophilia A, which prevents normal blood clotting. If the blood does not clot properly, it can lead to painful bleeding inside the joints that can cause scarring and damage.

In July, the companies announced positive data from the pivotal phase III AFFINE study on giroctocogene fitelparvovec. The study achieved its primary objective of non-inferiority, as well as superiority, of total annualized bleeding rate from Week 12 through at least 15 months of follow-up post-infusion compared with standard Factor VIII (FVIII) prophylactic treatment. The study also met key secondary objectives.

Sangamo said that Pfizer had informed the company of its intention to file regulatory applications for giroctocogene fitelparvovec in the United States and EU in early 2025.

Pfizer had in-licensed global rights to giroctocogene fitelparvovec from Sangamo in 2019 and was responsible for pivotal studies as well as regulatory and potential commercialization activities for the candidate. Sangamo was eligible to earn up to $220 million in milestone payments from Pfizer upon achieving certain regulatory and commercial milestones for giroctocogene fitelparvovec. 

Other Approved Gene Therapies to Treat Hemophilia

Pfizer received FDA approval for two gene therapies for hemophilia, Hympavzi (marstacimab) for hemophilia A or B and Beqvez/Durveqtix (fidanacogene elaparvovec), for moderate to severe hemophilia B this year.

BioMarin’s BMRN Roctavian, an adeno-associated virus-based gene therapy, was approved in June 2023 to treat adult patients with severe hemophilia A. Roctavian was the first one-shot gene therapy approved for treating severe hemophilia A in adults. Roctavian was approved in the European Union in 2022. However, the drug has not been able to generate any significant sales for BioMarin in 2024.

SGMO’s Other Pipeline Candidates

Sangamo’s another key pipeline candidate is isaralgagene civaparvovec, or ST-920, an investigational gene therapy for the treatment of Fabry disease. The company plans to seek accelerated approval for isaralgagene civaparvovec from the FDA based on data from the ongoing phase I/II STAAR study. It expects to file a biologics license application to the FDA in the second half of 2025.

It expects to begin clinical studies (phase I/II) on ST-503 for the treatment of intractable pain due to idiopathic small fiber neuropathy in mid-2025.

SGMO’s Zacks Rank

Sangamo currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Sangamo Therapeutics, Inc. Price and Consensus

Sangamo Therapeutics, Inc. price-consensus-chart | Sangamo Therapeutics, Inc. Quote

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