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Sigilon (SGTX) Down as FDA Places Hold on Hemophilia Study

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Shares of Sigilon Therapeutics, Inc. (SGTX - Free Report) plunged 25.3% after the company announced that the FDA placed a clinical hold on its phase I/II study evaluating its pipeline candidate SIG-001 in patients with severe or moderately severe hemophilia A.

The clinical hold came in place following the clinical stage biotechnology company’s announcement of a serious adverse event (SAE) and a temporary enrollment halt.

We note that SIG-001 is the company’s most advanced and investigational therapy in development to prevent bleeding episodes in patients with moderate-severe to severe hemophilia A.

Three patients have been dosed with SIG-001 to date. The third patient who received the highest dose of the study drug developed inhibitors to Factor VIII (FVIII), a well-known complication of FVIII therapy.

Consequently, the FDA requested additional information or data on factors potentially contributing to the development of inhibitors in this patient, such as family history and immune stimulation from a recent vaccination. The three patients enrolled in this study will continue to be under observation per study protocol.

The setback will delay the development of the candidate, which was granted an Orphan Drug designation to treat hemophilia A by the FDA in August 2019 and EMA in November 2020.

This apart, the company is developing SIG-009 for patients with Factor VII deficiency and SIG-003 for patients with Hemophilia B.

The stock has slumped 86.9% so far this year compared with the  industry’s decrease of 8.3%.

Zacks Investment Research
Image Source: Zacks Investment Research

Other candidates in the company’s pipeline include SIG-007 (developed for patients with a confirmed diagnosis of Fabry disease), SIG-018 for patients with mucopolysaccharidosis type 2 or MPS-2 and SIG-020 for patients with mucopolysaccharidosis type 6 or MPS-6. The company is also developing SIG-002 for the treatment of type 1 Diabetes in collaboration with Eli Lilly.

Treatments approved for hemophilia A include Roche’s (RHHBY - Free Report) hemophilia A and Novo Nordisk’s (NVO - Free Report) NovoSeven among others.

Zacks Rank & Stock to Consider

Sigilon currently carries a Zacks Rank #3 (Hold).  A better-ranked stock in the healthcare sector is Zoetis, Inc. (ZTS - Free Report) , which carries a Zacks Rank #2 (Buy) at present. You can see  the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Zoetis’ earnings estimates have been revised 7 cents upward for 2021 and 9 cents for 2022 over the past 90 days. The stock has rallied 16.5% year to date.