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Vertex (VRTX) to Begin Clinical Study on Type I Diabetes Drug
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Vertex Pharmaceuticals (VRTX - Free Report) announced the clearance of an Investigational New Drug (IND) application by the FDA for VX-264, its novel encapsulated cell therapy candidate for the potential treatment of type I diabetes (T1D).
VX-264 is a stem cell-derived, fully differentiated pancreatic islet cell therapy encapsulated into an immunoprotective device, which is being developed by Vertex.
The company plans to initiate a phase I/II trial to study the safety, tolerability and efficacy of VX-264 in patients with T1D by the first half of 2023.
Vertex has earlier received approval from Health Canada on the Clinical Trial Application (CTA) for beginning clinical testing of VX-264. A phase I/II study is ongoing in Canada.
Vertex’s shares have risen 21.3% in the past year against the industry’s 8.1% decline.
Image Source: Zacks Investment Research
The VX-264 program uses the same stem cell-derived pancreatic islet cells as Vertex’s VX-880 program.
The company is pursuing multiple investigational approaches using stem cell-derived islets with the aim of replacing the insulin-producing islet cells that are destroyed in people with T1D. While VX-880 is meant for the transplantation of islet cells alone, using immunosuppression to protect the implanted cells, VX-264 involves the implantation of the islet cells inside an immunoprotective device.
A phase I/II study is ongoing on VX-880, Vertex’s stem cell-derived fully differentiated islet cell replacement therapy for treating T1D with impaired hypoglycemic awareness and severe hypoglycemia. Proof-of-concept has been achieved in the VX-880 program, with the first two patients treated with half the targeted dose. The study is ongoing in the United States and Canada. Part B of the study has completed its enrollment, while part C is expected to begin in 2023.
Loss per share estimates for Kala Pharmaceuticals have narrowed from $19.67 to $15.35 for 2023 and from $14.41 to $13.12 for 2024, in the past 60 days. The stock has plunged 70.4% in the past year.
KALA’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for CRISPR Therapeutics have narrowed from $8.21 to $7.39 for 2023 in the past 60 days.
CRSP's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 3.19%. The stock has declined 26.6% in the past year.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.84 to $2.57 for 2023 and from $2.79 to $2.49 for 2024 in the past 60 days. The stock has plunged 33.5% in the past year.
ALLO’s earnings beat estimates in all the last four quarters, the average surprise being 8.33%.
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Vertex (VRTX) to Begin Clinical Study on Type I Diabetes Drug
Vertex Pharmaceuticals (VRTX - Free Report) announced the clearance of an Investigational New Drug (IND) application by the FDA for VX-264, its novel encapsulated cell therapy candidate for the potential treatment of type I diabetes (T1D).
VX-264 is a stem cell-derived, fully differentiated pancreatic islet cell therapy encapsulated into an immunoprotective device, which is being developed by Vertex.
The company plans to initiate a phase I/II trial to study the safety, tolerability and efficacy of VX-264 in patients with T1D by the first half of 2023.
Vertex has earlier received approval from Health Canada on the Clinical Trial Application (CTA) for beginning clinical testing of VX-264. A phase I/II study is ongoing in Canada.
Vertex’s shares have risen 21.3% in the past year against the industry’s 8.1% decline.
Image Source: Zacks Investment Research
The VX-264 program uses the same stem cell-derived pancreatic islet cells as Vertex’s VX-880 program.
The company is pursuing multiple investigational approaches using stem cell-derived islets with the aim of replacing the insulin-producing islet cells that are destroyed in people with T1D. While VX-880 is meant for the transplantation of islet cells alone, using immunosuppression to protect the implanted cells, VX-264 involves the implantation of the islet cells inside an immunoprotective device.
A phase I/II study is ongoing on VX-880, Vertex’s stem cell-derived fully differentiated islet cell replacement therapy for treating T1D with impaired hypoglycemic awareness and severe hypoglycemia. Proof-of-concept has been achieved in the VX-880 program, with the first two patients treated with half the targeted dose. The study is ongoing in the United States and Canada. Part B of the study has completed its enrollment, while part C is expected to begin in 2023.
Zacks Rank & Stocks to Consider
Vertex’s currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector include Kala Pharmaceuticals (KALA - Free Report) , CRISPR Therapeutics (CRSP - Free Report) and Allogene Therapeutics (ALLO - Free Report) , all holding a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here
Loss per share estimates for Kala Pharmaceuticals have narrowed from $19.67 to $15.35 for 2023 and from $14.41 to $13.12 for 2024, in the past 60 days. The stock has plunged 70.4% in the past year.
KALA’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for CRISPR Therapeutics have narrowed from $8.21 to $7.39 for 2023 in the past 60 days.
CRSP's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 3.19%. The stock has declined 26.6% in the past year.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.84 to $2.57 for 2023 and from $2.79 to $2.49 for 2024 in the past 60 days. The stock has plunged 33.5% in the past year.
ALLO’s earnings beat estimates in all the last four quarters, the average surprise being 8.33%.