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CRISPR (CRSP), Vertex Fall Despite FDA Nod to SCD Drug Casgevy
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CRISPR Therapeutics (CRSP - Free Report) and Vertex Pharmaceuticals Inc. (VRTX - Free Report) announced that the FDA has approved Casgevy (exagamglogene autotemcel [exa-cel]) for the treatment of sickle cell disease (SCD) for patients aged 12 years and older with recurrent vaso-occlusive crises (VOCs).
Casgevy became the first CRISPR-based gene-editing therapy to be approved in the United States. In an SEC filing, Vertex announced pricing Casgevy at $2.2 million in the United States.
SCD is a group of inherited blood disorders affecting approximately 100,000 people in the United States. It is a complex and progressive genetic disease that generally leads to unpredictable and debilitating vaso-occlusive events (VOEs). High concentrations of sickle hemoglobin in red blood cells cause them to become misshapen, sticky and rigid, with a shorter life span, which manifests acutely as hemolytic anemia, vasculopathy and vaso-occlusion.
Per CRSP, the FDA approval of Casgevy provides SCD patients, for the first time, with a durable one-time therapy that offers the potential of a functional cure for their disease by eliminating severe VOCs and hospitalizations caused by severe VOCs.
CRSP has stated that the Casgevy administration requires specialized expertise. As a result, VRTX is currently holding discussions with potential hospitals to establish a network of independently operated and authorized treatment centers throughout the United States to offer Casgevy to patients.
Year to date, shares of CRISPR have shot up 58.8% against the industry’s 20.4% fall.
Image Source: Zacks Investment Research
Despite the FDA approval of Casgevy in the treatment of SCD, CRISPR’s stock fell 8.1% on Friday, as the investors did not cheer the long and arduous treatment process of the gene therapy drug, along with several side effects of treatment stated by the company under Casgevy safety information. The hefty price tag of the drug also limits patient access. Vertex also declined 1.1% on Friday.
CRSP has stated that the entire treatment process with Casgevy could take more than six months to be completed. During this period, the patient will have to be kept under doctor supervision, which would drive up hospitalization costs and other associated medical expenses in addition to Casgevy’s cost.
CRISPR has also stated under safety information that the Casgevy treatment process may inhibit a patient’s ability to reproduce. Furthermore, according to a Bloomberg analyst, the stock price drop on Friday was due to the FDA highlighting the required chemotherapy treatments that patients must undergo when using the CRISPR therapy, which could potentially impact the uptake of the drug.
Cagevy is being jointly developed by CRISPR and Vertex. Per the terms of the agreement, the latter is responsible for the global development, manufacturing and commercialization of Casgevy with support from CRISPR. VRTX will record the entirety of Casgevy’s revenues. CRSP is entitled to receive from Vertex, a 40% share in the net profits or losses from Casgevy. The FDA approval of Casgevy in SCD has triggered a $200 million milestone payment to CRISPR from Vertex.
Year to date, shares of Vertex have gained 21.3% against the industry’s 20.4% decline.
Image Source: Zacks Investment Research
CRISPR and Vertex are also developing Cagevy for the treatment of transfusion-dependent beta thalassemia (TDT) in the United States. A regulatory filing for the use of Casgevy for this indication is currently under review. A decision from the FDA is expected on Mar 30, 2024.
We would like to remind the investors that last month, CRISPR and Vertex announced the approval of Casgevy in the U.K. for treating both SCD and TDT indications.
The companies have filed similar regulatory submissions for exa-cel in Europe, which was validated by the European Medicines Agency in January 2023.
It is important to note that the FDA also approved bluebird bio’s(BLUE - Free Report) one-time gene therapy, lovotibeglogene autotemcel (lovo-cel), for the treatment of SCD in patients aged 12 years and older who have a history of VOEs. The FDA approved lovo-cel under the brand name Lyfgenia.
However, shares of bluebird were down 40.5% despite receiving FDA approval for lovo-cel. This is mostly because of the boxed warning of hematologic malignancy issued with Lyfgenia’s label.
Some patients developed blood cancer when being treated with BLUE’s Lyfgenia. bluebird bio has assigned a price tag of $3.1 million to its gene therapy drug.
The long-term safety of both these therapies from CRISPR/Vertex and bluebird remains unknown and hence the investors seem wary. Per the FDA, patients who received Casgevy or Lyfgenia will be followed in a long-term study to evaluate each product’s safety and effectiveness.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share has remained constant at 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 earnings per share has increased from 62 cents to 64 cents. Year to date, shares of PBYI have lost 2.4%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
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CRISPR (CRSP), Vertex Fall Despite FDA Nod to SCD Drug Casgevy
CRISPR Therapeutics (CRSP - Free Report) and Vertex Pharmaceuticals Inc. (VRTX - Free Report) announced that the FDA has approved Casgevy (exagamglogene autotemcel [exa-cel]) for the treatment of sickle cell disease (SCD) for patients aged 12 years and older with recurrent vaso-occlusive crises (VOCs).
Casgevy became the first CRISPR-based gene-editing therapy to be approved in the United States. In an SEC filing, Vertex announced pricing Casgevy at $2.2 million in the United States.
SCD is a group of inherited blood disorders affecting approximately 100,000 people in the United States. It is a complex and progressive genetic disease that generally leads to unpredictable and debilitating vaso-occlusive events (VOEs). High concentrations of sickle hemoglobin in red blood cells cause them to become misshapen, sticky and rigid, with a shorter life span, which manifests acutely as hemolytic anemia, vasculopathy and vaso-occlusion.
Per CRSP, the FDA approval of Casgevy provides SCD patients, for the first time, with a durable one-time therapy that offers the potential of a functional cure for their disease by eliminating severe VOCs and hospitalizations caused by severe VOCs.
CRSP has stated that the Casgevy administration requires specialized expertise. As a result, VRTX is currently holding discussions with potential hospitals to establish a network of independently operated and authorized treatment centers throughout the United States to offer Casgevy to patients.
Year to date, shares of CRISPR have shot up 58.8% against the industry’s 20.4% fall.
Image Source: Zacks Investment Research
Despite the FDA approval of Casgevy in the treatment of SCD, CRISPR’s stock fell 8.1% on Friday, as the investors did not cheer the long and arduous treatment process of the gene therapy drug, along with several side effects of treatment stated by the company under Casgevy safety information. The hefty price tag of the drug also limits patient access. Vertex also declined 1.1% on Friday.
CRSP has stated that the entire treatment process with Casgevy could take more than six months to be completed. During this period, the patient will have to be kept under doctor supervision, which would drive up hospitalization costs and other associated medical expenses in addition to Casgevy’s cost.
CRISPR has also stated under safety information that the Casgevy treatment process may inhibit a patient’s ability to reproduce. Furthermore, according to a Bloomberg analyst, the stock price drop on Friday was due to the FDA highlighting the required chemotherapy treatments that patients must undergo when using the CRISPR therapy, which could potentially impact the uptake of the drug.
Cagevy is being jointly developed by CRISPR and Vertex. Per the terms of the agreement, the latter is responsible for the global development, manufacturing and commercialization of Casgevy with support from CRISPR. VRTX will record the entirety of Casgevy’s revenues. CRSP is entitled to receive from Vertex, a 40% share in the net profits or losses from Casgevy. The FDA approval of Casgevy in SCD has triggered a $200 million milestone payment to CRISPR from Vertex.
Year to date, shares of Vertex have gained 21.3% against the industry’s 20.4% decline.
Image Source: Zacks Investment Research
CRISPR and Vertex are also developing Cagevy for the treatment of transfusion-dependent beta thalassemia (TDT) in the United States. A regulatory filing for the use of Casgevy for this indication is currently under review. A decision from the FDA is expected on Mar 30, 2024.
We would like to remind the investors that last month, CRISPR and Vertex announced the approval of Casgevy in the U.K. for treating both SCD and TDT indications.
The companies have filed similar regulatory submissions for exa-cel in Europe, which was validated by the European Medicines Agency in January 2023.
It is important to note that the FDA also approved bluebird bio’s (BLUE - Free Report) one-time gene therapy, lovotibeglogene autotemcel (lovo-cel), for the treatment of SCD in patients aged 12 years and older who have a history of VOEs. The FDA approved lovo-cel under the brand name Lyfgenia.
However, shares of bluebird were down 40.5% despite receiving FDA approval for lovo-cel. This is mostly because of the boxed warning of hematologic malignancy issued with Lyfgenia’s label.
Some patients developed blood cancer when being treated with BLUE’s Lyfgenia. bluebird bio has assigned a price tag of $3.1 million to its gene therapy drug.
The long-term safety of both these therapies from CRISPR/Vertex and bluebird remains unknown and hence the investors seem wary. Per the FDA, patients who received Casgevy or Lyfgenia will be followed in a long-term study to evaluate each product’s safety and effectiveness.
CRISPR Therapeutics AG Price and Consensus
CRISPR Therapeutics AG price-consensus-chart | CRISPR Therapeutics AG Quote
Zacks Rank
CRISPR currently has a Zacks Rank #2 (Buy), while Vertex has a Zacks Rank #3 (Hold) at present.
Another Stock to Consider
Another top-ranked stock worth mentioning is Puma Biotechnology, Inc. (PBYI - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share has remained constant at 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 earnings per share has increased from 62 cents to 64 cents. Year to date, shares of PBYI have lost 2.4%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.