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Talaris (TALS) Down on Patient Death From Renal Transplant Study
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Talaris Therapeutics recently reported the death of a patient in its phase III study evaluating its pipeline candidate, FCR001, in living donor kidney transplant (LDKT) recipients.
Post the update, Talaris’ stock declined 43.39% on Oct 20. Shares of Talaris have plunged 91% in the year-to-date period compared with the industry’s fall of 30.2%.
Image Source: Zacks Investment Research
Talaris provided an update on its ongoing phase III FREEDOM-1 study treating LDKT patients back in June 2022. Three patients who were more than 12 months post-transplant were dosed with FCR001 and abstained from all chronic anti-rejection drugs. All these patients exhibited stable kidney function.
Severe adverse events were consistent with those expected in kidney transplant patients. Three cases of low-grade acute graft-vs-host disease (aGvHD) were observed, and one of the three was subsequently diagnosed with moderate chronic GvHD. However, all three subjects responded to treatment and the issues were resolved at the time of the update.
To investigate the aGVHD cases in the subjects, Talaris conducted an internal review of all the GvHD cases in phase II and III studies of FCR001. Based on this update, Talaris modified the FREEDOM-1 study protocol to eliminate plerixafor from the donor mobilization regimen in all but exceptional cases. It also added a second dose of post-transplant cyclophosphamide (PTCy) for the FCR001 recipients.
All the findings and recommendations were reviewed by the Data Monitoring Committee (DMC). Study screening and enrollment of the study continued with these modifications.
However, the patient who had previously developed moderate chronic GvHD had to be hospitalized with grade IV GvHD, with serious infections and complications, leading to respiratory and renal failure and, ultimately, death.
The company has identified that the deceased patient had a related, same-sex donor with an HLA mismatch of 2/6. Plerixafor was not used to mobilize this donor. Moreover, the starting FCR001 dosage contained many CD34+ cells and total nucleated cells. Both these factors were identified by Talaris as a risk for the occurrence of GvHD.
As the deceased patient was treated before the study protocol amendment, he had not received a second post-transplant dose of cyclophosphamide.
The company also reported that the two other patients who were previously reported to have grade II aGvHD witnessed complete resolution.
Post the death of the patient in the phase III FREEDOM-1 study, the evaluation was temporarily halted and further reviewed by the FREEDOM-1 DMC. The DMC then decided that the study was fit to continue with patient enrollment and dosing. Talaris has reported both the death and the DMC’s decision to the FDA.
Aerie Pharmaceuticals' loss estimates for 2022 remained steady at $1.82 in the past 30 days. The loss estimates for 2023 also remained steady at 96cents per share in the same time frame.
AERI surpassed earnings in two of the trailing four quarters, missing the same on the remaining two occasions. The average negative earnings surprise for Aerie is 70.27%.
Acer’s loss per share estimates for 2022 remained steady at $2.47 in the past 30 days. The loss per share for 2023 has also remained steady at $1.07 in the same time frame.
Earnings of Acadia beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions. The average negative earnings surprise for ACER 106.16%.
Catalyst’s earnings per share estimates for 2022 remained steady at 70 cents in the past 30 days. The same for 2023 has also remained steady at 85 cents in the same time frame.
Earnings of Catalyst was in-line with the estimates in one of the trailing four quarters, beat the same in one and missed estimates on the remaining two occasions. The average negative earnings surprise for CPRX is 5.41%.
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Talaris (TALS) Down on Patient Death From Renal Transplant Study
Talaris Therapeutics recently reported the death of a patient in its phase III study evaluating its pipeline candidate, FCR001, in living donor kidney transplant (LDKT) recipients.
Post the update, Talaris’ stock declined 43.39% on Oct 20. Shares of Talaris have plunged 91% in the year-to-date period compared with the industry’s fall of 30.2%.
Image Source: Zacks Investment Research
Talaris provided an update on its ongoing phase III FREEDOM-1 study treating LDKT patients back in June 2022. Three patients who were more than 12 months post-transplant were dosed with FCR001 and abstained from all chronic anti-rejection drugs. All these patients exhibited stable kidney function.
Severe adverse events were consistent with those expected in kidney transplant patients. Three cases of low-grade acute graft-vs-host disease (aGvHD) were observed, and one of the three was subsequently diagnosed with moderate chronic GvHD. However, all three subjects responded to treatment and the issues were resolved at the time of the update.
To investigate the aGVHD cases in the subjects, Talaris conducted an internal review of all the GvHD cases in phase II and III studies of FCR001. Based on this update, Talaris modified the FREEDOM-1 study protocol to eliminate plerixafor from the donor mobilization regimen in all but exceptional cases. It also added a second dose of post-transplant cyclophosphamide (PTCy) for the FCR001 recipients.
All the findings and recommendations were reviewed by the Data Monitoring Committee (DMC). Study screening and enrollment of the study continued with these modifications.
However, the patient who had previously developed moderate chronic GvHD had to be hospitalized with grade IV GvHD, with serious infections and complications, leading to respiratory and renal failure and, ultimately, death.
The company has identified that the deceased patient had a related, same-sex donor with an HLA mismatch of 2/6. Plerixafor was not used to mobilize this donor. Moreover, the starting FCR001 dosage contained many CD34+ cells and total nucleated cells. Both these factors were identified by Talaris as a risk for the occurrence of GvHD.
As the deceased patient was treated before the study protocol amendment, he had not received a second post-transplant dose of cyclophosphamide.
The company also reported that the two other patients who were previously reported to have grade II aGvHD witnessed complete resolution.
Post the death of the patient in the phase III FREEDOM-1 study, the evaluation was temporarily halted and further reviewed by the FREEDOM-1 DMC. The DMC then decided that the study was fit to continue with patient enrollment and dosing. Talaris has reported both the death and the DMC’s decision to the FDA.
Talaris Therapeutics, Inc. Price
Talaris Therapeutics, Inc. price | Talaris Therapeutics, Inc. Quote
Zacks Rank and Stocks to Consider
Talaris currently has a Zacks Rank #4 (Sell).
Some better-ranked stocks in the same sector include Aerie Therapeutics , sporting a Zacks Rank #1 (Strong Buy) and Acer Therapeutics (ACER - Free Report) and Catalyst Pharmaceuticals (CPRX - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Aerie Pharmaceuticals' loss estimates for 2022 remained steady at $1.82 in the past 30 days. The loss estimates for 2023 also remained steady at 96cents per share in the same time frame.
AERI surpassed earnings in two of the trailing four quarters, missing the same on the remaining two occasions. The average negative earnings surprise for Aerie is 70.27%.
Acer’s loss per share estimates for 2022 remained steady at $2.47 in the past 30 days. The loss per share for 2023 has also remained steady at $1.07 in the same time frame.
Earnings of Acadia beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions. The average negative earnings surprise for ACER 106.16%.
Catalyst’s earnings per share estimates for 2022 remained steady at 70 cents in the past 30 days. The same for 2023 has also remained steady at 85 cents in the same time frame.
Earnings of Catalyst was in-line with the estimates in one of the trailing four quarters, beat the same in one and missed estimates on the remaining two occasions. The average negative earnings surprise for CPRX is 5.41%.