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eFFECTOR Therapeutics (EFTR) Plunges 82% as NSCLC Study Fails
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eFFECTOR Therapeutics, Inc. (EFTR - Free Report) plunged 82% in the last trading session on Apr 4, after the company announced disappointing top-line results from the primary analysis of its mid-stage non-small cell lung cancer (NSCLC) study. Consequently, the company has abandoned the tomivosertib development program in frontline NSCLC.
The randomized phase II KICKSTART study is evaluating the safety and efficacy of its investigational candidate, tomivosertib, in comparison with placebo, each administered in combination with Merck’s (MRK - Free Report) Keytruda (pembrolizumab) for the frontline treatment of patients with NSCLC with PD-L1 ≥50%.
Upon evaluation of 36 events in the primary analysis of the mid-stage study, the two-sided p value for progression free survival (PFS), the primary endpoint of the study, calculated based on a stratified log rank test, was 0.21, which did not meet the pre-specified threshold of p≤0.2.
Overall survival results, although not mature at the time of the analysis, did not show any trend favoring treatment with the tomivosertib/Keytruda combo. Furthermore, treatment-emergent adverse events in the tomivosertib plus Keytruda arm, of severity Grade 3 or higher, were observed in 67% of the patients, which is significantly higher than those observed in the placebo plus Keytruda arm.
However, the hazard ratio of 0.62 for PFS was only found to be in favor of the tomivosertib/Keytruda treatment arm. The median PFS was 13 weeks in the tomivosertib plus Keytruda arm, which represents some benefit over the 11.7 weeks observed in the placebo plus Keytruda arm.
Year to date, shares of eFFECTOR Therapeutics have plunged 74.7% compared with the industry’s 3.7% decline.
Image Source: Zacks Investment Research
Following the decision to stop the tomivosertib development program, EFTR announced that it will now focus its resources on another clinical-stage candidate, zotatifin. It is currently being developed in a phase IIa dose-escalation study as a monotherapy, in combination with fulvestrant as well as in combination with fulvestrant and abemaciclib for the treatment of estrogen receptor positive breast cancer.
eFFECTOR Therapeutics’ zotatifin has a novel mechanism of action that is distinct from that of tomivosertib’s. The company is currently gearing up to initiate a registrational study of zotatifin for breast cancer indication later in 2024.
Additional data from the phase IIa study of zotatifin, including the recommended phase II dose for zotatifin, combined with fulvestrant and abemaciclib, is expected to be reported in the second half of 2024.
eFFECTOR Therapeutics also reported that a separate investigator-sponsored study of tomivosertib in acute myeloid leukemia (AML) is currently ongoing and will remain unchanged. The company clarified that the mechanistic rationale to test tomivosertib in AML is entirely distinct from the rationale in NSCLC. Hence, the failure of the NSCLC study will not affect the outcome of the AML study.
Currently, Merck markets Keytruda as the standard of care in the frontline treatment of metastatic NSCLC. Keytruda, an anti-PD-1 therapy, is Merck’s blockbuster oncology drug and is approved for several types of cancer, accounting alone for around 45% of the company’s pharmaceutical sales in 2023.
Merck’s Keytruda is presently approved to treat eight indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally, bolstering MRK’s position in the oncology market.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 50 cents. Year to date, shares of ADMA have gained 38.9%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has remained constant at $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share has remained constant at 6 cents. Year to date, shares of FGEN have soared 78.3%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
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eFFECTOR Therapeutics (EFTR) Plunges 82% as NSCLC Study Fails
eFFECTOR Therapeutics, Inc. (EFTR - Free Report) plunged 82% in the last trading session on Apr 4, after the company announced disappointing top-line results from the primary analysis of its mid-stage non-small cell lung cancer (NSCLC) study. Consequently, the company has abandoned the tomivosertib development program in frontline NSCLC.
The randomized phase II KICKSTART study is evaluating the safety and efficacy of its investigational candidate, tomivosertib, in comparison with placebo, each administered in combination with Merck’s (MRK - Free Report) Keytruda (pembrolizumab) for the frontline treatment of patients with NSCLC with PD-L1 ≥50%.
Upon evaluation of 36 events in the primary analysis of the mid-stage study, the two-sided p value for progression free survival (PFS), the primary endpoint of the study, calculated based on a stratified log rank test, was 0.21, which did not meet the pre-specified threshold of p≤0.2.
Overall survival results, although not mature at the time of the analysis, did not show any trend favoring treatment with the tomivosertib/Keytruda combo. Furthermore, treatment-emergent adverse events in the tomivosertib plus Keytruda arm, of severity Grade 3 or higher, were observed in 67% of the patients, which is significantly higher than those observed in the placebo plus Keytruda arm.
However, the hazard ratio of 0.62 for PFS was only found to be in favor of the tomivosertib/Keytruda treatment arm. The median PFS was 13 weeks in the tomivosertib plus Keytruda arm, which represents some benefit over the 11.7 weeks observed in the placebo plus Keytruda arm.
Year to date, shares of eFFECTOR Therapeutics have plunged 74.7% compared with the industry’s 3.7% decline.
Image Source: Zacks Investment Research
Following the decision to stop the tomivosertib development program, EFTR announced that it will now focus its resources on another clinical-stage candidate, zotatifin. It is currently being developed in a phase IIa dose-escalation study as a monotherapy, in combination with fulvestrant as well as in combination with fulvestrant and abemaciclib for the treatment of estrogen receptor positive breast cancer.
eFFECTOR Therapeutics’ zotatifin has a novel mechanism of action that is distinct from that of tomivosertib’s. The company is currently gearing up to initiate a registrational study of zotatifin for breast cancer indication later in 2024.
Additional data from the phase IIa study of zotatifin, including the recommended phase II dose for zotatifin, combined with fulvestrant and abemaciclib, is expected to be reported in the second half of 2024.
eFFECTOR Therapeutics also reported that a separate investigator-sponsored study of tomivosertib in acute myeloid leukemia (AML) is currently ongoing and will remain unchanged. The company clarified that the mechanistic rationale to test tomivosertib in AML is entirely distinct from the rationale in NSCLC. Hence, the failure of the NSCLC study will not affect the outcome of the AML study.
Currently, Merck markets Keytruda as the standard of care in the frontline treatment of metastatic NSCLC. Keytruda, an anti-PD-1 therapy, is Merck’s blockbuster oncology drug and is approved for several types of cancer, accounting alone for around 45% of the company’s pharmaceutical sales in 2023.
Merck’s Keytruda is presently approved to treat eight indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally, bolstering MRK’s position in the oncology market.
eFFECTOR Therapeutics, Inc. Price and Consensus
eFFECTOR Therapeutics, Inc. price-consensus-chart | eFFECTOR Therapeutics, Inc. Quote
Zacks Rank and Other Stocks to Consider
eFFECTOR Therapeutics currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the drug/biotech industry are ADMA Biologics (ADMA - Free Report) and FibroGen (FGEN - Free Report) . ADMA sports a Zacks Rank #1 (Strong Buy) and FGEN carries a Zacks Rank #2 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 ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 50 cents. Year to date, shares of ADMA have gained 38.9%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has remained constant at $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share has remained constant at 6 cents. Year to date, shares of FGEN have soared 78.3%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.