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Genprex (GNPX) Up on Advancing Early-Stage NSCLC Study
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Genprex’s (GNPX - Free Report) shares rallied 10.4% in the past week against the industry's 2.4% decline.
Image Source: Zacks Investment Research
A significant part of this upside can be attributed to the completion of the phase I portion of the Acclaim-1 phase I/II clinical study. The study evaluates a combination of GNPX’s lead drug, Reqorsa and AstraZeneca's (AZN - Free Report) Tagrisso (osimertinib) for patients with late-stage non-small cell lung cancer (NSCLC).
The early-stage Acclaim-1 study has three portions — a phase I dose escalation portion, a phase II dose expansion portion and a phase II randomized portion.
The Safety Review Committee reviewed data from the phase I portion and found that Reqorsa was generally well tolerated with no dose-limiting toxicities. As a result, the committee granted permission to proceed with the phase II expansion portion of the study.
The recommended dose in the study was determined at 0.12 mg/kg of Reqorsa, the highest dose administered in the previous phase I portion of the study.
The phase II expansion portion of the study will enroll around 66 patients, divided into two cohorts. While the first one will consist of patients who have received only Tagrisso, the other will include those who have received both Tagrisso and chemotherapy treatments.
This approach aims to evaluate the toxicity profiles, efficacy and other endpoints among patients with different eligibility criteria.
The combination of Reqorsa and Tagrisso has received Fast Track Designation from the FDA for treating the Acclaim-1 patient population. The designation is designed to expedite the development and review of drugs to treat serious medical conditions and fulfill unmet curative needs.
Tagrisso is already approved for the treatment of NSCLC. The strong oncology performance of the drug is driving growth for AZN.
AstraZeneca is also progressing with Acclaim-2 in the phase I/II study, which evaluates a combination of Reqorsa and Merck’s (MRK - Free Report) Keytruda for late-stage NSCLC patients who have progressed after Keytruda treatment.
Keytruda is already approved for the management of many cancers globally. The drug’s sales are growing from continued strong momentum in metastatic indications, including some types of NSCLC, renal cell carcinoma, head and neck squamous cell carcinoma cancers, and a rapid uptake across recent earlier-stage launches. In the first quarter of 2023, Merck recorded revenues of $5.8 billion from Keytruda product sales.
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Genprex (GNPX) Up on Advancing Early-Stage NSCLC Study
Genprex’s (GNPX - Free Report) shares rallied 10.4% in the past week against the industry's 2.4% decline.
Image Source: Zacks Investment Research
A significant part of this upside can be attributed to the completion of the phase I portion of the Acclaim-1 phase I/II clinical study. The study evaluates a combination of GNPX’s lead drug, Reqorsa and AstraZeneca's (AZN - Free Report) Tagrisso (osimertinib) for patients with late-stage non-small cell lung cancer (NSCLC).
The early-stage Acclaim-1 study has three portions — a phase I dose escalation portion, a phase II dose expansion portion and a phase II randomized portion.
The Safety Review Committee reviewed data from the phase I portion and found that Reqorsa was generally well tolerated with no dose-limiting toxicities. As a result, the committee granted permission to proceed with the phase II expansion portion of the study.
The recommended dose in the study was determined at 0.12 mg/kg of Reqorsa, the highest dose administered in the previous phase I portion of the study.
The phase II expansion portion of the study will enroll around 66 patients, divided into two cohorts. While the first one will consist of patients who have received only Tagrisso, the other will include those who have received both Tagrisso and chemotherapy treatments.
This approach aims to evaluate the toxicity profiles, efficacy and other endpoints among patients with different eligibility criteria.
The combination of Reqorsa and Tagrisso has received Fast Track Designation from the FDA for treating the Acclaim-1 patient population. The designation is designed to expedite the development and review of drugs to treat serious medical conditions and fulfill unmet curative needs.
Tagrisso is already approved for the treatment of NSCLC. The strong oncology performance of the drug is driving growth for AZN.
AstraZeneca is also progressing with Acclaim-2 in the phase I/II study, which evaluates a combination of Reqorsa and Merck’s (MRK - Free Report) Keytruda for late-stage NSCLC patients who have progressed after Keytruda treatment.
Keytruda is already approved for the management of many cancers globally. The drug’s sales are growing from continued strong momentum in metastatic indications, including some types of NSCLC, renal cell carcinoma, head and neck squamous cell carcinoma cancers, and a rapid uptake across recent earlier-stage launches. In the first quarter of 2023, Merck recorded revenues of $5.8 billion from Keytruda product sales.
GENPREX Price and Consensus
GENPREX price-consensus-chart | GENPREX Quote
Zacks Rank and Stock to Consider
Currently, Genprex carries a Zacks Rank #3 (Hold).
A better-ranked stock in the same sector is ADMA Biologics (ADMA - Free Report) , carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per estimates for ADMA have narrowed from 19 cents to 9 cents for 2023 in the past 60 days. Shares of ADMA have risen 1% in the past week.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met the mark in one, delivering an average surprise of 19.3%.