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Moderna (MRNA) Up 6% on Upbeat Data From Cancer Jab Study
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Shares of Moderna (MRNA - Free Report) rose 6.2% on Apr 9 after management announced encouraging data from a portion of an early-stage study on mRNA-4157/V940, its investigational individualized neoantigen therapy (INT), in certain patients with head and neck cancer. The INT is being developed in collaboration with Merck (MRK - Free Report) .
This portion of the study evaluated the combination of mRNA-4157 and Merck’s blockbuster immuno-oncology drug Keytruda in patients with human papillomavirus negative (HPV-) head and neck squamous cell carcinoma (HNSCC).
Data from the study showed that treatment with the combination not only achieved positive clinical responses in HPV- HNSCC patients but even showed evidence of activation of immune responses. The combined therapy was also found to be safe and well-tolerated by study participants.
Per management, treatment with the combination achieved an objective response rate (ORR) in six out of 22 patients, including two complete responses and four partial ones. The disease control rate was 63.6%. These results were presented at the American Society of Cataract and Refractive Surgery (ASCRS) earlier this week.
Moderna and Merck are already evaluating mRNA-4157 in two separate pivotal late-stage studies in melanoma and non-small cell lung cancer (NSCLC) indications. The companies intend to expand mRNA-4157 across multiple oncology indications and also start more clinical studies throughout this year. Last month, Moderna/Merck posted details on a government website of a phase II/III study evaluating the INT in patients with cutaneous squamous cell carcinoma (CSCC), a form of skin cancer.
Merck and Moderna entered a strategic partnership in 2016 to develop and market mRNA-based therapeutics to treat various types of cancer. Per the terms of the collaboration, the companies will share costs and profits equally.
Year to date, Moderna’s shares have gained 12.2% against the industry’s 5.4% fall.
Image Source: Zacks Investment Research
Unlike other therapies that are uniformly designed to treat all patients, the INT aims to bring individualized treatment to cancer patients. mRNA-4157 is tailored for each patient based on the unique mutational signature of a patient's tumor.
As opposed to traditional medications, mRNA-based therapies teach the body how to make a specific protein that can help your immune system prevent or treat certain diseases. The COVID-19 pandemic further demonstrated the significant potential of mRNA-based therapeutics. By way of COVID-19 vaccines, mRNA vaccines have generated immune responses against the virus at record-high levels compared with traditional protein-based and adeno-based vaccines.
Currently, Moderna has only one commercial product, its COVID-19 vaccine, which is currently facing a steep/significant decline in revenues, ever since the pandemic ended. Using the robust cash sales generated during the pandemic years, Moderna has significantly accelerated its pipeline development, which has shown high clinical efficacy across multiple different indications.
Moderna plans to launch 15 new marketed products, including four in rare disease indications, over the next five years. These include vaccines for RSV, CMV and influenza. Management expects potential FDA approval for its RSV vaccine mRNA-1345 in June. If approved, mRNA-1345 could be Moderna’s second product launch, whose commercial launch is expected in the third quarter of 2024.
Management believes that the company’s vaccine portfolio targets large addressable markets with an estimated total addressable market (TAM) of around $52 billion for infectious disease vaccines.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have surged 35.2%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.06 to $4.43. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.04. Year to date, shares of ANIP have risen 21.6%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
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Moderna (MRNA) Up 6% on Upbeat Data From Cancer Jab Study
Shares of Moderna (MRNA - Free Report) rose 6.2% on Apr 9 after management announced encouraging data from a portion of an early-stage study on mRNA-4157/V940, its investigational individualized neoantigen therapy (INT), in certain patients with head and neck cancer. The INT is being developed in collaboration with Merck (MRK - Free Report) .
This portion of the study evaluated the combination of mRNA-4157 and Merck’s blockbuster immuno-oncology drug Keytruda in patients with human papillomavirus negative (HPV-) head and neck squamous cell carcinoma (HNSCC).
Data from the study showed that treatment with the combination not only achieved positive clinical responses in HPV- HNSCC patients but even showed evidence of activation of immune responses. The combined therapy was also found to be safe and well-tolerated by study participants.
Per management, treatment with the combination achieved an objective response rate (ORR) in six out of 22 patients, including two complete responses and four partial ones. The disease control rate was 63.6%. These results were presented at the American Society of Cataract and Refractive Surgery (ASCRS) earlier this week.
Moderna and Merck are already evaluating mRNA-4157 in two separate pivotal late-stage studies in melanoma and non-small cell lung cancer (NSCLC) indications. The companies intend to expand mRNA-4157 across multiple oncology indications and also start more clinical studies throughout this year. Last month, Moderna/Merck posted details on a government website of a phase II/III study evaluating the INT in patients with cutaneous squamous cell carcinoma (CSCC), a form of skin cancer.
Merck and Moderna entered a strategic partnership in 2016 to develop and market mRNA-based therapeutics to treat various types of cancer. Per the terms of the collaboration, the companies will share costs and profits equally.
Year to date, Moderna’s shares have gained 12.2% against the industry’s 5.4% fall.
Image Source: Zacks Investment Research
Unlike other therapies that are uniformly designed to treat all patients, the INT aims to bring individualized treatment to cancer patients. mRNA-4157 is tailored for each patient based on the unique mutational signature of a patient's tumor.
As opposed to traditional medications, mRNA-based therapies teach the body how to make a specific protein that can help your immune system prevent or treat certain diseases. The COVID-19 pandemic further demonstrated the significant potential of mRNA-based therapeutics. By way of COVID-19 vaccines, mRNA vaccines have generated immune responses against the virus at record-high levels compared with traditional protein-based and adeno-based vaccines.
Currently, Moderna has only one commercial product, its COVID-19 vaccine, which is currently facing a steep/significant decline in revenues, ever since the pandemic ended. Using the robust cash sales generated during the pandemic years, Moderna has significantly accelerated its pipeline development, which has shown high clinical efficacy across multiple different indications.
Moderna plans to launch 15 new marketed products, including four in rare disease indications, over the next five years. These include vaccines for RSV, CMV and influenza. Management expects potential FDA approval for its RSV vaccine mRNA-1345 in June. If approved, mRNA-1345 could be Moderna’s second product launch, whose commercial launch is expected in the third quarter of 2024.
Management believes that the company’s vaccine portfolio targets large addressable markets with an estimated total addressable market (TAM) of around $52 billion for infectious disease vaccines.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank & Key Picks
Moderna currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include ADMA Biologics (ADMA - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have surged 35.2%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.06 to $4.43. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.04. Year to date, shares of ANIP have risen 21.6%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.