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Why Moderna (MRNA) Stock Price Was Up 9% on Monday
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Shares of Moderna (MRNA - Free Report) rose 8.7% on Mar 11, after a government website posted details of the initiation of a phase II/III study on mRNA-4157/V940, its investigational individualized neoantigen therapy (INT), in patients with cutaneous squamous cell carcinoma (CSCC), a form of skin cancer. The therapy is being developed in collaboration with Merck (MRK - Free Report) .
The phase II/III study (called INTerpath-007) will evaluate the safety and efficacy of mRNA-4157, combined with Merck’s blockbuster immuno-oncology drug Keytruda, as neoadjuvant and adjuvant therapy in patients with resectable locally advanced CSCC, when compared with standard of care (SoC) only. The study is expected to begin next month.
The primary endpoint of the INTerpath-007 study is event-free survival (EFS). The secondary endpoints include overall response rate (ORR), disease free survival (DFS) and overall survival (OS).
Once initiated, the INTerpath-007 study will be Moderna/Merck’s third clinical study in the INTerpath program evaluating the INT in multiple cancer indications. Last year, Moderna initiated two pivotal late-stage studies evaluating the mRNA-4157/Keytruda combination in melanoma and non-small cell lung cancer (NSCLC) indications. The companies intend to expand mRNA-4157 to other oncology indications,
Moderna/Merck had previously announced their intent to expand mRNA-4157 across multiple oncology indications and also start more clinical studies throughout this year. The initiation of this new study highlights the companies’ confidence in the INTerpath program. Some Wall Street analysts also pointed out rising annual cases of CSCC. Shares were up, likely due to these reasons.
Year to date, Moderna’s shares have gained 12.6% compared with the industry’s 1.0% growth.
Image Source: Zacks Investment Research
Merck and Moderna entered a strategic partnership in 2016 to develop and market mRNA-based therapeutics to treat various types of cancer. In 2022, Merck exercised its option to develop mRNA-4157 with Moderna. Per the terms of the collaboration, the companies will share costs and profits equally.
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.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 18 cents to 30 cents. Meanwhile, during the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 40.3%.
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 $4.40. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.01. Year to date, shares of ANIP have risen 22.3%.
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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Why Moderna (MRNA) Stock Price Was Up 9% on Monday
Shares of Moderna (MRNA - Free Report) rose 8.7% on Mar 11, after a government website posted details of the initiation of a phase II/III study on mRNA-4157/V940, its investigational individualized neoantigen therapy (INT), in patients with cutaneous squamous cell carcinoma (CSCC), a form of skin cancer. The therapy is being developed in collaboration with Merck (MRK - Free Report) .
The phase II/III study (called INTerpath-007) will evaluate the safety and efficacy of mRNA-4157, combined with Merck’s blockbuster immuno-oncology drug Keytruda, as neoadjuvant and adjuvant therapy in patients with resectable locally advanced CSCC, when compared with standard of care (SoC) only. The study is expected to begin next month.
The primary endpoint of the INTerpath-007 study is event-free survival (EFS). The secondary endpoints include overall response rate (ORR), disease free survival (DFS) and overall survival (OS).
Once initiated, the INTerpath-007 study will be Moderna/Merck’s third clinical study in the INTerpath program evaluating the INT in multiple cancer indications. Last year, Moderna initiated two pivotal late-stage studies evaluating the mRNA-4157/Keytruda combination in melanoma and non-small cell lung cancer (NSCLC) indications. The companies intend to expand mRNA-4157 to other oncology indications,
Moderna/Merck had previously announced their intent to expand mRNA-4157 across multiple oncology indications and also start more clinical studies throughout this year. The initiation of this new study highlights the companies’ confidence in the INTerpath program. Some Wall Street analysts also pointed out rising annual cases of CSCC. Shares were up, likely due to these reasons.
Year to date, Moderna’s shares have gained 12.6% compared with the industry’s 1.0% growth.
Image Source: Zacks Investment Research
Merck and Moderna entered a strategic partnership in 2016 to develop and market mRNA-based therapeutics to treat various types of cancer. In 2022, Merck exercised its option to develop mRNA-4157 with Moderna. Per the terms of the collaboration, the companies will share costs and profits equally.
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.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank & Key Picks
Moderna currently carries a Zacks Rank #3 (Hold). A couple of 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 18 cents to 30 cents. Meanwhile, during the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 40.3%.
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 $4.40. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.01. Year to date, shares of ANIP have risen 22.3%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.