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Moderna (MRNA) Begins Rare Disease Study, Inks Supply Agreement
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Moderna (MRNA - Free Report) announced that it has initiated a phase I/II study to evaluate the safety and tolerability of its investigational messenger RNA (“mRNA”) candidate, mRNA-3705, in patients with methylmalonic acidemia (“MMA”), a rare multi-organ disease.
The phase I/II study, referred to as the Landmark study, will evaluate mRNA-3705 in five different dosing regimens administered to patients aged one year and above via intravenous infusion. The company may also initiate expansion cohorts upon determining an optimized dose for the candidate.
Shares of Moderna have rallied 257.8% so far this year against the industry’s 1% decline.
Image Source: Zacks Investment Research
We inform investors that mRNA-3705 has been granted Orphan Drug and Rare Pediatric Disease designations by the FDA. The drug is designed to instruct the body to restore the missing or dysfunctional proteins that cause MMA and uses Moderna’s proprietary lipid nanoparticle formulation, same as the company’s other mRNA candidates for chikungunya virus (mRNA-1944) and propionic acidemia (mRNA-3927).
In a separate press release, Moderna announced a revised supply agreement with the Government of Canada for expanded supply of up to 105 million doses of its COVID-19 vaccine and booster vaccine. Per the agreement, Moderna will provide 20 million doses each year in 2022 and 2023, with an option for an additional 15 million doses each year. The agreement provides an option for up to 35 million doses in 2024.
Please note that the company’s COVID-19 vaccine, mRNA-1273, is its only commercial product that is driving revenues. Last week, the company announced that the FDA has expanded the emergency use authorization for mRNA-1273 to include a third dose for certain immunocompromised individuals. Per the Centers for Disease of Control and Prevention, the additional dose needs to be administered after at least 28 days from the completion of the two-dose regimen.
Apart from the above-mentioned indications, Moderna is also working to advance mRNA-based therapeutics for other rare diseases such as propionic acidemia, glycogen storage disease type 1a and phenylketonuria. Currently, the company has active clinic programs in five different therapeutic areas: infectious disease, oncology, cardiovascular, rare disease and autoimmune disease.
Moderna currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the same sector include Horizon Therapeutics , Repligen Corporation (RGEN - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) . While Horizon and Repligen each carry a Zacks Rank #1 (Strong Buy) at present, Vertex currently holds a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings per share estimates for 2021 have increased from $3.62 to $4.46 in the past 30 days. The same for 2022 has risen from $5.18 to $5.84 over the same period. The stock has rallied 45.2% in the year so far.
Repligen’s earnings per share estimates for 2021 have increased from $2.26 to $2.76 in the past 30 days. The same for 2022 has risen from $2.56 to $3.02 over the same period. The stock has rallied 33.6% in the year so far.
Vertex’s earnings per share estimates for 2021 have increased from $11.22 to $12.37 in the past 30 days. The same for 2022 has risen from $12.26 to $13.13 over the same period.
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Moderna (MRNA) Begins Rare Disease Study, Inks Supply Agreement
Moderna (MRNA - Free Report) announced that it has initiated a phase I/II study to evaluate the safety and tolerability of its investigational messenger RNA (“mRNA”) candidate, mRNA-3705, in patients with methylmalonic acidemia (“MMA”), a rare multi-organ disease.
The phase I/II study, referred to as the Landmark study, will evaluate mRNA-3705 in five different dosing regimens administered to patients aged one year and above via intravenous infusion. The company may also initiate expansion cohorts upon determining an optimized dose for the candidate.
Shares of Moderna have rallied 257.8% so far this year against the industry’s 1% decline.
Image Source: Zacks Investment Research
We inform investors that mRNA-3705 has been granted Orphan Drug and Rare Pediatric Disease designations by the FDA. The drug is designed to instruct the body to restore the missing or dysfunctional proteins that cause MMA and uses Moderna’s proprietary lipid nanoparticle formulation, same as the company’s other mRNA candidates for chikungunya virus (mRNA-1944) and propionic acidemia (mRNA-3927).
In a separate press release, Moderna announced a revised supply agreement with the Government of Canada for expanded supply of up to 105 million doses of its COVID-19 vaccine and booster vaccine. Per the agreement, Moderna will provide 20 million doses each year in 2022 and 2023, with an option for an additional 15 million doses each year. The agreement provides an option for up to 35 million doses in 2024.
Please note that the company’s COVID-19 vaccine, mRNA-1273, is its only commercial product that is driving revenues. Last week, the company announced that the FDA has expanded the emergency use authorization for mRNA-1273 to include a third dose for certain immunocompromised individuals. Per the Centers for Disease of Control and Prevention, the additional dose needs to be administered after at least 28 days from the completion of the two-dose regimen.
Apart from the above-mentioned indications, Moderna is also working to advance mRNA-based therapeutics for other rare diseases such as propionic acidemia, glycogen storage disease type 1a and phenylketonuria. Currently, the company has active clinic programs in five different therapeutic areas: infectious disease, oncology, cardiovascular, rare disease and autoimmune disease.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank & Other Stocks to Consider
Moderna currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the same sector include Horizon Therapeutics , Repligen Corporation (RGEN - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) . While Horizon and Repligen each carry a Zacks Rank #1 (Strong Buy) at present, Vertex currently holds a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Horizon’s earnings per share estimates for 2021 have increased from $3.62 to $4.46 in the past 30 days. The same for 2022 has risen from $5.18 to $5.84 over the same period. The stock has rallied 45.2% in the year so far.
Repligen’s earnings per share estimates for 2021 have increased from $2.26 to $2.76 in the past 30 days. The same for 2022 has risen from $2.56 to $3.02 over the same period. The stock has rallied 33.6% in the year so far.
Vertex’s earnings per share estimates for 2021 have increased from $11.22 to $12.37 in the past 30 days. The same for 2022 has risen from $12.26 to $13.13 over the same period.