Yahoo Finance Moderna (MRNA) Posts Upbeat Data on Protein Replacement Therapy
Moderna MRNA announced interim results from an ongoing phase I/II study, which is evaluating the safety, pharmacodynamics and pharmacokinetics of mRNA-3927, its investigational mRNA therapy for propionic acidemia (“PA”). These results were announced at the 2023 American Society of Gene + Cell Therapy (“ASGCT”) Annual Meeting.
Management enrolled study participants aged one year and older with genetically confirmed PA in the study. Data from the phase I/II study showed that treatment with mRNA-3927 was generally well-tolerated at the doses administered and study participants who received the therapy exhibited early signs of dose-dependent pharmacology and potential clinical benefits.In fact, the study participants who had reported metabolic decompensation events (“MDEs”) in the 12 months prior to being dosed with mRNA-3927 either had a lower incidence or no MDEs post-treatment.
Based on these results, the company has advanced mRNA-3927 to dose-expansion phase to further assess safety, efficacy, and determine the recommended dose of the candidate for future clinical studies.
Per management, the above results from the phase I/II study marks the first time that a company reported clinical data on an mRNA therapeutic for intracellular protein replacement. The study utilized a dose-escalation approach and those who completed this study are eligible to continue treatment in an open-label extension study.
In the year so far, Moderna has lost 29.7% compared with the industry’s 7.1% fall.
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As of May 19, 2023, a total of 16 study participants received mRNA-3927 doses across five dose cohorts. Of these 16 participants, 11 have completed the study and have been enrolled in the open-label extension study. Five participants have been administered mRNA-3927 for more than a year. Moderna claims to have administered more than 280 doses of mRNA-3927 across the two studies.
Per MedlinePlus (a service of the National Library of Medicine), PA is an inherited disorder in which the body is unable to process certain parts of proteins and lipids (fats) properly. The disorder is characterized by recurrent life-threatening MDEs and multisystemic complications.
Moderna has only marketed product in its pipeline, i.e., its COVID vaccine, the demand for which has started to fall significantly ever since COVID-19 infections have started to decline. As a result, the company has now geared up and started focusing on rapidly advancing its mRNA-based pipeline targeting infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases.
Moderna’s key candidates include mRNA-1647 (cytomegalovirus vaccine), mRNA-1010 (flu vaccine), mRNA-1345 (respiratory syncytial virus vaccine) and mRNA-4157 (personalized cancer vaccine). These candidates are currently in late or mid-stage development.
Moderna, Inc. Price
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Zacks Rank & Stocks to Consider
Moderna currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector are ANI Pharmaceuticals ANIP, Allogene Therapeutics ALLO and Lisata Therapeutics LSTA. While ANI Pharmaceuticals sports a Zacks Rank #1 (Strong Buy), Allogene and Lisata carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2023 earnings per share have increased from $2.42 to $3.31. During the same period, the earnings estimates per share for 2024 have risen from $3.76 to $4.32. Shares of ANI Pharmaceuticals are up 14.3% in the year-to-date period.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average earnings surprise of 68.64%. In the last reported quarter, ANI Pharmaceuticals’ earnings beat estimates by 244.12%.
In the past 60 days, estimates for Allogene Therapeutics’ 2023 loss per share have improved from $2.50 to $2.32. During the same period, the loss estimates per share for 2024 have narrowed from $2.48 to $2.21. Shares of Allogene Therapeutics have declined 3.3% in the year-to-date period.
Earnings of Allogene Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. On average, the company’s earnings witnessed a surprise of 5.08%. In the last reported quarter, Allogene Therapeutics’ earnings beat estimates by 7.94%.
In the past 60 days, estimates for Lisata Therapeutics’ 2023 loss per share have improved from $3.81 to $3.46. During the same period, the loss estimates per share for 2024 have narrowed from $4.01 to $3.09. Shares of Lisata Therapeutics have surged 62.1% in the year-to-date period.
Earnings of Lisata Therapeutics beat estimates in two of the last four quarters while missing the mark on the other two occasions. On average, the company’s earnings witnessed a negative surprise of 11.89%. In the last reported quarter, Lisata Therapeutics’ earnings beat estimates by 4.94%.
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