The biotech sector has been in focus in the past week with key pipeline and regulatory updates. Among these, Moderna MRNA provided insight into its financial targets for 2027 and other pipeline updates.
Recap of the Week’s Most Important Stories:
Updates From Moderna: Moderna MRNA announced several updates about the advancements of its mRNA pipeline and its business outlook for 2027. It expects respiratory product sales between $8 billion and $15 billion by 2027. Based on this revenue guidance, it expects to generate operating profit within $4-$9 billion from the respiratory vaccines. Management intends to spend $6-$8 billion in additional R&D over the next few years.
Concurrently, management provided an update on the seasonal influenza vaccine candidate, mRNA-1010. The company provided the first interim analysis from a phase III efficacy study (P302) conducted in the Northern Hemisphere evaluating mRNA-1010 vis-à-vis a licensed seasonal influenza vaccine. The independent Data and Safety Monitoring Board (“DSMB”) completed the first interim analysis of efficacy and informed that mRNA-1010 did not meet the statistical threshold necessary to declare early success and recommended that the study continues with efficacy follow-up toward the next analysis. The DSMB did not identify any safety concerns. Blinded follow-up for safety and efficacy is ongoing in this trial.
A preliminary analysis of some participants in the P302 study also revealed that participants administered mRNA-1010 achieved geometric mean titer ratios consistent with superiority against the influenza A strains and consistent with non-inferiority against the influenza B strains. However, the study did not pre-specify success criteria for immunogenicity endpoints.
In addition, Moderna announced several other updates related to the development of its other pipeline candidates. Management expects to file for approval of its respiratory syncytial virus (RSV) vaccine mRNA-1345 before the end of this quarter. Management also announced that it recently started dosing participants in a late-stage study with mRNA-1283, a next-generation refrigerator-stable COVID-19 vaccine.
KALA Up on Fast Track Designation for Candidate: Kala Pharmaceuticals KALA announced that the FDA has granted Fast Track designation to lead candidate KPI-012 for the treatment of persistent corneal epithelial defect (PCED). Shares were up on the same. This designation from the FDA facilitates the rapid development and expedites the review of drug candidates being developed to treat serious conditions and for which nonclinical and/or clinical data demonstrate the potential to address unmet medical needs. The goal is to make these treatments rapidly available to patients. The Fast Track Designation allows frequent interactions with the FDA to discuss the product development plan. The designated candidates may also be eligible for priority review and accelerated approval if supported by clinical data.
KPI-012 is a human mesenchymal stem cell secretome (MSC-S), which contains numerous human-derived biofactors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases.
Kala Pharmaceuticals currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
InflaRx Surges on EUA for Gohibic: InflaRx N.V. IFRX surged after the company announced that Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorization (EUA) by the FDA for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). The data supporting the EUA were based on the previously announced results of the multicenter late-stage PANAMO trial.
InflaRx is in discussions with the FDA related to the submission of a biologics license application (BLA) for full approval of Gohibic in this COVID-19 indication. InflaRx continues to develop vilobelimab in other indications, including pyoderma gangrenosum, for which the company is currently initiating a phase III trial.
The Nasdaq Biotechnology Index has gained 0.52% in the past four trading sessions. Among the biotech giants, Bristol Myers has gained 1.39% during the period. Over the past six months, shares of Gilead have soared 27.90%. (See the last biotech stock roundup here: Biotech Stock Roundup: BLUE Announces Q4 Results, ONCT, ASND & RNA Fall on Updates)
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What's Next in Biotech?
Stay tuned for other updates.
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