Elasomeran

Moderna has binned three more clinical programs as it aims to reduce R&D spend.\n Moderna, an mRNA specialist known for its COVID-19 vaccine Spikevax, is winding down development of three clinical mRNA programs, including two investigational vaccines for infectious diseases. The company is ending development of a therapeutic vaccine candidate coded mRNA-1608 for herpes simplex virus (HSV). Moderna has decided not to advance the program into phase 3 testing, according to a Nov. 20 release.  Moderna had launched a phase 1/2 study for the vaccine back in 2023, with the trial wrapping earlier this spring, according to ClinicalTrials.gov.The discontinuation follows GSK’s discarded efforts to develop the first vaccine for HSV after a phase 1/2 trial ended in failure. GSK’s recombinant protein vaccine, dubbed GSK3943104, failed to hit the primary efficacy endpoint of reducing episodes of recurrent genital herpes in the phase 2 portion of the study, the pharma announced this September.GSK’s exit from the HSV race left Moderna and BioNTech in the running. Now that Moderna has bowed out, BioNTech’s mRNA vaccine remains the only active HSV injection in big biopharma development, with a phase 1 trial ongoing.Next up on Moderna’s discard pile is another vaccine candidate, this one dubbed mRNA-1468 and designed to prevent shingles—also called herpes zoster virus—in healthy adults age 50 and older. The investigational shot is currently being tested in a phase 1/2 trial slated to read out in mid-2026, but the Massachusetts-based company has decided not to advance the asset into late-stage testing. Moderna’s also pulling the plug on mRNA-3745, an intravenous solution that was designed to treat a genetic disorder called glycogen storage disease type 1a. A phase 1/2 open-label study assessing the therapy began in 2022, but Moderna has said it won’t be moving the program forward into phase 2 development.The cuts come after the biopharma discontinued a vaccine known as mRNA-1647 in congenital cytomegalovirus in October. The candidate failed to protect women from the virus in a large phase 3 trial, though Moderna has said it will continue to evaluate the vaccine in an active phase 2 trial in patients who\'ve had bone marrow transplants.Moderna has “prioritized our pipeline and R&D investments as part of our broader cost efficiency efforts,” a spokesperson told Fierce Biotech about the cuts. The company did not provide further reasoning behind the specific discontinuations.With much of Moderna’s recent rise tied to its COVID-19 vaccine, the company has struggled to match the sales highs it experienced amid the pandemic. In the same release laying out the discontinuations, the mRNA specialist outlined a three-year business strategy and set a goal to boost revenue by up to 10% in 2026. The company also said it has closed a five-year loan from Ares Management worth $1.5 billion. Lately, the biopharma has turned its focus toward its oncology programs, Kyle Holen, M.D., Moderna’s head of development, therapeutics and oncology, told Fierce in October.Moderna has “many new oncology programs [and] not as many” new infectious disease programs, Holen said, adding that most of the company\'s upcoming investigational new drug applications will be in the oncology space.The Moderna moves come amid the federal government\'s pullback from both mRNA and vaccines, a pivot that has included the government axing funding for Moderna’s bird flu vaccine candidate earlier this year.  

By channeling proceeds from its commercial products into late-stage oncology and rare disease programs, Moderna believes it can “set the stage for additional growth in 2027 and 2028." With much of Moderna’s rise in this decade tied to its COVID-19 vaccine, the company has struggled in recent years to match the sales highs it experienced during the pandemic.Now, in an effort to correct course, the Cambridge, Massachusetts-based mRNA specialist is laying out a three-year business strategy, highlighting promising avenues for growth and setting out a goal to lift revenue by up to 10% in 2026. The new game plan debuted at Moderna’s analyst day event on Thursday.On the commercial front, Moderna plans to build a “large seasonal vaccine franchise for at-risk populations” over the next three years, CEO Stéphane Bancel said in a statement. The company will then reinvest revenues into its roster of experimental cancer and rare disease therapeutics, the helmsman explained."We plan to deliver up to 10 percent revenue growth in 2026 while continuing to reduce our R&D investments and diversify further into oncology,” Bancel explained. “Our financial outlook remains strong, and we are focused on disciplined execution as we advance our pipeline and bring innovative mRNA medicines to patients around the world."Digging deeper into Moderna’s seasonal vaccine ambitions, the company figures that sales from products like COVID shot Spikevax and its next-generation sibling mNEXSPIKE, plus its respiratory syncytial virus (RSV) prophylactic mRESVIA and potential launches in norovirus and beyond, should allow it to break even by 2028 and continue to fund development activities.By channeling proceeds from its commercial products into late-stage oncology and rare disease programs, Moderna aims to “set the stage for additional growth in 2027 and 2028, with early-stage pipeline investments expected to mature" starting in 2029, the company said in the release.The company further expects a financial boost next year from long-term partnerships in countries such as the United Kingdom, Canada and Australia focused on R&D investment, national security and domestic manufacturing. Over that same span, Moderna is banking on “continued strong uptake” of its next-generation COVID vaccine mNEXSPIKE in the U.S., with sales likely to be buoyed by launches in other countries as well, according to the company.Additionally, the European market presents an enticing opportunity come 2027, when an existing supply contract for Pfizer’s COVID shot, Comirnaty, is slated to expire, Moderna noted. The company stressed that it has the commercial infrastructure in place to support the up to six seasonal vaccine products it hopes to have approved by 2028 and added that it will make “targeted investments” in its European commercial infrastructure “as needed.” With regards to potential approvals beyond seasonal inoculations, Moderna has put its chips behind four key assets in cancer and rare diseases. On the oncology front, the company is now in late-stage testing with its Merck-partnered cancer vaccine mRNA-4157, also known as intismeran autogene, which is running through the clinical gauntlet in potential indications such as melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma.The company also has high hopes for mRNA-4359, a cancer antigen therapy designed to elicit T-cell immune responses against tumor and immunosuppressive cells. That asset is currently engaged in a phase 1/2 study, with the midstage portion including cohorts in first-line metastatic melanoma and first-line metastatic NSCLC, Moderna said.In rare diseases, Moderna is prioritizing the propionic acidemia asset, mRNA-3927, and prospective methylmalonic acidemia treatment, mRNA-3705. A registrational trial for the first asset has now reached target enrollment, while the second is slated to begin registrational testing next year, according to the company.The company’s slimmed-down clinical focus comes on the heels of several pipeline purges. Besides its recent high-profile cytomegalovirus discontinuation, the company revealed that programs for herpes simplex virus, varicella zoster virus and glycogen storage disease type 1a will not move to the next stages of development.Moderna will tighten its belt under the strategy as well, noting that it will reduce its expected 2026 and 2027 cash costs to roughly $4.2 billion and a range of $3.5 billion to $3.9 billion, respectively. To get there, the company says it will enforce “disciplined cost management and R&D prioritization.”Meanwhile, helping pad the company’s coffers as it waits for new growth spigots to open, Moderna said Thursday that it has also closed a five-year loan from Ares Management worth $1.5 billion.“The non-dilutive financing bolsters the company's strong balance sheet and provides increased flexibility,” Moderna explained in its release. As of Thursday, the mRNA drugmaker now projects that it will have a higher year-end cash and investment balance of $7.1 billion to $7.6 billion, which it linked “to the $0.6 billion initial loan draw.” The new strategy follows a rough third-quarter for Moderna, during which the company reported $1 billion in revenue, down some 45% from the sum its products generated for the same period in 2024. Notably, almost all of the company’s sales were linked to its COVID vaccines at $971 million, while RSV immunization mRESVIA—approved last May—generated just $2 million in the quarter.With the results in hand, Moderna narrowed its guidance range for the year to 2025 sales of $1.6 billion to $2 billion, moving the high end of its range down $200 million from its previous forecast.