RVMD Stock Jumps Overnight: New Drug Heads To FDA After ‘Unprecedented’ 1-Year Survival Win In Pancreatic Cancer

• The company is advancing a rolling NDA submission and is planning global regulatory filings.
• Daraxonrasib reduced the risk of death by 60%, helping patients live a median of 13.2 months compared with 6.7 months for standard chemotherapy.
• Patients reported longer pain control and better quality of life on Daraxonrasib.

Shares of Revolution Medicines (RVMD) surged 20% in overnight trading ahead of Monday, after the drugmaker said it is preparing an FDA filing for Daraxonrasib, a pancreatic cancer treatment that became the first drug to push the median survival beyond a year in a Phase 3 trial for the disease.

RVMD shares jumped over 9% in May, marking their second straight month of gains. 

RVMD’s FDA Filing Comes Into Focus

The results from the Phase 3 RASolute 302 study were presented during an ASCO Plenary Session and also published in The New England Journal of Medicine. Revolution Medicines said it is moving ahead with a rolling New Drug Application (NDA) submission and plans to pursue global regulatory approvals following the study's success.

The company said it will submit the data to global regulators, including the U.S. Food and Drug Administration (FDA), under a Commissioner's National Priority Voucher. The FDA has also authorized an expanded access treatment protocol for eligible patients, allowing them to receive the therapy before potential approval.

“In this trial, Daraxonrasib redefined treatment expectations in previously treated metastatic pancreatic cancer by reducing the risk of death by 60% and increasing median overall survival to more than one year, a result not previously reported in any Phase 3 clinical trial in any line of therapy for this disease,” CEO Mark Goldsmith said in a statement. 

Why RVMD Trial Results Stood Out

The 500-patient global study tested once-daily Daraxonrasib against standard chemotherapy in patients with previously treated metastatic pancreatic cancer. Patients receiving Daraxonrasib lived a median of 13.2 months, nearly double the 6.7 months seen with chemotherapy. The treatment also reduced the risk of death by 60%.

“In the randomized Phase 3 RASolute 302 trial, once-daily oral daraxonrasib demonstrated unprecedented improvements in overall survival (OS) and progression-free survival (PFS) compared to standard of care cytotoxic chemotherapy in patients with previously treated metastatic PDAC, with or without an identified tumor RAS mutation,” the company said.   

Daraxonrasib also kept the disease under control for longer. Patients receiving the drug went a median of 7.2 months before their cancer worsened, compared with 3.6 months for those treated with chemotherapy. Meanwhile, about 32% of patients treated with Daraxonrasib saw their tumors shrink, compared with 11% of those receiving chemotherapy. Similar improvements were seen among patients with the most common RAS mutations.

Notably, the benefit was observed across multiple patient groups, including those with RAS mutations and those without an identified RAS mutation. RAS mutations are genetic changes that keep cancer-growth signs permanently switched on, helping tumors grow and spread. 

Additionally, patients maintained control of cancer-related pain for a median of 9.2 months, compared with 3.8 months on chemotherapy, while overall quality of life was preserved for 5.7 months versus 2.6 months on chemotherapy. The treatment also appeared easier to stay on, with just 1.2% of patients discontinuing Daraxonrasib due to side effects, compared with 11.2% for chemotherapy. Severe treatment-related side effects also occurred less frequently in the Daraxonrasib arm.

How Do Retail Traders Feel About RVMD?

On Stocktwits, retail sentiment for RVMD jumped to ‘extremely bullish’ from ‘bearish’ levels a day ago. The ticker has seen a 291% jump in message volumes over the past week, along with a 5% rise in watcher base over the same period. 

One user said Merck or Eli Lilly would be “crazy to not pay $250 for this immediately.” They also said: “Oncologists crying at how good the data is, patients asking for the treatment themselves, FDA about to pass it at historical speed.  This thing will be $15 billion annual revenue with no effort for these two.”

Another user said, “Dr. Brian Wolpin [principal investigator for the RASolute 302 trial] presenting daraxonrasib data and getting a standing ovation right in the middle of the talk says everything you need to know about how the survival benefit in PDAC is landing with clinicians.”

RVMD stock has surged over 300% over the past year. 

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