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Revolution Medicines Reports Second Quarter 2024 Financial Results and Update on Corporate Progress

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Revolution Medicines (Nasdaq: RVMD) reported its Q2 2024 financial results and corporate progress. Key highlights include:

1. Advancing RMC-6236 into pivotal trials for pancreatic and lung cancer

2. Expanding RMC-6236 into earlier treatment lines

3. Progressing RMC-6291 and RMC-9805 for late-stage development

4. Appointment of Frank Clyburn to the board of directors

5. Q2 financial results: $1.59 billion cash position, $134.9 million R&D expenses, $21.7 million G&A expenses, and $133.2 million net loss

6. Reiterated 2024 GAAP net loss guidance of $560-600 million

7. Current cash can fund operations into 2027

Revolution Medicines (Nasdaq: RVMD) ha riportato i risultati finanziari del secondo trimestre del 2024 e i progressi aziendali. I punti salienti includono:

1. Avanzamento di RMC-6236 verso studi clinici cruciali per il cancro al pancreas e ai polmoni

2. Espansione di RMC-6236 in linee di trattamento più precoci

3. Proseguimento dello sviluppo di RMC-6291 e RMC-9805 per fasi avanzate

4. Nomina di Frank Clyburn nel consiglio di amministrazione

5. Risultati finanziari del secondo trimestre: posizione di cassa di 1,59 miliardi di dollari, spese per ricerca e sviluppo di 134,9 milioni di dollari, spese generali e amministrative di 21,7 milioni di dollari e perdita netta di 133,2 milioni di dollari

6. Ripetuta previsione di perdita netta GAAP per il 2024 di 560-600 milioni di dollari

7. La liquidità attuale può finanziare le operazioni fino al 2027

Revolution Medicines (Nasdaq: RVMD) informó sobre los resultados financieros del segundo trimestre de 2024 y los avances corporativos. Los puntos destacados incluyen:

1. Avance de RMC-6236 hacia ensayos clínicos clave para el cáncer de páncreas y de pulmón

2. Expansión de RMC-6236 en líneas de tratamiento más tempranas

3. Progreso de RMC-6291 y RMC-9805 para el desarrollo en etapas avanzadas

4. Nombramiento de Frank Clyburn en la junta directiva

5. Resultados financieros del segundo trimestre: posición de efectivo de 1.59 mil millones de dólares, gastos de I+D de 134.9 millones de dólares, gastos generales y administrativos de 21.7 millones de dólares y pérdida neta de 133.2 millones de dólares

6. Reiteración de la guía de pérdida neta GAAP para 2024 de 560-600 millones de dólares

7. El efectivo actual puede financiar las operaciones hasta 2027

Revolution Medicines (Nasdaq: RVMD)는 2024년 2분기 재무 결과와 기업 진행 상황을 보고했습니다. 주요 하이라이트는 다음과 같습니다:

1. 췌장암 및 폐암에 대한 주요 임상 시험을 위해 RMC-6236을 진전시키기

2. 더 이른 치료 라인으로 RMC-6236 확장하기

3. 후기 개발을 위한 RMC-6291RMC-9805 진행하기

4. 이사회에 Frank Clyburn 임명하기

5. 2분기 재무 결과: 15억 9천만 달러의 현금 보유, 1억 3천 490만 달러의 연구개발 비용, 2천 170만 달러의 일반 관리 비용, 1억 3천 320만 달러의 순손실

6. 2024년 GAAP 순손실 예상치를 5억 6천만~6억 달러로 고지하기

7. 현재 현금으로 2027년까지 운영 자금 지원 가능

Revolution Medicines (Nasdaq: RVMD) a annoncé ses résultats financiers du deuxième trimestre 2024 ainsi que ses progrès d'entreprise. Les points saillants comprennent :

1. Avancement de RMC-6236 dans des essais cliniques clés pour le cancer du pancréas et le cancer du poumon

2. Expansion de RMC-6236 dans des lignes de traitement précoce

3. Progrès de RMC-6291 et RMC-9805 pour le développement avancé

4. Nommer Frank Clyburn au conseil d'administration

5. Résultats financiers du deuxième trimestre : 1,59 milliard de dollars en liquidités, 134,9 millions de dollars de dépenses de R&D, 21,7 millions de dollars de dépenses générales et administratives, et 133,2 millions de dollars de perte nette

6. Réaffirmation de l'orientation de perte nette GAAP pour 2024 de 560 à 600 millions de dollars

7. La trésorerie actuelle peut financer les opérations jusqu'en 2027

Revolution Medicines (Nasdaq: RVMD) hat die Finanzergebnisse für das zweite Quartal 2024 und Fortschritte im Unternehmen bekannt gegeben. Die wichtigsten Highlights sind:

1. Fortführung von RMC-6236 in entscheidenden Studien für Bauchspeicheldrüsen- und Lungenkrebs

2. Erweiterung von RMC-6236 in frühere Behandlungsphasen

3. Fortschritte bei RMC-6291 und RMC-9805 für die späte Entwicklung

4. Ernennung von Frank Clyburn in den Vorstand

5. Finanzergebnisse für das zweite Quartal: 1,59 Milliarden Dollar Barmittel, 134,9 Millionen Dollar F&E-Ausgaben, 21,7 Millionen Dollar allgemeine und administrative Ausgaben und 133,2 Millionen Dollar Nettoverlust

6. Bestätigung der GAAP Nettoverlustprognose für 2024 von 560-600 Millionen Dollar

7. Aktuelles Bargeld kann die Operationen bis 2027 finanzieren

Positive
  • Strong preliminary progression-free survival (PFS) and overall survival (OS) data for RMC-6236 in pancreatic cancer
  • Plans to initiate pivotal Phase 3 study for RMC-6236 in second-line pancreatic cancer treatment
  • Expansion of RMC-6236 into earlier lines of therapy for pancreatic and lung cancer
  • Appointment of Frank Clyburn, former Merck executive, to the board of directors
  • Robust cash position of $1.59 billion as of June 30, 2024
  • Current cash can fund planned operations into 2027
Negative
  • Increased net loss of $133.2 million in Q2 2024 compared to $98.3 million in Q2 2023
  • Higher R&D expenses of $134.9 million in Q2 2024 compared to $98.0 million in Q2 2023
  • Increased G&A expenses of $21.7 million in Q2 2024 compared to $14.6 million in Q2 2023
  • Zero revenue for Q2 2024 compared to $3.8 million in Q2 2023 due to termination of Sanofi collaboration agreement

Insights

Revolution Medicines' Q2 2024 results show significant R&D investment and cash burn, reflecting its focus on advancing its oncology pipeline. The company reported $134.9 million in R&D expenses, up 37.7% year-over-year, primarily due to increased clinical trial expenses. This led to a net loss of $133.2 million, wider than the $98.3 million loss in Q2 2023.

Despite the losses, Revolution Medicines maintains a strong cash position of $1.59 billion, which it projects will fund operations into 2027. This runway is important for supporting its ambitious clinical development plans, including pivotal trials for RMC-6236. The company's financial guidance for 2024, projecting a net loss between $560 million and $600 million, indicates continued heavy investment in its pipeline.

Revolution Medicines is making significant strides in its RAS-targeted oncology programs. The RMC-6236 monotherapy data in pancreatic cancer is particularly promising, with a median PFS of 8.1 months in KRAS G12X patients. This compares favorably to current second-line treatments, potentially positioning RMC-6236 as a breakthrough therapy.

The company's strategy to expand into earlier lines of therapy and combination approaches is scientifically sound. The planned Phase 3 trial for RMC-6236 in second-line pancreatic cancer and the upcoming pivotal study in NSCLC could be major catalysts. Additionally, the RAS(ON) inhibitor doublet approach with RMC-6291 and RMC-6236 shows promise in preclinical models, potentially addressing resistance mechanisms in KRAS-mutated cancers.

The appointment of Frank Clyburn to Revolution Medicines' board is a strategic move. Clyburn's experience in building Merck's oncology business, particularly the Keytruda franchise, brings valuable commercial expertise as the company approaches late-stage development. This addition, along with key hires in medical affairs, corporate affairs and drug safety, signals Revolution Medicines' preparation for potential commercialization.

The company's focus on RAS-addicted cancers represents a significant market opportunity. With multiple candidates targeting different RAS mutations and combination strategies, Revolution Medicines is positioning itself as a potential leader in this space. The progress in pancreatic cancer, a notoriously difficult-to-treat indication, could be particularly impactful if RMC-6236 continues to show strong results in pivotal trials.

Revolution Medicines to hold webcast today at 4:30 p.m. Eastern Time

REDWOOD CITY, Calif., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced its financial results for the quarter ended June 30, 2024, and provided an update on corporate progress.

The company continues making progress on its 2024 development priorities:

  • Advancing its RAS(ON) multi-selective inhibitor RMC-6236 into monotherapy pivotal trials.
    • Pancreatic cancer: The company recently provided updated data on the clinical safety, tolerability and antitumor activity in patients with pancreatic ductal adenocarcinoma (PDAC) from its ongoing RMC-6236 monotherapy study. Strong preliminary progression-free survival (PFS) and overall survival (OS) PDAC data support the company’s plans to initiate a pivotal, randomized, controlled Phase 3 monotherapy study in the second-line (2L) treatment of patients with metastatic PDAC this year; work is underway toward this goal.
    • Lung cancer: Data from the RMC-6236 monotherapy study in patients with non-small cell lung cancer (NSCLC) continue to mature. The company remains on track to initiate a pivotal study in previously-treated patients with RAS-mutated NSCLC this year.

  • Expanding the reach of RMC-6236 monotherapy and/or combinations into earlier lines of therapy. Based on compelling preliminary monotherapy data in 2L PDAC, the company plans to evaluate RMC-6236 in earlier lines of treatment for pancreatic cancer including the first-line, locally advanced, and resectable settings. In addition to monotherapy, the company is currently evaluating RMC-6236 in combination with chemotherapy, which is the current standard of care for patients with PDAC.

  • Qualifying its RAS(ON) mutant-selective inhibitors, RMC-6291 (G12C-selective inhibitor) and RMC-9805 (G12D-selective inhibitor), for late-stage development.

    • With the goal of moving RMC-6291 into early lines of therapy in NSCLC, the company is currently evaluating the RAS(ON) inhibitor doublet of RMC-6291 with RMC-6236 as well as RMC-6291 with pembrolizumab.
      • This doublet approach was recently highlighted in the Cancer Discovery publication that demonstrated robust antitumor activity by a RAS(ON) multi-selective inhibitor in combination with a RAS(ON) G12C-selective inhibitor in preclinical models of refractory KRAS G12X NSCLC.
    • The company continues to enroll patients with solid tumors harboring KRAS G12D mutations in the RMC-9805 monotherapy study.
  • In support of its continuing pipeline momentum and commercial ambitions, the company appointed Frank Clyburn to its board of directors; Mr. Clyburn is a distinguished executive who led Merck’s global Keytruda® franchise from its inception and helped establish Merck as a global leader in oncology. The company also expanded its senior management group with key new hires in medical affairs, corporate affairs, drug safety and program leadership.

“Confidence in our RAS(ON) inhibitor platform and assets continues to grow and has been bolstered particularly by the strength of the interim safety, PFS and OS data shown in July for patients with pancreatic cancer in the RMC-6236 monotherapy study. Based on current benchmarks for first- and second-line treatment of metastatic PDAC, we believe RMC-6236 has the potential to become an important new therapeutic option to address large unmet medical needs for patients with this threatening disease,” said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “The appointment of Frank Clyburn to our board of directors and several strategic additions to our executive team support our deep focus on enabling the next stage of growth and maturation for Revolution Medicines. We have made substantial progress in planning for the initiation of our first pivotal, Phase 3 study for RMC-6236 in pancreatic cancer, and are working actively to prepare to advance RMC-6236 into earlier lines of therapy.”

Clinical Development Highlights

Plans to Advance RMC-6236 Monotherapy into Pivotal Trials
Pancreatic cancer: On July 15, 2024, the company reported updated data on the clinical safety, tolerability and antitumor activity from its ongoing monotherapy study evaluating RMC-6236 in patients with previously treated metastatic PDAC across dose cohorts ranging from 160 mg daily to 300 mg daily as of a May 11, 2024 data cutoff date. Key findings included:

  • A total of 127 patients treated were evaluated for safety and tolerability.
    • Approximately 22 percent of these patients experienced a Grade 3 or higher treatment-related adverse event (TRAE), and 96 percent of these patients experienced a TRAE of any grade.
    • The most common TRAEs observed were rash and gastrointestinal-related toxicities. Reported TRAEs led to dose modifications (dose interruption and/or reduction) in 28 percent of these patients and there were no discontinuations due to TRAEs.
  • The company also reported preliminary PFS and OS data in 2L treatment of patients with metastatic PDAC.
    • The median PFS for patients with KRAS G12X mutations (n=42) was 8.1 months (95% confidence interval (CI); 5.9 months – not-estimable (NE)) and for patients with any RAS mutation (G12X, G13X and Q61X) (n=56) was 7.6 months (95% CI; 5.3 months – NE).
    • For patients with KRAS G12X mutations and those with any RAS mutation, the observed OS was not estimable (95% CI for both groups; 8.5 months, NE).
  • Based on initial feedback from the U.S. Food and Drug Administration, including supportive discussions on high-level trial design including a 300 mg daily dose, the company expects to initiate its Phase 3 registrational trial in the 2L treatment of patients with metastatic PDAC, called RASolute 302, this year.

Lung cancer: The company expects to share updated NSCLC data from its ongoing RMC-6236 monotherapy study in the fourth quarter of 2024 and to launch a registrational study to evaluate RMC-6236 in previously-treated patients with advanced NSCLC in the fourth quarter of 2024.
        
Evaluating RMC-6236 in Earlier Lines of Therapy

  • PDAC. Evaluation is ongoing for RMC-6236 in combination with standard of care chemotherapy in first-line PDAC.

  • NSCLC. Evaluation is ongoing for RMC-6236 in combination with pembrolizumab, with or without chemotherapy, in patients with advanced RAS-mutated NSCLC. The company expects to disclose initial clinical pharmacokinetic (PK), safety, tolerability and antitumor activity data for the combination of RMC-6236 with pembrolizumab in the fourth quarter of 2024.

Qualifying RMC-6291 for Late-Stage Development

  • Combination Development. Evaluation of RMC-6291 with RMC-6236 and RMC-6291 with pembrolizumab, with or without chemotherapy, is ongoing. The company expects to disclose initial clinical PK, safety, tolerability and antitumor activity data for the combination of RMC-6291 with RMC-6236 in the fourth quarter of 2024 and for the combination RMC-6291 with pembrolizumab in the first half of 2025.

Qualifying RMC-9805 for Late-Stage Development

  • Monotherapy Development. The company expects to disclose initial clinical PK, safety, tolerability and antitumor activity data for RMC-9805 in the fourth quarter of 2024.

RAS Innovation Engine
Beyond the first wave of clinical-stage RAS(ON) inhibitors, additional clinical development opportunities include the RAS(ON) mutant-selective inhibitors RMC-5127 (G12V), RMC-0708 (Q61H) and RMC-8839 (G13C) and the RAS companion inhibitors RMC-4630 (SHP2) and RMC-5552 (mTORC1/4EBP1).

Corporate and Financial Highlights

Update to Revolution Medicines’ Board of Directors
In addition, the company has appointed Frank Clyburn to its board of directors as a Class II director, with a term expiring at the company’s 2025 annual meeting of stockholders. Mr. Clyburn brings significant and relevant experience to Revolution Medicines as it embarks on late-stage clinical development and commercial planning for its RAS(ON) inhibitor programs. Most recently, Mr. Clyburn served as the chief executive officer and as a board director of International Flavors & Fragrances (IFF). Notably, Mr. Clyburn previously served as executive vice president and president of human health for Merck. During his tenure, he built Merck’s leading oncology business, directing the successful global launch and commercialization of Keytruda® to create the dominant immuno-oncology franchise. Earlier in his career, Mr. Clyburn served as vice president of the oncology and internal medicine business units at Sanofi Aventis and held several leadership roles within the company. Mr. Clyburn received his M.B.A. from Arizona State University and his B.A. from Franklin & Marshall College.

Addition of New Leaders
The company has made several strategic leadership hires across research and development, corporate affairs and program management, including:

  • Mary Pinder-Schenck, M.D., senior vice president, head of medical affairs
  • Ryan Asay, senior vice president, corporate affairs
  • Mason Shih, M.D., senior vice president, head of drug safety
  • Jing Yi, Ph.D., senior vice president, head of program leadership

Second Quarter Results

Cash Position: Cash, cash equivalents and marketable securities were $1.59 billion as of June 30, 2024.

Revenue: Total revenue was zero for the quarter ended June 30, 2024, compared to $3.8 million for the quarter ended June 30, 2023. The decrease in revenue was due to the termination of the company’s collaboration agreement with Sanofi in 2023.

R&D Expenses: Research and development expenses were $134.9 million for the quarter ended June 30, 2024, compared to $98.0 million for the quarter ended June 30, 2023. The increase in expense was primarily due to increases in clinical trial expenses for RMC-6236, RMC-6291 and RMC-9805, preclinical portfolio expenses, personnel-related expenses related to additional headcount and stock-based compensation expense.

G&A Expenses: General and administrative expenses were $21.7 million for the quarter ended June 30, 2024, compared to $14.6 million for the quarter ended June 30, 2023. The increase was primarily due to increases in personnel-related expenses related to additional headcount, commercial preparation activities and stock-based compensation expense.

Net Loss: Net loss was $133.2 million for the quarter ended June 30, 2024, compared to net loss of $98.3 million for the quarter ended June 30, 2023.

Financial Guidance
Revolution Medicines is reiterating the updated projected full year 2024 GAAP net loss guidance that it shared in July 2024 of between $560 million and $600 million, which includes estimated non-cash stock-based compensation expense of between $70 million and $80 million. Based on the company’s current operating plan, the company projects current cash, cash equivalents and marketable securities can fund planned operations into 2027.

Webcast
Revolution Medicines will host a webcast this afternoon, August 7, 2024, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: https://ir.revmed.com/events-and-presentations. Following the live webcast, a replay will be available on the company’s website for at least 14 days.

About Revolution Medicines, Inc.
Revolution Medicines is a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS companion inhibitors for use in combination treatment strategies. The company’s RAS(ON) inhibitors RMC-6236, a RAS(ON) multi-selective inhibitor, RMC-6291, a RAS(ON) G12C-selective inhibitor, and RMC-9805, a RAS(ON) G12D-selective inhibitor, are currently in clinical development. Additional RAS(ON) mutant-selective inhibitors in the company’s development pipeline include RMC-5127 (G12V), RMC-0708 (Q61H) and RMC-8839 (G13C), in addition to RAS companion inhibitors RMC-4630 and RMC-5552.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding the company’s financial projections and expectations related to the company’s capital resources; the company’s development plans and timelines and its ability to advance its portfolio and R&D pipeline; progression of clinical studies and findings from these studies, including the safety, tolerability, potential efficacy and durability of the company’s candidates being studied; the company’s expectations regarding timing of data disclosures and clinical study initiation; the company’s plans, priority and timing to expand the reach of its RAS(ON) inhibitors into earlier lines of therapy; the potential advantages and effectiveness of the company’s clinical and preclinical candidates, including its RAS(ON) inhibitors; initial feedback from the FDA regarding further development of RMC-6236; the company’s plans for regulatory engagement and initiation of pivotal and registrational clinical trials for RMC-6236, including data to support the initiation of these trials; and the company’s commercial plans. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company’s development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company’s programs’ current stage of development, the process of designing and conducting preclinical and clinical trials, risks that the results of prior clinical trials may not be predictive of future clinical trials, clinical efficacy, or other future results, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company’s business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 7, 2024, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.


REVOLUTION MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited)
  Three Months Ended
June 30,
  Six Months Ended
June 30,
 
  2024  2023  2024  2023 
Revenue:                
Collaboration revenue $  $3,824  $  $10,838 
Total revenue     3,824      10,838 
Operating expenses:                
Research and development  134,932   97,981   252,953   166,928 
General and administrative  21,711   14,640   44,549   27,864 
Total operating expenses  156,643   112,621   297,502   194,792 
Loss from operations  (156,643)   (108,797)   (297,502)   (183,954) 
Other income (expense), net:                
Interest income  21,487   10,499   45,247   17,558 
Other income (expense), net  16      (2,793)    
Change in fair value of warrant liability and contingent earn-out shares  1,907      5,812    
Total other income, net  23,410   10,499   48,266   17,558 
Loss before income taxes  (133,233)   (98,298)   (249,236)   (166,396) 
Net loss $(133,233)  $(98,298)  $(249,236)  $(166,396) 
Net loss per share attributable to common stockholders, basic and diluted $(0.81)  $(0.92)  $(1.51)  $(1.65) 
Weighted-average common shares used to compute net loss per share, basic and diluted  165,141,936   106,884,185   164,935,542   100,891,375 


REVOLUTION MEDICINES, INC.
SELECTED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, unaudited)
    
  June 30,
2024
  December 31,
2023

 
         
Cash, cash equivalents and marketable securities $1,590,715  $1,852,955 
Working capital (1)  1,519,398   1,735,430 
Total assets  1,808,437   2,061,705 
Total liabilities  189,589   235,511 
Total stockholders' equity  1,618,848   1,826,194 

 

(1) Working capital is defined as current assets less current liabilities.


FAQ

What were Revolution Medicines' (RVMD) key financial results for Q2 2024?

Revolution Medicines reported a cash position of $1.59 billion, R&D expenses of $134.9 million, G&A expenses of $21.7 million, and a net loss of $133.2 million for Q2 2024.

What is the progress of RMC-6236 in pancreatic cancer trials?

Revolution Medicines reported strong preliminary PFS and OS data for RMC-6236 in pancreatic cancer and plans to initiate a pivotal Phase 3 study in second-line treatment of metastatic pancreatic cancer in 2024.

When does Revolution Medicines (RVMD) expect to share updated NSCLC data for RMC-6236?

Revolution Medicines expects to share updated NSCLC data from its ongoing RMC-6236 monotherapy study in the fourth quarter of 2024.

Who was recently appointed to Revolution Medicines' board of directors?

Frank Clyburn, a former Merck executive who led the global Keytruda franchise, was appointed to Revolution Medicines' board of directors as a Class II director.

What is Revolution Medicines' (RVMD) financial guidance for 2024?

Revolution Medicines reiterated its 2024 GAAP net loss guidance of between $560 million and $600 million, including estimated non-cash stock-based compensation expense of $70-80 million.

Revolution Medicines, Inc.

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Biotechnology
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