|Bid||0.00 x 0|
|Ask||0.00 x 0|
|Day's Range||70.75 - 71.50|
|52 Week Range||54.00 - 125.00|
|Beta (5Y Monthly)||0.49|
|PE Ratio (TTM)||34.12|
|Forward Dividend & Yield||1.51 (2.08%)|
|Ex-Dividend Date||Sep 28, 2020|
|1y Target Est||80.95|
Merck & Co Inc (NYSE: MRK) and Eisai Co Ltd (OCTMKT: ESALY) unveiled new data from the Phase 3 CLEAR study (KEYNOTE-581/Study 307) evaluating a combo of Merck’s Keytruda and Eisai’s Lenvima (lenvatinib) or Lenvima plus chemotherapy everolimus against Pfizer Inc’s (NYSE: PFE) Sutent (sunitinib) for the first-line treatment of advanced renal cell carcinoma. The companies presented the data at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium. The combination of Keytruda and Lenvima significantly extended the time patients lived without their disease getting worse in a head-to-head matchup with sunitinib, the standard of care. Keytruda and Lenvima’s combo posted a 61% reduction in the risk of disease progression or death and cut the risk of dying alone by 34%. Patients in the Keytruda plus Lenvima arm saw significant improvement in progression-free survival (PFS) at a median of 23.9 months versus 9.2 months for patients treated with sunitinib alone. The combo posted a complete response rate of 16.1% and a partial response rate of 54.9% versus 4.2% and 31.9%, respectively, for sunitinib. Median overall survival was not reached in either treatment arm after a median follow-up of 27 months. By contrast, Lenvima plus everolimus cut the risk of disease progression or death by 35% with a median PFS of 14.7 months versus 9.2 months in the sunitinib arm. Lenvima-everolimus arm did not demonstrate an improvement in overall survival compared with sunitinib. The combination arm posted a complete response rate of 9.8% and a partial response rate of 43.7%, significantly better than sunitinib. Price Action: MRK shares are down 1.2% at $74.1, and ESALY stock decreased 0.68% at $74.1 during market trading on the last check Tuesday. See more from BenzingaClick here for options trades from BenzingaExelixis' Cabozantinib Data Shows Clinically Significant Benefit Versus Pfizer's Sutent, In A Type Of Kidney CancerPfizer's PANZYGA Wins FDA Approval For Rare Peripheral Nerves Disorder© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
If the FDA approves aducanumab, Wall Street expects Biogen’s shares to climb as much as 70%. The consequences of failure are nearly as stark.
Biogen Inc (NASDAQ: BIIB) shares are up sharply Friday after the company announced a delay in the FDA decision for its Alzheimer's treatment candidate, aducanumab. What Happened: The FDA has extended the review period for the biologic license application for aducanumab by three months, Biogen and Eisai Co., Ltd (OTC: ESALY) said in a statement. Biogen is co-developing aducanumab with the Japanese pharma company. Biogen, the sponsor of the BLA, said it submitted a response to an information request by the FDA that included additional analyses and clinical data. The regulatory agency, deeming the submission as a major amendment to the application, extended the review period to give time for review. The PDUFA goal data now stands postponed from March 7 to June 7. Why It's Important: The positive stock reaction to the delay in decision is apparently a relief rally, as investors were positioning for a rejection following a negative Adcom verdict issued in early November. After nearly shelving the development of aducanumab for Alzheimer's disease, Biogen resurrected the clinical program following subset analysis of data. The company made a regulatory submission in July and the FDA accepted the application for priority review in August, assigning a PDUFA goal date of March 7. Analysts are optimistic that the drug will ultimately clear the regulatory hurdle, given there is a serious unmet need and that there are no FDA-approved therapies to treat the disease per se. In premarket trading, Biogen shares were advancing 11.69% to $299.18 and Eisai was advancing 3.26% to $77.05. See more from BenzingaClick here for options trades from BenzingaThe Daily Biotech Pulse: Novavax Vaccine Readout, Clinical Hold On Bellicum Study Lifted, Lilly Earnings, NLS Pharma IPOChinese EV Maker Xpeng To Recall 13,399 G3 SUVs, Cites Potential Inverter Issue© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.