ALPMY - Astellas Pharma Inc.
| Previous Close | 15.60 |
| Open | 15.05 |
| Bid | 0.00 x 0 |
| Ask | 0.00 x 0 |
| Day's Range | 15.05 - 15.54 |
| 52 Week Range | 12.77 - 18.37 |
| Volume | 117,887 |
| Avg. Volume | 42,520 |
| Market Cap | 29.369B |
| Beta (5Y Monthly) | 0.80 |
| PE Ratio (TTM) | 18.10 |
| EPS (TTM) | 0.85 |
| Earnings Date | N/A |
| Forward Dividend & Yield | 0.37 (2.36%) |
| Ex-Dividend Date | Sep 25, 2019 |
| 1y Target Est | N/A |
- PR Newswire
Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for PADCEV™ (enfortumab vedotin-ejfv) in combination with Merck's (known as MSD outside the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.
- PR Newswire
XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. (NYSE: PFE) announced today results of the final overall survival (OS) analysis from the Phase 3 PROSPER trial, which evaluated XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with non-metastatic castration-resistant prostate cancer (nmCRPC).
- PR Newswire
Seattle Genetics and Astellas Announce Updated Results from Phase 1b/2 Trial of PADCEV™ (enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab as Investigational First-Line Treatment for Advanced Bladder Cancer
Seattle Genetics, Inc. (Nasdaq: SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced updated results from the phase 1b/2 clinical trial EV-103 in previously untreated patients with locally advanced or metastatic urothelial cancer who were ineligible for treatment with cisplatin-based chemotherapy. Forty-five patients were treated with the combination of PADCEV™ (enfortumab vedotin-ejfv) and pembrolizumab and were evaluated for safety and efficacy. After a median follow-up of 11.5 months, the study results continue to meet outcome measures for safety and demonstrate encouraging clinical activity for this platinum-free combination in a first-line setting. Updated results will be presented during an oral session on Friday, February 14 at the 2020 Genitourinary Cancers Symposium in San Francisco (Abstract 441). Initial results from the study were presented at the European Society of Medical Oncology Congress in September 2019.
- Benzinga
The Daily Biotech Pulse: Sanofi Reports Positive Readout, Tonix Vaccine Candidate Aces Animal Study, Hologix's Weak Guidance
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech Stocks Hitting 52-week highs on Jan. 29) 10X Genomics Inc (NASDAQ: TXG ) Agile Therapeutics ...
- PR Newswire
Astellas Submits Supplemental New Drug Application for Approval of Evrenzo® (roxadustat) for the Treatment of Anemia Associated with Chronic Kidney Disease in Non-Dialysis Dependent Patients in Japan
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, "FibroGen") today announced the submission of a supplemental New Drug Application (sNDA) to Japan's Ministry of Health, Labour and Welfare to gain marketing approval for Evrenzo® (generic name: roxadustat) for the treatment of anemia associated with chronic kidney disease (CKD) in non-dialysis dependent (NDD) patients. Roxadustat was approved in Japan for the treatment of anemia associated with CKD in dialysis dependent (DD) patients in September 2019 and launched for use in this indication in November 2019.
- PR Newswire
Astellas Completes Acquisition of Audentes Therapeutics
Astellas Pharma Inc. (TSE: 4503) (President and Chief Executive Officer: Kenji Yasukawa, Ph.D., "Astellas") today announced that it has successfully completed the previously announced acquisition of Audentes Therapeutics, Inc. ("Audentes"), through a tender offer by its indirect wholly-owned subsidiary Asilomar Acquisition Corp. ("Asilomar") for all of the issued and outstanding shares of common stock of Audentes for a price of US$60.00 per share net to the seller in cash ("Tender Offer") and the subsequent merger of Asilomar with and into Audentes. Astellas commenced the Tender Offer on December 16, 2019, New York City time, and the Tender Offer expired at 12:00 midnight, New York City time, at the end of the day on January 14, 2020. As of the expiration of the Tender Offer, 35,852,857 shares of Audentes common stock were validly tendered and not properly withdrawn, representing approximately 76.7% of the shares of Audentes common stock outstanding, and such shares have been accepted for payment under the terms of the Tender Offer. The acquisition positions the combined company to become a global leader in AAV-based genetic medicines.
- Zacks
Astellas Acquires Xyphos to Boost Immuno-oncology Pipeline
Astellas (ALPMY) acquires Xyphos and gains the latter's novel and proprietary ACCEL technology platform.
- Benzinga
The Daily Biotech Pulse: Flexion Receives FDA Nod For Zilretta Label Expansion, Astellas Goes Shopping
The following is a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks that hit 52-week highs on Dec. 26.) Aimmune Therapeutics Inc (NASDAQ: AIMT ...
- Reuters
Astellas ramps up M&A, buys U.S. biotech Xyphos for as much as $665 million
Astellas Pharma Inc has bought U.S.-based Xyphos Biosciences Inc to expand its immuno-oncology business, a deal worth up to $665 million including potential development milestones and its second acquisition announced this month. Japan's second biggest drugmaker by sales paid $120 million upfront for Xyphos and the rest will be milestone payments, the companies said in a statement. Astellas also said this month it had agreed to purchase Audentes Therapeutics Inc for about $3 billion to expand its push into genetic medicines.
- PR Newswire
Astellas Strengthens Immuno-oncology Pipeline with Acquisition of Xyphos Biosciences, Inc.
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Xyphos Biosciences, Inc. (CEO: James Knighton, "Xyphos") today announced that Astellas has acquired Xyphos. With the acquisition Astellas will gain Xyphos' novel and proprietary ACCEL (Advanced Cellular Control through Engineered Ligands) technology platform, as well as industry-leading immuno-oncology talent, to develop new and potentially better ways to mobilize, target and control immune cells to find, modulate and destroy targeted cells throughout the body.
- MarketWatch
Seattle Genetics' stock rises on approval of bladder cancer drug
The Food and Drug Administration on Wednesday approved Padcev as a treatment for metastatic urothelial cancer. The therapy is jointly being developed by Astellas Pharma Inc. and Seattle Genetics , which began collaborating on this product in 2007. In morning trading on Thursday, Astellas stock was up 0.9% and Seattle's was up 1.25%. The FDA granted the first-in-class drug accelerated approval, based on the EV-201 Phase 2 clinical trial of 125 patients, which reported that 12% of the patients who received Padcev had a complete response to treatment and 32% had a partial response, such as a decrease in tumor size. A confirmatory Phase 3 trial is currently being conducted. Year-to-date, Seattle's stock is up 98%, while shares of Astellas stock have gained 37%. The S&P 500 is up 27%.
- PR Newswire
FDA Grants Accelerated Approval to Astellas' and Seattle Genetics' PADCEV™ (enfortumab vedotin-ejfv) for People with Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to PADCEV™ for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV is approved under the FDA's Accelerated Approval Program based on tumor response rate. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. PADCEV is the first FDA approved treatment in the U.S. for these patients. It is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.1,3
- Benzinga
The Daily Biotech Pulse: Roche Gets US Antitrust Clearance For Spark Purchase, An Orphan Drug Designation For Prevail, Dynavax Names CEO
The following is a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks that hit 52-week highs Dec. 16.) Acceleron Pharma Inc (NASDAQ: XLRN ) Amarin ...
- MarketWatch
Pfizer stock ticks higher on new FDA approval for prostate cancer drug
Pfizer Inc. shares ticked higher in the extended session Monday after the drug maker said the Food and Drug Administration approved a new indication for a cancer drug it makes with Astellas Pharma Inc. . Pfizer shares rose 1.2% after hours, following a 2.1% advance to close the regular session at $39.14. Pfizer said the FDA approved Xtandi to treat patients with metastatic castration-sensitive prostate cancer, or prostate cancer that spreads to other parts of the body and is responsive to treatments that lower testosterone. Xtandi is already approved to treat non-metastatic and metastatic castration-resistant prostate cancer.
- PR Newswire
XTANDI® (enzalutamide) Approved by U.S. FDA for the Treatment of Metastatic Castration-Sensitive Prostate Cancer
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). In 2019, it is estimated that just over 40,000 men in the United States are living with mCSPC, a form of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone.1,2,3
- Moody's
Astellas Pharma Inc. -- Moody's reviews Astellas Pharma's A1 ratings for downgrade
Moody's Japan K.K. has placed Astellas Pharma Inc.'s A1 issuer ratings under review for downgrade. The rating action follows Astellas' announcement on 3 December 2019 that it had entered into a definitive agreement to acquire the entire stock of Audentes Therapeutics, Inc. for approximately USD3 billion. "This acquisition indicates an urgency for Astellas to feed its long term product pipeline after a wave of patent expiries this year, and signals a rise in acquisition event risk," says Akifumi Fukushi, a Moody's Vice President and Senior Analyst.
- GuruFocus.com
Astellas-Audentes Deal Likely to Ignite More Acquisitions
Companies with gene therapy capabilities are becoming more attractive to members of Big Pharma, who are eager to add the technology to their portfolios Continue reading...
- PR Newswire
Astellas and MBC BioLabs Announce Golden Ticket Winners - Supporting Biotech Start-Ups to Accelerate Innovative Science
Astellas Venture Management (President: Shunichiro Matsumoto, Ph.D., MBA, "AVM"), a wholly-owned venture capital subsidiary of Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas"), and Mission Bay Capital BioLabs ("MBC BioLabs"), a life-science incubator, today announced AmbAgon Therapeutics and Gordian Biotechnology as the winners of the Astellas-sponsored "Golden Ticket Competition." The award supports advancing early-stage companies' pre-clinical scientific discoveries, reflecting Astellas' ongoing commitment to discovering and advancing innovative science for the potential future benefit of patients worldwide.
- PR Newswire
SHAREHOLDER ALERT: WeissLaw LLP Investigates Audentes Therapeutics, Inc.
WeissLaw LLP is investigating possible breaches of fiduciary duty and other violations of law by the Board of Directors of Audentes Therapeutics, Inc. ("Audentes" or the "Company") (NASDAQ: BOLD) in connection with the proposed acquisition of the Company by Astellas Pharma Inc. ("Astellas Pharma") (OTC:ALPMY). Under the terms of the acquisition agreement, BOLD shareholders will receive $60.00 per share in cash.
- Investor's Business Daily
This Gene Therapy Stock Just Netted A $3 Billion Bid — Who's Next?
Shares of Audentes Therapeutics rocketed more than 100% Tuesday on news Japanese pharmaceutical company Astellas Pharma will acquire the gene therapy biotech company for $3 billion.
- MarketWatch
Astellas’ $3 billion gene therapy deal steadies investors after stalled Roche acquisition
Astellas Pharma Inc.’s $3 billion acquisition of Audentes Therapeutics is a strong indicator that the pharmaceutical industry’s march into gene therapy development isn’t going to slow down in 2020.
- Benzinga
Japan's Astellas To Buy Gene Therapy Company Audentes For $3B Cash
Astellas and Audentes Therapeutics Inc (NASDAQ: BOLD) said they have entered a definitive agreement for the former to acquire the latter for $60 per share in cash, representing a total equity value of about $3 billion. The per-share transaction value represents a 110% premium to Audentes' Monday closing price of $28.61. Astellas, through Asilomar, an acquisition vehicle of its U.S. subsidiary, will commence in the next few weeks a tender offer to buy all outstanding Audentes shares.
- Barrons.com
Gene-Therapy Firm Audentes Sells for Double Its Share Price. It Could Be the First of Many More Deals.
Astellas Pharma is paying $60 a share in cash for a gene-therapy stock that closed at $28.61 on Monday.
- MarketWatch
Astellas bets $3 billion in gene therapy deal
Shares of Astellas Pharma Inc. rose about 1% in premarket trading after the Japanese drugmaker said Monday evening that it plans to acquire Audentes Therapeutics for $3 billion in cash. Audentes is developing gene therapies. Its stock jumped 105% in premarket trading. "This is just another bullish domino for genetic medicine," Raymond James' Steven Seedhouse wrote in a research note. In recent years, there have been a number of high-profile buyouts of companies developing gene therapies, including Roche's $4.8 billion pending acquisition of Spark Therapeutics and Novartis's $8.7 billion purchase of AveXis. Astellas said the boards of both companies have approved the deal. Shares of Astellas have gained 35% year-to-date, while the S&P 500 is up about 24%.
