Fri, Aug. 5, 5:42 PM
Fri, Aug. 5, 11:28 AM
- AstraZeneca (AZN +1.2%) shoots to a 52-week high, as the failure of Bristol-Myers Squibb's (BMY -16.7%) immunotherapy drug Opdivo to slow disease progression in previously untreated patients with lung cancer was viewed by investors as good news for rivals AZN and Merck (MRK +6.7%).
- Analysts at Leerink, Jefferies and Deutsche Bank say the news increases the potential market opportunity for AZN's combination of durvalumab and tremelimumab.
- Cancer is the hottest area of research across the drug industry, which some analysts believe could make AZN a takeover target again, with speculation recently turning to Novartis as a bidder.
Fri, Jul. 29, 5:39 PM
Thu, Jul. 28, 10:02 AM| Thu, Jul. 28, 10:02 AM | 2 Comments
Thu, Jul. 28, 5:50 AM
Wed, Jul. 20, 12:53 PM
Thu, Jun. 30, 5:37 PM
Fri, Jun. 24, 10:25 AM
- Intrepid biotech investors are, no doubt, seriously considering deploying some cash today in response to the (hopefully temporary) bearish reaction to the Brexit vote. Nasdaq is currently down 2.7%, the Dow 2.2% and the IBB 3.3%.
- Representative tickers: (GILD -2.2%)(GSK -2.4%)(AZN -2.7%)(PFE -1.1%)(MRK -1.9%)(CELG -3.2%)(BMY -2%)(BIIB -2.4%)(AMGN -2.7%)(AGN -2.8%)(TEVA -0.8%)(ABT -3.4%)(MDT -1.4%)
Wed, Jun. 15, 4:19 PM
- In a regulatory filing, Relypsa (NASDAQ:RLYP) reports that retail prescriptions for hyperkalemia drug Veltassa (patiromer) in May were 1,230, up 32.5% from April. New patients who started with a free starter supply totaled 1,385 (+13.9%). Units sold in the hospital/institution setting, however, were down 3.8% (277 in May versus 288 in April).
- The company says the numbers are estimates as they have not been verified by a third party.
- Investors are looking for a healthy ramp considering the company's window of opportunity since competitor AstraZeneca (NYSE:AZN) received a Complete Response Letter (CRL) from the FDA last month regarding its NDA for ZS-9.
- Previously: FDA rejects AstraZeneca's ZS-9 NDA; competitor Relypsa up 29% premarket (May 27)
- Update: Shares are now up 6% on turnover of ~100K.
Fri, May 27, 7:25 AM
- In a shot to the corporate solar plexus, AstraZeneca (NYSE:AZN) receives a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking approval of hyperkalemia drug ZS-9 (sodium zirconium cyclosilicate). In a statement, it said the CRL refers to observations from a pre-approval on-site manufacturing inspection. The agency also cited the receipt of recently-submitted data which it has yet to review. The company is reviewing the CRL to determine appropriate action.
- AstraZeneca acquired the rights to ZS-9 via its $2.7B acquisition of ZS Pharma in December 2015.
- Competitor Relypsa (NASDAQ:RLYP) is up 29% premarket on robust volume. Its hyperkalemia drug, Veltassa (patiromer) was approved by the FDA in October 2015.
- AstraZeneca is down 1% premarket on increased volume.
Thu, May 26, 11:52 AM
- Nano cap Biodel (BIOD -14.3%) gives all its merger news pop back as shares have completely retraced from yesterday's up move which was over 40% at one time but failed to hold.
- Tuesday evening, the company announced that it would combine with privately held Albireo. The new company will do business as Albireo Pharma and trade under the symbol "ALBO." A syndicate of institutional investors, including AstraZeneca (AZN -0.1%) will invest $10M in the new organization.
- Under the terms of the deal, Biodel shareholders will own ~33% of the combined firm while Albireo shareholders will own ~67%. Albireo chief Ron Cooper will be serve as President & CEO of Albireo Pharma while Chairman David Chiswell, Ph.D,, will continue as Chairman. The transaction should close in Q3.
- The combined firm will focus on developing bile acid modulators for the treatment of a range of liver, gastrointestinal and other disorders. Albireo's lead product candidate is Phase 2-stage A4250 for the treatment of a pediatric orphan disease called Progressive Familial Intrahepatic Cholestasis, an inherited disorder characterized by the buildup of bile in the liver which usually leads to liver failure.
Tue, May 17, 9:09 AM
- Relypsa (NASDAQ:RLYP) slumps 7% premarket on increased volume in apparent response to chatter that Veltassa (patiromer) sales will continue to under-impress (sales were $0.6M in Q1). Citigroup cut its price target on the stock to $25 from $30.
- Update: A survey of 112 nephrologists conducted by Zug, Switzerland-based Spherix Global Insights revealed that more than half of the Veltassa user base is in the trial mode. The majority expect to increase their use of Veltassa in the near term, although the six-hour dose separation requirement is the leading disadvantage with 90% of the respondents saying it will (at least somewhat) limit their use of the product. The feedback is largely consistent with what was provided by cardiologists (n=93), although they are less familiar with Veltassa.
- Commercialization partner Vifor Fresenius Medical Care Renal Pharma Ltd. filed a Marketing Authorization Application (MAA) with the European Medicines Agency several weeks ago seeking approval to sell Veltassa in the EU.
- Relypsa is neck-and-neck with AstraZeneca (AZN +0.2%) and its hyperkalemia drug ZS-9. Regulatory applications are under review in both the U.S. and Europe. The FDA's action date is May 26. Veltassa was approved in the U.S. in October 2015 and launched two months later.
Fri, May 6, 5:37 PM
Thu, May 5, 9:14 AM
- In a letter to Medivation's (NASDAQ:MDVN) board, Sanofi (NYSE:SNY) CEO Olivier Brandicourt reiterates his firm's strong desire to negotiate the terms of an acquisition, saying its $9.3B offer ($52.50 per share) represents a tidy 50% premium over what shares were trading three months before.
- He also says Sanofi has had extensive discussions with Medivation's top shareholders and they back the deal. Going a step further, he says Sanofi is prepared to go directly to shareholders if management does not proceed.
- A competing bid appears likely [Pfizer (NYSE:PFE), AstraZeneca (NYSE:AZN)] so whatever Medivation decides to do, Sanofi will probably have to up its offer.
- MDVN is up a fraction premarket while SNY is down 3%.
- Update: Medivation reiterates that Sanofi's bid is "substantially inadequate."
Tue, May 3, 6:34 PM
- Medivation (NASDAQ:MDVN) +3.9% AH following a Reuters report that Pfizer (NYSE:PFE) has approached the company to express interest in an acquisition, raising the possibility of a bid rivaling Sanofi's (NYSE:SNY) $9.3B offer by Sanofi.
- MDVN has not yet decided whether it should engage with PFE in negotiations and is in discussions with its financial and legal advisers, according to the report.
- MDVN last week rejected SNY's $52.50/share takeover proposal, and PFE, Novartis (NYSE:NVS) and AstraZeneca (NYSE:AZN) have been speculated as potential suitors.
Fri, Apr. 29, 3:09 PM
- Also mentioned alongside AZN and PFE as weighing bids for Medivation (MDVN +2.3%) is Novartis (NYSE:NVS), according to the report.
- Earlier today, Medivation rejected Sanofi's (SNY -4.6%) $9.3B, or $52.50 per share offer, with one of Bloomberg's sources saying the company is looking for at least $65 per share. Sanofi has the capacity to go higher, say sources, but is naturally reluctant to overpay.
AstraZeneca Plc is a global research-based biopharmaceutical company, which primarily focuses on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. The... More
Industry: Drug Manufacturers - Major
Country: United Kingdom