SA News • Yesterday, 3:30 PM
Update: AstraZeneca Inks Lucrative Deal With Omnis Pharmaceuticals
- Earlier in the week, AstraZeneca announced that it inked a deal with Omnis Pharmaceuticals for the development of oncolytic viruses in immuno-oncology.
- I reiterate my bullish thesis on AstraZeneca.
- As expected, AstraZeneca continues to improve its long-term growth prospects.
Update: AstraZeneca Anti-Clotting Drug Moves Closer To Market
- AstraZeneca announced Wednesday a favorable outcome from the Phase 3 study of its anti-clotting drug Brilinta.
- I reiterate my bullish thesis on AstraZeneca.
- As expected, the company continues to enhance its growth prospects.
Update: In A Surprise Twist, AstraZeneca Wins Accelerated FDA Approval For LynparzaTrevor Lowenthal • Dec. 21, 2014
- On Friday, AstraZeneca announced accelerated FDA approval for Lynparza. This comes a day after the EU approved Lynparza (olaparib).
- I reiterate my bull thesis on AstraZeneca. The company projects Lynparza to be a $2 billion-a-year seller, and the two approvals last week position the company to fulfill this projection.
- As expected, AstraZeneca continues to enhance its growth prospects as an independent pharmaceutical company. FDA approval for Lynparza corroborates this position.
- On Thursday, AstraZeneca announced that the EC has granted Marketing Authorization for Lynparza (olaparib).
- I reiterate my bull thesis on AstraZeneca. The company projects Lynparza to be a $2 billion-a-year seller.
- As expected, AstraZeneca continues to enhance its growth prospects as an independent pharmaceutical company. EC approval for Lynparza corroborates this position.
- On Tuesday, AstraZeneca announced the EU approval for Moventig (naloxegol) for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxatives.
- I reiterate my bull thesis on AstraZeneca.
- As expected, Astra continues to enhance its growth prospects as an independent pharmaceutical company. Also, as expected, the EC aligned its decision on Moventig with the EMA.
Update: AstraZeneca On A Hot Streak, Announces Positive Data From The Phase 3 Study Of Brodalumab
- AstraZeneca announced yesterday positive Phase 3 data from the AMAGINE program on brodalumab.
- I reiterate my bull thesis on AstraZeneca. The development of brodalumab represents a significant revenue opportunity.
- As expected, Astra continues to enhance its growth prospects independent of Pfizer. Yesterday's announcement corroborates this position.
Update: AstraZeneca Wins EC Marketing Authorization For Duaklir GenuairTrevor Lowenthal • Nov. 25, 2014
- AstraZeneca announced EU Marketing Authorization for Duaklir Genuair on Monday.
- I reiterate my bull thesis on AstraZeneca.
- As expected, AstraZenca continues to improve its growth prospects as an independent pharmaceutical company. Monday's announcement corroborates this position.
Update: AstraZeneca Q3 Earnings Fail To Impress, But Long-Term Prospects Remain IntactTrevor Lowenthal • Nov. 7, 2014
- Astra reported Q3 earnings on Thursday.
- I reiterate my bull thesis on Astra.
- As expected, Astra remains fully capable of earnings growth independent of Pfizer. The latest earnings report corroborates this position.
- AstraZeneca may not receive a fresh offer from Pfizer in the wake of new tax rules announced by the Treasury.
- AstraZeneca though looks attractive even without a bid from Pfizer.
- The company recently received approval for Xigduo XR in the U.S. and has also sealed the Almirall transaction.
- AstraZeneca’s oncology portfolio also looks promising, with olaparib recently receiving positive recommendation in the European Union.
- There is 10%-12% upside potential in AstraZeneca shares in the near-term.
- AstraZeneca announced today FDA approval for its diabetes combo pill Xigduo XR.
- I reiterate my bull thesis following the approval.
- As expected, AstraZeneca continues to enhance its growth prospects, thus supporting my thesis that it can thrive independent of Pfizer.
Update: AstraZeneca Receives Positive EMA Recommendation For Olaparib
- AstraZeneca announced Friday the EU recommendation for approval for Olaparib.
- I reiterate my bull thesis, as Astra continues to increase its growth prospects.
- As expected, the company continues to demonstrate its viability independent of Pfizer. The positive EU recommendation corroborates this position.
Update: AstraZeneca Moves Closer To EU Approval For Moventig
- AstraZeneca announces a positive EMA opinion for Moventig.
- I reiterate my bull thesis on AstraZeneca given the market potential in the EU for this opioid-induced constipation drug.
- The positive EMA opinion follows the recent FDA approval for Moventig.
- AstraZeneca announced today a licensing agreement with Eli Lilly for AZD3293 to target Alzheimer's disease.
- I reiterate my bull thesis on AstraZeneca given the value proposition of this arrangement.
- I didn't anticipate this agreement in my initial report.
AstraZeneca Has 30% Upside As A Takeover Candidate
- Pfizer's last bid for AstraZeneca is a 27% premium over the current stock price.
- Talks may resume as early as this month if AstraZeneca is interested, but are more likely to resume in November.
- This deal is beneficial to AstraZeneca's shareholders over the short-term, but is likely to hinder innovation at the combined company over the long-term.
- AstraZeneca has an attractive drug pipeline and is expecting to grow revenues 7.5% annually as a result of this pipeline.
- Pfizer has been slashing R&D spending and is in desperate need of a drug pipeline to carry its company into future success.
Update: AstraZeneca's Earnings Beat Reaffirms Bull Thesis
- AstraZeneca is attempting to make an earnings comeback after being hindered by a series of patent expirations, which has taken a toll on revenues.
- Pfizer isn't budging with respect to unveiling whether it still has plans to acquire AstraZeneca after the 3-to-6-month waiting period.
- Regardless, AstraZeneca is proving that it can exceed expectations independent of Pfizer, pursuant to the latest earnings report. Thus, I reaffirm my bull thesis in light of strong earnings performance.
- AZN is a solid company with a fine management team, but is a poor investment choice at its current stock price given its uncertain future.
- Unfavorable politics and negative sentiment in the US and UK make another offer for AZN by Pfizer unlikely in 2014.
- Conservative estimates of revenues in 2023 are $31 billion vs. company estimates of $45 billion.
- At the current price of $73, investors are paying for hope on a pipeline that won't deliver significant revenues for at least 5 years.
- AstraZeneca tumbled after rejecting Pfizer's "final" bid, and considerable risks remain.
- Nevertheless, both its impressive dividend yield of 5.30% and extensive pipeline keep me interested.
- To take advantage of its high yield, I have constructed a conservative yield-enhancing strategy that reduces risk and provides investors with peace of mind.
AstraZeneca Continues To Benefit From Pfizer Courtship
- Pfizer made a generous new offer to acquire AstraZeneca for $106 billion in cash and shares.
- Pfizer CFO Frank D'Amelio revealed that every option, including a hostile takeover, remains on the table when it comes to buying AstraZeneca.
- Pfizer’s attention, in addition to strong fundamentals and innovation at AstraZeneca, will likely continue to be a boon for AstraZeneca shares.
Yesterday, 3:30 PM
- The FDA approves the Abbreviated New Drug Application (ANDA) from Teva Pharmaceutical Industries (TEVA -1.8%) subsidiary Ivax Pharmaceuticals for a generic version of AstraZeneca's (AZN -0.2%) Nexium (esomeprazole magnesium delayed-release capsules). Esomeprazole is a proton pump inhibitor that reduces stomach acid.
- The primary indication is the treatment of gastroesophageal reflux disease (GERD) in adults and children at least one year old. It is also cleared for the reduction in risk of gastric ulcers associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), the treatment of stomach infection from Helicobactor pylori in conjunction with certain antibiotics and the treatment of conditions where the stomach produces excess acid, including Zollinger-Ellison syndrome.
- It is the first generic esomeprazole to gain regulatory clearance in the U.S.
Yesterday, 8:47 AM
- Citing its lack of abuse and dependence potential, the U.S. Drug Enforcement Agency (DEA) removes naloxegol from its list of Schedule II drugs.
- Naloxegol was developed by Nektar Therapeutics (NASDAQ:NKTR) for the treatment of opioid-induced constipation. It is marketed under the brand name Movantik by AstraZeneca (NYSE:AZN).
Thu, Jan. 22, 8:34 AM
- A Phase 2 clinical trial measuring progression-free survival (PFS) in patients with metastatic castration-resistant prostate cancer receiving Xtandi (enzalutamide) or bicalutamide met its primary endpoint of a statistically significant increase in PFS for enzalutamide.
- Median PFS for the enzalutamide cohort was 15.7 months versus 5.8 months for the bicalutamide group (p<0.0001), although the median time on treatment was twice as long for the enzalutamide group (11.7 months) compared to the bicalutamide group (5.8 months).
- Data from the trial will be presented at a future medical conference.
- Enzalutamide is being co-developed by Medivation (NASDAQ:MDVN) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY).
- Related ticker: (NYSE:AZN)
Thu, Jan. 22, 7:49 AM
- The European Medicines Agency (EMA) accepts AstraZeneca's (NYSE:AZN) Marketing Authorization Application (MAA) for lesinurad 200 mg tablets for the treatment of patients with gout, a form of inflammatory arthritis.
- Lesinurad is a selective uric acid reabsorption inhibitor that inhibits the URAT1 transporter, which is responsible for the majority of the reabsorption of filtered uric acid from the renal tubular lumen. Inhibiting URAT1 increases uric acid secretion and thereby lowers serum uric acid.
- AstraZeneca obtained the rights to lesinurad via its acquisition of Ardea Biosciences in June 2012.
Mon, Jan. 19, 5:26 PM
- As expected, the European Commission approves Boehringer Ingelheim's OFEV (nintedanib) for the treatment of patients with idiopathic pulmonary fibrosis (IPF). The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in November backing approval.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug (Nov. 21, 2014)
- IPF-related tickers: (NYSE:BMY) (OTCQX:RHHBY) (NASDAQ:FGEN) (NYSE:AZN) (OTCPK:ALPMF) (OTCPK:ALPMY)
Mon, Jan. 19, 5:11 PM
- As expected, the European Commission approves Novartis' (NYSE:NVS) Cosentyx (secukinumab) as a first-line systemic treatment for adult patients with moderate-to-severe psoriasis. It is the first interleukin-17A inhibitor cleared in Europe.
- Cosentyx is also cleared for sale in Australia and Japan. FDA approval is imminent considering the unanimous positive vote by the Dermatologic and Ophthalmic Drugs Advisory Committee in October.
- Previously: Europe Ad Comm gives thumbs up to Novartis psoriasis drug (Nov. 21, 2014)
- Previously: Ad Comm backs approval of secukinumab (Oct. 21, 2014)
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Wed, Jan. 14, 9:13 AM
- Express Scripts' (NASDAQ:ESRX) success in containing the prices of new HCV therapies by pitting Gilead Sciences (NASDAQ:GILD) against AbbVie (NYSE:ABBV) is sending shock waves through the biotech/pharma industry. Most of the big players slumped yesterday as investors fear that ESRX's tactics will spread to other high cost areas like cancer and cholesterol.
- At JPM15 yesterday, CEO George Paz said that the new cholesterol-lowering post-statin PCSK9 inhibitors will be the next big opportunity to pit drug firms against each other in order to drive costs down. FDA clearance of the first two therapies, one from Amgen (NASDAQ:AMGN) and the other from Regeneron Pharmaceuticals (NASDAQ:REGN) (NYSE:SNY), is expected to occur at about the same time.
- The prices of emerging cancer therapies will also be in payers' crosshairs. Amgen's Blincyto, for example, costs $178,000 per standard course of treatment while Merck's (NYSE:MRK) Keytruda is close behind at $150,000.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NYSE:LLY) (ABBV) (NYSE:PFE) (NASDAQ:BIIB) (NYSE:ABT) (NASDAQ:CELG) (NYSE:BMY) (OTCQX:RHHBY) (NYSE:JNJ) (NYSE:NVS) (OTCPK:BAYRY)
Wed, Jan. 14, 7:52 AM
- A Phase 3 study assessing AstraZeneca's (NYSE:AZN) Brilinta (ticagrelor) plus low dose aspirin for the prevention of arterothrombotic events in patients who had experienced a heart attack within one to three years of the start of the trial met its primary efficacy endpoint of a composite of cardiovascular (CV) death, myocardial infarction or stroke.
- The study, PEGASUS-TIMI 54, assessed two doses of ticagrelor (60 mg or 90 mg twice daily) on a background of low dose aspirin compared to placebo plus low dose aspirin in patients at least 50 years old with a history of heart attack and one additional CV risk factor. The trial was designed to better understand the management of patients with a history of heart attack beyond one year. Over 21,000 patients were involved in the trial. Complete results will be presented at a scientific meeting this year.
- Brilinta is a direct-acting P2Y12 receptor antagonist in a class of compounds called cyclo-pentyl-triazolo-pyrimidines. It works by inhibiting platelet activation which reduces the rate of thrombotic CV events.
Sun, Jan. 11, 10:29 PM
- Based on an assessment by the independent Data Monitoring Committee, Bristol-Myers Squibb (NYSE:BMY) stops its Phase 3 trial, CheckMate-017, evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced squamous cell non-small cell lung cancer (NSCLC). The committee concluded that the study met its primary endpoint of demonstrating superior overall survival (OS) compared to docetaxel. This is the first time a PD-1 inhibitor has shown a survival advantage in lung cancer.
- Eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension.
- The company will complete a full analysis of the data and work with investigators on the future presentation and publication of the results.
- PD-1-related tickers: (NASDAQ:MDVN) (NYSE:MRK) (NASDAQ:FPRX) (NASDAQ:CELG) (OTCQX:RHHBY) (NYSE:AZN)
Thu, Jan. 8, 7:55 PM
- The FDA approves Daiichi-Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
- Edoxaban is an anticoagulant that inhibits factor Xa. It was approved in Japan in 2011 for the prevention of venous thromboembolism in patients undergoing total knee replacement surgery, total hip replacement surgery and hip fracture surgery.
- Anticoagulant-related tickers: (NASDAQ:ISIS) (NYSE:BAX) (NASDAQ:PTLA) (NASDAQ:MSLI) (NYSE:MRK) (NYSE:JNJ) (NASDAQ:MDCO) (NASDAQ:SCLN) (NYSE:PFE) (NYSE:BMY) (NYSE:AZN) (OTCPK:BAYRY)
Dec. 22, 2014, 12:58 PM
- Thinly-traded nano cap Advaxis (ADXS +29.8%) zooms ahead on a 7x surge in volume. Shares have rocketed up 80% from the close of $3.78 on December 12. On December 15, the FDA cleared the company's IND to conduct a Phase 1/2 trial of ADXS-HPV alone or in combination with MedImmune's (AZN +0.7%) investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of HPV-associated cervical cancer and HPV-associated head and neck cancer.
- A week earlier, the agency cleared its IND for the start of a Phase 1/2 trial of ADXS-PSA in combination with Merck's Keytruda (pembrolizumab) for the treatment of prostate cancer.
- Separately, the company completed securities purchase agreements with two institutional investors for the sale of ~3.9M shares of common stock at $4.25 per share. Proceeds will fund the continued clinical development of its cancer immunotherapy pipeline.
- Previously: Advaxis submits IND for HPV-associated cancers (Nov. 12, 2014)
- Previously: Advaxis files IND for prostate cancer therapy candidate (Nov. 5, 2014)
Dec. 21, 2014, 7:09 AM
- "I consider it unlikely that Pfizer (NYSE:PFE) will return with a bid," reports Swedish business daily Dagens Industri quoting AstraZeneca (NYSE:AZN) CEO Pascal Soriot. "I can't say it will never happen, but the probability that Pfizer returns is much less."
- Although British takeover rules now allow Pfizer to renew its pursuit of AstraZeneca, the recent U.S. clampdown on tax inversions makes an acquisition unlikely.
- Pfizer also reached a major cancer drug deal with Merck KGaA last month, reducing its need for AstraZeneca's products.
- Previously: Astrazeneca cools speculation for another takeover bid (Nov. 28 2014)
Dec. 19, 2014, 12:33 PM
Dec. 19, 2014, 12:22 PM| Comment!
Dec. 18, 2014, 7:22 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Lynparza (olaparib) for the maintenance treatment of adult patients with platinum-resistant relapsed BRCA-mutated (germline and/or somatic) high grade serious epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy.
- Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that exploits DNA repair pathway deficiencies to preferentially kill cancer cells. It is the first PARP inhibitor approved for patients with platinum-sensitive relapsed BRCA-mutated ovarian cancer. Appropriate patients will be identified through a validated diagnostic test.
- The company is investigating the efficacy of olaparib in other cancer types.
Dec. 11, 2014, 10:38 AM
- Today is shaping up to be another session of positive money flow into AstraZeneca (AZN +0.5%). Shares are up a fraction on turnover of 3M compared to the average daily volume of 2.1M. Yesterday, shares rose 2.2% on a 3x surge in volume.
- Investors appear to like the potential of Moventig (naloxegol) in Europe.
- Previously: Moventig cleared in Europe for OIC (Dec. 9, 2014)
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