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  • Tue, Nov. 29, 9:59 AM
    • Results from a proof-of-concept Phase 1 trial assessing Blueprint Medicines' (BPMC -8.6%) BLU-554 in patients with advanced hepatocellular carcinoma (HCC) showed anti-tumor activity albeit with side effects. The data are being presented today at the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Munich, Germany.
    • BLU-554 was evaluated in the dose escalation stage of the study. As of the November 7 data cutoff date, 25 HCC patients received five dose levels (140 mg once daily to 900 mg once daily). Most patients had been previously treated with sorafenib [Bayer's (OTCPK:BAYRY) NEXAVAR].
    • One patient had a confirmed partial response (PR) while 12 had stable disease implying a disease control rate of 52% (n=13/25).
    • Of the 10 evaluable patients with FGF19 overexpression, five showed radiographic tumor reduction including on confirmed PR.
    • 72% of patients (n=18/25) discontinued treatment due to cancer progression (n=15), treatment-related adverse events (n=2) and investigator's decision (n=1).
    • The most common adverse events (AEs) were diarrhea (72%), nausea (44%), abdominal pain (40%), vomiting (40%), fatigue (36%) and elevated liver enzymes (32%, 28%). Serious AEs occurring in three or more patients included anemia, elevated liver enzymes, abdominal pain and decreased lymphocytes. Two patients experienced dose-limited toxicities at 900 mg which then defined 600 mg as the maximum tolerated dose.
    • Enrollment in a 45-subject expansion phase is underway.
    • BLU-554 inhibits a protein called fibroblast growth factor receptor 4 (FGFR4). Investigators measured the levels of the protein FGF19 because it activates the FGFR4 pathway.
    | Tue, Nov. 29, 9:59 AM
  • Mon, Nov. 28, 1:41 PM
    • Presenting at the Robin Hood Investors Conference, Greenlight Capital's (NASDAQ:GLRE) David Einhorn tells the crowd he likes Bayer (OTCPK:BAYRY) as a standalone or after a merger with Monsanto (NYSE:MON).
    • Both stocks are modestly lower on the session, but have perked up since Einhorn made his comments.
    | Mon, Nov. 28, 1:41 PM | 5 Comments
  • Fri, Nov. 18, 12:14 PM
    • The president-elect intends to nominate Alabama Senator Jeff Sessions as the next Attorney General. While the immediate focus (in much of the media) seems likely to be his hardline stance against illegal immigration, Evercore ISI's Terry Haines says the choice means an immediate shift from the "red light" antitrust policy of the Obama administration.
    • Source: Bloomberg
    • That, of course, would be of particular interest to AT&T (NYSE:T) and Time Warner (NYSE:TWX), as well as Bayer (OTCPK:BAYRY) and Monsanto (NYSE:MON).
    | Fri, Nov. 18, 12:14 PM | 50 Comments
  • Tue, Nov. 15, 12:58 PM
    • Bayer (OTCPK:BAYRY -0.4%) says it will issue €4B ($4.3B) in mandatory convertible notes as part of measures to fund its acquisition of Monsanto (MON +0.4%).
    • Bayer says issuing the notes, set to mature in November 2019, is the first part of ~$19B in previously announced equity capital measures related to the MON acquisition.
    • Separately, MON reaffirms in an 8-K filing that it projects FY 2017 EPS of $4.50-$4.90, in line with the $4.72 analyst consensus estimate, and expects its seed and genomics segment gross profit to increase Y/Y by mid-single digits as a percent, with soybean gross profit alone expected to grow by more than 20%.
    | Tue, Nov. 15, 12:58 PM | 14 Comments
  • Tue, Nov. 15, 7:30 AM
    • Bayer (OTCPK:BAYRY) announces a Phase 3 clinical, CHICO, assessing a pediatric formulation of Nifurtimox (an adult formulation is marketed by the company in South America as Lampit) for the treatment of children (including newborns) with Chagas disease, an infectious disease caused by single-cell parasites called trypanosoma. They are transmitted to humans via the feces/urine of kissing bugs, so named because they prefer to bite humans around the mouth or eyes.
    • CHICO is evaluating fast-disintegrating 30 mg and 120 mg tablets that can be divided for weight-adjusted doses in all age groups in ~390 children. The study is a two-arm design with 30-day and 60-day treatment cycles at 25 sites in Argentina, Colombia and Bolivia. Enrollment began in January 2016.
    • Although regarded as a tropical disease, it is believed that more than 300K Americans are infected with Chagas. Children are particularly at risk but they have the best chances of being completely cured.
    • The company announced the study at the 65th annual meeting of the American Society of Tropical Medicine & Hygiene in Atlanta, GA.
    | Tue, Nov. 15, 7:30 AM
  • Mon, Nov. 14, 12:39 PM
    • Results from a Phase 3b clinical trial, PIONEER AF-PCI, showed Bayer's (OTCPK:BAYRY -1.1%) blood thinner Xarelto (rivaroxaban) was more effective than a vitamin K antagonist (VKA) in reducing the risk of bleeding in patients with non-valvular atrial fibrillation (AF) after percutaneous coronary intervention (PCI). The data were presented today at the American Heart Association Scientific Sessions 2016 in New Orleans, LA.
    • A once-daily dose of 15 mg of rivaroxaban, in combination with single antiplatelet therapy, reduced the rate of clinically significant bleeding by 41% compared to VKA plus dual antiplatelet therapy (DAPT) through 12 months, equivalent to an absolute risk reduction of 9.9%.
    • Rivaroxaban 2.5 mg twice daily plus DAPT reduced the risk of clinically significant bleeding 37% compared to VKA + DAPT through 12 months, equivalent to an absolute risk reduction of 8.7%.
    • 20 - 45% of AF patients may have to undergo PCI, which increases the risk of blood clots. Until now, there has been a dearth of clinical evidence to guide the best treatment strategies in these patients.
    • Xarelto is currently approved for seven indications in a range of venous and arterial thromboembolic conditions.
    | Mon, Nov. 14, 12:39 PM
  • Mon, Nov. 7, 5:21 PM
    • U.S. state attorneys general have joined a federal antitrust probe of the planned merger between Dow Chemical (NYSE:DOW) and DuPont (NYSE:DD), adding a new risk to the deal's completion, Reuters reports.
    • About seven states, including California, have joined the probe of Dow's planned merger with DuPont, according to the report, which adds that some of the state AGs would join an investigation of the proposed merger of Monsanto (NYSE:MON) and Bayer (OTCPK:BAYRY).
    • The states are said to be concerned that the companies may raise pesticide and herbicide prices for farmers following a merger, and have less incentive to compete to introduce better and cheaper products.
    | Mon, Nov. 7, 5:21 PM | 11 Comments
  • Mon, Nov. 7, 6:34 AM
    • Bayer (OTCPK:BAYRY) submits marketing applications in the U.S. Europe and Japan seeking approval of Stivarga (regorafenib) for the second-line treatment of patients with unresectable hepatocellular carcinoma (HCC), the third type of cancer for the kinase inhibitor. It is currently approved for the treatment of metastatic colorectal cancer and metastatic gastrointestinal stromal tumors.
    • The data supporting the filings were generated in the Phase 3 RESORCE study that showed HCC patients who progressed during treatment with Nexavar (sorafenib) who received regorafenib experienced significantly improved overall survival (OS) compared to placebo with 37% less risk of death. Median OS in the regorafenib plus best supportive care (BSC) group was 10.6 months versus 7.8 months for placebo plus BSC.
    • The U.S. application has Fast Track status.
    • Bayer developed regorafenib under its 2011 license agreement with now-Amgen (NASDAQ:AMGN) subsidiary Onyx Pharmaceuticals. Onyx receives a royalty on global net oncology sales of regorafenib.
    | Mon, Nov. 7, 6:34 AM
  • Tue, Nov. 1, 10:33 AM
    • Casebia Therapeutics, the joint venture between CRISPR Therapeutics (CRSP +0.7%) and Bayer (OTCPK:BAYRY +1.5%), appoints James Burns, Ph.D., as President & CEO. He spent the bulk of his career at Sanofi-Genzyme, most recently as Head of Sanofi's North American R&D Hub.
    • Related tickers: (EDIT +0.8%)(NTLA -0.6%)
    | Tue, Nov. 1, 10:33 AM
  • Tue, Nov. 1, 9:21 AM
    • Ionis Pharmaceuticals (NASDAQ:IONS) perks up 2% premarket on light volume in response to its announcement of successful results from a Phase 2 clinical trial assessing antithrombotic candidate IONIS-FXIrx in patients with end stage renal disease (ESRD) on hemodialysis. Results showed statistically significant dose-dependent reductions in Factor XI activity with no clinically meaningful reductions in platelet levels and treatment-related significant bleeding events, a major risk in these patients.
    • The company says IONIS-FXIrx is the only antithrombotic in development that has shown the potential to separate anti-clotting activity from bleeding risk.
    • The Phase 2 study involved 43 ESRD patients receiving hemodialysis. Each received 200 mg or 300 mg of IONIS-FXIrx or placebo for 12 weeks. The mean percent reductions in FXI activity were 56% (p<0.001), 71% (p<0.001) and 4%, respectively. In addition, a decrease in severe clotting events in the dialysis circuit versus baseline was observed after six weeks in the treatment group. There were no clinically meaningful changes in laboratory values, including those related to liver function. IONIS-FXIrx was well-tolerated with no flu-like symptoms and no injection site reactions.
    • IONIS-FXIrx is an antisense drug that reduces the production of Factor XI, a key component of the coagulation pathway. High levels of Factor XI increase the risk of thrombosis (a clot inside a blood vessel).
    • The company is set to receive a $55M milestone payment from licensee Bayer (OTCPK:BAYRY) triggered by the review of the Phase 2 data and advancement to Phase 3.
    | Tue, Nov. 1, 9:21 AM | 26 Comments
  • Mon, Oct. 31, 11:36 AM
    • Shire plc (SHPG -3.3%) slumps in early trading on increased volume in apparent response to comments made by Express Scripts (ESRX +2.6%) Chief Medical Officer Steven Miller during a phone interview. He said the company is mulling ways to manage the rising costs of hemophilia medicines without forcing patients to switch treatments. Shire is a major player in the space after its merger with Baxalta. Hemophilia products accounted for over 46% of Baxalta's business in 2015.
    • Related tickers: (OTCPK:BAYRY -0.7%)(PFE -0.2%)(NVO -0.4%)(BMRN -0.6%)(BAX +0.9%)(BIIB -0.4%)(SGMO +1.4%)
    | Mon, Oct. 31, 11:36 AM | 3 Comments
  • Wed, Oct. 26, 7:57 AM
    • Bayer (OTCPK:BAYRY) Q3 results (€M): Total Revenues; 11,262 (+2.3%); Pharmaceuticals: 4,152 (+7.3%); Consumer Health: 1,425 (+0.1%); Crop Science: 2,057 (-1.2%); Animal Health: 360 (+0.8%); Covestro: 3,004 (-0.2%).
    • Net Income: 1,187 (+18.8%); EPS: 1.43 (+18.2%); CF Ops: 3,053 (+31.0%).
    | Wed, Oct. 26, 7:57 AM | 4 Comments
  • Wed, Oct. 26, 3:49 AM
    • Nintendo (OTCPK:NTDOY) revealed an operating loss of ¥5.95B in the period from March to September, while lowering its outlook and dividend.
    • A hard landing! Airbus (OTCPK:EADSY) missed forecasts on supply chain issues, but the aircraft maker maintained its full year guidance.
    • Brazil provided some bright side for Santander (NYSE:SAN) as a pick-up in performance lifted earnings above expectations, offsetting Brexit concerns.
    • Provisions ate into the quarterly profit at Lloyds (NYSE:LYG), as the bank set aside another £1B to pay compensation for mis-sold payment protection insurance.
    • Bayer (OTCPK:BAYRY) raised guidance for the full year on strong pharma results in its first quarterly scorecard since securing the Monsanto merger.
    | Wed, Oct. 26, 3:49 AM | 2 Comments
  • Thu, Oct. 20, 6:45 PM
    • Morgan Stanley (NYSE:MS) stands to collect $120M if Bayer (OTCPK:BAYRY) closes its $57B takeover deal for Monsanto (NYSE:MON), which would be the second-largest deal fee for a single bank on record.
    • The big payout is a bright spot in an otherwise down year for M&A activity, as global deal volume YTD currently stands at ~$2.6T, 24% lower than the same period in 2015.
    • The payments were disclosed in a MON proxy filing, which also showed the company held takeover talks with three other groups - identified by Financial Times as BASF (OTCQX:BASFY), Koch Industries and China's Sinochem - before agreeing to the pending deal with Bayer.
    | Thu, Oct. 20, 6:45 PM | 8 Comments
  • Wed, Oct. 12, 10:44 AM
    • Teva Pharmaceutical Industries (TEVA -0.6%) begins the U.S. commercial launch of RAJANI (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.02 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), its generic version of Bayer's (OTCPK:BAYRY -0.4%) Beyaz.
    • According to IMS, the American market is ~$133M.
    | Wed, Oct. 12, 10:44 AM | 8 Comments
  • Tue, Oct. 11, 10:03 AM
    • Bayer (OTCPK:BAYRY -0.2%) has finalized the syndication of a $57B bridge loan to support its acquisition of Monsanto (MON +0.1%), Bloomberg reports.
    • A total of 27 lenders joined the 12-month deal including European and Japanese banks, according to the report.
    • Bayer is set to buy MON for $66B, with plans to fund the deal with a combination of debt, the issuance of $19B of mandatory convertible bonds and a rights offer.
    | Tue, Oct. 11, 10:03 AM | 14 Comments