Mon, Nov. 23, 8:19 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Baxalta's (NYSE:BXLT) ONCASPAR (pegaspargase) as a component of combination chemotherapy in pediatric and adult patients with acute lymphoblastic leukemia.
- Oncaspar is a first-line biologic used as a component of a multi-agent chemotherapy regimen to treat acute ALL. It is an asparagine-specific enzyme that kills certain leukemic cells by depleting plasma asparagine. Some leukemic cells need exogenous asparagine to survive because they lack the essential enzyme to synthesize it themselves.
- Baxter International (NYSE:BAX) acquired it in May 2015 from Italy's Sigma-Tau Finanziaria S.p.A. for $900M.
- ALL accounts for more than 80% of all cases of childhood leukemia. There are as many a 5K new cases of ALL in Europe each year.
Tue, Nov. 10, 9:04 AM
Wed, Oct. 28, 4:53 PM
Tue, Oct. 27, 9:19 AM
- Baxter International (BAX) Q3 results: Revenues: $2,487M (-8.2%); COGS: $1,453M (-4.2%); R&D Expense: $148M (-0.7%); SG&A: $794M (-4.0%); Operating Income: $92M (-57.6%); Net Income: $2M (-98.9%); EPS: $0.00.
- Q4 Guidance: GAAP EPS: $0.23 - 0.25; EPS before special items: $0.30 - 0.32.
- H2 Guidance: GAAP EPS: $0.58 - 0.60; EPS before special items: $0.71 - 0.73 from $0.58 - 0.62.
Tue, Oct. 27, 6:46 AM
Mon, Oct. 26, 6:47 PM
- Four senators are asking the FTC to look into possible illegal price inflation in the market for saline solution for hospitals, which they say has risen in price 200%-300% since a 2013 shortage began.
- The solution is commonly used for intravenous hydration or in medicine dilution, and hospital demand has been on the rise, according to the FDA. The main suppliers in the U.S. are Baxter (NYSE:BAX), B. Braun Medical and Hospira (NYSE:PFE).
- For their part, suppliers are pushing back against the claims. Baxter says average price for its one-liter solution has increased in single- to low-double-digits annually since late 2013 and that it is working to boost supply.
- Meanwhile, a Pfizer spokesman says Hospira boosted production of saline products in 2013 and current prices represent "one of health care's greatest values."
- Previously: Baxter reports tomorrow (Oct. 26 2015)
Mon, Oct. 26, 5:30 PM
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Mon, Oct. 26, 4:52 PM
Tue, Oct. 13, 8:44 AM
- The FDA issues 510(k) clearance for Baxter International's (NYSE:BAX) AMIA automated peritoneal dialysis (APD) system with the SHARESOURCE web-based remote connectivity platform for the treatment of end-stage renal disease (ESRD).
- The AMIA APD system combines voice guidance features and a touchscreen control panel with the two-way connectivity of SHARESOURCE, which allows doctors to access their home patients' treatment data and deliver prescriptions remotely. The commercial launch will commence this quarter.
- About 600K Americans live with ESRD.
Wed, Sep. 30, 12:28 PM
- Baxter International (BAX) says it will immediately add Third Point LLC partner Munib Islam to its board of directors and add another mutually agreed upon director in the near term. The additions will expand the board to 12 members.
- Third Point, an activist event-driven investor, is led by CEO Dan Loeb. It is Baxter's largest shareholder with ~10% stake. Having a presence on the board is part of its approach of implementing strategies to unlock shareholder value.
Tue, Sep. 15, 11:35 AM
- The FDA approves privately-held Octapharma's NUWIQ, Antihemophilic Factor (Recombinant), an intravenous therapy for adults and children with hemophilia A. The approval includes on-demand treatment and control of bleeding episodes, routine prophylaxis to reduce the frequency of bleeding episodes and perioperative management of bleeding.
- NUWIQ is the first B-domain-deleted recombinant Factor VIII derived from a human cell line, not chemically modified or fused with another protein, for the treatment of hemophilia A, which affects ~16K Americans.
- NUWIQ was cleared in Europe in August 2014.
- Related tickers: (BAX +0.3%)(BXLT -0.5%)(OTCQX:RHHBY +0.6%)(SGMO +2.4%) (OTCPK:CHGCY) (OPK +2.3%)(ALNY)(BIIB +0.5%)(OTCPK:BAYRY +0.4%)
Tue, Sep. 1, 5:52 PM
- Baxalta (NYSE:BXLT) files an S-1 with the SEC in connection with the proposed secondary offering of up to $1.45B of BXLT common stock currently held by Baxter International (NYSE:BAX).
- As Baxter has previously disclosed, it intends to dispose of its Baxalta stake in a tax-free manner via certain debt-for-equity exchanges. It has 18 months to complete the disposition.
Wed, Aug. 5, 3:35 PM
- Baxter International (BAX +4.7%) is up on more than a 4x surge in volume in apparent response to a 13D filing by noted investor Daniel Loeb's Third Point LLC that disclosed a 7% stake of 37,925,000 shares.
- In a press release, Baxter says that it has "engaged in discussions with Third Point representatives and expects to continue a constructive dialogue." It also says that the Board and management are committed to enhancing value for all Baxter shareholders.
Tue, Aug. 4, 7:46 AM
- Shire plc (NASDAQ:SHPG) discloses that it made a proposal to Baxter (NYSE:BAX) spin-off Baxalta (NYSE:BXLT) to combine the firms in an all-stock transaction valued at $30B or $45.23 per share. Baxalta had previously declined to enter into discussions with Shire about a potential merger.
- Update: BXLT up 19% premarket on robust volume. SHPG down 4% on high volume.
Mon, Aug. 3, 9:14 AM
- Baxalta (BXLT) announces that it published pivotal Phase 3 data for its investigational Von Willebrand treatment BAX 111 in the journal of American Society and Hematology.
- The data demonstrated that 100% of the patients treated with BAX 111, a highly purified recombinant von Willebrand factor candidate, achieved success in the management of bleeding episodes.
- BAX 111 is currently under review by FDA. If approved, it would become the first recombinant replacement treatment for managing bleeding episodes for von Willebrand patients. Previously: Baxter's recombinant von Willebrand factor delivers 100% treatment success rate (April 20)
- Related tickers: (BAX)
Wed, Jul. 29, 4:41 PM
- Baxter International (NYSE:BAX) Q2 results ($M): Total Revenues: 3,893 (-8.7%); BioScience: 1,429 (-18.4%); Medical Products: 2,464 (-1.9%).
- Sales by segment: Hemophilia: 672 (-25.7%); Immunoglobulin Therapies: 422 (-41.4%); Inhibitor Therapies: 183 (-0.5%); BioTherapeutics: 152 (-1.9%); Fluid Systems: 518 (-3.0%); Renal: 949 (-9.1%); Integrated Pharmacy Solutions: 548 (-16.3%); Surgical Care: 333 (-3.8%).
- Net Income: 332 (-36.2%); EPS: 0.60 (-36.8%).
- Q3 Guidance: Revenues: flat from (9 - 10%); GAAP EPS: $0.00 - 0.02.
- H2 Guidance: GAAP EPS: $0.23 - 0.27.
- Shares are unchanged after hours.
Baxter International Inc is a healthcare company. It develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma and other chronic conditions.
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