Tue, Sep. 20, 4:20 PM
- Shire plc (NASDAQ:SHPG) has apparently lost its enthusiasm for myelofibrosis candidate pacritinib after mixed results in a mid-stage study. Also dampening the mood was a full clinical hold imposed by the FDA in February due to excessive deaths in the test group due to intracranial hemorrhage, cardiac failure and cardiac arrest.
- Shire inherited the program by way of the Baxalta deal. Baxter International (NYSE:BAX) inked a collaboration with discoverer CTI BioPharma (NASDAQ:CTIC) in 2013 to develop the oral tyrosine kinase inhibitor for certain blood-related cancers. Baxter paid CTI $60M upfront and up to $112M in milestones for the privilege.
- According to a regulatory filing by CTIC, the companies have entered into a non-binding term sheet regarding the termination of the collaboration agreement and the return of pacritinib to CTIC.
Mon, Sep. 19, 9:19 AM
- Baxter International (NYSE:BAX) announces the European launch of NUMETA G13E 300 mL, the only ready-to-use parenteral (intravenous) nutrition (PN) product available to treat preterm infants (less than 37 weeks gestation age) who are at high risk for infection and malnutrition in the early hours and days of their lives.
- NUMETA G13E addresses an important medical need to support preterm neonatal patients who have acute nutritional requirements by providing a balanced formulation of amino acids (protein), glucose (carbohydrates), lipids (fats) and electrolytes in a triple-chamber system.
- Brik Eyre, president of Baxter's Hospital Products business said, ''Baxter’s NUMETA G13E is a well-balanced, ready-to-use formula in a triple-chamber system that simplifies the preparation process for healthcare workers and helps reduce the potential risk to patients of infection and dosing errors.''
- First patients receiving NUMETA G13E IV nutrition therapy were located in Sweden.
Fri, Sep. 16, 7:13 AM
- Baxter International (NYSE:BAX) initiated with Overweight rating and $52 (11% upside) price target by Barclays.
- Sophiris Bio (NASDAQ:SPHS) initiated with Buy rating and $8 (170% upside) price target by Roth Capital.
- C.R. Bard (NYSE:BCR) initiated with Buy rating and $235 (5% upside) price target by Evercore ISI.
- Health Insurance Innovations (NASDAQ:HIIQ) initiated with Buy rating and $9 (82% upside) price target by Lake Street Capital.
- ViewRay (NASDAQ:VRAY) initiated with Buy rating and $6 (60% upside) price target by BTIG Research.
- Aerie Pharmaceuticals (NASDAQ:AERI) initiated with Strong Buy rating and $48 (57% upside) price target by Raymond James.
- Vertex Pharmaceuticals (NASDAQ:VRTX) initiated with Market Perform rating by Raymond James.
- Mirna Therapeutics (NASDAQ:MIRN) initiated with Buy rating and $6 (155% upside) price target by H.C. Wainwright.
- Oasmia Pharmaceutical AB (NASDAQ:OASM) initiated with Buy rating and $6 (82% upside) price target by Rodman & Renshaw.
- Gilead Sciences (NASDAQ:GILD) initiated with Buy rating and $112 (42% upside) price target by Berenberg Bank.
Tue, Jul. 26, 1:13 PM
- "We see an obvious flaw in this analysis," says David Einhorn in his Q2 letter to Greenlight Capital investors. He's referring to Andrew Left's Citron's short of Chemours (CC +8.5%). Left contended Chemours could face $5B in liabilities thanks to 3.5K lawsuits from people living near its Teflon plant in Parkersburg, WV. Double-checking with Left, Einhorn found no math to justify that lofty figure.
- Others have pegged the liability at just several hundred million dollars, not enough to topple the company.
- Greenlight is an owner of 8.8M shares as of March 31.
- In other Greenlight news, the hedge fund took advantage of the post-Brexit panic to cover shorts against Intuitive Surgical (ISRG +0.2%), Under Armour (UA -5.8%), and United Rentals (URI +2.3%).
- Longs sold out of include: American Capital Agency (AGNC +0.4%), Baxter International (BAX +3.3%), Ingram Micro (IM -0.7%), and Oil States International (OIS +0.7%).
- Greenlight fell 2.6% in Q2, bringing it nearly back to break-even for the year.
Tue, Jul. 26, 7:32 AM
- Baxter International (NYSE:BAX) Q2 Results ($M): Total Revenues: 2,585 (+4.4%); Hospital Products: 1,620 (+6.2%); Renal: 965 (+1.7%).
- Fluid Systems: 586 (+13.1%); Integrated Pharmacy Solutions: 563 (+2.7%).
- Net Income: 1,212 (+265.1%); Non-GAAP Net Income: 256 (+139.3%); EPS: 2.19 (+265.0%); Non-GAAP EPS: 0.46 (+142.1%).
- 2016 Guidance: Sales Growth: 1 - 2%; EPS: $8.87 - 8.94 from $8.94 - 9.06.
- Q3 Guidance: Sales Growth: 2 - 3%; EPS: $0.25 - 0.29.
Tue, Jul. 26, 7:01 AM
Mon, Jul. 25, 5:30 PM
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Tue, Jul. 19, 9:04 AM
Wed, Jun. 29, 9:54 AM
- Health Canada approves Baxter International's (BAX +1.5%) AMIA Automated Peritoneal Dialysis (APD) System with the SHARESOURCE Connectivity Platform for at-home dialysis. AMIA is the first APD device cleared in the U.S. and Canada that includes patient/user-friendly features such as voice guidance, touchscreen control panel and two-way telemedicine capabilities for remote patient management.
- A pilot launch in Canada will commence later this year. The system was launched in the U.S. in late 2015. There are ~400 currently in place.
Mon, May 16, 12:21 PM
- Novo Nordisk (NVO +1.1%) submits its Biologics License Application (BLA) to the FDA seeking approval of its long-acting factor IX, nonacog beta pegol, for the treatment of patients with hemophilia B. The glycopegylated recombinant factor IX has a 5x longer half-life than standard factor IX products which enables once-weekly dosing.
- Related tickers: (BIIB +1.3%)(DMTX +8%)(QURE +2.9%)(SGMO -3.3%)(BAX +0.4%)
Fri, May 13, 7:36 AM
- The European Commission approves Biogen (NASDAQ:BIIB) and collaboration partner Swedish Orphan Biovitrum AB's (OTC:BIOVF) Alprolix (Coagulation Factor IX [Recombinant], Fc Fusion Protein) for the treatment of hemophilia B. It is administered every 7-10 days so it provides prolonged protection against bleeding episodes as well as on-demand treatment.
- The data supporting the marketing application was generated in two Phase 3 trials, B-LONG, in adults and adolescents, and Kids B-LONG, in children under age 12.
- Swedish Orphan has final development and commercialization rights in Europe, North Africa, Russia and most of the Middle East. Biogen has commercialization rights in North America and the rest of the world ex-Swedish Orphan territory.
- Alprolix in now approved in the EU, U.S., Canada, Japan, Australia, New Zealand and certain other countries.
- Previously: Biogen's hemophilia B med successful in Phase 3 trial in children (Feb. 27, 2015)
- Related tickers: (NYSE:NVO)(NASDAQ:DMTX)(NASDAQ:QURE)(NASDAQ:SGMO)(NYSE:BAX)
Wed, May 11, 12:03 PM
- The European Commission approves CSL Behring's Orphan Drug-tagged IDELVION [Coagulation Factor IX (Recombinant), Albumin Fusion Protein] for the treatment and prophylaxis of bleeding in patients of all ages with hemophilia B (factor IX deficiency). The labeling includes routine prophylaxis to prevent/reduce the frequency of bleeding episodes, on-demand control and perioperative management of bleeding. Market launch will commence in the next few months. Orphan Drug status means that IDELVION has a 10-year period of market exclusivity in the EU for the indication.
- IDELVION's principal value proposition is 14-day dosing. This is achieved via the maintaining of high levels of factor IX activity, above 5% over 14 days at 75 IU/kg, via the fusion with recombinant albumin.
- The FDA approved IDELVION in early March.
- Related tickers: (BIIB -0.8%)(NVO -0.1%)(DMTX -0.8%)(QURE -1.2%)(SGMO -0.2%)(BAX +1.9%)
Mon, May 9, 5:30 PM
- At its investor conference, Baxter International (NYSE:BAX) announced that it expects top line growth of 4% per year through 2020 and 3 - 4% from 2016 through 2018. In 2018, it sees non-GAAP EPS of $2.10 - 2.25, non-GAAP operating margin of 14 - 15% and free cash flow of ~$1B.
- In 2020, it expects non-GAAP margin to widen to 17 - 18%, non-GAAP EPS of $2.75 - 3.00 and FCF of ~$1.75B.
- Consensus view for 2016 is EPS of $1.65 on revenues of $10.1B.
Fri, May 6, 10:32 AM
- Baxter International (BAX -1.1%) initiated with Buy rating and $51 (13% upside) price target by Evercore ISI.
- Intrexon (XON +2.3%) initiated with Market Outperform rating and $42 (62% upside) price target by JMP Securities.
- Heron Therapeutics (HRTX -8.8%) initiated with Buy rating and $41 (143% upside) price target by Cantor Fitzgerald.
- Dr. Reddy's Laboratories (RDY -2.5%) initiated with Neutral rating and Rs.3,334 price target (8% upside) by Goldman Sachs.
- Aeglea BioTherapeutics (AGLE +7.4%) initiated with Buy rating and $12 (33% upside) price target by UBS.
- Cardiome (CRME +34.9%) upgraded to Speculative Buy from Hold by Mackie Research. Price target raised to $8.60 (58% upside) from $5.20.
- Medivation (MDVN +1.2%) upgraded to Buy from Neutral by Citigroup. Price target raised to $73 (22% upside) from $37.
- Masimo (MASI -0.3%) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $52 (13% upside) from $43.
- GlaxoSmithKline (GSK -1%) upgraded to Buy from Reduce by Oddo & Cie.
- Cogentix Medical (CGNT -1%) downgraded to Neutral from Buy with a price target of $1.15 (14% upside) by Roth Capital.
- Bruker (BRKR +0.8%) downgraded to Neutral from Outperform by BTIG Research.
- Relypsa (RLYP -4%) downgraded to Underperform from Neutral by Mizuho Securities. Price target cut to $31 (132% upside) from $34.
- Molina Healthcare (MOH -0.7%) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to $45 (0% upside) from $75. Downgraded to Neutral from Buy by UBS. Price target lowered to $54 (20% upside) from $76.
- Sarepta Therapeutics (SRPT +1.8%) downgraded to Underperform from Market Perform by Leerink Swann. Price target lowered to $5 (71% downside risk) from $13.
- Sanofi (SNY -0.4%) downgraded to Hold from Buy with an €81 (15% upside) price target by HSBC.
Thu, May 5, 9:28 AM
Tue, May 3, 8:41 AM