Alexion Pharmaceuticals, Inc.NASDAQ
Alexion: 2 Global Drug Rollouts, But Upside Already Priced In
Cheryl Swanson • 10 Comments
Cheryl Swanson • 10 Comments
Yesterday, 2:04 PM
- The healthcare sector - particularly pharmaceuticals and biotechs - had a rough session on Wednesday after the president-elect promised to bring down drug prices.
- Sporting sizable gains yesterday afternoon and again this session, the sector has recovered all of Wednesday's slide and more.
- Up 1.15% today, the XLV has joined the broader market in the green for the week, as has the IBB. The SPDR S&P Pharmaceuticals ETF (XPH +1.5%) is having the best day of all, but remains marginally lower on the week.
- Individual movers: The Medicines Co. (MDCO +6.2%), Alexion Pharma (ALXN +5.5%), Arena Pharma (ARNA +4.7%), Teva (TEVA +1.3%)
- ETFs: IBB, XLV, IYH, XBI, VHT, PJP, BBH, HQH, FBT, CURE, HQL, XPH, PBE, FXH, FHLC, IHE, RXL, LABU, BBC, PPH
Thu, Dec. 8, 7:30 AM
- Philip van Doorn and team at Marketwatch put together a list of 18 S&P 500 names with consensus sell-side price targets at least 30% above the current price.
- Ten of the 18 stocks are in healthcare, which has been roughed up by a combination of Obamacare, Clinton's talk about drug pricing (back when all thought she would be the next POTUS), and now Trump joining in the bashing.
- The list (in order of possible upside): Mallinckrodt PLC (NYSE:MNK) - 56% potential upside, Endo International PLC (NASDAQ:ENDP) - 52% upside, Hanesbrands (NYSE:HBI) - 45% upside, Edwards Lifesciences (NYSE:EW) - 44% upside, Mylan (NASDAQ:MYL) - 42% upside, Allergan (NYSE:AGN) - 39% upside, Alexion (NASDAQ:ALXN) - 37% upside, Activision Blizzard (NASDAQ:ATVI) - 35% upside, Salesforce.com (NYSE:CRM) 34% upside, NRG Energy (NYSE:NRG) - 34% upside, Centene (NYSE:CNC) 34% upside, Gilead (NASDAQ:GILD) 33% upside, Facebook (NASDAQ:FB) 32% upside, Boston Scientific (NYSE:BSX) - 32% upside, Pitney owes (NYSE:PBI) - 32% upside, Molson Coors (NYSE:TAP) - 30% upside, Newell Brands (NYSE:NWL) - 30% upside, Zimmer Bioment (NYSE:ZBH) - 30% upside.
Tue, Nov. 29, 1:21 PM
- Barclays upgrades Alexion Pharmaceuticals (ALXN +4.2%) to Overweight from Equal Weight with a $155 (25% upside) price target.
- The company has been mentioned as an attractive acquisition target for some time. A few weeks ago, the company announced that it would delay the filing of its quarterly report due to an internal probe related to Soliris sales practices.
Fri, Nov. 18, 11:13 AM
- Barron's Ben Levisohn reports that Gilead Sciences (GILD -1.3%) has a range of attractive candidates should it decide to spend some its $32B cash hoard on an acquisition, a virtual certainty after the recent momelotinib disappointment.
- Considering the company's stated interest in oncology, obvious choices are Incyte (INCY -1.1%) and TESARO (TSRO -3%).
- Venturing out into the rare disease space, Alexion Pharmaceuticals (ALXN -1.6%), Vertex Pharmaceuticals (VRTX -1.6%) and BioMarin Pharmaceutical (BMRN -1.1%) are attractive fare.
- None of these companies are a surprise to biotech followers. All have been noted as buyout targets for some time now.
Wed, Nov. 9, 5:12 PM
- Alexion Pharmaceuticals (ALXN +6.5%) has resumed trading after a halt, down 1.3%, as the company says it's delayed its 10-Q while it pursues an internal probe.
- The company filed a notification of late filing with the SEC as it undergoes an investigation into sales practices around its product Soliris (eculizumab). The Audit and Finance Committee has hired outside counsel and is probing the practices due to allegations from a former employee.
- The company says it hasn't identified instances where orders weren't placed by customers for patients, but it's uncertain when the investigation will be complete.
Fri, Nov. 4, 9:14 AM
Fri, Nov. 4, 7:42 AM
- Theravance Biopharma (NASDAQ:TBPH) initiated with Overweight rating and $42 (71% upside) price target by Piper Jaffray.
- Viveve Medial (Pending:VIVE) initiated with Buy rating and $8 (59% upside) price target by B. Riley.
- Alexion Pharmaceuticals (NASDAQ:ALXN) initiated with Buy rating and $164 (29% upside) price target by Deutsche Bank.
- Halozyme Therapeutics (NASDAQ:HALO) initiated with Buy rating and $12 (42% upside) price target by Deutsche Bank.
- Cynosure (NASDAQ:CYNO) initiated with Buy rating and $60 (47% upside) price target by Aegis Capital.
- ARIAD Pharmaceuticals (NASDAQ:ARIA) initiated with Hold rating and $9.50 (10% upside) price target by Deutsche Bank.
- Aurinia Pharmaceuticals (NASDAQ:AUPH) initiated with Speculative Buy rating and $8 (214% upside) price target by Mackie Research Capital.
- Achaogen (NASDAQ:AKAO) initiated with Buy rating and $10 (166% upside) price target by Aegis Capital.
- Kindred Biosciences (NASDAQ:KIN) initiated with Buy rating and $7.50 (46% upside) price target by Ladenburg Thalmann.
- Global Blood Therapeutics (NASDAQ:GBT) initiated with Buy rating and $47 (210% upside) price target by Roth Capital.
- Obalon Therapeutics (Pending:OBLN) initiated with Buy rating and $28 (207% upside) price target by Canaccord Genuity. Initiated with Buy rating and $18 (97% upside) price target by Stifel Nicolaus.
Thu, Nov. 3, 11:49 AM
- Achillion Pharmaceuticals (ACHN -33.1%) plummets on more than triple normal volume in apparent response to the company's report of Phase 1 data regarding ACH-4471, a factor D inhibitor in development for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
- The early-stage study explored the safety, pharmacodynamics and pharmacokinetics of ACH-4471. As far as safety signals were concerned, there were two cases of self-limited grade 3 (5 - 10x the upper limit of normal or ULN) and grade 4 (greater than 10x ULN) elevations in a liver enzyme called alanine transaminase (ALT) which is a biomarker of liver damage. They were observed after treatment in the mid- and high-dose groups. There were no signs of symptoms of hepatic decompensation and both patients' ALT returned to normal without intervention during follow-up. Additionally, no treatment-related fever or infections were observed.
- The company says preliminary results from the study should be available in the first half of next year.
- The treatment of PNH and aHUS, both orphan diseases, is dominated by Alexion Pharmaceuticals' (ALXN +2.4%) Soliris (eculizumab). ACH-4471 is orally administered while Soliris is an intravenous formulation.
Thu, Oct. 27, 10:17 AM
- Alexion Pharmaceuticals (ALXN +7.8%) Q3 results: Revenues: $799.1M (+19.9%); Operating Income: $179.3M (+16.0%); Net Income: $94.3M (+151.3%); EPS: $0.42 (+151.9%); Non-GAAP EPS: $1.23 (+13.9%); Quick Assets: $1,312.9M (-5.2%).
- 2016 Guidance: Total Revenues: upper end of $3.05B - 3.1B; Soliris: $2.835B - 2.875B (unch); Metabolic revenues: $225M - 235M from $200M - 220M; GAAP EPS: $1.79 - 2.26 from $1.91 - 2.26; Non-GAAP EPS: upper end of $4.50 - 4.65.
Thu, Oct. 27, 9:23 AM
- Alexion Pharmaceuticals (NASDAQ:ALXN) is up 6% premarket on light volume in response to its announcement that it has initiated simultaneous registration trials to support regulatory applications for Orphan Drug-tagged ALXN1210, the company's next-generation drug intended to replace Soliris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
- Both studies are open-label with enrollment commencing this quarter. The first Phase 3 will compare ALXN1210 to Soliris in complement inhibitor treatment-naive PNH patients for 26 weeks. The co-primary endpoints are the normalization of lactate dehydrogenase (LDH) levels and the percentage of subjects who achieve transfusion avoidance.
- The second Phase 3, also with a 26-week treatment period, will assess the safety and efficacy of ALXN1210 in complement inhibitor treatment-naive adolescent and adult aHUS patients. The primary endpoint is complete thrombotic microangiopathy (TMA) response at Week 26.
- In both trials, ALXN1210 will be administered intravenously once every eight weeks. Soliris is administered once per week for five weeks then every two weeks thereafter. Both are complement protein 5 (C5) antibodies.
Thu, Oct. 27, 6:33 AM
Wed, Oct. 26, 5:30 PM
- ABB, ABMD, ACOR, AET, ALLE, ALV, ALXN, AMT, APD, ASPS, AUO, AVT, AXTA, BBW, BC, BCOR, BGCP, BMS, BMY, BWA, BX, CBG, CCMP, CELG, CFX, CHH, CL, CLF, CMC, CME, CMS, COLB, COP, COR, CRI, CRR, CRS, CVE, CVI, CVRR, CWT, CYS, DFT, DLX, DOW, DPS, EME, EPD, EQGP, EQM, EQT, EXLS, F, FCFS, FCN, FMS, GCI, GLOP, GNC, GOV, GTLS, HCA, HEES, I, IDA, IDCC, IP, IPGP, IRDM, IVZ, LANC, LAZ, LKQ, LLL, MD, MDP, MDXG, MHO, MJN, MO, MPC, MPLX, MSCI, MTH, MTRN, NEWM, NMR, NOK, NOV, NTCT, ODFL, ORI, PATK, PENN, PF, PJC, POT, PRLB, PTEN, PX, QSII, RDN, RGS, ROCK, RTN, SCG, SEE, SFE, SILC, SIRI, SMP, SQNS, SRPT, STM, SUP, SWK, TCK, TDC, TFX, THRM, TKR, TMO, TPH, TPX, TREE, TROW, TUES, TWTR, TZOO, UAN, UFS, UPS, UTHR, VC, VLP, WCC, WEX, WST, WWE, XEL, XRS, YNDX
Thu, Oct. 20, 11:44 AM
- Micro cap Omeros (OMER +5.9%) perks up on 60% higher volume in response to its announcement of positive results from a Phase 2 clinical trial assessing lead product OMS721 for the treatment of patients who have thrombotic microangiopathy (TMA) associated with a hematopoietic stem cell transplant (HSCT), a condition with a high mortality rate. TMA means that there is damage to the smallest blood vessels and blood clots are involved.
- The data showed clinically meaningful improvements in measures of red blood cell destruction, specifically, lactate dehydrogenase (LDH) and haptoglobin levels, following treatment with OMS721 for up to eight weeks. In three patients who completed treatment, the average LDH level decreased as much as 43% from baseline (672 U/L to 380 U/L; p<0.01) and haptoglobin levels increased almost five-fold (1.54 g/L from 0.33 g/L; p<0.06). Both are biomarkers for hemolytic anemia. Mean platelet count increased as much as three-fold from baseline (57,000/uL from 18,000/uL).
- No significant safety signals were observed. According to ClinicalTrials.gov, the estimated study completion date is June 2018.
- OMS721 is the company's lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of thrombotic microangiopathies, including atypical hemolytic uremic syndrome (aHUS), a condition that was approved by the FDA for Alexion Pharma's (NASDAQ:ALXN) Soliris (eculizumab) in September 2011.
Mon, Oct. 17, 9:27 AM
- Thinly traded micro cap Omeros (NASDAQ:OMER) is up 20% premarket on increased volume in response to its announcement of positive results from an open-label Phase 2 clinical trial assessing lead product candidate OMS721 in patients with four different types of complement-associated kidney diseases: IgA nephropathy, membranous nephropathy, lupus nephritis and complement component 3 (C3) glomerulopathy. The data showed statistically valid effects in key endpoints of improved renal function.
- Each of the disease cohorts will have enrolled four subjects, all with high levels of urinary protein (proteinuria) despite ongoing corticosteroid treatment. Patients have been treated with OMS721 for a total of 12 weeks along with tapered corticosteroid therapy, if tolerated. They were then followed for six weeks post treatment. Key efficacy measures are urine albumin-to-creatine ratios (uACRs) throughout the study and the change in 24-hour urine protein levels from baseline to the end of treatment.
- Two patients with IgA nephropathy, two with membranous nephropathy and two with lupus nephritis completed the study. In the IgA nephropathy subjects, mean uACR decreased to 525 mg/g from a baseline of 1,264 mg/g (p=0.011) while mean urine protein excretion declined to 1,119 mg/day from 3,156 mg/day (p=0.017).
- Data from for membranous nephropathy group showed reductions in the two endpoints as well, but the effects fell short of statistical significance. No treatment effect was observed in the lupus nephritis patients.
- No significant safety signals were observed.
- The company intends to submit the data for presentation at the European Renal Association-European Dialysis Transplant Association 54th Annual Congress in June 2017 in Madrid, Spain.
- OMS721 is the company's lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 program for the treatment of thrombotic microangiopathies, including atypical hemolytic uremic syndrome (aHUS), a condition that was approved by the FDA for Alexion Pharma's (NASDAQ:ALXN) Soliris (eculizumab) in September 2011.
Fri, Oct. 14, 10:23 AM
- Bristol-Myers Squibb (BMY +0.3%) appears to have some work to do in order for cancer med Opdivo (nivolumab) to be routinely available through the UK's National Health Service (NHS) for lung cancer patients. Its advisory committee on costs and services, the National Institute for Health and Care Excellence (NICE) says the company needs to make a case to include Opdivo in its Cancer Drugs Fund (CDF), a government set-aside to pay for cancer medicines that have not been approved by NICE and, therefore, are not available within the NHS in England (Scotland, Wales and Northern Ireland do not have a similar program in place).
- NICE's appraisal committee concluded that nivolumab was not cost-effective for all patients with squamous and non-squamous advanced non-small cell lung cancer (NSCLC), but did appear to benefit some patients more than others. NICE's Carole Longson says, "Nivolumab appears to be more effective in certain lung cancer patients. However, we do not have the full picture yet and we need more evidence to find out the extent of this benefit. If the company puts forward a CDF proposal, nivolumab could be made available to some patients with lung cancer whilst more evidence is gathered on its value." The committee has asked the company to show Opdivo's cost-effectiveness in NSCLC patients with PD-L1 levels of 10% or more.
- Nivolumab is licensed in the UK for the treatment of advanced NSCLS patients who have been previously treated with chemotherapy, in addition to indications in melanoma and kidney cancer.
- Bristol-Myers is not alone it dealing with price hawk NICE. Alexion Pharmaceuticals (ALXN +1.1%) has had to run the gauntlet with Strensig (asfotase alfa), Amgen (AMGN +0.5%) with Repatha (evolocumab) and Roche (OTCQX:RHHBY +0.3%) with Gazyvaro (obinutuzumab) and Kadcyla (ado-trastuzumab emtansine).
Fri, Oct. 7, 11:48 AM
- Lexicon Pharmaceuticals (NASDAQ:LXRX) initiated with Buy rating and $26 (38% upside) price target by H.C. Wainwright.
- Zynerba Pharmaceuticals (NASDAQ:ZYNE) initiated with Buy rating and $22 (54% upside) price target by H.C. Wainwright.
- Mazor Robotics (NASDAQ:MZOR) initiated with Buy rating and $25 (10% upside) price target by B. Riley.
- Lipocine (NASDAQ:LPCN) initiated with Buy rating and $25 (350% upside) price target by H.C. Wainwright.
- TG Therapeutics (NASDAQ:TGTX) initiated with Buy rating and $28 (218% upside) price target by Brean Capital.
- Immunomedics (NASDAQ:IMMU) initiated with Buy rating and $5.50 (113% upside) price target by Jefferies.
- AmerisourceBergen (NYSE:ABC) initiated with Neutral rating by UBS.
- ARIAD Pharmaceuticals (NASDAQ:ARIA) initiated with Buy rating and $22 (65% upside) price target by SunTrust Robinson Humphrey.
- Amarin (NASDAQ:AMRN) initiated with Buy rating and $6 (92% upside) price target by Cantor Fitzgerald.
- Corbus Pharmaceuticals (NASDAQ:CRBP) initiated with Buy rating and $17 (94% upside) price target by Cantor Fitzgerald.
- Heron Therapeutics (NASDAQ:HRTX) initiated with Buy rating and $41 (142% upside) price target by Brean Capital.
- Zogenix (NASDAQ:ZGNX) initiated with Outperform rating and $17 (64% upside) price target by Leerink Swann.
- GW Pharmaceuticals (NASDAQ:GWPH) initiated with Outperform rating and $162 (23% upside) price target by Leerink Swann. Initiated with Buy rating and $189 (44% upside) price target by Goldman Sachs.
- SAGE Therapeutics (NASDAQ:SAGE) initiated with Outperform rating and $68 (57% upside) price target by Leerink Swann.
- Alexion Pharmaceuticals (NASDAQ:ALXN) initiated with Buy rating and $221 (79% upside) price target by Brean Capital.
- Axsome Therapeutics (NASDAQ:AXSM) initiated with Buy rating and $20 (136% upside) price target by Brean Capital.
- Recro Pharma (NASDAQ:REPH) initiated with Buy rating and $21 (156% upside) price target by Brean Capital.
- SCYNEXIS (NASDAQ:SCYX) initiated with Buy rating and $16 (226% upside) price target by Brean Capital.
- Sorrento Therapeutics (NASDAQ:SRNE) initiated with Buy rating and $15 (94% upside) price target by Roth Capital.
- Global Blood Therapeutics (NASDAQ:GBT) initiated with Outperform rating and a $75 - 81 (322% upside from midpoint) target price range by Wells Fargo.
- Alder Biopharmaceuticals (NASDAQ:ALDR) initiated with Buy rating and $45 (49% upside) price target by Brean Capital.