Receptos Continues To Reward
Stephen Simpson, CFA
Stephen Simpson, CFA
Multiple Observations On Celgene's Latest Licensing Deals, And Its Valuation
DoctoRx • 75 Comments
DoctoRx • 75 Comments
Yesterday, 8:13 AM
- Results from an investigator-sponsored Phase 2 clinical trial evaluating Acceleron Pharma's (NASDAQ:XLRN) sotatercept in patients with myelofibrosis showed a 36% response rate. The data were presented at the 58th American Society of Hematology (ASH) annual meeting in San Diego.
- 19 subjects were enrolled in the study. 14 who received at least five doses of sotatercept were evaluable for response. Five of the 14 (36%) achieved an anemia response, defined as a composite of independence from red blood cell transfusion and hemoglobin response from baseline.
- 68% (n=13/19) have discontinued, including five non-responders, two who progressed, two proceeded to stem cell transplantation, one transformed to acute myeloid leukemia and one withdrew consent.
- Adverse events possibly related to treatment were grade 3 (severe) hypertension leading to discontinuation, grade 1 myalgia, bone pain, pain in extremity and injection site reaction.
- Sotatercept is a fusion protein that acts as a ligand trap for proteins involved in fibrosis and late-stage erythropoiesis (red blood cell production). It is being co-developed with Celgene (NASDAQ:CELG) for the treatment of chronic kidney disease.
- Management will host a conference cal this morning at 9:00 am ET to discuss the data.
Sun, Dec. 4, 2:45 PM
- Results from a Phase 1 study assessing Juno Therapeutics' (NASDAQ:JUNO) JCAR014 in heavily pretreated patients with chronic lymphocytic leukemia (CLL) who failed to respond to AbbVie's (NYSE:ABBV) IMBRUVICA (ibrutinib) showed an encouraging treatment effect. The data were presented at the 58th American Society of Hematology (ASH) annual meeting in San Diego.
- The 24 participants in the study had received a median of five previous therapies, including ibrutinib. All failed and had poor prognoses. Three failed prior allogeneic stem cell transplants. All received lymphodepletion therapy prior to receiving JCAR014.
- 88% (n=15/17) of efficacy-evaluable patients experienced a complete bone marrow response determined by flow cytometry while 50% (n=7/14) had no detectable disease. All seven were alive and progression-free during the follow-up period (3 - 26 months).
- Two of 24 (8%) patients developed grade 3 (severe) to grade 5 (death) severe cytokine release syndrome (CRS) while 25% (n=6/24) developed grade 3 - 5 neurotoxicity. The most frequent severe treatment-emergent adverse events were febrile neutropenia (75%), CRS (29%), fever (17%), lung infection (13%), encephalopathy (13%) and hypotension (13%). There was one treatment-related death in a patient who developed CRS and cerebral edema.
- JCAR014, part of Juno's CD19-focused CAR T program, is being co-developed and will be co-commercialized with Celgene (NASDAQ:CELG). A study assessing JCAR014 in combination with ibrutinib in CLL should start in early 2017. The data generated in the JCAR014 studies will support a potential Juno-sponsored study of JCAR017 in CLL.
- The company will host an investor and analyst event and webcast tomorrow, Monday, December 5, at 11:30 am ET to discuss the data.
Fri, Dec. 2, 4:08 PM
- Celgene (CELG -1.1%) inks an agreement to acquire privately held Acetylon Pharmaceuticals for an undisclosed sum. The Boston, MA-based biopharma firm is developing next-generation small molecule histone deacetylase (HDAC) inhibitors that allow for the epigenetic regulation of gene and protein function.
- One of its lead product candidates is ricolinostat (ACY-1215), an HDAC6 inhibitor in development for the treatment of blood cancers and solid tumors. Another is citarinostat (ACY-241), a candidate to treat solid tumors.
- Prior to the deal close, Acetylon will spin out a new company called Regenacy Pharmaceuticals, LLC, that will focus on developing novel drug candidates that selectively regenerate intracellular transport and upregulate gene expression to modify the course of disease. Regenacy will have exclusive global rights to ricolinostat for the treatment of certain non-cancer disorders including neuropathies. It will also have exclusive global rights to HDAC1,2 inhibitor candidates and intellectual property for all indications including sickle cell disease and beta thalassemia.
- Regenacy will be owned by Acetylon shareholders, excluding Celgene, which will fund operations.
Tue, Nov. 29, 1:08 PM
- Oppenheimer initiates coverage on Celgene (CELG +2.1%) with an Outperform rating and $141 (15% upside) price target.
- The company expects revenues as high as $13B next year with Revlimid pitching in more than $8B. Crohn's candidate GED-0301 is one of its promising pipeline candidates along with blood disorder candidate luspatercept.
Fri, Nov. 18, 4:01 PM
- An affiliate of Celgene (CELG -0.1%) inks a deal with privately held Triphase Accelerator Corp. for the rights to marizomib, a brain-penetrant proteasome inhibitor in development for the treatment of glioblastoma and relapsed/refractory multiple myeloma.
- Under the terms of the agreement, Celgene will make an upfront payment and regulatory, approval and sales milestone payments. Specific financial terms are not disclosed.
Fri, Nov. 18, 7:48 AM
- San Diego, CA-based biopharmaceutical outfit PharmAkea expands its strategic collaboration with Celgene (NASDAQ:CELG) focused on discovering small molecule drugs to treat fibrotic diseases. The original three-year partnership was inked in October 2013.
- Under the terms of the new agreement, PharmAkea will receive $9M to extend the collaboration for nine months. It is currently currently conducting early-stage studies of a small molecule LOXL2 inhibitor and is preparing to enter Phase 1 development with an Autotaxin inhibitor.
Wed, Nov. 9, 8:08 AM
- Biotechs and Big Pharma look like they will jump out of the blocks this morning. Most leading names are up premarket.
- Sampling: (NASDAQ:AMGN) +4%; (NASDAQ:GILD) +2%; (NASDAQ:REGN) +3%; (NASDAQ:BIIB) +4%; (NASDAQ:VRTX) +2%; (NASDAQ:CELG) +3%; (NYSE:BMY) +2%; (NYSE:PFE) +5%; (NYSE:MRK) +2%; (NYSE:AZN) +1%; (NYSE:GSK) +1%; (NYSE:JNJ) +2%; (NYSE:ABBV) +4%; (NYSE:LLY) +3%; (NYSE:NVS) +3%; (NYSE:AGN) +4%; (NASDAQ:TEVA): +6%
Wed, Nov. 9, 3:03 AM
- Healthcare stocks, the weakest sector this year, may become winners, as Obamacare reforms are set to be "repealed and replaced" and major legislation Clinton proposed is unlikely to be imposed on drugmakers.
- While Trump hasn't set out a comprehensive alternative to the Affordable Care Act (which may see 22M Americans lose current coverage), he said he'll encourage competition between markets in different states.
- Insurance stocks: UNH, AET, ANTM, CI, HUM, WCG, CNC, MOH, GTS, HQY
- Drugmakers premarket: MYL +5.8%, NVS +3.4%, SNY +2.9%, AZN +2.4%, GSK +1.9%, PFE +1.8%, CELG +1%, ABBV, MRK, BMY, LLY, JNJ, ABT, ACET, ZTS, BIIB, REGN
Mon, Nov. 7, 5:15 PM
- Mizhuo initiates Celgene (NASDAQ:CELG) at Buy with $130 PT. Implied upside 21%.
- Firm says Ozanimod (MS, UC...) and GED-301 (Chron's) has 2/3 chances of working in their lead indications.
- Notes a series of singles/doubles in near to medium term - added "call options" on CELG.
- Active buyer of its own shares. Seems to believe its guidance is conservative.
Tue, Nov. 1, 12:07 PM
- The European Medicines Agency (EMA) signs off on the design of a Phase 3 clinical trial assessing Can-Fite BioPharma's (CANF) lead product candidate CF101 (Piclidenoson) for the treatment of psoriasis. The study should commence in the latter half of next year.
- The randomized, double-blind, placebo-controlled trial will enroll ~400 patients with moderate-to-severe plaque psoriasis. Oral medication will be administered twice daily for 32 weeks. Piclidenoson will be compared to Celgene's (CELG +1.1%) Otezla (apremilast) in addition to placebo. The primary endpoint will be the proportion of subjects who achieve a 75% improvement in psoriasis symptoms at Week 16. Secondary endpoints include non-inferiority to apremilast.
- Piclidenoson is an anti-inflammatory oral small molecule drug. Its mechanism of action is mediating A3 adenosine receptors, key signalling proteins which play key roles in the production of inflammatory cytokines.
Thu, Oct. 27, 8:01 AM
- Celgene (NASDAQ:CELG) Q3 results ($M): Total Revenues: 2,982.8 (+27.8%); Net Product Sales: 2,968.6 (+28.4%).
- Net Income: 171.4 (+602.6%); Non-GAAP Net Income: 1,263.5 (+25.0%); EPS: 0.21 (+625.0%); Non-GAAP EPS: 1.58 (+28.5%).
- Key Product Sales: Revlimid: 1,891.1 (+30.1); Pomalyst/Imnovid: 341.1 (+33.0%); Otezla: 274.6 (+98.0%); Abraxane: 233.3 (+1.5%); Vidaza: 154.7 (+4.8%).
- 2016 Guidance: Total Product Sales: ~$11.2B from ~$11.0B; Revlimid Sales: ~$7.0B from ~$6.8B; EPS: $3.12 - 3.29 from $3.82 - 4.05; Non-GAAP EPS: $5.88 - 5.92 from $5.70 - 5.75.
- 2017 Guidance: Total Product Sales: high end of $12.7B - 13.0B; Revlimid: more than $8.0B; Non-GAAP EPS: high end of $6.75 - 7.00.
- Consensus Q3 view was EPS of $1.48 on revenues of $2.8B.
- Shares are up 3% premarket on light volume.
Thu, Oct. 27, 7:32 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, 7:15 AM
- England's National Institute for Health and Care Excellence (NICE), an advisory group to the National Health Service (NHS) on costs and quality, issues a positive final appraisal determination providing patient access to Celgene's (NASDAQ:CELG) OTEZLA (apremilast) for the treatment of chronic plaque psoriasis.
- Patients in England and Wales will now have access to OTEZLA, joining those in Scotland who have had access since June 2015.
Tue, Oct. 18, 12:20 PM
- Galapagos NV (GLPG +5%) is up on modestly higher volume in early trading. The bullish action is being stoked by increased optimism with Crohn's disease (CD) candidate filgotinib after Celgene (CELG +0.8%) released early-stage data on its CD candidate GED-0301.
- Yesterday, Celgene announced Phase 1b data which showed a 67% clinical response rate and 48% remission rate in patients treated with GED-0301 for 12 weeks. Clinical response was defined as at least a 100 point drop in a CD symptom scale called Crohn's Disease Activity Index (CDAI) while clinical remission was defined as a CDAI score less than 150. Patients with active CD have CDAI scores of 220 - 450. A Phase 3 study is currently recruiting patients. According to ClinicalTrials.gov, the estimated completion date is April 2022.
- A Phase 2 study, FITZROY, showed a statistically valid proportion of patients receiving filgotinib for 10 weeks achieved clinical remission compared to placebo (48% vs. 23%; p=0.0067). The proportion of clinical responders (60% vs. 41%; p=0.0386) also favored filgotinib. Both endpoints were based on the same CDAI metrics as Celgene. A Phase 3 study in adults with moderately to severely active Crohn's should commence shortly. According to ClinicalTrials.gov, the estimated study completion date is December 2019. It is being developed with collaboration partner Gilead Sciences (GILD +1.4%).
Tue, Oct. 18, 10:29 AM
- Biotech industry offers "attractive buying opportunities" given pre-election weakness, Jefferies says.
- Valuation multiples are near-historic lows; policy concerns are likely overstated.
- Firm recommends using weak sentiment to buy attractive names. Likes: Gilead (NASDAQ:GILD) and Celgene (NASDAQ:CELG) in large-caps, The Medicines Co. (NASDAQ:MDCO), Alkermes (NASDAQ:ALKS) and Vertex (NASDAQ:VRTX) in mid-caps. Alder Biopharmaceuticals (NASDAQ:ALDR), Cempra (NASDAQ:CEMP), Ultragenyx (NASDAQ:RARE) and Immunomedics (NASDAQ:IMMU) in small-caps.