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
Celgene: A Pre-Earnings Discussion Based On Recent News
DoctoRx • 39 Comments
DoctoRx • 39 Comments
Mon, Jul. 25, 11:04 PM
- The FDA designates Janssen Biotech's (NYSE:JNJ) DARZALEX (daratumumab) a Breakthrough Therapy, in combination with Celgene's (NASDAQ:CELG) REVLIMID (lenalidomide) and dexamethasone, for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy.
- DARZALEX is currently approved in the U.S. for the treatment of MM patients who have received at least three prior lines of therapy. Several months ago, the European Commission approved it as monotherapy in adults with relapsed/refractory MM whose prior therapy included a proteasome inhibitor [e.g. Takeda's Ninlaro (ixazomib)] and an immunomodulatory agent and have shown disease progression on the last therapy.
- Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, a protein expressed on the surface of many immune cells. Once bound, it induces rapid tumor cell death through multiple mechanisms.
- Breakthrough Therapy status provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA) (or supplemental NDA in this case).
Mon, Jul. 25, 6:00 PM
- Celgene (NASDAQ:CELG) eases 3% after hours on robust volume in response to its announcement that it will not seek a new indication for Revlimid (lenalidomide) as maintenance therapy in patients with diffuse large B-cell lymphoma (DLBCL) who responded to first-line rituximab (Roche's Rituxan) plus R-CHOP chemo.
- The company's decision was based on the results from a randomized Phase 3 study, REMARC, that showed a statistically valid improvement in progression-free survival in the treatment group versus placebo, but no difference in overall survival.
- Revlimid is currently approved for multiple myeloma, myelodysplastic syndromes and mantle cell lymphoma.
Mon, Jul. 25, 5:37 PM
Fri, Jul. 22, 8:31 AM
- OncoSec Medical (NASDAQ:ONCS) initiated with Buy rating and $6 (253% upside) price target by Rodman & Renshaw.
- Invivo Therapeutics Holdings (NASDAQ:NVIV) initiated with Buy rating and $23.25 (254% upside) price target by Ladenburg Thalmann.
- TESARO (NASDAQ:TSRO) initiated with Outperform rating and $105 (14% upside) price target by Baird.
- Selecta Biosciences (Pending:SELB) initiated with Buy rating and $23 (64% upside) price target by Stifel Nicolaus.
- Syros Pharmaceuticals (NASDAQ:SYRS) initiated with Neutral rating and $10 (11% downside risk) price target by H.C. Wainwright.
- Voyager Therapeutics (NASDAQ:VYGR) initiated with Buy rating and $33 (161% upside) price target by Stifel Nicolaus.
- AveXis (NASDAQ:AVXS) initiated with Market Perform rating by Wells Fargo.
- Celgene (NASDAQ:CELG) initiated with Buy rating and $150 (40% upside) price target by Stifel Nicolaus.
- ReWalk Robotics (NASDAQ:RWLK) initiated Overweight rating and $10 (49% upside) price target by Piper Jaffray.
Tue, Jul. 19, 10:50 AM
- Prompted by moderating growth from traditional drug sales, large cap drug/biotech firms have their sights set on developers of cancer therapies, in particular immunotherapies, to boost both their top and bottom lines. Roche (OTCQX:RHHBY -1.5%), Amgen (AMGN +0.1%), Sanofi (SNY -1.3%) and Gilead Sciences (GILD -1.2%) are all actively on the prowl for acquisitions.
- Medivation (MDVN +0.1%), with its prostate cancer drug Xtandi (enzalutamide), is currently in play. Sanofi has been the most aggressive with two unsuccessful bids, but Pfizer (PFE) and Celgene (CELG -0.6%) are supposedly interested.
- Analysts say Incyte (INCY -0.4%), with polycythemia vera and myelofibrosis drug Jakafi (ruxolitinib), and Seattle Genetics (SGEN -0.8%), with lymphoma drug Adcetris (brentuximab vedotin), are the most attractive takeover targets.
- Recent transactions include AbbVie's (ABBV -0.3%) buyout of Stemcentryx, Jazz Pharmaceuticals' (JAZZ -0.8%) takeout of Celator Pharmaceuticals and Bristol-Myers Squibb's (BMY -0.2%) acquisition of Cormorant Pharmaceuticals.
Fri, Jul. 15, 7:00 AM
- The European Commission approves Celgene's (NASDAQ:CELG) top seller Revlimid (lenalidomide) for relapsed/refractory mantle cell lymphoma, a rare subtype of non-Hodgkin's lymphoma that is very resistant to treatment. Fewer than half of sufferers survive longer than five years.
- The data supporting approval was generated in a Phase 2 study in 254 patients who failed to respond to their last treatment and had relapsed one to three times. Those treated with Revlimid experienced progression-free survival of 8.7 months compared to 5.2 months for investigator's choice of therapy (p=0.004) with a 39% reduction in the risk of death over the study period (hazard ratio = 0.61).
- The new indication adds to Revlimid's European label of treatment-naive multiple myeloma (MM) and in combination with dexamethasone in MM patients who have received at least one prior line of therapy.
Fri, Jun. 24, 10:25 AM
- Intrepid biotech investors are, no doubt, seriously considering deploying some cash today in response to the (hopefully temporary) bearish reaction to the Brexit vote. Nasdaq is currently down 2.7%, the Dow 2.2% and the IBB 3.3%.
- Representative tickers: (GILD -2.2%)(GSK -2.4%)(AZN -2.7%)(PFE -1.1%)(MRK -1.9%)(CELG -3.2%)(BMY -2%)(BIIB -2.4%)(AMGN -2.7%)(AGN -2.8%)(TEVA -0.8%)(ABT -3.4%)(MDT -1.4%)
Wed, Jun. 15, 11:18 AM
- Nano cap Cellectar Biosciences (CLRB +17.6%) heads north on a 2.5x surge in volume in response to its announcement of preliminary results from an in vivo tumor-targeting study in mice that showed product candidate CLR 1602, a phospholipid drug conjugate, could be more than 30x more tumor selective than free paclitaxel. The data will be presented at the 35th National Medicinal Chemistry Symposium in Chicago at the end of the month.
- According to the company, the enhanced tumor uptake is at least partially due to CLR 1602's extended half-life, 96 hours or more, compared to free paclitaxel which is cleared from plasma within 24 hours.
- CLR 1602 is a Cremophor EL-free formulation of paclitaxel. Cremophor EL is used to increase the solubility of certain drugs (e.g. Taxol) but it induces unwanted side effects, some quite serious.
- Cellectar intends to conduct further studies, including a comparison with Celgene's (CELG +0.3%) Abraxane (paclitaxel protein-bound particles for injectable suspension)(albumin-bound).
Wed, Jun. 15, 8:14 AM
- Celgene Corporation (CELG) announces that the company's board has authorized the repurchase of up to an additional $3B of common stock, effective immediately, bringing the total available for buybacks up to ~$5.3B.
- Since 2009, the company has returned ~$15.2B to shareholders through its repurchase program.
Fri, Jun. 10, 7:50 AM
- Acceleron Pharma (NASDAQ:XLRN) and development partner Celgene (NASDAQ:CELG) announce preliminary results from a Phase 2 clinical trial evaluating Fast Track-tagged luspatercept in patients with beta thalassemia, an inherited blood disorder that reduces the production of hemoglobin. The results were presented at the 21st Congress of the European Hematology Association in Copenhagen.
- 80% (n=24/30) of patients treated with luspatercept achieved at least a 20% reduction in transfusion burden while 36% (n=8/22) achieved an increase in hemoglobin of at least 1.5 g/dL (normal range for men: 13.5 - 17.5 g/dL; women: 12.0 - 15.5 g/dL). In the long-term extension study the proportions improved to 96% (n=23/24) and 56% (n=15/27), respectively.
- Luspatercept is a protein therapeutic called a ligand trap. It promotes red blood cell formation by inhibiting members of the transforming growth factor beta superfamily, proteins that induce programmed cell death (apoptosis). A Phase 3 study in beta thalassemia, BELIEVE, is ongoing.
- Acceleron will host a conference call this morning at 8:00 am ET to discuss the data.
Sun, Jun. 5, 8:54 PM
- A Phase 2 clinical trial evaluating Halozyme Therapeutics' (NASDAQ:HALO) lead product candidate, PEGPH20, in combination with Celgene's (NASDAQ:CELG) Abraxane (nab-paclitaxel) and the chemo agent gemcitabine (PAG arm), compared to Abraxane and gemcitabine alone (AG arm) showed a significant treatment effect in 135 subjects with metastatic pancreatic cancer treated in Stage One of the study. The data were presented yesterday at ASCO16 in Chicago.
- Median progression-free survival (PFS) in the PAG arm was 9.2 months compared to 6.0 months in the AG arm. The overall response rate also favored the PAG arm, 50% versus 33% as did the median duration of response: 8.1 months versus 3.7 months. Median overall survival (OS) was similar: 11.8 months for the PAG arm compared to 10.9 for the AG arm.
- On the negative side, the rate of thromboembolic (blood clot) events was higher in the PAG arm (43%) compared to the AG arm (25%) but the incidence rates were reduced to 9% and 6%, respectively, with the use of the blood thinner heparin on a preventative basis.
- PEGPH20 is an investigational drug administered intravenously that temporarily degrades hyaluronan, a chain of natural sugars that builds up around cancer cells inhibiting the effectiveness of cancer-killing therapies.
- A Phase 3 study assessing PEGPH20 in pancreatic cancer commenced in March. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoints, PFS and OS, is October 2018. The estimated study completion date is December 2019.
Sun, Jun. 5, 7:34 PM
- Juno Therapeutics (NASDAQ:JUNO) reports encouraging results from two early-stage studies assessing two CAR-T candidates in its CD19 program. The results were presented yesterday at ASCO16 in Chicago.
- Results from a randomized Phase 1/2 study assessing JCAR014 in patients with relapsed/refractory acute lymphoblastic leukemia (ALL) showed a 100% (n=34/34) complete remission rate in efficacy-evaluable subjects and a 94% (n=32/34) complete remission rate as measured by flow cytometry. In the group that receive the chemo regimen fludarabine/cyclophosphamide (Flu/Cy) as a pretreatment, the complete response rate was also 100% (n=22/22) both clinically and by flow cytometry. Median disease-free survival and overall survival have not been reached in the 18 months of follow up.
- In patients with non-Hodgkin lymphoma, mainly diffuse large B-cell lymphoma, who received the Flu/Cy pretreatment followed by JCAR014, the overall response rate was 80% (n=16/20) and the complete response rate was 50% (n=10/20).
- Treatment-related side effects continue to be substantial. Serious cytokine release syndrome (sCRS) or "cytokine storm", a serious and potentially life-threatening immune response, was observed in 39% (n=14/36) of patients and grade 3 (severe) or higher neurotoxicity was observed in 39% (n=14/36).
- Results from an ongoing Phase 1 trial evaluating JCAR017 in pediatric and young adult patients with CD19-positive relapsed/refractory ALL showed a complete remission rate of 93% (n=39/42) both clinically and as measured by flow cytometry as did those receiving the Flu/Cy pretreatment (n=14/14).
- The incidence rates of sCRS and grade 3 or higher neurotoxicity were both 24% (n=10/42).
- The company and Celgene (NASDAQ:CELG) are partnering on the development and commercialization of Juno's CD19 program. Juno retains exclusive rights in North America and China and Celgene elsewhere.
- Previously: Celgene exercises option on Juno's CD19 program (April 11)
Fri, Jun. 3, 8:17 AM
- Ophthotech (NASDAQ:OPHT) upgraded to Overweight from Neutral by JPMorgan. Price target raised to $84 (45% upside) from $60.
- Intuitive Surgical (NASDAQ:ISRG) downgraded to Neutral from Buy by Goldman Sachs. Price target raised to $674 (5% upside) from $633.
- Celgene (NASDAQ:CELG) downgraded to Neutral from Buy by BTIG Research.
- Medtronic (NYSE:MDT) downgraded to Neutral from Buy by BTIG Research. $82 price target removed.
- Portola Pharmaceuticals (NASDAQ:PTLA) downgraded to Neutral from Outperform by Credit Suisse. Price target lowered to $30 (7% upside) from $33.
Wed, May 25, 9:00 AM
- According to Bloomberg, Celgene (NASDAQ:CELG) is considering a bid for Medivation (NASDAQ:MDVN), currently trying to hold off Sanofi (NYSE:SNY). Other suitors supposedly in the mix are Pfizer (NYSE:PFE), AstraZeneca (NYSE:AZN) and Amgen (NASDAQ:AMGN).
- Sanofi is trying to replace Medivation's board after it rejected its per-share offer of $52.50.
- Previously: Amgen another possible Medivation suitor (May 5)
Tue, May 17, 4:33 PM
- Celgene (NASDAQ:CELG) and Agios Pharmaceuticals (NASDAQ:AGIO) ink a collaboration to discover, develop and commercialize novel immuno-oncology therapies based on Agios' cellular metabolism research platform.
- Under the terms of the agreement, Agios will receive an upfront cash payment of $200M plus milestones. Agios will lead exploratory research, drug discovery and early development. Celgene will have the option, up through Phase 1 dose escalation, to designate a program for collaboration for a fee of at least $30M. Celgene also has the option to extend the research term for up to two years for a pre-specified fee.
- The companies will enter into a global co-development and co-commercialization agreement under which costs and profits will be shared equally. Agios will be eligible to earn up to $169M in clinical and regulatory milestones per program. Celgene will have a one-time opportunity to select a metabolic immuno-oncology program under which costs and profits will be shared 65% by Celgene and 35% by Agios. If Celgene does so, Agios will be eligible for clinical and development milestones up to $209M.
- If the collaboration produces any inflammation or autoimmune programs, Celgene will have the option for an exclusive global license including leading worldwide development and commercialization. Agios will be eligible for up to $386M in milestones for these programs, in addition to double-digit royalties on net sales.
- Agios and Celgene will alternate leadership of all 50/50 programs in the U.S., with Agios leading the first. Celgene will lead ex-U.S. development and commercialization for all programs and will be the global lead for the 65/35 program.
- The companies have also modified certain rights under their 2010 collaboration. Neither party will have financial or other obligations to each other related to AG-120, which Agios previously had U.S. rights to. The rights to two cancer metabolism programs will advance under the structure of the new agreement. Following the expiration of the discovery phase of the 2010 agreement on April 14, all other cancer metabolism programs discovered at Agios will remain wholly owned by Agios. AG-221 and AG-881 remain part of the 2010 partnership.
- Agios will host a conference call this afternoon at 5:00 pm ET to discuss the deal.
- AGIO is up 4% after hours on increased volume.
Wed, May 11, 3:21 PM
- As expected, the European Commission approves Empliciti (elotuzumab), in combination with Celgene's (CELG -2.4%) Revlimid (lenalidomide) and dexamethasone, for the treatment of patients with multiple myeloma (MM) who have received at least one prior line of therapy. The approval follows a positive opinion recommending approval in late January by the European Medicines Agency's Advisory Committee (CHMP).
- Elotuzumab is a humanized IgG1 monoclonal antibody that binds to a protein called SLAMF7 (Signaling Lymphocytic Activation Molecule Family member 7), expressed on myeloma cells and immune cells like Natural Killer (NK) cells. The improved adhesion between the two enhances the ability of NK cells to kill myeloma cells.
- Empliciti was co-developed by Bristol-Myers Squibb (BMY -1%) and AbbVie (ABBV -1.5%). Bristol-Myers is solely responsible for commercialization. The FDA approved it in November 2015.
- Previously: European Ad Comm backs Bristol-Myers and AbbVie's elotuzumab for multiple myeloma (Jan. 29)
Celgene Corp. is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. Its targeting areas include intracellular signaling... More
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