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Today, 7:21 AM
- Incyte (NASDAQ:INCY) terminates its Phase 3 clinical trial assessing Jakafi (ruxolitinib), in combination with chemo agent capecitabine, for the second-line treatment of advanced or metastatic pancreatic cancer after an interim analysis failed to show sufficient efficacy.
- Based on these data and the interim analysis of the Phase 2 sub-study of Jakafi, in combination with Bayer's (OTCPK:BAYRY) STIVARGA (regorafenib), in patients with metastatic colorectal cancer and high C-reactive protein (CRP), the company will stop all Jakafi studies in solid tumors, including Phase 2 trials in breast and lung cancer. It will also discontinue its dose-finding study of INCB39110 ( a selective JAK1 inhibitor) as first-line treatment for pancreatic cancer.
- Data from all the discontinued trials will be analyzed and shared with the scientific community over the next few months.
- Ongoing studies of Jakafi and selective JAK1 inhibitors in hematology will continue as will those assessing selective JAK1 inhibition in solid tumors based on different hypotheses. These include a series of studies evaluating INCB39110 in combination with Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab) and Incyte's epacadostat and INCB50465. A Phase 1/2 trial will also be conducted assessing INCB39110 plus AstraZeneca's (NYSE:AZN) TAGRISSO (osimertinib).
- Jakafi is a JAK1/JAK2 inhibitor cleared in the U.S. for the treatment of a type of blood cancer called polycythemia vera and a bone marrow disorder called myelofibrosis.
- Shares are off 10% premarket on light volume.
Thu, Feb. 4, 11:01 AM
- ImmunoGen (IMGN +9.7%) establishes a clinical research collaboration with Merck (MRK -1.4%) to evaluate the combination of IMGN's mirvetuximab soravtansine and Keytruda (pembrolizumab) for the treatment of patients with folate receptor (FR) alpha-positive ovarian cancer. The combination therapy will be added to IMGN's Phase 1b/2 clinical trial called FORWARD II. The agreement, through a Merck subsidiary, includes an option to expand the collaboration to include a Phase 3 study if the results are positive.
- Mirventuximab soravtansine is an antibody-drug conjugate (ADC) that contains a monoclonal antibody (mirventuximab) that binds to FRalpha-positive tumor cells thereby delivering its cytotoxic payload, soravtansine or DM4.
- KEYTRUDA helps the immune system fight tumor cells by blocking the interaction between PD-1, a cell surface receptor expressed on T cells and pro-B cells, and its ligands PD-L1 and PD-L2. PD-1 is an immune checkpoint which down regulates the immune system. Blocking its action activates the immune system to attack cancer cells.
Wed, Jan. 27, 3:30 PM
- As if biotech investors need reminding, biotechs (and healthcare stocks) are getting some rude treatment today, the market's foul mood notwithstanding. The Nasdaq Composite Index is down 2.5%,but the SPDR S&P Biotech ETF (XBI -4.7%) almost twice as much. The iShares Nasdaq Biotechnology ETF (IBB -3.5%) is faring a bit better, but still down more than the broad market.
- Only Biogen and Abbott have bucked the trend.
- Sample of tickers: (AMGN -2.5%)(BIIB +5.7%)(CELG -3.9%)(GILD -3.3%)(ALXN -1.2%)(ABT +0.3%)(BMY -1.8%)(MRK -3%)(VRX -4%)(PFE -0.9%)
- ETFs: BIB, BIS, CNCR
Mon, Jan. 25, 6:50 AM
- Affimed N.V. (NASDAQ:AFMD) and a subsidiary of Merck (NYSE:MRK) establish a clinical trial collaboration whereby Merck will supply KEYTRUDA (pembrolizumab) to Affimed in a Phase 1b clinical trial assessing the combination of the PD-1 inhibitor and Affimed's lead product candidate AFM13 for the treatment of patients with Hodgkin lymphoma whose disease has relapsed or is refractory to chemotherapy, including treatment with Takeda (OTCPK:TKPHF)(OTCPK:TKPYY) and Seattle Genetics' (NASDAQ:SGEN) ADCETRIS (brentuximab vedotin). The objective of the study, to be conducted by Affimed and expected to commence in H1, is to establish a dosing regimen of the combo as well as its safety and efficacy.
- In preclinical patient derived xenograft models, the combination eradicated up to 90% of tumors. The collaboration may expand to include a Phase 3 trial if the Phase 1b is successful.
- AFM13 is a bispecific antibody that binds to a protein expressed in a range of T-cell and B-cell lymphomas called CD30 and to a protein expressed on the immune system's natural killer cells called CD16A, both of which play key roles in the activation of the immune system to detect and kill cancer cells.
- Shares are up 13% premarket on average volume.
Dec. 4, 2015, 12:01 PM
- Relypsa (RLYP +16.6%) jumps on increased volume in response to rumors that Merck (MRK +0.5%) may be eyeing the company. Actelion Pharmaceuticals (OTCPK:ALIOY -0.4%) is another rumored suitor considering AstraZeneca's (AZN +0.4%) recent takeover of ZS Pharma (ZSPH -0.1%).
- Relypsa's sole product is Veltassa (patiromer for oral suspension) for the treatment of hyperkalemia (abnormally high levels of serum potassium), cleared by the FDA on October 21.
- Previously: Good news is bad news for Relypsa; shares down 26% premarket after approval of Veltassa (Oct. 22)
- Previously: ZS Pharma take out by AstraZeneca puts the spotlight on Relypsa; shares rise 17% premarket (Nov. 6)
Sep. 17, 2015, 1:44 PM
- Eli Lilly (LLY +6.7%) jumps on 30% higher volume in response to its announcement of results from a Phase 3 clinical trial, called EMPA-REG, that showed patients with type 2 diabetes at high risk of cardiovascular (CV) events treated with Jardiance (empaglifozin), in addition to standard-of-care treatment, experienced a significant reduction in both CV risk and death.
- Specifically, patients taking Jardiance showed a 14% reduction in the risk of the combined endpoint of CV death, non-fatal heart attack or non-fatal stroke and a 38% reduction in the risk of CV death. Treatment with Jardiance also resulted in a 32% reduction in all-cause mortality and a 35% reduction in heart failure-related hospitalization, all versus placebo. The data were presented today at the 51st European Association for the Study of Diabetes Annual Meeting in Stockholm, Sweden and published in the New England Journal of Medicine.
- EMPA-REG was a long-term, multicenter, double-blind, placebo-controlled study involving more than 7,000 people across 42 countries with type 2 diabetes at high risk of CV events. The median observation period was 3.1 years.
- Almost 400M people worldwide have diabetes. As many as 95% of the cases are type 2.
- Jardiance was co-developed with privately held Boehringer Ingelheim under the companies' January 2011 diabetes alliance.
- Related tickers: (SNY +0.1%)(NVO -0.7%)(MRK -0.8%)
Sep. 17, 2015, 7:59 AM
- Interim results from a Phase 2 clinical trial evaluating Achillion Pharmaceuticals' (NASDAQ:ACHN) NS5A inhibitor odalasvir (ACH-3102), in combination with Gilead Sciences' (NASDAQ:GILD) Sovaldi (sofosbuvir), without ribavirin, in HCV-1 patients showed a 100% cure rate (SVR12) in HCV-1 patients (n=6/6) after six or eight weeks of treatment.
- The Phase 2 trial was an open-label, randomized, partial-crossover study to assess the safety, tolerability and efficacy of six or eight weeks of odalasvir and sofosbuvir, without ribavirin, in patients with HCV-1 infection. Eighteen patients were initially enrolled, including six as observational (group 1). Twelve patients completed eight weeks of treatment (50 mg odalasvir/400 mg sofosbuvir) while the observational group received nothing. All twelve subjects achieved SVR24. Following this phase, the six observational patients plus six additional patients (group 2) received six weeks of treatment with the same combo regimen. All achieved SVR24. Six additional rollover patients (group 3) were treated for six weeks with the combo regimen and all achieved SVR12.
- In a summary that is a bit confusing, the company states that 18 subjects (groups two and three) achieved SVR12 after six weeks of therapy, although it states that only group 3 (n=6) achieved this. Also, the total number of patients in groups 2 and 3 is 12 (6 + 6). Group 1 (n=6) is apparently included as well?
- In May, the company inked a global license and commercialization deal with Janssen Pharmaceuticals (NYSE:JNJ) for HCV products containing one or more of Achillion's HCV assets, including odalasvir, ACH-3422 and sovaprevir.
- Previously: Achillion inks collaboration deal with J&J's Janssen Pharmaceuticals in hep C (May 19)
- ACHN is up 5% premarket on light volume.
- Related tickers: (NYSE:MRK) (NYSE:BMY) (NYSE:ABBV)
Aug. 4, 2015, 10:00 AM
- Thinly traded micro cap Codexis (CDXS +23.1%) is up on average volume in response to its announcement after the close yesterday that it licensed its CodeEvolver platform technology to Merck (MRK -0.1%), the second member of Big Pharma to sign on.
- Under the terms of the agreement, Merck has a non-exclusive license to use the CodeEvolver protein engineering platform technology to develop novel enzymes for use in the manufacture of Merck's pharmaceutical products. Codexis is eligible to receive up to $18M over the next 15 - 24 months, $5M up front and $13M related to certain technology transfer milestones. It is also eligible to receive up to a maximum of $15M for each pharmaceutical ingredient using novel enzymes developed with CodeEvolver by Merck and used in commercial manufacturing.
- Codexis will host a conference call this morning at 11:00 am ET to discuss the deal.
Jul. 31, 2015, 8:47 AM
- An interim analysis of data from a Phase 3 ring vaccination trial in Guinea shows Merck's (NYSE:MRK) Ebola vaccine candidate, rVSV-ZEBOV, was 100% effective in protecting people from Ebola virus infection within six to 10 days of vaccination (p=0.0036). The preliminary conclusions will be published online today in The Lancet.
- Over 4,000 people have received the vaccine to date. Merck licensed rVSV-ZEBOV from NewLink Genetics (NASDAQ:NLNK) who licensed it from the Public Health Agency of Canada.
- The make the vaccine, a virus similar to the rabies virus called vesicular stomatitis virus is weakened by removing one of its genes which is then replaced with a single Ebola virus gene that, by itself, cannot cause disease.
- Two other trials assessing rVSV-ZEBOV are ongoing: a Phase 3 study, called STRIVE, in Sierra Leone and a Phase 2, called PREVAIL, in Liberia.
- MRK is up a fraction premarket. NLNK is up 9% on light volume.
May 29, 2015, 5:24 PM
- Bristol-Myers Squibb (NYSE:BMY) stumbled 7% today on a 4.5x surge in volume in response to the presentation of an abstract (#109) at ASCO that underwhelmed many investors. The data were from Phase 3 study, called CheckMate-057, assessing the company's PD-1 inhibitor, Opdivo (nivolumab) compared to the standard-of-care chemotherapy agent docetaxel in treatment-experienced patients with advanced, non-squamous non-small cell lung cancer, the most common form of lung cancer. A drug used after another (treatment experienced) is called a second line setting.
- The study met its primary endpoint of a statistically significant 27% reduction in the risk of cancer progression or death compared to docetaxel (p=0.0015). The trial also evaluated the efficacy of Opdivo compared to docetaxel by the level of PD-L1 expression, 1%, 5% and 10%. As expected, the median overall survival (OS) in the Opdivo group was significantly longer than the chemo cohort for all three levels where PD-L1 was highly expressed (greater than or equal to 1, 5, 10%).
- What raised eyebrows was the absence of a treatment benefit compared to docetaxel in the three groups with low PD-L1 expression (<1%, <5%, <10%). Median OS was barely higher in the Opdivo group with <1% expression and lower than docetaxel in the other two. This potentially opens the door for eventual competitors such as Roche (OTCQX:RHHBY) and Merck (NYSE:MRK) whose offerings show strong efficacy in tumors that highly express PD-L1. Had Opdivo shown a significant OS advantage in low PD-L1 expression tumors, its dominance in the second line setting would have been virtually assured.
- CheckMate-057 was stopped early based on the successful achievement of its primary endpoint, per the recommendation of the independent Data Monitoring Committee.
- Previously: Phase 3 study stopped early after Bristol-Myers' Opdivo hits efficacy endpoint (April 17)
Apr. 28, 2015, 9:12 AM
Apr. 27, 2015, 5:40 PM
Apr. 22, 2015, 8:50 AM| Apr. 22, 2015, 8:50 AM | 14 Comments
Dec. 19, 2014, 6:35 PM
- The FDA has approved the use of Cubist's (NASDAQ:CBST) Zerbaxa (ceftolozane/tazobactam) for "the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative bacteria."
- Cubist adds the FDA's decision was "supported by positive data from two pivotal Phase 3 clinical trials - one in patients with cUTI and the other in patients with cIAI."
- Cubist, still set to be acquired by Merck (NYSE:MRK) for $9.5B, is up 2% AH.
- Previous: PDUFA date approaches for Zerbaxa
Dec. 8, 2014, 6:11 PM
- The judge handling Cubist's (NASDAQ:CBST) infringement suit against Hospira (NYSE:HSP) over a generic version of Cubist's Cubicin has ruled several of Cubist's patent claims are invalid.
- Commenting on the ruling, Evercore ISI thinks Hospira will be able to launch a generic version of the drug by June 2016 in a "worst-case scenario." Cubist received a favorable ruling regarding its patent claims last year.
- Merck (NYSE:MRK), which announced this morning it's buying Cubist for $9.5B, is down 1.4% AH. Cubist is down 2.1%, and Hospira is up 2.3%.
Dec. 8, 2014, 1:23 PM
- Micro cap Cellceutix (OTCPK:CTIX +22.1%) jumps on a 5x surge in volume after the FDA grants Qualified Infectious Disease Product (QIDP) status to Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The company is scheduled to meet with the FDA later this month on a planned Phase 3 trial evaluating the safety and efficacy of Brilacidin for ABSSSI.
- Brilacidin is a member of a new class of antibiotics called defensin-mimetics, which are modeled after host defense proteins. These are the "front line" of defense in the human immune system.
- In a Phase 2b clinical trial, a single dose of Brilacidin demonstrated equivalent effectiveness as a seven-day regimen of daptomycin (CBST +35.4%) for the treatment of ABSSSI.
- Among the benefits of QIDP is Fast Track and Priority Review status and a five-year period of market exclusivity if approved.
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