Tue, Aug. 18, 9:49 AM
- The FDA accepts for review the supplemental Biologics License Application (sBLA) from Merck (MRK -0.1%) seeking approval for the use of Keytruda (pembrolizumab) as first-line treatment of unresectable or metastatic melanoma. The PDUFA date is December 19.
- In addition, the FDA extended its action date for a separate sBLA seeking approval for the use of Keytruda for the treatment of ipilimumab-refractory advanced melanoma to December 24.
- Keytruda is currently cleared for the treatment of unresectable or metastatic melanoma with disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
- Ipilimumab is marketed under the brand name Yervoy by Bristol-Myers Squibb (BMY +0.7%).
Fri, Aug. 14, 8:50 AM
- Akebia Therapeutics (NASDAQ:AKBA) initiated with Equal Weight rating and $10 (33% upside) price target by Morgan Stanley.
- Rockwell Medical (NASDAQ:RMTI) initiated with Underweight rating and $7 (39% downside risk) price target by Morgan Stanley.
- Incyte (NASDAQ:INCY) initiated with Overweight rating and $125 (16% upside) price target by Barclays.
- TG Therapeutics (NASDAQ:TGTX) coverage resumed by HC Wainwright with a Buy rating and $22 (39% upside) price target.
- Biogen (NASDAQ:BIIB) initiated with Buy rating and $380 (21% upside) price target by HC Wainwright.
- ProNAi Therapeutics (NASDAQ:DNAI) initiated with Outperform rating and $36 (44% upside) price target by Wedbush.
- Chiasma (NASDAQ:CHMA) initiated with Overweight rating and $40 (62% upside) price target by Barclays.
- Natera (NASDAQ:NTRA) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target maintained at $20 (29% upside).
- Merck (NYSE:MRK) upgraded to Outperform from Market Perform by BMO Capital Markets. Price target raised to $70 (19% upside) from $65.
- Keryx Biopharmaceuticals (NASDAQ:KERX) downgraded to Neutral from Buy by Roth Capital. Price target lowered to $6 (1% downside risk) from $11.
Mon, Aug. 10, 8:39 AM
- Immune Design (NASDAQ:IMDZ) and subsidiaries of Merck (NYSE:MRK) enter into a clinical collaboration to evaluate the safety and efficacy of two IMDZ investigational immuno-oncology agents combined with Keytruda (pembrolizumab). The first Phase 1 study will assess the combination of G100, a product candidate generated from IMDZ's GLAAS discovery platform, and Keytruda in patients with non-Hodgkin's lymphoma. The second Phase 1 will assess LV305, generated from IMDZ's ZVex platform, and Keytruda in patients with melanoma.
- Both G100 and LV305 are designed to be "off-the-shelf" therapies. They activate the immune system via the induction and/or expansion of anti-tumor CD8 T cells.
- Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2.
Fri, Aug. 7, 8:14 AM
- A new class of cancer therapeutics has been rekindled of late led by Pfizer (NYSE:PFE) and Bristol-Myers Squibb (NYSE:BMY). They are called immune system accelerators, antibodies that target a protein called 4-1BB, also known as CD137.
- When the immune system's T-cells and natural killer (NK) cells identify cancer cells, the 4-1BB protein appears on their surfaces which accelerates their attack. The protein was discovered over 20 years ago, but its development was abandoned in 2008 after early-stage studies done by Bristol showed signs of liver damage. Scientists eventually realized that lower doses of 4-1BB, given at the right time, could elicit the desired anti-cancer effect without the unwanted toxicity. Early results have been impressive. A 38-subject study done by Pfizer, 40% of patients with follicular lymphoma and a third of those with mantle cell lymphoma experienced a reduction in cancer with no serious side effects.
- Phase 1 studies are underway assessing combinations of immune checkpoint inhibitors, like Roche's (OTCQX:RHHBY) Rituxan (rituximab) and accelerators. Studies are planned for Pfizer's 4-1BB candidate in combination with Herceptin (trastuzumab) and the combination of Bristol's 4-1BB candidate, urelumab, with Eli Lilly's (NYSE:LLY) Erbitux (cetuximab). Bristol in currently enrolling patients in five Phase 1 studies in multiple myeloma, lymphomas and solid tumor cancers. Pfizer is planning trials with an immunotherapy from Kyowa Hakko Kirin and Merck's (NYSE:MRK) Keytruda (pembrolizumab).
- Johnson & Johnson (NYSE:JNJ) and AbbVie (NYSE:ABBV) are a step behind doing preclinical work on their accelerator candidates.
Tue, Aug. 4, 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.
Fri, Jul. 31, 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.
Thu, Jul. 30, 1:37 PM
- Unsurprisingly, Express Scripts (ESRX -0.6%) takes a dim view of the proposed price of the cholesterol-lowering PCSK9 inhibitor Praluent (alirocumab). Last Friday, co-developers Sanofi (SNY +1.6%) and Regeneron Pharmaceuticals (REGN +0.4%) announced that the wholesale acquisition cost (WAC) of the once-every-two-week injection will be $40 per day or $14,600 per year. This is several orders of magnitude above the cost of statins, which average $2 - 3 per day.
- WAC is the average price that wholesalers and distributors pay for the drug. Patients will, of course, pay quite a bit more.
- Pharmacy benefit managers, still feeling the pinch from Gilead's (GILD +1.8%) HCV meds Sovaldi and Harvoni, will likely ratchet up their opposition as Praluent's U.S. launch commences.
- Related tickers: (AET +0.9%)(CTRX)(CNC +0.9%)(CI -0.7%)(HUM)(MRK +0.3%)(OCR +0.4%)(UNH -0.7%)(CVS -0.5%)
Thu, Jul. 30, 9:52 AM
- Tesaro (TSRO -3.8%) secures an exclusive license agreement with China-based Jiangsu Hengrui Medicine Co. for the development, registration, manufacture and commercialization of rolapitant in China. Specific financial terms are not disclosed.
- Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist under development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The company's NDA is currently under FDA review with a PDUFA date of September 5.
- CINV-related tickers: (GALE -1.8%)(HRTX -2.2%)(MRK -0.1%)(RDHL -0.1%) (OTC:ESALF) (OTCPK:ESALY) (OPK -1.3%)(INSY -2.3%)(GWPH -2.1%)
Tue, Jul. 28, 8:45 PM
- The FDA accepts for review the New Drug Application (NDA) from Merck (NYSE:MRK) for its once-daily single tablet combination of grazoprevir/elbasvir for the treatment of adult patients with chronic HCV genotypes 1, 4 or 6 infection. The agency will review the application under its Priority Review protocol. The PDUFA date is January 28, 2016.
- The FDA has designated grazoprevir/elbasvir a Breakthrough Therapy for the treatment of patients with HCV-1 with end stage renal disease and for the treatment of HCV-4. The designation provides for more intensive guidance from the agency, the involvement of more senior personnel and a rolling review of the NDA.
- Five days ago, the European Medicines Agency accepted the company's Marketing Authorization Application (MAA) under accelerated review for the treatment of HCV-1, 3, 4 or 6 infection.
- Related tickers: (NYSE:BMY) (NASDAQ:GILD) (NYSE:ABBV)
Tue, Jul. 28, 10:08 AM
- The European Medicines Agency validates Teva Pharmaceutical Industries' (TEVA -1.6%) Marketing Authorization Application (MAA) for reslizumab for the treatment of inadequately controlled asthma in adult patients with elevated blood eosinophils despite an inhaled corticosteroid-based regimen. A final decision by the European Commission is anticipated in H2 2016.
- Reslizumab is an investigational humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood of many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
- Teva's Biologics License Application (BLA) is currently under review by the FDA. A decision is expected in March 2016.
- Asthma-related tickers: (SNY -0.1%)(GSK -0.4%)(AZN -0.7%)(OTCQX:RHHBY)(AMGN +2.2%)(MRK -1.1%)(NVS +0.7%)(THRX +1.5%)
Tue, Jul. 28, 7:53 AM
- Merck (NYSE:MRK) Q2 results ($M): Total Revenues: 9,785 (-10.5%); Pharmaceutical: 8,564 (-5.8%); Animal Health: 840 (-3.7%); Other: 381 (-2.8%).
- Net Income: 688 (-66.2%); EPS: 0.24 (-64.7%).
- Key Product Sales: Januvia: 1,044 (-1.3%); Zetia: 635 (-11.4%); Janumet: 554 (+6.7%); Remicade: 455 (-25.0%); Gardisil: 427 (+4.4%); Isentress: 375 (-17.2%); Proquad, MMRII & Varivax: 358 (+9.8%); Vytorin: 320 (-23.3%); Cubicin: 293 (+999%); Nasomex: 215 (-16.7%); Singulair: 212 (-25.4%); Keytruda: 110.
- 2015 Guidance: EPS: $1.52 - 1.71 from $1.58 - 1.85; Non-GAAP EPS: $3.45 - 3.55 from $3.35 - 3.48.
Tue, Jul. 28, 7:12 AM
Mon, Jul. 27, 5:30 PM
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Mon, Jul. 27, 1:11 PM
Mon, Jul. 27, 12:51 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval for Merck's (MRK -1.2%) ZERBAXA (ceftolozane/tazobactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), acute pyelonephritis (kidney infection) or complicated urinary tract infections (cUTI).
- ZERBAXA, intravenously administered, is a combination of the cephalosporin antibacterial drug ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium.
- A final decision by the European Commission usually takes ~60 days.
- ZERBAXA is cleared in the U.S. for the treatment of cUTI and cIAI (in combination with metrodinazole).
Fri, Jul. 24, 12:05 PM
- The FDA approves AbbVie's (ABBV -3%) Technivie (ombitasvir, paritaprevir, ritonavir), in combination with ribavirin, for the treatment of HCV genotype 4 infection in patients with poor liver function (cirrhosis) without scarring (fibrosis). Technivie is the first approved treatment for HCV-4 that does not require the use of interferon.
- About 3M Americans are chronically infected with HCV. Genotype 4 is the least common, representing ~1% of the total.
- Related tickers: (GILD -2.7%)(MRK -0.9%)
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