Cubist Pharmaceuticals: An Extraordinary Arbitrage Opportunity
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Cubist Pharmaceuticals: Doomsday Preparation Update
Today, 9:12 AM
- Merck (MRK) Q2 results: Total Revenues: $9,844M (+0.6%); Pharmaceutical: $8,700M (+1.6%); Animal Health: $898M (+6.9%); Other Revenues: $246M (-35.4%).
- Net Income: $1,205M (+75.4%); Non-GAAP Net Income: $2,587M (+6.0%); EPS: $0.43 (+79.2%); Non-GAAP EPS: $0.93 (+8.1%).
- Key Product Sales: Januvia / Janumet: $1,634M (+2.3%); Zetia / Vytorin: $994M (+4.1%); Gardasil / Gardasil 9: $393M (-8.0%); Proquad / MMRII / Varivax: $383M (+7.0%); Cubicin: $357M (+21.8%); Remicade: $339M (-25.5%); Isentress: $338M (-9.9%); Keytruda: $314M (+185.5%).
- 2016 Guidance: Revenues: $39.1B - 40.1B; EPS: $1.98 - 2.08; Non-GAAP EPS: $3.67 - 3.77.
Today, 6:46 AM
Yesterday, 5:30 PM
Tue, Jul. 26, 1:13 PM
Mon, Jul. 25, 9:43 AM
- Merck (MRK -0.4%) announces that its experimental Ebola vaccine, V920 (rVSVdeltaG-ZEBOV-GP, live attenuation) has received accelerated review status in the U.S. and EU.
- The FDA has tagged V920 a Breakthrough Therapy which 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).
- The European Medicines Agency (EMA) has granted PRIME status to V920 which provides early and proactive support from the regulator, including the appointment of a liaison called a rapporteur, with the aim of optimizing clinical trial design as well as accelerated review of the Marketing Authorization Application (MAA).
- Merck licensed V920 from NewLink Genetics (NLNK +1.6%) in late 2014.
Fri, Jul. 22, 8:40 AM
- Johnson & Johnson (NYSE:JNJ) upgraded to Buy from Hold by Argus Research. Price target raised to $145 (16% upside) from $130.
- Humana (NYSE:HUM) upgraded to Buy from Hold by Jefferies. Price target raised to $210 (22% upside) from $199.
- Teva Pharmaceutical Industries (NYSE:TEVA) upgraded to Buy from Hold by HSBC. Price target raised to $65 (19% upside) from $61.
- Relypsa (NASDAQ:RLYP) downgraded to Neutral from Buy by Citigroup. Price target raised to $32 (0% upside) from $25.
- Evoke Pharma (NASDAQ:EVOK) downgraded to Hold from Buy by Noble Financial. Downgraded to Hold from Buy by Brean Capital. Downgraded to Neutral from Buy by Rodman & Renshaw.
- Merck (NYSE:MRK) downgraded to Market Perform from Outperform with a $62 (5% upside) price target by BMO Capital.
- St. Jude Medial (NYSE:STJ) downgraded to Neutral from Outperform by Wedbush. Price target raised to $84 (3% upside) from $70.
- Teva Pharmaceutical Industries (TEVA) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $60 (10% upside) from $70.
Thu, Jul. 21, 5:27 PM
- The FDA approves Merck (NYSE:MRK) Animal Health's BRAVECTO (fluralaner topical solution) for the topical treatment of fleas and ticks in cats and dogs. According to the company, a single dose is effective for up to 12 weeks. The product will be sold exclusively through licensed veterinarians beginning in Q1 2017.
Thu, Jul. 21, 5:01 PM
- Merck (NYSE:MRK) reports that the FDA has requested new data and analyses from the pivotal trials (MODIFY 1 and MODIFY II) supporting its Biologics License Application (BLA) seeking approval of bezlotoxumab for the prevention of Clostridium difficile infection recurrence. The request constitutes a major amendment to the BLA so the agency's action date is automatically extended 90 days to October 23. The original PDUFA date was July 23.
- The company says it looks forward to working with the FDA on its review of the application.
- Previously: FDA accepts Merck's bezlotoxumab BLA, action date July 23 (Jan. 27)
Mon, Jul. 18, 7:18 AM
- The European Medicines Agency accepts for review Samsung Bioepis' Marketing Authorization Application (MAA) seeking approval of SB5, its biosimilar candidate to AbbVie's (NYSE:ABBV) Humira (adalimumab).
- SB5 is the third anti-TNF-alpha biosimilar candidate submitted for review by Samsung Bioepis. Benepali (etanercept) was approved in January and Flixabi (infliximab) was approved in May. If the MAA for SB5 is approved, Biogen (NASDAQ:BIIB) will be responsible for commercialization.
- Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. It has 13 biosimilar candidates in its pipeline, including six in its first wave. It is responsible for development and manufacturing of all immunology and oncology biosimilar candidates as well as global clinical trials and regulatory submissions. Following approval, Biogen and Merck (NYSE:MRK) are responsible for marketing and distribution.
Mon, Jul. 11, 8:11 AM
- Mylan N.V. (NASDAQ:MYL) announces the U.S. launch of Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, a generic version of Merck's (NYSE:MRK) Temodar.
- Temozolomide Capsules are indicated for the treatment of adult patients with newly diagnosed cancerous tumors known as glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.
- According to IMS Health, total U.S. sales of Temozolomide Capsules was ~$177M for the 12 months ending May 31, 2016.
Wed, Jun. 29, 8:03 AM
- Merck (NYSE:MRK) announces a strategic collaboration and license agreement with Moderna Therapeutics to develop and commercialize novel messenger RNA (mRNA)-based personalized cancer vaccines. The collaboration will combine Merck’s established leadership in immuno-oncology with Moderna’s pioneering mRNA vaccine technology and GMP manufacturing capabilities to advance individually tailored cancer vaccines for patients across a spectrum of cancers.
- The companies believe that the mRNA-based personalized cancer vaccines’ ability to specifically activate an individual patient’s immune system has the potential to be synergistic with checkpoint inhibitor therapies, including Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab).
- In addition, Moderna has developed a rapid cycle time, small-batch manufacturing technique that will uniquely allow the company to supply vaccines tailored to individual patients within weeks.
- Under the terms of the agreement, Merck will make a cash payment to Moderna of $200M, which Moderna will use to lead all research and development efforts and to fund a portion of the build-out of a GMP manufacturing facility in suburban Boston. Following human proof-of-concept studies, Merck has the option to make an additional undisclosed payment to Moderna. If exercised, the companies with equally share cost and profits under a global collaboration for the development of personalized cancer vaccines.
- The firms have an existing partnership to discover and develop mRNA-based infectious disease vaccines and passive immunity treatments.
Tue, Jun. 28, 7:57 AM
- BioLineRx (NASDAQ:BLRX) announces the filing of regulatory submissions required to commence a Phase 2a trial assessing BL-8040, in combination with Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab), for the treatment of pancreatic cancer. The study, called COMBAT, is expected to commence in Q3.
- The 30-subject, open-label, single-arm study is designed to evaluate the clinical response, safety and tolerability of the combination as well as multiple pharmacodynamic parameters, including the ability to improve infiltration of T cells into the tumor and their reactivity in patients with metastatic pancreatic adenocarcinoma.
Mon, Jun. 27, 7:51 AM
- Merck (NYSE:MRK) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen.
- Data supporting the CHMP opinion were based on two studies, KEYNOTE-010, which assessed overall survival (OS) and KEYNOTE-001, which assessed overall response rates (ORR).
- KEYNOTE-010 is an open-label, randomized phase 2/3 trial assessing OS with two doses of KEYTRUDA (2 mg/kg or 10 mg/kg every three weeks) compared to docetaxel (75 mg/m2 every three weeks), a standard of care chemotherapy, in patients with any level of PD-L1 expression. KEYNOTE-001 is a multicenter, open-label multi-cohort, activity-estimating study evaluating ORR of KEYTRUDA (2 mg/kg or 10 mg/kg every three weeks).
- Keytruda is currently approved in the EU for the treatment of melanoma.
- A final decision by the European Commission usually takes ~60 days.
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%)
Mon, Jun. 20, 10:06 AM
- Enanta Pharmaceuticals (ENTA +2.5%) commences the proof-of-concept portion of its ongoing Phase 1 study evaluating EDP-494, a pan-genotypic cyclophilin inhibitor, in patients with hepatitis C virus (HCV) genotypes 1 or 3 infection. The double-blind, randomized phase will assess the safety, pharmacokinetics and anti-viral activity of two different oral doses of EDP-494 in treatment-naive HCV patients, administered once daily for 14 days.
- According to the company, there is increasing resistance to currently available direct-acting HCV antivirals (DAAs). EDP-494 avoids this problem via its unique mechanism of action, inhibiting a protein called cyclophilin which plays an essential role in HCV replication. EDP-494 is called a host-targeting antiviral which means that it targets the host proteins that are involved in the viral life cycle. Other HCV therapies are categorized as virus-targeting antivirals since they act directly on viral proteins. It says cyclophilin inhibitors may have the highest barrier to resistance of any class of HCV treatments.
- After the Phase 1 is completed, Enanta intends to develop EDP-494, in combination with one or more DAAs, for treatment-resistant HCV infection.
- HCV-related tickers: (GILD +1.6%)(JNJ +1.1%)(BMY +1%)(MRK +1%)(GSK +3.4%)(RGLS +0.7%)(ABBV +1.7%)
Thu, Jun. 16, 8:19 AM
- A 305-subject Phase 3 clinical trial, KEYNOTE-024, assessing Merck's (NYSE:MRK) PD-1 inhibitor, Breakthrough Therapy-tagged KEYTRUDA (pembrolizumab), for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) who tumors express high levels of PD-L1 met its primary endpoint. The study showed KEYTRUDA was superior to chemo as measured by progression-free survival (PFS) and overall survival (OS).
- Based on the positive results, the independent Data Monitoring Committee has recommended that the trial be stopped and the patients receiving chemo be offered the opportunity to switch to KEYTRUDA.
- The company intends to present the complete results at a future medical conference.
- Merck is currently advancing five late-stage studies evaluating KEYTRUDA in NSCLC as monotherapy and in combination.
Merck & Co., Inc. provides various health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products worldwide. It is a global research-driven pharmaceutical company that discovers, develops, manufactures and markets vaccines and... More
Industry: Drug Manufacturers - Major
Country: United States
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