Fri, May 20, 9:17 AM
- Johnson & Johnson (NYSE:JNJ) closes an underwriting agreement with a lineup of big banks for €4B aggregate principal amount of debt in four tranches:
- €1B aggregate principal amount of 0.250% Notes due 2022; €750M aggregate principal amount of 0.650% Notes due 2024; €750M aggregate principal amount of 1.150% Notes due 2028 and €1.5B aggregate principal amount of 1.650% Notes due 2035.
Thu, May 19, 3:38 PM
- IPO Merus B.V. (Pending:MRUS) is holding its ground on its debut day. Shares are up 5% from the issue price of $10 on modest turnover of 868K shares.
- The Netherlands-based company develops immuno-oncology-focused bispecific antibody therapeutics based on its technology platform called Biclonics. A bispecific antibody has the ability to bind to two or more targets simultaneously. Its lead product candidate is MCLA-128, in Phase 1/2 development in Europe for the treatment of various solid tumors, including breast, colorectal and ovarian cancers. Other pipeline candidates are MCLA-117 for blood cancers, MCLA-158 for colorectal cancer, MCLA-134 for solid tumors and MCLA-145 for solid tumors.
- 2015 Financials (€M): Revenue: 2.0 (+51.7%); Operating Expenses: 25.0 (+33.7%); Net Loss: (23.2) (-33.2%); CF Ops: (23.0) (-57.9%).
- Related tickers: (AMGN -1.5%)(MGNX +1.2%)(JNJ -0.7%)(AFMD +0.3%)(PIRS -7%)(OTC:GNMSF)
Wed, May 18, 3:50 PM
- Thinly traded micro cap MacroGenics (MGNX +16.5%) is up on more than triple normal volume in response to its announcement of a collaboration and license deal with Janssen Biotech (JNJ -0.3%) to develop and commercialize MGD015, a preclinical bispecific molecule based on its proprietary Dual-Affinity Re-Targeting (DART) technology, for the treatment of range of blood cancers and solid tumors.
- Under the terms of the agreement, MacroGenics will receive an upfront license fee of $75M, up to $665M in milestones and double-digit royalties on global net sales. It also has the option to co-promote MGD015 with Janssen in the U.S. and may choose to fund a portion of late-stage development in exchange for a share of the profits in the U.S. and Canada. Janssen will be responsible for completing IND-enabling activities and future clinical development.
- The collaboration builds on Janssen's experience with MGD011, a DART molecule targeting CD19 and CD3.
- MGD015 is designed to redirect T cells, via their CD3 component, to eliminate cells that overexpress an undisclosed antigen in various blood cancers and solid tumors. It is manufactured using a conventional antibody platform which avoids the complexity inherent in patient-specific approaches like chimeric antigen receptor T-cells (CAR-T).
- The DART platform enables the creation of molecules that simultaneously bind to two or more targets. According to the company, a 2011 study showed DART molecules were consistently more potent in eliminating CD19-positive cells than a competing platform, bispecific T cell engager (BiTE), commercialized by Amgen (AMGN +0.3%) via Blincyto (blinatumomab).
- Previously: MacroGenics teams up with Janssen in blood cancer (Dec. 22, 2014)
- Previously: Amgen collaborates with leading cancer center on BiTE technology (Jan. 12, 2015)
Tue, May 17, 11:09 AM
- HP Inc.'s (HPQ +0.6%) first 3D printers will be known as the Jet Fusion 3D 4200 and 3200. As the company claimed in 2014, the industrial-class printers are said to print objects 10x as fast as current hardware. HP also claims they'll do so at half the cost, and - thanks to HP's proprietary Multi Jet Fusion inkjet printing process - give customers "an unprecedented ability to transform part properties and deliver mass customization."
- Initial partners for the printers include Nike, BMW, Johnson & Johnson (NYSE:JNJ), contract manufacturer Jabil. CAD/CAM software firm Autodesk, industrial prototyping firm Proto Labs (PRLB +0.6%), and 3D printing software/services firm Materialise (MTLS +1%). Proto Labs will provide a product testing site for HP's printers, and Materialise's Magics 3D Print Suite will be compatible with them.
- J&J, meanwhile, will be collaborating with HP on using 3D printing to create personalize health care offerings. In the near-term, the companies will work on the "personalization of instrumentation and software for patient-specific healthcare devices."
- The 4200 will be delivered in late 2016, and the 3200 in 2017. Pricing for the 3200 starts at $130K (no word yet for the 4200). Long-term HP wants to offer 3D printers capable of embedding sensors and including "embedded information" such as invisible traces or codes.
- HP is hoping its entry into the growing 3D printing market will boost a printing unit that saw revenue drop 17% Y/Y in the January quarter to $4.64B. 3D Systems (DDD +3.2%) and Stratasys (SSYS +4.2%), two of the biggest players in the industrial 3D printing market, are trading higher. They sold off in 2014 when HP first unveiled Multi Jet Fusion.
Tue, May 17, 3:02 AM
- The U.S. Supreme Court has backed out of a divisive clash involving religious groups that object to mandatory contraceptive coverage under Obamacare, issuing a compromise that said the two sides might be able to work out their differences.
- With four conservative justices and four liberals, the judges sent the case back to the lower courts, but suggested the government arrange coverage directly with health insurers rather than requiring employers to sign off on it.
- Related tickers: PFE, MRK, JNJ, TEVA, CHD, OTCPK:BAYRY
Fri, May 13, 5:56 PM
- Johnson & Johnson (NYSE:JNJ) finished with a modest loss after BTIG Research downgraded shares to Neutral from Buy, citing decreased confidence that it will be able to execute a transformational medical device acquisition given recent stock appreciation in the group.
- JNJ has enjoyed positive results from the over-the-counter drug market and oncology drugs, and a cardiovascular medical device could have helped the company diversify, but BTIG believes as companies such as Edwards Lifesciences (NYSE:EW) have grown, it has become less likely that JNJ can afford a large, money-making acquisition.
- JNJ is up nearly 11% YTD, while EW is more than 30% higher.
Fri, May 13, 11:51 AM
- ConforMIS (CFMS -51%) downgraded to Neutral from Overweight by JP Morgan. Price target lowered to $8 (62% upside) from $18.
- Johnson & Johnson (JNJ -0.5%) downgraded to Neutral from Buy by BTIG Research.
- EPIRUS Biopharmaceuticals (EPRS +2.2%) downgraded to Neutral from Buy by BTIG Research.
- BioDelivery Sciences (BDSI -1%) downgraded to Hold from Buy by Canto Fitzgerald. Price target lowered to $5 (150% upside) from $9.
- NewLink Genetics (NLNK +7.6%) downgraded to Neutral from Buy by SunTrust Robinson Humphrey. Price target lowered to $12 (15% upside) from $59.
- St. Jude Medical (STJ +0.3%) downgraded to Equal Weight from Overweight by Barclays. Price target raised to $80 (5% upside) from $74.
- Zoetis (ZTS +0.3%) downgraded to Sell from Neutral by Goldman Sachs. Price target raised to $48 (4% upside) from $46.
- Cogentix Medical (CGNT +9.1%) downgraded to Neutral from Buy by Roth Capital. Price target is $1.15 (25% upside).
Wed, May 11, 7:55 AM
- Janssen Pharmaceuticals' (NYSE:JNJ) Janssen Research & Development, LLC initiates a Phase 2b clinical trial assessing the safety, pharmacokinetics and efficacy of different regimens of AL-335, odalasvir and simeprevir in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) genotype 1-6 infection, with and without cirrhosis.
- The global, open-label, four-arm study will randomize ~400 subjects to receive once-daily treatment for six or eight weeks. Participants in two of the four arms will be treated with the combination of AL-335, odalasvir and simeprevir while those in the other two arms will receive only AL-335 and odalasvir. The primary endpoint is the percentage cure rate as determined by SVR12. The trial should start next month and end in July 2017.
- AL-335 is a uridine-based nucleoside NS5B polymerase inhibitor being developed by Janssen unit Alios BioPharma. Odalasvir (formerly ACH-3102) is an NS5A inhibitor discovered by Achillion Pharmaceuticals (NASDAQ:ACHN). Simeprevir, a NS3/4A protease inhibitor, is currently marketed by Janssen as Olysio.
Wed, May 11, 4:51 AM
- The U.S. Attorney's Office for the Southern District of New York is investigating contracts between drugmakers and pharmacy benefit managers.
- Federal prosecutors have approached at least three companies, including Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK) and Endo International (NASDAQ:ENDP).
- When drugs are knocked off their formularies, patients may have to pay full price for them. PBMs often keep or dump a product depending on whether they can obtain favorable pricing.
Mon, May 9, 4:57 PM
- Thinly traded nano cap EPIRUS Biopharmaceuticals (NASDAQ:EPRS) reprioritizes its pipeline, suspending development of lead product candidate BOW015, a biosimilar to J&J's (NYSE:JNJ) Remicade (infliximab), to focus on developing biosimilars for the treatment of rare diseases. For example, the company will allocate additional resources to advance BOW080, a biosimilar candidate to Alexion Pharmaceuticals' (NASDAQ:ALXN) Soliris (eculizumab), currently approved in the U.S. for the treatment of orphan diseases paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, and BOW070, a biosimilar candidate to Roche's (OTCQX:RHHBY) Actemra (tocilizumab) for the treatment of a rare lymphoproliferative disorder called Castleman's disease.
- The company intends to rationalize the BOW015 program including possible partnerships, divestitures or other alternatives.
- The reallocation of resources will include a workforce reduction of up to 40%. Concurrently, President & CEO Amit Munshi has stepped down, replaced by board member Scott Rocklage, Ph.D., former CEO of Cubist Pharmaceuticals.
Mon, May 2, 8:33 PM
- After a three-week trial in Missouri, Johnson & Johnson (NYSE:JNJ) has been ordered to pay $55M to a woman who said using the company's talc products caused her to contract ovarian cancer.
- The same court had ruled against Johnson & Johnson in a similar case in February, ordering it to pay $72M at that time ($62M of that in punitive damages).
- J&J faces about 1,200 lawsuits charging it with not adequately warning about cancer risks in using the products, which include Baby Powder and Shower to Shower Powder, for feminine hygiene.
- The company is appealing the earlier verdict. Talc litigation is concentrated in Missouri and New Jersey state courts.
- Now read Johnson & Johnson's Consumer Health Problems »
Mon, May 2, 7:55 AM
- April monthly performance was: +0.42%
- $0.19 in dividends were paid in April
- Top 10 Holdings as of 3/31/2016: Exxon Mobil Corporation (XOM): 3.51%, AT&T Inc (T): 3.5%, Microsoft Corp (MSFT): 3.01%, Apple Inc (AAPL): 2.86%, Verizon Communications Inc (VZ): 2.85%, General Electric Co (GE): 2.34%, Chevron Corp (CVX): 2.27%, Johnson & Johnson (JNJ): 2.27%, Procter & Gamble Co (PG): 1.95%, Wal-Mart Stores Inc (WMT): 1.85%
Fri, Apr. 29, 8:13 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of IMBRUVICA (ibrutinib) as a single agent for the treatment of adults with previously untreated chronic lymphocytic leukemia (CLL).
- IMBRUVICA is currently approved for the treatment of adult CLL patients who have received at least one prior line of therapy or first-line if they have the genetic mutations 17p deletion or TP53 and are unsuitable for chemo, adults with relapsed/refractory mantle cell lymphoma and adults with Waldenstrom's macroglobulinemia.
- A final decision from the European Commission usually takes ~60 days.
- IMBRUVICA is marketed in the EU by Janssen-Cilag International NV (NYSE:JNJ).
- The FDA approved the expanded use last month.
Thu, Apr. 28, 10:38 AM
Tue, Apr. 26, 4:21 PM| Tue, Apr. 26, 4:21 PM | 6 Comments
Tue, Apr. 26, 11:56 AM
- China's Center for Drug Evaluation puts hepatitis C candidates on an accelerated review track with the aim of finally granting access to the drugs for its ~13M HCV-positive citizens. China was not part of the large-scale licensing effort by Gilead Sciences (GILD -0.9%) in 2015 which enabled a number of generics firms to manufacture and distribute Sovaldi (sofosbuvir) to certain emerging markets at a heavily discounted price. AbbVie (ABBV -0.3%), Merck (MRK -0.4%) and Bristol-Myers Squibb (BMY -0.2%) followed with licensing deals with The Medicines Patent Pool for African countries.
- Bristol-Myers, AbbVie, Johnson & Johnson (JNJ -0.6%) (via a joint venture called Xian Janssen) and Chinese firm Ascletis Pharmaceuticals all have submissions under review. No word on Gilead's application status is provided.
Johnson & Johnson operates as an investment holding company with interests in health care products. It engages in research and development, manufacture and sale of personal care hygienic products, pharmaceuticals and surgical equipment. The company, through its subsidiaries operates in three... More
Industry: Drug Manufacturers - Major
Country: United States
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