Fri, Apr. 29, 4:54 PM
- Cranbury, NJ-based Oncobiologics (Pending:ONS) is set for its IPO of 5M shares of common stock at $11 - 13.
- The clinical-stage biopharmaceutical firm develops biosimilars in immunology and oncology based on its proprietary BioSymphony Platform. Its most advanced candidates are ONS-3010, a biosimilar of AbbVie's (NYSE:ABBV) Humira (adalimumab) and ONS-1045, a biosimilar of Roche's (OTCQX:RHHBY) Avastin (bevacizumab). According to the company, both are Phase 3-ready.
- Other pipeline candidates are ONS-4010 [biosimilar of Amgen's (NASDAQ:AMGN) Prolia/Xgeva (denosumab)], ONS-1055 [biosimilar of Eli Lilly's (NYSE:LLY) Erbitux (cetuximab)] and ONS-3030 [biosimilar of Roche's Actemra/Roactemra (tocilizumab)].
- 2015 Financials ($M): Collaboration Revenue: 5.2 (-42.9%); Operating Expenses: 51.8 (+142.1%); Net Loss: (53.0) (-156.0%); Cash Burn: (27.5) (-292.9%).
Tue, Apr. 26, 9:57 AM
- Transition Therapeutics (TTHI +7%) announces that the first patient has been dosed in its 125-subject Phase 2 clinical trial assessing TT701 for the treatment of symptoms of androgen deficiency in men with prostate cancer who have undergone radical prostatectomy for organ-localized prostate cancer.
- The company acquired global exclusive rights to TT701, an androgen receptor modulator, from Eli Lilly (LLY -0.3%) in May 2015. The dosing of the first patient triggered a $500K milestone payment to Lilly.
- Previously: Transition Therapeutics licenses androgen receptor modulator from Lilly (May 6, 2015)
Tue, Apr. 26, 7:07 AM
- Eli Lilly (NYSE:LLY) Q1 results ($M): Total Revenues: 4,865.1 (+4.7%); Animal Health: 754.6 (+0.6%).
- Net Income: 440.1 (-16.9%); Non-GAAP Net Income: 882.3 (-4.5%); EPS: 0.41 (-18.0%); Non-GAAP EPS: 0.83 (-4.6%).
- Key Product Sales: Humalog: 606.3 (-11.4%); Cialis: 576.7 (+7.1%); Alimta: 564.2 (-1.5%); Humulin: 356.4 (+12.9%); Forteo: 318.6 (+8.7%); Zyprexa: 212.8 (-3.1%); Cymbalta: 198.7 (-30.8%); Trulicity: 143.6 (+684.7%); Effient: 131.5 (+8.0%); Cyramza: 131.0 (+94.1%).
- 2016 Guidance: Revenues: $20.6B - 21.1B from $20.2B - 20.7B; EPS: $2.68 - 2.78 from $2.83 - 2.93: Non-GAAP EPS: $3.50 - 3.60 from $3.45 - 3.55.
Tue, Apr. 26, 6:26 AM
Mon, Apr. 25, 5:30 PM
- ABG, ABX, AHGP, AIXG, AKS, ALLY, ARLP, ATI, AVX, AXE, BAX, BEAV, BLMN, BP, CNC, CNX, COH, CPLA, CRS, CTG, CYNO, DD, DFRG, DTE, ENTG, ETR, FBC, FCAU, FCH, FCX, FLIR, FLWS, FMER, GLPI, GLW, GPK, HSY, HUBB, HZO, ICLR, IIVI, IR, JBLU, JNS, LLY, LMT, LPT, MAS, MDXG, MHFI, MMM, NCI, ODP, PAG, PCAR, PCH, PG, PH, PNR, POL, R, RAI, SAH, SAVE, SCL, SIR, SPG, ST, SUI, SVU, TEN, TMUS, TRI, TROW, WAB, WAT, WDR, WHR, WYN
Mon, Apr. 25, 5:23 PM
- Aratana Therapeutics (NASDAQ:PETX) licenses the rights to develop, manufacture, market and commercialize grapiprant products, including Galliprant, to Eli Lilly's (NYSE:LLY) Elanco Animal Health Division. Elanco will have exclusive rights ex-U.S. and co-exclusive rights with Aratana in the U.S.
- Under the terms of the agreement, Aratana will receive an upfront payment of $45M, a $4M milestone related to Galliprant's approval in Europe, a $4M milestone related to the manufacturing of Galliprant, up to $75M in sales-based milestones and mid-single-digit to low-double-digit royalties.
- Shares are up 16% after hours on robust volume.
Wed, Apr. 20, 11:18 AM
- According to Leerink's Geoff Porges, drug makers appear to be taking little heed to politicians' outcries over high prices. In a research note, he says, "The price increases for established brands across our coverage have been substantial indeed. To the surprise of many investors, it now appears these price increases are likely to flow through to actual sales growth, with such growth more than offsetting any volume weakness in Q1 and resulting in significant positive revenue surprises for those companies when they report Q1 results."
- He cites Johnson & Johnson's (JNJ +0.8%) Q1 results released yesterday. Its total business was flat (+0.6%) but its pharmaceuticals unit was up 12.9%. His analysis showed as much as 90% of the list price increases are flowing through to reported sales, some as high as 100%.
- Over the past year, Amgen (AMGN +0.7%) increased its drug prices 8 - 28%, Gilead Sciences (GILD +0.9%) 10 - 18% for its HIV drugs and Biogen (BIIB -1.6%) 10 - 18%, according to Mr. Porges.
- Biogen reports tomorrow. Eli Lilly (LLY -0.3%), Baxalta (BXLT -1.4%), AbbVie (ABBV +0.9%), Celgene (CELG +0.4%), Bristol-Myers Sqibb (BMY +0.3%) and Shire (SHPG -1.6%) report next week. Pfizer (PFE +1%) and Merck (MRK -0.2%) report the week after. Amgen (AMGN +0.7%) is due to report shortly as is Gilead.
Tue, Apr. 19, 8:33 AM
- Eli Lilly (NYSE:LLY) and co-developer Boehringer Ingelheim announce plans to conduct two outcomes studies assessing diabetes med Jardiance (empagliflozin) for the treatment patients with chronic heart failure. The trials should commence within the next 12 months and will enroll participants with and without type 2 diabetes (T2D).
- Jardiance was the first diabetes drug to show a reduction in the risk of cardiovascular (CV) death in a dedicated CV outcomes trial. The study, EMPA-REG OUTCOME, demonstrated that treatment with Jardiance plus standard of care reduced CV death by 38% and reduced the risk of hospitalization for heart failure in T2D patients at high risk of CV events.
- Lilly's supplemental New Drug Application (sNDA) seeking approval of a CV reduction claim for Jardiance is currently under FDA review.
- Read now Eli Lilly: Regulatory Risk Is A Factor
Mon, Apr. 18, 7:17 AM
- Eli Lilly (NYSE:LLY) informs Transition Therapeutics (NASDAQ:TTHI) that will not advance TT401 into Phase 3 development. Under the terms of their collaboration agreement, all rights to the diabetes product candidate will be transferred back to Transition. Lilly will be eligible to receive a royalty on future TT401 sales and a royalty of on non-royalty income. The royalty that Transition is eligible to receive on sales of related Lilly compounds remains in place.
- A recently completed Phase 2 study in 420 type 2 diabetics who received the highest dose of TT401 administered once per week showed superior weight loss compared to currently available extended-release exenatide [AstraZeneca's (NYSE:AZN) Bydureon] and placebo after 12 and 24 weeks of treatment. It also showed similar HbA1c reduction as exenatide over the same treatment periods.
- TT401 is an oxyntomodulin analog with a dual mechanism of action on the GLP1 and Glucagon receptors, similar to Lilly's Trulicity (dulaglutide). Lilly opted out because TT401 did not demonstrate a significant advantage in lowering HbA1c.
- Previously: Transition's type 2 diabetes candidate shows positive results in mid-stage study but shares slump 32% on risk that Lilly will back out of development (Feb. 1)
Mon, Apr. 11, 8:24 AM
- Can-Fite BioPharma (NYSEMKT:CANF) announces that its candidate for the treatment of erectile dysfunction (ED), CF602, showed statistically significant full recovery one hour after a single 500 u/kg dose in a preclinical diabetic rat model.
- According to the company, CF602's novel mechanism of action may provide a treatment benefit to patients who do not respond adequately to PDE5 inhibitors [Pfizer's (NYSE:PFE) Viagra (sildenafil citrate), Eli Lilly's (NYSE:LLY) Cialis (tadalafil), Bayer (OTCPK:BAYRY) and GlaxoSmithKline's (NYSE:GSK) Levitra (vardenafil HCl)].
- Last October, the company announced the results from a preclinical study that showed CF602 restored the impaired vascular endothelial growth factor system in the penises of diabetic rats which induced an increase in nitric oxide which resulted in improved penile erection compared to placebo. Its unique mechanism of action is apparently similar to Viagra.
- The company intends to file an Investigational New Drug (IND) with the FDA in Q4.
- Shares are up 7% premarket on increased volume.
- Previously: Can-Fite's CF602 shows Viagra-like action in diabetic rats; shares up 10% premarket (Oct. 22, 2015)
Fri, Apr. 8, 11:05 AM
- MacroGenics (MGNX +3.1%) initiated with Buy rating and $35 price target by BTIG Research.
- Viking Therapeutics (VKTX -39.4%) initiated with Buy rating and $6 price target by H.C. Wainwright.
- Pfizer (PFE -0.3%) initiated with an Overweight rating and $38 price target by JP Morgan.
- Medivation (MDVN -0.1%) initiated with Buy rating and $56 price target by SunTrust Robinson Humphrey.
- Eyegate Pharmaceuticals (EYEG +6.5%) initiated with Buy rating and $10 price target by Noble Financial.
- Eiger Biopharmaceuticals (EIGR +0.5%) initiated with Buy rating and $35 price target by Jefferies.
- Vertex Pharmaceuticals (VRTX +0.3%) initiated with Market Perform rating and a $90 price target by BMO Capital.
- SocGen has been busy with initiations on six large cap pharmas: Buy: Merck (MRK +0.1%); Hold: Johnson & Johnson (JNJ -0.4%), Eli Lilly (LLY -0.3%) and Pfizer; Sell: Bristol-Myers Squibb (BMY -0.4%) and AbbVie (ABBV -0.9%).
- Tokai Pharmaceuticals (TKAI -6.7%) initiated with Buy rating and $16 price target by Bank of America. Initiated with Buy rating by Janney Capital.
- Cellectis (CLLS -0.1%) initiated with Buy rating and $45 price target by Ladenburg Thalmann.
- Novartis (NVS +0.5%) initiated with Hold rating by Argus Research.
- TherapeuticsMD (TXMD) initiated with Buy rating and $10 price target by Goldman Sachs.
- Protalix (PLX -4.2%) initiated with Buy rating and $3.50 price target by Rodman & Renshaw.
- Raptor Pharmaceuticals (RPTP -0.4%) upgraded to Outperform from Market Perform by JMP Securities.
- Ironwood Pharmaceuticals (IRWD -0.6%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $16 from $12.
- Intercept Pharmaceuticals (ICPT -6%) upgraded to Outperform from Market Perform by Wells Fargo.
- Edwards Lifesciences (EW -0.1%) upgraded to Buy from Neutral with $115 price target by BTIG Research.
- Express Scripts (ESRX +0.7%) upgraded to Outperform from Market Perform by Cowen & Company. Price target raised to $80 from $76.
- BIND Therapeutics (BIND -7%) downgraded to Market Perform from Outperform by Cowen & Company.
- Allergan (AGN -0.5%) downgraded to Neutral from Buy by Mizuho Securities. Downgraded to Neutral from Positive by Susquehanna. Price target lowered to $275 from $345.
- Bruker (BRKR +0.2%) downgraded to Market Perform from Outperform by Leerink Swann. Price target is $27.
Fri, Apr. 8, 7:58 AM
- Based on an interim safety analysis by the independent Data Monitoring Committee, the Phase 2/3 study, AMARANTH, assessing AZD3293 (LY3314814) for the treatment of early Alzheimer's disease (AD) will advance to Phase 3 without modification. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint, the change in Clinical Dementia Rating at week 104, is August 2019. The estimated study completion date is August 2021.
- AZD3293 (LY3314814), an inhibitor of an enzyme called BACE (beta secretase cleaving enzyme), is being co-developed and will be co-commercialized by Eli Lilly (NYSE:LLY) and AstraZeneca (NYSE:AZN) under their 2014 strategic alliance. Lilly leads clinical development, assisted by AstraZeneca's Neuroscience Research and Development Team, while AstraZeneca will be responsible for manufacturing. Both firms will commercialize and will equally share future costs for development and commercialization as well as net revenues after launch. The advancement of AMARANTH to Phase 3 triggers a $100M milestone payment to AstraZeneca from Lilly.
- BACE is an enzyme associated with the development of amyloid beta. Inhibiting its action is expected to prevent the formation of amyloid plaque and eventually slow the progression of AD.
- A new Phase 3 study, DAYBREAK, assessing AZD3293/LY3314814 in patients with mild AD should commence in Q3.
Mon, Apr. 4, 7:32 AM
- March monthly performance was: +6.31%
- 52-week performance vs. the S&P 500 is: -1%
- $0.07 in dividends were paid in March
- Top 10 Holdings as of 12/31/2015: General Mills Inc (GIS): 3.41%, Coca-Cola Co (KO): 2.73%, Campbell Soup Co (CPB): 2.68%, AT&T Inc (T): 2.57%, Heineken NV (OTCQX:HINKF): 2.37%, The Kraft Heinz Co (KHC): 1.98%, Eli Lilly and Co (LLY): 1.9%, Exelon Corp (EXC): 1.88%, Walgreens Boots Alliance Inc (WBA): 1.87%, PPL Corp (PPL): 1.82%
Thu, Mar. 31, 7:52 AM
- A 527-subject Phase 3 clinical trial, RA-BEACON, assessing once-daily oral baricitinib for the treatment of moderate-to-severe rheumatoid arthritis (RA), met its primary endpoint of improved ACR 20 response (20% improvement in RA symptoms) compared to placebo at week 12. The results were published today in the New England Journal of Medicine.
- The ACR 20 response rates were 55% for baricitinib 4 mg, 49% for baricitinib 2 mg and 27% for placebo (p <= 0.001).
- Baricitinib inhibits JAK1 and JAK2, enzymes that play key roles in a range of inflammatory diseases. It is being co-developed by Eli Lilly (NYSE:LLY) and Incyte (NASDAQ:INCY) under an exclusive global license and collaboration agreement inked in December 2009. RA-BEACON is the second of four late-stage studies demonstrating the effectiveness of baricitinib. The NDA, submitted by Lilly in January, is currently under FDA review.
- Previously: Lilly files baricitinib NDA for rheumatoid arthritis triggering $35M milestone to co-developer Incyte (Jan. 19)
Tue, Mar. 22, 4:14 PM
- The FDA approves Eli Lilly's (NYSE:LLY) ixekizumab, branded as Taltz, for the treatment of adults with moderate-to-severe plaque psoriasis.
- Approval in Europe should happen in the next month. CHMP adopted a positive opinion recommending approval in late February.
- Ixekizumab is a monoclonal antibody that binds to interleukin-17A, a pro-inflammatory cytokine produced by the immune system's T cells. In psoriasis, IL-17A plays a major role in the excess proliferation and activation of skin cells.
Mon, Mar. 21, 7:20 AM
- Amgen (NASDAQ:AMGN) and co-developer UCB (OTCPK:UCBJF)(OTCPK:UCBJY) announce that the Phase 3 study, BRIDGE, assessing romosozumab in men with osteoporosis met its primary endpoint of a statistically significant increase in bone mineral density (BMD) at the lumbar spine compared to placebo at month 12.
- All secondary endpoints were also met. Subjects receiving romosozumab showed statistically valid increases in BMD at the femoral neck and total hip at month 12 and statistically valid increases in BMD at the lumbar spine, femoral neck and total hip at month 6, both versus placebo.
- The study enrolled 245 men who were randomized 2:1 to receive either a monthly subcutaneous injection of romosozumab (210 mg) or placebo for 12 months.
- The incidence of adverse events was comparable between the arms. The most frequent (>5%) were nasopharyngitis, back pain, hypertension, headache and constipation. Injection site reactions were reported in 5.5% of patients in the romosozumab cohort compared to 3.7% in the placebo group. Most were mild in severity. The incidence of confirmed cardiovascular (CV) serious adverse events (SAEs) was 4.9% (n=8/163) for romosozumab and 2.5% (n=2/81) for placebo. Both arms had one confirmed CV death.
- The results will be submitted for presentation at a future medical conference. The companies intend to discuss the data with global regulators.
- Romosozumab is a monoclonal antibody that inhibits sclerostin, a protein that has anti-anabolic effects on bone formation. It has a dual effect of increasing bone formation and decreasing bone breakdown.
- Related ticker: (NASDAQ:RDUS)(NYSE:LLY)
Eli Lilly & Co. discovers, develops, manufactures and sells pharmaceutical products. The company operates through the following business segments: Human Pharmaceutical Products and Animal Health. The Human Pharmaceutical products segment includes the discovery, development, manufacturing,... More
Industry: Drug Manufacturers - Major
Country: United States
Other News & PR