Oct. 21, 2015, 4:41 PM
- Eli Lilly (NYSE:LLY) will report Q3 results tomorrow before the open. Consensus view is EPS of $0.75 (+14%) on revenues of $4.98B (+2%).
Oct. 19, 2015, 2:36 PM
- Eli Lilly (NYSE:LLY) declares $0.50/share quarterly dividend, in line with previous.
- Forward yield 2.51%
- Payable Dec. 10; for shareholders of record Nov. 13; ex-div Nov. 10.
Oct. 16, 2015, 12:32 PM
- Opko Health (OPK +2.5%) initiated with Overweight rating and $14 (47% upside) price target by JP Morgan.
- Jazz Pharmaceuticals (JAZZ +1.7%) initiated with Outperform rating and $200 (44% upside) price target by Northland Capital Markets.
- Mallinckrodt (MNK) initiated with Outperform rating and $92 (37% upside) price target by Northland Capital Markets.
- Shire (SHPG +1.1%) initiated with Outperform rating and $288 (38% upside) price target by Northland Capital Markets.
- Nabriva Therapeutics (NBRV +2.2%) initiated with Outperform rating and $19 (90% upside) price target by Leerink.
- Penumbra (PEN -0.2%) initiated with Buy rating and $48 (20% upside) price target by Canaccord Genuity.
- REGENXBIO (RGNX -3.6%) initiated with Overweight rating and $36 (100% upside) price target by Piper Jaffray.
- Dyax (DYAX -0.9%) upgraded to Outperform from Market Perform by Leerink. Price target raised to $36 (29% upside) from $25.
- Eli Lilly (LLY +1.5%) upgraded to Outperform from Neutral by Credit Suisse. Price target raised to $105 (30% upside) from $89.
- Athenahealth (ATHN -4.6%) downgraded to Underperform from Buy by Jefferies. Price target lowered to $105 (22% downside risk) from $125.
- Halyard Health (HYH -1.5%) downgraded to Underweight from Equal Weight by Morgan Stanley. Price target lowered to $27 (6% downside risk) from 38.
Oct. 14, 2015, 7:49 AM
- Top-line results from a Phase 3 clinical trial, RA-BEAM, showed that Eli Lilly (NYSE:LLY) and Incyte's (NASDAQ:INCY) orally administered baricitinib was superior to AbbVie's (NYSE:ABBV) injectable Humira (adalimumab) in improving symptoms in patients with rheumatoid arthritis (RA). RA-BEAM evaluated the safety and efficacy of baricitinib in RA patients who failed to respond to methotrexate therapy compared to placebo for 24 weeks or Humira for 52 weeks. More than 1,300 participants were randomized to receive either 4 mg oral baricitinib once-daily on background methotrexate, 40 mg injectable Humira every other week on background methotrexate or placebo on background methotrexate.
- The study met its primary endpoint a statistically significant proportion of patients achieving ACR20 (20% improvement in RA symptoms) at week 12 versus placebo. In addition, at week 24, baricitinib was superior to placebo in preventing progressive structural joint damage. The treatment benefits of baricitinib observed at weeks 12 and 24 were maintained through 52 weeks of therapy.
- More patients receiving baricitinib achieved ACR20 after 12 weeks of therapy as well as improved DAS28-hsCRPscore (measurement of disease activity and coronary risk) compared to Humira.
- Serious adverse events were comparable between placebo and baricitinib. The most common were nasopharyngitis and bronchitis.
- The results will be submitted for publication and presentation at future medical conferences in 2016.
- Baricitinib is a once-daily, orally administered, selective JAK1 and JAK2 inhibitor, enzymes that play key roles in a range of inflammatory diseases. It is being co-developed by Lilly and Incyte under an exclusive global license and collaboration agreement inked in December 2009.
Oct. 13, 2015, 7:42 AM
- Eli Lilly (NYSE:LLY) enters into a preclinical research collaboration with Inglewood, CA-based ImaginAb to study potential novel T cell-based immuno-oncology therapies. Under the terms of the partnership, ImaginAb will conduct preclinical research using its immune imaging agent, IAB22M2C (an anti-human CD8 probe) to detect T cell trafficking, redirection and infiltration in response to Lilly oncology molecules. ImaginAb retains full rights to its imaging agents used in the project.
- CD8-positive T cells, known as cytotoxic T cells, are associated with positive clinical response to anti-PD-1 therapy in melanoma. IAB22M2C is a PET-based imaging agent that detects CD8-positive T cells which will provide a whole-body picture of immune response. This will potentially enable better patient selection and well as a better understanding of the mechanisms of immune-modulating treatments.
- Financial terms are not disclosed.
Oct. 12, 2015, 1:14 PM
- The FDA removes its partial clinical hold of Biodel's (BIOD +3.5%) Phase 2b trial, called Study 3-250, comparing BIOD-531 to Eli Lilly's (LLY -8.1%) Humalog Mix 75/25 in type 2 diabetics who are taking insulin. The agency's action clears the use of the company's investigational U-400 syringes in the study.
- In addition, this quarter Biodel will commence a Phase 2a standardized meal challenge study and independent market analysis to determine if the patient populations and market segments form BIOD-531 can be expanded.
- The Phase 2a study will assess the hypothesis that treatment with BIOD-531 can reduce the injection burden and achieve glucose control at least as effective as that with separate basal and prandial injections in type 2 diabetics.
- The company will continue Study 3-250 to allow completion of patients currently enrolled but will suspend new patient recruitment until the results are in from the Phase 2a trial and market analysis early next year.
Oct. 12, 2015, 9:13 AM
Oct. 12, 2015, 8:38 AM
- Eli Lilly (NYSE:LLY) is down 10% premarket on robust volume in response to its announcement that it has terminated the development of evacetrapib for the treatment of high-risk atherosclerotic cardiovascular disease due to lack of efficacy. Its decision was based on a review by the independent data monitoring committee.
- The move will result in a Q4 charge to R&D expense of up to $90M ($0.05 per share after tax). The company will incorporate the change in its 2015 guidance that it will provide during its earnings call on October 22.
- SVP and President of Lilly Bio-Medicines David Ricks says, "We're obviously disappointed in this outcome, as we hoped the evacetrapib would offer an advance in treatment for people with high-risk cardiovascular disease. We'll be working with investigators to appropriately conclude these trials. We remain confident in our pipeline as we prepare for launches in other therapeutics areas with significant unmet needs."
- Related tickers and status premarket: (NASDAQ:REGN) +4%; (NASDAQ:AMGN) +3%; (NASDAQ:ESPR) +14%; (NYSE:SNY) +1%.
Oct. 12, 2015, 6:58 AM
- Eli Lilly (NYSE:LLY) and Suzhou, China-based Innovent Biologics broaden their drug development collaboration that was inked in March. Under the expanded agreement, the companies will work together on developing and commercializing up to three anti-PD-1-based bispecific antibodies for the treatment of cancer over the next decade, both inside and outside of China. Innovent will have the rights to develop, manufacture and commercialize the product candidates in China subject to a Lilly opt-in right for co-development and commercialization. Under the original agreement, Lilly had rights outside of China.
- Innovent is eligible to receive more than $1B in additional development, regulatory and commercial milestones both inside and outside of China. It is also eligible for sales-based royalties and other payments based on ex-China commercialization. Additional financial terms are not disclosed.
- Lilly will create the three anti-PD-1-based product candidates using an antibody sequence contributed by Innovent.
- Previously: Lilly inks drug development deal in China (March 20)
Oct. 9, 2015, 4:42 PM
- Eli Lilly (NYSE:LLY) acquires the global rights to an intranasal glucagon developed by privately-held Montreal-based Locemia Solutions. The product candidate, currently in Phase 3 development, is a potential needle-free rescue treatment for severe hypoglycemia in diabetic patients treated with insulin.
- It employs a proprietary glucagon nasal powder formulation that is delivered in an emergency situation via a single-use, ready-to-use device. The caregiver presses a small plunger on the bottom of the device to release the glucagon as a puff in the nose where it is absorbed in the nasal passages.
- Financial terms of the deal are not disclosed.
Oct. 9, 2015, 10:00 AM
- Thermo Fisher Scientific (TMO +0.3%) initiated with Buy rating and $145 (15% upside) price target by Argus.
- Fate Therapeutics (FATE +0.4%) initiated with Outperform rating and $8 (41% upside) price target by Raymond James.
- Ocata Therapeutics (OCAT +2.1%) initiated with Outperform rating and $8 (66% upside) price target by Raymond James.
- Eli Lilly (LLY +2.8%) upgraded to Outperform from Neutral by Credit Suisse. Price target raised to $105 (22% upside) from $89.
- Abbott Laboratories (ABT +1%) upgraded to Overweight from Equal Weight by Barclays. Price target lowered to $52 (26% upside) from $55.
- NuVasive (NUVA -1.6%) upgraded to Buy from Hold by Canaccord Genuity. Price target raised to $58 (16% upside) from $52.
- Amicus Therapeutics (FOLD +5.4%) upgraded to Buy from Neutral with an $8 (11% upside) price target by Chardan Capital.
- Bluebird bio (BLUE +1.5%) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target maintained at $143 (61% upside).
- Pfizer (PFE +0.5%) upgraded to Outperform from Equal Weight by Morgan Stanley. Price target raised to $38 (15% upside) from $35.
- Vertex Pharmaceuticals (VRTX +1.2%) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $148 (35% upside) from $118.
- Alexion Pharmaceuticals (ALXN -0.2%) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $211 (29% upside) from $186.
Oct. 8, 2015, 8:40 AM
- The FDA designates Eli Lilly's (NYSE:LLY) Phase 3-stage abemaciclib a Breakthrough Therapy for the treatment of refractory hormone-receptor-positive (HR+) advanced/metastatic breast cancer.
- Abemaciclib is a cyclin-dependent kinase (CDK) 4 and 6 inhibitor. CDKs play a key role in cell cycle progression. In cancer, uncontrolled cell growth arises from the loss of control in regulating the cell cycle due to increased signaling from CDK 4 and 6.
- Breakthrough Therapy status allows for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the NDA.
Sep. 29, 2015, 9:37 AM
- Top-line results from a Phase 3 study, RA-BEGIN, showed that baricitinib, a JAK inhibitor being co-developed by Eli Lilly (NYSE:LLY) and Incyte (NASDAQ:INCY) for the treatment of rheumatoid arthritis, was non-inferior to methotrexate as determined by ACR20 response (20% improvement in RA symptoms) rate after 24 weeks of treatment.
- The companies reported successful results in two earlier Phase 3s, RA-BEACON and RA-BUILD a few months ago. Top-line results from a fourth Phase 3, RA-BEAM are expected later this year.
- Previously: Baricitinib successful in second Phase 3 study in rheumatoid arthritis (Feb. 23)
Sep. 28, 2015, 4:34 PM
- After feedback from Japanese regulatory authorities that would have required additional clinical trials to support its marketing application there (and delayed commercialization for one year), Zosano Pharma (NASDAQ:ZSAN) decides to terminate its development of once-daily ZP-PTH for severe osteoporosis. After discussing the situation with collaboration partner Eli Lilly (NYSE:LLY), the companies agreed to end their partnership.
- Zosano will focus its development efforts on a once-weekly formulation of ZP-PTH, which was a project prior to its deal with Lilly for a daily version. The company plans to initiate a Phase 2 trial of the weekly version in H1 2016.
- ZP-PTH is a rapid delivery patch that is an alternative to daily injections. It delivers PTH1-34, teriparatide (PTH), a compound that stimulates the formation of new bone.
- The company will host a conference call today at 5:00 pm ET to discuss its plans.
- Shares are off 37% after hours but only on volume of 60 shares.
Sep. 28, 2015, 12:51 PM
- Results from a Phase 2 clinical trial assessing Eli Lilly's (LLY -4.8%) CYRAMZA (ramucirumab), in combination with docetaxel, in patients with locally advanced or metastatic urothelial carcinoma who failed prior platinum-based treatment showed a statistically significant improvement in median progression-free survival (PFS). The results were presented at the European Cancer Congress in Vienna, Austria.
- Participants in the three-arm 140-subject trial were randomized to receive either a combination of ramucirumab and docetaxel (n=46), docetaxel alone (n=45) or a combination of icrucumab and docetaxel (n=49). Therapy continued until disease progression or an elevation in toxicity levels that interrupted treatment.
- Median PFS in the three arms was 5.4 months, 2.8 months and 1.6 months, respectively (p<0.001). Objective response (complete or partial) rate (ORR) was 24%, 9% and 12%, respectively. The disease control (response + stable disease) rate (DCR) was 78%, 58% and 45%, respectively. The DCR results were also statistically significant. Overall survival (OS) also favored ramucirumab, but the trial was not powered for statistical validation.
- The incidence of serious adverse events in the ramucirumab arm was consistent with prior Phase 3 trials. The most common (at least grade 3) were fatigue (35%), febrile neutropenia (17%), pneumonia (13%), anemia (13%), sepsis (11%), edema (9%) and six others (7% each).
- A Phase 3 study, RANGE, is now underway.
- CYRAMZA, VEGF Receptor 2 antagonist, is currently cleared for the second-line treatment of gastric or gastro-esophageal junction adenocarcinoma, the second-line treatment of non-small cell lung cancer and the second-line treatment of colorectal cancer.
Sep. 28, 2015, 10:26 AM
- Eli Lilly (LLY -2.2%) and Sanofi (SNY -0.6%) resolve their patent dispute regarding Lilly's insulin glargine product, Basaglar, tentatively approved by the FDA in August 2014. The resolution, under which Sanofi grants Lilly a royalty-bearing license, will enable Lilly to sell Basaglar in the Kwikpen device globally and will also enable Lilly to launch the product in the U.S. on December 15, 2016 with alliance partner Boehringer Ingelheim. Lilly intends to request final clearance from the FDA as soon as feasible.
- Specific financial details of the settlement are not disclosed.