the company will issue its second quarter 2016 financial results for the period ended June 30, 2016, on Tuesday, August 9, 2016, after the market closes. Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results.
Conference Call Details
To access the live conference call via phone, please dial 844-831-4029 from the United States and Canada or 920-663-6278 internationally. The participant passcode is 60834344. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing 855-859-2056 from the United States and Canada or 404-537-3406 internationally. The replay passcode is 60834344.
Omeros' Lead MASP-3 Inhibitor OMS906 Demonstrates Blockade of the Alternative Pathway of Complement System
Date(s): 4-Aug-2016 7:00 AM
-- Shows Marked Efficacy in Model of Arthritis --
SEATTLE--(BUSINESS WIRE)--Aug. 4, 2016-- Omeros Corporation (NASDAQ: OMER) today announced results from its OMS906 complement program. OMS906 is Omeros' lead antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the protein activator of the alternative pathway of complement (APC). OMS906 significantly reduced both incidence and severity of disease in a well-established animal model of arthritis mediated by the APC.
In the animal model, induced by administration of auto-antibodies against mouse connective tissue, OMS906 reduced the incidence and severity of disease as measured by clinical arthritis scores in a dose-dependent fashion. Compared to control-treated animals, OMS906 reduced the incidence by 86 percent (p-value
•Omeros should report earnings next week.
•Omidria’s progress in Q2 will be the center of investor attention.
•Looking at growth scenarios for Omidria in Q2 and 2H 2016.
•Cash burn and the prospects of cash flow breakeven later this year are of utmost importance.
•The second quarter report could catalyze the stock substantially higher in the following months.
I believe the following is very good news for OMER ........ an expeditious path to eventual OMS721 approval in both the USA and Europe. And OMS721 promises to be an excellent revenue generator.
Omeros Corporation Confirms OMS721 Phase 3 Development Plan with European Medicines Agency
Date(s): 28-Jul-2016 9:28 AM
-- One Single-Arm, Open-Label Phase 3 Pivotal Trial Planned to Support Approval in Both Europe and the U.S. --
SEATTLE, July 28, 2016 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has received scientific advice from the European Medicines Agency (EMA) in connection with the company's OMS721 Phase 3 program for the treatment of atypical hemolytic uremic syndrome (aHUS). Based on this EMA advice, the company plans to run the same, single Phase 3 clinical program to support OMS721 marketing approval applications in both the U.S. and in the European Union for the treatment of aHUS. OMS721 is Omeros' lead human monoclonal antibody in its mannan-binding lectin-associated serine protease-2 (MASP-2) program for the treatment of thrombotic microangiopathies (TMAs), including aHUS and hematopoietic stem cell transplant-related (HSCT) TMAs, and for the treatment of complement-related renal diseases. Omeros plans to commercialize OMS721 initially for administration as a subcutaneous injection.
The company met with the EMA's Scientific Advice Working Party earlier this month to discuss the requirements for a successful European Marketing Authorization Application (MAA) for OMS721 in the treatment of aHUS. The advice provided to Omeros by the EMA is generally consistent with that received from the U.S. Food and Drug Administration (FDA) earlier this year and will allow Omeros to submit applications for approval in the U.S. and in the European Union based on a single data set
(more info in the whole news release)
Date(s): 7-Jul-2016 7:00 AM
SEATTLE--(BUSINESS WIRE)--Jul. 7, 2016-- Omeros Corporation (NASDAQ:OMER), a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system, today announced that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the Cantor Fitzgerald 2nd Annual Healthcare Conference in New York next week. The presentation is scheduled for Tuesday, July 12, 2016 at 10:45 a.m. EDT.
The presentation will be webcast. The live and archived webcasts can be accessed on the "Events" page of the company's website Omeros dot com.
Brian Feroldi: Omeros is an underdog stock that I've followed for some time with great interest: It stands a real chance of wreaking havoc on the business model of Alexion Pharmaceuticals, a biotech giant that I'm quite fond of.
Right now Alexion Pharmaceuticals' best selling drug is Soliris, which is approved to treat two ultrarare diseases: paroxysmal nocturnal hemoglobinuria, or PNH, and atypical hemolytic uremic syndrome, or aHUS. Soliris is currently the only drug on the market that treats either of these diseases, and since they are both orphan indications, Alexion yields enormouspricing power. Soliris' list price tops $537,000 per year in the U.S., and worldwide sales of the drug are expected to top $2.8 billion in 2016.
A market that massive is bound to create competition, which is where Omeros comes into the picture. Omeros' most exciting product candidate is OMS721, which the company is studying as a potential treatment for aHUS. The drug has already performed well in early clinical trials, and right now it is starting Phase 3. While it's hard to handicap its chances of regulatory success, OMS721 already has both orphan-drug designation and fast-track status. To me, that hints that it has a better-than-average chance of finding its way to market.
That fact should concern Alexion Pharmaceuticals investors, since Omeros could start a price war if OMS721 does win approval. If that happens, it would greatly hinder Alexion's growth prospects, which would certainly do bad things to its lofty stock price.
It's worth pointing out that Alexion is aware of the potential threat, and it's studying Soliris for uses beyond PHN and aHUS. If those go well, they could help to soften the blow if OMS721 does eventually find its way to market.
Still, Omeros stands a chance of being a real thorn in Alexion's side if things go according to plan, which is why it is one underdog stock that I plan on watching like a hawk.