|Over a week ago|
Omeros, Quantom Leap announce first patients dosed in I-SPY COVID-19 trial » 08:4803/2303/23/21
Omeros Corporation and…
Omeros Corporation and Quantum Leap Healthcare Collaborative announced that dosing of patients with narsoplimab in the I-SPY COVID-19 Trial began earlier this month. The I-SPY COVID-19 Trial is an adaptive platform trial sponsored by Quantum Leap Healthcare Collaborative. The goal of the trial is to screen rapidly, in parallel, multiple promising agents in order to identify drugs that will have a high impact on reducing mortality and avoid or reduce the duration of mechanical ventilation for critically ill COVID-19 patients.
|Over a month ago|
Omeros reports Q4 EPS (60c), consensus (64c) » 16:0603/0103/01/21
Reports Q4 revenue…
Reports Q4 revenue $10.6M, consensus $14.91M. At December 31, 2020, the company had cash, cash equivalents and short-term investments available for operations of $135.0 million.
Omeros initiated with a Buy at UBS » 07:4602/0102/01/21
UBS analyst Colin Bristow…
UBS analyst Colin Bristow initiated coverage of Omeros with a Buy rating and $25 price target. The company's Narsoplimab is the "central tenet" of the bullish thesis as the only drug to target the lectin pathway, which should allow for differentiation vs. other complement inhibitors, the analyst tells investors in a research note. Bristow adds that the market is underappreciating this asset, specifically its potential in IgA nephropathy.
Omeros hires Nadia Dac as Chief Commercial Officer » 08:4801/2601/26/21
Omeros announced that…
Omeros announced that Nadia Dac has joined Omeros as its Chief Commercial Officer. In this role, Ms. Dac will be responsible for all commercial operations at Omeros, including overseeing preparations for the commercial launch of narsoplimab, the company's mannan-binding lectin-associated serine protease-2, MASP-2, inhibitor. A Biologics License Application for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy is under Priority Review by U.S. Food and Drug Administration. Ms. Dac will also be responsible for driving continued sales growth of Omeros' commercial product OMIDRIA(, the only drug of its kind approved for use during cataract and lens replacement surgery. "We're pleased that Nadia has joined our senior leadership team," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Nadia has already hit the ground running, and her high-caliber expertise is a welcome and timely addition at this important juncture in our company's development. The breadth and depth of her U.S. and global commercial experience as a strategic leader will be a valuable asset to Omeros as we look ahead to bringing our second product to market and advancing our diverse pipeline."
Omeros price target raised to $34 from $31 at H.C. Wainwright » 06:2201/2001/20/21
H.C. Wainwright analyst…
H.C. Wainwright analyst Raghuram Selvaraju raised the firm's price target on Omeros to $34 from $31 and keeps a Buy rating on the shares after the company announced that the Biologics License Application for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy has been accepted for filing by the FDA.
Omeros announces narsoplimab BLA accepted by FDA » 08:3701/1901/19/21
Omeros Corporation announced that the biologics license application, or BLA, for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or HSCT-TMA, has been accepted for filing by the FDA. The BLA has been granted priority review with an FDA action date of July 17 under the Prescription Drug User Fee Act, or PDUFA. FDA also indicated in its filing letter that the Agency is not currently planning to hold an advisory committee meeting to discuss the BLA.
|Over a quarter ago|
Omeros price target raised to $25 from $20 at Maxim » 07:5912/0412/04/20
Maxim analyst Jason…
Maxim analyst Jason McCarthy raised the firm's price target on Omeros to $25 from $20 and keeps a Buy rating on the shares. The analyst is citing the recent CMS guidelines, which confirm that Omidria will qualify for separate payment under the ambulatory surgical center payment system as a non-opioid pain management drug. McCarthy adds that this decision marks a significant event for Omeros, as Omidria is the cash engine for the company.
CMS confirms separate payment in ASCs Omeros' cataract surgery drug Omidria » 07:3412/0312/03/20
Omeros announced that…
Omeros announced that the Centers for Medicare & Medicaid Services CMS confirmed separate payment in ambulatory surgery centers ASCs for Omeros' cataract surgery drug OMIDRIA1%/0.3%. In its final rule directed to the Medicare outpatient prospective payment system and the ASC payment system for calendar year 2021, CMS confirmed that OMIDRIA qualifies for separate payment under CMS' policy for non-opioid pain management surgical drugs when used in the ASC setting. This separate payment for OMIDRIA is effective retroactively beginning October 1. "Omeros appreciates CMS' decision to continue paying separately for our ophthalmic drug OMIDRIA," said Gregory A. Demopulos, M.D., Omeros' chairman and chief executive officer. "Having just come off its pass-through status, this is the first time that OMIDRIA qualifies under CMS' payment policy for non-opioid pain-management surgical drugs in the ASC setting. In addition to reducing patient exposure to opioids, CMS' decision continues to provide important access to OMIDRIA for Medicare beneficiaries and to allow ophthalmic surgeons to use their best medical judgment to treat those patients. This is a good outcome for surgical facilities, surgeons and their patients
Omeros completes rolling submission of BLA to FDA for narsoplimab » 09:1111/1811/18/20
Omeros announced that it…
Omeros announced that it has completed the rolling submission of its Biologics License Application, BLA, to the U.S. Food and Drug Administration , FDA, for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, HSCT-TMA. Narsoplimab targets mannan-binding lectin-associated serine protease-2, MASP-2, the effector enzyme of the lectin pathway of complement, and has received breakthrough therapy designation and orphan drug designation from FDA for HSCT-TMA. This final portion of the rolling BLA submission, comprised of the BLA's clinical sections, follows the previously submitted chemistry, manufacturing and controls, CMC, and nonclinical sections, which are under review by FDA. The clinical sections are based on previously reported results of the pivotal trial of narsoplimab in HSCT-TMA in which the drug met its primary endpoint and demonstrated similarly strong response across its secondary endpoints. Omeros has requested priority review for the BLA, and applicable regulations provide FDA up to 60 days to determine the filing and review designation for the application.
Omeros reports Q3 adjusted EPS (34c), consensus (61c) » 16:0711/0911/09/20
Reports Q3 revenue…
Reports Q3 revenue $26.1M, consensus $19.1M. "The final clinical study results for narsoplimab in the treatment of transplant-associated TMA speak for themselves. The non-clinical and CMC sections of the BLA are under review by FDA, and the clinical sections, which will be submitted next week, are complete, comprehensive and compelling. In anticipation of priority review, our team is readying for a successful commercial launch. Beyond TA-TMA and its Phase 3 trials in IgA nephropathy and aHUS, narsoplimab is increasingly recognized as a likely answer to severe COVID-19. Our complement franchise continues expanding with our MASP-3 inhibitor OMS906 on course and marching through its Phase 1 program. Confident that OMIDRIA qualifies for separate payment from CMS, we expect that the drug will increasingly support our unique portfolio of complement inhibitors and the rest of our exciting pipeline programs. Developing a life-saving drug is a rare opportunity, and all of us at Omeros are energized and inspired by the patients - children and adults - who are alive today because of our team's efforts," said Gregory A. Demopulos, Omeros' chairman and CEO.