Dynavax kan finne pÄ Ä gjÞre en nÄdelÞs bounce OM de til slutt fÄr godkjenning:
Har enda ikke fÄtt satt meg inn i Dynavax, og har lite erfaringer med vaksiner, men jeg har sett litt pÄ TG therapeutics og syns de ser veldig spennende. Har enda ikke tatt en posisjon, men vurderer og ta en liten posisjon nÄ fÞr ASCO.
Et svĂŠrt ruglete regulatorisk landskap, nĂŠrmest et minefelt.
For dvax altsÄ
Interessant selskap med et meget spennende produkt presenterte data pÄ ASCO.
Ja jammen var det mye buzz rundt Loxo i gÄr.
TGTX i dag:
Spent pÄ om ASCO buzz kan dra IBB i brudd over 300
Veldig spennende resultater for CAR-T terapi rettet mot myelomatose. ForelĂžpig ser det ut som Nanjing Legends Biotech sin data er mest lovende, men det er enda tidlig i utviklingen.
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VANVITTIG sÄ 300 skal vÊre et glasstak da? Spennende Ä se hva som skjer nÄr SMA1000 nÄr igjen kursen.
Omeros jager 20 uten news overhodet. Gotta respect the trendkanal.
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Rent bortsett fra at det var STORE news som kom i dag etter at aksjen hadde fĂžket langt allerede. Lekkasjer lukter det lang vei.
Title: FDA Grants Breakthrough Therapy Designation to Omerosâ MASP-2 Inhibitor OMS721 for the Treatment of IgA Nephropathy
Date(s): 13-Jun-2017 11:30 AM
For a complete listing of our news releases, please click here
- Omerosâ Second Phase 3 Clinical Program for OMS721 Slated to Begin this Year -
SEATTLEâ(BUSINESS WIRE)âJun. 13, 2017-- Omeros Corporation (NASDAQ: OMER) today announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to OMS721 for the treatment of Immunoglobulin A (IgA) nephropathy. OMS721 is Omerosâ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.
Breakthrough therapy designation was granted based on data from Omerosâ Phase 2 clinical trial evaluating OMS721 in patients with IgA nephropathy and other kidney diseases. The data were recently presented at the 54th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress in Madrid. Proteinuria is an important marker for disease progression in patients with IgA nephropathy, and improvement in proteinuria is associated with improved clinical outcomes. The clinical trial data show unprecedented improvement in proteinuria following only 12 weeks of OMS721 treatment, with a 77-percent mean reduction in urine albumin-to-creatinine ratios (p = 0.026) and a 73-percent mean reduction in 24-hour urine protein levels (p = 0.013). In response, many physicians attending ERA-EDTA in Madrid and representing centers across Europe, the U.S. and Asia that manage large numbers of IgA nephropathy patients asked to participate in Omerosâ planned Phase 3 clinical trial. These physicians have been added to the ongoing clinical site evaluation for the Phase 3 clinical program.
FDAâs breakthrough therapy designation enables expedited development and review of a drug candidate for the treatment of a serious or life-threatening disease. Preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies is required. Benefits of breakthrough therapy designation include the eligibility for priority review of the application and rolling submission of portions of the application. FDA personnel, including senior management, provide guidance to the company to determine the most efficient route to approval. OMS721 is the only drug candidate in development for the treatment of IgA nephropathy that has been granted breakthrough therapy designation by FDA.
âWe are pleased that FDA has granted breakthrough designation to OMS721 for IgA nephropathy and appreciate the Agencyâs recognition of the potential importance of OMS721 in the treatment of this disease,â stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. âOMS721 appears to be helping IgA nephropathy patients with a rapidity and magnitude not previously seen with any other therapy, and we look forward to working closely with the FDA to accelerate its development.â
There is no approved treatment for IgA nephropathy. The most common primary glomerulopathy globally, it accounts for up to 10 percent of all dialysis patients. In the U.S. alone, an estimated 120,000 to 180,000 patients have this disease. Approximately 40 percent of IgA nephropathy patients develop end-stage renal disease, a life-threatening condition, within 20 to 30 years following diagnosis.
OMS721 is also being evaluated in a Phase 3 clinical program for atypical hemolytic uremic syndrome and in a Phase 2 clinical program for hematopoietic stem cell transplant-associated thrombotic microangiopathy.
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Har vĂŠrt inn og ut av aksjen et par ganger, men har gĂ„tt glipp av de to siste byksene. Tenkte det var âfor sentâ Ă„ hoppe pĂ„ igjen etter fĂžrste, men er litt mer usikker nĂ„.
FĂ„r de medisinen godkjent og tar markedet fra Alexion snakker vi ~1 mrd USD i Ă„ret?
TP 50 USD desember?
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Ja nÄr omer var nede pÄ $8 var jo consensus price target $65 eller deromkring, helt crazy.
Caset er ogsÄ massivt derisket med alle dataene som har kommet det siste Äret, eneste som legger demper nÄ er fare for dilution, det er fremdeles mulig at de mÄ krype til korset og gjÞre en siste vekstemisjon.
Men de har en finansieringsavtale pÄ plass som lar dem lÄne ganske mye mer om kursen holder seg over $16, og det begynner jo Ä se lovende ut.
Fremdeles 20% aksjer short, helt villt.
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Kan det stemme at det er et par andre premisser som ligger bak finansieringsavtalen ogsÄ? Inntekter fra salg?
Jeg har ikke full oversikt mÄ jeg innrÞmme. Det er jo forskjellige transjer som blir tatt ut, og noen kan sikkert fint ha andre kriterier enn market cap. Burde hatt svaret klart. 
Spent pÄ denne i Äpningen i dag. Skal den cruise videre eller fÄr vi en liten sell on news her? Jeg er dÄrlig pÄ Nasdaq og aner ikke hvordan RSI og glidende snitt ser ut, men frister med en 10-minutters trade pÄ Äpning.
Edit: Med breakthrough, hvor lang tidshorisont for neste steg? 6-9 mnd?
Tekniske indikatorer skyhÞye, sÄ kan nok bli en dipp ja.
Er vel dagen for det i min portefĂžlje. 
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Ăsj, jeg kom meg ikke inn for min lille trade. Sommeravslutning for kiden i barnehagen gikk foran Ă„ justere kjĂžpsposten min.
Har du sikret noe?
Njet tovaritsj.
Det er jo fantastisk Ä investere i et selskap som har en fantastisk pipeline hvor stordelen av aksjeprisen rettferdiggjÞres av det produktet de allerede har i markedet. Hvis de plutselig lander en partneravtale for Europa for Omidria kan du legge en femmer pÄ aksjekursen bare der.
Omeros har definitivt vÊrt et lyspunkt pÄ en ellers mÞrk dag