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* * $CBIO Video Chart 10-03-2019 * *
Link to Video - click here to watch the technical chart video
News: $CBIO Catalyst Biosciences Provides DalcA Phase 2b Trial Update
SOUTH SAN FRANCISCO, Calif., Oct. 03, 2019 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO), today provided an update on enrollment in its Phase 2b study of dalcinonacog alfa (DalcA), a next-generation subcutaneously (SQ) administered Factor IX (FIX) therapy being developed for...
Read the whole news CBIO - Catalyst Biosciences Provides DalcA Phase 2b Trial Update
News: $CBIO 22NW: Catalyst Biosciences Needs Change Now
SEATTLE , Oct. 2, 2019 /PRNewswire/ -- Dear Catalyst Biosciences, Inc. Shareholders: 22NW, LP ("22NW" or "we") is one of the largest shareholders of Catalyst Biosciences, Inc (the "Company") (NASDAQ: CBIO) with ownership of approximately 6% of the Company's outstanding shares. As ment...
Got this from CBIO - 22NW: Catalyst Biosciences Needs Change Now
VOLUME HAS SPIKED IN ANTICIPATION OF POSITIVE CLINICAL DATA
CATALYST BIOSCIENCES INC CBOE ($CBIO)
CBIO will release at the ISTH conference final Phase 2 data for marzeptaacog alfa in hemophilia. Dr . Johnny Mahlangu, M.D., Professor of haematology, faculty of health sciences, head of the School of Pathology at the University of Witwatersrand in Johannesburg, South Africa, and a principal investigator on the MarzAA Phase 2 study, will deliver an oral presentation on the final data from the Company's next-generation engineered subcutaneous ( SQ ) coagulation Factor VIIa (FVIIa) marzeptacog alfa (activated) (MarzAA) Phase 2 trial for the treatment of hemophilia A or B with inhibitors. Additionally, the Company will have three posters covering (1) quality of life improvements for subjects in the Phase 2 MarzAA trial, (2) in silico and in vitro immunogenicity risk assessment of its next-generation engineered SQ coagulation Factor IX (FIX), dalcinonacog alfa (DalcA) compared with wildtype FIX and (3) the ongoing Phase 2b study of DalcA.
COMPANY PROFILE
COMPANY PROFILE
Catalyst Biosciences , Inc. is a clinical-stage biopharmaceutical company, which engages in the development of novel medicines to address serious medical conditions. Its pipeline includes hemostasis such as Factor VIIa marzeptacog alfa, Factor IX dalcinonacog alfa, and Factor Xa; and anti-complement. The company was founded on August 20, 2015 and is headquartered in South San Francisco, CA.
* * $CBIO Video Chart 07-08-2019 * *
Link to Video - click here to watch the technical chart video
News: $CBIO Catalyst Biosciences Meets the Primary Endpoint of Reduction in Annualized Bleeding Rate in the Phase 2 Trial of Subcutaneous Marzeptacog Alfa (Activated) in Patients with Hemophilia A or B with Inhibitors
Subcutaneous MarzAA (FVIIa) prophylaxis reduced the annualized bleeding rate by more than 90% compared with pretreatment Data presented at the 2019 Congress of the International Society on Thrombosis and Haemostasis Company to host investor call and webcast on Monday, July 8 at 8:...
Read the whole news Catalyst Biosciences Meets the Primary Endpoint of Reduction in Annualized Bleeding Rate in the Phase 2 Trial of Subcutaneous Marzeptacog Alfa (Activated) in Patients with Hemophilia A or B with Inhibitors
Just took a quick look at this one
P2/3 about to report
Market size appears to be about 20,000 people domestically with up to max 2B/yr (these are expensive drugs - looking at the competition)
Cut that in half and say $1B domestic, double it for Europe, back to about $2B
Meanwhile, Phase 2/3... odds are they will have to raise $ to build-out go to market and or larger PIII study.
77% apparently is held by institutional investors.
Seems very few people are watching, not enough volatility ?
Showing $8.83 netcash remaining after the executives raided-the-till heavily this quarter. Still my favorite play - added at 8.02 at the open - many catalysts working here:
Expected Milestones
Present final results for all subjects from the MarzAA Phase 2 open-label SQ efficacy trial at the ISTH meeting in July 2019; initiate a MarzAA Phase 1 pharmacokinetic and pharmacodynamic study in Q2 2019 with final data read out in Q4 2019; and request an End of Phase 2 meeting with the FDA by the end of 2019.
Complete the DalcA Phase 2b open-label SQ long-term dosing study, with final data readout in Q4 2019.
News: $CBIO Catalyst Biosciences & Mosaic Biosciences Present Preclinical Data on Pegylated CB 2782 for the Treatment of Dry Age-Related Macular Degeneration
A single intravitreal injection of 125 μg CB 2782-PEG achieved complete, rapid and sustained pharmacodynamic inhibition (>99%) of complement factor 3 (C3) in non-human primates (NHP), supporting dosing three to four times a year Data support CB 2782-PEG’s potential as...
Got this from https://marketwirenews.com/news-releases/catalyst-biosciences-mosaic-biosciences-present-preclinical-data-on-pegylated-cb-2782-for-the-treatment-of-dry-age-related-macular-degeneration-8074858.html
News: $CBIO Catalyst Biosciences Rises on European Orphan Designation
Catalyst Biosciences (NASDAQ: CBIO ) has officially received orphan designation from the European Commission for marzeptacog alfa (activated) (MarzAA) to treat haemophilia B with or without inhibitors, the company announced on Monday (April 1). In an interview with the Investing N...
Read the whole news https://marketwirenews.com/news-releases/catalyst-biosciences-rises-on-european-orphan-designation-7927808.html
News: $CBIO Catalyst Biosciences Receives Orphan Designation from the European Commission for Marzeptacog Alfa (Activated)
SOUTH SAN FRANCISCO, Calif., April 01, 2019 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (Nasdaq: CBIO) today announced that the European Commission has awarded orphan designation of its Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA) for the treatment of haemophilia B (...
Got this from https://marketwirenews.com/news-releases/catalyst-biosciences-receives-orphan-designation-from-the-european-commission-for-marzeptacog-alfa-activated--7925162.html
Continue holding the 5k from this old post. I would be more apt to begin plunging AGAIN here at below $8 but for that S-3 filed on 12/21/18 - (what an IGNORANT time to file an S-3, remember how the market was in freefall back then) - so maybe we can expect more dumb moves from these guys?
Trying CBIO again at 8.10 on decent news today not sure why down so much but was up in pre-market. Looks like most bios down so far today.
CBIO now at 10.40 should've held but very happy. Nice trade and hold for you.
Seems like my other bios/pharmas I am holding are up as well. Waiting on some near catalysts.
Flipped the 9.55's again today at 9.88. Holding 5k shares for possible fireworks. Don't see many stocks trading below $10+ netcash.
Just sold the CBIO here at 10 the gift that keeps on giving. Hopeful of waiting for the next train.
Flipped another small chunk recently from 9.55 at 9.88 then rebought at 9.55 - looking for 8's to add.
Trying CBIO here again at 9.10 got stopped out 2x recently. Making lower lows now but 3rd time a charm?
Back in CBIO this morning 10.06 hoping to do it again.
Nice trade. It's been a good trader off the low $9's. With close to $12netcash, I plan to be flipping/holding this one longterm.
Pre-market back in the 12's...whoa! Being shorted again just have 500 shares left will hold!
Out most of my remaining shares here at 15.60 pre-market!!!
https://ih.advfn.com/p.php?pid=nmona&article=77885985&symbol=CBIO
CBIO still climbing....been peeling off a few shares at a time don't see any news other than multiple presentations coming up.
Any body still in CBIO here?
CBIO turning around here. Very low float finally reversing. Price will move quickly once shorts realize what direction this is going and once some momentum builds up
And she’s still running. If this dips, I? think it’s a good load candidate. Such a low, positive sentiment around the company and momentum is just getting started it seems
I should have done my analysis.. smh hindsights 20/20
Definitely not too late. Long position here has been very favourable for anyone who decided to hold. I? still don’t think it’s too late. Likely to see this continue to make big gains with the up trend this is on
* * $CBIO Video Chart 11-17-17 * *
Link to Video - click here to watch the technical chart video
jump to 9.28 now at 5.44 sheesh
Big Holiday cash grab CONGRAT$ to who ever sold, in that flurry to $9.29
and sorry to who ever bought and is red
**TGIBF**
Thank God its Black Friday
l;ol
Someone loaded half million shares. Maybe trying to jump start CBIO > a super low floater.
Any big pivot points that could set off a big squeeze?
$CBIO https://www.streetinsider.com/Corporate+News/Catalyst+Biosciences+%28CBIO%29+Completes+First+Subcutaneous+Dosing+Cohort+in+Ongoing+Hemophilia+B+Clinical+Trial/13323360.html
Catalyst Biosciences (CBIO) Completes First Subcutaneous Dosing Cohort in Ongoing Hemophilia B Clinical Trial
StreetInsider.com - 4h ago
Catalyst Biosciences, Inc. (Nasdaq: CBIO), today announced that its collaborator ISU Abxis has completed dosing of the first subcutaneous cohort (N = 3, the second of up to five patient cohorts) in an ongoing Phase 1/2 proof-of-concept clinical trial ...
CBIO: FDA granted Orphan Drug Status approval 9/20/17.
News is posted ONLY on FDA website.
CBIO posted other good news today but the FDA news is not up on the wires yet.
the CBIO main Hemo drug is the one posted on FDA site.
That is SERIOUS news.
Gonna be a crazy day here. Think a lot of people will be showing up on ihub once this hits the top gainers charts for all the hot stock seekers. Don't fret potential investors! You're not too late. Conference announcement tomorrow should bring more eyes on this. But these eyes won't be the day traders, they'll be knowledgeable people who are in and around the science and bioscience community. Should build a base of longs is what I'm saying...
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All currently approved medicines for hemophilia are injected into a patient’s veins – at Catalyst, we believe that a clotting factor that could instead be injected just under the skin would enhance the treatment, and lives, of patients with hemophilia.
Catalyst is focused on the prevention of spontaneous bleeding in hemophilia, even during surgery, using our potent, coagulation factors to promote blood clotting. We plan to initiate two clinical trials in 2017, one in patients with Hemophilia B using our next-generation Factor IX, CB 2679d, and the other in hemophilia inhibitor patients using our next-generation Factor VIIa, marzeptacog alfa (activated) (formerly known as CB 813d).
Hemophilia patients suffer from spontaneous bleeding episodes and substantially prolonged bleeding times that can become limb- or life-threatening following injury or trauma. In cases of severe hemophilia, spontaneous bleeding into muscles or joints is frequent and often results in permanent, disabling joint damage. Hemophilia results from a genetic or acquired deficiency of a protein required for normal blood coagulation.
Hemophilia patients are currently treated with replacement therapy of key coagulation proteins, Factor VIII for Hemophilia A or Factor IX for Hemophilia B. A complication for hemophilia patients receiving factor replacement therapy is the production of antibodies against the replacement factor, also called inhibitors. The overall prevalence of inhibitor formation is up to 30% in patients with hemophilia A and up to 5% in patients with hemophilia B.
Inhibitor patients are treated with what are known as “bypass” agents that initiate coagulation by a pathway that is independent of Factor VIII or Factor IX. There are currently two approved “bypass agents”, Factor VIIa (for example NovoSeven™) and FEIBA™. However, current hemophilia drugs for patients with inhibitors have significant limitations regarding potency, duration of action and often require frequent dosing – and they are all injected intravenously which is not ideal for patients who predominantly take these medicines at home.
We believe that the shortcomings of currently approved therapies are barriers to prophylactic treatment strategies that, if surmounted, could provide meaningfully improved long-term clinical outcomes for patients. Catalyst's engineered proteases in the fields of hemostasis are designed to overcome the significant limitations of current treatment options, facilitate preventative treatment, and ultimately deliver substantially better outcomes for patients.
Catalyst created a portfolio of improved Factor IX proteases, including the clinical development candidate CB 2679d for treatment of hemophilia B, a life-long disease caused by a genetic deficiency in coagulation Factor IX.
The leading recombinant human Factor IX on the market for treating acute bleeding episodes in hemophilia B patients has a short half-life and is therefore not ideal for prophylactic treatment.
CB 2679d has shown significantly higher potency in pre-clinical studies versus other FIX products on the market and in development. Based on data from well-validated animal models of hemophilia, CB 2679d may provide hemophilia B patients with a viable subcutaneous prophylactic therapy.
Catalyst has a collaboration with ISU Abxis to advance the development of CB 2679d through Phase 1/2 proof-of-concept study in hemophilia B patients. After Phase 1, ISU Abxis retains exclusive commercial rights in Korea while Catalyst retains full development and commercial rights for CB 2679d outside of Korea.
Marzeptacog alfa (activated) (formerly known as CB 813d) is a next-generation Factor VIIa that was designed to allow for the effective, long-term, prophylaxis in hemophilia patients with inhibitors. Catalyst has successfully completed an intravenous Phase 1 clinical trial in patients with severe hemophilia A and B with and without inhibitors.
Catalyst designed marzeptacog alfa (activated) (formerly known as CB 813d) to combine higher clot-generating activity at the site of bleeding and improved efficacy. Catalyst anticipates that this product candidate could be used for subcutaneous prophylactic treatment.
Positive results from an open label, multicenter Phase 1 intravenous dosing clinical trial of marzeptacog alfa (activated) (formerly known as CB 813d) were reported in June 2015. Marzeptacog alfa (activated) (formerly known as CB 813d) was given intravenously to 25 non-bleeding hemophilia patients in single ascending dose cohorts who were then observed for up to 60 days post treatment. Results showed that single doses of marzeptacog alfa (activated) (formerly known as CB 813d) were well tolerated when administered to hemophilia A and B patients, and there were no instances of antibody response or thrombosis. Marzeptacog alfa (activated) (formerly known as CB 813d) demonstrated pharmacological efficacy as measured by significant shortening of aPTT (activated partial thromboplastin time) and PT (prothrombin time) for up to 48 hours post dosing. The results were presented in a poster session at the International Society on Thrombosis and Haemostasis (ISTH) Meeting in June 2015.
Catalyst has identified Factor Xa variants that have enhanced potency, improved safety, and superior duration of action in preclinical models of bleeding compared with a competing Factor Xa in clinical development. Catalyst believes that a safe and effective Factor Xa product has the potential to be used both to treat hemophilia patients and to reduce blood loss in trauma and surgery in patients with normal coagulation systems and clotting activity or those who are taking anti-platelet agents or anticoagulants.
Catalyst’s FXa program has reached the lead candidate stage of research and is available for partnering.
Catalyst has developed and optimized a propriety method to create novel proteases that include anti-C3 protease assets such as CB 2782 for ischemia-reperfusion injury such as delayed graft function (DGF) after kidney transplantation and the preclinical leads in the dry age-related macular degeneration (AMD) program. In 2016, Catalyst reduced resources deployed towards its anti-complement research programs and all related research activities were discontinued. These assets are available for partnering.
The complement cascade is a series of molecular processes that plays a central role in the body’s inflammatory and immune responses and helps to localize specific immune system cells at the site of infection or inflammation. Drugs that target the complement cascade could potentially be used in a number of indications, including prevention of transplant rejection, age-related macular degeneration, cardiovascular disease, pulmonary diseases, and autoimmune disease.
CB 2782 is a novel protease derived from human membrane type serine protease 1 (MTSP-1) that cleaves complement factor 3 (C3) and may be developed to prevent delayed graft function (DGF) following kidney transplant as a result of ischemia-reperfusion injury. Other opportunities might include coronary artery bypass graft (CABG), acute myocardial infarction (AMI), and stroke. Catalyst also has earlier stage, distinct anti-complement lead molecules for dry age-related macular degeneration (dry AMD) and other chronic, and selected orphan, diseases.
Catalyst created improved protease variants using a rational design strategy. In this process, a small number of amino acids in a given protease are substituted in an iterative fashion with different amino acids to improve a molecule’s biological properties. This approach led to product candidates that have the potential to be improved versions of Factor VIIa, Factor IX, and Factor Xa that may have many important and differentiated advantages including higher activity, longer duration of action, and improved safety.
Catalyst has developed and optimized a propriety method to create novel proteases that currently make up part of our partnering portfolio, including our anti-C3 proteases including CB 2782 for delayed graft function (DGF) and the leads in our dry age-related macular degeneration (AMD) program. In September 2016, Catalyst reduced resources deployed towards its anti-complement research programs and all related research activities were discontinued. Catalyst intends to explore licensing opportunities for its anti-complement programs in DGF and Dry AMD.
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