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CTI BioPharma Corp. (CTIC)

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3.7100-0.0300 (-0.80%)
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  • N
    Niall
    Up 5% Friday and 4% premarket this morning and no news or postings on this board (?). Does anyone has any incite on this?
  • K
    Koyo
    For the last 12 years, this company has been consistently failed to pass FDA on all of their drug. I really don't have high hope for them.
  • T
    Tony
    Some notes from today's conference call:

    -Interim results from the PRE-VENT Covid trial is now expected in 1st half of 2021. CEO said “significant” enrollment increase in past few weeks. They increased the sample size for the interim study to 200 patients (was originally 154 patients).
    -Rolling NDA is still on track for submission Q1 2021. This would be for U.S. regulatory approval. European regulatory approval is still contingent on completion of phase 3 PACIFICA trial (expected 2022).
    -Began pre-commercial activities to prepare for commercial launch of pacritinib in 2021, pending FDA approval for treatment of myelofibrosis. This included hiring head of marketing & sales team. Other marketing support roles expected to be hired next year, as they approach commercial launch.
    -Cash $54.7 million at end of Q3. Enough to fund operations into Q4 2021. Will revise guidance as expenses increase due to pre-commercial activities.
    -Phase 1 GVHD study (run by Moffit Cancer Research Ctr) is promising, with results to be presented in December. Expected to transition into a Phase 2 study. If that Phase 2 has positive results, it could lead to a potential Phase 3 trial run by the company.
  • C
    Clarence
    CTIC longs, of which I am one: I see a short squeeze soon in AKBA? down from $13
    to $2's and the data on the blovkbuster Vadadustat showed the pill for anemia no difference in superiority than the injectable for the $2B dialysis market of which i am long over 30K shares.....imo
  • T
    Tony
    Another potential catalyst on the horizon. In December, CTIC will be presenting its case for pacritinib as a treatment for Graft vs Host Disease (GVHD). The Moffitt Cancer Center and Research Institute is currently conducting a Phase 1/2 trial using pacritinib as a treatment for GVHD. The primary completion date was expected to be this December. If that Phase 1/2 trial is promising, the upcoming presentation may indicate that CTIC is planning to start a new phase 3 trial using pacritinib as a GVHD treatment. Expanding the scope of use for pacritinib would create additional revenue sources.

    https://www.prnewswire.com/news-releases/cti-biopharma-announces-oral-presentation-at-the-62nd-american-society-of-hematology-meeting-301166463.html
    Bullish
  • B
    Blockbuster
    KTRA =MCap $33 M --Cash $24 M --2x BIG PHASE 3 Cancer Programs / important Phase 2 DATA IMMINENT / UNDISCOVERED stock = 1000%+ Upside Potential guys
    https://assets.wallstreet-online.de/_media/8763/board/20201112172159-screenshot-2020-11-12-powerpoint-presentation-kin.png

    #+#+#+#+
  • T
    Tony
    They are actually doing a conference call after the Q3 ER is released. Scheduled for 4:30PM on the 10th. If I recall, there was no conference call following this year's Q1 or Q2 ERs. Possibly providing new updates on the NDA submission. Also, many sites were originally reporting the ER was going to be released this week. I wonder if they delayed it because they are hoping to have interim results for their Covid trial before the ER & conference call.
  • c
    clne
    What’s with the earnings? Any news?
  • M
    Mike
    I bought 1000 more shares pre-market, seeing a nice spike... and now down, down, down.... oops.
  • B
    Bob
    This stock has consistently gone up everyday since I purchased. Winner for the long haul. A lot of potential here!
    Bullish
  • I
    I R
    Brookline Capital Initiates Coverage On CTI Biopharma With Buy Rating, $7 Price Target
  • T
    Tony
    $CTIC announced today they initiated the rolling NDA. According to the PR, they seem pretty confident of an approval decision next year.

    "We have started pre-commercial activities and are planning for a commercial launch in 2021, subject to priority review."

    https://www.prnewswire.com/news-releases/cti-biopharma-initiates-rolling-submission-of-new-drug-application-nda-for-pacritinib-in-myelofibrosis-patients-with-severe-thrombocytopenia-301150876.html
  • J
    Jonathan
    almost felt like overbought but what do I know
  • T
    Tim
    I'm new to CTIC and reading some of the posts here makes me wonder whether people really read the press releases or at least visit their web site. A stock selling at $3, with a low float of 45m, and only 73.7M outstanding and a (pacritinib) blockbuster drug in its final stages of FDA approval, what else can you ask for? I don't own CTIC but I'll be one by cob today and at $3 and change I'm going in big. This is a unique company and about to change millions Myelofibrosis Patients with Severe Thrombocytopenia patients.
  • J
    Joe Little
    Such a tight coil this thing has formed between 3 and 3.30, I’m glad I didn’t sell, imo the next press release for this company will push sp to 4-5
  • B
    Bruce H
    NOVN big news out will see $10 tomorrow!!!!!!

    MORRISVILLE, N.C., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced positive in vitro results showing the potential efficacy of its NITRICIL™ platform technology as an antiviral against SARS-CoV-2, the virus that causes COVID-19. To evaluate the ability of its NITRICIL™ platform technology as a potential nasal treatment option for COVID-19, the Company initiated in vitro assessments targeting the reduction of viral burden in differentiated normal human bronchial epithelial cells. The studies were conducted at the Institute for Antiviral Research at Utah State University and these results demonstrate the first instance of an antiviral effect from a nitric oxide-based medicine in a 3-D tissue model that has similar structure to the human airway epithelium.

    https://novan.gcs-web.com/news-releases/news-release-details/novans-nitriciltm-technology-shows-vitro-antiviral-effect
    - F irst demonstration of antiviral effect of nitric oxide -based medicine against SARS-CoV-2 in an in vitro model that mimics the human airway epithelium - Company believes preclinical results demonstrate high potential for clinical tr
    - F irst demonstration of antiviral effect of nitric oxide -based medicine against SARS-CoV-2 in an in vitro model that mimics the human airway epithelium - Company believes preclinical results demonstrate high potential for clinical tr
    novan.gcs-web.com
  • c
    clne
    Whats happening
  • T
    Tony
    For anyone that doubts the long-term prospects or chances for approval, I have a question. When is the last time the FDA authorized a fast-tracked rolling NDA submission while the Phase 3 clinical trial was still in progress? I tried to find an example and could not. Every recent NDA filing has been after successful completion of Phase 3 trials. The PACIFICA trial is still continuing until sometime in 2022. Letting them go ahead with an NDA before that trial is over seems to be a good sign that this is headed for approval.
    Bullish
  • T
    Tony
    Still waiting for the interim data. They expect it later this year. They updated their study in August to add more clinical sites, which will hopefully speed up enrollment.
  • j
    james
    I feel encouraged that CTCI has nice sizable institutional holders. 46% of institutions hold. Only 45 million shares in the float. Shorty beware.
    Bullish