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Chimerix, Inc. (CMRX)

NasdaqGS - NasdaqGS Real Time Price. Currency in USD
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3.6200+0.1800 (+5.23%)
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  • C
    Cosco
    FDA decision on BCV is any day now. Strange there is so much price weakness. Any thoughts from the Board ?
  • C
    Cosco
    CMRX hit a 52 week high on Monday and then someone unloaded 570k shares.
  • A
    Alvin
    One thing i’ve noticed in 2020 is that when the volume is high we usually go north quickly. This seems like a bullish sign to me.

    Today the volume was double the norm and we had a good day.
  • A
    Aurelio
    So yesterday the stock did not trade in AH and today it jumped .13 I don't see any new news? Any word?
    Bullish
  • C
    Cosco
    I'm just hypothesizing here in an attempt to get the board thinking. Here's my take.

    Mike Sherman indicated in a previous announcement they would be bringing on approximately six more sites in order to gather sufficient data to evaluate efficacy once the optimum dose had been determined for Cohorts 1 and 2 most likely before moving on to Cohort 3 which would entail more participants. Sherman has indicated the results of Cohorts 1 and 2 would most likely be announced this quarter.

    Considering no more additional sites have been added this may indicate they have sufficient data points.

    Additionally, it's my understanding that DSTAT treats advanced lung injury (ALI) which is later in the COVID disease stage. I have been reading that the monoclonal antibodies and remdesivir are most effective in early infection stage. That seems to open up a door for DSTAT in later stage.

    Relating to BCV for BARDA small pox. The NDA was most likely submitted September 30th with Sherman stating an announcement would be made once the FDA accepts the NDA and establishes a PDUFA. The NDA review process takes 60 days; therefore, a PDUFA should be announced around December 1. My experience has been that once a PDUFA date has been set then BARDA will begin moving on the contract.

    Discussion welcome.
  • A
    Alvin
    Yesterday’s presentation is on the website now. For those of us that have been following chimerix, there wasn’t much new information. He confirmed that they have completed enrollment in cohort 1 of the covid trial, readout in Q1.

    For those of us new to chimerix, this presentation provides a great overview of company activity.
  • A
    Alvin
    Today was a bit of a mixed bag.

    I’m pleased that multiple NDAs have been filed for Brincidofovir for smallpox. They expect the PDUFA date in late November/ early December.

    It seems like the Covid/ALI study hasn’t gone anywhere. Perhaps they should have done the first two cohorts open, without the placebo to get some data. Please tell me if I misunderstood, but I interpreted no progress.

    They expect BARDA to announce an RFP in Q1 for the strategic stockpile with a possible award announcement near the PDUFA date. This is slower than i expected.

    The DSTAT for leukemia seems on target to start in Q1. This is where the primary focus will be. This is a billion dollar opportunity with great phase 2 data.

    That’s what i heard today. I’d like to hear your opinions and please correct anything i said incorrectly.
  • Y
    Yahoo Finance Insights
    Chimerix reached a 52 Week high at 3.93
  • d
    domenico
    Anybody here ????I am ringing the bell ,nobody answer . every one is out celebrating ?
  • J
    Jim
    Well CMRX sure won't be accused of over hyping.. Sure hope they have spectacular news with the qtr report
  • A
    Alvin
    We’re about three weeks from earnings and an operational update. I think we’ll hear something before then.

    We expect four pieces of news by the end of January, the first three are expected any time.

    1. PDUFA date for smallpox treatment.
    2. BARDA contract for smallpox treatment. Potentially 100m a year for 5-12 years.
    3. Results from first two cohorts of Covid/ALS phase 2/3 trial.
    4. Initiation of phase 3 trial for Cancer treatment.
  • H
    Henry
    What is driving the price up today?
  • A
    Alvin
    The volume is above average and the price is going up. That’s a good combination.
  • m
    matan
    Today is the PREVIEW for TOMORROW
    Come and see the Money
    You can RelaX
  • J
    John
    would be nice to see this stock above $4
  • G
    Gregory
    I've been a holder for many months. Many drug application potentials, but what does everyone think about a price target. Analysts have a large range of $3 to $10. It appears that if they also came our besides norovirus & herpes Tx., this could be a big deal? Thank you............gk
  • C
    Cosco
    I went back and reviewed my notes from CMRX QTR 2 (ending 6/30/2020) CC. Mike Sherman stated, "For brincidofovir, we plan to deliver our last element of the rolling submission this quarter (3rd QTR ending 9/30/2020) so we expect to receive the 2021 PDUFA action date in the fourth quarter of this year. We plan to communicate via press release as we receive that date from the FDA."

    I was looking for an announcement verifying completion of the rolling NDA; however, after reading Mr. Sherman's comment they may not announce until the FDA accepts the NDA and provides the PDUFA. However, BARDA does not require an official NDA acceptance or PDUFA to begin deliveries of DSAT but most likely once CMRX completes the NDA filing that would increase the chances of a BARDA contract.
  • J
    Jim
    CT filing followed up by big volume and price increase tells us something big is in the works.
  • A
    Alvin
    They opened the 10th site for the Covid/ALS phase 2 study.
  • J
    Jim
    Plot thickens. SEC CT order filed. CT order is confidential treatment of data or fact of some sort.