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Wow never seen a stock move up from negative FDA adcomm. That's hilarious.
Sold at $41.
The AdCom votes were not in CYTK's favor.
What is weird is the target prices from Oppenheimer ($55) and JPM ($71).
Anyways, I may still keep a eye on CYTK from time to time, but for now, I'm out.
Best of luck with your investments!
Sorry to anyone holding here. I hope you can find another trade/investment to make up for it.
AdCom: 8 to 3 against!
Trading halted today
FDA Advisory Committee to Review the New Drug Application for Omecamtiv Mecarbil for the Treatment of Heart Failure with Reduced Ejection Fraction
AdCom Tomorrow.
Should be interesting. Lots of chatter about some 'FDA concerns'. That sounds like soft bashing, as the FDA is not going to give *any* info on CYTK, even less so before an AdCom. That's not how the FDA works.
The first step is the AdCom votes. Let's see where that lands.
Best of luck with your investments!
Dec. 13th AdCom Docs
https://www.fda.gov/advisory-committees/advisory-committee-calendar/december-13-2022-cardiovascular-and-renal-drugs-advisory-committee-meeting-announcement-12132022
Tuesday should be 'interesting'.
Best of luck with your investments!
AdCom in 2 weeks, Dec. 13th.
Should be interesting, maybe not as big a mover as a PDUFA, but a good indication. Depending on the votes, I may buy or sell 'some' shares.
Best of luck with your investments!
All the stock of this company is owned by Institutions 113% 13.83 % short. Short sellers are betting against the super well funded uber diamond hands. Supply demand will go asymmetrical approaching the vertical. I am glad you are here. Not a lot of retail to post when the big boys own all of the shares and hold all of the shorted shares long. How will short sellers cover if Institutions Diamond Hand. (Which is what they ALWAYS DO!)
SA Article
CM in Q4 of 2022. With proof of concept established with omecamtiv mecarbil for heart failure, plus several catalysts expected within a year, these are the reasons why I believe that Cytokinetics is a great speculative biotech play to look into.
Omecamtiv Mecarbil Holds Great Potential With A Few Catalysts
The main drug in the pipeline for Cytokinetics would be omecamtiv mecarbil. That's because not only has it established proof of concept by meeting the primary composite endpoint for the phase 3 GALACTIC-HF study, but it now has two catalysts on the way which traders/investors can focus on. Before going over these catalysts though, it's important to highlight why the biotech was able to move on to file a New Drug Application (NDA) to the FDA. The reason again is because of the impressive results it was able to obtain from the late-stage GALACTIC-HF study. There was a total of 8,256 patients who were recruited that were at risk of hospitalization or death, despite still receiving ongoing standard of care (SOC) therapy. It was noted that omecamtiv mecarbil met on the primary composite endpoint compared to placebo. That is, treatment with Omecamtiv mecarbil reduced the risk of cardiovascular death or heart failure events compared to placebo (patients who received standard of care). With this primary composite endpoint being met, it now provides Cytokinetics the avenue to move towards possible FDA approval. It has already met with the FDA and because additional data was sent to the agency, it needed additional time to review it. Thus, one major catalyst which investors can look forward to would be the PDUFA date established for omecamtiv mecarbil for the treatment of heart failure patients, which is set for February 28, 2023. That's not the only catalyst which investors have to look forward to either. Before this FDA final decision for omecamtiv, the FDA advisory panel committee is going to review the drug first on December 13, 2022. If the advisory committee review goes well, plus the FDA chooses to ultimately approve it for marketing of this heart failure indication, then the expected launch would happen in Q1 of 2023.
SA Article
CM in Q4 of 2022. With proof of concept established with omecamtiv mecarbil for heart failure, plus several catalysts expected within a year, these are the reasons why I believe that Cytokinetics is a great speculative biotech play to look into.
Omecamtiv Mecarbil Holds Great Potential With A Few Catalysts
The main drug in the pipeline for Cytokinetics would be omecamtiv mecarbil. That's because not only has it established proof of concept by meeting the primary composite endpoint for the phase 3 GALACTIC-HF study, but it now has two catalysts on the way which traders/investors can focus on. Before going over these catalysts though, it's important to highlight why the biotech was able to move on to file a New Drug Application (NDA) to the FDA. The reason again is because of the impressive results it was able to obtain from the late-stage GALACTIC-HF study. There was a total of 8,256 patients who were recruited that were at risk of hospitalization or death, despite still receiving ongoing standard of care (SOC) therapy. It was noted that omecamtiv mecarbil met on the primary composite endpoint compared to placebo. That is, treatment with Omecamtiv mecarbil reduced the risk of cardiovascular death or heart failure events compared to placebo (patients who received standard of care). With this primary composite endpoint being met, it now provides Cytokinetics the avenue to move towards possible FDA approval. It has already met with the FDA and because additional data was sent to the agency, it needed additional time to review it. Thus, one major catalyst which investors can look forward to would be the PDUFA date established for omecamtiv mecarbil for the treatment of heart failure patients, which is set for February 28, 2023. That's not the only catalyst which investors have to look forward to either. Before this FDA final decision for omecamtiv, the FDA advisory panel committee is going to review the drug first on December 13, 2022. If the advisory committee review goes well, plus the FDA chooses to ultimately approve it for marketing of this heart failure indication, then the expected launch would happen in Q1 of 2023.
December 13, 2022 as AdCom Date for Omecamtiv Mecarbil,
(from StreetInsider)
PDUFA of February 28, 2023
SA article / Ph III ALS - DMC recommended Continuation
Same news packaged in a different way on SA:
Continuation of COURAGE-ALS Following First Interim Analysis
October 10 2022 - 07:30AM
GlobeNewswire Inc.
From $32 to $42 in 6 months. Not too shabby!!!
Aug 4th is the Earnings Call for CYTK!
NJ Common Pension Fund D Acquires 6,275 Shares of Cytokinetics
AdCom scheduled for December 13, 2022.
PDUFA now Feb. 28, 2023
omecamtiv mecarbil growing body of evidence
AdCom later this year. PDUFA maintained Nov. 30, 2022
[CYTK] was informed that the Agency plans to convene an Advisory Committee meeting for the New Drug Application (NDA) for omecamtiv mecarbil. Cytokinetics expects the FDA to inform it of the date and topics for the Advisory Committee Meeting in a subsequent communication. A late-cycle communication meeting has been proposed to occur later this year.
Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction (HFrEF).
The FDA has assigned the NDA a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2022.
Oppenheimer :Price Target to $57 From $53, Maintains Outperform Rating
HC Wainwright: Price Target to $75 from $69, Keeps Buy Rating
And the PPS goes up 11.5%
Could be in anticipation of the upcoming Q1 call on May 4th.
Best of luck with your investments!
(PDUFA) target action date of November 30, 2022
https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-announces-fda-acceptance-new-drug-application
Cheers!
CYTK: FDA accepts NDA application for OMECAMTIV MECARBIL
Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil that enrolled over 8,000 patients in 35 countries across 945 sites.
CYTK. New high
Happy holidays
Kiwi
CYTK Back in. Hoping to make up a loss.
Year end cleaning up.
https://stockcharts.com/h-sc/ui?s=CYTK
Well I have some of all the ones you mentioned. Although it is dropping today I thought the deficiencies the FDA cited were actually not that grave and hopefully addressed quickly.
CYTK looks strong and just won’t go down and I agree looks more like a BO candidate than AMRN at this point in time. Maybe if the infringement trial is not dismissed there may be a little more interest in Amarin.
Rose ...that was a preplanned sale
Still like CYTK more than AMRN, AUPH, AXSM at these levels .... they are presenting at AHA
We need the infringement case to proceed for AMRN to move. Auto switching at pharmacies are killing their script numbers .
AUPH ...market is for severe LN .. about 10% of those with LN imho . Stock will drop at least 20% if they GIA.
AXSM ...looked like a down grade today ? The earning report was OK but I didn't like them saying they needed weeks to months to cure the deficiencies raised by the FDA ...if I heard that correctly
SOUTH SAN FRANCISCO, Calif., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced two presentations at the American Heart Association (AHA) Scientific Sessions 2021, taking place online from November 13, 2021 – November 15, 2021, including the presentation of additional results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) assessing the effect of omecamtiv mecarbil on stroke in patients with heart failure with reduced ejection fraction (HFrEF), and the presentation of preclinical data relating to a cardiac troponin activator that is a closely related analog to CK-3828136 (CK-136).[/quote]
Kiwi
A Director sold at $40 but it appears to be part of a pre-planned sale:
https://www.sec.gov/Archives/edgar/data/1061983/000106198321000250/xslF345X03/edgardoc.xml
Yes, now we are barcoding from one of those
stuipd algo's...
I did take some profits from my calls...glad to do that anytime.
New high today
Mkt likes their presentation
Kiwi
That was a few days ago, the 28th. Today the 30th, something new is up.
Could simply be price being setup for the Oct 7th deal.
I think the MM will have the SP priced in for good news, and then plenty of room for a slide/short if nothing too interesting is said.
Perhaps some info, like data, got leaked in prep for it??
So many unknowns!
Should be a fun Week or Two !!!
Cytokinetics: Cramer “This is early stage, and here’s what’s interesting about this company: Once again we find these companies that big pharma needs. This is a very good spec. Small molecule therapeutics. The big companies, the Pfizers, love these guys.”
Inv Conference on Oct 7.
SOUTH SAN FRANCISCO, Calif., Sept. 23, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK), today announced that it will host an Analyst and Investor Day on Thursday, October 7, 2021 from 8:30 AM to 11:30 AM ET. The event will be held at the Westin Grand Central Hotel in New York City, and streamed live online. Members of Cytokinetics’ senior management will be joined by expert clinicians to provide updates on the company’s plans for commercialization and advancing cardiovascular pipeline.
A panel discussion on the challenges of treating patients with heart failure with reduced ejection fraction (HFrEF) and the unmet need in this patient population will feature the following experts:
Tariq Ahmad, MD, MPH, FACC, Associate Professor of Medicine; Medical Director of Advanced Heart Failure, Cardiovascular Medicine, Yale School of Medicine
Alanna Morris, MD, MSc, FHFSA, FACC, FAHA, Associate Professor of Medicine, Division of Cardiology; Director of Heart Failure Research, Emory University Clinical Cardiovascular Research Institute
At the time the pop looked overdone.
No deeply held viewpoint. Again, I'm trader. Another can be a chartist. Another the fundamentals, etc.
GL!
MG
Whats the rational for being short ?
CYTK'S clinical data looks as good ( if not better ) than MYOK's ( that Co sold for $13B AND CYTK is currently trading at 1/4 that ) ) and they have over $700m cash on hand ...
Kiwi
CYTK No worries.
I'm about 40% out of my short with a modest profit.
Like I said, it'll require patience.
I'm a trader.
MG
Let’s see how well that short position does on Monday
The data they released today looks pretty good and the Co is currently valued at roughly a quarter of what MYOK sold for
Kiwi
I am growing impatient waiting and there a lot of newbies that are upside down big on this short.
it’s coming up on a month and no one has even posted here
really nervous
Will require a little patience
MG
wow
this stock goes up a dollar so easily!
resilient in a down market too!
I wonder how long it can keep this up?
stock holding up pretty nicely
especially considering the over 50% rise it just had
big winner here !!!
CYTK ...and dropped some more today
Snapshot:CYTK
CYTOKINETICS INC
28.20 Down -0.84 (-2.8926 %) AS OF 4:00:00PM ET 07/26/2021)
Starting to behave as it should.
I banked some small green late last week as a safeguard, in case they took it up after the Offering closed. Holding the rest of my short. Should drop a good sum more.
Chart: https://stockcharts.com/h-sc/ui?s=CYTK
those pesky longs keep buying this stock
wait …what?
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