Leslie CAI

How likely is aficamten to get approved for nHCM by FDA? $CYTK

@epickram @mahanoycitykid same here🙋

@mahanoycitykid I flagged yesterday post close that I flipped from short to long $CYTK based on the pre announcement alone

@epickram not one word about $CYTK 🤔 no correction

ACACIA-HCM trial topline results - aficamten in nHCM. Incredibly proud and thankful to our patients and team for their commitment and hard work. This represents the first effective treatment for patients with nHCM. looking forward to seeing the full results. #CardioTwitter

$CYTK strong efficiency, strong safety profile. Very undervalued now.

There is no reason for preannouncing a failed trial and presenting their results in premarket trading time. So the topline for Acacia is at least one PE hit. $CYTK

@MM3915038575333 But I think it will be after the Q1 results

@lesyncai Acacia Monday?

$cytk no acacia today

@epickram Yeah... just went through your comments on $CYTK and I largely agree with your views. I used to be pretty bullish on afi in nhcm, but the more I think about the post-hoc analysis for Mava regarding the patient selection issues, the less certain I am.

@lesyncai Yea idk about that there hasn’t been one successful RCT and two have already failed

CMI works in nHCM $CYTK

@epickram @nociFTW @PersimmonTI any idea on why they don’t disclose baseline characteristics this time? they did this for both sequoia and maple

@nociFTW @PersimmonTI That $CYTK has no way of knowing who the “right” patients are and couldn’t just hand pick these patients in ACACIA since it enrolled concurrently with ODYSSEY

$CYTK case in point

@cosmokramer313 @MM3915038575333 @QuiteSkeptic The last patient visit happened on Feb 1st in China sites. my friend took part in acacia

@MM3915038575333 @QuiteSkeptic @lesyncai where do you see the last patient visit being in Jan?

$CYTK chances of them eating 💩on ACACIA?

@MM3915038575333 Obviously, they can’t share too much information with me. They simply said “won’t be too fast”. I guess the result will be announced in mid-May, after the Q1 meeting (they will say topline in May during the meeting, just like Maple). The result is overdue, which is weird.

@lesyncai Did they mention specific timing?

@MM3915038575333 my friends work for sanofi and they said unlikely today haha

@lesyncai Why?

@PersimmonTI More than that coming.

@MM3915038575333 @QuiteSkeptic weird

@QuiteSkeptic @lesyncai That’s irrelevant. Last patient visit was in early January. Data way overdue now $CYTK

@QuiteSkeptic the time has already exceed the time they used for SEQUOIA and MAPLE topline results...

$CYTK taking this much time to release data may be to dangle the extension data with further time to justify a failed study.

acacia topline announcement by $CYTK

@nociFTW I think it is unlikely to happen that quick as he said they have not yet discussed with ESC how much information they can disclose when announcing their topline results.

$cytk Fatty sez the read out is in q2, but not tomorrow. Must be tonight then …

@MM3915038575333 @Biotech_FC heard from where😯

@Biotech_FC Heard it’s coming Monday. We’ll see if they pre announce tonight. $CYTK

Do we get ACACIA data next week? $CYTK

@avidresearch but i do think the results will come out in April

@avidresearch actually the last subject visit occurred around 1 January 2026, followed by a one-month washout period. at least this is the situation in their sites in China.

$CYTK Completed enrollment in late Q1 of 2025. A 36-wk primary endpoint last subject visit would be around early December. A bit surprised they are guiding for Q2. Would think they could see Top line in March? “With respect to the ongoing clinical trial program for aficamten, the next major data milestone for us will be the readout of ACACIA-HCM, the pivotal Phase 3 trial in nHCM. We completed enrollment of the primary cohort, excluding Japan, in the first quarter of 2025, and we now expect to report the top line results from this cohort of ACACIA-HCM in the second quarter of 2026.”