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u/Ateyo94

r/biotech_stocks r/ValueInvesting
▲ 0 r/biotech_stocks

Thoughts on $CAPR?

DA PDUFA Target Action Date (Deramiocel BLA)

  • Original Deadline: August 22, 2026
  • Current Status: In flux / expected to be extended.

Key Details

  • Context: The original Prescription Drug User Fee Act (PDUFA) action date for Capricor's Biologics License Application (BLA) for deramiocel in Duchenne muscular dystrophy (DMD) was set for August 22, 2026.
  • Pending Extension: During the Q2 2026 earnings call, CEO Linda Marbán announced that Capricor is submitting a major BLA amendment containing 24-month open-label extension data from the HOPE-3 study and refined data analyses.
  • FDA Position: The FDA indicated it is willing to review the incoming amendment, which will automatically trigger an official extension of the PDUFA action date beyond August 22. The updated target date will be formally established once the FDA officially receives and files the amendment.

Other Deadlines to Note

  • Class Action Securities Litigation: Shareholders wishing to apply for Lead Plaintiff status in the active class action lawsuit against Capricor have until September 28, 2026.
reddit.com
u/Ateyo94 — 2 days ago
▲ 0 r/biotech_stocks

Suspicious LinkedIn posts from Sterg (SLS)

  1. If Sterg is so confident the trial is a slam dunk why does he keep making those LinkedIn posts? Why not just wait until we get the results
  2. There is a big cult like following, how many hyped up stocks have succeeded?
  3. Why is everyone invested in SLS emotional!?

I hold a small position.

reddit.com
u/Ateyo94 — 3 days ago
▲ 0 r/biotech_stocks

$SION and $TENX down 80-90% on Phase 3. $SLS next?

SLS seems to have the most bandwagoners I have ever seen, perhaps the largest subreddit community...

Some red flags of $SLS

P.S I hold a small position in $SLS.

reddit.com
u/Ateyo94 — 10 days ago
▲ 18 r/biotech_stocks+1 crossposts

- 100% local disease control rate achieved in evaluable patients in pooled analysis of two first-in-human trials of Alpha DaRT^(®) in pancreatic adenocarcinoma -

- Favorable safety profile observed, with only 8 device-associated adverse events in 7 of 26 subjects (27%), nearly all resolving within two weeks in some of the most challenging, heavily pre-treated patients in oncology -

- Highly heterogeneous patient population for whom available options are extremely limited included patients ineligible for chemotherapy as well as patients who had received up to four prior lines of chemotherapy -

- Streamlined outpatient endoscopic ultrasound (EUS)-guided procedure designed for seamless integration into standard GI endoscopy workflow -

- Results shared in oral presentation at DDW 2026, the first presentation of Alpha DaRT at a premier international gastroenterology conference -

u/Ateyo94 — 4 months ago
▲ 15 r/biotech_stocks

- 100% local disease control rate achieved in evaluable patients in pooled analysis of two first-in-human trials of Alpha DaRT^(®) in pancreatic adenocarcinoma -

- Favorable safety profile observed, with only 8 device-associated adverse events in 7 of 26 subjects (27%), nearly all resolving within two weeks in some of the most challenging, heavily pre-treated patients in oncology -

- Highly heterogeneous patient population for whom available options are extremely limited included patients ineligible for chemotherapy as well as patients who had received up to four prior lines of chemotherapy -

- Streamlined outpatient endoscopic ultrasound (EUS)-guided procedure designed for seamless integration into standard GI endoscopy workflow -

- Results shared in oral presentation at DDW 2026, the first presentation of Alpha DaRT at a premier international gastroenterology conference -

u/Ateyo94 — 3 months ago