🔥 CAPR DD: The Little Biotech That Could (Or Could Not) – A Degenerate’s Guide to a $14 Lottery Ticket 🎢
Ticker: CAPR (Capricor Therapeutics)
Current Price (Mar 2025): ~$14
Market Cap: ~$580M
My Position: 835 Sept $15 Calls @ $5.50 (Yes, I YOLO’d ~$459K)
Sector: Biotech / Rare Disease
Catalyst: FDA Priority Review for first-in-class DMD therapy – PDUFA date Aug 31, 2025
TL;DR: 🚀 FDA decision coming in August for a rare disease therapy with no direct competition. Company fully funded till 2027 (so no rug-pull dilution incoming), has a big pharma partner handling commercialization, and analysts are way more bullish than the market. Meanwhile, shorts are betting against it despite FDA giving it the fast lane. If this goes through, 💰💰. If it fails, 💀.
This is a classic biotech play: under-the-radar, asymmetric risk/reward, and trading like it’s already dead when it’s not. So, why hasn’t this thing mooned yet?
🎯 The Big Catalyst – FDA’s Priority Review
WTF Happened?
On March 4, 2025, Capricor ($CAPR) announced that the FDA accepted its BLA (Biologics License Application) for Deramiocel (CAP-1002), an investigational cell therapy for Duchenne muscular dystrophy (DMD) cardiomyopathy.
💡 Key FDA facts:
✅ Priority Review – This means FDA cut the review time from 10 months to 6. VIP fast lane. 🏎️
✅ PDUFA date set for Aug 31, 2025 – The final decision deadline. 🗓️
✅ No review issues flagged yet. No AdCom (yet). If no AdCom by summer, that’s bullish. 🚀
✅ If approved, it would be the first therapy specifically for DMD heart disease.
Why It Matters
👶 DMD is a brutal genetic disorder that leads to early death (heart failure in teens/20s).
💊 There are NO approved drugs for the heart problems in DMD. Deramiocel could extend lives.
📈 FDA already fast-tracked this under multiple designations (RMAT, Orphan, Rare Pediatric).
💡 The FDA doesn’t hand out Priority Review & Rare Disease incentives unless they think the drug has a real shot.
The Stock’s Reaction? Total Apathetic Shrug. 🤨
When FDA acceptance was announced, CAPR barely moved (+3% close). This was after a pre-market +14% spike. Instead of 🚀, we got… meh.
WTF?
🤔 Why Is This Still Trading Like a Penny Stock?
1️⃣ BLA Acceptance Was “Priced In” – CAPR ran from ~$4 to the mid-teens in late 2024 as traders anticipated the FDA submission. So no new buying frenzy.
2️⃣ Shorts Are Doubting FDA Approval – There’s a high short interest (~20% of the float), likely betting FDA will demand more data.
3️⃣ Biotech Market Sentiment is Trash Right Now – The sector is struggling. Risk-off mode.
4️⃣ Earnings Are Coming – Guidance Will Matter – Market might be waiting to hear about cash burn & commercialization plans.
💡 Why is the borrow rate climbing? That means hedgies are paying more to bet against this.
💰 The Financials – No Dilution Incoming (Unlike Most Biotech Wrecks)
Most small-cap biotechs bleed out before FDA decisions because they need cash injections (= stock offerings = price nukes). But CAPR doesn’t need money until at least 2027.
💰 Cash: ~$175M (after big 2024 raise)
🔥 Runway: 2027 (even at high burn)
📉 No Debt / No ATM Financing – No surprise 5pm “surprise dilution” announcements.
💸 Partner Funding: Nippon Shinyaku (Japanese pharma) has already invested $15M in equity at a 20% premium & will handle global commercialization.
🚀 If Deramiocel gets FDA approval, CAPR gets:
✅ $100M+ just from selling the Priority Review Voucher (PRV)
✅ Milestone payments from Nippon Shinyaku ($705M total potential)
✅ Royalties on sales (double-digit %)
🔥 The Big Question: What’s the Market Missing?
🔍 Current Market Cap: ~$580M
📊 Analysts’ Price Targets: $34-$77
👀 Short Interest: ~8.16M shares (20.4% of float)
📈 Stock Should Be Priced Higher If Approval Odds Are Good
📜 Biotech Playbook: Past FDA Approval Trades
✔️ Sarepta (SRPT) 2016 – 131% gain in one month when their DMD drug got approved despite a shaky FDA panel.
✔️ Spark (ONCE) 2017 – FDA approval → Acquired by Roche for $4.3B.
✔️ Krystal Biotech (KRYS) 2023 – Ran from ~$70 to $130 pre-FDA approval.
🚀 CAPR is following a similar setup.
🎲 The Play – How Degenerates Could Trade This
1️⃣ Run-Up Trade: Buy shares/calls leading into August & sell before FDA decision.
2️⃣ Binary Bet: Hold through the PDUFA for moonshot approval or fiery death.
3️⃣ Straddle/Strangle: If you expect a massive move but not sure which way.
4️⃣ Wheel It: Sell cash-secured puts to collect premium from high IV.
If approved, this could be a multi-bagger stock overnight. If rejected, 💀.
🚨 Final Ape Thoughts
🔥 FDA Priority Review isn’t given out lightly.
🔥 No competing therapies exist.
🔥 CAPR is fully funded into 2027, so dilution isn’t a near-term risk.
🔥 Stock is undervalued compared to potential payout.
🚀 The trade? If the market realizes this is actually a solid biotech setup, it could run. If not, the PDUFA itself will be the make-or-break moment.
🦍 Who else is loading up? Let’s discuss.
📌 TL;DR
• FDA Priority Review → Decision due Aug 31, 2025.
• If approved, first-in-class drug with no competition.
• Company has cash till 2027. No dilution threat pre-PDUFA.
• Market is skeptical despite FDA green light & strong partnerships.
• Short interest is high, but could be wrong (like SRPT, ONCE, KRYS).
• Massive upside if approved, nuclear downside if rejected.
Disclosure: I hold 835 September $15 calls. I’m just a crayon-eating degenerate, not a financial advisor. This is biotech gambling. Do your own DD. 🦍🚀
💬 Drop Your Thoughts – Is This a $30 Stock in the Making or a Future Biotech Bag?
