PoA = probability-of-approval band (directional only; not FDA guidance).
Rule: FDA decision events get a %; data/KOL/conference events get N/A.
THE FRAME (MAR 13–MAR 20): “STORYTAPE PRINTS → ONE HARD CLOCK → NEXT WEEK’S AHO DECISION”
Last Friday’s setup was LNTH + MDA on-ramp. That tape has now largely printed:
$LNTH ( ▼ 0.15% ) got its clean CMC approval on Mar 6, so that overhang is gone.
$NBP delivered positive Phase 2a VIS-101 wet AMD data on Mar 9, pushing the discussion toward durability and next-trial shape rather than “does it work at all.”
$CAPR ( ▼ 6.82% ) is no longer just a conference name: FDA lifted the prior CRL, resumed BLA review, and set a new PDUFA date of Aug. 22, 2026, while new HOPE-3 analyses at MDA added functional and cardiac support.
$BBIO ( ▲ 1.97% ) used MDA to strengthen the “NDA in H1 2026” case with interim FORTIFY data.
So the tape now narrows to:
Mon Mar 16: one real FDA clock, $ALDX ( ▼ 9.42% ) .
Mon Mar 16: one important data event, $RLAY ( ▼ 1.42% ) .
Fri Mar 20: next hard FDA decision, $RYTM ( ▼ 5.18% ) .
WHAT PRINTED SINCE LAST FRIDAY
LNTH — $LNTH ( ▼ 0.15% ) | PYLARIFY TruVu | FDA APPROVAL (Mar 6) | PoA: N/A
This came through as the expected clean CMC/manufacturing print. Reuters reported the new formulation increases radioactive concentration and batch size, with Lantheus guiding to a 4Q26 phased launch tied to reimbursement-code timing.
NBP — NovaBridge (Nasdaq: NBP) | VIS-101 | Positive Phase 2a data (Mar 9) | PoA: N/A
The headline read was better than “merely viable”: the company said VIS-101 produced more than 10 ETDRS letters of mean BCVA improvement after three loading doses, with roughly two-thirds retreatment-free at four months and about half at six months. That is enough to keep the asset in the “durability contender” bucket, though it still needs sharper comparative framing versus incumbents.
CAPR — $CAPR ( ▼ 6.82% ) | deramiocel | Regulatory + MDA upgrade | PoA: N/A
This is the biggest new intelligence item. On Mar. 10, Capricor said FDA lifted the CRL and assigned a new Aug. 22, 2026 PDUFA for deramiocel. Then on Mar. 12, the company reported late-breaking HOPE-3 analyses showing a significant GST composite benefit, approximately 83% slowing of progression on DVA, and cardiac benefit including reduced fibrosis progression and improved LVEF in the baseline-cardiomyopathy subgroup.
BBIO — $BBIO ( ▲ 1.97% ) | BBP-418 | MDA interim strengthens NDA setup | PoA: N/A
BridgeBio’s Mar. 11 release said FORTIFY interim results showed early separation from placebo on 100-meter timed test, a roughly 31-second advantage at 12 months, broad subgroup consistency, and a safety profile comparable to placebo. The company now explicitly says it intends to submit an NDA in H1 2026.
IMMEDIATE VISIBILITY / TRADEABLE WINDOWS (NEXT ~7 DAYS)
ALDX — $ALDX ( ▼ 9.42% ) | reproxalap | PDUFA: Mon Mar 16 | PoA: 65%
This is the real hard clock in front of us. The FDA extended review to Mar. 16, 2026 after a major amendment / CSR submission. The trade is straightforward: does FDA accept the efficacy package despite the asset’s prior CRLs, or does reproxalap remain trapped in “not enough controlled evidence” purgatory.
What will trade:
whether the agency buys the resubmission as a real efficacy fix, not just procedural cleanup
any sign that labeling/PMR language is manageable rather than restrictive
RLAY — $RLAY ( ▼ 1.42% ) | zovegalisib | ESMO TAT: Mon Mar 16 | PoA: N/A
Relay has already signaled this is the first presentation of 400 mg BID fed, the Phase 3 dose, and it granted Breakthrough Therapy news in February. That makes Mar. 16 more important than a typical conference abstract: the market will be asking whether this dose keeps the activity narrative intact while staying visibly cleaner than legacy PI3K baggage.
What will trade:
whether the 400 mg BID fed dose preserves the efficacy story
whether safety remains “low-grade / manageable” enough to support ReDiscover-2 confidence
ANVS — $ANVS ( ▲ 2.03% ) | buntanetap | AD/PD presentations begin Tue Mar 17 | PoA: N/A
Not a classic binary, but still a live small-cap neuro catalyst. Annovis said its AD/PD 2026 presentations will highlight PD cognition/biomarker findings and give an update on the ongoing pivotal Phase 3 study in early AD.
RYTM — $RYTM ( ▼ 5.18% ) | IMCIVREE (AHO) | PDUFA: Fri Mar 20 | PoA: 78%
This remains the next meaningful FDA decision after ALDX. Rhythm said the sNDA is under review with a Mar. 20 goal date and that it submitted the final data package to FDA on Mar. 2. That keeps the setup constructive heading into the decision.
QUICK CALENDAR (MAR 13–MAR 20)
Day | Ticker | Event | Why it matters |
|---|---|---|---|
Mon Mar 16 | $ALDX | PDUFA (reproxalap) | real FDA binary; efficacy posture is the trade |
Mon Mar 16 | $RLAY | ESMO TAT | first look at Phase 3 dose framing for zovegalisib |
Tue Mar 17 | $ANVS | AD/PD 2026 presentations begin | PD cognition/biomarker signal + Phase 3 AD update |
Fri Mar 20 | $RYTM | PDUFA (AHO) | next clean FDA decision after ALDX |
WHAT WE MISSED / WHAT CHANGED
These are the real deltas versus the Mar. 6 Friday note:
$CAPR ( ▼ 6.82% ) is no longer just an MDA data story — it is now an active BLA review story with a new Aug. 22, 2026 PDUFA.
$BBIO ( ▲ 1.97% ) got stronger than “encouraging” phrasing — BridgeBio is now openly guiding to an H1 2026 NDA submission off interim FORTIFY.
$NBP delivered an actual positive readout, not just a scheduled call. The durability language is now the important part of the tape.
No date conflicts found in your near-term March stack for ALDX Mar 16, RLAY Mar 16, ANVS Mar 17, RYTM Mar 20, RCKT Mar 28, and LNTH-2501 Mar 29 based on the attached sheet plus current company updates.
CLOSING NOTE
This week is no longer about waiting for MDA to happen. It already happened.
The actionable shift is:
CAPR graduated from “conference volatility” to real regulatory tape
BBIO tightened its path to filing
NBP earned the right to be judged on durability
ALDX is now the only immediate hard FDA clock before RYTM next Friday.
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Disclaimer: informational only; not investment advice; biotech carries risk of total loss