PoA = directional probability band (not FDA guidance).
Rule: FDA decision events get a %; data/webinars/conferences get N/A.
THE FRAME (MAR 16–22): “ONE HARD FDA CLOCK → AD/PD CLUSTER → FRIDAY AHO DECISION”
This week has a cleaner shape than last week:
Today: one real FDA binary, $ALDX ( ▲ 7.15% ) . The March 16 PDUFA remains the live clock.
Today: one meaningful oncology data event, $RLAY ( ▲ 0.1% ) at ESMO TAT, now with explicit 400 mg BID fed Phase 3-dose framing and recent Breakthrough Therapy support.
Midweek: AD/PD becomes the real volatility cluster, led by $ANVS ( ▲ 9.92% ) , $GANX ( ▲ 3.29% ) , and then $CRVO ( ▼ 3.77% ) .
Friday: next hard FDA decision is $RYTM ( ▲ 1.29% ) for acquired hypothalamic obesity. Rhythm said on March 1 it would submit the final data package on March 2, 2026.
WHAT CHANGED SINCE LAST MONDAY
CAPR — $CAPR ( ▲ 2.71% ) | deramiocel | Now an active BLA review story | PoA: N/A
FDA resumed review, assigned a new Aug. 22, 2026 PDUFA, and Capricor followed with new HOPE-3 analyses showing added functional and cardiac support. That moves CAPR out of “conference only” territory and into real regulatory tape.
RLAY — $RLAY ( ▲ 0.1% ) | zovegalisib | Now more important than a routine conference abstract | PoA: N/A
Relay has now clearly framed the March 16 presentation around initial Phase 1/2 data at 400 mg BID fed, the Phase 3 dose, and the program already carries Breakthrough Therapy designation.
GANX — $GANX ( ▲ 3.29% ) | GT-02287 | New FDA nuance added | PoA: N/A
Gain said it remains on track for a Phase 2 start in 3Q26 after submitting additional preclinical data requested by FDA in support of an IND. That gives the name more than just “conference biomarker” relevance.
THIS WEEK’S HARD EVENTS (IN ORDER)
ALDX — $ALDX ( ▲ 7.15% ) | reproxalap (dry eye) | PDUFA: Mon Mar 16 | PoA: 65%
This is the immediate hard clock. FDA’s current target remains March 16, 2026, after the prior extension tied to a major amendment / clinical study report.
What will trade:
whether the agency treats the resubmission as a substantive efficacy fix
any label/PMR language that signals “approvable but constrained” versus clean clearance
RLAY — $RLAY ( ▲ 0.1% ) | zovegalisib | ESMO TAT: Mon Mar 16 | PoA: N/A
This is the first real look at the 400 mg BID fed Phase 3 dose in breast cancer.
What will trade:
whether the 400 mg BID fed dose preserves the efficacy story
whether safety still looks cleaner than legacy PI3K baggage
AD/PD CLUSTER (MAR 17–21): THE MIDWEEK STORYTAPE
ANVS — $ANVS ( ▲ 9.92% ) | buntanetap | AD/PD presentations begin Tue Mar 17 | PoA: N/A
Annovis says the presentations will focus on PD cognition and biomarker findings and provide an update on the ongoing pivotal Phase 3 study in early AD.
GANX — $GANX ( ▲ 3.29% ) | GT-02287 | Oral symposium: Wed Mar 18 | PoA: N/A
Gain says the oral will include interim Phase 1b biomarker and clinical endpoints, with emphasis on CNS target engagement and early clinical-improvement signals.
CRVO — $CRVO ( ▼ 3.77% ) | neflamapimod | Scientific symposium: Fri Mar 20 | PoA: N/A
CervoMed’s setup is more strategic than binary: new analyses are positioned to support the planned Phase 3 dosing regimen and enrichment strategy in DLB without AD co-pathology.
ABOS — $ABOS ( ▲ 1.22% ) | sabirnetug | Oral presentation: Sat Mar 21 | PoA: N/A
Acumen’s AD/PD presence is not a topline efficacy readout. The company is presenting brain-delivery and CSF biomarker treatment-response data around sabirnetug.
NEXT HARD FDA CLOCK
RYTM — $RYTM ( ▲ 1.29% ) | IMCIVREE (acquired hypothalamic obesity) | PDUFA: Fri Mar 20 | PoA: 78%
This remains the next meaningful FDA decision after ALDX. Rhythm reiterated the March 20, 2026 goal date and said on March 1 that it would submit the final data package to FDA on March 2. The setup still reads constructive.
WEEKLY CALENDAR (ONE SCREEN)
Date | Ticker | Catalyst | PoA |
|---|---|---|---|
Mon Mar 16 | $ALDX | PDUFA — reproxalap | 65% |
Mon Mar 16 | $RLAY | ESMO TAT — zovegalisib | N/A |
Tue Mar 17 | $ANVS | AD/PD presentations begin | N/A |
Wed Mar 18 | $GANX | AD/PD oral symposium | N/A |
Fri Mar 20 | $RYTM | PDUFA — IMCIVREE (AHO) | 78% |
Fri Mar 20 | $CRVO | AD/PD scientific symposium | N/A |
Sat Mar 21 | $ABOS | AD/PD oral presentation | N/A |
NEXT-UP HARD CLOCKS (BEYOND THIS WEEK)
These sit just outside the current Monday window and become the immediate watchlist for next week:
Date | Ticker | Catalyst |
|---|---|---|
Tue Mar 24 | PDUFA — linerixibat (PBC) | |
Sat Mar 28 | PDUFA — KRESLADI (LAD-I) | |
Sun Mar 29 | PDUFA — LNTH-2501 (SSTR+ NETs) |
WEEKLY POSTURE (ONE PARAGRAPH)
This week starts with a real FDA binary (ALDX) and a meaningful oncology data check (RLAY), then pivots into a neuro storytape cluster where the market is mostly trading mechanistic coherence, biomarker credibility, and Phase 3 path clarity (ANVS → GANX → CRVO/ABOS). The next clean hard decision after today is $RYTM on Friday, and the following week already has a visible three-clock setup in GSK / RCKT / LNTH.
Disclaimer: informational only; not investment advice; biotech carries risk of total loss