RegulaEdge

Daily FDA & CMS regulatory intelligence for biotech and pharma investors. Signals by 7am. Not investment advice.

[RegulaEdge @RegulaEdge]

6/3 — 🟡 MED IMPACT — CMS Rule

$MOH ↓ CNC ↓ ELV ↓ UNH ↓

CMS issued an interim final rule requiring c...

Source: https://t.co/LtVlID4FiV
Full signal: https://t.co/tzR8wOoUpD

#CMS #healthcarefinance #investing

[RegulaEdge @RegulaEdge]

6/1 — 🏛 FDA policy watch

Streamlined nonclinical safety requirements for oncology biologics and ADCs could meaningfully compress preclinical timelines, accelerating IND filings and reducing early-stage development costs. This sig...

#FDA #biotech #regulatory

[RegulaEdge @RegulaEdge]

6/1 — 📊 RegulaEdge signal accuracy — last 90 days

20 of 54 HIGH/MED signals called correctly at T+5 (37%)

Methodology: UP signal correct if price >+1% at T+5. DOWN correct if <-1%.

Full track record: https://t.co/4ZHsISbGH2

#quant #biotech #FDA

[RegulaEdge @RegulaEdge]

6/1 — 🔴 HIGH IMPACT — SEC 8-K Corporate Disclosure

$RLYB ↑

Rallybio Corp (RLYB) has announced a reverse merger with priva...

Source: https://t.co/urCW8PsTjn
Full signal: https://t.co/kvdFdDt87N

#biotech #SEC #investing

[RegulaEdge @RegulaEdge]

5/29 — 🏛 FDA policy watch

Patient input gathered here shapes future FDA guidance on clinical endpoints for chronic wound therapies, potentially clarifying approval pathways for an underserved indication. Investors in wound care b...

#FDA #biotech #regulatory

[RegulaEdge @RegulaEdge]

5/29 — 📋 This week in FDA & CMS

APGE ↑ — 8-K: Apogee Therapeutics, Inc. (APGE) …
OTLK ↑ — 8-K: Outlook Therapeutics, Inc. (OTLK)…
$APGE ↑ — 8-K: Apogee Therapeutics, Inc. (APGE) …

Full signals: https://t.co/4ZHsISbGH2

#FDA #biotech #investing

[RegulaEdge @RegulaEdge]

5/28 — ⚠️ Proposed rule to watch — FDA

$MRNA

FDA's VRBPAC meets June 18, 2026 to review Moderna's mRNA flu vaccine MFLUSIVA —

Full signal: https://t.co/m832BZB3RR

#FDA #biotech #investing

[RegulaEdge @RegulaEdge]

5/28 — 🏛 FDA policy watch

FDA's comment period extension signals cautious, deliberate policymaking on AI-driven trial design—delaying near-term clarity but reducing downstream regulatory risk. Investors should monitor final guida...

#FDA #biotech #regulatory

[RegulaEdge @RegulaEdge]

5/28 — ⏰ PDUFA in 3 days

review

Cingulate Inc.. FDA action date: May 31.

Full calendar: https://t.co/9XUFW37LAP

#PDUFA #biotech #FDA

[RegulaEdge @RegulaEdge]

5/28 — ⚪ LOW IMPACT — SEC 8-K Corporate Disclosure

$IMUX →

Immunic, Inc. (IMUX) is presenting additional Phase 2 CALLIPER...

Source: https://t.co/urCW8PsTjn
Full signal: https://t.co/V5AbN2XFti

#biotech #SEC #investing

[RegulaEdge @RegulaEdge]

5/27 — 🏛 FDA policy watch

Legacy DESI closures signal FDA housekeeping, not pipeline risk. Investors should note tightening enforcement on unapproved legacy combinations, but market impact is minimal with no major commercial prod...

#FDA #biotech #regulatory

[RegulaEdge @RegulaEdge]

5/27 — ⏰ PDUFA in 3 days

$ALDX — Aldeyra Therapeutics, Inc.

Signs and Symptoms of Dry Eye Disease Lexington, Mass, Aldeyra Therapeutics, Inc.. FDA action date: May 30.

Full calendar: https://t.co/9XUFW38jqn

#PDUFA #biotech #FDA

[RegulaEdge @RegulaEdge]

5/27 — 🔴 HIGH IMPACT — SEC 8-K Corporate Disclosure

$APGE ↑ REGN ↓ SNY ↓ LLY ↓

Apogee Therapeutics (APGE) announced...

Source: https://t.co/urCW8Ptr8V
Full signal: https://t.co/776mkGi8x5

#biotech #SEC #investing

[RegulaEdge @RegulaEdge]

5/22 — 🏛 FDA policy watch

Routine bioequivalence guidance updates signal stable generic drug pathways, posing no disruption to ANDA timelines or approval velocity. Predictable FDA procedural activity supports steady generic pipel...

#FDA #biotech #regulatory

[RegulaEdge @RegulaEdge]

5/22 — 📋 This week in FDA & CMS

$WVE ↑ — 8-K: Wave Life Sciences Ltd. (WVE) — 2026-…
OTLK → — 8-K: Outlook Therapeutics, Inc. (OTLK) — 2…
AORT ↑ — 8-K: Artivion, Inc. (AORT) — 2026-05-18

Full signals: https://t.co/4ZHsIScewA

#FDA #biotech #investing

[RegulaEdge @RegulaEdge]

5/22 — 🟡 MED IMPACT — FDA Notice

$MRNA ↑

FDA has scheduled a Vaccines and Related Biological Products Advisory Comm...

Source: https://t.co/LtVlID5d8t
Full signal: https://t.co/1fWcgD84LH

#biotech #FDA #investing

[RegulaEdge @RegulaEdge]

5/20 — 🟡 MED IMPACT — CMS Rule

$CVS → ELV → MOH → CNC →

CMS finalizes the 2027 Notice of Benefit an...

Source: https://t.co/LtVlID4FiV
Full signal: https://t.co/7lXGGe72cR

#CMS #healthcarefinance #investing

[RegulaEdge @RegulaEdge]

5/19 — ⚪ LOW IMPACT — SEC 8-K Corporate Disclosure

$TRDA →

Entrada Therapeutics (TRDA) filed an 8-K containing a May 2026...

Source: https://t.co/urCW8PsTjn
Full signal: https://t.co/znSVY5ewzG

#biotech #SEC #investing

[RegulaEdge @RegulaEdge]

5/18 — 🔴 HIGH IMPACT — SEC 8-K Corporate Disclosure

$OTLK →

Outlook Therapeutics (OTLK) has completed a formal dispute re...

Source: https://t.co/urCW8PsTjn
Full signal: https://t.co/SiPdqIVgpa

#biotech #SEC #investing

[RegulaEdge @RegulaEdge]

5/15 — 🔧 How it works

"We parse every Federal Register drop in real time, run it through our policy impact engine, and surface the trades that matter before the Street catches up."

https://t.co/jYu4w7T3aZ

#buildinpublic #fintech #FDA