PDUFA Pulse

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$SPRO moves onto the forward board. PDUFA: Jun 18 Asset: tebipenem HBr - potential first oral carbapenem for cUTI incl. pyelo Partner: GSK PIVOT-PO stopped early for efficacy PoA 92.5%. Cleanest small-cap setup in the June window. archive.pdufapulse.com

Big one June 2: $AZN DATROWAY® sBLA decision. 1L metastatic TNBC, patients ineligible for PD-1/PD-L1. TROPION-Breast02: 43% reduction in progression/death, ~5-mo OS benefit vs chemo. Priority Review. PoA 86%. Among the highest-conviction setups in the window. t.co/8q4r41aJNB

$MNKD next Friday. PDUFA May 29, Afrezza peds T1D/T2D ages 4–17. PoA 72%. Cleanest debate on the board: • INHALE-1 missed HbA1c noninferiority on full ITT • Defense rests on modified analysis excluding one nonadherent patient • Pulm function, weight, satisfaction all support FDA call is whether the sensitivity case holds.

Adding $IRWD to the live FDA board. PDUFA: Sun May 24 Asset: LINZESS® for functional constipation, ages 2–5 PoA: 65% Already approved in older peds. Ages 2–5 is the harder review — safety sensitivity is higher and the under-2 contraindication keeps the risk conversation alive.

Next 6 weeks of FDA catalysts: IRWD → MNKD → CING → AZN SPRO → ACHV → ARQT Starts May 24 with Ironwood (LINZESS, peds FC ages 2–5). Ends June 29 with Arcutis (ZORYVE, peds psoriasis). 🔸Full board in today's PDUFA Pulse 👇 archive.pdufapulse.com

📅 PDUFA COUNTDOWN: Afrezza pediatric — May 29, 2026 $MNKD — MannKind Corporation FDA decision on sBLA to expand Afrezza (inhaled insulin) to children & adolescents ages 4-17 with T1D or T2D. Why this matters: • If approved → FIRST needle-free mealtime insulin for pediatric patients • Inhaled insulin has been available to adults for 10+ years. Zero needle-free options exist for kids. • Based on Phase 3 INHALE-1: 52 weeks of safety/efficacy data, Afrezza + basal insulin vs. MDI • INHALE-1ST trial (newly diagnosed peds T1D) also enrolling ~100 patients The needle burden in pediatric diabetes is real. Multiple daily injections in a 4-year-old is a different clinical reality than in adults. 14 days out. ⏳ $MNKD | PDUFA May 29

FDA Center for Drug Evaluation & Research (CDER) Acting Director Tracy Beth Hoeg expected to depart from agency - Reuters

🔔 PDUFA UPDATE | $BIIB / Eisai Leqembi Iqlik SC starting dose pushed: May 24 → August 24, 2026 🔷FDA requested additional info and classified it as a major amendment, triggers an automatic 3-month extension. No approvability concerns have been raised. 🔷This sBLA is for weekly 500mg SC as a starting dose. SC maintenance (360mg) was already approved in Aug 2025, but patients still need IV infusions to initiate treatment. 🔷Approval here = first anti-amyloid with at-home injection from Day 1 through maintenance. The IV requirement has been the single biggest adoption barrier for Leqembi. This filing removes it. Clarity AD OLE data showed SC achieved equivalent exposure to biweekly IV. Leqembi is now approved in 53 countries. New PDUFA: August 24, 2026 📅

Otarmeni (Regeneron) - first gene therapy for genetic hearing loss. • Approved Apr 23 under CNPV pilot • 61 days from BLA filing → approval (tied for fastest modern BLA) • Regeneron offering it free to US patients • Accelerated approval; confirmatory durability data still required The CNPV pilot is the meta-story here. FDA hosting a public meeting Jun 4 to discuss the program's criteria and process. Worth watching if you care about future accelerated review pathways.

$AZN / $DSNKY — Enhertu neoadjuvant sBLA PDUFA: May 18 FDA reviewing T-DXd → THP for high-risk HER2+ stage II/III breast cancer (DESTINY-Breast11). Separate from the post-neoadjuvant sBLA (DESTINY-Breast05), which has a Jul 7 PDUFA after Priority Review + BTD. Two Enhertu decisions in ~7 weeks.

Not every FDA catalyst is a tiny biotech binary. $AZN has a June 2 Priority Review date for DATROWAY in 1L metastatic TNBC patients who are not candidates for PD-1/PD-L1 therapy. Less casino feel than small-cap binaries. Still meaningful label-expansion stakes.

$CING is not a “new molecule” story. It’s a 505(b)(2) ADHD setup: known active ingredient, differentiated timed-release delivery, and a bid for full-day symptom control. That can be cleaner than novel biology. But the market question is whether differentiation matters in a crowded stimulant category.

A useful way to read FDA catalysts: The commercial hook is not always the regulatory hook. For $MNKD, the commercial hook is needle-free insulin. The regulatory hook is pediatric efficacy + pulmonary safety. Investors tend to trade the first. FDA reviews the second.

$MNKD is now the next hard FDA clock. The obvious bull case: pediatric Afrezza = needle-free mealtime insulin for ages 4–17. The real FDA question is narrower: Can the HbA1c noninferiority + pulmonary monitoring package support pediatric expansion?

FDA is calling on patients, clinicians, and researchers to help identify drugs that could be repurposed to treat chronic and rare diseases and help address other unmet medical needs. Share your ideas to help advance new treatment options. fda.gov/news-events/pr…

PDUFA Pulse is out. The board rotated again: ✅ $ARGX — approved May 8. Done. ➡️ $BIIB — extended to August. Gone. Live stack: $MNKD → May 29 $CING → May 31 $AZN → Jun 2 $ACHV → Jun 20 $ARQT → Jun 29 Next hard clock is $MNKD. 18 days out. Read it free 👇 t.co/8q4r41aJNB

it has been an insane week in biotech - Isomorphic Labs raised $2B on top of $600M. Demis Hassabis is betting everything that AI can design drugs better than humans. Thrive and Alphabet both in. - Odyssey Therapeutics IPO'd at $304M. ninth biotech to go public in 2026. collectively raised $3.2B in IPOs this year alone. - Bayer made its first drug company acquisition in years, centered around a glaucoma therapy. longevity adjacency is real. - biotech M&A already on a faster pace than every year since 2018 - Enhanced Games start this month. Peter Thiel backed. $1M prize for breaking the 100m sprint record. a swimmer already broke a world record two months into his stack. and we are still very bullish on: - gene therapy - longevity - human data infrastructure - neurotech - peptides and protocol validation - epigenetic reprogramming - generally non-consensus bio the stuff that felt fringe two years ago is becoming the category bio/acc

BREAKING: President Trump has reportedly signed off on firing FDA Commissioner Marty Makary after a chaotic 14-month tenure. This caps off one of the most volatile periods in modern FDA history. Makary’s leadership saw a massive talent drain—with over 3,500 staff exits driven by DOGE mandates—and a revolving door of executives, including 5 different CDER heads in just 18 months. Crucially for biotech, Makary enabled the highly controversial Vinay Prasad at CBER, whose unpredictable CRLs and strict RCT demands crushed multiple innovative pipelines. The Alpha: The FDA is now facing a total leadership vacuum. While the departure of Makary (and previously Prasad) removes a highly restrictive and arbitrary regulatory regime, the intense politicization of the agency creates massive short-term uncertainty. Keep a close eye on biotechs that recently received surprise CRLs or rejections under the previous regime, such as Replimune ($REPL), Capricor ($CAPR), and Disc Medicine ($IRON). A new acting commissioner could open the door for immediate regulatory appeals and a pivot back to flexibility. $REPL $CAPR $IRON $MRNA $XBI $IBB

Proud moment for the FDA—the first real-time clinical trial!

PDUFA Pulse drops tomorrow 6 AM PST. The board reshuffled last week: ✅ $ARGX — approved May 8, off the board ➡️ $BIIB — extended to August, off the near-term board The next live stack: $MNKD → $CING → $AZN → $ACHV → $ARQT $MNKD is the next hard clock. May 29. Pediatric inhaled insulin. The INHALE-1 HbA1c read is the scrutiny point. Full breakdown in tomorrow's issue: (it's free sign up!) t.co/8q4r41aJNB