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Hey everyone, back with the weekly rundown.
I'm the dev behind CatalystAlert.io. Each week I pull from our calendar and lay out what's ahead so you can do your own research. Not investment advice, just the calendar.
As always, cross-check against company IR pages and FDA.gov before relying on any of this.
**Last Week's Scorecard (May 19-25)**
What tracked as resolved:
UCBJY (UCB): FINTEPLA received a formal FDA approval on May 22, matching the PDUFA date. NDA NDA212102. $54B company.
HRMY (Harmony Biosciences): Wakix (pitolisant) sNDA shows a positive outcome in our system covering cataplexy in pediatric narcolepsy. Our confirmation date is February 18, earlier than the May 19 PDUFA date we were tracking. This was likely approved ahead of schedule. Verify the exact timeline via the company's press releases. $1.3B company.
Phase 3 positive outcomes already confirmed in our data:
AMGN (Amgen): Romiplostim in chemotherapy-induced thrombocytopenia, 162 patients enrolled, positive outcome confirmed April 7. $150B.
BMY (Bristol-Myers Squibb): Ozanimod in ulcerative colitis, 120 patients enrolled, positive outcome confirmed February 27. $84B.
TAK (Takeda): Vedolizumab IV in Crohn's disease, 120 patients enrolled, positive outcome confirmed March 30. $50B.
Still open from last week (no confirmed outcome in our data):
SOBI (Swedish Orphan Biovitrum): Efanesoctocog alfa in severe Hemophilia A, 93 enrolled. No outcome yet.
SNY (Sanofi): Amlitelimab in atopic dermatitis, 390 enrolled. No outcome yet.
UCBJY (UCB): Bimekizumab in psoriatic arthritis, 1,131 enrolled. Large trial, still pending.
Three PDUFAs from last week are marked as withdrawn from our tracking after we could not verify the underlying source data: CINGW (CTx-1301, ADHD, May 19), CRNX (paltusotine, acromegaly, May 21), and RARE (DTX401, glycogen storage disease type Ia, May 22). If you have confirmed information on any of these, drop it in the comments.
**This Week (May 26-June 1): Heavy Phase 3 window, quiet on PDUFAs**
PDUFA watch: None active this week. Both entries we had for this window are withdrawn from our database after verification issues. TNXP (TNX-1800 for COVID-19, May 31) and DNLI (DNL310 for Hunter syndrome, June 1) are no longer tracked.
Phase 3 calendar:
**May 27**
SNY (Sanofi): RSVt vaccine in RSV immunization, 6,300 patients enrolled. This is one of the largest RSV trial completions in the near-term window. Sanofi has been building its RSV vaccine program and this dataset lands in a market where GSK's Arexvy and Pfizer's Abrysvo are already established. $106B company.
**May 29**
NVS (Novartis): Ribociclib in early (adjuvant) breast cancer, 5,101 patients enrolled. Large CDK4/6 inhibitor trial in the early-stage setting, distinct from the advanced disease trials that defined the class. $288B company.
AZN (AstraZeneca): Durvalumab in unresectable locally advanced urothelial cancer, 908 enrolled. $292B.
AZN (AstraZeneca): Benralizumab in severe eosinophilic asthma, 504 enrolled.
**May 30**
RHHBY (Roche): Alectinib in neoplasms, 200 enrolled. The same trial has a crizotinib comparison arm that already reported a negative outcome in March. $339B.
VNDA (Vanda Pharmaceuticals): Tradipitant in motion sickness, 705 enrolled. NK1 receptor antagonist, Phase 3 completion. $269M company.
**May 31**
RHHBY (Roche): Mosunetuzumab vs rituximab/lenalidomide comparison in relapsed or refractory follicular lymphoma, 478 enrolled. Multiple arms of this trial (bispecific antibody vs standard chemoimmunotherapy) complete this week.
TEVA (Teva Pharmaceutical): Fp/ABS combination in asthma, 724 enrolled. $18B.
Also on the May 31 calendar: VRTX (Vertex) has two trials with May 31 completion dates, VX-147 in proteinuric kidney disease and CTX001 in sickle cell disease. Both reported positive results in March, ahead of the primary completion date. Already resolved.
**June 1**
OTSKF (Otsuka): Centanafadine in ADHD, 308 enrolled. $34B.
ARDX (Ardelyx): Tenapanor 50mg in IBS-C, 180 enrolled. $924M.
HNSPF (Hansoh Pharmaceutical): HS-20117 in non-squamous non-small cell lung cancer, 1,080 enrolled. Chinese company listed on HKEX.
**PDUFA Dates: Looking Ahead to June 2-15**
|Expected|Ticker|Company|Notes|
|:-|:-|:-|:-|
|Jun 7|ARGX|argenx|Efgartigimod priority BLA for generalized myasthenia gravis. Our data shows this as approved but we have no confirmed decision date. Verify via FDA.gov before acting on this. $50B.|
|Jun 8|RYTM|Rhythm Pharmaceuticals|IMCIVREE priority NDA for obesity caused by genetic deficiencies. Same situation, shows approved in our data without a confirmed date. Verify. $7.4B.|
|Jun 10|BMY|Bristol-Myers Squibb|Sotyktu (deucravacitinib) for psoriatic arthritis. FDA approved this on April 1, ahead of the June 10 PDUFA date. Already resolved. $84B.|
|Jun 15|IRON|Disc Medicine|DISC-0123 NDA. Complete Response Letter received April 1, ahead of the June 15 PDUFA date. Outcome: negative. $983M.|
If any of these are wrong or stale, tell us. We trace every correction back to the source.
**Phase 3 Completions: June 2-15**
**June 2**
NVO (Novo Nordisk): Tirzepatide in type 2 diabetes, 1,023 enrolled. $197B.
AZN (AstraZeneca): Durvalumab in esophageal squamous cell carcinoma, 640 enrolled.
UCBJY (UCB): Zilucoplan (RA101495) in generalized myasthenia gravis, 200 enrolled. $54B.
**June 5**
SNY (Sanofi): MenACYW conjugate vaccine in meningococcal infection, 1,602 enrolled.
IPSEY (Ipsen): Botulinum toxin type A in episodic migraine, 759 enrolled. $17B.
TAK (Takeda): Zasocitinib in plaque psoriasis, 606 enrolled. $50B.
**June 8**
SNY (Sanofi): Dupilumab in lichen simplex chronicus, 138 enrolled.
UCBJY (UCB): Rozanolixizumab in generalized myasthenia gravis, 12 enrolled. Small cohort, early signal read.
**June 11**
GSK (GSK): BLU-5937 in chronic cough, 975 enrolled. Selective P2X3 antagonist. $104B.
**June 15**
CGON (CG Oncology): Cretostimogene grenadenorepvec in non-muscle-invasive bladder cancer, 367 enrolled. $1.7B.
ARWR (Arrowhead Pharmaceuticals): Plozasiran injection in severe hypertriglyceridemia, 311 enrolled. $1.4B.
IONS (Ionis Pharmaceuticals): ION363 in ALS, 89 enrolled. Small but watched closely given the indication. $5.3B.
AKBA (Akebia Therapeutics): Vadadustat in CKD-related anemia, 350 enrolled. $946M.
FOLD (Amicus Therapeutics): Cipaglucosidase alfa plus miglustat in late-onset Pompe disease, 21 enrolled. $1.7B.
**Themes to watch this window**
Myasthenia gravis concentration in the June 2-8 stretch: UCB zilucoplan Phase 3 completes June 2, the argenx efgartigimod PDUFA falls June 7 (already showing approved in our database, verify), and UCB rozanolixizumab Phase 3 completes June 8. Three gMG data points inside six days, covering both complement inhibition and FcRn targeting approaches. Worth tracking if you follow this indication.
RSV vaccine landscape: Sanofi's RSVt vaccine Phase 3 primary completion on May 27 with 6,300 patients enrolled is the largest near-term RSV dataset in our calendar. The established players (GSK, Pfizer) have existing market share. How Sanofi's efficacy data compares will shape the longer-term competitive picture for adult RSV vaccination.
CDK4/6 inhibitor in early breast cancer: Ribociclib completing its 5,101-patient adjuvant trial on May 29 is a meaningful dataset for this class in the early-stage setting. The CDK4/6 inhibitors are standard of care in advanced disease but adjuvant results across the class have been mixed depending on drug and regimen. This is a genuine uncertainty read.
**Free educational content on CatalystAlert**
Free learning hub at catalystalert.io/learn, no signup:
PDUFA Dates Explained: What FDA action dates mean and why they shift (8 min)
Advisory Committee Meetings: How AdCom votes actually impact approvals (10 min)
Clinical Trial Phases: Phase 1/2/3 design, endpoints, success rates (12 min)
FDA Special Designations: Orphan Drug, Breakthrough, Fast Track, Priority (9 min)
Biotech Catalyst Trading: How to identify, track, and position around catalysts (15 min)
NDA vs BLA Applications: Drug vs biologics applications explained (6 min)
Disclaimer: The data presented is for informational purposes only and does not constitute investment advice. We are not a source of truth. Dates, drug names, trial phases, and any other data points may contain errors, be outdated, or be inaccurate. Catalyst dates can shift, trials get delayed or cancelled, and outcomes are inherently uncertain. Always verify against official sources (SEC filings, FDA.gov, ClinicalTrials.gov, company press releases) before making any decisions. Use at your own risk.
**We want your feedback, especially the critical kind**
Biotech data is messy. If you spot a wrong date, a drug that doesn't match its indication, a PDUFA that was actually a CRL or was never resubmitted, a Phase 3 that already read out or was discontinued, a ticker mapped to the wrong company, or anything that just doesn't look right, drop a comment or DM. Every correction gets traced back to the source. If it's a systemic issue, we fix the pipeline so the same class of error can't repeat.
All data pulled from CatalystAlert.io. Feedback, feature requests, bug reports all welcome.

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CRNX
Crinetics Pharmaceuticals, Inc.
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