FDA Calendar Q1 2026: Every PDUFA Date, Phase 3 Readout and Drug Approval in January-March
Q1 2026 is shaping up to be one of the busiest quarters for biotech catalysts in recent memory. We are tracking over 50 catalyst events between January and March, including a major PDUFA decision, multiple NDA filings, and a wave of Phase 2 and Phase 3 data readouts that could move stocks in a big way.
Below, we break down the key catalysts on the BiopharmaWatch FDA Calendar for Q1 2026, highlight the ones with the highest Probability of Approval (POA), and give you a closer look at six events we think deserve extra attention. If you are investing in biotech or just following the FDA pipeline, this is the quarter to pay close attention.
The Full Q1 2026 Catalyst Lineup
Here is a snapshot of the biggest catalysts sitting on the calendar right now. We pulled these directly from the BiopharmaWatch FDA Calendar, which tracks every upcoming readout, filing, and FDA decision date across biotech and pharma.
| Ticker | Drug / Treatment | Stage | Catalyst | POA | Indication |
|---|---|---|---|---|---|
| RCKT | KRESLADI (lenti gene therapy) | PDUFA | PDUFA Date (Mar 28) | 76% | Severe LAD-I |
| BTAI | BXCL501 (IGALMI) | NDA | NDA Filing | 82% | Agitation in bipolar/schizophrenia |
| MNPR | ALXN1840 | Phase 3 | NDA Submission | 80% | Wilson Disease |
| ALMS | ESK-001 (TYK2 inhibitor) | Phase 3 | Phase 3 data readout | 75% | Plaque psoriasis |
| ANNX | Tanruprubart (ANX005) | Phase 3 | Phase 3 data readout | 65% | Guillain-Barre Syndrome |
| OCUL | AXPAXLI (axitinib hydrogel) | Phase 3 | Phase 3 data readout | 65% | Wet AMD |
| PVLA | QTORIN rapamycin | Phase 3 | Phase 3 data readout | 60% | Microcystic lymphatic malformations |
| ATAI | VLS-01 (buccal film DMT) | Phase 2 | Phase 2 data readout | 60% | Treatment-resistant depression |
| ABVX | Obefazimod | Phase 3 | Phase 3 data readout | 55% | Ulcerative colitis |
| SXTP | ARAKODA (tafenoquine) | Phase 2 | Phase 2 data readout | 40% | Babesiosis |
| MAZE | MZE829 (APOL1 inhibitor) | Phase 2 | Interim results | 35% | APOL1 kidney disease |
| NAYA | NY-500 (PD-1 x VEGF antibody) | Phase 1/2a | Phase 1/2a data readout | 30% | HCC and solid tumors |
| PMVP | Rezatapopt (PC14586) | Phase 2 | Phase 2 data readout | 30% | TP53 Y220C solid tumors |
| OCGN | OCU410ST (modifier gene therapy) | Phase 2/3 | Phase 2/3 data readout | 20% | Stargardt disease |
| ATAI | EMP-01 | Phase 2 | Top-line data | 20% | Social anxiety disorder |
| ACRS | ATI-052 (anti-TSLP/IL-4R bispecific) | Phase 1a | Phase 1a data readout | 12% | Immuno-inflammatory diseases |
| MGX | MGX-001 (gene editing therapy) | Preclinical | IND Submission | 12% | Hemophilia A |
| PALI | PALI-2108 (PDE4 B/D inhibitor) | Phase 1b | Phase 1b data readout | 9% | Fibrostenotic Crohn's disease |
That is a lot of data points in one quarter. Some of these are binary events where the stock moves 30%+ in either direction overnight. Others are earlier-stage readouts that set the tone for where a program is headed. Either way, you want to know about them before they happen, not after.
Six Catalysts Worth a Closer Look
Not every catalyst carries the same weight. Below are six Q1 2026 events that stand out based on a combination of POA score, stage, and how much the stock could move on the news.
Rocket Pharmaceuticals (RCKT): KRESLADI PDUFA Date, March 28 - POA 76%
This is the single biggest binary event on the Q1 calendar. Rocket Pharmaceuticals has a PDUFA date set for March 28, 2026 for KRESLADI, a lentiviral gene therapy targeting severe Leukocyte Adhesion Deficiency type I (LAD-I). LAD-I is a rare, life-threatening immunodeficiency that usually kills patients in childhood without a bone marrow transplant, and there is no approved gene therapy for it today.
Rocket filed the BLA earlier this year, and the clinical data package looks solid. The POA sits at 76%, which reflects both the strength of the data and the fact that this is a rare disease with a genuine unmet need. If the FDA approves, RCKT gets a first-in-class gene therapy on the market. If they get a Complete Response Letter, expect a significant sell-off. This is the kind of event where you need to have done your homework weeks in advance.
Annexon Biosciences (ANNX): Tanruprubart Phase 3 Readout - POA 65%
Annexon's tanruprubart (formerly ANX005) is a monoclonal antibody that targets C1q, part of the classical complement pathway, for Guillain-Barre Syndrome (GBS). GBS is a rare and potentially life-threatening autoimmune disorder that attacks the peripheral nervous system. Right now there is no FDA-approved treatment. Patients get IVIg or plasma exchange, and that is about it.
Phase 3 trial results presented at the American Academy of Neurology and Peripheral Nerve Society meetings showed statistically significant improvements in core functional outcomes versus placebo. Patients treated with tanruprubart experienced rapid motor function recovery within the first week, with lasting improvement observed through week 26. Patients also achieved independent ambulation and ventilator independence roughly a month earlier than the control group, and they spent a full week less in intensive care.
The drug has FDA Breakthrough Therapy, Fast Track, and three QIDP designations. Historical approval rates for orphan neuroimmunology biologics sit between 55% and 70%. No CRLs or regulatory setbacks on record. Our POA estimate is 65%, and Annexon plans to file a BLA later in 2026 if the data holds.
PolyPid (PYPO): D-PLEX100 NDA Filing - POA 75%
PolyPid is moving toward an NDA filing for D-PLEX100, a locally applied, prolonged-release drug for preventing surgical site infections (SSIs). The data behind this one is strong. The SHIELD II Phase 3 trial showed a 58% reduction in surgical site infections with high statistical significance (p less than 0.005) across 798 patients.
SSIs are a massive problem. They cost the U.S. healthcare system up to $10 billion a year and represent a substantial unmet medical need. D-PLEX100 has FDA Breakthrough Therapy, Fast Track, and three QIDP designations, which gives it priority review eligibility and extended market exclusivity. PolyPid held a pre-NDA meeting by end of 2025, and the NDA submission is targeted for early 2026. Historical NDA approval rates for drugs at this stage sit around 90.6%, and products with breakthrough designations tend to do even better. The consistent safety profile across trials and PolyPid's partnership with ADVANZ PHARMA for European commercialization add further confidence. We estimate a 75% probability of regulatory approval.
Alumis (ALMS): ESK-001 Phase 3 for Plaque Psoriasis - POA 75%
Alumis is running two pivotal Phase 3 trials (ONWARD1 and ONWARD2) for ESK-001, an oral TYK2 inhibitor for moderate-to-severe plaque psoriasis. This is a competitive space, but ESK-001 has shown strong efficacy that keeps getting better over time.
In Phase 2 open-label extension data presented in early 2025, PASI 90 response rates went from 52.4% at Week 12 to 61.3% at Week 52. PASI 100 rates climbed from 26.8% to 38.8%. Safety and tolerability stayed favorable throughout. The Phase 3 trials include an active comparator arm against apremilast (the current standard oral therapy), which is exactly what the FDA wants to see. No CRLs, no regulatory delays, and Phase 3 success rates for oral small molecule drugs in dermatology run between 60% and 75%. Our POA estimate: 75%.
Atai Life Sciences (ATAI): VLS-01 Phase 2 for Treatment-Resistant Depression - POA 60%
VLS-01 is a buccal film formulation of DMT developed by Atai Life Sciences for treatment-resistant depression (TRD). This is one of the more interesting psychedelic-derived therapies in development because of how practical the delivery method is. The buccal film induces a short psychedelic experience that resolves within 90 to 120 minutes, which means the entire in-clinic treatment takes about two hours. That is a big deal for scalability.
Phase 1b data showed favorable safety and tolerability along with meaningful improvements in depression scores. The Phase 2 Elumina trial is a randomized, double-blind, placebo-controlled study using the MADRS scale as its primary endpoint. Topline results from the first treatment period are expected in Q1 2026. There are no regulatory designations yet and no PDUFA date, but the Phase 2 readout will be a make-or-break moment for the program. No CRLs or delays on record. Our POA sits at 60%, which reflects the strong early signal offset by the fact that psychedelic drugs in psychiatry are still proving themselves to regulators.
Monopar Therapeutics (MNPR): ALXN1840 NDA for Wilson Disease - POA 80%
Monopar is preparing to submit an NDA for ALXN1840, an oral therapy for Wilson disease, a rare genetic disorder caused by copper accumulation. The pivotal Phase 3 FoCus trial compared ALXN1840 against standard treatments (chelation and zinc therapy), and long-term data presented at EASL 2025 showed sustained improvements in both patient-reported and clinician-assessed symptoms, along with increased copper mobilization.
ALXN1840 has Orphan Drug Designation in both the U.S. and EU, which means faster regulatory review. There have been no CRLs or regulatory setbacks. The drug's mechanism of action, selectively binding and removing excess copper, is well-matched to the biology of the disease. With a strong data package, orphan designation, and no regulatory red flags, we put the POA at 80%.
More Q1 2026 Catalysts at a Glance
Beyond the six deep dives above, there are plenty of other catalysts that could move stocks this quarter. Here is a quick rundown:
- BioXcel (BTAI) is filing its NDA for BXCL501 (IGALMI) for acute agitation in bipolar and schizophrenia. POA: 82%. This one is further along than most people realize.
- Ocular Therapeutix (OCUL) expects Phase 3 data from the SOL-1 trial for AXPAXLI in wet AMD. POA: 65%. The sustained-release hydrogel implant could change the injection burden for patients.
- Palvella (PVLA) should report top-line Phase 3 SELVA trial results for QTORIN rapamycin in microcystic lymphatic malformations. POA: 60%. First potential approved therapy for this condition.
- Abivax (ABVX) has Phase 3 maintenance data coming for obefazimod in ulcerative colitis. POA: 55%. The ABTECT program enrolled 1,275 patients.
- 60 Degrees Pharma (SXTP) expects Phase 2 interim data for ARAKODA (tafenoquine) in babesiosis. POA: 40%. Repurposing an approved malaria drug for a tick-borne infection.
- Maze Therapeutics (MAZE) is reading out Phase 2 interim data for MZE829, an oral APOL1 inhibitor for APOL1 kidney disease. POA: 35%. First-in-class drug targeting over one million patients in the U.S.
- PMV Pharma (PMVP) has Phase 2 data for rezatapopt in TP53 Y220C solid tumors. POA: 30%. Precision oncology play targeting a specific mutation.
- NAYA Biosciences (NAYA) is reading out Phase 1/2a data for NY-500, a PD-1 x VEGF bifunctional antibody in HCC and solid tumors. POA: 30%.
- Ocugen (OCGN) has Phase 2/3 data coming for OCU410ST, a modifier gene therapy for Stargardt disease. POA: 20%.
- Aclaris (ACRS) expects Phase 1a data for ATI-052, a bispecific anti-TSLP/IL-4R antibody for immuno-inflammatory diseases. POA: 12%.
- Metagenomi (MGX) plans to submit an IND for MGX-001, a gene editing therapy for hemophilia A. POA: 12%. Very early, but the preclinical data in nonhuman primates showed sustained Factor VIII activity for over 16 months.
- Palisade Bio (PALI) expects Phase 1b results for PALI-2108, a gut-targeted PDE4 B/D inhibitor for fibrostenotic Crohn's disease. POA: 9%. Early stage, but a novel approach to a tough-to-treat condition.
Why This Quarter Matters for Your Portfolio
When you look at the Q1 2026 calendar, you are looking at a mix of late-stage binary events (RCKT's PDUFA, BTAI's NDA, MNPR's NDA) and earlier-stage readouts that will shape how the market values these companies for the next 12 to 18 months. The POA numbers give you a starting point, but they are not the whole picture. You also want to think about market cap relative to the opportunity, what the stock has already priced in, and whether there is a run-up trade or a post-catalyst play.
The point is: you need to see these dates coming. That is exactly what the BiopharmaWatch FDA Calendar is built for. Every catalyst, every readout, every PDUFA date, updated daily, with POA scores, stage filters, therapeutic area filters, and the ability to search by company or ticker.
If you are not already using it, check it out here. It is free, and it is the fastest way to stay on top of what is actually moving biotech stocks.