FDA Calendar Q2 2026: Every PDUFA Date, Phase 3 Readout and Drug Approval in April-June
Q2 2026 is shaping up to be one of the busiest quarters for biotech catalysts we have ever tracked. We are following 272 catalyst events between April and June, including 17 PDUFA decisions, 52 Phase 3 data readouts, 25 NDA/BLA filings, and dozens of Phase 2 readouts that could reshape the biotech landscape.
Below, we break down the key catalysts on the BiopharmaWatch FDA Calendar for Q2 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 Q2 2026 PDUFA Calendar
Here is a snapshot of every PDUFA decision 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.
| Date | Ticker | Drug / Treatment | Indication | POA |
|---|---|---|---|---|
| Apr 3 | BIIB | nusinersen (SPINRAZA) | spinal muscular atrophy (SMA) | 78% |
| Apr 10 | REPL | RP1 (vusolimogene oderparepvec) | advanced melanoma | 62% |
| Apr 10 | REPL | RP1 (vusolimogene oderparepvec) | anti-PD-1 failed melanoma | 60% |
| Apr 13 | TVTX | FILSPARI (sparsentan) | Focal Segmental Glomerulosclerosis (FSGS) | 68% |
| Apr 23 | GRCE | GTx-104 (injectable formulation of nimodipine) | aneurysmal Subarachnoid Hemorrhage (aSAH) | 70% |
| Apr 28 | MRK | doravirine/islatravir | HIV-1 | 85% |
| Apr 30 | AXSM | AXS-05 | Alzheimer’s disease agitation | 78% |
| May 10 | ARGX | VYVGART® (efgartigimod alfa-fcab) | Acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG) | 87% |
| May 18 | TSE:4568, AZN | ENHERTU (fam-trastuzumab deruxtecan-nxki) | Neoadjuvant treatment of adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer (ENHERTU followed by paclitaxel, trastuzumab and pertuzumab [THP]) | 12.5% |
| May 24 | BIIB | LEQEMBI IQLIK (lecanemab-irmb) | Alzheimer's disease (AD) | 88% |
| May 29 | MNKD | Afrezza (insulin human) Inhalation Powder | type 1 diabetes, type 2 diabetes | 72% |
| May 31 | CING | CTx-1301 (dexmethylphenidate) | Attention-Deficit/Hyperactivity Disorder (ADHD) | 75% |
| Jun 2 | AZN | DATROWAY (datopotamab deruxtecan-dlnk) | Unresectable or metastatic triple negative breast cancer (TNBC) in patients who are not candidates for PD-1/PD-L1 inhibitor therapy | 86% |
| Jun 5 | ARVN | Vepdegestrant (PROTAC estrogen receptor degrader) | Estrogen receptor-positive (ER+)/HER2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer | 80% |
| Jun 10 | CAMX | Oclaiz™ (CAM2029) | Acromegaly | 78% |
| Jun 20 | ACHV | Cytisinicline | Nicotine dependence, smoking cessation | 82% |
| Jun 29 | ARQT | ZORYVE® (roflumilast) cream 0.3% | plaque psoriasis | 100% |
That is a lot of binary events in one quarter. Some of these are decisions where the stock moves 30%+ in either direction overnight. Others are label expansions on already-approved drugs. Either way, you want to know about them before they happen, not after.
Six PDUFA Decisions Worth a Closer Look
Not every PDUFA carries the same weight. Below are six Q2 2026 events that stand out based on a combination of POA score, stage, and how much the stock could move on the news.
BIIB (BIIB): LEQEMBI IQLIK (lecanemab-irmb) PDUFA Date, May 24 - POA 88%
The LEQEMBI IQLIK subcutaneous autoinjector is under a supplemental biologics license application (sBLA), significantly enhancing its approval probability to 88% compared to new drug candidates. Lecanemab, the active ingredient, received full FDA approval in July 2023 after demonstrating strong clinical efficacy in treating early Alzheimer's disease, targeting amyloid-beta protofibrils. Clinical data from Phase 3 Clarity AD open-label extension studies indicate that the 500 mg subcutaneous formulation is bioequivalent to the approved intravenous dosing, with consistent clinical benefits and improved safety profiles. The FDA granted Priority Review and Fast Track Status to this application, indicating its potential to offer significant improvements in patient treatment accessibility and convenience. Lecanemab's prior success in converting from accelerated to full approval establishes confidence in regulatory outcomes, supported by long-term data showing sustained clinical benefits and no new safety signals. The transition to a subcutaneous formulation aligns with industry trends, and user experience studies showed high satisfaction rates among participants administering the drug at home. While there are standard regulatory risks, Eisai's established manufacturing capabilities and the absence of major deficiencies noted in the FDA’s pre-submission review bolster confidence in the application. Historical data suggests high approval rates for supplemental applications, particularly those with strong clinical data, further supporting the projected 88% probability of approval for the subcutaneous formulation by May 2026.
ARGX (ARGX): VYVGART® (efgartigimod alfa-fcab) PDUFA Date, May 10 - POA 87%
VYVGART (efgartigimod alfa-fcab) is set to receive FDA review for AChR-antibody seronegative generalized myasthenia gravis, with an estimated approval probability of 87%. The supplemental Biologics License Application (sBLA) was accepted by the FDA on January 13, 2026, and has a PDUFA target action date of May 10, 2026, with Priority Review status linked to historically high approval rates. The approval case is primarily supported by the Phase 3 ADAPT SERON trial, which enrolled 119 participants and met its primary efficacy endpoint with a statistically significant p-value of 0.0068, demonstrating a mean improvement of 3.35 points on the MG-ADL scale by week four. This trial is notable as it is the first global Phase 3 study to show efficacy across all three seronegative disease subtypes: MuSK-antibody positive, LRP4-antibody positive, and triple-seronegative patients. Secondary efficacy endpoints also indicated sustained improvements in Quantitative Myasthenia Gravis (QMG) scores, with no new safety signals, maintaining consistency with the drug's established safety profile from previous approvals. Efgartigimod's earlier FDA approval for AChR-antibody seropositive gMG and the subsequent approval of the subcutaneous formulation bolster the regulatory risk profile, providing a strong precedent for this application. The drug's mechanism, a human IgG1 antibody fragment targeting the neonatal Fc receptor, is well-characterized and previously approved modalities have shown high approval rates for supplemental applications. Argenx's proven regulatory track record across multiple jurisdictions adds confidence, having successfully navigated prior submissions without any Complete Response Letters. The target patient population has significant unmet medical needs, comprising approximately 15% of the gMG population, with seronegative patients facing diagnostic delays and inferior treatment responses compared to seropositive cohorts. VYVGART's ability to provide treatment across serologically heterogeneous populations addresses a therapeutic gap, aligning with FDA priorities for therapies targeting rare and severe conditions. While regulatory uncertainties exist, including sample size limitations and potential variability in treatment response among seronegative subtypes, these are outweighed by the favorable clinical and regulatory factors supporting approval. Considering the comprehensive risk-benefit analysis, including prior approval precedents and the strong clinical efficacy data, the likelihood of approval stands at 87%, reflecting the overall positive outlook for VYVGART's sBLA.
AZN (AZN): DATROWAY (datopotamab deruxtecan-dlnk) PDUFA Date, June 2 - POA 86%
DATROWAY (datopotamab deruxtecan-dlnk) is an antibody-drug conjugate targeting TROP2, developed for patients with unresectable or metastatic triple-negative breast cancer (TNBC) ineligible for PD-1/PD-L1 therapy. The FDA accepted the supplemental Biologics License Application (sBLA) on February 3, 2026, granting it Priority Review status with a PDUFA target action date set for June 2, 2026, under Project Orbis for concurrent international review. The Phase 3 TROPION-Breast02 trial showed strong efficacy, with a median overall survival (OS) of 23.7 months for DATROWAY compared to 18.7 months for chemotherapy, demonstrating a 21% reduction in death risk (hazard ratio 0.79, p = 0.0291). Progression-free survival (PFS) outcomes were equally impressive, with a median PFS of 10.8 months for DATROWAY versus 5.6 months for chemotherapy, yielding a 43% reduction in disease progression risk (hazard ratio 0.57, p < 0.0001). DATROWAY achieved an objective response rate of 62.5%, significantly higher than the 29.3% observed with chemotherapy, with a median duration of response of 12.3 months compared to 7.1 months. The trial enrolled a high-risk population, including patients with de novo or recurrent disease and poor prognostic factors, indicating its relevance to real-world scenarios. Historical FDA data supports a high probability of approval, with Priority Review applications historically achieving an approximately 91% approval rate. DATROWAY's previous FDA approval for HR-positive, HER2-negative breast cancer in January 2025 has already established its manufacturing quality and safety profile, reducing regulatory risks for the current application. The application addresses a significant unmet medical need, as around 70% of metastatic TNBC patients are ineligible for immune checkpoint inhibitors, with traditional chemotherapy offering limited efficacy. Safety data indicate manageable adverse events, with Grade 3 or higher treatment-related adverse events occurring in 33% of DATROWAY patients, comparable to 29% in the chemotherapy group. While interstitial lung disease (ILD) was present in 3.6% of patients, the overall safety profile has been accepted by the FDA, aligning with prior approvals for DATROWAY. Competitive landscape analysis shows recognition of TROP2-directed ADCs as effective therapies, with Trodelvy already approved for certain TNBC indications, reinforcing the value of DATROWAY. Multiple regulatory advantages, including Priority Review and Project Orbis participation, bolster the likelihood of approval, with dual primary endpoint achievement providing robust clinical evidence. Risks include the open-label trial design, the significance of the OS p-value, and ILD safety signals, though these are not anticipated to impede approval considering the strong efficacy data and unmet medical need. The 86% estimated Probability of Approval reflects high confidence from Priority Review status, biologic class success rates, prior FDA approval, and robust Phase 3 data, tempered by safety and design considerations.
MRK (MRK): doravirine/islatravir PDUFA Date, April 28 - POA 85%
Doravirine/islatravir (DOR/ISL), Merck’s investigational two-drug HIV-1 regimen, demonstrates a strong likelihood of FDA approval based on robust Phase 3 trial results, a favorable safety profile, and a unique resistance profile. The pivotal studies, MK-8591A-051 (N=553) and MK-8591A-052 (N=513), evaluated DOR/ISL against baseline antiretroviral therapies (ART) and bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), respectively. These trials met the primary endpoint of non-inferiority, with viral suppression rates of 95.6% vs. 91.9% (vs. bART) and 91.5% vs. 94.2% (vs. BIC/FTC/TAF) at week 48, with no treatment-emergent resistance observed. The combination leverages Doravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), and Islatravir, a novel nucleoside reverse transcriptase translocation inhibitor (NRTTI), offering complementary mechanisms and a high barrier to resistance, as evidenced by hypersusceptibility profiles in resistant isolates. Phase 2 data also showed sustained efficacy up to 96 weeks with a safety profile comparable to lamivudine/truvada regimens. Merck’s expertise in HIV research, including prior regulatory successes (e.g., Pifeltro), mitigates sponsor-specific risks. Regulatory factors, including the absence of Complete Response Letters (CRLs) or known delays, and the April 28, 2026, PDUFA date, further bolster confidence. While infectious disease drugs historically show lower approval rates than small molecules (~16% for therapeutics), DOR/ISL’s design as a simplified two-drug regimen with proven non-inferiority, active comparator arms, and no safety signals in trials elevate its PoA. The regimen’s alignment with HIV treatment trends favoring fewer drugs and lower resistance risk positions it favorably against existing three-drug regimens. Competitive landscape dynamics, such as Gilead’s bictegravir-based therapies, provide context but do not overshadow DOR/ISL’s differentiated profile. The lack of resistance mutations in trials and the combination’s synergy in resistance selection studies strengthen its case. While cross-trial comparisons risk overinterpretation, the consistency of viral suppression and safety metrics across studies supports an 85% PoA, factoring in the residual risks associated with late-stage regulatory reviews.
ACHV (ACHV): Cytisinicline PDUFA Date, June 20 - POA 82%
Cytisinicline, developed by Achieve Life Sciences (ACHV), is currently under FDA review, with its New Drug Application accepted on September 3, 2025, and a PDUFA date set for June 20, 2026. The drug targets nicotine dependence and smoking cessation, functioning as a partial agonist at nicotinic acetylcholine receptors, showcasing a strong therapeutic potential. Efficacy results from two pivotal Phase 3 trials, ORCA-2 and ORCA-3, involving over 1,600 participants, demonstrate statistically significant continuous abstinence rates, with odds ratios ranging from 2.85 to 8.0 compared to placebo across multiple treatment durations. Long-term follow-up data indicates sustained efficacy through 24 weeks, with continuous abstinence rates maintaining significance (p<0.001 for most comparisons). Cytisinicline exhibits an excellent safety profile, with low discontinuation rates (1.7-2.9%) and no reported serious adverse events, making it a promising alternative to existing treatments like varenicline. The drug's mechanism of action and tolerability are likely superior to current smoking cessation therapies, addressing a significant unmet medical need as the first new FDA-approved pharmacotherapy for smoking cessation in approximately 20 years. Comprehensive long-term safety data from the ORCA-OL study, involving over 300 participants with six months of exposure and over 200 with one year, revealed no significant safety concerns, supporting a favorable regulatory review process. The acceptance of the NDA by the FDA, combined with robust clinical data and the indication's potential to meet significant public health needs, underscores a high probability of approval.
ARVN (ARVN): Vepdegestrant (PROTAC estrogen receptor degrader) PDUFA Date, June 5 - POA 80%
Vepdegestrant (ARV-471) is an oral PROTAC ER degrader developed by Arvinas in collaboration with Pfizer, targeting ESR1-mutated ER+/HER2- advanced or metastatic breast cancer. The FDA accepted the New Drug Application (NDA) for vepdegestrant in August 2025, with a PDUFA action date set for June 5, 2026, indicating a strong regulatory pathway following positive Phase 3 trial results. The Phase 3 VERITAC-2 trial enrolled 624 patients, demonstrating a median progression-free survival (PFS) of 5.0 months in the ESR1-mutant subgroup, compared to 2.1 months for fulvestrant, achieving a 43% reduction in risk of disease progression or death (HR=0.57, p<0.001). The drug received Fast Track designation in February 2024, highlighting the FDA's acknowledgment of the significant unmet medical need in the targeted population. While the intent-to-treat population did not show statistical significance (HR=0.83, p=0.07), the NDA is focused on the clearly defined ESR1-mutated indication where substantial clinical benefit was observed. Vepdegestrant is poised to be the first approved PROTAC mechanism and offers the advantage of oral administration over intramuscular fulvestrant, combined with a favorable safety profile characterized by low discontinuation rates and minimal gastrointestinal side effects. The competitive landscape includes elacestrant (ORSERDU), which was approved in 2023 for ESR1-mutated patients, presenting some commercial risk but also validating the approach for mutation-specific therapies. Historical approval rates for NDAs at this stage are approximately 90.6%, providing a positive backdrop for vepdegestrant's potential regulatory success. Key risks involve the modest absolute PFS benefit of 2.9 months and competition from existing therapies, yet the strong statistical significance, innovative mechanism, and pressing unmet need support an optimistic outlook for approval.
Top Phase 3 Data Readouts to Watch
Beyond the PDUFA dates, there are 52 Phase 3 data readouts scheduled for Q2 2026. Many of these will determine whether a company files for approval or goes back to the drawing board. Here are the ones that matter most:
| Ticker | Drug | Catalyst | Indication | POA |
|---|---|---|---|---|
| IMCR | KIMMTRAK (tebentafusp) | phase 3 data readout | metastatic uveal melanoma | 100% |
| INSM | ARIKAYCE | Phase 3 data readout | Mycobacterium avium complex (MAC) lung disease | 100% |
| NVCR | Tumor Treating Fields | Phase 3 topline data readout | newly diagnosed glioblastoma | 100% |
| CYTK | Aficamten | Phase 3 topline data readout | non-obstructive hypertrophic cardiomyopathy (HCM) | 95% |
| VRDN | VRDN-003 (subcutaneous anti-IGF-1R antibody) | Phase 3 data readout | Chronic thyroid eye disease (TED) | 75% |
| AVDL | LUMRYZ (sodium oxybate) | phase 3 data readout | idiopathic hypersomnia | 75% |
| EXEL | zanzalintinib in combination with atezolizumab | Phase 3 data readout | previously treated colorectal cancer, overall survival in patients without active liver metastases (NLM subgroup) | 75% |
| EYPT | DURAVYU™ (EYP-1901) | phase 3 data readout | wet age-related macular degeneration, diabetic macular edema | 72% |
| GERN | RYTELO (imetelstat) | Phase 3 data readout | relapsed/refractory myelofibrosis | 72% |
| MNMD | MM120 ODT (lysergide D-tartrate) | Phase 3 data readout | Generalized Anxiety Disorder (GAD) | 70% |
| IVVD | VYD2311 (vaccine alternative monoclonal antibody candidate) | phase 3 data readout | prevention of COVID | 70% |
| AVBP | firmonertinib | phase 3 data readout | non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations | 70% |
| CADL | aglatimagene besadenovec (CAN-2409) | Phase 3 data readout | intermediate- to high-risk localized prostate cancer | 65.5% |
| EDSA | Paridiprubart (anti-TLR4 antibody) | phase 3 data readout | Acute Respiratory Distress Syndrome (ARDS) | 65% |
| MBRX | Annamycin | Interim Results | relapsed or refractory acute myeloid leukemia (AML) | 65% |
| UTHR | Tyvaso® (treprostinil) inhalation solution | Phase 3 data readout | Idiopathic pulmonary fibrosis (IPF) | 65% |
| MDWD | EscharEx® | Interim results | Venous leg ulcers (VLUs) | 65% |
| BFRI | Ameluz® (aminolevulinic acid hydrochloride) | NDA Submission | mild to moderate actinic keratoses (AKs) | 65% |
| OCS | OCS-01 (dexamethasone eye drop) | phase 3 data readout | Diabetic Macular Edema (DME) | 65% |
| AVIR | bemnifosbuvir and ruzasvir (fixed-dose combination) | phase 3 data readout | hepatitis C virus (HCV) | 65% |
More Q2 2026 Catalysts at a Glance
Beyond the tables above, there are plenty of other catalysts that could move stocks this quarter. Here is a quick rundown of additional Phase 3 and NDA/BLA events:
- CDTX — CD388 for Prevention of seasonal influenza. POA: 65%. Phase 3 data readout.
- CRMD — REZZAYO (rezafungin) for Prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation. POA: 60%. phase 3 data readout.
- EYPT — DURAVYU (vorolanib intravitreal insert) for wet age-related macular degeneration (wet AMD). POA: 55%. phase 3 data readout.
- LPCN — LPCN 1154 for Postpartum Depression (PPD). POA: 55%. Phase 3 data readout.
- XENE — azetukalner for focal onset seizures. POA: 50%. Phase 3 data readout.
- BCTX — Bria-IMT (combination regimen with immune checkpoint inhibitor) for Advanced metastatic breast cancer. POA: 45%. phase 3 data readout.
- MLTX — sonelokimab for adolescent hidradenitis suppurativa (HS). POA: 45%. Phase 3 data readout.
- MNMD — MM120 (Lysergide D-Tartrate) for Generalized Anxiety Disorder. POA: 45%. Phase 3 topline data readout.
- PROK — Rilparencel for Chronic Kidney Disease (CKD), Type 2 Diabetes. POA: 45%. Phase 3 data readout.
- NMRA — navacaprant for Major Depressive Disorder (MDD). POA: 40%. Phase 3 topline data readout.
- ATYR — efzofitimod for pulmonary sarcoidosis. POA: 15%. phase 3 data readout.
NDA and BLA Filings Expected in Q2 2026
Companies filing NDAs and BLAs this quarter are signaling they believe their data is strong enough for FDA review:
- ETON — KHINDIVI™ (hydrocortisone) Oral Solution NDA for Pediatric patients with adrenocortical insufficiency. POA: 100%.
- BBIO — Encaleret NDA for Autosomal dominant hypocalcemia type 1 (ADH1). POA: 90%.
- BBIO — BBP-418 NDA for Limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). POA: 86%.
- ROIV — brepocitinib NDA for dermatomyositis. POA: 85%.
- COGT — bezuclastinib (in combination with sunitinib) NDA for Gastrointestinal Stromal Tumors (GIST). POA: 80%.
- KYTX — KYSA-8 BLA for Stiff Person Syndrome. POA: 78%.
- KYTX — KYV-101 BLA for stiff person syndrome. POA: 74%.
- REGN — Dupixent® (dupilumab) BLA for Chronic spontaneous urticaria (CSU) in children aged 2 to 11 years. POA: 72.5%.
- NASDAQ: BLTE — Tinlarebant (a/k/a LBS-008) NDA for Stargardt disease type 1 (STGD1). POA: 72%.
- OCGN — OCU400 (novel modifier gene therapy for retinitis pigmentosa) BLA for Retinitis pigmentosa. POA: 70%.
- MLTX — sonelokimab BLA for Hidradenitis suppurativa (HS). POA: 70%.
- RARE — UX111 BLA for Sanfilippo syndrome type A. POA: 60%.
- CLNN — CNM-Au8 (orally administered nanocrystal suspension) NDA for amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS). POA: 52%.
- CLNN — CNM-Au8 NDA for Amyotrophic lateral sclerosis (ALS). POA: 40%.
Why This Quarter Matters for Your Portfolio
When you look at the Q2 2026 calendar, you are looking at a mix of late-stage binary events 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 key themes for Q2 2026:
- Alzheimer's dominance — BIIB has two PDUFA dates (SPINRAZA Apr 3, LEQEMBI May 24), and AXSM targets Alzheimer's agitation (Apr 30). Three decisions in one quarter for neurodegenerative disease.
- Oncology wave — Multiple oncology PDUFAs (REPL, AZN x2, ARVN) plus major Phase 3 readouts. Breast cancer alone has three PDUFA decisions packed into May-June.
- Rare disease pipeline — GRCE, TVTX, CAMX, and multiple NDA/BLA filings from BBIO, KYTX, and DNLI. Orphan drug designations give these programs faster review and extended exclusivity.
- Psychedelics and psychiatry — MNMD's MM120 for GAD and NMRA's navacaprant for MDD are two of the most-watched psychiatric readouts of the year.
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.