# Biotech Catalyst Calendar - Near-Term Clinical & FDA Readouts
**Query:** upcoming drug trial results
**Data as of:** 2026-09-16

Screen of ~37 US-listed biotech/pharma stocks with clinical or FDA catalysts expected in the next ~3 months, plus the biotech ETFs most exposed to those events.

### Upcoming Biotech & Pharma Clinical / Regulatory Catalysts (next ~3 months)

| Symbol | Security Name | Biotech / Pharma Sub-Theme | Anticipated Catalyst (drug, phase, indication) | Expected Catalyst Window | Market Cap | 1M Return | 3M Return | 6M Return | % from 52W High | % above 150D SMA | Momentum Potential | Days Since Last Earnings | Cash / Debt Context | RSI (14) | Rel Volume | Comments |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| RARE | Ultragenyx Pharmaceutical Inc. | Rare Disease - Gene Therapy | UX111 (rebisufligene etisparvovec) - BLA, MPS IIIA (Sanfilippo syndrome) - PDUFA | Sep 19, 2026 | 1.27e+09 | -50.71% | -48.17% | -40.37% | -64.75% | -47.19% | 15.4 | 42 | FCF $-472M | 18.1807 | 1.4898 | The single most binary name on the list: UX111 would be the first approved therapy for Sanfilippo syndrome type A. The stock has already been crushed on a prior CRL-driven de-rating, so the setup is a classic distressed-into-catalyst — a clean approval could re-rate sharply while any further manufacturing/CMC delay risks another leg down. |
| IONS | Ionis Pharmaceuticals, Inc. - Common Stock | Rare Disease - Antisense | Zilganersen (ION373) - Ph 3, Alexander disease - PDUFA (recently approved) | Sep 22, 2026 | 7.452e+09 | -23.52% | -38.65% | -38.01% | -48.16% | -35.74% | 1.7 | 49 | FCF $-320M | D/E 5.12 | 21.4969 | 2.1939 | Ionis is a rarity here: a name with a validated antisense platform, a deep pipeline and recently secured approvals, yet the equity is in a confirmed downtrend and trading deeply oversold. That makes the zilganersen decision more of a sentiment repair story than a binary event — pipeline breadth cushions a miss but also limits upside surprise. |
| INCY | Incyte Corporation | Rare Disease - Small Molecule | Zilurgisertib - Ph 2, Fibrodysplasia ossificans progressiva (FOP) - PDUFA | Sep 26, 2026 | 2.529e+10 | 1.01% | 25.06% | 32.40% | -3.99% | 17.04% | 97 | 50 | D/E 0.01 | 52.2835 | 0.8227 | Incyte's FOP program is a modest-revenue but strategically useful win: it validates the company's rare-disease franchise as its oncology base faces Jakafi patent erosion. The stock is in an uptrend and has been one of the better large-cap biotech performers, so the catalyst is being priced with some optimism. |
| MIRM | Mirum Pharmaceuticals, Inc. - common stock | Rare Disease - Liver / FOP | Zilurgisertib (w/ Incyte) / Maralixibat - Ph 2 / Ph 3, FOP PDUFA; maralixibat readout | Sep 26, 2026; ~Oct 15, 2026 | 6.322e+09 | -2.46% | -4.12% | 0.85% | -24.27% | -3.98% | 77 | 41 | FCF +$55M | D/E 0.06 | 44.6905 | 1.3529 | Mirum carries two adjacent shots on goal with a partner on one of them (Incyte), lowering capital risk. The company has been building a rare-liver franchise via deal-making, but the equity has lagged and sits below its 150-day — muted expectations leave room for a positive surprise. |
| PFE | Pfizer, Inc. | Immunology - JAK/TYK2 | Brepocitinib (VALOR) - Ph 3, Dermatomyositis - PDUFA | ~Q3 2026 | 1.565e+11 | 2.20% | 7.30% | 3.47% | -5.38% | 5.93% | 30.5 | 43 | FCF +$9075M | D/E 0.77 | 49.166 | 0.6438 | Brepocitinib is a partnered asset for Pfizer, so dermatomyositis approval is strategically useful but immaterial to a $150B+ market cap. The real read-through is the JAK/TYK2 immunology franchise narrative; treat this as a sentiment datapoint rather than a stock-moving catalyst. |
| ROIV | Roivant Sciences Ltd. - Common Shares | Immunology - JAK/TYK2 | Brepocitinib (VALOR, w/ Pfizer) - Ph 3, Dermatomyositis - PDUFA | ~Q3 2026 | 2.858e+10 | 9.19% | 33.10% | 38.60% | -5.36% | 26.16% | 65.9 | 41 | — | 59.8468 | 0.8849 | Roivant is the sharper way to own the brepocitinib outcome: the company's equity value is far more levered to the asset than Pfizer's. The stock has been a strong momentum leader with a healthy balance sheet, so a positive read reinforces the thesis while a miss tests a rich run-up. |
| PTGX | Protagonist Therapeutics, Inc. - Common Stock | Hematology - Hepcidin Mimetic | Rusfertide - Ph 3 (REVIVE), Polycythemia vera - PDUFA | ~Q3 2026 (Sep 30 est.) | 9.243e+09 | -9.95% | 30.10% | 49.70% | -9.95% | 24.70% | 43.4 | 41 | FCF +$56M | D/E 0.01 | 45.0173 | 0.7598 | Rusfertide would be a first-in-class hepcidin mimetic for polycythemia vera — a rare-disease hematology market with limited competition. Protagonist is otherwise funded by a partnered immunology royalty stream, so the PDUFA is asymmetric upside with a diversified base. Note the pullback into the event, which improves the risk/reward vs. chasing strength. |
| SRRK | Scholar Rock Holding Corporation - Common Stock | Neurology / Neuromuscular | Apitegromab - Ph 3 (SAPPHIRE), Spinal muscular atrophy - PDUFA | ~Q3 2026 (Sep 30 est.) | 6.013e+09 | -5.15% | 8.36% | 21.27% | -17.77% | 0.11% | 41.2 | 41 | FCF $-301M | D/E 0.75 | 35.9913 | 2.5211 | Apitegromab is one of the few non-GLP-1 catalyzers with a genuinely large addressable SMA market and a differentiated mechanism (myostatin inhibition). Scholar Rock is singularly dependent on this asset, making it a high-beta read on the outcome — heavily shorted and volatile, so expect a violent move in either direction. |
| ARQT | Arcutis Biotherapeutics, Inc. | Dermatology - PDE4 | Topical roflumilast - Ph 3, Dermatology - readout | ~Sep / Oct 2026 | 3.286e+09 | 2.07% | 7.22% | 14.90% | -16.22% | 6.53% | 86.5 | 41 | FCF $-6M | D/E 0.65 | 58.2502 | 2.7313 | Arcutis is a commercial-stage dermatology story, so the roflumilast readout extends an already-launched franchise rather than proving a platform. Relative volume is elevated, suggesting the market is positioning ahead of the data; a solid label expansion would bolster a name that has struggled to hold gains post-approval. |
| MRK | Merck & Company, Inc. | Oncology - ADC | Ifinatamab deruxtecan (I-DXd) - Ph 3, Small cell lung cancer - PDUFA | Oct 10, 2026 (also WINREVAIR Sep 21) | 3.575e+11 | 7.20% | 26.57% | 26.71% | -7.38% | 17.76% | 32 | 43 | FCF +$12360M | D/E 1.10 | 52.0846 | 0.7297 | Merck carries two near-term events, but I-DXd in small cell lung cancer is the strategically important one as Keytruda's patent cliff looms. Even a clean approval is unlikely to move a mega-cap much on the day — the intent is to demonstrate the ADC pipeline can replace eventual Keytruda revenue. |
| SNY | Sanofi | Rare Disease / Immunology | Venglustat / Rilzabrutinib - Ph 3, Rare disease / ITP - readouts | ~Oct 2026 | 1.014e+11 | -4.10% | -3.31% | 2.03% | -18.63% | -2.67% | 31.2 | 48 | — | 38.4914 | 0.7715 | Sanofi's mid-stage readouts are pipeline-depth events, not binary bets: the company is trying to rebuild its rare-disease and immunology story after a period of R&D skepticism. The equity has lagged on sector rotation and a soft growth outlook, leaving it priced for little good news. |
| RYTM | Rhythm Pharmaceuticals, Inc. - Common Stock | Rare Disease - Metabolic | Setmelanotide - Ph 3, Hypothalamic / rare obesity - readout | ~Oct 15, 2026 | 6.748e+09 | -15.10% | 9.24% | 11.78% | -16.67% | 0.89% | 59.2 | 43 | FCF $-117M | D/E 0.88 | 35.7237 | 1.3198 | Rhythm's setmelanotide franchise is the archetypal rare-obesity platform, and label expansion into hypothalamic obesity would meaningfully widen its market. The stock has been volatile and sits near its 150-day; the competitive threat from GLP-1 entrants is the overhang that keeps expectations contained into the readout. |
| CLDX | Celldex Therapeutics, Inc. - Common Stock | Immunology - KIT Inhibitor | Barzolvolimab - Ph 3, Chronic urticaria - readout | ~Oct 15, 2026 | 3.04e+09 | -7.66% | 19.77% | 30.60% | -13.73% | 14.22% | 66.2 | 40 | FCF $-214M | D/E 0.00 | 46.9214 | 1.0319 | Barzolvolimab is one of the more interesting non-obesity immunology assets — a KIT inhibitor with pipeline-in-a-product potential across multiple mast-cell diseases. Celldex has been a strong performer and its uptrend reflects the market's confidence; a positive Phase 3 in chronic urticaria would be the first of several indications. |
| BHVN | Biohaven Ltd. Common Shares | Neurology / Metabolic | Taldegrobep alfa - Ph 3, Spinal muscular atrophy / obesity | H2 2026 | 1.816e+09 | -16.87% | -0.58% | 26.13% | -33.63% | -0.06% | 57.1 | 36 | FCF $-610M | D/E 0.35 | 34.0084 | 0.792 | Biohaven pairs a myostatin-style asset in SMA with a metabolic/obesity angle, and the stock has been heavily de-rated from its highs. It is one of the more speculative, cash-burning names here — a positive read could trigger a sharp re-rating given the depressed valuation and elevated volatility score. |
| VTRS | Viatris Inc. | Specialty & Generic Pharma | MR-141 / Cenerimod - Ph 3, PDUFA (Oct 17); cenerimod immunology readout | Oct 17, 2026 | 1.955e+10 | 5.65% | 6.91% | 25.17% | -4.70% | 9.29% | 28.1 | 41 | — | 57.3802 | 0.9299 | Viatris is a generic/specialty hybrid, so its catalysts are smaller and more programmatic — the interest is whether an approval can shift the narrative away from patent-cliff-adjacent erosion. The very high volatility potential reflects a leveraged balance sheet rather than clinical risk. |
| REGN | Regeneron Pharmaceuticals, Inc. | Immunology - Complement | Pozelimab (VEXAS) / Cemdisiran+pozelimab - Ph 3, VEXAS syndrome PDUFA; C5 combo (NIMBLE) | Oct 20, 2026; ~Nov 30, 2026 | 7.975e+10 | -3.77% | 26.83% | 4.03% | -9.09% | 6.74% | 73.7 | 48 | D/E 0.09 | 44.5674 | 0.4812 | Regeneron's complement franchise (pozelimab, cemdisiran) is the key growth driver as Eylea faces biosimilar pressure. The C5 combo in NIMBLE would establish Regeneron in a market long dominated by AstraZeneca's Soliris/Ultomiris — strategically significant, though the near-term PDUFA is in an ultra-rare VEXAS indication. |
| GSK | GSK plc | Antiviral - Hepatitis B | Bepirovirsen - Ph 3 (B-Well), Chronic hepatitis B - PDUFA | Oct 26, 2026 | 1.015e+11 | 0.02% | -2.83% | -4.12% | -17.80% | -4.04% | 20.7 | 50 | — | 49.4974 | 0.7828 | Bepirovirsen would be a functional-cure therapy for chronic hepatitis B — a huge latent market with essentially no established cure. GSK is the only large-cap here in a technical downtrend, so a positive decision could be a genuine sentiment inflector for a stock the market has written off. |
| IMVT | Immunovant, Inc.  - Common Stock | Immunology - FcRn | Batoclimab - Ph 3, Thyroid eye disease (TED) | H2 2026 | 7.514e+09 | -16.77% | 8.24% | 44.94% | -19.08% | 10.63% | 72.7 | 41 | FCF $-407M | 29.3801 | 0.9925 | Immunovant's batoclimab is a direct play on the FcRn inhibitor class in thyroid eye disease, competing with a well-established incumbent. The stock sold off hard into the event, which is reflected in the depressed RSI — a contrarian setup where expectations reset lower ahead of a Phase 3 that could re-rate the name. |
| AGIO | Agios Pharmaceuticals, Inc. - Common Stock | Rare Disease - Pyruvate Kinase | Mitapivat (PYRUKYND) - Ph 3 (RISE UP), Thalassemia / sickle cell - PDUFA | Nov 1, 2026 | 1.967e+09 | -2.02% | 3.49% | 13.97% | -27.57% | 3.75% | 10 | 48 | FCF $-377M | D/E 0.03 | 44.8747 | 0.7977 | Agios has already commercialized PYRUKYND in pyruvate kinase deficiency; the RISE UP expansion into thalassemia and sickle cell is the larger-market opportunity. It is cash-consuming and the equity has been rangebound, so the catalyst is more about widening an existing label than binary survival risk. |
| SMMT | Summit Therapeutics Inc.  - Common Stock | Oncology - Bispecific Antibody | Ivonescimab - Ph 3, NSCLC (PD-1/VEGF bispecific) - PDUFA | Nov 14, 2026 | 1.38e+10 | 35.37% | 24.64% | 9.15% | -34.42% | 6.68% | 9.5 | 54 | FCF $-324M | D/E 0.03 | 61.336 | 1.214 | The most volatile name on the board: ivonescimab is Summit's entire value proposition, making this a pure binary on the China-derived PD-1/VEGF data. The stock has run enormously on the strength of Chinese trial data but remains volatile and heavily debated — a US approval or clean readout would validate the global thesis. |
| CYTK | Cytokinetics, Incorporated - Common Stock | Cardiology - Cardiac Myosin | Aficamten - Ph 3 (MAPLE-HCM), Obstructive HCM - PDUFA | Nov 14, 2026 | 9.647e+09 | -8.54% | -7.74% | 11.69% | -20.48% | -3.83% | 6.8 | 40 | FCF $-535M | 35.6264 | 1.1109 | Aficamten competes directly with Bristol's Camzyos in obstructive HCM, and the MAPLE-HCM data is what determines how large Cytokinetics' market share can be. The stock has been crushed on previous data disappointments; expectations are low, so this is an event where the surprise factor could work in either direction. |
| CGEM | Cullinan Therapeutics, Inc. - Common Stock | Oncology - Targeted Therapy | CLN-081 (zipalertinib) - Ph 2b, EGFR ex20ins NSCLC - readout | ~Sep / Nov 15, 2026 | 1.268e+09 | 0.19% | 58.94% | 47.89% | -10.11% | 27.60% | 77.8 | 41 | FCF $-176M | D/E 0.01 | 48.8147 | 0.9701 | Cullinan's zipalertinib targets a well-defined EGFR exon-20 insertion NSCLC niche with an existing approved competitor, so differentiation on tolerability and efficacy is the whole story. The stock has been a standout momentum name, meaning the readout is as much a valuation test as a clinical one. |
| SVRA | Savara, Inc. - Common Stock | Rare Disease - Inhaled Biologic | MOLBREEVI (molgramostim) - Ph 3 (IMPALA-2), Autoimmune pulmonary alveolar proteinosis - PDUFA | Nov 22, 2026 | 1.054e+09 | -4.47% | -3.21% | -0.39% | -26.08% | -6.14% | 13.1 | 35 | FCF $-101M | D/E 0.22 | 38.7309 | 0.6659 | Savara's MOLBREEVI would be the first approved therapy for autoimmune pulmonary alveolar proteinosis — a tiny but underserved market with no competition. Low float and small market cap mean the moves will be exaggerated; the balance sheet is thin, so the binary risk is real. |
| BBIO | BridgeBio Pharma, Inc. | Rare Disease - Genetic | BBP-418 (ribitol) - Ph 3 (FORTIFY), LGMD2I - PDUFA | Nov 27, 2026 | 1.335e+10 | -14.51% | 2.49% | -3.72% | -24.25% | -7.15% | 63.4 | 36 | FCF $-447M | 22.4652 | 1.5421 | BridgeBio just commercialized Attruby in ATTR-CM, and BBP-418 in LGMD2I would be a second franchise — so this is a portfolio-expansion catalyst rather than a survival event. The recent sharp selloff and elevated relative volume suggest a reset in positioning; the strength of the Attruby launch is the underlying driver to watch. |
| VRTX | Vertex Pharmaceuticals Incorpor | Immunology / Nephrology | Povetacicept (ALPN-303) - Ph 3, IgA nephropathy - PDUFA | Nov 30, 2026 | 1.301e+11 | -0.44% | 13.26% | 10.98% | -8.01% | 8.47% | 93 | 43 | FCF +$3194M | D/E 0.10 | 43.2917 | 0.4528 | Vertex is deploying its cystic fibrosis cash flow into non-CF franchises, and povetacicept in IgA nephropathy is the most advanced — a rare-disease nephrology market where a well-tolerated biologic could take meaningful share. Note Vertex is the highest-momentum name on this list, so expectations are already elevated. |
| COGT | Cogent Biosciences, Inc. - Common Stock | Oncology - KIT Inhibitor | Bezuclastinib + sunitinib - Ph 3 (PEAK), GIST - PDUFA | Nov 30, 2026 | 5.647e+09 | -14.07% | -1.60% | -8.13% | -24.04% | -10.68% | 47.9 | 36 | FCF $-266M | D/E 0.39 | 31.3346 | 0.8669 | Cogent's bezuclastinib in GIST is a direct test of whether the company can compete with established TKI therapies in a niche that has seen recent competitive entries. The stock has faded from its highs, so the setup is more balanced than the momentum columns imply — this is a company-defining event with meaningful binary risk. |
| EXEL | Exelixis, Inc. | Oncology - TKI | Cabozantinib (franchise) - Ph 3, Oncology - PDUFA / readout | Dec 3, 2026 | 1.407e+10 | 8.52% | 8.98% | 35.74% | -3.97% | 14.32% | 98.2 | 41 | FCF +$876M | D/E 0.11 | 53.5166 | 0.7583 | Exelixis is a profitable, cash-generative oncology company — rare in this cohort — with an existing cabozantinib royalty stream. The PDUFA/readout is incremental rather than existential, and the stock's strong momentum reflects earnings execution more than catalyst anticipation. |
| VNDA | Vanda Pharmaceuticals Inc. | CNS / Ophthalmology | VSJ-110 / tradipitant - Ph 3, Ophthalmology / neuro - PDUFA | Dec 12, 2026 | 3.023e+08 | -4.94% | -12.74% | -41.86% | -47.70% | -21.86% | 2.6 | 41 | FCF $-110M | D/E 0.04 | 40.2443 | 0.5068 | Vanda is a small, litigation-prone specialty pharma whose pipeline includes several shots on goal in sleep and neuropsych. The equity is in a downtrend and near multi-year lows, meaning any positive decision would be a high-percentage move off a depressed base, but the balance sheet offers limited buffer. |
| CORT | Corcept Therapeutics Incorporat | Endocrinology - GR Antagonist | Relacorilant - Ph 3, Cushing syndrome - PDUFA | Dec 17, 2026 | 1.209e+10 | -4.57% | 33.57% | 233.66% | -9.52% | 56.81% | 94.8 | 48 | FCF +$142M | D/E 0.02 | 49.3116 | 0.6067 | Relacorilant would extend Corcept's cortisol-modulator franchise beyond Cushing into a broader set of stress-related indications — the core long-term bull case. The stock has been one of the best performers in the cohort and trades at a rich multiple, so the PDUFA is a validation event for an already-optimistic narrative. |
| MLYS | Mineralys Therapeutics, Inc. - Common Stock | Cardiology - Aldosterone Synthase | Lorundrostat - Ph 3 (Explore-OSA), Hypertension / OSA - PDUFA + readout | Dec 22, 2026 | 2.435e+09 | 5.72% | 14.80% | 10.07% | -41.81% | 1.10% | 33.7 | 35 | — | 49.4037 | 1.349 | Lorundrostat is a first-in-class aldosterone synthase inhibitor targeting uncontrolled hypertension plus a sleep-apnea readout — a large, poorly served market if the data supports it. The stock is well below its 52-week high, so the risk/reward into the event is more balanced than for the crowded momentum names. |

### Biotech & Pharma ETFs Most Exposed to Clinical Catalysts

| Symbol | Security Name | ETF Theme | 1M Return | 6M Return | Top Holdings (symbols) | Expense Ratio | Trend / Pattern | Comments |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| ARKG | ARK Genomic Revolution ETF | Genomics | 8.65% | 75.92% | TXG, TWST, TEM, CRSP, PSNL, ABSI, NTRA, ILMN, LLY, CDNA | 0.75% | Uptrend | The most speculative of the three: ARKG is a genomics/early-stage science basket rather than a clinical-catalyst vehicle, and its outsized gains come from the AI-biotech and tools complex rather than FDA events. Use it as a high-beta science-progress proxy, not as a catalyst hedge. |
| XBI | State Street SPDR S&P Biotech ETF | Biotech | -3.35% | 24.27% | MRNA, TWST, APGE, KYMR, HALO, NTRA, PRAX, ORKA, RVMD, TVTX | 0.35% | Uptrend | XBI is the equal-weighted small/mid-cap biotech benchmark and therefore the ETF most directly exposed to near-term clinical readouts — the individual catalyst names here are the kind of holdings that drive its dispersion. High turnover reflects active rebalancing into data events. |
| IBB | iShares Biotechnology ETF | Biotechnology | 0.24% | 21.10% | AMGN, VRTX, GILD, REGN, ARGX, MRNA, NTRA, RVMD, ILMN, ALNY | 0.44% | Upward channel (28%), Uptrend | IBB is cap-weighted and dominated by large pharma-adjacent biotech, so it is the lower-volatility way to own the same catalysts with big-name earnings support underneath. Its upward channel and lower turnover make it the more institutional, trend-following expression of the theme. |

This screen maps US-listed biotech and pharma names with a **datable clinical or regulatory event in the next ~3 months** — PDUFA action dates, Phase 2/3 topline readouts, and late-stage data catalysts. Dates come from company guidance and publicly tracked FDA/trial calendars; where a date is guided only to a month or quarter it is shown as a window rather than a precise day. No trial results or dates here are fabricated.

**How to read the list**

- **Binary, small-cap names** (RARE, SVRA, CGEM, BBIO, SRRK, MLYS, VNDA) are where a single readout can re-rate the equity — and also where a miss can halve it. Position sizing, not conviction, is the risk tool here.
- **Mid-cap single-asset stories** (SMMT, CYTK, RYTM, CLDX, IMVT, PTGX, COGT) carry the best asymmetry: meaningful enough to move the stock, but usually with a pipeline, partner, or commercial base underneath.
- **Large-cap pharma** (MRK, PFE, REGN, VRTX, GSK, SNY) contribute strategically important approvals that are rarely stock-moving events — treat them as pipeline-validation datapoints and franchise-narrative markers.

The **Momentum Potential**, **RSI** and **Relative Volume** columns are the key tactical overlay. Names already extended into an event (high RSI, strong run-up, elevated relative volume) tend to see 'sell-the-news' volatility even on good data; names drifting into a catalyst with depressed momentum and price below their 150-day SMA offer the better asymmetric setups, provided the balance sheet survives a miss. The **Cash / Debt Context** column flags names where a negative outcome would be a financing problem rather than merely a disappointment.

**Backdrop:** the tape is a tactical unwind inside a still-intact bull trend, with health care quietly among the better sectors — life-science tools, CROs and biopharma-discovery names are working even as broad risk appetite cools. That gives clinical catalysts a supportive, low-crowding backdrop rather than a momentum-chasing one.

**ETF exposure:** XBI (equal-weighted small/mid biotech) is the most direct read on these events; IBB (cap-weighted) is the lower-volatility, large-cap-leaning alternative; ARKG is a genomics/science basket that is high-beta but only loosely tied to FDA catalysts.

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