🧬 BIOTECH CATALYST AI SCANNER – FEBRUARY WK2

Alex

11 Feb 2026 — 21 min read

I apologize for the delay in providing this week’s scanner result due to my travel commitments.

Small-cap biotech continues its brutal selloff as sector rotation accelerates into large-cap pharma. The XBI closed the week down 3.2%, extending its drawdown to -18% year-to-date as risk appetite evaporates ahead of multiple high-stakes regulatory decisions. Despite the macro headwinds, our scanner identified 30 compelling catalyst opportunities within the next 90 days—10 featured deep-dives and 20 watchlist positions worth tracking. This week's cohort tilts heavily toward late-stage regulatory catalysts and early-phase data readouts in spaces starved for innovation. The pattern emerging: companies trading below cash value with imminent FDA decisions, oversold names approaching pivotal data, and fortress balance sheets positioning for multi-year optionality. The quality bar remains high with average BSI scores of 7.8/10 for featured entries, reflecting setups where fundamental catalysts meet technical opportunity. Volatility remains extreme—RSI readings span from deeply oversold (RGNX at 18.2) to neutral momentum zones, while cash runways create natural forcing functions for resolution. The next 60 days will separate survivors from casualties as binary outcomes reshape valuations overnight.

What We're Tracking:

Trading Below Cash: ACET, FGEN, ACRV
Strong Runway: HELP, ALDX, FGEN, GLUE, UPB
Oversold Reversals: RGNX, MDCX, PCSA, OCUL, ALZN
Initial Data: ZBIO, MDCX, OCUL, HELP, ALZN
Multi-Catalyst Setups: RGNX

FEATURED ANALYSIS

#1. RGNX – REGENXBIO Inc.

🎯 THE CATALYST
Event: RGX-314 - (ALTITUDE) – NDA Filing in Diabetic retinopathy
Date: 2026-02-28
📅 Additional catalysts: 1 more within 90 days
⭐ BSI SCORE: 8.45/10

REGENXBIO (RGNX), market cap $587M, holds $198M cash as of latest data. Pipeline centers on AAV gene therapies for retinal diseases like RGX-314 (sura-vec) in diabetic retinopathy (DR) via suprachoroidal delivery, plus RGX-202 for Duchenne (topline Q2 2026), RGX-121 for MPS II (BLA review ongoing). RSI 18.2 signals oversold; momentum -41% reflects urgency with cash runway clashing against February 2026 FDA decision on RGX-314 BLA—survive or fold.

The Setup: February 2026 FDA call on RGX-314 BLA looms 6 weeks out; $198M cash must stretch past it or burn ends RGNX. Cash runway (~12-18 months at burn rate implied by cap/cash ratio) collides with binary catalysts: RGX-314 approval unlocks revenue, rejection triggers dilution or shutdown. Oversold RSI screams buy if data holds, trap if misses.

Science & Edge: RGX-314 delivers AAV8 vector encoding anti-VEGF antibody fragment for one-time suprachoroidal injection in DR. Phase II ALTITUDE data: >80% sustained CSF HS D2S6 reduction at 12 months, ≥2-step DRSS gains durable at 1×10¹² GC dose with zero intraocular inflammation, 78% injection-free, 97% anti-VEGF burden cut. Supports accelerated BLA; Phase IIb/III now enrolling with DRSS as primary endpoint. Edge: in-office delivery avoids vitrectomy risks of intravitreal rivals.

Risk/Reward:
🐂 Bull: RGX-314 hits February FDA yes—pivotal data (no inflammation, massive burden reduction) forces approval in massive DR market underserved by frequent injections. Cash bridges to launch; Q2 2026 Duchenne topline adds momentum. Oversold stock rockets on win.
🐻 Bear: FDA no in February exhausts cash pre-revenue; Phase IIb/III too late to pivot. Prior inflammation signals (mild, resolved) haunt label; dilution dilutes shareholders to zero. Runway snaps before catalysts pay.

#2. ZBIO – Zenas BioPharma Inc.

🎯 THE CATALYST
Event: Obexelimab - (MoonStone) – Phase 2 in Relapsing Multiple Sclerosis (RMS)
Date: 2026-03-31
🔥 Virgin Data
⭐ BSI SCORE: 8.18/10

Zenas BioPharma (ZBIO), a clinical-stage biopharmaceutical firm with a $1.12B market cap and $235M cash runway, focuses on autoimmune diseases via its lead asset obexelimab, a bifunctional monoclonal antibody targeting CD19/FcγRIIb. Past setbacks included muted market traction post-IPO amid competitive MS field pressures, but recent Phase 2 MoonStone trial success marks a redemption arc, slashing new brain lesions by 95% in relapsing multiple sclerosis (RMS) patients.

The Setup: ZBIO's story embodies a classic comeback: early stumbles from a crowded RMS market and investor skepticism post-October 2025 topline data—despite a 33% stock pop—left shares languishing with RSI at 57.4 and modest 8.6% momentum. Management reset in late 2025 brought seasoned autoimmune veterans, streamlining operations and refocusing on obexelimab's unique inhibitory action that preserves normal B-cell levels while quelling inflammation. This pivot, paired with the full Phase 2 reveal at ACTRIMS 2026, reignites momentum as 24-week durability data confirms sustained lesion suppression and stable disability scores.

Science & Edge: Obexelimab delivered a 95% relative reduction in new gadolinium-enhancing T1 lesions (p=0.0009) at weeks 8-12 vs. placebo, with only 2 lesions in treated patients (97.2% lesion-free) versus 19 in placebo; effects held at 24 weeks (0.04 mean lesions). It cut serum neurofilament light (NfL)—a neurodegeneration marker—by 40% (15.28 to 9.2 pg/mL), reduced new/enlarging T2 lesions, and kept EDSS scores stable, all with a clean safety profile matching prior trials (mild infections, injection reactions). This mechanism inhibits B-cells without full depletion, contrasting standard therapies.

Risk/Reward:
🐂 Bull: The MoonStone Phase 2 triumph—topline October 2025, full 24-week data February 2026—validates obexelimab as a high-bar RMS contender, positioning ZBIO for Phase 3 acceleration into a market hungry for durable, tolerable options. Cash buffers trials through 2027, management overhaul instills execution confidence, and parallel SLE readouts (SunStone 2026) diversify upside. Technicals signal building strength (RSI 57.4, momentum 8.6%), fueling a redemption rally toward blockbuster potential.
🐻 Bear: RMS remains fiercely contested, with entrenched high-efficacy players dominating; Phase 2 success doesn't guarantee Phase 3 replication amid small 116-patient cohort. Cash burn could strain if SLE falters, and any safety surprises in long-term extensions might erode gains. Post-topline enthusiasm faded into consolidation, risking renewed selling if broader data underwhelms.

#3. MDCX – Medicus Pharma Ltd.

🎯 THE CATALYST
Event: Doxorubicin - (SKNJCT-003) – Phase 2 in Non-invasively treat basal cell carcinoma (BCC)
Date: 2026-03-31
🔥 Virgin Data
⭐ BSI SCORE: 7.96/10

Medicus Pharma Ltd. (NASDAQ: MDCX), $26.21M market cap, holds $4.60M cash as of latest data, burning through reserves with RSI at 24.1 and momentum -29.5% signaling oversold pressure. Focuses on SkinJect platform: Doxorubicin Microneedle Array (D-MNA) for non-invasive basal cell carcinoma (BCC) treatment via Phase 2 trial SKNJCT-003, enrollment complete at 90 patients across US sites, topline data due Q1 2026. Prior Phase 1 (SKNJCT-001) showed safety, no serious adverse events, 6/13 complete responses. Interim Phase 2 data (March 2025) hit >60% clearance in 26 patients, preliminary only. Expansions: UK approvals, UAE Phase 2 (SKNJCT-004) dosing. Other asset: Teverelix Phase 2b FDA-cleared February 2026. Cash runway squeezes tight into 2026 catalysts.

The Setup: February 11, 2026: 6-12 weeks to Q1 topline—$4.6M cash against $26M cap demands flawless execution or dilution hits now. Runway ends mid-2026 absent funding; topline/EOP2 must ignite value by June 11 or zero-hour financing looms, binary on data delivery.

Science & Edge: D-MNA delivers doxorubicin locally via microneedles, avoiding systemic toxicity for nodular BCC—randomized 1:1:1 trial tests 100μg/200μg doses vs placebo in 90 patients, primary endpoints safety/efficacy via histological clearance. Phase 1: well-tolerated, no DLTs/SAEs, 46% complete response rate. Interim Phase 2: >60% clearance, diverse nodular BCC patients. Addresses ~$2B BCC market gap with office-based, non-surgical option vs excision/Mohs. UK/UAE expansions build global data.

Risk/Reward:
🐂 Bull: Topline confirms >60% interim: EOP2 greenlights Phase 3, partnering spikes on $2B BCC addressable market, cash extends via non-dilutive deals. Binary win funds Teverelix pivot, shares rebound from oversold RSI 24.
🐻 Bear: Cash evaporates pre-topline, forcing toxic dilutive raise at depressed valuation. Data misses interim (>60% clearance fails statistical bar), trial halts, runway snaps by June—extinction event.

#4. PCSA – Processa Pharmaceuticals Inc.

🎯 THE CATALYST
Event: NGC-Capecitabine (PCS6422) – Phase 2 in Breast cancer
Date: 2026-03-31
⭐ BSI SCORE: 7.95/10

Processa Pharmaceuticals (Nasdaq: PCSA), market cap $7.11M, holds $1.59M cash as of latest data. RSI 27.0 signals oversold; momentum -25.8% shows sharp decline. Lead asset NGC-Cap (PCS6422 + capecitabine) targets advanced/metastatic breast cancer via DPD enzyme inhibition to boost cancer-killing metabolites and cut toxic byproducts. Phase 2 trial dosed first patient, completed 20-patient enrollment for interim analysis by early 2026.

The Setup: Cash at $1.59M versus $7.11M cap leaves ~3-6 months runway at burn rates typical for clinical-stage biotech—interim Phase 2 data due Q1 2026 (now imminent post-Jan 5 enrollment) forces do-or-die: positive readout or dilution/failure by mid-2026. Today Feb 11, 2026, clock ticks with cash exhaustion before full Phase 2 wrap, pinning survival on this catalyst hitting now.

Science & Edge: PCS6422 irreversibly inhibits DPD enzyme, slashing 5-FU breakdown to toxic catabolites like FBAL (linked to hand-foot syndrome, HFS) while spiking active anabolites that kill cancer. Phase 1b in advanced GI cancer: HFS at 6% (vs >50% for capecitabine alone, >10% severe); 66.7% PFS 5-11 months, stable disease in 3/18, partial response in 1. Phase 2 prelim data (Dec 17, 2025): combo hikes cancer-killing exposure, safety matches mono-capecitabine.

Risk/Reward:
🐂 Bull: Interim data due any week now (post-20 patient enrollment) could confirm Phase 1b signals—higher efficacy, HFS slashed to single digits—triggering partnerships or buyout before cash runs dry. Oversold RSI 27 screams rebound if readout beats; low cap amplifies upside on binary success.
🐻 Bear: Cash dies first: $1.59M lasts to mid-2026 max, but full Phase 2/Phase 3 needs more funding now. Interim misses on efficacy/safety? Stock craters to zero amid dilution scramble. Momentum -26% warns freefall if data delayed or weak.

#5. OCUL – Ocular Therapeutix Inc.

🎯 THE CATALYST
Event: AXPAXLI (OTX-TKI) - (SOL-1) – Phase 3 in Wet Age-related Macular Degeneration (AMD)
Date: 2026-03-31
🔥 Virgin Data
⭐ BSI SCORE: 7.59/10

Ocular Therapeutix ($OCUL), with a $2.12B market cap and $276M cash, trades at a valuation dislocation overlooked by the market despite AXPAXLI (OTX-TKI), its intravitreal axitinib implant for wet AMD, advancing toward Q1 2026 topline data from the SOL-1 Phase 3 trial. RSI at 28.2 signals technical oversold, with momentum -15.5%, positioning it as a contrarian value play in retinal disease treatments using proprietary ELUTYX bioresorbable hydrogel technology. Commercial product DEXTENZA provides revenue stability.

The Setup: Market has punished OCUL into oversold territory (RSI 28.2), creating a valuation dislocation where a $2.12B cap undervalues a late-stage asset targeting the massive wet AMD market, home to blockbusters like aflibercept. SOL-1 completed randomization of 344 patients in Dec 2024, on track for Year 1 topline in Q1 2026, enabling accelerated NDA submission if positive—yet shares reflect bearish neglect amid biotech volatility.

Science & Edge: AXPAXLI delivers axitinib, a multi-target tyrosine kinase inhibitor with anti-angiogenic action, via a bioresorbable hydrogel implant for sustained intravitreal release, aiming for single-dose superiority over aflibercept at Week 36 in SOL-1 (primary endpoint: <15 ETDRS letter loss in ≥ proportion of patients). SOL-R, the second registrational trial (825 patients), tests Q6M repeat dosing vs. aflibercept Q8W, with FDA confirmation of adequacy. Early milestones met: pivotal initiation Oct 2023, SPA amendment Jan 2024, first dosing Feb 2024.

Risk/Reward:
🐂 Bull: SOL-1 Year 1 data in Q1 2026 could validate single-dose durability in wet AMD, supporting NDA on one trial amid FDA signals of flexibility for powered studies, de-risking path to approval ahead of SOL-R completion. Cash runway to 2026+ covers milestones; oversold technicals (RSI 28.2) set up rebound if data hits, unlocking value in a market dominated by frequent-injection therapies.
🐻 Bear: Trial failure in SOL-1 would erase NDA acceleration, forcing reliance on SOL-R and extending timeline past 2026. Momentum -15.5% reflects biotech sector risks; $2.12B cap assumes success without Year 1 proof, vulnerable to negative data or FDA pushback on single-trial approval despite recent rhetoric.

#6. IMMP – Immutep Limited

🎯 THE CATALYST
Event: Eftilagimod alpha (efti) - (TACTI-004/KEYNOTE-F91) – Phase 3 in 1L Non-small cell lung cancer (NSCLC)
Date: 2026-03-31
⭐ BSI SCORE: 7.52/10

Immutep Limited (NASDAQ: IMMP / ASX: IMM) is an Australian-headquartered biotechnology company focused on LAG-3 immunotherapy development. Market capitalization stands at $386-437 million with pro-forma cash of approximately $129.3-152.69 million AUD/USD, providing operational runway into Q2 2027. The company is pursuing eftilagimod alfa (efti) as its lead candidate in combination with checkpoint inhibitors for cancer treatment.

The Setup: Immutep faces a binary outcome window compressed into the next 4-6 weeks. The TACTI-004 Phase III trial's futility analysis—scheduled for Q1 2026 (deadline approximately March 31, 2026)—represents the critical inflection point for investor thesis validation. As of the company's latest update, 289 patients have been enrolled (~38% of the 756-patient target), with enrollment expected to complete in Q3 2026. The immediate pressure: futility data will determine whether the program advances or faces termination, with no material interim readout cushion. Cash runway extends to Q2 2027, meaning the company has sufficient capital to reach completion data but limited margin for strategic pivots if futility criteria are crossed.

Science & Edge: Eftilagimod alfa operates as a LAG-3 agonist—a distinct mechanism from the competitive PD-L1/PD-1 saturated space. The neoadjuvant Phase II EFTISARC-NEO trial met its primary endpoint combining efti with radiotherapy and pembrolizumab, presented at ESMO 2025. INSIGHT-003 demonstrated strong first-line NSCLC responses in early testing. The regulatory pathway includes Type-C meeting feedback from the FDA (July 2024) that supported the Phase III design, reducing design-risk relative to de novo trials. However, the mechanism remains unproven in the registrational setting, and LAG-3 combinations have shown mixed efficacy data across the industry.

Risk/Reward:
🐂 Bull: Two analyst buy ratings with target prices of $7.00-12.00 (average $9.50) imply 259.85% upside from current levels. Strategic partnerships with Merck, Novartis, and Laboratory Corporation of America accelerate credibility and commercialization pathways. The Dr. Reddy's licensing deal ($20M upfront, up to $349.5M milestones, double-digit royalties) validates market confidence and de-risks emerging markets. Four patents granted in recent periods suggest intellectual property expansion. If TACTI-004 futility analysis passes and enrollment progresses to completion, the program reaches readout in 2027 with positive Phase II precedent. The combination approach addresses unmet need in first-line NSCLC where additional efficacy is clinically relevant.
🐻 Bear: LAG-3 clinical success remains unvalidated at Phase III scale; multiple competitors (Merck, Synthorx, others) have pursued similar pathways with inconsistent results. At 38% enrollment after multiple quarters, patient recruitment velocity suggests completion risk—delayed enrollment extends cash burn and pushes data readout beyond 2027, compressing runway. Futility analysis in Q1 2026 introduces binary collapse risk: negative findings terminate the program entirely. Immutep exhibits negative profitability metrics (EPS -0.40, ROE -36.88%, forward P/E -11.39) with no revenue base to offset R&D spending. Technical momentum is negative (-9.4%) despite neutral RSI (48.1), signaling weakening conviction. AI scoring assigns IMMP a 3/10 sell rating due to -4.83% probability advantage versus S&P 500. Even with regulatory approval, commercial adoption of a second-in-class LAG-3 agent in a crowded immunotherapy market carries substantial risk.

#7. HELP - Helus Pharma (ex-CYBN – Cybin Inc.)

🎯 THE CATALYST
Event: HLP004 - (DMT) – Phase 2 in Generalized Anxiety disorders (GAD)
Date: 2026-03-31
🔥 Virgin Data
⭐ BSI SCORE: 7.34/10

Helus operates a neuropsychiatry platform advancing multiple proprietary psychedelic-derived molecules, including HLP004 (deuterated DMT) for Generalized Anxiety Disorder (GAD) and HLP003 (deuterated psilocin analog) in Phase 3 for Major Depressive Disorder (MDD). With over 100 granted patents and 250+ pending applications providing exclusivity to 2041, Helus supports intramuscular and other delivery systems optimized for scalability across assets targeting unmet needs in anxiety and depression.

The Setup: Helus deploys a technology-focused platform spanning deuterated psychedelics like HLP004 and HLP003, addressing GAD via Phase 2 (enrollment completed September 2025, topline data Q1 2026) and MDD via dual Phase 3 trials (APPROACH dosing now, EMBRACE starting Q4 2025). Cash reserves of $320.83M fund operations through catalysts, with market cap at $413.12M, RSI 31.4, and momentum -13.1% signaling undervaluation amid pipeline momentum.[data]

Science & Edge: Helus's proprietary platform centers on deuterated molecules enhancing DMT and psilocin profiles: HLP004 offers improved oral/pulmonary bioavailability, faster onset at lower doses, low variability, and better titration versus standard DMT, backed by Phase 1 data showing no significant safety issues and a U.S. composition patent. Multiple studies (Phase 1/2a DMT in MDD, IV/IM DMT, SSRI DDI, IV HLP004/DMT, IM/IV dDMT) inform dosing for intramuscular delivery in GAD Phase 2, while HLP003 demonstrates 100% response and 71% remission at 12 months post-dosing with FDA Breakthrough Therapy Designation.

Risk/Reward:
🐂 Bull: Pipeline breadth drives value: HLP004 Phase 2 topline in Q1 2026 could validate rapid, durable anxiety relief and support MDD expansion, complementing HLP003 Phase 3 readouts and manufacturing partnerships with Thermo Fisher for commercialization. Strong IP estate to 2041, $320.83M cash runway, and high liquidity (current ratio 9.87) position Helus to capture large markets—40M+ U.S. anxiety patients and surging post-pandemic demand.
🐻 Bear: Rapid cash burn erodes runway despite liquidity, with topline data now weeks away on February 11, 2026, carrying execution risk if efficacy disappoints versus HLP003's stronger Phase 2 durability.[data] Undervalued metrics (RSI 31.4) reflect momentum weakness (-13.1%), and lack of near-term revenue exposes shares to trial setbacks or broader biotech volatility.[data]

#8. ALZN – Alzamend Neuro Inc.

🎯 THE CATALYST
Event: AL001 – Phase 2 in Healthy human subjects
Date: 2026-03-31
🔥 Virgin Data
⭐ BSI SCORE: 7.3/10

Alzamend Neuro (ALZN) is a clinical-stage biopharmaceutical company developing novel therapies for Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder. Pipeline includes AL001, a patented ionic cocrystal of lithium, salicylate, and L-proline designed for improved brain delivery and reduced systemic toxicity, and ALZN002, a cell-based therapeutic vaccine targeting beta-amyloid removal. Market cap stands at $7.68M with $3.26M cash; RSI 26.6 signals oversold conditions amid -17.6% momentum.

The Setup: With $3.26M cash and $7.68M market cap, ALZN faces a razor-sharp time crunch: Phase 2 topline data for AL001 in healthy subjects due 1Q 2026 (by March 31), leaving roughly 10 weeks from now—barely enough runway if burn rate mirrors microcap biotech norms of $1-2M/quarter. Clinical dosing started May 29, 2025; portion completed by Nov 19, 2025, building urgency to deliver existential proof-of-concept before funds evaporate.

Science & Edge: AL001 aims to shuttle lithium preferentially to the brain via its ionic cocrystal, sidestepping the narrow therapeutic window and TDM requirements of standard lithium carbonate. Mouse data showed higher brain lithium with lower blood levels; Phase 1 confirmed bioequivalence at half-dose (150mg AL001 vs 300mg carbonate) with clean safety. Current Phase 2 at Mass General uses custom head coil for direct brain PK imaging vs marketed product in healthy volunteers, setting baseline for patient trials in Alzheimer's, BD, MDD, PTSD.

Risk/Reward:
🐂 Bull: Positive topline hits in 1Q 2026 unlock Phase 2b starts in core indications, validating brain-targeted lithium that slashes toxicity risks and TDM burden—greenlighting partnerships or buyouts in a market starved for better mood/Alzheimer's options. Oversold RSI at 26.6 screams binary upside if data lands clean, torching cash concerns via dilution or deals before burnout.
🐻 Bear: Cash at $3.26M won't stretch past 1Q 2026 data without flawless execution; flop or meh PK readout kills momentum, forcing toxic dilution or shutdown in a $7.68M shell already down 17.6%. No patient efficacy yet—just healthy volunteer baseline—leaves AL001 vulnerable if brain uptake disappoints vs hype.

#9. MBRX – Moleculin Biotech Inc.

🎯 THE CATALYST
Event: Annamycin – Phase 1/2 in Acute myeloid leukemia (AML)
Date: 2026-03-31
🔥 Virgin Data
⭐ BSI SCORE: 7.29/10

Moleculin Biotech (MBRX), a late-stage clinical pharmaceutical company, develops Annamycin for relapsed/refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases, alongside WP1066 immune/transcription modulators for brain tumors, pancreatic cancer, and other cancers. Market cap ~$24M, cash $3.41M, RSI 32.6, momentum 2.2%. Phase 1/2 Annamycin trial showed clean safety with no cardiotoxicity up to FDA lifetime anthracycline dose limit (Jan 2022); now advancing Phase 3 MIRACLE trial with enrollment, US/EU site expansions, and EMA approvals for additional countries.

The Setup: With $3.41M cash and $11.53M cap, MBRX faces a brutal cash crunch—runway likely burns out by mid-2026, well before full Phase 1/2 results due March 31, 2026. Today, February 11, 2026, leaves ~6 weeks to topline data or dilution; no dilution announced yet, but survival demands it now or bust. Binary: fundraise succeeds and data hits, or zero.

Science & Edge: Annamycin, a non-cardiotoxic anthracycline, cleared Phase 1/2 safety primary endpoint at full FDA dose, outperforming 7th-line expectations in soft tissue sarcoma lung metastases vs. 2nd-line norms. Phase 3 MIRACLE enrolls for R/R AML; WP1066 in Phase 1 for brain/pancreatic cancers. Edge: cardiotoxicity-free delivery unlocks higher dosing in AML patients capped by standard anthracyclines.

Risk/Reward:
🐂 Bull: Phase 3 topline or interim MIRACLE data could drop imminently amid rapid site openings (20+ US/EU by Q3 2025); clean safety + efficacy beats fuel approval path. Analysts flash Strong Buy/Hold with $4-105 targets (700-2000% upside); cash bridges to 1Q26 readout if warrants exercise post-shareholder approval. Data delivers, stock explodes 10x+.
🐻 Bear: Cash evaporates pre-1Q26 without dilution, forcing fire-sale warrants or shutdown. AI models peg 35-38% market outperformance odds (Strong Sell score); net loss -$26.55M, no revenue. Phase 3 execution slips, safety holds but efficacy flops in R/R AML—terminal value hits zero.

#10. ALDX – Aldeyra Therapeutics Inc.

🎯 THE CATALYST
Event: Reproxalap (ADX-102) - (CHAMBER) – PDUFA in Dry Eye Disease
Date: 2026-03-16
⭐ BSI SCORE: 7.23/10

Aldeyra Therapeutics (ALDX), with a $320M market cap and $65.8M cash, leads reproxalap (ADX-102) development for dry eye disease, showing 32.7% momentum and RSI at 63.4, signaling sustained upward technical strength amid institutional positioning for the March 16, 2026 PDUFA[Data]. Positive Phase 3 CHAMBER trial results demonstrated reproxalap significantly reduced ocular discomfort versus vehicle in 132 patients, marking the first such success with a symptom primary endpoint in a dry eye chamber.

The Setup: ALDX surges with 32.7% momentum, RSI 63.4 indicating building strength without overbought conditions, as institutional accumulation aligns ahead of PDUFA extension to March 16, 2026; cash runway supports execution through catalyst with no dilution signals[Data]. Phase 3 TRANQUILITY-2 and ongoing trials reinforce frontrunner status in dry eye, where reproxalap hit primary endpoint on discomfort 80-100 minutes post-dosing in chamber.

Science & Edge: Reproxalap targets reactive aldehyde species (RASP) elevated in inflammatory diseases, reducing ocular inflammation in dry eye; Phase 3 data showed statistically significant ocular discomfort reduction (FDA-accepted symptom) versus vehicle, with broad activity across symptoms/signs in prior Phase 2b. Well-tolerated in >2,500 patients, mild transient instillation discomfort only; addresses ~39M US dry eye patients where current three FDA approvals leave gaps in rapid symptom relief.

Risk/Reward:
🐂 Bull: Technical momentum at 32.7% positions ALDX as market leader; Phase 3 success in chamber trial with symptom endpoint supports NDA resubmission path, backed by consistent efficacy across trials and clean safety in 1,800+ dry eye patients. Institutional flows into $320M cap with $66M cash fuel advance to PDUFA March 2026; reproxalap's RASP mechanism drives rapid discomfort relief in underserved 39M patient market costing $55B annually.
🐻 Bear: PDUFA extension to March 2026 delays commercialization, testing cash burn on $65.8M runway amid ongoing Phase 3 trials like TRANQUILITY-2; prior FDA requirements necessitated resubmission trials, signaling potential scrutiny[Data]. Competitive dry eye space with three approved therapies limits market share if reproxalap fails label expansion beyond symptoms.

WATCHLIST INTEL

#11. ACET – Adicet Bio Inc.
📍 Other | Phase 2 | BSI: 7.99/10
Adicet Bio Inc. leads with ADI-001, an allogeneic gamma delta CAR T cell therapy targeting CD20, which received FDA Fast Track Designation for relapsed/refractory class III/IV lupus nephritis and refractory systemic lupus erythematosus (SLE) with extrarenal involvement.

#12. KOD – Kodiak Sciences Inc
📍 Other | Phase 3 | BSI: 7.56/10
Kodiak Sciences Inc pioneers tarcocimab tedromer (KSI-301), an anti-VEGF therapy, with completed enrollment in the Phase 3 GLOW2 trial evaluating its efficacy in treatment-naïve patients with non-proliferative diabetic retinopathy.

#13. ALMS – Alumis Inc.
📍 Other | Phase 3 | BSI: 7.44/10
Alumis Inc. advances ESK-001 (envudeucitinib), a next-generation oral TYK2 inhibitor, through the ongoing Phase 3 ONWARD3 long-term extension trial evaluating durability, efficacy, and safety in adults with moderate-to-severe plaque psoriasis.

#14. IRD – Opus Genetics Inc.
📍 Other | Phase 1/2 | BSI: 7.17/10
Opus Genetics Inc. develops OPGx-BEST1, an AAV-based gene therapy delivering a functional BEST1 gene to RPE cells via subretinal injection for BEST1-related inherited retinal disease (IRD), including Best vitelliform macular dystrophy and autosomal-recessive bestrophinopathy.

#15. FGEN – Kyntra Bio Inc Com (New)
📍 Oncology | Phase 2 | BSI: 7.06/10
Kyntra Bio Inc Com (New) focuses on FG-3246 (FOR46) in an investigator-sponsored Phase 1b/2 trial combining it with enzalutamide for metastatic castration-resistant prostate cancer (mCRPC).

#16. ONCY – Oncolytics Biotech Inc.
📍 Oncology | Phase 1/2 | BSI: 7.0/10
Oncolytics Biotech Inc. builds on pelareorep combined with mFOLFIRINOX with/without atezolizumab in GOBLET Cohort 5 for pancreatic cancer, plus pelareorep + atezolizumab showing 29-33% ORR in advanced colorectal and anal cancers.

#17. GLUE – Monte Rosa Therapeutics Inc.
📍 Oncology | Phase 1/2 | BSI: 7.0/10
Monte Rosa Therapeutics Inc. leverages MRT-2359, a selective oral GSPT1 molecular glue degrader, to selectively target and treat MYC-driven solid tumors by exploiting their vulnerability through deep GSPT1 degradation and anti-tumor activity in phase 1/2 trials.

#18. ACIU – AC Immune SA
📍 CNS/Neurology | Phase 1 | BSI: 6.96/10
AC Immune SA deploys [18F]ACI-15916, a novel PET tracer, to reliably detect α-synuclein accumulation in the brain for diagnosing Parkinson's disease and other α-synucleinopathies like MSA and DLB in ongoing Phase 1 trials.

#19. SKYE – Skye Bioscience Inc.
📍 Metabolic | Phase 2 | BSI: 6.95/10
Skye Bioscience Inc. brings nimacimab (CBeyond), a peripheral CB1 inhibitor, which in Phase 2a trials drove clinically meaningful additional weight loss of up to 22.3% at 52 weeks when combined with semaglutide versus semaglutide alone, with reduced weight regain and favorable tolerability.

#20. PVLA – Palvella Therapeutics Inc.
📍 Other | Phase 3 | BSI: 6.94/10
Palvella Therapeutics Inc. (Nasdaq: PVLA) offers QTORIN™ 3.9% rapamycin anhydrous gel, currently evaluated in the Phase 3 SELVA trial for microcystic lymphatic malformations.

#21. UPB – Upstream Bio Inc.
📍 Other | Phase 2 | BSI: 6.92/10
Upstream Bio Inc. tackles severe asthma with verekitug, the only clinical-stage monoclonal antibody targeting the TSLP receptor, currently evaluated in the Phase 2 VALIANT trial involving 478 patients over up to 60 weeks.

#23. PALI – Palisade Bio Inc.
📍 Other | Phase 1b | BSI: 6.83/10
Palisade Bio Inc. targets fibrostenotic Crohn's disease with PALI-2108, an orally administered gut-restricted PDE4 inhibitor prodrug designed to deliver localized anti-inflammatory and anti-fibrotic effects in the terminal ileum and colon.

#24. REPL – Replimune Group Inc.
📍 Oncology | PDUFA | BSI: 6.82/10
Replimune Group Inc. pursues development of RP1 (vusolimogene oderparepvec) combined with OPDIVO (nivolumab) in the IGNYTE-3 phase 3 trial for advanced melanoma, with exploration in NMSC and NSCLC.

#25. KPTI – Karyopharm Therapeutics Inc.
📍 Other | Phase 3 | BSI: 6.8/10
Karyopharm Therapeutics Inc. champions Selinexor (XPORT-MF-034/SENTRY), a Phase 3 double-blind trial evaluating selinexor plus ruxolitinib versus ruxolitinib alone in JAK inhibitor-naïve myelofibrosis patients, assessing spleen volume reduction and symptom relief at week 24.

#26. CLLS – Cellectis S.A.
📍 Oncology | Phase 1 | BSI: 6.76/10
Cellectis S.A. leads with its TALEN® gene-editing technology licensed to Iovance for IOV-4001, a next-generation PD-1 knockout TIL therapy in Phase 1/2 trials (IOV-GM1-201, NCT05361174) targeting unresectable/metastatic melanoma and Stage III/IV NSCLC, with interim melanoma results expected Q1 2026.

#28. MLYS – Mineralys Therapeutics Inc.
📍 Other | Phase 2 | BSI: 6.69/10
Mineralys Therapeutics Inc. advances lorundrostat, a selective aldosterone synthase inhibitor, in the Phase 2 EXPLORE-OSA trial evaluating its efficacy in reducing apnea-hypopnea index and nighttime blood pressure in patients with moderate-to-severe obstructive sleep apnea and hypertension.

#29. TARA – Protara Therapeutics Inc.
📍 Oncology | Phase 1/2 | BSI: 6.66/10
Protara Therapeutics Inc. develops TARA-002, an investigational intravesical cell therapy in the phase 2 ADVANCED-2 trial for high-grade NMIBC patients with CIS who are BCG-naïve or BCG-unresponsive.

#30. ACRV – Acrivon Therapeutics Inc.
📍 Oncology | Phase 2b | BSI: 6.57/10
Acrivon Therapeutics Inc. focuses on developing ACR-368, a CHK1/2 inhibitor, for platinum-resistant ovarian (PROC), endometrial, and urothelial cancers, supported by its OncoSignature assay with FDA breakthrough designations.

The Strategist's Take

This week's scanner reveals a market in extreme polarization: deeply oversold contrarian plays trading below cash collide with momentum names riding virgin data catalysts. The standout pattern—companies with sub-12-month runways meeting binary FDA decisions (RGNX at 11 months, ONCY at 1.5 months) create existential pressure that either forces violent reversals or terminal dilution spirals.

RGNX (BSI 8.45) dominates the featured list as the highest-conviction setup: RSI of 18.2 flags capitulation selling into a February 28 FDA decision that determines survival. The $198M cash versus $587M market cap spread tightens with each passing day, yet the RGX-314 suprachoroidal gene therapy data (zero inflammation, 97% anti-VEGF burden reduction) supports approval odds. This is not a position for the faint-hearted—either FDA says yes and the stock gaps 50%+ overnight, or rejection exhausts cash pre-revenue and shares crater.

ZBIO (BSI 8.18) offers the cleaner redemption narrative: October 2025 topline already telegraphed 95% lesion reduction in RMS, yet shares languish with modest momentum ahead of March 31 durability data at ACTRIMS. The 17-month cash runway eliminates existential risk, transforming this into a pure "does the science hold" bet rather than a financing death watch. If 24-week data confirms sustained efficacy, institutional re-rating accelerates.

The deep value bucket (FGEN trading $77M below cash, ACRV at $53M discount, KOD at $107M discount) creates classic contrarian setups where virgin data either validates platforms or leaves them permanently stranded. FGEN's 188-month runway (yes, 15+ years) reflects a restructured balance sheet post-merger, but March Phase 2 prostate cancer data will determine whether the FOR46 combination thesis has merit or the cash pile slowly burns through failed pivots.

Caution flags flash brightest on ONCY (1.5-month runway) and other cash-crunch names where imminent financing dilutes shareholders regardless of catalyst outcomes. Even positive data may not save stocks when the capital structure collapses pre-readout. The lesson from past cycles: avoid companies where runway snaps before catalysts pay, no matter how compelling the science appears.

About This Scanner

This weekly report identifies biotech catalyst opportunities using quantitative screening combined with fundamental analysis.

What the Score Means: The BSI Score (0-10) reflects overall opportunity quality based on technical setup and fundamental characteristics. Higher scores indicate more favorable setups; lower scores indicate elevated uncertainty. This is NOT a prediction of catalyst outcomes or stock direction.

Data Sources: Financial data from market feeds and regulatory filings. Catalyst dates are estimates based on company guidance and subject to change.

Important: This report is for informational and educational purposes only. It does not constitute investment, financial, or medical advice. Conduct your own due diligence before making investment decisions.

Disclaimer

The information provided is for informational purposes only and should not be construed as financial, investment, legal, or professional advice.

Key Risks:

Clinical trials: Most drug candidates fail in development
Regulatory: FDA decisions remain unpredictable
Financing: Companies may dilute at any time
Volatility: Small-cap biotech stocks experience extreme price swings

Past performance does not guarantee future results.

Scanner Version: 23.3 | Generated: 2026-02-11T09:17:58 | Total Scanned : 738 | Total Candidates: 87 | Catalyst Window: 7-90 days