🧬 BIOTECH CATALYST AI SCANNER — November WK3

After an extremely tough week for the biotech sector—and the broader market—we're finally seeing signs of recovery. With the government shutdown issue now resolved, the sector should hopefully regain momentum in the coming weeks.

From last week's top 15 picks, IFRX and GLTO showed particularly notable performance. IFRX surged on a positive data readout, while GLTO rocketed higher for different reasons. As IFRX's case demonstrates, the estimated dates in our catalyst scanner are just that—estimates. The company's readout came several weeks earlier than the scanner indicated, highlighting the importance of staying vigilant. Beyond these standouts, MIST, ALDX, CLLS, and ANIX also demonstrated resilience with decent momentum despite the challenging market conditions.

As I emphasize every week: this scanner is a tool for generating ideas, not a substitute for your own research. Always conduct thorough due diligence before making investment decisions. If you're finding it challenging to evaluate biotech stocks, I've just published an extensive article that walks through the complete framework I use for my due diligence process.

As usual, the article below is automatically generated using machine learning model that is AI enhanced via AI API and its output is not audited.

Executive Summary

This report outlines 33 high-value biotech catalyst candidates identified by the AI Enhanced Intelligence Scanner on November 13, 2025. The analysis covers key regulatory decisions (PDUFAs), upcoming data readouts, and conference presentations.

This week's scanner is dominated by oncology, with two major conference clusters informing the rankings: the American Society of Hematology (ASH) 2025 (beginning December 6) and the San Antonio Breast Cancer Symposium (SABCS) 2025 (beginning December 11).

Tier A - Top 5 Candidates

#1. MIST - Milestone Pharmaceuticals Inc.

📊 FINANCIAL SNAPSHOT Price: $1.93 | Market Cap: $164M | Shares: 85.2M | Volume: 1.6x avg Cash: $205M (36m+ runway) | RSI: 53 | Momentum: -5.9%

🎯 CATALYST CARDAMYST (etripamil) - PDUFA Regulatory Decision on December 13, 2025 (29 days) Stage: PDUFA | Indication: Paroxysmal supraventricular tachycardia (PSVT)

⭐ SCANNER SCORE: 8.3/10 A high-confidence setup driven by a date-certain binary event, strong Phase 3 data, and a robust financial position that removes funding overhang.

Setup: CARDAMYST (etripamil) is a novel, self-administered calcium channel blocker nasal spray for PSVT. The upcoming PDUFA decision is supported by a strong data package, including the RAPID trial. Recent pooled analysis from AHA 2025 (622 patients) confirmed a median time to conversion of 18.5 minutes, with a 59.6% conversion rate at 30 minutes versus ~31% for placebo (Hazard Ratio: 2.62, p<0.001).

Core Thesis: MIST is positioned to address a significant unmet need for an at-home, rapid-acting PSVT treatment, aiming to replace emergency room visits (IV adenosine/verapamil) as the standard of care. The mechanism is validated, and the self-administration provides a powerful patient-empowerment narrative. With no advanced-stage pipeline competitors for this specific self-administered, rapid-acting niche, CARDAMYST has a clear path to market.

Catalyst Risk/Reward: Approval is the base case, given the strong efficacy and safety data (>1,050 patients). The risk/reward hinges on the label's breadth (e.g., any restrictions on self-administration). A clean label could establish a new standard of care. A Complete Response Letter (CRL) would be a significant downside shock, but seems unlikely given the data.

Key Risk: The primary risk is commercial execution. While clinically differentiated, the company must effectively educate both patients and physicians to shift behavior from established emergency care protocols to at-home self-administration.

Verification: ✓ PDUFA date confirmed | ✓ RAPID trial data (p<0.001) verified | ✓ Competitor landscape spot-checked

#2. AUTL - Autolus Therapeutics plc | MULTI-CATALYST

📊 FINANCIAL SNAPSHOT Price: $1.36 | Market Cap: $362M | Shares: 266.1M | Volume: 2.1x avg Cash: $326M (12mo runway) | RSI: 42 | Momentum: -16.0%

🎯 CATALYST AUTO8 - (MCARTY) - Conference Presentation at ASH 2025 on December 7, 2025 (23 days) Stage: Phase 1 | Indication: Multiple Myeloma

Additional Pipeline: • Obe-cel (CARLYSLE): Conference Presentation at ASH 2025 (Dec 8, 24d) | Indication: Systemic Lupus Erythematosus (SLE)

⭐ SCANNER SCORE: 8.3/10 A strong, data-driven setup for a multi-catalyst update at ASH, though tempered by a competitive CAR-T landscape and a narrowing cash runway.

Setup: Autolus is set to present updates on two key pipeline assets at ASH 2025. The lead catalyst is long-term follow-up data for AUTO8, a dual-targeting (BCMA and CD19) CAR-T for multiple myeloma. This dual-target approach aims to prevent antigen escape, a common resistance mechanism in a field dominated by single-target approved therapies like Abecma and Carvykti.

Core Thesis: The core thesis rests on differentiation. For AUTO8 in myeloma, the dual-targeting (BCMA/CD19) mechanism must demonstrate superior durability or depth of response versus approved competitors. For Obe-cel in SLE, recent data (83.3% remission rate) is highly promising, targeting an "immune reset" in refractory autoimmune disease. A positive update on Obe-cel's durability could validate its best-in-class potential in a lucrative new market for CAR-T.

Catalyst Risk/Reward: Base case: AUTO8 data confirms durability, and Obe-cel data reinforces high remission rates. Upside: AUTO8 data shows clear superiority over Abecma/Carvykti, and Obe-cel durability extends beyond 12 months, triggering a re-valuation. Downside: AUTO8 durability wanes, or Obe-cel responses prove transient, putting pressure on the company's 12.9-month runway.

Key Risk: Competition and Cash. AUTL competes directly with giants like BMS, J&J, and Novartis in the cell therapy space. Furthermore, with only ~13 months of cash, the company is under pressure to deliver definitive data at ASH to support a future capital raise on favorable terms.

Verification: ✓ ASH 2025 confirmed (AUTO8 & Obe-cel) | ✓ Catalyst dates verified | ✓ Obe-cel 83.3% remission rate verified

#3. ANIX - Anixa Biosciences Inc.

📊 FINANCIAL SNAPSHOT Price: $4.39 | Market Cap: $145M | Shares: 32.9M | Volume: 0.9x avg Cash: $14M (24m+ runway) | RSI: 60 | Momentum: +1.4%

🎯 CATALYST α-lactalbumin - Conference Presentation at SABCS 2025 on December 11, 2025 (27 days) Stage: Phase 1 | Indication: Breast cancer vaccine

⭐ SCANNER SCORE: 8.0/10 A high-impact data catalyst for a novel vaccine technology with a strong scientific rationale, backed by a solid 28-month cash runway.

Setup: Anixa is presenting final, comprehensive results from its completed Phase 1 trial of its α-lactalbumin breast cancer vaccine at SABCS. This vaccine targets a protein typically expressed only during lactation but also found in many breast cancers, particularly triple-negative breast cancer (TNBC). The goal is to train the immune system for primary prevention and recurrence reduction.

Core Thesis: The thesis is built on a strong scientific and safety foundation. Topline data from the 35-patient trial (run at the Cleveland Clinic) has already confirmed the vaccine is safe and well-tolerated, with over 75% of participants developing a strong immune response. The SABCS presentation is expected to provide the full dataset, including T-cell response analysis. As there are no currently approved breast cancer vaccines, Anixa is pioneering a new treatment and prevention paradigm.

Catalyst Risk/Reward: Base case: The full data confirms the strong immunogenicity (>75%) and clean safety profile. Upside: Data shows compelling, durable antigen-specific T-cell responses, providing a clear green light for Phase 2/3 trials and validating the platform. Downside: The full dataset reveals mixed or weak T-cell responses, suggesting the antibody response may not be clinically meaningful.

Key Risk: Translation to Efficacy. The key risk is translating a confirmed immune response (immunogenicity) into clinical efficacy (preventing recurrence or cancer). This Phase 1 trial was not designed to measure efficacy, so the market must extrapolate the vaccine's potential from immunological biomarkers alone.

Verification: ✓ SABCS 2025 confirmed | ✓ Catalyst date Dec 11 verified | ✓ >75% immune response rate spot-checked

#4. SNTI - Senti Biosciences Inc.

📊 FINANCIAL SNAPSHOT Price: $1.89 | Market Cap: $49M | Shares: 26.2M | Volume: 0.3x avg Cash: $1.8M (check for funding) ⚠️ | RSI: 49 | Momentum: -9.1%

🎯 CATALYST SENTI-202 - Conference Presentation at ASH 2025 on December 8, 2025 (24 days) Stage: Phase 1 | Indication: Acute Myeloid Leukemia (AML)

⭐ SCANNER SCORE: 8.0/10 Exceptional clinical data for a highly advanced, logic-gated cell therapy is overshadowed by an existential and immediate financing risk.

Setup: Senti is presenting updated Phase 1 data for SENTI-202, an off-the-shelf, logic-gated CAR-NK cell therapy for AML. This "smart" therapy is designed to attack cells expressing CD33 or FLT3 (an "OR" gate) while sparing healthy stem cells that express EMCN (a "NOT" gate). Prior data is strong: 3 complete responses (CR) and 1 CRh (complete response with partial hematologic recovery) among 7 patients.

Core Thesis: The science is the core thesis. SENTI-202's logic-gated design addresses AML heterogeneity and leukemic stem cells while simultaneously aiming to reduce the myelosuppression (marrow damage) that plagues other therapies. The 2/3 patients achieving MRD-negative CRs in the initial cohort is a powerful signal of deep responses. This ASH update will be critical to see if these responses are durable and consistent in new patients.

Catalyst Risk/Reward: Base case: The new data confirms high CR/CRh rates in a larger patient set. Upside: Data shows durable MRD-negative responses, validating the logic-gate platform as a potential cure and sparking a major rally (assuming financing). Downside: Efficacy wanes in new patients, or new toxicities emerge.

Key Risk: Financing. This is the dominant factor. With only $1.8M in cash and a 0.4-month runway, the company is on financial life support. The science, no matter how good, is irrelevant if the company cannot fund operations. An immediate, highly dilutive financing is inevitable, regardless of the ASH data.

Verification: ✓ ASH 2025 confirmed | ✓ Catalyst date Dec 8 verified | ✓ 3 CRs / 7 patients data spot-checked

#5. ATOS - Atossa Therapeutics Inc.

📊 FINANCIAL SNAPSHOT Price: $0.81 | Market Cap: $105M | Shares: 129.2M | Volume: 0.6x avg Cash: $49M (24m+ runway) | RSI: 37 | Momentum: -21.0%

🎯 CATALYST (Z)-Endoxifen - (RECAST DCIS) - Conference Presentation at SABCS 2025 on December 11, 2025 (27 days) Stage: Phase 2 | Indication: Ductal Carcinoma In Situ (DCIS)

⭐ SCANNER SCORE: 7.6/10 A solid setup for initial Phase 2 data in a key indication, supported by a healthy cash position and a clear mechanism of action.

Setup: Atossa is presenting initial results from its multi-arm Phase 2 RECAST DCIS trial at SABCS. This trial is evaluating (Z)-Endoxifen, a potent SERM (selective estrogen receptor modulator), as a neoadjuvant (pre-surgical) treatment for women with HR-positive DCIS. The trial is designed to measure clinical, imaging, and biomarker endpoints.

Core Thesis: The thesis is based on (Z)-Endoxifen's potency and consistency. Unlike tamoxifen, which must be activated by the CYP2D6 enzyme, (Z)-Endoxifen is the active metabolite itself. This may offer more potent ER-blocking and more consistent efficacy across all patients. Success in the neoadjuvant DCIS setting could establish (Z)-Endoxifen as a new standard and a potential non-surgical alternative for some patients.

Catalyst Risk/Reward: Base case: The SABCS presentation shows clear biomarker and imaging responses (e.g., tumor shrinkage, Ki-67 reduction) and confirms a favorable tolerability profile. Upside: Data is strong enough to define a clear non-surgical path forward, potentially challenging tamoxifen. Downside: Responses are modest or inconsistent, suggesting limited differentiation from existing therapies.

Key Risk: Clinical Bar. The main risk is demonstrating a compelling enough benefit over the existing, cheap, and well-understood standard of care (tamoxifen) to justify a new, branded therapeutic.

Verification: ✓ SABCS 2025 confirmed | ✓ Catalyst date Dec 11 verified | ✓ RECAST DCIS trial design verified

⭐ Tier B - Next 10 Candidates

#6. CRDL - Cardiol Therapeutics Inc.

📊 FINANCIAL SNAPSHOT Price: $1.04 | Cap: $87M | Shares: 83.7M | Cash: $23M (12m+ runway) RSI: 44 | Momentum: 0.0% | Volume: 0.6x avg

🎯 CATALYST CardiolRx - (ARCHER) - Conference Presentation on November 29, 2025 (15d) | Phase 2

⭐ SCANNER SCORE: 7.5/10

Thesis: CardiolRx, a pharmaceutically-produced CBD solution, targets myocardial inflammation. Data from the Phase 2 ARCHER trial in acute myocarditis showed a notable improvement in left ventricular extracellular volume (ECV), a key imaging endpoint, narrowly missing significance (p=0.0538) but showing significant reductions in LV mass.

Ranking Context: This presentation offers a deeper dive into the ARCHER data. The setup is strong as it addresses a high unmet need (no standard of care for acute myocarditis) with a safe, well-tolerated oral drug.

Key Risk: The p=0.0538 on the primary endpoint was a near-miss. The company must convincingly frame this as a positive signal (which the LV mass data supports) rather than a trial failure.

Verification: ✓ Catalyst date confirmed

#7. LPCN - Lipocine Inc.

📊 FINANCIAL SNAPSHOT Price: $2.92 | Cap: $16M | Shares: 5.6M | Cash: $14M (12m+ runway) RSI: 55 | Momentum: -9.0% | Volume: 0.7x avg

🎯 CATALYST LPCN 2101 - Conference Presentation at AES 2025 on December 7, 2025 (23d) | Phase 2

⭐ SCANNER SCORE: 7.5/10

Thesis: LPCN 2101 is an oral neuroactive steroid (NAS) that acts as a positive allosteric modulator (PAM) of the GABAA receptor, a validated anti-seizure mechanism. The company will present two Phase 2 pharmacokinetic and toxicokinetic studies at the American Epilepsy Society meeting.

Ranking Context: This score is driven by a well-validated mechanism in a large market. A favorable PK/TK profile from these studies would be a critical de-risking step before advancing to larger efficacy trials against entrenched competitors (e.g., Keppra, Lamictal).

Key Risk: The epilepsy market is extremely crowded. LPCN 2101 must demonstrate a clear differentiation in safety, tolerability, or efficacy to gain traction.

Verification: ✓ AES 2025 confirmed | ✓ Catalyst date verified

#8. CRVS - Corvus Pharmaceuticals Inc.

📊 FINANCIAL SNAPSHOT Price: $8.18 | Cap: $611M | Shares: 74.7M | Cash: $61M (12m+ runway) RSI: 63 | Momentum: +16.2% | Volume: 0.4x avg

🎯 CATALYST Soquelitinib (CPI-818) - Conference Presentation at ASH 2025 on December 8, 2025 (24d) | Phase 1

⭐ SCANNER SCORE: 7.4/10

Thesis: Soquelitinib is a selective oral ITK inhibitor. By inhibiting ITK, it aims to block Th2/Th17 cell development and promote Th1 anti-tumor immunity. The company will present final Phase 1/1b results in relapsed T-cell lymphomas, a follow-up to prior data that showed tumor responses in advanced, refractory patients.

Ranking Context: This presentation serves as the final data package for the Phase 1/1b trial, which has already supported the launch of a Phase 3 registrational trial. Strong, consistent data here will validate the pivotal study and build confidence in the mechanism.

Key Risk: The ITK inhibitor space is novel. The key risk is translating these early-stage responses into durable efficacy in a larger Phase 3 setting against established PTCL competitors like brentuximab vedotin.

Verification: ✓ ASH 2025 confirmed | ✓ Catalyst date verified

#9. CGEM - Cullinan Therapeutics Inc.

📊 FINANCIAL SNAPSHOT Price: $8.35 | Cap: $493M | Shares: 59.1M | Cash: $315M (24m+ runway) RSI: 58 | Momentum: +7.9% | Volume: 0.6x avg

🎯 CATALYST CLN-049 - (Florentine) - Conference Presentation at ASH 2025 on December 8, 2025 (24d) | Phase 1

⭐ SCANNER SCORE: 7.4/10

Thesis: CLN-049 is a bispecific T-cell engager targeting FLT3 on AML cells and CD3 on T-cells. Recent Phase 1 data (cutoff June 2025) in heavily pretreated R/R AML was strong, showing a ~30% composite complete response (CRc) rate, even in high-risk TP53-mutated patients.

Ranking Context: This ASH presentation is an update to already-promising data. The key catalysts are a manageable safety profile (no treatment discontinuations due to immune-related AEs) and efficacy in a tough-to-treat population, all backed by a solid 25.6-month cash runway.

Key Risk: Cytokine Release Syndrome (CRS). While CRS has been limited to Grade 1/2 so far, managing this toxicity is the primary challenge for all T-cell engagers.

Verification: ✓ ASH 2025 confirmed | ✓ Catalyst date verified

#10. CLLS - Cellectis S.A.

📊 FINANCIAL SNAPSHOT Price: $3.65 | Cap: $263M | Shares: 72.1M | Cash: $200M (18m+) RSI: 54 | Momentum: -12.5% | Volume: 0.5x avg

🎯 CATALYST ALLO-501/501A + ALLO-647 - (ALPHA2) - Conference Presentation at ASH 2025 on December 7, 2025 (23d) | Phase 2

⭐ SCANNER SCORE: 7.4/10

Thesis: Cellectis is presenting data on its allogeneic (off-the-shelf) anti-CD19 CAR-T program. Data from the ALPHA2 study in CAR T-naïve large B-cell lymphoma (LBCL) patients has shown a 67% ORR and 58% CR rate for the Phase 2 regimen, with no GvHD reported.

Ranking Context: This is a key update for one of the leading allogeneic CAR-T platforms. The score reflects the potential to disrupt the autologous market (Yescarta, Breyanzi) by offering an "off-the-shelf" product, removing manufacturing delays.

Key Risk: Durability and Competition. The primary risk for all allogeneic CAR-Ts is durability of response. Furthermore, it faces intense competition not only from autologous CAR-Ts but also from approved bispecific antibodies.

Verification: ✓ ASH 2025 confirmed | ✓ Catalyst date verified

#11. ALDX - Aldeyra Therapeutics Inc.

📊 FINANCIAL SNAPSHOT Price: $5.30 | Cap: $319M | Shares: 60.2M | Cash: $13M (5mo) RSI: 54 | Momentum: -0.7% | Volume: 1.3x avg

🎯 CATALYST Reproxalap (ADX-102) - PDUFA Regulatory Decision on December 16, 2025 (32d) | PDUFA

⭐ SCANNER SCORE: 7.3/10

Thesis: Reproxalap is a first-in-class small-molecule modulator of reactive aldehyde species (RASP) for Dry Eye Disease (DED). This PDUFA date follows a resubmission that included positive results from a second Phase 3 dry eye chamber trial, which met the primary endpoint for ocular discomfort (p=0.002).

Ranking Context: This is a high-stakes binary event. Approval would validate the RASP platform in a crowded DED market. The recent positive Phase 3 data significantly improves the odds, but a prior CRL keeps risk elevated.

Key Risk: Cash Runway. The company has only 5.4 months of cash. A second CRL would be catastrophic, while an approval would likely be immediately followed by a capital raise to fund the commercial launch.

Verification: ✓ PDUFA date confirmed | ✓ Ocular discomfort p=0.002 verified

#12. XCUR - Exicure Inc.

📊 FINANCIAL SNAPSHOT Price: $3.60 | Cap: $23M | Shares: 6.4M | Cash: $3M (2mo) ⚠️ RSI: 33 | Momentum: -29.4% | Volume: 0.5x avg

🎯 CATALYST GPC-100 (burixafor) - Conference Presentation at ASH 2025 on December 8, 2025 (24d) | Phase 2

⭐ SCANNER SCORE: 7.3/10

Thesis: XCUR is presenting Phase 2 data for GPC-100, a CXCR4 antagonist, for stem cell mobilization in multiple myeloma patients. Interim data from the first 10 patients was positive, with all achieving the primary endpoint (high CD34+ cell counts) enabling same-day stem cell collection.

Ranking Context: The data is strong, indicating a potential best-in-class mobilization agent that could be more convenient than the standard of care (Plerixafor). The setup is positive from a data perspective but dire from a financial one.

Key Risk: Financing. Similar to SNTI, XCUR's cash position is critical. With only 2.3 months of runway, the company is in a precarious position. This ASH presentation must be compelling enough to secure immediate, life-saving financing.

Verification: ✓ ASH 2025 confirmed | ✓ Catalyst date verified

#13. TCRX - TScan Therapeutics Inc.

📊 FINANCIAL SNAPSHOT Price: $1.19 | Cap: $68M | Shares: 56.7M | Cash: $169M (12m+) RSI: 31 | Momentum: -43.6% | Volume: 0.9x avg

🎯 CATALYST TSC-100, TSC-101 - (ALLOHA) - Conference Presentation at ASH 2025 on December 6, 2025 (22d) | Phase 1

⭐ SCANNER SCORE: 7.3/10

Thesis: TScan is developing donor-derived, engineered TCR-T cell therapies (TSC-100/101) to eliminate residual patient hematopoietic cells after HCT, a major cause of relapse. Data as of Nov 2024 was highly promising, showing a strong trend in Event-Free Survival (HR=0.30) for the treatment arm vs. control (8% relapse vs 33% relapse).

Ranking Context: This ASH presentation is an update on a potentially game-changing approach to prevent post-transplant relapse. The company is well-funded with 15.6 months of cash, allowing it to focus on execution.

Key Risk: The data is still from a small patient set. The key risk is whether this strong survival trend (HR=0.30) holds as the dataset matures and expands.

Verification: ✓ ASH 2025 confirmed | ✓ Catalyst date verified

#14. AGIO - Agios Pharmaceuticals Inc.

📊 FINANCIAL SNAPSHOT Price: $43.63 | Cap: $2.5B | Shares: 58.3M | Cash: $910M (24m+) RSI: 60 | Momentum: +8.4% | Volume: 1.6x avg

🎯 CATALYST Mitapivat - (ENERGIZE-T) - Conference Presentation at ASH 2025 on December 8, 2025 (24d) | Phase 3

⭐ SCANNER SCORE: 7.3/10

Thesis: Agios is presenting Phase 3 ENERGIZE-T data for Mitapivat in transfusion-dependent thalassemia (TDT). Prior data was positive, with 30.4% of patients achieving the primary endpoint (≥50% reduction in transfused RBC units), a rate numerically higher than the approved competitor, Luspatercept (~21%).

Ranking Context: This is a large-cap, well-funded company presenting strong Phase 3 data that supports regulatory submission. The score reflects a high-probability, de-risked event in a commercially validated indication.

Key Risk: Competition. Mitapivat must compete with approved therapies (Luspatercept) and curative gene therapies (from Bluebird/Vertex). The key risk is securing market share and favorable pricing.

Verification: ✓ ASH 2025 confirmed | ✓ Catalyst date verified

#15. AAPG - Ascentage Pharma Group International

📊 FINANCIAL SNAPSHOT Price: $32.95 | Cap: $2.9B | Shares: 87.1M | Cash: $1.3B (cash rich) RSI: 43 | Momentum: -6.0% | Volume: 0.6x avg

🎯 CATALYST Olverembatinib - (POLARIS-1) - Conference Presentation at ASH 2025 on December 6, 2025 (22d) | Phase 3

⭐ SCANNER SCORE: 7.3/10

Thesis: Ascentage is presenting Phase 3 data for Olverembatinib, a third-generation TKI, in newly diagnosed Ph+ ALL. This drug targets the T315I mutation, a key resistance mechanism. Data from July 2025 was outstanding: 94.3% CR rate and 66.0% MRD negativity, including in high-risk subgroups.

Ranking Context: This ASH presentation will update the market on exceptional Phase 3 data for a drug that could challenge established TKIs like ponatinib and asciminib. The company is well-capitalized to pursue global registration.

Key Risk: Olverembatinib is already approved in China. The primary risk for US/EU investors is the complex regulatory and commercial path for a China-based biotech, as well as competition from Novartis and Takeda.

Verification: ✓ ASH 2025 confirmed | ✓ Catalyst date verified

📋 Tier C - Additional Candidates

Scanner identified 18 additional candidates. Organized by catalyst type:

🏛️ Regulatory Decisions (4 candidates)

Date-certain binary events with FDA approval decisions.

• OMER (Score 7.1/10) | Narsoplimab | PDUFA Dec 26 (42d) → PDUFA for HSCT-TMA; no advanced competition | $469M cap | Cash: $18M (2mo) ⚠️

• CYTK (Score 6.0/10) | Aficamten | PDUFA Dec 26 (42d) → PDUFA for Hypertrophic cardiomyopathy (HCM) | $8.1B cap | Cash: $910M (24m+)

• AXGN (Score 5.9/10) | Avance Nerve Graft | PDUFA Dec 5 (21d) → BLA for peripheral nerve repair | $1.1B cap | Cash: $37M (24m+)

• AMGN (Score 3.6/10) | UPLIZNA (Inebilizumab) | PDUFA Dec 14 (30d) → sBLA for Myasthenia gravis; strong Phase 3 (p<0.001) | $181.1B cap | Cash: $11.7B (cash rich)

🔬 Data Readouts (2 candidates)

Phase 3 and initial data readouts expected by month-end.

• IMRN (Score 6.4/10) | Travelan | Initial Data Nov 30 (16d) → Phase 2 data in gut health; 90.5% protection in prior study | $11M cap | Cash: $14M (N/A)

• NAMS (Score 3.5/10) | Obicetrapib | Full Results Nov 30 (16d) → Full Phase 3 BROOKLYN data (HeFH); met primary (p<0.0001) | $4.3B cap | Cash: $687M (36m+)

📊 Conference Presentations (12 candidates)

Data presentations, primarily clustered at the ASH 2025 meeting.

• GLTO (Score 7.2/10) | GB3226 | ASH 2025 Dec 6 (22d) → First-in-class dual ENL-YEATS/FLT3 inhibitor (preclinical) | $31M cap | Cash: $6M (7mo)

• ARVN (Score 7.1/10) | ARV-393 | ASH 2025 Dec 6 (22d) → Preclinical data for BCL6 PROTAC degrader | $669M cap | Cash: $759M (36m+)

• SLS (Score 7.0/10) | Tambiciclib (SLS009) | ASH 2025 Dec 7 (23d) → Phase 2 data (CDK9i + venetoclax); 8.8mo mOS in refractory AML | $157M cap | Cash: $72M (24m+)

• MRKR (Score 6.7/10) | Neldaleucel (MT-601) | ASH 2025 Dec 6 (22d) → Phase 1 data in post-CAR T lymphoma | $12M cap | Cash: $8M (12m)

• ALLO (Score 6.4/10) | ALLO-501/501A | ASH 2025 Dec 7 (23d) → Allogeneic CAR-T data; 58% CR rate in LBCL | $276M cap | Cash: $238M (18m+)

• TERN (Score 6.3/10) | TERN-701 | ASH 2025 Dec 8 (24d) → Phase 1 allosteric BCR::ABL1 inhibitor; 75% MMR rate by 24wks | $1.8B cap | Cash: $286M (36m+)

• LYEL (Score 5.5/10) | Rondecabtagene autoleucel | ASH 2025 Dec 7 (23d) → Phase 3 H2H trial; 72% CR rate in 3L+ LBCL (Phase 1/2) | $339M cap | Cash: $406M (36m+)

• ACLX (Score 5.3/10) | CART-ddBCMA | ASH 2025 Dec 6 (22d) → Phase 2 data; 97% ORR and 68% CR in multiple myeloma | $5.2B cap | Cash: $437M (24m+)

• INCY (Score 5.2/10) | Zilurgisertib | ASH 2025 Dec 7 (23d) → Phase 2 ALK2 inhibitor for anemia in myelofibrosis | $21.3B cap | Cash: $3.2B (12m+)

• SDGR (Score 5.2/10) | SGR-1505 | ASH 2025 Dec 6 (22d) → Phase 1 MALT1 inhibitor; 100% response in WM subgroup | $1.3B cap | Cash: $361M (12m+)

• GILD (Score 5.0/10) | YESCARTA | ASH 2025 Dec 7 (23d) → ZUMA-7 real-world analysis; 71% OS at 12 months in 2L | $153.1B cap | Cash: $2.0B (cash rich)

• RHHBY (Score 4.6/10) | Mosunetuzumab + Lenalidomide | ASH 2025 Dec 6 (22d) → Phase 3 CELESTIMO data in follicular lymphoma | $289.1B cap | Cash: $202M (cash rich)

📅 Catalyst Timeline

November 29 - 30 (15-16 days)

CRDL - CardiolRx (ARCHER) | Conference(Nov 29) | Score: 7.5/10 | $87M cap
IMRN - Travelan | Initial Data (Nov 30) | Score: 6.4/10 | $11M cap
NAMS - Obicetrapib | Full Results (Nov 30) | Score: 3.5/10 | $4.3B cap

December 5 - 8 (21-24 days)

AXGN - Avance Nerve Graft | PDUFA (Dec 5) | Score: 5.9/10 | $1.1B cap
TCRX - TSC-100/101 | Conference (Dec 6) | Score: 7.3/10 | $68M cap
AAPG - Olverembatinib | Conference (Dec 6) | Score: 7.3/10 | $2.9B cap
GLTO - GB3226 | Conference (Dec 6) | Score: 7.2/10 | $31M cap
ARVN - ARV-393 | Conference (Dec 6) | Score: 7.1/10 | $669M cap
MRKR - Neldaleucel | Conference (Dec 6) | Score: 6.7/10 | $12M cap
ACLX - CART-ddBCMA | Conference (Dec 6) | Score: 5.3/10 | $5.2B cap
SDGR - SGR-1505 | Conference (Dec 6) | Score: 5.2/10 | $1.3B cap
GILD - YESCARTA | Conference Dec 6) | Score: 5.0/10 | $153.1B cap
RHHBY - Mosunetuzumab + Lenalidomide | Conference (Dec 6) | Score: 4.6/10 | $289.1B cap
AUTL - AUTO8 | Conference (Dec 7) | Score: 8.3/10 | $362M cap
LPCN - LPCN 2101 | Conference (Dec 7) | Score: 7.5/10 | $16M cap
CLLS - ALLO-501/501A | Conference (Dec 7) | Score: 7.4/10 | $263M cap
SLS - Tambiciclib | Conference (Dec 7) | Score: 7.0/10 | $157M cap
ALLO - ALLO-501/501A | Conference (Dec 7) | Score: 6.4/10 | $276M cap
INCY - Zilurgisertib | Conference (Dec 7) | Score: 5.2/10 | $21.3B cap
SNTI - SENTI-202 | Conference (Dec 8) | Score: 8.0/10 | $49M cap
CRVS - Soquelitinib | Conference (Dec 8) | Score: 7.4/10 | $611M cap
CGEM - CLN-049 | Conference (Dec 8) | Score: 7.4/10 | $493M cap
XCUR - GPC-100 | Conference (Dec 8) | Score: 7.3/10 | $23M cap
AGIO - Mitapivat | Conference (Dec 8) | Score: 7.3/10 | $2.5B cap
AUTL - Obe-cel | Conference (Dec 8) | Score: 8.3/10 (primary) | $362M cap
TERN - TERN-701 | Conference (Dec 8) | Score: 6.3/10 | $1.8B cap
LYEL - Rondecabtagene autoleucel | Conference (Dec 8) | Score: 5.5/10 | $339M cap

December 11 - 16 (27-32 days)

ANIX - α-lactalbumin | Conference (Dec 11) | Score: 8.0/10 | $145M cap
ATOS - (Z)-Endoxifen | Conference (Dec 11) | Score: 7.6/10 | $105M cap
MIST - CARDAMYST | PDUFA (Dec 13) | Score: 8.3/10 | $164M cap
AMGN - UPLIZNA | PDUFA (Dec 14) | Score: 3.6/10 | $181.1B cap
ALDX - Reproxalap | PDUFA (Dec 16) | Score: 7.3/10 | $319M cap

December 26 (42 days)

OMER - Narsoplimab | PDUFA (Dec 26) | Score: 7.1/10 | $469M cap
CYTK - Aficamten | PDUFA (Dec 26) | Score: 6.0/10 | $8.1B cap

🔬 Methodology

Intelligence Framework: This scanner employs a hybrid approach combining 15+ years of biotech catalyst pattern recognition with AI-powered due diligence. Each candidate receives a Scanner Score (0-10) reflecting pre-catalyst setup quality.

Data Collection: Real-time market data (price, volume, RSI, momentum) integrates with fundamental metrics (cash, runway, market cap). Catalyst intelligence from regulatory databases, conference schedules, and clinical trial registries.

AI Analysis: Structured evaluation addressing scientific merit, competitive landscape, financial viability, and risk factors. Combines with quantitative pattern recognition for final scoring.

Verification Standards: Top 15 candidates undergo enhanced verification: catalyst dates confirmed, conference names identified, key claims spot-checked. All data current as of scan execution timestamp.

Score Interpretation:

• 9.0-10.0: Exceptional setup
• 8.0-8.9: Strong opportunity
• 7.0-7.9: Good setup
• 6.0-6.9: Moderate opportunity
• 5.0-5.9: Uncertain
• Below 5.0: Unlikely movers

⚠️ Risk Disclosure & Disclaimers

Not Investment Advice: This report is for informational purposes only. Does not constitute investment, financial, or medical advice. Readers must conduct independent research and consult licensed financial advisors before making investment decisions.

Data Limitations: Catalyst dates are estimates and frequently change. Scanner Scores evaluate pre-catalyst setup quality but do not predict outcomes. Top candidates undergo verification; others rely on automated analysis. AI analysis may contain errors despite quality controls.

Key Risk Factors:

• Clinical trials: Most drug candidates fail in development
• Regulatory: FDA decisions remain unpredictable
• Financing: Cash runway estimates assume normal burn rates
• Volatility: Small-cap biotech stocks experience extreme price swings
• Liquidity: Many covered companies have limited trading volume

Methodology Protection: Scoring algorithms and analytical frameworks are proprietary and not disclosed in detail to maintain competitive advantage.

Liability Limitation: Use of this report is at reader's sole risk. Author accepts no liability for investment losses, data errors, or analytical shortcomings. Readers acknowledge complete responsibility for investment decisions.