10 Small-Cap Biotechs with Key Catalysts for 2025 July List________________________________________
🔬 10 Small-Cap Biotechs with Key Catalysts for 2025 July List
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1. Allogene Therapeutics (NASDAQ: ALLO)
• Catalyst: Phase 2 data for ALLO-501A (anti-CD19 CAR-T for large B-cell lymphoma) expected in H2 2025; potential pivotal data could lead to regulatory submission.
• Highlights: “Off-the-shelf” allogeneic CAR-T approach could transform cell therapy; watch for manufacturing/scalability updates.
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2. Lixte Biotechnology (NASDAQ: LIXT)
• Catalyst: Phase 2 combo trial of LB-100 (PP2A inhibitor) + immunotherapy in solid tumors, with key data expected in late 2025.
• Highlights: If efficacy signals emerge, could prompt partnerships or additional trials.
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3. Iovance Biotherapeutics (NASDAQ: IOVA)
• Catalyst: Commercial launch and sales uptake for AMTAGVI (lifileucel, first FDA-approved TIL therapy in advanced melanoma); upcoming label expansion studies in lung and cervical cancer.
• Highlights: Investor focus on launch ramp, real-world data, and new trial initiations in 2025.
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4. RenBio (NASDAQ: RENB)
• Catalyst: Phase 1/2 data for RB-100 (bispecific antibody platform in solid tumors) expected mid-to-late 2025.
• Highlights: Pipeline progress and partnership announcements possible.
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5. IGM Biosciences (NASDAQ: IGMS)
• Catalyst: Phase 2 data for IGM-2323 (CD20 x CD3 bispecific in non-Hodgkin lymphoma) expected early 2025; ongoing updates from IgM antibody platform.
• Highlights: Investor interest in clinical safety, efficacy, and potential for big pharma tie-ups.
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6. Zura Bio (NASDAQ: ZURA)
• Catalyst: Phase 2b/3 trial start and topline data for tibulizumab (IL-7Ra mAb for autoimmune diseases) expected late 2025.
• Highlights: Focus on rare and orphan autoimmune indications.
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7. INmune Bio (NASDAQ: INMB)
• Catalyst: Phase 2 Alzheimer’s data (XPro1595, targeting neuroinflammation) and oncology pipeline updates expected H1 2025.
• Highlights: Any signal in Alzheimer’s is high-impact; monitoring for FDA guidance.
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8. Veru Inc (NASDAQ: VERU)
• Catalyst: Phase 3 trial results for enobosarm (oral SARM) in advanced breast cancer expected 2025; also, COVID/sepsis drug updates.
• Highlights: Regulatory clarity and partnership/M&A rumors are potential drivers.
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9. Century Therapeutics (NASDAQ: IPSC)
• Catalyst: First-in-human data for iPSC-derived NK and CAR-T cell therapies, with updates expected at major meetings in 2025.
• Highlights: Platform validation and early efficacy/safety signals.
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10. ProKidney (NASDAQ: PROK)
• Catalyst: Phase 3 pivotal data for REACT (cell therapy for chronic kidney disease/diabetes) due late 2025.
• Highlights: If positive, could become the first autologous cell therapy for kidney disease.
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🔎 How to Monitor These Catalysts
• FDA submissions/meetings (ALLO, PROK, VERU)
• Clinical trial readouts (LIXT, RENB, IGMS, ZURA, INMB, IPSC)
• Commercial/launch data (IOVA)
• Partnership/M&A activity (IGMS, VERU, RENB)
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📊 Summary Table
Ticker Company Upcoming Catalyst/Event Timeframe
ALLO Allogene Therapeutics Phase 2 LBCL CAR-T pivotal data H2 2025
LIXT Lixte Biotechnology LB-100 + immunotherapy Phase 2 data Late 2025
IOVA Iovance Biotherapeutics AMTAGVI launch data; label expansions Throughout 2025
RENB RenBio Bispecifics Phase 1/2 data Mid-to-late 2025
IGMS IGM Biosciences IGM-2323 Phase 2 data (lymphoma) Early 2025
ZURA Zura Bio Tibulizumab Phase 2b/3 topline data Late 2025
INMB INmune Bio Alzheimer’s/oncology trial updates H1 2025
VERU Veru Inc Enobosarm Phase 3 (breast cancer) 2025
IPSC Century Therapeutics First-in-human iPSC cell therapy data 2025
PROK ProKidney REACT Phase 3 (CKD) pivotal readout Late 2025
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⚠️ Word of Caution
Small-cap biotech stocks can be extremely volatile, especially around catalyst events (trial data, FDA decisions). Sharp price swings—both up and down—are common. Always conduct your own research and be aware of the risks.
IOVA
IOVA a volatile medical stock approaches earnings LONGIOVA has doubled in February and broke out above its volume profile high volume area about
one week ago as it runs to earnings. Since it settled down two days ago into a relative side-
ways consolidation. I will take a long trade here for a pre-earnings play to presume that the
buying and bullish momentum will resume nearly immediately.
FDA Grants Approval to Iovance's AMTAGVI for Advanced Melanoma
In a significant stride towards revolutionizing cancer treatment, Iovance Biotherapeutics, Inc. (NASDAQ: NASDAQ:IOVA ) has achieved a monumental milestone. The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Iovance's AMTAGVI™ (lifileucel) suspension for intravenous infusion, marking a groundbreaking advancement in the fight against advanced melanoma.
Unveiling a Paradigm Shift in Cancer Therapy:
AMTAGVI™ represents a paradigm shift in cancer therapy, offering a novel approach to treating solid tumor cancers. Unlike conventional treatments, AMTAGVI™ harnesses the power of the body's own immune system by deploying patient-specific T cells known as Tumor-Infiltrating Lymphocytes (TILs). This innovative therapy targets adult patients with unresectable or metastatic melanoma who have previously undergone treatment with a PD-1 blocking antibody and, if applicable, a BRAF inhibitor.
Personalized Precision Medicine:
At the core of AMTAGVI™ lies a personalized precision medicine approach. Through a proprietary process, the therapy collects and expands a patient's unique T cells derived from their own tumor tissue. By returning billions of activated T cells to the body, AMTAGVI™ empowers the immune system to recognize and destroy cancer cells with unprecedented specificity.
Accelerated Approval and Clinical Efficacy:
The FDA's accelerated approval of AMTAGVI™ underscores its remarkable clinical efficacy and potential to address unmet medical needs. Clinical trials, including the pivotal C-144-01 study, demonstrated deep and durable responses in patients with advanced melanoma. Notably, a substantial percentage of patients achieved objective responses, with a median duration of response surpassing 12 months.
Transformative Impact on Patient Care:
For patients grappling with advanced melanoma, AMTAGVI™ offers a ray of hope where conventional treatments have fallen short. With an estimated 8,000 melanoma-related deaths annually in the U.S. alone, the approval of AMTAGVI™ signifies a critical breakthrough in transforming the treatment landscape and improving patient outcomes.
Commitment to Accessibility and Support:
Recognizing the importance of accessibility, Iovance is dedicated to ensuring the widespread availability of AMTAGVI™ through its comprehensive support program, IovanceCares™. This initiative provides patients and Authorized Treatment Centers (ATCs) with invaluable resources, including copay support, financial assistance, and travel accommodations, to facilitate seamless access to therapy.
Conclusion:
In the realm of cancer therapeutics, the approval of AMTAGVI™ marks a historic milestone, heralding a new era of personalized and precision medicine. As Iovance ( NASDAQ:IOVA ) continues its pursuit of addressing unmet medical needs across various solid tumor types, the groundbreaking success of AMTAGVI™ serves as a beacon of hope for patients, clinicians, and researchers alike in the relentless fight against cancer.
IOVA Iovance Biotherapeutics Options Ahead of EarningsAnalyzing the options chain of IOVA Iovance Biotherapeutics prior to the earnings report this week,
I would consider purchasing the 7.5usd strike price Puts with
an expiration date of 2023-6-16,
for a premium of approximately $0.70
If these options prove to be profitable prior to the earnings release, I would sell at least half of them.
Looking forward to read your opinion about it.
Iovance BioTherapeutics (NASDAQ: $IOVA) Popping Pre-market! 🎉Iovance Biotherapeutics, Inc., a clinical-stage biotechnology company, focuses on developing and commercializing cancer immunotherapy products to harness the power of a patient's immune system to eradicate cancer cells. It has six ongoing phase 2 clinical studies, including C-144-01, of its lead product candidate, lifileucel, for the treatment of metastatic melanoma; C-145-04, of its product candidate lifileucel for recurrent, metastatic, or persistent cervical cancer; and C-145-03, of its product candidate LN-145, for recurrent and/or metastatic head and neck squamous cell carcinoma. Iovance Biotherapeutics, Inc. has collaborations and licensing agreements with H. Lee Moffitt Cancer Center; M.D. Anderson Cancer Center; Ohio State University; Centre hospitalier de l'Université de Montreal; Cellectis S.A.; and Novartis Pharma AG. The company was formerly known as Lion Biotechnologies, Inc. and changed its name to Iovance Biotherapeutics, Inc. in June 2017. Iovance Biotherapeutics, Inc. was incorporated in 2007 and is headquartered in San Carlos, California.
IOVA - IOVANCE FINISHED FUELING UP AND ABOUT TO TURN ON ENGINEIovance Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient's own immune cells to attack cancer. TIL cells are extracted from a patient's own tumor tissue, expanded through a proprietary process, and infused back into the patient. Upon infusion, TIL reach tumor tissue, where they attack cancer cells. The company has completed dosing in the pivotal study in patients with metastatic melanoma and cervical cancer. In addition, the company's TIL therapy is being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including head and neck and non-small cell lung cancer. A clinical study to investigate Iovance T cell therapy for blood cancers called peripheral blood lymphocyte (PBL) therapy is open to enrollment.
What an amazing opportunity. RISK 5% REWARD 22% 4.44 RISK TO REWARD RATIO
Enough cash on hand ~$720M cash (9/30/20) to last 3 years of R&D
2021 - Year to get some FDA News - HUGE POTENTIAL MARKET FOR CANCER TREATMENT
Research/ Study showing promise.
Developing Iovance manufacturing facility plans for commercialization 75 Million$ Investment scheduled for completion this year.
IOVA relative strength compared to SPY! HOMERUN ?!Hi traders,
I would like to share my yesterday´s trade in the IOVA market. We can easily see some relative strength compared to the SPY. (especially during the Coronavirus crisis) -> Long sign.
This market went up with confidence and Insiders increased their LONG positions => they believe that their company will rise.
So If you want, you can take the trade as soon as the markets open.
Good trading,
Jakub
FINEIGHT