Goldman Sachs has spotlighted an often-overlooked sector poised to benefit from lower borrowing costs: biotechnology stocks. In a recent note to clients, John Flood, Goldman’s Head of Americas Equities Sales Trading, highlighted biotech as an under-the-radar opportunity for those seeking to capitalize on the Fed’s rate cuts. Flood noted that biotechnology stocks are uniquely sensitive to changes in interest rates as they often rely on projected future profits and are heavily impacted by the cost of capital. With little or no current profitability but significant upside potential, if clinical trials succeed, these stocks have an “option-like structure” that makes them particularly responsive to interest rate movements.
The note also emphasized that biotech has recently seen improved fundamentals driven by positive clinical outcomes and a more favorable regulatory environment. Despite these tailwinds, biotech remains under-owned by hedge funds. According to Goldman’s data, the sector ranks in the 13th percentile in hedge fund long/short positioning over the past year and just the 4th percentile over the past five years.
Recent performance data supports Goldman’s outlook. The iShares Biotech ETF climbed 7.7% in Q3, outperforming the Nasdaq Biotech Index and more than doubling the S&P 500’s 3.2% gain over the same period. For investors anticipating a continued decline in bond yields, Goldman suggests biotechnology stocks may offer more attractive exposure compared to other rate-sensitive equity sectors, which are more dependent on broader economic growth trends.
Read Also: 12 Best Technology Penny Stocks To Buy According to Hedge Funds and 12 Best Energy Stocks To Invest In Now.
Biotech Innovations: Small Caps Lead the Way
In an interview with Yahoo Finance on October 30, Stacey Sears, Portfolio Manager at Emerald Advisers, provided a comprehensive overview of the current landscape and investment opportunities in small and emerging biotechnology companies.
Sears acknowledged that there has been a significant innovation in the healthcare industry, especially over the past 20 to 30 years, which was catalyzed after the decoding of the human genome in 2003, as it identified over 8,000 genetic diseases. This breakthrough provided a roadmap for researchers and scientists, leading to accelerated innovation in areas such as DNA and RNA editing and the development of treatments for orphan and rare diseases.
Sears noted that small and emerging biotechnology companies have been at the forefront of this innovation. In 2023, approximately two-thirds of all clinical trials were initiated by small and emerging biotechnology firms, and about 56% of new drug substances approved by regulatory bodies originated from these smaller companies.
Sears pointed out that the sector has been underperforming over the past couple of years. This underperformance is largely due to the inverse correlation between healthcare stocks and interest rates and yields. However, she noted that the sector is now starting to see a favorable shift. Clinical advancements have continued unabated, and the pipeline of new treatments and drugs remains robust. Large pharmaceutical companies are facing a patent cliff, estimated to be around $30 billion by the end of this decade as their drugs become generic. Small and emerging biotechnology companies are seen as key sources for filling this pipeline. This situation is creating a potential M&A tailwind, as larger companies look to acquire innovative smaller firms to bolster their drug pipelines.
The biotechnology sector presents a unique investment opportunity, driven by favorable interest rates, ongoing clinical advancements, and increased M&A activity. Small and emerging biotech firms, in particular, are poised to play a critical role in addressing unmet medical needs and fueling innovation in the healthcare space. With that in context, let’s take a look at the 12 best biotech penny stocks to invest in now.
Our Methodology
To compile our list of the 12 best biotech penny stocks to invest in now, we used Finviz and Yahoo stock screeners to find the 30 largest biotechnology companies trading below the price of $5 as of December 26. We then used Insider Monkey’s Hedge Fund database to rank 12 stocks according to the largest number of hedge fund holders, as of Q3 2024. The list is sorted in ascending order of hedge fund sentiment.
Why do we care about what hedge funds do? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter’s strategy selects 14 small-cap and large-cap stocks every quarter and has returned 275% since May 2014, beating its benchmark by 150 percentage points (see more details here).
12 Best Biotech Penny Stocks To Invest In Now
12. OmniAb, Inc. (NASDAQ:OABI)
Number of Hedge Fund Investors: 19
Stock Price as of December 26: $3.53
OmniAb, Inc. (NASDAQ:OABI) is a biotechnology company that provides a platform for pharmaceutical companies and research institutions to discover new therapeutics by using antibody discovery technologies. The company’s innovative technologies are designed to accelerate the discovery of novel antibodies and enable pharmaceutical companies to advance their drug development pipelines efficiently and effectively.
OmniAb, Inc.’s (NASDAQ:OABI) proprietary discovery technology platform includes a diverse array of transgenic animals such as the OmniRat, OmniMouse, and OmniChicken. These animals are engineered to produce high-affinity, fully human antibodies, which are crucial for developing effective therapeutics. The company is continuously expanding its technology, with the recent launch of OmnidAb, a heavy-chain OmniChicken technology. This new addition to the platform is designed to support innovations to become more efficient by allowing faster and more cost-effective development of new transgenic animals and technology elements.
OmniAb, Inc. (NASDAQ:OABI) is enhancing its platform to meet the evolving needs of the industry. The company has recently launched a new platform called OmniHub, that integrates machine learning and AI tools with deep bioinformatics capabilities to enhance antibody discovery workflows. The company has expanded its partnerships, signing new agreements with institutions such as 92Bio, Memorial Sloan Kettering Cancer Center, and the Queen Mary University of London.
Looking ahead, OmniAb, Inc. (NASDAQ:OABI) plans to launch other novel technologies and partner experience enhancements. Additionally, the company is focusing on enhancing the partner experience, which includes improving the accessibility and usability of its technology platform. By making its technology more user-friendly and accessible, OmniAb, Inc. (NASDAQ:OABI) aims to attract a broader range of partners and increase the adoption of its platform.
11. Ardelyx, Inc. (NASDAQ:ARDX)
Number of Hedge Fund Investors: 20
Stock Price as of December 26: $4.64
Ardelyx, Inc. (NASDAQ:ARDX) is a biopharmaceutical company dedicated to developing therapies for kidney and gastrointestinal diseases. The company’s lead product, IBSRELA, is approved for the treatment of irritable bowel syndrome with constipation (IBS-C), while another key candidate, XPHOZAH, addresses hyperphosphatemia in chronic kidney disease patients.
Ardelyx, Inc. (NASDAQ:ARDX) is actively expanding its commercial reach to drive market penetration and increase patient access to its therapies. The company recently completed the expansion of its field sales team for IBSRELA, which is expected to significantly enhance its ability to reach and educate healthcare providers about the benefits of IBSRELA. This expanded sales force will also help healthcare providers expand their understanding of appropriate IBSRELA patient profiles. Moreover, the company is leveraging key industry conferences to highlight the impact of IBS-C on patients’ lives and the unique benefits of IBSRELA.
Ardelyx, Inc. (NASDAQ:ARDX) is committed to expanding its pipeline and exploring strategic partnerships to further enhance its product portfolio. The company is dedicated to developing and in-licensing or acquiring new products that align with its mission to serve patients with gastrointestinal and kidney diseases.
10. Autolus Therapeutics plc (NASDAQ:AUTL)
Number of Hedge Fund Investors: 20
Stock Price as of December 26: $2.25
Autolus Therapeutics plc (NASDAQ:AUTL) is a biopharmaceutical company dedicated to the development and commercialization of next-generation, programmed T-cell therapies for the treatment of cancer and autoimmune diseases. The company’s lead product, AUCATZYL, recently received FDA approval for the treatment of relapsed or refractory adult ALL (Acute Lymphoblastic Leukemia).
With the recent approval of AUCATZYL, Autolus Therapeutics plc (NASDAQ:AUTL) is now fully focusing on a successful commercial launch. The company has been diligently preparing for this by ensuring that all necessary elements are in place to deliver this groundbreaking therapy to patients. A key aspect of this preparation has been the onboarding of treatment centers. Currently, over 30 centers across the United States are ready to activate, which covers approximately 60% of the target patient population. By the end of 2025, Autolus Therapeutics plc (NASDAQ:AUTL) aims to expand this network to 90% coverage to ensure access to the therapy. The company has also invested in a state-of-the-art commercial manufacturing facility, The Nucles, which has the capacity to produce up to 2,000 doses annually to support the needs of patients in both the US and Europe.
Autolus Therapeutics plc (NASDAQ:AUTL) is also expanding the utility of its lead candidate, obe-cel. The company is conducting clinical trials to explore the potential of obe-cel in treating other conditions, including systemic lupus and multiple myeloma. Furthermore, Autolus Therapeutics plc (NASDAQ:AUTL) has been building a strong, experienced team with a track record in both commercial and clinical development. The company has also been focused on enhancing scientific communication, presenting data at key medical conferences, and preparing for peer-reviewed publications.
9. Absci Corporation (NASDAQ:ABSI)
Number of Hedge Fund Investors: 20
Stock Price as of December 26: $3.01
Absci Corporation (NASDAQ:ABSI) is a leading biotechnology company revolutionizing the drug discovery and development process through the integration of artificial intelligence (AI) and synthetic biology. The company has developed a proprietary platform that combines AI-driven design with advanced protein engineering and manufacturing capabilities. This integrated approach allows the company to rapidly identify and develop high-quality therapeutic candidates, from initial concepts to clinical trials. Absci Corporation’s (NASDAQ:ABSI) innovative technology has attracted partnerships with some of the world’s leading pharmaceutical and biotech organizations, including AstraZeneca, Merck, Almirall, and Twist Bioscience.
Absci Corporation (NASDAQ:ABSI) is focusing on advancing three of its wholly owned proprietary programs. The company’s lead asset, ABS-101, is a potential best-in-class TL1A antibody designed to treat inflammatory diseases. The company is currently conducting further studies and plans to initiate Phase I clinical trials in the first half of 2025. Another promising program, ABS-201, targets a dermatological indication with a significant unmet need. Absci Corporation (NASDAQ:ABSI) is on track to select a development candidate for this program by the end of 2024 and plans to present a preclinical data package at its upcoming R&D Day. The company’s third proprietary program, ABS-301, is a first-in-class immune-oncology antibody designed to bind to a novel target discovered through the company’s reverse immunology platform. Absci Corporation (NASDAQ:ABSI) anticipates completing mode-of-action validation studies for ABS-301 in the first half of 2025 and sharing data shortly thereafter.
One of the key strategies Absci Corporation (NASDAQ:ABSI) is employing to grow its business is through strategic partnerships with industry leaders. These collaborations leverage the strengths of both parties to accelerate the development of novel therapeutics. For example, the company’s partnership with AstraZeneca focuses on the discovery of an AI-designed antibody against an oncology target. Additionally, Absci Corporation’s (NASDAQ:ABSI) recent partnership with Twist Bioscience brings together Absci’s Generative AI capabilities with Twist’s DNA synthesis platform, further enhancing the company’s ability to design and test novel therapeutic candidates.
Absci Corporation (NASDAQ:ABSI) is also investing in research and development to advance its proprietary programs and partnered projects. Additionally, the company is actively seeking new partnerships and is on track to sign two more collaborations that will further diversify its revenue streams and enhance its pipeline.
8. Prime Medicine, Inc. (NASDAQ:PRME)
Number of Hedge Fund Investors: 21
Stock Price as of December 26: $2.76
Prime Medicine, Inc. (NASDAQ:PRME) is a biotechnology company pioneering the field of gene editing with its Prime Editing technology. This next-generation technology allows precise and flexible genetic modifications by addressing the root causes of genetic diseases. The company offers transformative therapies for a wide range of inherited conditions by offering one-time therapeutic solutions that have the potential to correct over 90% of known genetic mutations.
Prime Medicine, Inc.’s (NASDAQ:PRME) core technology, Prime Editing, is designed to be modular and versatile, capable of addressing a broad range of genetic conditions across multiple tissues and developmental stages. The company’s lead candidate, PM359, is currently in Phase 1/2 clinical trials for the treatment of chronic granulomatous disease (CGD), a rare genetic disorder that impairs the immune system’s ability to fight off infections. PM359 uses an ex vivo approach, where hematopoietic stem and progenitor cells (HSPCs) are extracted from the patient, genetically modified, and then reinfused into the patient to restore immune function. Clinical data for PM359 is expected in 2025 and will provide critical insights into its efficacy and safety.
Prime Medicine, Inc. (NASDAQ:PRME) is focusing on expanding its pipeline and exploring new therapeutic applications for its Prime Editing platform. One of the company’s key preclinical programs targets Wilson’s disease, a genetic disorder that leads to copper accumulation in the liver. An Investigational New Drug application for this program is scheduled in the first half of 2026.
In addition to these programs, Prime Medicine, Inc. (NASDAQ:PRME) is exploring the use of Prime Editing for other challenging genetic conditions, such as cystic fibrosis (CF), retinitis pigmentosa (RHO adRP), and Friedreich’s Ataxia. The company’s technology can address a variety of genetic errors, from single nucleotide mutations to the elimination of repetitive DNA sequences.
7. C4 Therapeutics, Inc. (NASDAQ:CCCC)
Number of Hedge Fund Investors: 21
Stock Price as of December 26: $3.87
C4 Therapeutics, Inc. (NASDAQ:CCCC) is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapies for the treatment of cancer and other serious diseases. The company’s innovative approach centers on the use of targeted protein degradation, a cutting-edge technology that aims to eliminate disease-causing proteins by hijacking the body’s natural protein disposal system.
C4 Therapeutics, Inc. (NASDAQ:CCCC) is developing CFT1946, an oral degrader targeting mutated BRAF, a key driver in various solid tumors, including melanoma, colorectal cancer, and lung cancer. The company presented early data from a phase 1 study at the European Society for Medical Oncology (ESMO) 2024 meeting. The data showed promising results, with no dose-limiting toxicities and two confirmed partial responses out of 27 evaluable patients. The trial is ongoing, with additional cohorts being enrolled, including patients with melanoma and those receiving CFT1946 in combination with cetuximab for colorectal cancer. Multiple readouts from this phase 1 study are expected in 2025, which could provide further validation of CFT1946’s potential.
C4 Therapeutics, Inc.’s (NASDAQ:CCCC) lead candidate, cemsidomide, formerly CFT7455 plays a crucial role in the survival and proliferation of certain blood cancers. The company has been advancing cemsidomide through a phase 1/2 clinical trial, initially focusing on patients with heavily pretreated multiple myeloma. The company is partnering with leading pharmaceutical companies to enhance its research and development capabilities. The partnership with Merck, in particular, has been instrumental in providing both financial support and scientific expertise.
6. Mereo BioPharma Group plc (NASDAQ:MREO)
Number of Hedge Fund Investors: 25
Stock Price as of December 26: $3.81
Mereo BioPharma Group plc (NASDAQ:MREO) is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for rare diseases. The company has a robust pipeline of drug candidates, including setrusumab, a monoclonal antibody in late-stage development for the treatment of osteogenesis imperfecta (OI).
Mereo BioPharma Group plc (NASDAQ:MREO) is partnering with Ultragenyx Pharmaceutical on the development of setrusumab for the treatment of osteogenesis imperfecta (OI), a genetic disorder characterized by brittle bones that fracture easily. The companies are conducting two pivotal phase 3 studies, ORBIT and COSMIC. These studies are designed to evaluate the efficacy and safety of setrusumab in reducing fracture rates in patients with OI. The ORBIT study compares setrusumab to a placebo, while the COSMIC study compares setrusumab to intravenous bisphosphonates (IV-BP), a current standard of care. Positive 14-month data from the phase 2/3 ORBIT study has shown a significant and sustained reduction in fracture rates, providing a strong foundation for the ongoing phase 3 trials.
The potential for interim analyses in the phase 3 studies of setrusumab represents a significant opportunity for Mereo BioPharma Group plc (NASDAQ:MREO). If certain p-value thresholds are met, interim analyses could provide early insights into the drug’s efficacy, potentially accelerating the development timeline. Regardless of the interim analysis outcomes, the final data analysis is scheduled for Q4 2025, which will be a critical milestone for the company. A positive final readout could pave the way for regulatory submissions and, ultimately, the approval of setrusumab, addressing a significant unmet need in the OI market, which is projected to reach $873.81 million by 2031.
5. Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX)
Number of Hedge Fund Investors: 26
Stock Price as of December 26: $4.00
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) is a biotechnology company dedicated to developing innovative treatments for patients with neurodegenerative diseases and endocrine conditions characterized by high unmet medical needs. The company has built a robust pipeline of promising therapies, including avexitide, AMX0035, and AMX0114.
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) is focusing on the advancement of avexitide, a GLP-1 receptor antagonist with both FDA therapy and orphan drug designations. Avexitide is being developed for the treatment of post-bariatric hypoglycemia (PBH), a debilitating condition that affects a significant portion of bariatric surgery patients. The company is on track to initiate a pivotal Phase III trial in PBH in the first quarter of 2025. This trial is designed to evaluate the efficacy and safety of avexitide in reducing hypoglycemia events, with topline data expected in 2026. The positive results from earlier clinical trials, including a 66% reduction in Level 3 hypoglycemia events and a 53% reduction in Level 2 hypoglycemia events, provide a strong foundation for the Phase III program.
Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) is also focusing on the continued development of AMX0035, a novel therapy with potential applications in multiple rare neurodegenerative diseases. The company recently reported positive topline data from the Phase II HELIOS trial of AMX0035 in Wolfram syndrome, a rare genetic disorder characterized by progressive insulin-dependent diabetes, optic atrophy, and deafness. The trial demonstrated significant improvements in pancreatic function and other disease measures, providing a strong rationale for advancing AMX0035 into a Phase III program. Amylyx Pharmaceuticals, Inc. (NASDAQ:AMLX) plans to meet with the FDA and other stakeholders to inform the design of this Phase III trial, with updates expected in 2025. Additionally, the ORION trial of AMX0035 in progressive supranuclear palsy (PSP) is recruiting well, and the company expects to share interim data in mid-2025.
4. Acelyrin, Inc. (NASDAQ:SLRN)
Number of Hedge Fund Investors: 28
Stock Price as of December 26: $3.17
Acelyrin, Inc. (NASDAQ:SLRN) is a biotechnology company dedicated to developing innovative immunological therapies for patients with severe and unmet medical needs. The company has a robust pipeline of therapeutic candidates, focusing on autoimmune and inflammatory diseases. Acelyrin, Inc. (NASDAQ:SLRN) partners with academic and clinical research institutions to advance treatments that improve patient outcomes.
Acelyrin, Inc. (NASDAQ:SLRN) is focusing on the development of its lead product candidate, lonigutamab. Lonigutamab is a humanized IgG1 monoclonal antibody that targets the Insulin-like Growth Factor 1 Receptor (IGF-1R) and is the only approved action for treating Thyroid Eye Disease (TED). TED is a vision-threatening autoimmune disease affecting over 100,000 people in the U.S., characterized by inflammation and tissue expansion behind the eyes, leading to symptoms such as eye-bulging, double vision, and potential blindness.
Acelyrin, Inc. (NASDAQ:SLRN) has made substantial progress with lonigutamab, including positive proof-of-concept data demonstrating rapid improvements in proptosis and clinical activity scores within three weeks of the first dose. The company is currently conducting an adaptive Phase 2 dose-finding trial to establish the optimal dose and regimen for the Phase 3 registrational program. Cohorts 2 and 3 have been completed, and the company is actively enrolling Cohort 4, which is designed to confirm the loading dose and provide additional data using MRI assessments. With FDA alignment on the dosing strategy, Acelyrin, Inc. (NASDAQ:SLRN) is on track to initiate its Phase 3 program in the first quarter of 2025. The company has also established a Scientific and Patient Advisory Board to provide strategic input and clinical expertise, ensuring a well-informed and patient-focused approach to the development of lonigutamab.
In addition to lonigutamab, Acelyrin, Inc. (NASDAQ:SLRN) is advancing its Phase 2b/3 trial of Izokibep, a small protein therapeutic designed to inhibit interleukin-17Ain noninfectious non-interior uveitis. Uveitis is a complex and heterogeneous disease characterized by ocular inflammation, primarily affecting the working-age population and leading to significant complications such as retinal detachment. Current treatment options are limited, with corticosteroids and adalimumab being the only approved therapies. However, these treatments come with substantial side effects and efficacy limitations, whereas, Izokibep, has shown promising preclinical and early clinical results.
3. Geron Corporation (NASDAQ:GERN)
Number of Hedge Fund Investors: 29
Stock Price as of December 26: $3.34
Geron Corporation (NASDAQ:GERN) is a biopharmaceutical company focused on the development and commercialization of innovative therapies such as telomerase inhibitors for hematologic malignancies (blood cancers). Geron Corporation (NASDAQ:GERN) has recently achieved a significant milestone with the FDA approval and commercial launch of RYTELO, a first-in-class telomerase inhibitor for the treatment of lower-risk myelodysplastic syndromes (MDS).
Geron Corporation (NASDAQ:GERN) is focusing on the commercialization of RYTELO in the United States. The company is expanding its reach by targeting more eligible patients and increasing awareness among healthcare providers (HCPs) through educational initiatives and market research. The company’s sales and marketing teams are working to reinforce the clinical benefits of RYTELO, including its high red blood cell transfusion independence rates and favorable safety profile.
Furthermore, Geron Corporation (NASDAQ:GERN) is actively preparing for the potential launch of RYTELO in the European Union, with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) reviewing the marketing authorization application which is expected to be completed by early 2025. Subject to regulatory approval, the company plans to commercialize RYTELO in select EU markets beginning in 2026. To facilitate this expansion, Geron Corporation (NASDAQ:GERN) is collaborating with experienced third parties to manage critical activities such as reimbursement, health technology assessments (HTA), market access, and distribution. This strategic approach aims to optimize patient access and revenues in prioritized countries, ensuring that RYTELO reaches those who need it most.
Geron Corporation (NASDAQ:GERN) is also advancing the pivotal Phase 3 IMpactMF trial in relapsed/refractory myelofibrosis (MF), which is expected to complete interim and final analyses in 2026 and 2027, respectively. A positive outcome in this trial could significantly expand the market opportunity for RYTELO and solidify its position as a transformative treatment in hematologic malignancies.
2. Relay Therapeutics, Inc. (NASDAQ:RLAY)
Number of Hedge Fund Investors: 30
Stock Price as of December 26: $4.23
Relay Therapeutics, Inc. (NASDAQ:RLAY) is a biopharmaceutical company that leverages computational technology such as the 4D drug design, to develop precision medicines targeting protein motion. This innovative approach has enabled the discovery of therapies for cancers and other diseases. Relay Therapeutics, Inc. (NASDAQ:RLAY) collaborates with biopharmaceutical partners and researchers to accelerate the delivery of transformative treatments. The company’s pipeline includes several clinical and preclinical programs.
Relay Therapeutics, Inc.’s (NASDAQ:RLAY) core technology, the 4D drug Design Platform, stands at the forefront of computational and experimental methods to understand the dynamic movement of proteins. This approach allows the company to design drugs that are more selective and less prone to off-target effects. For instance, Relay Therapeutics, Inc. (NASDAQ:RLAY) is developing Rly-4008, an oral small molecule inhibitor of fibroblast growth factor receptor 2 (FGFR2), which has shown promising early results in clinical trials, including an 88% overall response rate (ORR) in the ReFocus trial. This early success has positioned the company to file for FDA approval in treating cholangiocarcinoma with FGFR2 alterations.
Relay Therapeutics, Inc. (NASDAQ:RLAY) is expanding its clinical trials for Rly-4008 and Rly-2608. For Rly-4008, the company is exploring additional indications and has received guidance from the FDA to file for a new drug application (NDA) in cholangiocarcinoma, followed by a tumor-agnostic supplemental application. Additionally, Relay Therapeutics, Inc. (NASDAQ:RLAY) is seeking commercial partnerships to leverage the commercialization of rly-4008.
Relay Therapeutics, Inc. (NASDAQ:RLAY) is also committed to expanding its pipeline through both internal development and strategic collaborations. The company is advancing Rly-2608, a mutant PI3Ka inhibitor, which has shown promising interim data in heavily pretreated patients with PI3Ka-mutations. Relay Therapeutics, Inc. (NASDAQ:RLAY) is also developing additional candidates, including Rly-1156, a selective and Potent inhibitor of the PI3Ka pathway.
1. Nuvation Bio Inc. (NYSE:NUVB)
Number of Hedge Fund Investors: 34
Stock Price as of December 26: $2.82
Nuvation Bio Inc. (NYSE:NUVB) is a clinical biopharmaceutical company dedicated to the development of innovative therapies for patients with significant unmet medical needs, particularly in oncology. The company’s primary focus is on the development of targeted therapies for genetically defined cancers, with a current pipeline that includes Taletrectinib, a ROS1 inhibitor, and Safusidenib, a potential treatment for Diffuse IDH1-mutant glioma.
Nuvation Bio Inc. (NYSE:NUVB) is positioning itself for significant growth through a combination of strategic clinical development, regulatory milestones, and commercial readiness. The company’s lead candidate, Taletrectinib, is a key driver of this growth strategy. Taletrectinib is currently in two pivotal Phase 2 trials, TRUST-I and TRUST-II, targeting advanced ROS1-positive non-small cell lung cancer (NSCLC). The pooled data from these trials, presented at the European Society for Medical Oncology (ESMO) in September, demonstrated impressive outcomes that are notably superior to those of existing ROS1 inhibitors, such as crizotinib, entrectinib, and repotrectinib, positioning Taletrectinib as a potential best-in-class therapy.
On December 23, Nuvation Bio Inc. (NYSE:NUVB) achieved a significant regulatory milestone with the FDA’s acceptance of its New Drug Application (NDA) for Taletrectinib, which was granted Priority Review. The FDA has set a target action date of June 23, 2025, for the application, and Taletrectinib has already been awarded Orphan Drug and Breakthrough Therapy Designations by the agency.
To further enhance its competitive position, Nuvation Bio Inc. (NYSE:NUVB) is also advancing its second lead candidate, Safusidenib, which is currently in a Phase 2 trial for the treatment of Diffuse IDH1-mutant glioma.
In preparation for the potential approval and commercial launch of Taletrectinib, Nuvation Bio Inc. (NYSE:NUVB) is building a strong commercial infrastructure. This includes establishing a specialized sales force, developing comprehensive patient support programs, and forming strategic partnerships with key stakeholders in the oncology community. Nuvation Bio Inc. (NYSE:NUVB) is also actively exploring other potential indications for both Taletrectinib and Safusidenib, which could further expand their market reach and commercial potential.
While we acknowledge the potential of Nuvation Bio Inc. (NYSE:NUVB) to grow, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than NUVB but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock.
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