Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)

$6.43 ▲ +0.01 (+0.16%)

As of May 13, 2026 03:59 PM

Sector: Healthcare Industry: Biotechnology CIK: 0001347178

Market Cap 380.39 Mn

P/E -1.73

P/S 1.76

Div. Yield 0.00

ROIC (Qtr) -0.01

Revenue Growth (1y) (Qtr) 7.58

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About

Vanda Pharmaceuticals Inc. is a global biopharmaceutical company focused on the development and commercialization of innovative therapies that address high unmet medical needs. The company’s core activities involve researching, developing, and bringing to market prescription drugs for neuropsychiatric, sleep, neurological, and gastrointestinal disorders. Its commercial portfolio consists of four approved products: Fanapt for schizophrenia and bipolar I disorder, HETLIOZ for Non 24 Hour Sleep Wake Disorder and Smith Magenis syndrome sleep disturbances,...

Vanda Pharmaceuticals Inc. is a global biopharmaceutical company focused on the development and commercialization of innovative therapies that address high unmet medical needs. The company’s core activities involve researching, developing, and bringing to market prescription drugs for neuropsychiatric, sleep, neurological, and gastrointestinal disorders. Its commercial portfolio consists of four approved products: Fanapt for schizophrenia and bipolar I disorder, HETLIOZ for Non 24 Hour Sleep Wake Disorder and Smith Magenis syndrome sleep disturbances, PONVORY for relapsing forms of multiple sclerosis, and NEREUS for the prevention of vomiting induced by motion.

Revenue is generated primarily from the sale of these approved products to specialty pharmacies, specialty distributors, and wholesalers. The company’s sales are concentrated among a limited number of these customers, with four major accounts each contributing more than ten percent of total revenue. In addition to product sales, Vanda maintains licensing and collaboration agreements that support the development of its pipeline but do not currently represent a material source of revenue.

Vanda Pharmaceuticals operates in a highly competitive biopharmaceutical sector where it faces competition from large multinational pharmaceutical companies as well as specialized biotech firms. For Fanapt, competitors include other atypical and typical antipsychotics. For HETLIOZ, competitors consist of generic melatonin agonists and sedative hypnotic treatments for certain sleep related disorders, over the counter remedies such as Benadryl and Tylenol PM, melatonin agonists, and shift work and excessive sleepiness disorder treatments. For PONVORY, rivals are other sphingosine 1 phosphate receptor modulators and immunosuppressive therapies for multiple sclerosis. For NEREUS, competition comes from neurokinin 1 receptor antagonists and other antiemetics. The company’s competitive advantages stem from its expertise in pharmacogenetics and pharmacogenomics, its focus on niche indications with limited existing therapies, and its ability to secure orphan drug designations that provide market exclusivity.

The company’s customer base comprises specialty pharmacies, specialty distributors, and wholesalers that distribute its products to patients and healthcare providers. While the filing does not disclose the specific names of its major customers, it notes that four customers each accounted for more than ten percent of total revenue in 2025, together representing approximately seventy six percent of sales. This concentration underscores the importance of maintaining strong relationships with these key distribution partners.

Investment thesis

Bull case

Vanda’s Fanapt franchise is experiencing an unprecedented surge in prescription volume, driven by both new-to-brand uptake and the recent bipolar indication launch. The call highlighted a 28% year‑over‑year rise in total prescriptions and a staggering 149% jump in new‑to‑brand starts, underscoring that prescriber confidence is rising as the product becomes a preferred option for clinicians. With the commercial sales force expanding from roughly 160 to 300 representatives, the company has effectively increased prescriber touchpoints, and the data suggest that the momentum is far from plateauing. Market watchers often focus on revenue figures alone, but Fanapt’s gross‑to‑net dynamics, which have remained relatively stable despite Medicare benefit redesign and copay support adjustments, indicate that volume growth will translate into robust incremental revenue. Even if net price pressures persist, the scale of the patient base in the bipolar and schizophrenia spaces implies that Fanapt’s market share expansion will generate long‑term value. {bullet} The company’s recent FDA approval of tradipitant (Nirius) for motion sickness marks a strategic diversification beyond psychiatry, opening a sizeable new market that has remained underserved for over four decades. Motion sickness affects roughly 65‑78 million U.S. adults, a market with low therapeutic options that typically rely on antihistamines or anticholinergics with suboptimal efficacy. Nirius, a neurokinin‑1 receptor antagonist, has demonstrated strong tolerability and efficacy in preventing vomiting induced by motion, positioning it as a first‑class oral agent. Vanda’s launch plan targets late Q2 or Q3, and the company is also pursuing a label expansion into GLP‑1‑associated nausea, which could tap into the burgeoning obesity/diabetes drug market worth tens of billions annually. By aligning the product with an unmet need in a high‑volume therapeutic area, the company can generate new revenue streams that are orthogonal to its psychiatric portfolio, thereby diluting concentration risk and enhancing upside potential. {bullet} The pipeline depth is another source of upside that is not fully reflected in current guidance. The company’s exclusive global license for imsidolimab (BLA submitted) positions Vanda to capture market share in generalized pustular psoriasis, a rare yet severely debilitating disease with limited treatment options. Regulatory exclusivity is expected to extend into the late 2030s, providing a long commercial runway. Moreover, the Phase III desipramine program for major depressive disorder is poised to deliver an adjunctive therapy that could capture a large share of the 20 million‑patient MDD market, especially if the drug demonstrates rapid onset and improved tolerability. Together, these programs can create a cumulative pipeline value that rivals that of larger biotechs, and the company’s incremental R&D spend reflects a disciplined approach to securing future revenue. {bullet} Vanda’s commercial strategy for Fanapt and potential launch of Vasanti (a 505(b)(2) NDA for bipolar I disorder) illustrates a well‑structured transition plan that leverages the existing patient base. The company has openly discussed a day‑one commercial strategy that includes product‑switching from Fanapt to Vasanti, thereby ensuring continuity of care and minimizing prescriber resistance. Importantly, the company’s gross‑to‑net outlook for Vasanti is markedly more favorable, with a projected mid‑thirties percent net margin compared to Fanapt’s roughly 50% figure, owing to a Medicaid URA reset. This improvement in economics, coupled with the high prescription volume of Fanapt, suggests that Vasanti could deliver incremental margin without cannibalizing the existing revenue base. {bullet} The company’s investment in sales force expansion and direct‑to‑consumer campaigns has paid off, as demonstrated by Fanapt’s 36% quarterly TRx growth and the 108% new‑to‑brand surge in Q4. The data show that the growth is not merely a one‑off marketing spike but a sustained change in prescriber behavior, likely reinforced by the company’s robust educational outreach. By increasing brand visibility through targeted sponsorships and paid media, Vanda has cultivated a prescriber ecosystem that is more receptive to new product launches. This momentum provides a platform for future launches—such as Nirius and Vasanti—to achieve accelerated market penetration, potentially leading to higher-than‑expected revenue trajectories in the coming years. {bullet} Vanda’s cash position, while modest, remains sufficient to support the expected cash burn for 2026, which the company explicitly acknowledged would exceed 2025 levels. The company has outlined milestone payments of $10 million to Eli Lilly for Nirius and a potential $5 million to AnaptysBio for imsidolimab, indicating that the cash runway is aligned with planned commercialization activities. The absence of a 2026 cash guidance note signals confidence that the company can manage working capital needs, given the incremental revenue expected from Fanapt, HETLIOZ, and PONVORY, and the anticipated lift from the new product launches. Therefore, investors can view the cash burn as a necessary investment in high‑growth initiatives rather than an impending liquidity crisis. {bullet} The company’s approach to regulatory milestones reflects a proactive stance. With the PDUFA date for Vasanti set for February 2026, Vanda has signaled a likely approval trajectory and a planned launch in the latter half of the year. Similarly, the tradipitant GLP‑1 study is slated for Phase III completion by Q3/Q4, providing a potential market entry that aligns with the obesity/diabetes drug surge. Even the imsidolimab BLA, while still pending, represents a rare opportunity in a niche market, and the company’s strategic partnership with AnaptysBio provides a pipeline with strong development expertise. This portfolio of pending approvals underscores that Vanda’s growth is not a single‑product phenomenon but a diversified, staged expansion plan. {bullet} Finally, the company’s resilience in the face of generic competition for HETLIOZ demonstrates a sound commercial strategy. Despite three years of generic pressure, HETLIOZ retains the majority of U.S. market share, and the company’s inventory management strategy—adjusting specialty pharmacy orders—has kept sales relatively stable. This indicates that Vanda can navigate pricing pressures and maintain profitability across its product lines, a critical factor for sustaining long‑term growth in a highly competitive industry.

Vanda’s Fanapt franchise is experiencing an unprecedented surge in prescription volume, driven by both new-to-brand uptake and the recent bipolar indication launch. The call highlighted a 28% year‑over‑year rise in total prescriptions and a staggering 149% jump in new‑to‑brand starts, underscoring that prescriber confidence is rising as the product becomes a preferred option for clinicians. With the commercial sales force expanding from roughly 160 to 300 representatives, the company has effectively increased prescriber touchpoints, and the data suggest that the momentum is far from plateauing. Market watchers often focus on revenue figures alone, but Fanapt’s gross‑to‑net dynamics, which have remained relatively stable despite Medicare benefit redesign and copay support adjustments, indicate that volume growth will translate into robust incremental revenue. Even if net price pressures persist, the scale of the patient base in the bipolar and schizophrenia spaces implies that Fanapt’s market share expansion will generate long‑term value. {bullet} The company’s recent FDA approval of tradipitant (Nirius) for motion sickness marks a strategic diversification beyond psychiatry, opening a sizeable new market that has remained underserved for over four decades. Motion sickness affects roughly 65‑78 million U.S. adults, a market with low therapeutic options that typically rely on antihistamines or anticholinergics with suboptimal efficacy. Nirius, a neurokinin‑1 receptor antagonist, has demonstrated strong tolerability and efficacy in preventing vomiting induced by motion, positioning it as a first‑class oral agent. Vanda’s launch plan targets late Q2 or Q3, and the company is also pursuing a label expansion into GLP‑1‑associated nausea, which could tap into the burgeoning obesity/diabetes drug market worth tens of billions annually. By aligning the product with an unmet need in a high‑volume therapeutic area, the company can generate new revenue streams that are orthogonal to its psychiatric portfolio, thereby diluting concentration risk and enhancing upside potential. {bullet} The pipeline depth is another source of upside that is not fully reflected in current guidance. The company’s exclusive global license for imsidolimab (BLA submitted) positions Vanda to capture market share in generalized pustular psoriasis, a rare yet severely debilitating disease with limited treatment options. Regulatory exclusivity is expected to extend into the late 2030s, providing a long commercial runway. Moreover, the Phase III desipramine program for major depressive disorder is poised to deliver an adjunctive therapy that could capture a large share of the 20 million‑patient MDD market, especially if the drug demonstrates rapid onset and improved tolerability. Together, these programs can create a cumulative pipeline value that rivals that of larger biotechs, and the company’s incremental R&D spend reflects a disciplined approach to securing future revenue. {bullet} Vanda’s commercial strategy for Fanapt and potential launch of Vasanti (a 505(b)(2) NDA for bipolar I disorder) illustrates a well‑structured transition plan that leverages the existing patient base. The company has openly discussed a day‑one commercial strategy that includes product‑switching from Fanapt to Vasanti, thereby ensuring continuity of care and minimizing prescriber resistance. Importantly, the company’s gross‑to‑net outlook for Vasanti is markedly more favorable, with a projected mid‑thirties percent net margin compared to Fanapt’s roughly 50% figure, owing to a Medicaid URA reset. This improvement in economics, coupled with the high prescription volume of Fanapt, suggests that Vasanti could deliver incremental margin without cannibalizing the existing revenue base. {bullet} The company’s investment in sales force expansion and direct‑to‑consumer campaigns has paid off, as demonstrated by Fanapt’s 36% quarterly TRx growth and the 108% new‑to‑brand surge in Q4. The data show that the growth is not merely a one‑off marketing spike but a sustained change in prescriber behavior, likely reinforced by the company’s robust educational outreach. By increasing brand visibility through targeted sponsorships and paid media, Vanda has cultivated a prescriber ecosystem that is more receptive to new product launches. This momentum provides a platform for future launches—such as Nirius and Vasanti—to achieve accelerated market penetration, potentially leading to higher-than‑expected revenue trajectories in the coming years. {bullet} Vanda’s cash position, while modest, remains sufficient to support the expected cash burn for 2026, which the company explicitly acknowledged would exceed 2025 levels. The company has outlined milestone payments of $10 million to Eli Lilly for Nirius and a potential $5 million to AnaptysBio for imsidolimab, indicating that the cash runway is aligned with planned commercialization activities. The absence of a 2026 cash guidance note signals confidence that the company can manage working capital needs, given the incremental revenue expected from Fanapt, HETLIOZ, and PONVORY, and the anticipated lift from the new product launches. Therefore, investors can view the cash burn as a necessary investment in high‑growth initiatives rather than an impending liquidity crisis. {bullet} The company’s approach to regulatory milestones reflects a proactive stance. With the PDUFA date for Vasanti set for February 2026, Vanda has signaled a likely approval trajectory and a planned launch in the latter half of the year. Similarly, the tradipitant GLP‑1 study is slated for Phase III completion by Q3/Q4, providing a potential market entry that aligns with the obesity/diabetes drug surge. Even the imsidolimab BLA, while still pending, represents a rare opportunity in a niche market, and the company’s strategic partnership with AnaptysBio provides a pipeline with strong development expertise. This portfolio of pending approvals underscores that Vanda’s growth is not a single‑product phenomenon but a diversified, staged expansion plan. {bullet} Finally, the company’s resilience in the face of generic competition for HETLIOZ demonstrates a sound commercial strategy. Despite three years of generic pressure, HETLIOZ retains the majority of U.S. market share, and the company’s inventory management strategy—adjusting specialty pharmacy orders—has kept sales relatively stable. This indicates that Vanda can navigate pricing pressures and maintain profitability across its product lines, a critical factor for sustaining long‑term growth in a highly competitive industry.

Bear case

Vanda’s operating expenses have ballooned to $367 million in 2025, an increase of $128 million driven largely by SG&A spend for commercial launches and R&D, particularly the imsidolimab license. This surge in burn, combined with a one‑time $114 million deferred tax valuation allowance, has pushed the company into a net loss of $120 million, raising concerns about the sustainability of its cash runway. While the company claims that cash burn will exceed 2025 levels, it has not provided 2026 cash guidance, leaving investors uncertain about liquidity and the need for additional capital raises. The lack of transparency on working capital management further magnifies the risk that the company may need to raise debt or equity to fund future milestones, potentially diluting shareholders. {bullet} The Q&A session revealed significant enrollment delays for the iloperidone LAI Phase III program, with the company admitting that the study in Europe is subject to resistance from placebo‑controlled trials that it cannot control. This uncertainty translates into a timeline risk for a key product that could have positioned Vanda in the long‑acting injectable antipsychotic market, a segment that is highly competitive and dominated by large incumbents. Without a clear path to enrollment completion, the company risks missing market windows, which could result in lost sales and a lower valuation of the product. The admission that the study is not progressing at the desired pace signals a potential bottleneck that could undermine the company’s pipeline strategy. {bullet} Vanda’s HETLIOZ product faces an increasingly bleak outlook due to generic competition. The company explicitly stated that HETLIOZ sales may decline “in future periods, potentially significantly,” linked to generic entrants and a reduction in specialty pharmacy orders as inventory levels are worked down. This structural shift threatens to erode a core revenue stream that has historically contributed a sizable portion of the company's earnings. The risk is compounded by the fact that HETLIOZ’s market share retention is reliant on maintaining high inventory weeks at wholesalers, a fragile metric susceptible to payer negotiations and market consolidation. Thus, Vanda’s revenue projections that assume a modest decline may be overly optimistic if generic pricing accelerates or if specialty pharmacy contracts shift away from branded products. {bullet} The variable consideration dispute for PONVORY presents a legal and revenue uncertainty. With $3 million of variable consideration subject to dispute recognized in Q4 2024, the company faces potential litigation or renegotiation that could reduce PONVORY’s net sales. Given that PONVORY is part of the company’s dermatology and multiple sclerosis pipeline, any adverse resolution could limit the commercial upside of these programs. Furthermore, the dispute adds a layer of uncertainty to the company’s financial statements that could lead to restatement or investor scrutiny, detracting from the perceived reliability of reported earnings. {bullet} Gross‑to‑net dynamics, especially for Fanapt, are under stress from Medicare benefit redesign and copay support adjustments. While the company expects these dynamics to stabilize, the present 50% net margin indicates a thin profitability buffer that is vulnerable to payer repricing or policy changes. Any further adverse adjustments—such as increased Medicaid rebates or additional fee schedules—could erode the already modest margin, forcing the company to pursue further cost‑control measures or price reductions that would dampen growth. The company's current guidance assumes consistent gross‑to‑net behavior, yet payer environments in the U.S. are notoriously volatile, and the company may be exposed to significant margin compression. {bullet} The commercialization timing of new products is uncertain and may dilute the anticipated revenue boost. For instance, the Nirius launch is scheduled for late Q2/Q3, yet the company has not yet secured commercial supply, and the FDA approval for the motion sickness indication was only recently achieved. Even after approval, the company must establish a distribution network, marketing collateral, and prescriber education, which can take months. This delay can compress the revenue window and reduce the present‑value of the launch. Similarly, the Vasanti launch is contingent on FDA approval, which may not arrive until early 2026, delaying the product’s revenue contribution beyond the guidance period. Investors may therefore overestimate the near‑term upside that the company claims. {bullet} The reliance on a single product launch—Fanapt—to drive most of the company’s revenue growth introduces a concentration risk. The guidance for 2026 is heavily weighted toward Fanapt, with a projected 36% YoY growth, and does not include revenue from Vasanti or Nirius. Should Fanapt face unforeseen competition, changes in prescribing habits, or increased regulatory scrutiny (e.g., adverse events or safety concerns), the company could experience a sharp decline in sales. The company’s current sales force expansion and marketing spend are designed to sustain this growth, but such investments may not be sufficient to offset a sudden drop in prescriptions, especially if prescribers switch to alternative therapies. {bullet} The company’s pipeline, while diversified, contains multiple late‑stage programs that are not yet approved and may not reach market as scheduled. The Phase III VQW‑765 program for social anxiety disorder is still pending results, and the company has not provided a realistic timeline beyond the 2026 guidance period. Given that the social anxiety market is highly competitive with established therapies (SSRIs, benzodiazepines), Vanda’s product will need to demonstrate a superior benefit‑risk profile to capture market share. The risk of delayed or negative trial outcomes could diminish the pipeline’s value and further strain the company’s cash position, especially if the company must continue R&D spending without corresponding revenue streams. {bullet} Finally, the company’s approach to milestone payments and inventory build‑ups exposes it to cash flow risk. The CFO explicitly mentioned that a $10 million milestone payment to Eli Lilly for Nirius and a potential $5 million payment to AnaptysBio for imsidolimab will be made in 2026. These outlays, combined with the need to finance commercial inventory for upcoming launches, may strain working capital and force the company to draw on debt or equity financing. The lack of disclosed 2026 cash guidance further clouds the ability of investors to assess whether the company will generate sufficient cash flow to cover these obligations without compromising its strategic initiatives.

Vanda’s operating expenses have ballooned to $367 million in 2025, an increase of $128 million driven largely by SG&A spend for commercial launches and R&D, particularly the imsidolimab license. This surge in burn, combined with a one‑time $114 million deferred tax valuation allowance, has pushed the company into a net loss of $120 million, raising concerns about the sustainability of its cash runway. While the company claims that cash burn will exceed 2025 levels, it has not provided 2026 cash guidance, leaving investors uncertain about liquidity and the need for additional capital raises. The lack of transparency on working capital management further magnifies the risk that the company may need to raise debt or equity to fund future milestones, potentially diluting shareholders. {bullet} The Q&A session revealed significant enrollment delays for the iloperidone LAI Phase III program, with the company admitting that the study in Europe is subject to resistance from placebo‑controlled trials that it cannot control. This uncertainty translates into a timeline risk for a key product that could have positioned Vanda in the long‑acting injectable antipsychotic market, a segment that is highly competitive and dominated by large incumbents. Without a clear path to enrollment completion, the company risks missing market windows, which could result in lost sales and a lower valuation of the product. The admission that the study is not progressing at the desired pace signals a potential bottleneck that could undermine the company’s pipeline strategy. {bullet} Vanda’s HETLIOZ product faces an increasingly bleak outlook due to generic competition. The company explicitly stated that HETLIOZ sales may decline “in future periods, potentially significantly,” linked to generic entrants and a reduction in specialty pharmacy orders as inventory levels are worked down. This structural shift threatens to erode a core revenue stream that has historically contributed a sizable portion of the company's earnings. The risk is compounded by the fact that HETLIOZ’s market share retention is reliant on maintaining high inventory weeks at wholesalers, a fragile metric susceptible to payer negotiations and market consolidation. Thus, Vanda’s revenue projections that assume a modest decline may be overly optimistic if generic pricing accelerates or if specialty pharmacy contracts shift away from branded products. {bullet} The variable consideration dispute for PONVORY presents a legal and revenue uncertainty. With $3 million of variable consideration subject to dispute recognized in Q4 2024, the company faces potential litigation or renegotiation that could reduce PONVORY’s net sales. Given that PONVORY is part of the company’s dermatology and multiple sclerosis pipeline, any adverse resolution could limit the commercial upside of these programs. Furthermore, the dispute adds a layer of uncertainty to the company’s financial statements that could lead to restatement or investor scrutiny, detracting from the perceived reliability of reported earnings. {bullet} Gross‑to‑net dynamics, especially for Fanapt, are under stress from Medicare benefit redesign and copay support adjustments. While the company expects these dynamics to stabilize, the present 50% net margin indicates a thin profitability buffer that is vulnerable to payer repricing or policy changes. Any further adverse adjustments—such as increased Medicaid rebates or additional fee schedules—could erode the already modest margin, forcing the company to pursue further cost‑control measures or price reductions that would dampen growth. The company's current guidance assumes consistent gross‑to‑net behavior, yet payer environments in the U.S. are notoriously volatile, and the company may be exposed to significant margin compression. {bullet} The commercialization timing of new products is uncertain and may dilute the anticipated revenue boost. For instance, the Nirius launch is scheduled for late Q2/Q3, yet the company has not yet secured commercial supply, and the FDA approval for the motion sickness indication was only recently achieved. Even after approval, the company must establish a distribution network, marketing collateral, and prescriber education, which can take months. This delay can compress the revenue window and reduce the present‑value of the launch. Similarly, the Vasanti launch is contingent on FDA approval, which may not arrive until early 2026, delaying the product’s revenue contribution beyond the guidance period. Investors may therefore overestimate the near‑term upside that the company claims. {bullet} The reliance on a single product launch—Fanapt—to drive most of the company’s revenue growth introduces a concentration risk. The guidance for 2026 is heavily weighted toward Fanapt, with a projected 36% YoY growth, and does not include revenue from Vasanti or Nirius. Should Fanapt face unforeseen competition, changes in prescribing habits, or increased regulatory scrutiny (e.g., adverse events or safety concerns), the company could experience a sharp decline in sales. The company’s current sales force expansion and marketing spend are designed to sustain this growth, but such investments may not be sufficient to offset a sudden drop in prescriptions, especially if prescribers switch to alternative therapies. {bullet} The company’s pipeline, while diversified, contains multiple late‑stage programs that are not yet approved and may not reach market as scheduled. The Phase III VQW‑765 program for social anxiety disorder is still pending results, and the company has not provided a realistic timeline beyond the 2026 guidance period. Given that the social anxiety market is highly competitive with established therapies (SSRIs, benzodiazepines), Vanda’s product will need to demonstrate a superior benefit‑risk profile to capture market share. The risk of delayed or negative trial outcomes could diminish the pipeline’s value and further strain the company’s cash position, especially if the company must continue R&D spending without corresponding revenue streams. {bullet} Finally, the company’s approach to milestone payments and inventory build‑ups exposes it to cash flow risk. The CFO explicitly mentioned that a $10 million milestone payment to Eli Lilly for Nirius and a potential $5 million payment to AnaptysBio for imsidolimab will be made in 2026. These outlays, combined with the need to finance commercial inventory for upcoming launches, may strain working capital and force the company to draw on debt or equity financing. The lack of disclosed 2026 cash guidance further clouds the ability of investors to assess whether the company will generate sufficient cash flow to cover these obligations without compromising its strategic initiatives.

Product and Service Breakdown of Revenue (2025)

Equity Components Breakdown of Revenue (2025)

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