Showing 6 Drugs Out Of 1400. Click On The Tickers For More Details

Ticker	Name	Price	Market Capital	Event Type	Drug Name	Run Up/Down	Catalyst Date	Poa %	Poa Summary	Stage	Treatment	Hedge Funds	Description
SILO	Silo Pharma, Inc.	6.4 -1.08 %	6.4M	IND Submission	SPC-15 (intranasal p Read More	-25.05%	2026	8%	SPC-15, developed by Silo Pharma (NASDAQ: SILO), is a novel intranasal serotonin 5-HT4 receptor agonist aimed at preventing post-traumatic stress disorder (PTSD). Currently in the IND-enabling preclinical phase, the company plans to submit an Investigational New Drug (IND) application by late 2025. To date, SPC-15 has completed animal studies, showing no local or systemic toxicity and favorable pharmacokinetics, comparable to oral formulations, which is a prerequisite for clinical testing. However, there is currently no human data available, nor any objective response rates or statistical efficacy outcomes, leaving its efficacy and long-term safety in humans entirely unproven. The program is being prepared for the FDA's 505(b)(2) pathway, potentially allowing for an expedited review process based on existing safety or efficacy data from reference drugs. SPC-15’s mechanism of action is unique in the context of PTSD, as it differs from the two currently approved PTSD medications, which are both SSRIs, and from various historical candidates that have failed in this area. CNS small molecules, particularly those aimed at PTSD, have historically shown low Phase 1-to-approval probabilities, with average approval chances estimated at 5–8%, reflecting high attrition rates due to efficacy and safety concerns. Regulatory authorities have not approved a new therapy for PTSD in over two decades, indicating significant challenges in this indication. Currently, there are no Fast Track, Orphan Drug, or Breakthrough Therapy designations for SPC-15, and no PDUFA date has been set, as the drug has not yet entered clinical trials. Ongoing device studies are focused on the proprietary microchip-based nasal spray system, but no human pharmacodynamic or comparative studies against standard care have been reported. Silo Pharma retains global commercialization rights and is collaborating with Columbia University; however, the company has not previously brought a drug through FDA or EMA approval, introducing additional execution risk. Considering the early development stage, lack of human data, specific challenges in CNS and PTSD drug development, and absence of regulatory acceleration, the estimated probability of approval for SPC-15 remains at 5–8%, in line with historical trends in CNS small molecule development. Read More	IND 20%	Post-traumatic stress disorder Read More+	N/A	Silo Pharma plans to submit an investigational new drug application (IND) for SPC-15 to the FDA, which is expected to lead to a Phase 1 clinical trial upon approval. Read More
STTK	Shattuck Labs, Inc.	4.13 -6.55 %	467.8M	phase 1 data readout	SL-325 (DR3 blocking Read More	28.19%	Q2 2026	47%	SL-325 is a first-in-class Death Receptor 3 (DR3) blocking antibody developed by Shattuck Labs for the treatment of Crohn's disease. This innovative therapeutic candidate aims to achieve a complete and durable blockade of the DR3/TL1A signaling pathway, which has shown compelling monotherapy efficacy in inflammatory bowel disease (IBD) based on existing clinical literature. As of March 2026, SL-325 is in Phase 1 clinical trials, with data anticipated in the second quarter of 2026, and the company plans to initiate Phase 2 trials in Crohn's disease patients in the third quarter of 2026. The market analysis indicates a significant unmet medical need in Crohn's disease, affecting hundreds of thousands of patients globally. Despite the availability of established therapies such as TNF inhibitors, integrin antagonists, and JAK inhibitors, many patients continue to experience inadequate disease control, loss of response, or intolerable side effects. Although specific global market size figures for Crohn's disease are not provided, the strategic focus on SL-325 and its planned Phase 2 development highlight the perceived necessity for novel therapeutic approaches targeting the DR3/TL1A pathway. SL-325 is classified as a first-in-class drug, representing the first DR3 blocking antibody to enter human clinical trials. Preclinical studies have demonstrated high-affinity binding and superior activity compared to TL1A antibodies, providing a rationale for targeting the TNF receptor (DR3) rather than its ligand (TL1A). This mechanistic distinction positions SL-325 as a potentially differentiated approach within the competitive IBD therapeutic landscape. The ongoing Phase 1 trial is a randomized, double-blind, placebo-controlled study involving healthy volunteers, designed to evaluate safety, tolerability, immunogenicity, and pharmacokinetics. The trial is nearing completion, with results expected in the second quarter of 2026. Preclinical studies in non-human primates have shown no evidence of toxicity or residual DR3 agonism, and the receptor occupancy and pharmacokinetic profile suggest that extended dosing intervals may be feasible in humans. These favorable preclinical findings support the progression to Phase 2 trials. Currently, no clinical efficacy data are available, as the Phase 1 trial focuses on safety and pharmacokinetics in healthy volunteers rather than efficacy in patients. However, the robust preclinical safety profile, which includes GLP toxicology studies in cynomolgus macaques showing no toxicity signals or residual agonism at any dose level, enhances confidence in the drug's potential. The possibility of extended dosing intervals could also provide clinical advantages regarding patient convenience and compliance. As of now, SL-325 has not received any regulatory designations such as Fast Track, Breakthrough Therapy, Orphan Drug, Priority Review, or Accelerated Approval for Crohn's disease. This absence of special designations suggests that the FDA has not prioritized the program, which may indicate either early-stage evaluation or a standard regulatory pathway. The competitive landscape for Crohn's disease is highly saturated, with multiple approved therapies including TNF inhibitors, integrin antagonists, IL-12/IL-23 inhibitors, and JAK inhibitors. While SL-325's first-in-class status and novel mechanism offer potential differentiation, demonstrating clinical superiority over established therapies will be crucial for market penetration. The estimated probability of approval (PoA) for SL-325 is 42-52%. This assessment reflects a balanced view of significant opportunities and material risks. Positive factors include the first-in-class mechanism targeting a validated pathway, favorable preclinical safety data, and adequate funding to support clinical development. However, the program remains in early-stage development, with no human efficacy data and no regulatory designations to expedite review. The competitive IBD market and the binary nature of Phase 2 success present substantial risks. Approval will depend critically on Phase 1 data demonstrating acceptable safety and pharmacokinetics, followed by Phase 2 efficacy results that differentiate SL-325 from existing therapies. Key risks associated with SL-325 include potential safety or pharmacokinetic concerns arising from the Phase 1 trial, the possibility of Phase 2 efficacy failure, competitive displacement by other novel IBD therapies, regulatory pathway uncertainties, and manufacturing challenges. Significant upcoming catalysts include the Phase 1 data release in Q2 2026 and the Phase 2 trial initiation in Q3 2026, both of which will play a pivotal role in shaping the risk-benefit profile and investment thesis for Shattuck Labs. Read More	Phase 1 20%	Crohn’s disease	2	Shattuck Labs anticipates sharing data from the ongoing Phase 1 clinical trial of SL-325 in the second quarter of 2026. Read More
TCRX	TScan Therapeutics, Inc.	0.9185 -4.70 %	69.3M	phase 1 data readout	TSC-101	3.89%	Q2 2026	40%	TSC-101, developed by TScan Therapeutics (TCRX), is an innovative allogeneic, donor-derived T-cell receptor (TCR)-T therapy designed to target minor histocompatibility antigens (minor H antigens) that are present on recipient hematopoietic cells but absent on donor cells. This unique mechanism aims to selectively eliminate residual recipient disease following allogeneic hematopoietic cell transplantation (allo-HCT), thereby preventing relapse in hematologic malignancies without the need for broad immunosuppression. As a first-in-class approach, TSC-101 stands out from existing therapies such as bispecific antibodies, antibody-drug conjugates (ADCs), and checkpoint inhibitors by utilizing precise TCR targeting in the post-HCT setting, where there are currently no direct competitors employing this mechanism of action. The global market for hematologic malignancies is substantial, exceeding $15 billion, driven by the high incidence of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). There is a significant unmet need in this space, as relapse rates post-allo-HCT can range from 30% to 50%, despite the use of conditioning regimens. TSC-101 aims to address this unmet need by promoting long-term T-cell persistence and chimerism, which may allow for an expanded patient population through follow-on candidates such as TSC-102. Currently, TSC-101 is in Phase 1 development, being evaluated in the ALLOHA trial (NCT number not specified). This trial focuses on A*02:01-positive patients with hematologic malignancies undergoing allo-HCT. The multi-cohort, open-label design includes an internal control arm, with Cohort C (n>10) having completed its evaluation using commercial-ready manufacturing. The primary endpoints of the trial are safety, chimerism, and relapse-free survival (RFS), while secondary endpoints include persistence and efficacy signals. Preliminary Phase 1 data presented at the December 2025 ASH meeting indicated favorable safety profiles, durable persistence exceeding two years, a dose-response correlation, and a notable RFS benefit—82% relapse-free survival in the treatment group compared to 64% in the control group. Importantly, no severe adverse events or graft-versus-host disease signals were reported, which supports the FDA's alignment on a pivotal trial that will mirror the ALLOHA trial, with RFS as the primary endpoint for AML/MDS, set to launch in Q2 2026. Despite the promising data, TSC-101 has not received any regulatory designations for hematologic malignancies, such as Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval. The competitive landscape includes established therapies like venetoclax/azacitidine in AML, but there is a notable absence of options specifically targeting post-HCT relapse prevention. While there are other TCR-T therapies in development, TSC-101's donor-derived, off-the-shelf format provides a competitive advantage. The estimated probability of approval (PoA) for TSC-101 is 35-45%. This reflects the strong momentum observed in Phase 1, with promising efficacy and safety data, as well as alignment with the FDA for pivotal trial execution. However, the PoA is tempered by risks associated with pivotal execution in a novel modality, given the small sample size of 31 total patients and the absence of randomization or blinding to date. Historical data suggests that approximately 50% of Phase 2/3 trials for hematologic biologics with similar profiles succeed, although this is discounted due to uncertainties surrounding manufacturing and expansion capabilities. The sponsor has a clean track record with no prior approvals or rejections and has received FDA IND clearances for TSC-102, which extends the runway to H2 2027. Key risks include potential data underperformance, delays, or increased competition. Upcoming catalysts, including the Q2 2026 readout for Cohort C and the pivotal trial launch, may mitigate near-term risks. If TSC-101 maintains its RFS benefits, TScan Therapeutics could position itself for significant market success, targeting peak sales exceeding $1 billion in the relapse prevention market. Read More	Phase 1 20%	Hematologic malignancies	4	TScan Therapeutics plans to share initial data from patients enrolled in Cohort C of the ALLOHA™ study in the second quarter of 2026. Read More
SABS	SAB Biotherapeutics, Inc.	3.31 0.30 %	298.2M	Pre-clinical data readout	SAB-142	2.64%	2026-06-10	22%	SAB-142 is SAB Biotherapeutics’ lead asset targeting type 1 diabetes (T1D), a fully human anti-thymocyte immunoglobulin (hIgG) designed to delay the onset and progression of this autoimmune disease by modulating the immune response against pancreatic beta cells. As a first-in-class therapy, SAB-142 is positioned as a novel fully human alternative to rabbit anti-thymocyte globulin (ATG), aiming to preserve the same disease-modifying concept while potentially improving redosing and tolerability. The program has progressed beyond pre-clinical stages into human studies, with a first-in-human Phase 1 trial reported in Australia in October 2023. Currently, a Phase 2b study, named SAFEGUARD (NCT07187531), is underway, featuring a randomized, placebo-controlled, investigator- and participant-blinded design involving 159 participants across three arms: high-dose SAB-142, low-dose SAB-142, and placebo. The T1D market presents a significant opportunity, estimated at $30-35 billion globally. This figure reflects the ongoing chronic use of insulin, glucose-monitoring technologies, and the large population currently receiving treatment. However, a critical unmet need persists, as there remains no approved disease-modifying therapy that reliably prevents the onset of T1D or preserves beta-cell function at scale. The absence of such therapies underscores the importance of demonstrating a clear clinical benefit over existing insulin-centric care and other immune-modulating approaches currently in development. SAB-142 is still in the early clinical stage, having only reached first-in-human and early Phase 2 development. Consequently, there is no established proof of efficacy, and the primary uncertainty revolves around whether the biologic activity observed will translate into clinically meaningful beta-cell preservation. Additionally, the program carries inherent risks associated with safety and immunosuppression. As an anti-thymocyte immunoglobulin, there are central risks related to infection, immune suppression, and infusion-related toxicities. The trial protocol explicitly excludes patients with recent serious infections and significant liver disease, indicating a cautious approach to managing these risks. Furthermore, while rabbit ATG has demonstrated biologic and clinical activity in T1D, it does not guarantee that SAB-142 will achieve a superior benefit-risk profile or reproducible efficacy in the target population. Upcoming catalysts for SAB-142 include enrollment and interim progress updates from the Phase 2b SAFEGUARD study, with timing yet to be disclosed. Additionally, top-line efficacy and safety data from the Phase 2b study are anticipated by December 31, 2028. Further clinical updates from the SAB-142-101 early T1D study are also expected, although specific timelines remain undisclosed. In terms of regulatory designations, there is no public evidence of Fast Track, Orphan Drug, Breakthrough Therapy, Priority Review, or Accelerated Approval for SAB-142 in the context of T1D, suggesting that these designations should be treated as false in the absence of public notice. Given the current evidence, a probability of approval (PoA) of 22.0% is justified. This figure reflects a higher likelihood than that of an unvalidated preclinical asset, as the mechanism has class support and the program has entered controlled human testing. However, it remains significantly lower than late-phase assets due to the lack of human efficacy proof and the high bar for safety and durable disease modification that SAB-142 must clear. Overall, while the potential for SAB-142 exists within a substantial market, the path forward is fraught with challenges that must be navigated carefully. Read More	Pre-clinical 10%	Type 1 Diabetes (T1D)	1	Drug: SAB-142. Indication: Type 1 Diabetes (T1D). Timeline: 2026-06-10. Poster presentation on positive clinical translation of a juvenile non-human primate (NHP) study evaluating SAB-142, at the FOCIS 2026 Annual Meeting on June 10, 2026 in San Francisco. Read More
CMND	Clearmind Medicine Inc.	3.2 -2.65 %	1.4M	Phase 1/IIa data readout	CMND-100	-	2026-06-10	12.5%	Clearmind Medicine Inc. (CMND) is advancing CMND-100, a proprietary oral, non-hallucinogenic drug candidate derived from 5-methoxy-2-aminoindane (MEAI), a psychoactive compound structurally akin to MDMA. This innovative drug is designed to modulate reward mechanisms in the brain, aiming to produce an alcohol-like euphoric effect that could effectively reduce cravings and consumption in patients suffering from Alcohol Use Disorder (AUD). Unlike traditional psychedelics, CMND-100 seeks to provide a breakthrough non-hallucinogenic profile, targeting addictive behaviors without inducing perceptual distortions. The market for AUD represents a substantial global opportunity, estimated at $15 billion. This market is characterized by a high prevalence of affected individuals, with millions suffering worldwide, and a significant unmet need. Current treatment options, including naltrexone, acamprosate, and disulfiram, demonstrate only modest efficacy, achieving abstinence rates of 20-30% while facing challenges such as high relapse rates and poor adherence. The persistent unmet need is exacerbated by the serious complications associated with AUD, including liver disease, cardiovascular issues, and mental health disorders. CMND-100 is positioned as a first-in-class therapy, leveraging a novel MEAI mechanism that distinguishes it from existing opioid antagonists and GABA modulators, with no other drugs sharing this specific mechanism of action. As of May 13, 2026, the development of CMND-100 has progressed beyond the initial Phase I stage into a multinational, FDA-approved Phase I/IIa trial (HIC# 2000035043 at Yale), although no NCT number is listed in the sources. This trial is structured as a four-part study involving both single and multiple doses, enrolling participants aged 18-60, including healthy volunteers and individuals with moderate to severe AUD or binge drinking patterns (BMI 18-35). The trial is being conducted at prestigious sites such as Yale School of Medicine, Johns Hopkins, and IMCA Center in Israel. It features a partially blinded design with a placebo control, focusing on inpatient monitoring over 24 hours. The primary endpoints include safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD), while secondary endpoints assess preliminary efficacy through reductions in drinking patterns and cravings. Enrollment is ongoing, with 18 participants having completed treatment and follow-up. Positive interim data from the third dose cohort indicate high tolerability, no serious adverse events, and favorable safety at higher doses, although full PK/PD or efficacy metrics remain unreported. Currently, CMND-100 does not hold any specific regulatory designations for AUD, such as Fast Track or Breakthrough Therapy status. The safety profile appears robust thus far, with no discontinuations or adverse signals noted. In terms of competitive positioning, CMND-100 stands apart from established AUD treatments and the limited pipeline of alternatives, as there are no direct MEAI competitors. While psychedelic-adjacent programs, such as ibogaine derivatives, encounter regulatory challenges, precedents like nalmefene (approved in the EU for relapse risk) have shown modest efficacy but limited uptake. Recent rejections of suvorexant analogs for addiction due to safety and efficacy concerns further highlight the competitive landscape. Conversely, successes like the repurposing of semaglutide for AUD, which has shown promising Phase II signals, underscore the potential of reward modulation but also emphasize the necessity for robust Phase III data. The estimated probability of approval (PoA) for CMND-100 stands at 12.5%. This figure reflects the progress made in the Phase I/IIa trial, with historical data suggesting a PoA of approximately 10-15% from Phase I in addiction contexts, slightly enhanced by the clean safety profile and novel mechanism of action. However, the small size of the sponsoring biotech, which has no prior FDA approvals and lacks pharmaceutical partnerships, coupled with unproven long-term efficacy and the inherent risks associated with psychedelic compounds, tempers the outlook. While the standard PoA for Phase II to approval is around 30%, the early-stage nature of CMND-100 and execution challenges result in a lower estimate. The investment appeal is contingent on upcoming catalysts, such as the release of full Phase I/IIa data, but the high binary risk associated with this asset suggests it is best suited for speculative portfolios. Read More	Phase 1 20%	Alcohol Use Disorder	N/A	Drug: CMND-100. Indication: Alcohol Use Disorder. Timeline: 2026-06-10. Live webinar on June 10, 2026 will provide an in-depth review of the latest clinical data from the company’s ongoing FDA-approved Phase I/IIa multi-center trial evaluating CMND-100, a non-hallucinogenic MEAI-based oral candidate for AUD. Read More
IPSC	Century Therapeutics, Inc.	2.12 -4.07 %	407.6M	Pre-clinical data readout	CNTY-813	-	2026-06-08	21.5%	Century Therapeutics (NASDAQ: IPSC) is advancing CNTY-813, its lead program targeting type 1 diabetes (T1D) through an innovative allogeneic induced pluripotent stem cell (iPSC)-derived beta islet cell therapy. Utilizing the proprietary Allo-Evasion 5.0 technology, CNTY-813 aims to facilitate durable insulin production and glycemic control without the need for systemic immunosuppression, thereby positioning itself as a potentially curative option in a therapeutic landscape that has primarily focused on symptomatic insulin management. The T1D market is significant, with an estimated global market size of $15 billion for insulin and related therapies as of 2024. This market is driven by approximately 8-10 million patients worldwide who require lifelong daily insulin injections, facing risks of hypoglycemia and complications such as neuropathy and retinopathy. The unmet need in this area is acute, as no approved therapies currently restore endogenous insulin production without immunosuppression. CNTY-813 is classified as first-in-class, offering a novel hypoimmunogenic iPSC islet approach that stands apart from existing treatments, including standard insulins like Humalog and insulin pumps, as well as near-term competitors. As of May 14, 2026, CNTY-813 remains in pre-clinical development, with no clinical trials initiated and no NCT numbers or enrollment data available. The anticipated IND submission is set for 2026, with initial Phase 1 clinical data expected in 2027, according to the company's financing announcement. Details regarding trial design, endpoints, and safety profiles have not yet been disclosed. Notably, CNTY-813 has not received any regulatory designations for T1D, including Fast Track, Orphan Drug, or Breakthrough Therapy designations. The competitive landscape for CNTY-813 includes Vertex's zimislecel (formerly VX-880), which is currently in Phase 3 and requires immunosuppression, as well as pre-clinical efforts from ViaCyte/Sandoz. There are currently no direct approved rivals for curative cell therapies in this space. Century Therapeutics has not yet achieved any FDA approvals, having previously focused on iPSC platforms, and its prior oncology assets encountered setbacks. However, the pivot to T1D leverages advancements in Allo-Evasion technology. Notably, there are no partnerships currently associated with this program. Precedents in the field inform the estimated probability of approval (PoA) for CNTY-813, which is set at 18-25%. Vertex's VX-880 has demonstrated proof-of-concept for insulin independence in a small Phase 1/2 trial, though it requires immunosuppression, underscoring the value and risk associated with immune evasion technology. Historical challenges with Sernova's Cell Pouch and islet transplants, which have shown limited durability, highlight the typical pre-clinical to approval odds for cell therapies in T1D and autoimmunity, generally ranging from 10-20%. The PoA for CNTY-813 reflects strong financing and execution signals that mitigate some modality risks, despite the absence of human data and Century's unproven status. Key risks associated with CNTY-813 include high technical challenges related to iPSC-derived islet engraftment, vascularization, and long-term function in humans. Additionally, there are concerns regarding potential immune evasion failures leading to rejection, manufacturing scalability, and consistency of potency for allogeneic cell therapy at a commercial scale. Upcoming catalysts include the IND submission in 2026 and initial Phase 1 clinical data in 2027. The investment thesis for CNTY-813 presents a high-risk, high-reward opportunity for a breakthrough in T1D treatment, warranting close monitoring of preclinical updates. Read More	Pre-clinical 10%	type 1 diabetes	6	Drug: CNTY-813. Indication: type 1 diabetes. Timeline: June 8, 2026. Oral presentation at the ADA 86th Scientific Sessions on June 8, 2026 highlighting CNTY-813 preclinical data: scalable production of Allo‑Evasion™ 5.0‑engineered iPSC beta islets with robust endocrine function and demonstrated immune evasion. Read More