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label
int64
-1
1
UTHR
Pulmonary Arterial Hypertension
Phase 2
2017-07-10 00:00:00
Phase 2 data released July 10, 2017. Primary endpoint met. Secondary missed.
0
NVS
Non-radiographic axial spondyloarthritis
Approved
2020-06-16 00:00:00
FDA Approval announced June 16, 2020.
1
MRK
Hepatocellular carcinoma (HCC)
Approved
2018-11-09 00:00:00
FDA approval announced November 9, 2018.
1
MRK
Renal Cell Carcinoma
Approved
2021-08-11 00:00:00
FDA approval announced August 11, 2021.
1
PIRS
Gastric cancer
Phase 1
2019-11-09 00:00:00
Phase 1 data at SITC November 9, 2019 noted 2/18 response rate.
0
VBIV
Recurrent glioblastoma multiforme (rGBM)
Phase 2b
2023-09-07 00:00:00
Phase 2b treatment in the primary GBM expected to commenced, noted September 7, 2023.
1
AIM
Ovarian cancer
Phase 2
2022-03-09 00:00:00
Phase 2 data reported 2 complete responses, 3 partial responses, 3 stable diseases, 5 progressive diseases and a total clinical benefit rate of 61.6%, noted March 9, 2022.
0
IXHL
Obstructive sleep apnoea (OSA)
Phase 2
2022-06-03 00:00:00
Complete Phase 2 analysis concluded that treatment reduced primary endpoint apnoea hypopnea index relative to baseline at all three doses that were assessed. The low dose exhibited superior safety and efficacy metrics to mid and high doses. The low dose also reduced AHI by an average of 50.7% compared to baseline with 25% of participants experiencing a reduction in the apnoea hypopnea index of greater that 80%.
1
SNY
Asthma - 6-11 year-olds
Approved
2021-10-20 00:00:00
Approved October 20, 2021.
1
EXEL
First-Line RCC - cancer
Approved
2017-12-19 00:00:00
Approval announced December 19, 2017, ahead of PDUFA date of February 15, 2018.
1
ALGS
HBeAg-positive chronic hepatitis B (CHB)
Phase 1b
2023-06-21 00:00:00
Additional Phase 1b data presented at EASL demonstrated multi-log reductions in HBsAg, DNA, and RNA levels in subjects dosed for up to 36 weeks, noted June 21, 2023.
1
BXRX
Neuromuscular blockade (NMB) in patients undergoing elective surgery
Phase 2
2023-06-07 00:00:00
hase 2 primary efficacy endpoint was the proportion of patients that met criteria for Good or Excellent intubating conditions using a standardized scale. All patients, across regimens, met the primary efficacy criteria, noted June 7, 2023.
0
AZN
Venous thromboembolism (VTE) Prevention
Approved
2017-06-23 00:00:00
FDA Approval noted June 23, 2017.
1
SPRO
Nontuberculous mycobacterial (NTM) pulmonary disease (PD)
Phase 2
2021-02-05 00:00:00
Phase 2a trial placed on clinical hold - February 5, 2021.
0
AMGN
Oral corticosteroid dependent asthma.
Phase 3
2020-12-22 00:00:00
Phase 3 trial did not meet primary endpoint - December 22, 2020.
1
ZLAB
Non-Hodgkin Lymphoma (NHL)
Phase 2
2022-12-12 00:00:00
Phase 2 data presented at ASH showed a 49% ORR in heavily pre-treated patients who were naïve to prior CAR-T, with 31% achieving a complete response (CR), noted December 12, 2022.
1
COCP
Influenza
Phase 1
2023-05-04 00:00:00
Phase 1 data reported no serious AEs, treatment discontinuations, and no clinically significant observations noted in laboratory assessments, vital signs, physical exam findings, or ECGs, noted May 4, 2023.
1
LGND
Pneumococcal Conjugate Vaccine
Phase 3
2023-07-27 00:00:00
Phase 3 trial met primary endpoints, noted July 27, 2023.
0
MRK
Endometrial cancer
Approved
2019-09-17 00:00:00
FDA Approval announced September 17, 2019.
1
SRPT
Duchenne muscular dystrophy
Phase 3
2022-10-14 00:00:00
Phase 3 results presented at the World Muscle Society reported that mean dystrophin levels significantly increased from baseline after 48 weeks of casimersen treatment, noted October 14, 2022.
1
THRX
Gastrointestinal stromal tumors (GIST)
Phase 1/2
2023-05-25 00:00:00
Phase 1/2 dose-escalation data demonstrated encouraging safety profile through Cohort 6 (18 mg), supportive of continued dose escalation, noted May 25, 2023.
1
VIGL
Adult-Onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP)
Phase 1
2022-12-14 00:00:00
Phase 1 trial achieved favorable safety, tolerability and PK profiles in single ascending dose and multiple ascending dose cohorts. VGL101 achieved dose dependent, robust and durable decreases in CSF sTREM2 demonstrating proof of target engagement further validating its mechanism of action, noted December 14, 2022.
1
BMY
Gastric cancer
Approved
2021-04-16 00:00:00
FDA approval announced April 16, 2021.
1
PFE
ALK-positive Anaplastic Large Cell Lymphoma
Approved
2021-01-14 00:00:00
FDA approval announced January 14, 2021.
1
XAIR
Solid tumors
Phase 1
2023-11-03 00:00:00
Phase 1 data presented at SITC demonstrated early clinical proof of concept, noted November 3, 2023.
1
VERU
ER+/HER2- breast cancer
Phase 3
2023-09-11 00:00:00
Phase 3 enrollment discontinued due to prioritization with Phase 3 data overall response rates of 12.5% are observed in the enobosarm group in a heavily pretreated population versus no responses in the standard of care active control arm. Overall response rate was 20% for enobosarm monotherapy versus 0% for standard of care active control in patients who had ≤3 lines of prior endocrine therapy in the metastatic setting, noted September 11, 2023. ARTEST clinical data further validates the evaluation of enobosarm in the Phase 3 ENABLAR-2 study.
1
TRVI
Chronic cough - Idiopathic pulmonary fibrosis (IPF)
Phase 2
2022-09-19 00:00:00
Phase 2 full data reported that trial met primary endpoint, noted September 19, 2022.
0
GOSS
Nasal polyps / chronic rhinosinusitis
Phase 2
2020-10-13 00:00:00
Phase 2 trial did not meet primary endpoint - October 13, 2020.
1
AZN
Severe, uncontrolled asthma
Phase 3
2017-05-10 00:00:00
Phase 3 trial did not meet primary endpoint - May 10, 2017.
1
ATNF
Dupuytren’s disease (DD)
Phase 2/3
2021-12-01 00:00:00
Phase 2b data from 2b/3 trial reported that trial met its primary and secondary endpoint with no related severe adverse events, noted December 1, 2021.
0
ASND
Growth Hormone Deficiency - adults
Phase 3
2023-09-23 00:00:00
Phase 3 resultspresented at ESPE 2023 showed that the majority of children and adolescents treated once weekly with TransCon hGH (lonapegsomatropin) met or exceeded average parental height SDS at time of treatment completion or last visit, noted September 23, 2023.
1
ADAP
Synovial sarcoma or myxoid/round cell liposarcoma (MRCLS)
Phase 1
2022-05-26 00:00:00
Phase 1 data released May 26, 2022. The overall response rate was 36% in heavily pre-treated patients across both types of sarcomas (41% in synovial sarcoma and 10% for MRCLS), with a median duration of response of 52 weeks. As reported last year, the pivotal trial SPEARHEAD-1 met its primary endpoint for efficacy and the benefit:risk profile of afami-cel has been favorable with mainly low-grade cytokine release syndrome and tolerable/reversible hematologic toxicities.
1
PFE
Early stage breast cancer
Phase 3
2020-10-09 00:00:00
Phase 3 trial did not meet primary endpoint - October 9, 2020.
1
PDSB
Human papillomavirus (HPV) associated cancers
Phase 2
2022-12-28 00:00:00
Phase 2 data reported a median OS of 21 months, with 75% remain alive at a median follow-up of 27 months, noted December 28, 2022.
0
VTVT
Type 2 Diabetes
Phase 2
2016-12-14 00:00:00
Phase 2 primary endpoint met - December 14, 2016.
0
NKTR
Solid tumors
Phase 1/2
2019-03-01 00:00:00
Phase 1/2 initial data March 1, 2019 noted ORR 2/11 ( 18%) - maximum tolerated dose has not been reached.
1
RHHBY
Follicular lymphoma
Phase 3
2022-06-10 00:00:00
Phase 3 final analysis reported that PFS was significantly improved with Gazyva plus chemotherapy (63.4%) compared with Rituxan plus chemotherapy (55.7%), noted June 10, 2022.
1
RANI
Rheumatoid arthritis
Phase 1
2023-11-01 00:00:00
Program paused, noted November 1, 2023.
-1
IPSEY
Castration-Resistant Prostate Cancer
Phase 3
2023-08-21 00:00:00
Phase 3 data reported that the trial met one of two primary endpoints, demonstrating a statistically significant improvement in progression-free survival (PFS) at the primary analysis, noted August 21, 2023.
1
EYPT
Diabetic macular edema
Approved
2014-09-26 00:00:00
Approved Sept 26 2014.
1
KMDA
AATD - Alpha-1 Antitrypsin deficiency
Phase 2
2016-08-30 00:00:00
Top-line data released August 30, 2016. Primary endpoint met
0
FRTX
Axillary hyperhidrosis
Phase 3
2021-10-07 00:00:00
Phase 3 study demonstrated that dosing was generally well-tolerated, the proportion of subjects achieving at least a 2-point improvement in the HDSM-Ax1 score from baseline to EOT2 was 49.3% (n=173). Additionally the change in GSP3 from baseline to EOT was -129.5mg. Overall, 82% of patients who were randomized to the dose in the study completed the full six weeks of treatment. Five (2.9%) subjects who received the dose discontinued due to a TEAE. No treatment-related Serious Adverse Events (SAEs) were reported. Noted October 7, 2021.
1
BPMC
PDGFRA exon 18 mutant Gastrointestinal stromal tumors (GIST)
Approved
2020-01-09 00:00:00
FDA Approval announced January 9, 2020.
1
IPHA
Hematological malignancies
Phase 1/2
2023-10-16 00:00:00
Phase 1/2 data from ESMO abstract reported that 3/8 patients achieved complete remission (CR), noted October 16, 2023.
1
SGMO
Fabry disease
Phase 1/2
2023-05-22 00:00:00
FDA fast-track designation granted on May 22, 2023.
0
APLIF
Parasitic and anaerobic bacterial infections
Approved
2023-09-25 00:00:00
Approved September 25, 2023.
1
RHHBY
Third-line advanced or metastatic colorectal cancer
Phase 3
2018-05-10 00:00:00
Phase 3 data released May 10, 2018. Primary endpoint not met.
0
BMY
Lupus Erythematosus (SLE)
Phase 2
2021-11-08 00:00:00
Phase 2 52-week data reported that the primary endpoint, SRI-4 response at wk 24, was achieved by 54.3% of patients on iberdomide 0.45 mg vs. 34.9% on placebo, noted November 8, 2021.
1
FDMT
Fabry Disease
Phase 1/2
2023-10-30 00:00:00
Phase 1/2 FDA meeting to lift clinical hold and continue trial developments, noted October 30, 2023.
1
AMAM
HER2-positive metastatic breast cancer
Phase 3
2023-03-01 00:00:00
Phase 3 trial met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater progression-free survival benefit compared to the control, noted March 1, 2023.
1
NVS
Inoperable progressive midgut NETs
Approved
2018-01-26 00:00:00
Approved January 26, 2018. Acquired from Advanced Accelerator Applications (NASDAQ: AAAP).
1
JAGX
Chemotherapy-induced diarrhea (CID) in dogs
Approved
2021-12-21 00:00:00
FDA conditionally approved on December 21, 2021.
1
NKTR
Solid tumors
Phase 1/2
2021-11-12 00:00:00
Phase 1b data from 1b/2 trial reported 1 partial response (PR) and 5 stable disease (SD). Treatment was noted to be well tolerated, November 12, 2021.
1
FREQ
Acquired Sensorineural Hearing Loss (SNHL)
Phase 2b
2023-02-13 00:00:00
Phase 2b study failed to achieve its primary efficacy endpoint of an improvement in speech perception. The Company will now discontinue the FX-322 development program, noted February 13, 2023.
1
ERYP
Acute lymphoblastic leukemia (ALL)
Phase 2
2020-12-06 00:00:00
Phase 2 data presented at ASH December 6, 2020. Endpoints met.
1
ABBV
Upper Limb Spasticity
Approved
2021-07-29 00:00:00
FDA approval announced July 29, 2021.
1
ITCI
Bipolar depression
Phase 3
2019-07-08 00:00:00
Phase 3 trial met primary endpoint - July 8, 2019.
0
RHHBY
COVID-19 (Anti-viral antibody)
Phase 2/3
2021-09-30 00:00:00
Phase 3 trial met primary endpoint, with 36% reduced risk of death by day 29, and 56% reduced risk in patients who were seronegative. Of 2,007 patients (REGEN-COV=1,340, placebo=667) serious adverse events occurred in 21% REGEN-COV patients and 26% placebo patients, noted September 30, 2021.
1
MRK
Colorectal cancer (CRC)
Approved
2020-06-29 00:00:00
FDA Approval announced June 29, 2020.
1
BMRN
Hemophilia A
Approved
2023-06-29 00:00:00
Approved June 29, 2023.
1
BBIO
ATTR-PN
Phase 3
2022-02-28 00:00:00
Phase 3 trial has been initiated. Phase 3 trial has been withdrawn, noted February 2022.
0
PFE
Tick-borne encephalitis (TBE) vaccine
Approved
2021-08-13 00:00:00
FDA Approval announced August 13, 2021
1
PFE
COVID-19 Vaccine (Booster)
Phase 1/2
2022-05-23 00:00:00
Phase 1/2/3 booster trial in children reported that a 80.3% vaccine efficacy, noted May 23, 2022.
0
SNY
Coronavirus COVID-19
Phase 3
2020-09-01 00:00:00
Phase 3 global trial did not meet primary endpoint - September 1, 2020.
1
MRK
First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Approved
2017-05-10 00:00:00
Approved May 10, 2017.
1
ALEC
Alzheimer’s disease
Phase 2
2023-09-07 00:00:00
Phase 2 enrollment to be completed, noted September 7, 2023.
0
DRRX
Alcoholic hepatitis (AH)
Phase 2b
2023-09-07 00:00:00
Phase 2b last patient dosed, noted September 7, 2023
0
ZLAB
Chronic inflammatory demyelinating polyneuropathy (CIDP)
Phase 2
2023-07-17 00:00:00
Phase 2 trial met primary endpoints, noted July 17, 2023.
0
MRK
HER2-positive gastric or Gastroesophageal junction (GEJ) adenocarcinoma
Phase 3
2023-10-20 00:00:00
Phase 3 trial data presented at ESMO demonstrated a statistically significant PFS improvement in advanced HER2-positive gastric or GEJ adenocarcinoma in tumors expressing PD-L1 (Combined Positive Score [CPS] ≥1) compared to trastuzumab and chemotherapy alone October 20, 2023.
1
NVS
Alzheimer’s Disease
Phase 2/3
2019-07-11 00:00:00
Phase 2/3 trial discontinued due to lack of efficacy.
-1
CVAC
Covid-19 vaccine, omicron variant
Phase 1
2023-01-30 00:00:00
Phase 1 immunogenicity data reported that on day 29 at the 12µg dose level, CV0501 generated a ratio of post-boost to pre-boost serum neutralizing titers against BA.1 of 13.3, noted January 30, 2023.
0
ZLAB
Solid tumors
Phase 1
2021-10-07 00:00:00
Phase 1 updated data noted a confirmed responses for a cORR of 36% out of the 11 MET TKI-naïve NSCLC patients, cORR of 33% for the nine MET TKI-naïve GC/GEJ patients, and among the 12 patients with advanced other solid tumors, one patient with MET amplified colorectal cancer achieved a confirmed response, noted October 7, 2021.
1
LXRX
Diabetic Peripheral Neuropathy
Phase 2
2022-11-14 00:00:00
Phase 2 final results reported no evidence of withdrawal symptoms or rebound pain after treatment ended, noted November 14, 2022.
1
NVS
HR+/HER2- advanced breast cancer
Approved
2017-03-13 00:00:00
Priority review granted November 1, 2016. Approval announced March 13, 2017.
1
ABBV
Relapsed or refractory MCL mantle cell lymphoma
Approved
2013-11-13 00:00:00
Approved November 13, 2013.
1
IBRX
BCG-Unresponsive Bladder Cancer Carcinoma
BLA Filing
2023-10-23 00:00:00
BLA Resubmitted to the FDA, noted October 23, 2023.
0
BHC
Acne
Approved
2018-08-24 00:00:00
FDA Approval announced August 24, 2018.
1
LNTH
Prostate cancer
Approved
2021-05-27 00:00:00
FDA Approval announced May 27, 2021.
1
MITO
Barth syndrome
NDA Filing
2021-10-20 00:00:00
Refusal to File letter from FDA on October 20, 2021, due to issues with Phase 2 trial and open label extension.
0
ATHA
Mild-to-moderate Alzheimer's disease
Phase 2
2023-04-25 00:00:00
Phase 2 statistically significant decrease in plasma NfL levels compared with placebo, noted April 25, 2023.
0
FDMT
Wet age-related macular degeneration (AMD)
Phase 1/2
2023-07-29 00:00:00
Phase 1/2 additional dose response data demonstrated in favor of highest tested dose of 3E10 vg/eye, including 100% reduction in supplemental anti-VEGF injections (4 of 4 evaluable patients injection-free) and a clinically meaningful reduction in central subfield thickness (CST) at 36 weeks in patient population with high anti-VEGF need, noted July 29, 2023.
1
BMY
Melanoma
Phase 2/3
2023-10-22 00:00:00
Phase 2/3 data presented at ESMO reported that response to NIVO+RELA was associated with increased LAG-3+ CD4+ T cells at week 4, but on-treatment modulation of peripheral CD8+ T cells was not associated with NIVO+RELA efficacy, noted October 22, 2023.
1
INFI
Urothelial cancer
Phase 2
2022-08-09 00:00:00
Phase 2 data reported that 45% of patients were alive compared to only 24% in the control arm, noted August 9, 2022.
0
AMGN
Herceptin biosimilar
Approved
2019-06-13 00:00:00
FDA approval announced June 13, 2019.
1
MRK
HIV-1
Phase 2b
2021-10-27 00:00:00
Phase 2b data through 144 weeks demonstrated that dosing continued to maintain viral suppression, as measured by the number of study participants achieving HIV-1 RNA levels <50 copies/mL, similar to DOR/3TC/TDF, noted October 27, 2021.
1
BTAI
Adjunctive Treatment for Major Depressive Disorder (MDD) for At-Home Use
Phase 1b
2023-05-16 00:00:00
Phase 1b data topline data showed that BXCL501 was well tolerated across a broad dose range from 30mcg to 140mcg administered chronically, noted May 16, 2023.
1
SNY
Influenza A - children 6-35 months of age.
Approved
2019-11-04 00:00:00
sNDA FDA Approval announced for adults over 65 years of age.
1
IRWD
Irritable Bowel Syndrome
Phase 2
2020-05-27 00:00:00
Phase 2 trial did not meet primary endpoint - May 27, 2020.
1
KMDA
COVID-19
Phase 1/2
2021-03-31 00:00:00
Phase 1/2 top-line data released March 31, 2020. 11/12 patients recovered.
0
MDNA
Solid tumors
Phase 1/2
2023-08-09 00:00:00
Phase 1/2 sixth dose escalation cohort data and agent expansion data to showed durable anti-cancer activity observed during monotherapy dose escalation without dose-limiting toxicities. Late-stage pancreatic cancer patient achieved 80% tumor shrinkage with complete regression observed in two of three metastatic lesions in the liver in response to single-agent MDNA11, noted August 9, 2023.
1
RZLT
Congenital hyperinsulinism (HI)
Phase 2b
2022-03-23 00:00:00
Phase 2b study demonstrated highly significant improvements in hypoglycemia and good safety and tolerability, noted March 23, 2022.
1
AZN
COVID-19
Phase 3
2021-11-18 00:00:00
Phase 3 separate treatment trial showed an 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset.
1
GRTS
Non-small cell lung cancer (NSCLC)
Phase 2
2022-09-12 00:00:00
Phase 2 data presented at ESMO demonstrated early evidence of efficacy with a 39% molecular response rate in evaluable patients, noted September 12, 2022.
1
LLY
Psoriatic Arthritis
Phase 3
2018-12-17 00:00:00
Phase 3 trial met primary and key secondary endpoints.
0
SRPT
Duchenne muscular dystrophy
Phase 2
2022-07-06 00:00:00
Additional data reported that treated patients improved 3.1 points (unadjusted means) and 2.3 points (least squared means) in NSAA total scores from baseline, noted July 6, 2022.
1
LLY
Advanced solid tumors
Phase 1b
2023-04-18 00:00:00
Phase 1b data presented at AACR showed that dosing was well-tolerated with favorable pharmacokinetics and no apparent drug-drug interactions, noted April 18, 2023.
1
SCYX
Recurrent Vulvovaginal candidiasis (rVVC), Vaginal yeast infections
Approved
2022-12-01 00:00:00
FDA Approved on December 1, 2022.
1
DCPH
Gastrointestinal stromal tumor (GIST)
Phase 1/2
2021-11-30 00:00:00
Phase 1b/2 trial discontinued, noted November 30, 2021.
-1
KURA
Relapsed or refractory peripheral T-cell lymphoma
Phase 2
2021-12-13 00:00:00
Phase 2 final results reported an overall response rate of 56% and median overall survival of 32.8 months in patients with advanced AITL, noted December 13, 2021.
0
ANIK
Osteoarthritis of the knee
Phase 3
2022-11-01 00:00:00
Third Phase 3 trial met primary endpoint, noted November 1, 2022.
0