roymgabriel/BioPharma · Datasets at Hugging Face

ticker stringlengths 2 5	disease stringlengths 3 196	stage stringclasses 15 values	date stringlengths 6 8	catalyst stringlengths 20 963	label int64 4 6
ATHX	Ischemic stroke	Phase 3	10/10/23	Phase 3 trial was insufficiently powered to achieve the primary endpoint, noted October 10, 2023.	6
SYRS	Solid tumors	Phase 1b	5/25/23	Phase 1/1b data from ASCO reported that in solid tumors, data demonstrated a 100% disease control rate (DCR) with 10 mg SY-5609 monotherapy, with the PDAC patient experiencing a 10% tumor reduction, noted May 25, 2023.	6
CYCN	Heart failure HFpEF	Phase 2	10/30/19	Phase 2 trial did not meet primary endpoint - October 30, 2019.	4
CLVS	FAP-positive tumors	Phase 1/2	10/17/22	Phase 1 update at EANM noted that of 5 patients 45.5% had a Grade >3 treatment related adverse event, noted October 17, 2022.	6
ASRT	Hot flashes	CRL	5/31/13	CRL issued May 31, 2013.	5
TBPH	Neurogenic orthostatic hypotension (nOH)	Phase 3	8/28/23	Additional subgroup data reported benefits of ampreloxetine ranged from 0.5 to 2.2 point improvements relative to placebo across all subgroup categories and were demonstrated on the OHSA and OHQ composite scores, noted August 28, 2023.	6
MACK	Cancer - Heregulin Positive Non-Small Cell Lung Cancer	Phase 2	10/19/18	Phase 2 trial discontinued due to futility - noted October 19, 2018.	4
GSK	Non-small Cell Lung Cancer	Phase 3	1/20/21	Phase 3 trial unlikely to meet primary endpoint - to be discontinued.	4
GRTX	Esophagitis	Phase 2	10/27/22	Phase 2 Open-Label data reported that 14 of 29 evaluable patients (48.3%) experienced acute esophagitis at week 6, noted October 27, 2022.	6
NVS	Non-radiographic axial spondyloarthritis	Approved	6/16/20	FDA Approval announced June 16, 2020.	6
IMUX	Primary Sclerosing Cholangitis	Phase 2	2/18/21	Phase 2 data released February 18, 2021. Primary objective of therapeutic benefit achieved in 27.3% of patients.	5
PBYI	HER2 positive breast cancer with brain metastases	Phase 2	12/8/22	Phase 2 data reported an Objective Response Rate by RANO-BM was 33.3% of patients in cohort 4A, 29.4% in cohort 4B, and 28.6% in cohort 4C, noted December 8, 2022.	5
PTCT	Phenylketonuria (PKU)	Phase 3	5/17/23	Phase 3 results met primary endpoint, noted May 17, 2023.	5
MDGL	Non-alcoholic steatohepatitis (NASH) with liver fibrosis	PDUFA priority review	9/13/23	https://www.biopharmcatalyst.com/company/MDGL/news/158576	5
HCM	Neuroendocrine carcinoma	Phase 2	9/29/21	Updated Phase 2 data reported median OS was 10.3 months. PFS was 4.14 months. The confirmed ORR was 23.8% and DCR was 71.4%. All patients experienced TRAEs, including 9 (42.9%) who experienced Grade 3 or above TRAEs, noted September 29, 2021.	5
ASND	Achondroplasia	Phase 2	11/14/22	Phase 2 top-line data reported that trial met primary endpoint, noted November 14, 2022.	5
BGNE	Relapsed or refractory mantle cell lymphoma (MCL)	Approved	11/14/19	FDA Approval announced November 14, 2019.	6
MRK	Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)	Phase 3	8/25/23	Phase 3 data reported that at the second analysis, the trial did not demonstrate an improvement in OS compared to KEYTRUDA plus placebo, noted August 25, 2023.	6
TAK	Cytomegalovirus (CMV)	Approved	11/23/21	Approved November 23, 2021.	6
KPTI	Relapsed/Refractory Acute Myeloid Leukemia (AML)	Phase 2	3/2/17	Data Safety Monitoring Board (DSMB) noted March 2, 2017 that trial will not meet primary endpoint.	4
BGNE	Hepatocellular Carcinoma (HCC)	Phase 2	10/21/23	Phase 2 poster presented at ESMO reported that NV-assessed ORR was 35.5% with O+T+B vs. 37.5% with T+B, noted October 21, 2023.	6
DTIL	Non-Hodgkin Lymphoma (NHL)	Phase 1	5/31/23	Phase 1 update reported a 71% ORR and 43% CR rate, noted May 31, 2023.	5
CLRB	Various lymphoma	Phase 2	6/28/23	Phase 2 data from MM cohort reported an overall response rate (ORR) of 32%, a clinical benefit rate (CBR) of 75% and a disease control rate (DCR) of 85.7%, noted June 28, 2023.	5
AZN	Metastatic non-squamous non-small cell lung cancer (NSCLC)	Phase 2	9/9/23	Phase 2 data presented at WCLC reported that objective response rates of 49% and 56% with 5.4 mg/kg and 6.4 mg/kg doses, respectively, in primary analysis, noted September 9, 2023.	6
AMTI	Ulcerative colitis	Phase 2	7/6/22	Phase 2 top-line data reported a remission rate of 31.8% in the treatment group, versus 33.3% in the placebo group, noted July 6, 2022.	6
REGN	Non-small cell lung cancer (NSCLC)	Phase 3	9/19/21	Phase 3 data presented at ESMO September 19, 2021 showed trial met primary and all secondary endpoints, with an objective response rate of 43%.	6
NVS	Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)	Approved	5/1/18	Approval announced May 1, 2018.	6
APLS	COVID-19 / Acute respiratory distress syndrome (ARDS)	Phase 1/2	3/4/21	Phase 1/2 trial to be discontinued following Independent data monitoring committee (DMC) review which found no meaningful reduction in the overall mortality rate.	4
RARE	Glut1 DS patients with the movement disorder phenotype	Phase 3	10/26/18	Phase 3 data released October 26, 2018 - endpoints not met.	4
CHRS	Wet age-related macular degeneration (wAMD), among others	Approved	8/2/22	Biosimilar approved August 2, 2022.	6
MRK	Head and Neck Squamous Cell Carcinoma	Phase 2	11/9/21	Phase 2 clinical data showed that patients with ≥2L who have not received a prior checkpoint inhibitor ("CPI") (n=10), long-term follow-up data shows that dosing demonstrates a 12-month OS rate of 80% with a mOS of 24.5 months, which compares favorably with standard pembrolizumab therapy in patients with 2L CPI, noted November 9, 2021.	6
CRMD	Hemodialysis patients with central venous catheters	PDUFA	6/21/23	PDUFA date after resubmission on November 15, 2023.	5
AZN	Multiple HER2-expressing advanced solid tumors	Phase 2	10/23/23	Phase 2 data presented at ESMO 23 continued to demonstrate clinically meaningful and durable responses with a a median progression-free survival of 6.9 months and median overall survival of 13.4 months in the overall trial population, noted October 23, 2023.	6
FIXX	Phenylketonuria (PKU)	Phase 1/2	11/6/20	Data released November 6, 2020 noted 2/6 showed meaningful reductions in Phe.	6
AFMD	T-Cell, Cutaneous Lymphoma	Phase 1/2	12/7/20	Phase 1/2 data presented at ASH 2020. Objective Response Rate (ORR) of 42%(6/14).	5
AZN	Chronic Kidney Disease	Approved	4/30/21	FDA approval announced April 30, 2021.	6
LLY	Pediatric Patients with Moderate to Severe Plaque Psoriasis	Approved	3/30/20	FDA Approval announced March 30, 2020.	6
ABBV	Platysma prominence associated with platysma muscle activity (M21-310)	Phase 3	9/18/23	Phase 3 trial met all primary and secondary endpoints, noted September 18, 2023.	5
EIGR	Chronic hepatitis delta virus (HDV)	Phase 3	6/29/23	Phase 3 data presented at EASL showed that at week 48 the trial met its primary endpoint in both lonafarnib arms vs placebo, also 24-week post-treatment data demonstrated that both lonafarnib arms showed a statistically significant difference in composite response rate compared to placebo, noted June 24, 2023.	6

ATHX

Ischemic stroke

Phase 3

10/10/23

Phase 3 trial was insufficiently powered to achieve the primary endpoint, noted October 10, 2023.

6

SYRS

Solid tumors

Phase 1b

5/25/23

Phase 1/1b data from ASCO reported that in solid tumors, data demonstrated a 100% disease control rate (DCR) with 10 mg SY-5609 monotherapy, with the PDAC patient experiencing a 10% tumor reduction, noted May 25, 2023.

6

CYCN

Heart failure HFpEF

Phase 2

10/30/19

Phase 2 trial did not meet primary endpoint - October 30, 2019.

4

CLVS

FAP-positive tumors

Phase 1/2

10/17/22

Phase 1 update at EANM noted that of 5 patients 45.5% had a Grade >3 treatment related adverse event, noted October 17, 2022.

6

ASRT

Hot flashes

CRL

5/31/13

CRL issued May 31, 2013.

5

TBPH

Neurogenic orthostatic hypotension (nOH)

Phase 3

8/28/23

Additional subgroup data reported benefits of ampreloxetine ranged from 0.5 to 2.2 point improvements relative to placebo across all subgroup categories and were demonstrated on the OHSA and OHQ composite scores, noted August 28, 2023.

6

MACK

Cancer - Heregulin Positive Non-Small Cell Lung Cancer

Phase 2

10/19/18

Phase 2 trial discontinued due to futility - noted October 19, 2018.

4

GSK

Non-small Cell Lung Cancer

Phase 3

1/20/21

Phase 3 trial unlikely to meet primary endpoint - to be discontinued.

4

GRTX

Esophagitis

Phase 2

10/27/22

Phase 2 Open-Label data reported that 14 of 29 evaluable patients (48.3%) experienced acute esophagitis at week 6, noted October 27, 2022.

6

NVS

Non-radiographic axial spondyloarthritis

Approved

6/16/20

FDA Approval announced June 16, 2020.

6

IMUX

Primary Sclerosing Cholangitis

Phase 2

2/18/21

Phase 2 data released February 18, 2021. Primary objective of therapeutic benefit achieved in 27.3% of patients.

5

PBYI

HER2 positive breast cancer with brain metastases

Phase 2

12/8/22

Phase 2 data reported an Objective Response Rate by RANO-BM was 33.3% of patients in cohort 4A, 29.4% in cohort 4B, and 28.6% in cohort 4C, noted December 8, 2022.

5

PTCT

Phenylketonuria (PKU)

Phase 3

5/17/23

Phase 3 results met primary endpoint, noted May 17, 2023.

5

MDGL

Non-alcoholic steatohepatitis (NASH) with liver fibrosis

PDUFA priority review

9/13/23

https://www.biopharmcatalyst.com/company/MDGL/news/158576

5

HCM

Neuroendocrine carcinoma

Phase 2

9/29/21

Updated Phase 2 data reported median OS was 10.3 months. PFS was 4.14 months. The confirmed ORR was 23.8% and DCR was 71.4%. All patients experienced TRAEs, including 9 (42.9%) who experienced Grade 3 or above TRAEs, noted September 29, 2021.

5

ASND

Achondroplasia

Phase 2

11/14/22

Phase 2 top-line data reported that trial met primary endpoint, noted November 14, 2022.

5

BGNE

Relapsed or refractory mantle cell lymphoma (MCL)

Approved

11/14/19

FDA Approval announced November 14, 2019.

6

MRK

Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)

Phase 3

8/25/23

Phase 3 data reported that at the second analysis, the trial did not demonstrate an improvement in OS compared to KEYTRUDA plus placebo, noted August 25, 2023.

6

TAK

Cytomegalovirus (CMV)

Approved

11/23/21

Approved November 23, 2021.

6

KPTI

Relapsed/Refractory Acute Myeloid Leukemia (AML)

Phase 2

3/2/17

Data Safety Monitoring Board (DSMB) noted March 2, 2017 that trial will not meet primary endpoint.

4

BGNE

Hepatocellular Carcinoma (HCC)

Phase 2

10/21/23

Phase 2 poster presented at ESMO reported that NV-assessed ORR was 35.5% with O+T+B vs. 37.5% with T+B, noted October 21, 2023.

6

DTIL

Non-Hodgkin Lymphoma (NHL)

Phase 1

5/31/23

Phase 1 update reported a 71% ORR and 43% CR rate, noted May 31, 2023.

5

CLRB

Various lymphoma

Phase 2

6/28/23

Phase 2 data from MM cohort reported an overall response rate (ORR) of 32%, a clinical benefit rate (CBR) of 75% and a disease control rate (DCR) of 85.7%, noted June 28, 2023.

5

AZN

Metastatic non-squamous non-small cell lung cancer (NSCLC)

Phase 2

9/9/23

Phase 2 data presented at WCLC reported that objective response rates of 49% and 56% with 5.4 mg/kg and 6.4 mg/kg doses, respectively, in primary analysis, noted September 9, 2023.

6

AMTI

Ulcerative colitis

Phase 2

7/6/22

Phase 2 top-line data reported a remission rate of 31.8% in the treatment group, versus 33.3% in the placebo group, noted July 6, 2022.

6

REGN

Non-small cell lung cancer (NSCLC)

Phase 3

9/19/21

Phase 3 data presented at ESMO September 19, 2021 showed trial met primary and all secondary endpoints, with an objective response rate of 43%.

6

NVS

Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)

Approved

5/1/18

Approval announced May 1, 2018.

6

APLS

COVID-19 / Acute respiratory distress syndrome (ARDS)

Phase 1/2

3/4/21

Phase 1/2 trial to be discontinued following Independent data monitoring committee (DMC) review which found no meaningful reduction in the overall mortality rate.

4

RARE

Glut1 DS patients with the movement disorder phenotype

Phase 3

10/26/18

Phase 3 data released October 26, 2018 - endpoints not met.

4

CHRS

Wet age-related macular degeneration (wAMD), among others

Approved

8/2/22

Biosimilar approved August 2, 2022.

6

MRK

Head and Neck Squamous Cell Carcinoma

Phase 2

11/9/21

Phase 2 clinical data showed that patients with ≥2L who have not received a prior checkpoint inhibitor ("CPI") (n=10), long-term follow-up data shows that dosing demonstrates a 12-month OS rate of 80% with a mOS of 24.5 months, which compares favorably with standard pembrolizumab therapy in patients with 2L CPI, noted November 9, 2021.

6

CRMD

Hemodialysis patients with central venous catheters

PDUFA

6/21/23

PDUFA date after resubmission on November 15, 2023.

5

AZN

Multiple HER2-expressing advanced solid tumors

Phase 2

10/23/23

Phase 2 data presented at ESMO 23 continued to demonstrate clinically meaningful and durable responses with a a median progression-free survival of 6.9 months and median overall survival of 13.4 months in the overall trial population, noted October 23, 2023.

6

FIXX

Phenylketonuria (PKU)

Phase 1/2

11/6/20

Data released November 6, 2020 noted 2/6 showed meaningful reductions in Phe.

6

AFMD

T-Cell, Cutaneous Lymphoma

Phase 1/2

12/7/20

Phase 1/2 data presented at ASH 2020. Objective Response Rate (ORR) of 42%(6/14).

5

AZN

Chronic Kidney Disease

Approved

4/30/21

FDA approval announced April 30, 2021.

6

LLY

Pediatric Patients with Moderate to Severe Plaque Psoriasis

Approved

3/30/20

FDA Approval announced March 30, 2020.

6

ABBV

Platysma prominence associated with platysma muscle activity (M21-310)

Phase 3

9/18/23

Phase 3 trial met all primary and secondary endpoints, noted September 18, 2023.

5

EIGR

Chronic hepatitis delta virus (HDV)

Phase 3

6/29/23

Phase 3 data presented at EASL showed that at week 48 the trial met its primary endpoint in both lonafarnib arms vs placebo, also 24-week post-treatment data demonstrated that both lonafarnib arms showed a statistically significant difference in composite response rate compared to placebo, noted June 24, 2023.

6