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1
PCRX
Lower extremity nerve block
Phase 3
2022-09-21 00:00:00
Phase 3 trial data achieved the study's primary endpoint by demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl, noted September 21, 2022.
1
AMPH
Asthma
CRL
2016-12-27 00:00:00
CRL issued December 27, 2016.
0
FNCH
Clostridioides difficile infection
Phase 2
2022-06-01 00:00:00
Phase 2 data presented at DDW reported that 88.2% of participants were without CDI recurrence through 8 weeks in this post-hoc analysis, noted June 1, 2022.
1
ANIP
Urinary tract infections
Approved
2023-04-24 00:00:00
Approved April 24, 2023.
1
DERM
Papulopustular Rosacea
Phase 3
2023-07-11 00:00:00
Phase 3 topline data achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues, noted July 11, 2023.
1
OVID
Dravet Syndrome / Lennox-Gastaut Syndrome
Phase 3
2023-04-27 00:00:00
Phase 3 data reported that 78% of patients tolerated the highest dose level well with sustained reduction in frequency of drop seizures, noted April 27, 2023.
1
NCNA
Advanced biliary tract cancer
Phase 3
2022-03-02 00:00:00
Independent Data Monitoring Committee (IDMC) concluded that trial was unlikely to achieve its primary objective and that treatment did not into an overall survival benefit, noted March 2, 2022.
1
AERI
Dry eye disease
Phase 2b
2022-04-26 00:00:00
Phase 2b results reported that statistically significant improvements were reported with signs and symptoms following treatment, noted April 24, 2022.
1
CLVS
Endometrial Cancer
Phase 2
2022-06-07 00:00:00
Phase 2 data reported that 23 subjects had clinical benefit, with 1 (4%) with CR, 9 (39%) with PR, and 13 (57%) with stable disease as best response, noted June 7, 2022.
0
NVO
Type 1 and type 2 diabetes
Phase 3
2017-09-29 00:00:00
Approved September 29, 2017.
1
ORIC
Multiple myeloma
Phase 1b
2023-11-02 00:00:00
Phase 1b data from ASH abstract reported that ORIC-533 was very well tolerated, with 5 patients experiencing a total of 10 treatment-related adverse events (TRAEs), noted November 2, 2023.
1
AZN
Non-small cell lung cancer (NSCLC)
Phase 3
2023-10-23 00:00:00
Phase 3 reduced the risk of disease progression or death by 25% in overall population and by 37% in patients with non-squamous tumors , noted October 23, 2023.
1
HRMY
Fragile X syndrome
Phase 2/3
2022-05-13 00:00:00
Phase 2/3 long-term data reported that sustained improvement in ABC-CFXS Social Avoidance from baseline, noted May 13, 2022.
1
LLY
Refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), non-Hodgkin’s lymphomas (NHL); mantle cell lymphoma
Phase 1/2
2021-12-12 00:00:00
Phase 1/2 updated data reported an overall response rate (ORR) of 68% including 2 complete responses, noted December 12, 2021.
0
BMY
Ovarian Cancer - First-line maintenance treatment
Phase 3
2022-06-06 00:00:00
Additional Phase 3 data reported that median PFS for the HRD-positive patient population treated with rucaparib was 28.7 months, noted June 6, 2022.
1
RHHBY
Ovarian cancer
Approved
2018-06-13 00:00:00
FDA approval announced June 13, 2018.
1
ENSC
Nasal Opioid Abuse
Phase 1
2022-10-31 00:00:00
HAP data reported that PF614 powder produced significantly lower peak "drug liking" when compared with intranasal crushed IR oxycodone, noted October 31, 2022.
0
MEIP
High-risk Myelodysplastic Syndrome (MDS)
Phase 2
2018-05-31 00:00:00
Phase 2 commencement of dosing announced June 14, 2017 - analysis from first stage released May 31, 2018 - trial to expand enrollment.
0
MRK
Renal cell carcinoma
Approved
2019-04-22 00:00:00
FDA approval announced April 22, 2019.
1
REGN
Respiratory syncytial virus (RSV)
Phase 3
2017-08-14 00:00:00
Phase 3 data released August 14, 2017 - primary endpoint not met.
0
REGN
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
JAZZ
Acute lymphoblastic leukemia (ALL)
Approved
2021-06-30 00:00:00
FDA approval announced June 30, 2021.
1
ANAB
Acne
Phase 2
2022-03-14 00:00:00
Phase 2 data reported that the trial did not meet the primary or secondary endpoints, noted March 14, 2022.
1
MNOV
COVID-19 / acute respiratory distress syndrome (ARDS)
Phase 2
2022-06-08 00:00:00
Phase 2 trial met one co-primary endpoint with statistical significants with 71% of the treated group free from respiratory failure at Day 7, noted June 8, 2022.
1
IPSEY
Pancreatic cancer
Phase 3
2022-11-09 00:00:00
Phase 3 data met its primary endpoint demonstrating clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated. Key secondary efficacy outcomes of progression-free survival (PFS) also showed significant improvement over the comparator arm, noted November 9, 2022.
1
MRK
Pneumococcal Conjugate Vaccine
Phase 3
2023-07-27 00:00:00
Phase 3 trial met primary endpoints, noted July 27, 2023.
0
JNCE
Solid tumors
Phase 1
2023-03-16 00:00:00
Phase 1 data report 5 durable responses, with 4 being confirmed responses, noted March 16, 2023.
0
AMRX
Advanced prostatic cancer
Approved
2022-11-02 00:00:00
FDA Abbreviated New Drug Application (ANDA) approval on November 2, 2022.
1
NAVB
Rheumatoid arthritis
Phase 2b
2022-09-15 00:00:00
Phase 2b data reported that the quantitative TIL uptake in the hands and wrists of patients is proportional to the amount of macrophage involvement in an individual RA patient's joint inflammation, noted September 15, 2022.
0
RHHBY
BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma
Approved
2020-07-30 00:00:00
FDA approval announced July 30, 2020.
1
AFMD
CD30-positive peripheral T cell lymphoma (PTCL)
Phase 2
2023-04-16 00:00:00
Phase 2 presentation at AACR reported an objective response rate (ORR) of 32.4% and 10.2% complete response rate (CR) in the ITT population, noted April 16, 2023.
1
ABBV
Relapsed or refractory multiple myeloma
Phase 3
2023-09-29 00:00:00
Phase 3 data reported that it showed improvement in median PFS of 9.9 months compared to 5.8 months with the combination of study comparator pomalidomide and dexamethasone; however, the results did not reach statistical significance, noted September 29, 2023.
1
ADAP
Esophageal and esophagogastric junction cancers
Phase 2
2022-11-08 00:00:00
Phase 2 data reported that ORR has increased to 37% from 33%, and the median duration of response has increased to ~20 weeks from approximately 12 weeks, noted November 8, 2022.
0
SNY
Acid sphingomyelinase deficiency (ASMD)
Phase 3
2020-01-30 00:00:00
Phase 3 data met two independent primary endpoints- January 30, 2020. Combination endpoint was not met.
0
RHHBY
Cancer related diarrhea (CRD)
Phase 2
2021-12-10 00:00:00
Phase 2 results reported that CID occurred significantly less (23%) in the crofelemer group during cycle 1 and crofelemer patients were 1.8 times more likely than control patients to have their diarrhea resolved, noted December 10, 2021.
0
NVS
Acute heart failure
Phase 3
2017-03-22 00:00:00
Phase 3 data released March 22, 2017 - primary endpoints not met.
0
MRK
Metastatic non-small cell lung cancer (NSCLC)
Phase 3
2022-02-08 00:00:00
Phase 3 trial did not meet primary endpoints of overall survival, safety profile was consistent with that observed in the overall JAVELIN clinical development program, noted February 8, 2022.
1
GSK
HIV
Approved
2019-04-08 00:00:00
FDA approval announced April 8, 2019.
1
FRTX
Autoimmune and inflammatory diseases
Phase 1
2023-03-07 00:00:00
Phase 1 SAD and MAD topline results reported that trial met the primary endpoint, noted March 7, 2023.
0
DNLI
Hunter syndrome MPS II
Phase 1/2
2023-08-30 00:00:00
Additional data from SSIEM reported that data demonstrate rapid and sustained normalization of CSF heparan sulfate to normal healthy levels and improvement in lysosomal function biomarkers, noted August 30, 2023.
1
ARAV
Growth hormone deficiency, or GHD - pediatric
Phase 3
2017-09-21 00:00:00
Phase 3 top-line data released September 21, 2017 - primary endpoint not met.
0
ICPT
Primary Biliary Cholangitis (PBC)
Phase 2
2023-06-23 00:00:00
Phase 2 interim data presented at EASL showed combination of OCA 5-10 mg + bezafibrate 400 mg normalized a range of biomarkers of PBC (ALP, total bilirubin, GGT, ALT and AST) in 58% of patients at 12 weeks, noted June 23, 2023.
1
BHC
Acne vulgaris
Approved
2023-10-20 00:00:00
Approved on October 20, 2023.
1
SYBX
Cirrhotic patients with elevated ammonia
Phase 1/2
2019-08-20 00:00:00
Development to be discontinued due to lack of efficacy.
-1
RHHBY
SMA type 1/2/3 switching
Phase 2
2021-06-11 00:00:00
Phase 2 data reported a sustained >2-fold increase in median SMN protein levels versus baseline in all patients who received prior treatment, noted June 11, 2021.
1
PRQR
Leber's Congenital Amaurosis (LCA) - Genetic blindness
Phase 2/3
2022-04-13 00:00:00
Phase 2/3 analysis found that benefit was observed in mean change from baseline in BCVA, noted April 13, 2022.
1
KOD
Treatment-Naive Wet Age-Related Macular Degeneration (AMD)
Phase 3
2023-10-13 00:00:00
Phase 3 data presented at the Retina Society meeting reported a favorable safety profile with low rates of intraocular inflammation and no cases of intraocular inflammation with vasculitis or vascular occlusion, noted October 13, 2023.
1
BMY
Relapsed or refractory (R/R) large B-cell lymphoma
Approved
2021-02-05 00:00:00
FDA approval announced February 5, 2021.
1
AVIR
Dengue
Phase 2
2023-04-17 00:00:00
Additional Phase 2 data presented at ECCMID reported that AT-752 was well tolerated and had no clinically relevant effects on cardiac repolarization, heart rate, PR or QRS intervals, noted April 17, 2023.
1
MRNA
Personalized cancer vaccine, high-risk melanoma
Phase 2
2023-10-23 00:00:00
Phase 2 additional data presented at ESMO reported that local recurrence was more common in MRs; MNRs had more distant events. This trend was supported by stronger separation in DMFS vs RFS between MRs and MNRs, noted October 23, 2023.
1
PFE
Migraine
Approved
2023-03-10 00:00:00
Approved March 10, 2023.
1
BMRN
Phenylketonuria (PKU)
Phase 1/2
2021-09-06 00:00:00
Phase 1/2 clinical hold announced September 6, 2021.
0
PFE
First-Line Treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Approved
2017-12-19 00:00:00
Approval announced December 19, 2017.
1
ZYME
HER2-expressing Gastrointestinal Cancers (Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer)
Phase 2
2023-01-19 00:00:00
Phase 2 data presented at ASCO Gastrointestinal Cancers Symposium reported an overall confirmed objective response rate (cORR) of 79%, disease control rate (DCR) of 92%, and median progression-free survival (mPFS) of 12.5 months, noted January 19, 2023.
1
PFE
Renal cell carcinoma (RCC)
Approved
2019-05-14 00:00:00
FDA Approval announced May 14, 2019.
1
TSHA
Rett syndrome
Phase 1/2
2023-08-24 00:00:00
FDA granted Fast Track Designation (FTD), noted August 24, 2023.
0
XCUR
Merkel cell carcinoma / Cutaneous squamous cell carcinoma
Phase 1/2
2021-08-05 00:00:00
Phase 1b/2 interim data noted overall response rate (ORR) of 21% in all evaluable MCC patients - August 5, 2021.
1
BBIO
Molybdenum cofactor deficiency type A
Approved
2021-02-26 00:00:00
FDA approved February 26, 2021.
1
SUPN
Attention Deficit Hyperactivity Disorder (ADHD)
Phase 3
2020-02-25 00:00:00
Phase 3 trial did not meet primary endpoint.
1
MDWD
Venous leg ulcers (VLU’s)
Phase 2
2022-05-12 00:00:00
Phase 2 results reported that both primary and key secondary endpoints were met, noted May 12, 2022.
0
ALVR
BK viremia
Phase 2
2023-02-15 00:00:00
Phase 2 final results showed an even greater antiviral effect with treatment in patients with BK viral load ≥10,000 copies/mL at screening and in the biweekly posoleucel dosing group, identifying a dosing regimen and patient population to advance into a future trial., noted February 15, 2023.
1
RLMD
Major Depressive Disorder (MDD)
Phase 3
2023-09-20 00:00:00
Phase 3 results showed that patients newly treated with REL-1017 for up to one year experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and associated functional impairment, noted Septemeber 20, 2023.
1
TEVA
Osteoarthritis pain of the hip or knee
Phase 3
2020-08-05 00:00:00
Phase 3 data achieved the co-primary endpoints for fasinumab 1 mg monthly. Fasinumab every two months did not reach statistical significance - August 5, 2020.
1
OPK
Adults - growth hormone deficiency
Phase 3
2016-12-30 00:00:00
Phase 3 data released December 30, 2016 - primary endpoint not met.
0
IMVIQ
Diffuse Large B Cell Lymphoma (DLBCL)
Phase 2
2023-02-13 00:00:00
Phase 2b initial response data showed that from 6/8 patients evaluable for efficacy; 3 patients showed confirmed complete responses, 1 patient was assessed with stable disease as best response and 2 patients were assessed with progressive disease as best response; and 2 patients with poor level of baseline functionality (ECOG ≥ 2) failed to stay on study through to the first scan and therefore could not be evaluated, noted February 13, 2023.
1
TERN
Non-alcoholic steatohepatitis (NASH)
Phase 1
2022-11-04 00:00:00
Phase 1 data reported that TERN-501 was generally well tolerated and exhibited dose-dependent pharmacokinetics with low variability, noted November 4, 2022
1
MRK
Advanced renal cell carcinoma (RCC)
Phase 3
2023-08-17 00:00:00
Phase 3 trial met primary endpoint, noted August 18, 2023.
0
MRK
Metastatic non-small cell lung cancer (NSCLC)
Phase 3
2023-09-22 00:00:00
Phase 3 data reported that there was not an improvement in OS for patients who received KEYTRUDA plus LENVIMA compared to docetaxel, noted September 22, 2023.
1
AMGN
Plaque psoriasis
Phase 3
2022-04-18 00:00:00
Phase 3 data reported that trial met primary endpoint, noted April 18, 2022.
0
MRNA
COVID-19
Phase 3
2023-10-24 00:00:00
Phase 3 trial of mRNA-1083 in adults 50 years initiated, noted October 24, 2023.
0
ABBV
Parkinson's disease
CRL
2023-03-22 00:00:00
CRL issued by FDA on March 22, 2023.
0
JAZZ
Acute Myeloid Leukemia (AML)
Phase 1b
2022-12-12 00:00:00
Phase 1b subgroup analysis reported that complete remission (CR) was achieved by 14/17 (82%) patients with a FLT3 ITD mutation and by 5/6 (83%) patients with a FLT3 TKD mutation, noted December 12, 2022.
1
IGXT
Pain
PDUFA priority review
2023-09-19 00:00:00
In response to the CRL, Xiromed submitted to the FDA an Amendment to the ANDA, requesting priority review, noted September 19, 2023. In an Amendment Acknowledgement received from the FDA by the company, the FDA granted priority review with a Generic Drug User Fee Act (GDUFA) date for review of the Amendment of March 8, 2024, unless the Agency determines that an inspection is required. Alternatively, if the FDA determines that an inspection is required, the GDUFA goal date is July 8, 2024.
0
CRDF
KRAS-Mutated Colorectal Cancer
Phase 1/2
2022-09-10 00:00:00
Phase 1b/2 data presented at ESMO showed durable responses to treatment, with a median duration of response (mDoR) of 11.7 months, noted September 10, 2022.
1
ACRS
Rheumatoid arthritis (RA)
Phase 2a
2021-01-19 00:00:00
Phase 2a 12-week data released January 19, 2021 - generally well tolerated.
1
MRK
First and Second line locally advanced or metastatic urothelial cancer - bladder cancer
Approved
2017-05-18 00:00:00
Approved May 18, 2017.
1
ALNA
Gout in chronic kidney disease (CKD)
Phase 2a
2022-08-10 00:00:00
Cohort A and B initial data reported that the data was not statistically significant, noted August 10, 2022.
0
IVVD
COVID-19 Prevention
Phase 3
2023-09-11 00:00:00
Phase 3 dosing initiated, noted September 11, 2023.
0
RHHBY
Pemphigus vulgaris
Approved
2018-06-07 00:00:00
Approval announced June 7, 2018.
1
PBYI
Extended adjuvant treatment of early stage HER2-positive breast cancer
Phase 2
2021-12-13 00:00:00
Phase 2 dose escalation final findings reported that Neratinib DE + loperamide PRN during the first 2 weeks of treatment was associated with the lowest rates of grade 3 diarrhea (13.3%) and diarrhea-related discontinuations (3.3%) compared with all other anti-diarrheal strategies investigated in the trial, noted December 13, 2021.
1
ALKS
Schizophrenia, bipolar
Approved
2021-06-01 00:00:00
FDA approval announced June 1, 2021.
1
CMRX
Acute lung injury (ALI) in COVID-19
Phase 2
2021-05-06 00:00:00
Phase 2 initial data released May 6, 2021. One patients died in DSTAT arm.
0
SRNE
Lumbosacral radicular pain (sciatica)
Phase 3
2022-05-05 00:00:00
Phase 3 data presented at ASIPP reported that treatment reduced sciatica pain with an extended effect for up to 99 days following a single injection, noted May 5, 2022.
1
LEGN
Relapsed/Refractory Multiple Myeloma (R/R MM)
Phase 2
2022-12-12 00:00:00
Phase 2 26-month data reported that median PFS and OS were NR; 24-month PFS and OS rates were 52.6% and 74.2%, respectively, noted December 12, 2022.
0
AZN
Dyslipidaemia
Phase 2b
2022-04-04 00:00:00
Phase 2b study met its primary and secondary endpoints; ION449 was generally well tolerated, noted April 4, 2022
1
GSK
Multiple myeloma
Approved
2020-08-05 00:00:00
FDA approval granted August 5, 2020.
1
GSK
Ovarian cancer
Approved
2020-04-29 00:00:00
FDA Approval announced April 29, 2020.
1
MITO
Geographic atrophy (GA) / Age-related macular degeneration (AMD)
Phase 2b
2022-05-02 00:00:00
Phase 2b top-line data reported that trial did not meet primary endpoint, noted May 2, 2022.
1
RHHBY
Urothelial carcinoma
Phase 3
2019-09-30 00:00:00
Phase 3 data at ESMO 2019 noted median PFS=8.2 versus 6.3 months; hazard ratio (HR)=0.82.
0
NVO
Type 2 diabetes
Phase 3
2022-10-03 00:00:00
Phase 3a trial met primary endpoint, noted October 3, 2022.
0
LIAN
Ulcerative Colitis (UC)
Phase 1b
2022-08-03 00:00:00
Phase 1b top-line data reported that no serious adverse events (SAEs) were reported, noted August 3, 2022.
0
MRNA
Covid-19 Omicron Booster
Approved
2023-09-11 00:00:00
FDA approved on September 11, 2023.
1
LLY
Atopic Dermatitis
Phase 1
2023-10-13 00:00:00
Phase 1b data presented at EADV 2023 showed dose-dependent efficacy reported across all endpoints for REZPEG demonstrating a rapid onset of action and continuing benefit for 36 weeks after 12-week treatment period, noted October 13, 2023.
1
TARS
Lyme disease
Phase 1
2022-12-15 00:00:00
Phase 1 data data showed that treatment was well tolerated and safety data supports progression to Phase 2a (Carpo), noted December 15, 2022.
1
SGEN
Acute myeloid leukemia (AML) - cancer
Phase 3
2017-06-19 00:00:00
Phase 3 trial discontinued due to higher rate of deaths - June 19, 2017.
-1
PLX
Gaucher disease
Approved
2012-05-01 00:00:00
Approved May 1, 2012.
1
MREO
Solid tumors
Phase 1/2
2021-11-30 00:00:00
Phase 1b/2 interim data showed that the dose was well tolerated with a favorable safety profile. One complete response, one partial response and four cases of stable disease observed among 15 patients in the efficacy analysis set
1
SAGE
Major Depressive Disorder (MDD)
Phase 3
2019-12-05 00:00:00
Phase 3 data did not meet primary endpoint - December 5, 2019.
1
IMUX
Primary Sclerosing Cholangitis
Phase 2
2021-02-18 00:00:00
Phase 2 data released February 18, 2021. Primary objective of therapeutic benefit achieved in 27.3% of patients.
1
MRK
Small cell lung cancer (SCLC)
CRL
2021-03-01 00:00:00
FDA Approval announced June 18, 2019. Approval withdrawn March 1, 2021 due to not meeting post-marketing requirements following accelerated approval.
1