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MGTX | X-Linked Retinitis Pigmentosa | Phase 1/2 | 2020-10-03 00:00:00 | Phase 1/2 nine-month data presented at EURETINA 2020 Virtual Meeting October 3, 2020. | 1 |
SNY | Atopic dermatitis 6-11 year-olds | Approved | 2020-05-26 00:00:00 | FDA Approval announced May 26, 2020. | 1 |
PFE | Chronic low back pain | Phase 3 | 2019-02-19 00:00:00 | Phase 3 data released February 19, 2019. 10mg dose met primary endpoint. 5mg dose did not meet endpoint. | 1 |
JAZZ | COVID-19 | Phase 2 | 2021-12-13 00:00:00 | Phase 2 data reported that treatment in patients with grade 5 WHO COVID 19 ARDS does not induce bleeding, and is associated with rapid restoration of respiratory function (73% of patients). No oxygen support was needed at discharge and a 1-month OS rate of 89% was observed, which is higher than historical controls (77%) treated in the same setting, noted December 13, 2021. | 1 |
BMY | Melanoma | Approved | 2017-12-20 00:00:00 | Approval announced December 20, 2017. | 1 |
NVS | Severe aplastic anemia (SAA) | Approved | 2018-11-16 00:00:00 | sNDA approval announced November 16, 2018. | 1 |
IVVD | COVID-19 (prevention) | Phase 2/3 | 2023-03-23 00:00:00 | Phase 2/3 study suggests clinically meaningful protection can be achieved at low neutralizing antibody titers, noted March 23, 2023. | 1 |
TAK | Multiple myeloma | Phase 3 | 2019-11-08 00:00:00 | Phase 3 trial met primary endpoint - November 8, 2019. | 0 |
MRTX | Non-Small Cell Lung Cancer / Colorectal Cancer | Phase 1b | 2023-09-10 00:00:00 | Phase 1/1b two-year follow-up data presented at the World Conference on Lung Cancer reported a durable efficacy with a median overall survival (OS) of 14.1 months and a 2-year OS rate of 31% in patients with previously treated KRASG12C-mutated NSCLC, noted September 10, 2023. | 1 |
BCDA | Heart Failure | Phase 3 | 2023-09-05 00:00:00 | Phase 3 review determined that the study is unlikely to meet its primary three-tiered FS efficacy endpoint, as seen from the initial 102 randomized patient set assessed at 12-month follow-up, noted September 5, 2023. | 1 |
SIGA | Smallpox | Approved | 2018-07-13 00:00:00 | FDA approval announced July 13, 2018. | 1 |
BMY | Esophageal or Gastroesophageal Junction Cancer | Approved | 2021-05-20 00:00:00 | FDA approval announced May 20, 2021. | 1 |
GSK | Endometrial Cancer | Approved | 2023-07-31 00:00:00 | FDA approved on July 31, 2023. Ahead of PDUFA on Sept. 23, 2023. | 1 |
CNCE | Agitation in patients with Alzheimer's disease | Phase 3 | 2019-09-27 00:00:00 | Phase 3 trial did not meet primary endpoint - September 27, 2019. | 1 |
BMY | Psoriatic arthritis | Phase 2 | 2021-11-03 00:00:00 | Phase 2 reported suppressed blood biomarkers of the IL-23/IL-17 and IFN-1 pathways and key markers of joint damage. There were no clinically meaningful changes in mean levels of serum cholesterol, creatinine, neutrophils and platelets over time with deucravacitinib treatment, noted November 3, 2021. | 1 |
NVS | Atherosclerotic cardiovascular disease (ASCVD), increased risk of ASCVD or heterozygous familial hypercholesterolemia (HeFH) | Phase 3 | 2023-08-28 00:00:00 | Phase 3 data reported that eight in ten patients achieved target LDL-C threshold, noted August 28, 2023. | 1 |
BMY | Relapsed and/or Refractory (R/R) Multiple Myeloma (MM) | Phase 1 | 2022-12-10 00:00:00 | Phase 1 data is presented at ASH demonstrated deep and durable responses with a manageable safety profile across all dose levels, including patients previously treated with a B-cell maturation antigen (BCMA)-directed CAR T cell therapy, noted December 10, 2022. | 1 |
BMY | Refractory Acute myeloid leukemia (AML) - cancer | Phase 3 | 2022-06-07 00:00:00 | Phase 3 overall survival data reported that in the R172 subgroup was 14.6 months with ENA vs 7.8 months with CCR and 1-yr survival rates were 62% and 30%, respectively, noted June 7, 2022. | 0 |
IKT | Parkinson’s disease | Phase 2 | 2023-10-16 00:00:00 | Phase 2 update showed that at the end of study timepoint, participants administered the 200 mg dose had a combined Part 2 and Part 3 score that was lower by an average of -8.7 points. By contrast, the combined placebo score increased by an average of +1.7 points, a -10.4 point spread between actively treated versus placebo participants, noted October 16, 2023. | 1 |
DTIL | Relapsed or refractory B-cell precursor acute lymphoblastic leukemia and R/R non-hodgkin lymphoma | Phase 1/2 | 2022-06-08 00:00:00 | Phase 1/2 clinical update reported an 100% ORR, 73% CR rate and 50% durable response rate greater than six months, noted June 8, 2022. | 0 |
CTIC | Myelofibrosis | Approved | 2022-02-28 00:00:00 | Approved February 28, 2022. | 1 |
SNDX | HR+, HER2- breast cancer | Phase 3 | 2020-05-21 00:00:00 | Phase 3 did not meet overall survival primary endpoint - May 21, 2020. | 1 |
ALNY | Hepatitis B | Phase 2 | 2023-06-24 00:00:00 | Phase 2 part A preliminary 48-week post-treatment safety, tolerability and antiviral activity data demonstrated that combination resulted in a 2.7-3.1 log10 IU/mL decline in HBsAg levels at the end of treatment, noted June 24, 2023. | 1 |
DRRX | COVID-19 Patients with Acute Liver or Kidney Injury | Phase 2 | 2021-03-04 00:00:00 | Phase 2 trial to be discontinued due to limited number of patients eligible or willing to enroll. | -1 |
JNJ | Coronary Artery Disease or Peripheral Artery Disease | Phase 3 | 2017-02-08 00:00:00 | Phase 3 trial stopped early due to positive efficacy - February 8, 2017. | -1 |
JNJ | Non-small cell lung cancer | Phase 3 | 2023-10-24 00:00:00 | Phase 3 data presented at ESMO reported that the median PFS was 11.4 months and the ORR was 73%, noted October 24, 2023. | 1 |
PEPG | Duchenne muscular dystrophy (DMD) | Phase 2 | 2023-05-18 00:00:00 | Phase 2 received a No Objection Letter (NOL) for its Clinical Trial Application (CTA) from Health Canada to initiate the trial on 2H 2023., noted May 18, 2023. | 0 |
IFRX | Pyoderma Gangraenosum (PG) | Phase 2a | 2022-03-26 00:00:00 | Phase 2a final data reported a 69 days (mean) to target ulcer response (PGA ≤ 3) and 104 days (mean) to target ulcer closure, noted March 26, 2022. | 0 |
RLYB | Fetal and neonatal alloimmune thrombocytopenia (FNAIT) | Phase 1/2 | 2021-12-01 00:00:00 | Phase 1/2 data reported that treatment accelerated the elimination of HPA-1ab-positive platelets through 7 days following administration compared with placebo, noted December 1, 2021. | 1 |
VBIV | Hepatitis B | Phase 2 | 2023-09-06 00:00:00 | Phase 2a/2b top-line data showed increased HBsAg loss rate at the end of treatment and 12 weeks follow up, noted September 6, 2023. | 1 |
BBIO | Venous, Lymphatic, and Venolymphatic Malformations | Phase 1/2 | 2022-06-10 00:00:00 | Phase 1/2 preliminary results noted that treatment was generally well-tolerated with local self-limited rash was the only adverse experience reported, noted June 10, 2022. | 1 |
CABA | Systemic Lupus Erythematosus | Phase 1 | 2023-05-01 00:00:00 | Fast track designation granted by FDA on May 1, 2023. | 0 |
STOK | Dravet syndrome | Phase 1/2 | 2023-07-25 00:00:00 | Additional Phase 1/2s safety data showed that it has been generally well-tolerated among 74 patients treated with single and multiple doses of 10mg to 70mg, noted July 25, 2023. | 1 |
DARE | Female Sexual Arousal Disorder (FSAD) | Phase 2b | 2023-11-01 00:00:00 | Phase 2b exploratory data reported that trial achieved statistical significance and clinically meaningful improvement in Phase 2b co-primary endpoint assessing arousal sensation, and statistical significance in items from Phase 2b co-primary endpoint scale evaluating concern related to difficulties with sexual arousal in subset analyses, noted November 1, 2023. | 1 |
TAK | Alpha-1 Liver Disease | Phase 2 | 2023-06-24 00:00:00 | Phase 2 data presented at EASL showed that at week 48, patients receiving 25, 100, or 200 mg fazirsiran achieved serum Z-AAT reductions of 74%, 89%, and 94%, respectively, versus an increase of 9% observed in patients receiving placebo, noted June 24, 2023. | 1 |
AQST | Erectile dysfunction | CRL | 2018-11-16 00:00:00 | CRL issued November 16, 2018. | 0 |
NKTR | 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 |
JNJ | BRCA-positive mCRPC | Approved | 2023-08-11 00:00:00 | Approved August 11, 2023. | 1 |
MRK | Solid tumors | Phase 1/2 | 2023-10-12 00:00:00 | Phase 1/2 updated results presented at AACR-NCI-EORTC reported that the overall response rate (ORR) was 38% (6/16 evaluable patients) at the Recommended Phase 2 Dose (RP2D) of 2000 mg daily and 34% (13/38) in the efficacious dose range, noted October 12, 2023. | 1 |
MVIR | Advanced hepatocellular carcinoma (HCC) | Phase 2a | 2023-10-05 00:00:00 | Phase 2a data reported that 3 patients achieved Partial Response and 10 patients Stable Disease, providing 17% Overall Response Rate (ORR) and 72% Disease Control Rate (DCR), noted October 5, 2023. | 1 |
TAK | Frontline Hodgkin lymphoma | Approved | 2018-04-04 00:00:00 | sBLA approval announced March 20, 2018. | 1 |
ENDP | Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate | Approved | 2015-10-26 00:00:00 | Approved October 26, 2015. | 1 |
MRK | COVID-19 | Phase 3 | 2022-04-01 00:00:00 | Phase 3 final analysis reported that at day 3 infectious SARS-CoV-2 was detected in 0.0% of treated patients, compared with 21.8% with placebo, noted April 1, 2022. | 1 |
BMY | Large B-cell lymphoma (LBCL) | Approved | 2022-06-24 00:00:00 | Approved June 24, 2022. | 1 |
ARQT | Plaque psoriasis in children | Approved | 2023-10-06 00:00:00 | Approved for treatment of children aged 6 - 11 on October 6, 2023. | 1 |
BIIB | Alzheimer’s disease | Phase 3 | 2019-09-13 00:00:00 | Phase 3 trial discontinued due to unfavorable risk-benefit ratio. | 1 |
ALIM | Diabetic macular edema | Approved | 2014-09-26 00:00:00 | Approved September 26, 2014, | 1 |
TIL | Non-small cell lung cancer (NSCLC), ovarian cancer, and renal cell carcinoma (RCC) | Phase 1 | 2023-01-09 00:00:00 | Phase 1 prioritized with initial data expected 2023. Phase 1 dosing initiated, noted October 18, 2022. Phase 2 enrollment voluntarily paused due to manufacturing issues, noted October 31, 2022. Phase 2 reopened, noted January 9, 2023. | -1 |
HALO | HER2-positive early breast cancer | Approved | 2020-06-29 00:00:00 | FDA Approval announced June 29, 2020. | 1 |
VBLT | Recurrent glioblastoma (rGBM) cancer | Phase 3 | 2018-03-08 00:00:00 | Phase 3 top-line data released March 8, 2018 - primary endpoint not met. | 0 |
ALNY | Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR | Approved | 2018-08-10 00:00:00 | FDA Approval announced August 10, 2018. | 1 |
TAK | Acute Graft-Versus-Host Disease (aGvHD) in patients allo-HSCT | Phase 3 | 2023-02-18 00:00:00 | Phase 3 study met primary endpoint in lower gastrointestinal (GI) aGvHD-free survival by Day 180 after allo-HSCT with no relevant differences in safety profile versus placebo, noted February 18, 2023. | 0 |
LYRA | Chronic rhinosinusitis | Phase 2 | 2023-09-12 00:00:00 | Phase 2 top-line results met its primary endpoint with no serious adverse events observed, September 12, 2023. | 1 |
AZN | Third line HER2+ breast cancer | Phase 2 | 2021-09-18 00:00:00 | Updated Phase 2 data showed an ORR of 62.0%, including one additional CR (7.1%). The median PFS was 19.4 months, September 18, 2021. | 1 |
ABBV | Augmentation of the chin region | Approved | 2020-06-15 00:00:00 | FDA Approval announced June 15, 2020. | 1 |
NKTR | Melanoma | Phase 3 | 2022-03-14 00:00:00 | Phase 3 data did not meet the primary endpoints, noted March 14, 2022. | 1 |
BTAI | Opioid Withdrawal Symptoms | Phase 1/2 | 2021-03-31 00:00:00 | Phase 1b/2 top-line data released March 31, 2021. Primary endpoint met. Retention secondary endpoint not met. | 0 |
IOBT | Advanced melanoma | Phase 3 | 2023-06-14 00:00:00 | Phase 3 trial protocol calls for an interim analysis of overall response rate (ORR) one year after 225 patients have been randomized. Additionally the number of patients to be enrolled has been increased to 380 patients, which could potentially accelerate the time to reach the primary endpoint of progression free survival, noted June 14, 2023. | 1 |
CLVS | Cancer - ovarian second line | Approved | 2016-12-19 00:00:00 | Approved December 19, 2016. Original PDUFA date under priority review was February 23, 2017. | 1 |
NVO | Hemophilia A | Phase 1/2 | 2022-07-11 00:00:00 | Phase 1/2 trial met primary endpoint, noted July 11, 2022. | 0 |
BMY | Hypertrophic cardiomyopathy (HCM) | Approved | 2022-04-28 00:00:00 | Approved April 28, 2022. | 1 |
BPMC | Treatment-resistant EGFR-driven NSCLC | Phase 1/2 | 2023-06-05 00:00:00 | Phase 1/2 initial clinical data presented at ASCO reported confirmed partial responses observed in patients whose tumors had progressed following treatment with osimertinib, note June 5, 2023. | 1 |
MCRB | Gastrointestinal infections, bacteremia and graft versus host disease (GvHD) | Phase 1b | 2023-05-09 00:00:00 | Phase 1 initial safety and PK data from cohort 1 showed the successful engraftment of SER-155 bacterial strains and a substantial reduction in the cumulative incidence of pathogen domination, a biomarker associated with the risk of serious enteric infections and bloodstream infections, as well as GvHD, noted on May 9, 2023 | 1 |
PFE | COVID-19 vaccine | Phase 2/3 | 2022-11-04 00:00:00 | Phase 2/3 clinical trial demonstrated robust neutralizing immune response one month after a 30-µg booster dose of the COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)). Omicron BA.4/BA.5-neutralizing antibody titers increased 13.2-fold from pre-booster levels in adults older than 55 years of age and 9.5-fold in adults 18 to 55 years of age, noted November 4, 2022. | 1 |
ASLN | Biliary tract cancer | Phase 2/3 | 2019-11-11 00:00:00 | Phase 3 trial did not meet primary endpoint - November 11, 2019. | 1 |
KOD | Diabetic Macular Edema (DME) | Phase 3 | 2023-10-13 00:00:00 | Phase 3 data presented at the Retina Society meeting reported that 1/2 of patients achieved 6-month dosing at the primary endpoint, noted October 13, 2023. | 1 |
ZLDPF | Obesity | Phase 1b | 2023-06-24 00:00:00 | Phase 1b trial data showed that after one week of treatment, mean body weight reductions reached 2.6%, 3.6% and 4.2% from baseline following a single dose of 0.7 mg, 1.4 mg or 2.4 mg ZP8396, respectively. Reductions in body weight were dose-dependent, consistent and well-sustained during the additional five weeks of observation without further doses of ZP8396. Placebo-treated participants demonstrated a mean body weight increase of 0.6% after one week that continued to increase in most participants during the follow-up period, noted June 24, 2023. | 1 |
HALO | Multiple Myeloma | Approved | 2021-12-01 00:00:00 | Approved December 1, 2021. | 1 |
SNY | Rheumatoid arthritis | Approved | 2017-05-22 00:00:00 | CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017. | 1 |
BBIO | Cholangiocarcinoma | Approved | 2021-06-01 00:00:00 | FDA approval announced June 1, 2021. | 1 |
JNJ | Ankylosing Spondylitis | Approved | 2017-10-20 00:00:00 | Approval announced October 20, 2017. | 1 |
BIIB | Postpartum depression (PPD) | Phase 3 | 2022-10-17 00:00:00 | Additional Phase 3 data reported that a total of two participants (all in the zuranolone group) experienced four serious adverse events all of which were assessed by the investigator as unrelated to the therapy, noted October 17, 2022. | 0 |
MACK | Cancer - second line pancreatic | Approved | 2015-10-22 00:00:00 | Approved October 22, 2015. | 1 |
PCRX | Postoperative Pain Management | Phase 3 | 2021-09-21 00:00:00 | Phase 3 study found the PK profile was comparable across age groups and generally consistent with the profile in adult patients. No safety concerns were identified at a dose of 4 mg/kg, noted September 21, 2021. | 0 |
GBT | Sickle cell disease - children age 4-11 | Approved | 2021-12-17 00:00:00 | Approved December 17, 2021. | 1 |
MNKKQ | Deep partial thickness severe burns - skin defects | Approved | 2021-06-15 00:00:00 | FDA approval June 15, 2021. | 1 |
NBIX | Parkinson's disease | Approved | 2020-04-27 00:00:00 | FDA Approval announced April 27, 2020. | 1 |
MRTX | Renal cell carcinoma (RCC) | Phase 1/2 | 2020-02-15 00:00:00 | Phase 2 updated data presented at ASCO GU 2020. 15/38 (39%) partial response rate, PFS 10.3 months - February 15, 2020. | 1 |
NVS | Asthma | Phase 3 | 2019-10-22 00:00:00 | Phase 3 data did not meet primary endpoint - noted October 22, 2019. | 1 |
INSM | COVID-19 | Phase 3 | 2021-07-31 00:00:00 | Phase 3 failed noted July 2021. | -1 |
GSK | COVID-19 antibody | Approved | 2022-02-11 00:00:00 | EUA granted by FDA February 11, 2022. | 0 |
DRMA | Acne | Phase 2b | 2023-06-27 00:00:00 | EoP2b FDA established key elements of the DMT310 Phase 3 clinical program and delineated a potential regulatory pathway for approval of DMT310, noted June 27, 2023. | 1 |
VXRT | Norovirus vaccine | Phase 2 | 2023-09-06 00:00:00 | Phase 2 study met 5 of 6 primary endpoints,.Vaccination led to a statistically significant reduction in infection rate, a non-statistically significant reduction in norovirus acute gastroenteritis (AGE), and a substantial reduction in viral shedding, noted September 7, 2023. | 1 |
GRTX | Esophagitis | Phase 2 | 2022-10-27 00:00:00 | Phase 2 Open-Label data reported that 14 of 29 evaluable patients (48.3%) experienced acute esophagitis at week 6, noted October 27, 2022. | 1 |
EDSA | COVID-19, Acute Respiratory Distress Syndrome (ARDS) | Phase 2/3 | 2021-10-19 00:00:00 | Phase 2/3 additional results demonstrated the DSMB noted another mortality benefit in 136 hospitalized COVID-19 patients receiving supplemental oxygen (28-day mortality rate of 8.2% (5/61) in the EB05 + SOC arm versus 12.0% (9/75) in the placebo + SOC arm, Hazard Ratio (HR): 1.52 placebo vs. EB05, n=136). Phase 3 portion of the study to focus on critically ill population, noted October 19, 2021. | 1 |
GILD | Multiple Myeloma | Phase 2 | 2023-06-19 00:00:00 | Phase 2 clinical hold received by the FDA after a recent patient death, noted June 19, 2023. | 0 |
DRMA | Rosacea | Phase 2 | 2022-12-05 00:00:00 | Phase 2 top-line data reported that trial did not meet primary endpoint, noted December 5, 2022. | 1 |
IBRX | Merkel cell carcinoma (MCC) | Phase 2 | 2019-11-07 00:00:00 | Phase 2 data noted 2/7 responses (1 PR / 1 CR) - November 7, 2019. | 0 |
ADMP | Opioid overdose | Approved | 2021-10-18 00:00:00 | Approved October 18, 2021. | 1 |
GILD | Nonalcoholic steatohepatitis (NASH) | Phase 3 | 2019-04-25 00:00:00 | Phase 3 data April 25, 2019 did not meet primary endpoint. | 1 |
MNOV | Nonalcoholic steatohepatitis (NASH) | Phase 2 | 2018-04-02 00:00:00 | Noted April 2, 2018 that trial has been terminated early due meeting one of two primary endpoints (data from second endpoint not released). | 1 |
REGN | Eosinophilic esophagitis (EoE) in 1-11 year olds | Phase 3 | 2022-07-14 00:00:00 | Phase 3 data reported that trial met its primary endpoint, noted July 14, 2022. | 0 |
ABBV | Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). | Approved | 2020-04-21 00:00:00 | FDA Approval announced April 21, 2020. | 1 |
GTHX | Triple-negative breast cancer | Phase 2 | 2023-05-10 00:00:00 | Phase 2 additional data highlighted the potential for trilaciclib to meaningfully reduce adverse events related to use of sacituzumab. As expected, patients with PD-L1(+) tumors appear to respond earlier than patients with PD-L1(-) tumors, noted May 10, 2023 | 1 |
BMRN | (MPS IVA) Morquio A Syndrome | Approved | 2014-02-14 00:00:00 | Approved February 14, 2014. | 1 |
SONN | Healthy volunteers | Phase 1 | 2023-11-02 00:00:00 | Phase 1 interim analysis presented at CTAD reported that in single doses up to 300 ng/kg and in patients with advanced cancer in repeated doses up to at least 540 ng/kg. Incorporation of a desensitizing first dose at 150-300 ng/kg and dosing every 3 weeks has been implemented to capitalize on the potential benefits of tachyphylaxis with rhIL-12, noted November 2, 2023. | 1 |
ALDX | Psoriasis / atopic asthma / COVID-19 | Phase 2 | 2022-03-29 00:00:00 | Phase 2 top-line data reported statistically significant improvements in all three indications with no serious adverse events, noted March 29, 2022. | 1 |
BIIB | Multiple sclerosis (MS) | Approved | 2019-10-30 00:00:00 | FDA Approval announced October 30, 2019. | 1 |
GSK | Non-squamous non-small cell lung cancer (NSCLC) | Phase 2 | 2022-10-05 00:00:00 | Phase 2 trial met primary endpoint, noted October 5, 2022. | 0 |
MRK | Endometrial Cancer | Phase 3 | 2021-07-22 00:00:00 | FDA approval announced July 22, 2021. | 1 |