Drug Pipeline Database & Screener

Over 2000 drug entries from about 550 biotech companies in Phase 2, 3 or NDA development.

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09/21/2021
Drug Indication Stage News
AADI Aadi Bioscience Inc.
$29.91
+0.82  +2.82%
20.8 million
$623.3 million
09/21/2021
Tap to view 3 drugs
Drug Indication Stage News
AKB-4924 (GB004) - SHIFT-UC Ulcerative Colitis Phase 2 Phase 2 top-line data due 1H 2022.
Razuprotafib (AKB-9778) Open-angle glaucoma (OAG) Phase 2 Phase 2 data met primary endpoint with twice-daily dose group but not with once-daily group.
FYARRO PEComa​ NDA Filing Rolling NDA completed in May 2021.
ABBV AbbVie Inc.
$107.15
+0.75  +0.70%
1.8 billion
$189.4 billion
09/21/2021
Tap to view 53 drugs
Drug Indication Stage News
BOTOX Forehead lines Approved Approval (third indication) announced October 3, 2017.
Depatuxizumab mafodotin (ABT-414) Glioblastoma (rGBM) Phase 3 Phase 3 trial did not meet primary endpoint at interim analysis - May 17, 2019.
IMBRUVICA (Ibrutinib) Relapsed or refractory MCL mantle cell lymphoma Approved Approved November 13, 2013.
IMBRUVICA (Ibrutinib) Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy Approved Approved February 12, 2014.
VIEKIRA PAK HCV - genotype 1 Approved Approved December 19, 2014.
IMBRUVICA (Ibrutinib) Waldenström’s Macroglobulinemia Approved Approved January 29, 2015 - PCYC
VRAYLAR (cariprazine) Maintenance Treatment of Schizophrenia Approved Approval announced November 13, 2017.
Atogepant Chronic migraine PDUFA NDA acceptance announced March 30, 2021. PDUFA date late-3Q 2021. New Phase 3 data to be presented September 8, 2021.
Cenicriviroc (CVC) Nonalcoholic steatohepatitis (NASH) Phase 3 Phase 3 data due 2021.
ABICIPAR Age-related macular degeneration (AMD) CRL CRL issued June 26, 2020.
Oxymetazoline HCl cream 1.0% Facial Erythema (Redness) Associated with Rosacea Approved Approved January 19, 2017.
MVASITM (bevacizumab-awwb) Biosimilar candidate to Avastin (bevacizumab) Approved Approved September 14, 2017.
VENCLEXTA (venetoclax) (MURANO) Relapsed or refractory Chronic Lymphocytic Leukemia (CLL) Approved Approval announced June 11, 2018.
VENCLEXTA (venetoclax) - CANOVA Relapsed or refractory multiple myeloma Phase 3 Phase 3 data due in 2021.
SKYRIZI (risankizumab) Psoriasis Approved FDA approval announced April 23, 2019.
IMBRUVICA (Ibrutinib) Second-line Chronic graft-versus-host disease (GVHD) Approved Approval announced August 2, 2017.
RINVOQ (Upadacitinib) Atopic Dermatitis PDUFA PDUFA date early 3Q 2021 not met. The FDA cited its ongoing review of Pfizer's post-marketing study, ORAL Surveillance, evaluating tofacitinib in patients with rheumatoid arthritis for the delay.
IMBRUVICA (Ibrutinib) Marginal zone lymphoma Approved sNDA filing announced September 26, 2017. Priority Review. Approved January 19, 2017.
GLECAPREVIR / PIBRENTASVIR (G/P) Hepatitis C virus (HCV) Approved Approval announced August 3, 2017.
ORILISSA (Elagolix) Uterine Fibroids Approved FDA approval announced May 29, 2020.
ORILISSA (Elagolix) Endometriosis Approved FDA approval announced July 24, 2018.
UBRELVY (Ubrogepant) Migraine Approved FDA Approval announced December 23, 2019. Oral presentation of additional data September 11, 2021.
RINVOQ (Upadacitinib) Rheumatoid arthritis Approved FDA Approval announced August 16, 2019.
IMBRUVICA (Ibrutinib) and GAZYVA (Obinutuzumab) Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) Approved FDA approval announced January 28, 2019.
IMBRUVICA (ibrutinib) Waldenström’s Macroglobulinemia Approved FDA approval announced August 27, 2018.
IMBRUVICA (ibrutinib) Diffuse large B-cell lymphoma (DLBCL) Phase 3 Phase 3 trial did not meet primary endpoint - noted July 11, 2018.
VENCLEXTA (venetoclax) First line unfit AML Approved FDA approval announced November 21, 2018.
RINVOQ (Upadacitinib) - U-ACHIEVE Ulcerative colitis NDA Filing NDA filed September 16, 2021.
VENCLEXTA (venetoclax) and GAZYVA (obinutuzumab) Chronic Lymphocytic Leukemia Phase 3 FDA approval announced May 15, 2019.
IMBRUVICA (Ibrutinib) Pancreatic cancer Phase 3 Phase 3 primary endpoint not met (PFS/OS).
BOTOX Lower limb spasticity Approved FDA Approval announced October 24, 2019.
BOTOX Upper limb spasticity Approved FDA Approval announced June 21, 2019.
JUVÉDERM VOLUMA Mid-Face Injection Via Cannula Approved FDA Approval announced September 3, 2019.
IMBRUVICA (ibrutinib) and RITUXAN (rituximab) Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approved FDA Approval announced April 21, 2020.
SKYRIZI (risankizumab) vs COSENTYX (secukinumab) Plaque psoriasis Phase 3 Phase 3 trial met primary endpoint - January 14, 2020.
RINVOQ (Upadacitinib) Psoriatic arthritis PDUFA PDUFA estimate June 25, 2021 will not be met - noted June 25, 2021.
SKYRIZI (risankizumab) - MOTIVATE Crohn’s Disease NDA Filing Phase 3 regulatory application submission to FDA for the treatment of patients 16 years and older with moderate to severe Crohn's disease, September 20, 2021.
SKYRIZI (risankizumab) - (KEEPSAKE2) Psoriatic Arthritis Phase 3 Phase 3 trial met primary endpoint - January 5, 2021.
RINVOQ (Upadacitinib) Atopic dermatitis Phase 3 Phase 3 data met co-primary endpoints - June 18, 2020. Second Phase 3 trial also met primary endpoint - July 21, 2020.
VENCLEXTA (venetoclax) - (VIALE-A) Acute Myeloid Leukemia (AML) Approved FDA approval announced October 16, 2020.
IMBRUVICA (Ibrutinib) and prednisone Chronic Graft Versus Host Disease Phase 3 Phase 3 trial ongoing.
ABBV-951 Parkinson's disease Phase 3 Phase 3 data due late-2021.
JUVÉDERM VOLUMA Augmentation of the chin region Approved FDA Approval announced June 15, 2020.
BOTOX Neurogenic Detrusor Overactivity Approved FDA approval announced February 10, 2021.
RINVOQ (upadacitinib) Active Ankylosing Spondylitis PDUFA PDUFA estimate June 25, 2021 will not be met - noted June 25, 2021.
Pilocarpine (AGN-190584) Presbyopia NDA Filing NDA filing announced February 25, 2021.
VRAYLAR (cariprazine) Major depressive disorder Phase 3 Phase 3 data due 2021.
RINVOQ (Upadacitinib) Ulcerative Colitis (maintenance) Phase 3 Phase 3 trial met primary and all secondary endpoints - June 29, 2021.
RINVOQ (upadacitinib) Crohn's disease (induction/maintenance) Phase 3 Phase 3 data due 2021.
IMBRUVICA (Ibrutinib) - (SHINE) Mantle Cell Lymphoma Phase 3 Phase 3 data due 2021.
IMBRUVICA (Ibrutinib) + VENCLEXTA - Venetoclax (GLOW) Chronic Lymphocytic Leukemia Phase 3 Phase 3 data due 2021.
DALVANCE (dalbavancin) Acute bacterial skin and skin structure infections (ABSSSI) - pediatric Approved FDA approval announced July 23, 2021.
BOTOX Upper Limb Spasticity Approved FDA approval announced July 29, 2021.
ABCL AbCellera Biologics Inc.
$21.08
+0.43  +2.08%
278.7 million
$5.9 billion
09/21/2021
Tap to view 2 drugs
Drug Indication Stage News
BamlanivimabLY-CoV555 COVID-19 Antibody Approved Emergency Use Authorization (EUA) announced November 9, 2020.
Bamlanivimab and Etesevimab COVID-19 Anti-body Approved Emergency Use Authorization (EUA) expanded, announced September 16, 2021.
ABEO Abeona Therapeutics Inc.
$1.21
  +0.00%
101.2 million
$122.5 million
09/21/2021
Tap to view 4 drugs
Drug Indication Stage News
ABO-101 (Transpher B) Sanfilippo syndrome type B (MPS IIIB) Phase 1/2 Phase 1/2 two-year neurocognitive data due 1H 2022.
EB-101 - VITAL Recessive dystrophic epidermolysis bullosa (RDEB) Phase 3 Phase 3 top-line data due mid-2022.
ABO-102 Sanfilippo syndrome type A (MPS IIIA) Phase 1/2 Phase 1/2 updated safety data released February 12, 2021. Phase 1/2 pivotal data due in 2022.
ABO-202 CLN1 disease (Infantile Batten disease) Phase 1/2 Phase 1/2 trial planned.
ABIO ARCA biopharma Inc.
$3.02
+0.03  +1.00%
14.4 million
$43.5 million
09/21/2021
Tap to view 2 drugs
Drug Indication Stage News
Gencaro Chronic Heart Failure Phase 3 Phase 3 trial initiation on hold - dependent on obtaining additional financing.
rNAPc2 (AB201) - (ASPEN) COVID-19 Phase 2b Phase 2b enrollment initiated September 16, 2021, top-line data due 4Q 2021,
ABOS Acumen Pharmaceuticals Inc.
$15.04
+0.28  +1.90%
40.5 million
$608.6 million
09/21/2021
Tap to view 1 drug
Drug Indication Stage News
ACU193 Alzheimer’s disease Phase 1 Phase 1 data due by the end of 2022.
ABUS Arbutus Biopharma Corporation
$4.37
+0.08  +1.86%
99.2 million
$433.3 million
09/21/2021
Tap to view 5 drugs
Drug Indication Stage News
AB-729 Hepatitis B (HBV) Phase 1 Phase 1a/b data at EASL meeting June 26, 2021 - HBsAg declines below 100 IU/ml in 75% of treated subjects. Favorable safety and tolerability profile. Further data due 2H 2021.
AB-836 Hepatitis B Phase 1a Phase 1a/1b initial data due 2H 2021.
AB-729 and Vebicorvir (ABI-H0731) Hepatitis B virus (HBV) Phase 2 Phase 2 trial initiation announced February 26, 2021.
AB-729, ATI-2173 and Viread (tenofovir disoproxil fumarate) - ANTT201 Hepatitis B Phase 2a Phase 2 combination cohort to commence 2H 2021.
AB-729 and VTP-300 Hepatitis B Phase 2a Phase 2 trial to be initiated early 2022.
ACAD ACADIA Pharmaceuticals Inc.
$17.02
+0.31  +1.86%
160.6 million
$2.7 billion
09/21/2021
Tap to view 8 drugs
Drug Indication Stage News
NUPLAZID (pimavanserin) CLARITY-2 and CLARITY-3 Adjunctive Treatment in Patients With Major Depressive Disorder Phase 3 Phase 3 trial did not meet primary endpoint - July 20, 2020.
NUPLAZID (pimavanserin) Advance-2 Adjunctive treatment in patients with negative symptoms of schizophrenia Phase 3 Phase 3 trial initiated 3Q 2020.
NUPLAZID (pimavanserin) Enhance Adjunctive treatment of schizophrenia Phase 3 Phase 3 data did not meet primary endpoint - July 22, 2019.
NUPLAZID (pimavanserin) Parkinson’s disease psychosis (PDP) Approved Approved April 29 2016. Additional dose approval announced June 29, 2018.
NUPLAZID (pimavanserin) Alzheimer’s disease psychosis CRL CRL announced April 5, 2021.
Trofinetide (LAVENDER) Rett Syndrome Phase 3 Phase 3 data due 4Q 2021.
ACP-044 Postoperative pain following bunionectomy surgery Phase 2 Phase 2 top-line data due 4Q 2021.
ACP-044 Pain associated with osteoarthritis Phase 2 Phase 2 trial initiated 2Q 2021.
ACER Acer Therapeutics Inc.
$2.52
  +0.00%
14.3 million
$36.1 million
09/21/2021
Tap to view 4 drugs
Drug Indication Stage News
EDSIVO (celiprolol) Vascular Ehlers-Danlos Syndrome Phase 3 CRL issued June 25, 2019. Phase 3 trial planned.
ACER-001 Urea cycle disorder (UCD) NDA Filing NDA filing announced August 9, 2021.
Osanetant (ACER-801) induced Vasomotor Symptoms (iVMS) Phase 1/2 Phase 1/2 trial to be initiated 4Q 2021.
Emetine COVID-19 Phase 2/3 Phase 2/3 trial to be initiated 1H 2021.
ACET Adicet Bio Inc.
$7.05
+0.16  +2.32%
19.6 million
$138.1 million
09/21/2021
Tap to view 1 drug
Drug Indication Stage News
ADI-001 Non-Hodgkin’s lymphoma Phase 1 Phase 1 trial initiation announced March 10, 2021. Data due late-2021.
ACHL Achilles Therapeutics plc
$5.95
+0.08  +1.36%
40.6 million
$241.6 million
09/21/2021
Tap to view 2 drugs
Drug Indication Stage News
ATL001 - CHIRON Non Small Cell Lung Cancer Phase 1/2 Phase 1/2 update 4Q 2021.
ATL001 - THETIS Melanoma Phase 1/2 Phase 1/2 update 4Q 2021.
ACHV Achieve Life Sciences Inc.
$8.11
+0.19  +2.40%
9.5 million
$76.7 million
09/21/2021
Tap to view 1 drug
Drug Indication Stage News
Cytisine - ORCA-2 Smoking cessation Phase 3 Phase 2 data showed smokers who had previously failed Chantix demonstrated an abstinence rate of 51.3% with cytisinicline compared with 15.8% with placebo (p= 0.009). Phase 3 data due 1H 2022.
ACIU AC Immune SA
$6.80
+0.07  +1.12%
72.7 million
$493.7 million
09/21/2021
Tap to view 9 drugs
Drug Indication Stage News
Crenezumab - CREAD 2 Alzheimer’s disease Phase 3 Phase 3 trial terminated following interim analysis indicating primary endpoint would not be met.
Semorinemab Alzheimer’s disease Phase 2 Phase 2 top-line data did not meet endpoints - September 23, 2020.
ACI-24 (anti-Abeta vaccine) Alzheimer's disease-like characteristics in individuals with Down syndrome Phase 1b Phase 1b data presented at AAIC July, 2021.
Crenezumab - CREAD 1 Alzheimer’s disease Phase 3 Phase 3 trial terminated following interim analysis indicating primary endpoint would not be met.
Semorinemab (LAURIET) Alzheimer’s disease Phase 2 Phase 2 top-line data met one of two co-primary endpoints August 31, 2021. Top-line results to be presented at CTAD November 9-12, 2021.
ACI-3024 Alzheimer’s disease Phase 1 Phase 1 trial has completed.
ACI-35.030 Alzheimer’s Disease Phase 1/2 Phase 1b/2a further interim data due 4Q 2021.
ACI-24 Alzheimer’s disease (AD) Phase 2 Phase 2 interim analysis June 2, 2021. Good safety confirmed.
JACI-35.054 alternative anti-pTau vaccine Alzheimer’s disease Phase 1/2 Phase 1/2 trial ongoing.
ACOR Acorda Therapeutics Inc.
$4.28
-0.08  -1.83%
11.1 million
$47.6 million
09/21/2021
Tap to view 3 drugs
Drug Indication Stage News
Tozadenant Parkinson’s disease (PD) Phase 3 Noted November 15, 2017 seven cases of sepsis, five of which were fatal. Company noted November 20, 2017 that program will be discontinued.
Dalfampridine Post stroke deficits Phase 3 Phase 3 data released November 21, 2016 - failed to show efficacy, development to be discontinued.
INBRIJA (CVT-301) OFF episodes of Parkinson’s disease (PD) Approved FDA Approval announced December 22, 2018.
ACRS Aclaris Therapeutics Inc.
$16.95
+0.05  +0.30%
61.2 million
$1 billion
09/21/2021
Tap to view 9 drugs
Drug Indication Stage News
ATI-502 (ATI-50002-AA-201) - dose ranging Alopecia areata Phase 2 Phase 2 data did not meet primary endpoint - June 26, 2019.
ATI-502 (VITI-201 Topical) Vitiligo Phase 2 Development to be discontinued - noted August 8, 2019.
ESKATA (hydrogen peroxide) Seborrheic keratosis (SK) Approved Approval announced December 15, 2017.
A-101 (THWART-1 and THWART-2) Common warts (verruca vulgaris) Phase 3 Phase 3 data met all endpoints - September 16, 2019 and October 24, 2019.
ATI-450 Rheumatoid arthritis (RA) Phase 2b Phase 2b trial to be initiated 2H 2021.
ATI-1777-AD-201 Atopic dermatitis Phase 2a Phase 2a data met primary endpoint - June 8, 2021.
ATI-450 COVID-19 Phase 2a Phase 2a dosing commenced August 2020.
ATI-450 Hidradenitis suppurativa Phase 2 Phase 2 trial planned.
ATI-450 Psoriatic arthritis Phase 2 Phase 2 trial planned.
ACRX AcelRx Pharmaceuticals Inc.
$1.01
+0.01  +1.00%
119.2 million
$120.4 million
09/21/2021
Tap to view 3 drugs
Drug Indication Stage News
ARX-04 (SAP302) Patients who presented to emergency departments with moderate-to-severe acute pain associated with trauma or injury Phase 3 Phase 3 data released August 15 2016
DSUVIA (Sufentanil) Moderate-to-severe acute pain following a surgical procedure Approved FDA Approval announced November 2, 2018.
Zalviso Post-operative pain following open abdominal surgery and hip or knee replacement surgery Phase 3 CRL Jul 26 2014. NDA resubmission planned.
ACST Acasti Pharma Inc.
$2.11
+0.08  +3.94%
26 million
$93.4 million
09/21/2021
Tap to view 1 drug
Drug Indication Stage News
CaPre (TRILOGY 1 and 2) Hypertriglyceridemia Phase 3 Phase 3 TRILOGY 1 data did not meet primary endpoint - January 13, 2020. TRILOGY 2 data August 31, 2020 also did not meet primary endpoint.
ACXP Acurx Pharmaceuticals Inc.
$4.36
-0.26  -5.63%
10.1 million
$44.1 million
09/21/2021
Tap to view 1 drug
Drug Indication Stage News
Ibezapolstat C. difficile Infection Phase 2b Phase 2b trial to commence early 2022.
ADAG Adagene Inc.
$14.48
-0.22  -1.50%
54.5 million
$788.7 million
09/21/2021
Tap to view 5 drugs
Drug Indication Stage News
ADG106-P2001 Solid tumors Phase 2 Phase 2 results from combination trial 2022.
ADG116 Solid Tumors Phase 1 Phase 1 data of ADG-116 monotherapy (ADG116-1003) due 2H 2021. Phase 1 data of combination cohorts, ADG116 with toripalimab and ADG106 (ADG116-1003) due 2022.
ADG126 Solid tumors Phase 1 Phase 1 data of ADG126 monotherapy (ADG126-1001) due 2H 2021. Phase 1 data of ADG126 (ADG126-1002) due 2022.
ADG116 combined with KEYTRUDA (pembrolizumab) - (ADG116-P001; KEYNOTE C97) Solid tumors Phase 1 Phase 1 trial to be initiated 2022.
ADG126 combined with KEYTRUDA (pembrolizumab) - (ADG126-P001; KEYNOTE-C98) Solid tumors Phase 1 Phase 1 trial to be initiated in 2022.
ADAP Adaptimmune Therapeutics plc
$5.50
+0.42  +8.27%
156.1 million
$858.5 million
09/21/2021
Tap to view 5 drugs
Drug Indication Stage News
Afami-cel (ADP-A2M4) Solid tumors Phase 1 Phase 1 update at American Society for Radiation Oncology (ASTRO) October 24-27, 2021.
AFP (ADP-A2AFP) Hepatocellular carcinoma Phase 1 Phase 1 data displayed one complete response and a disease control rate of 64% with stable disease for ≥16 weeks in two patients. Phase 1 top-line data has an acceptable safety profile. Dose escalation is complete September 5, 2021.
Afami-cel - (SPEARHEAD‑1) Synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) Phase 2 Phase 2 enrolment has been completed. Initial data at ASCO June 4-8, 2021. Abstract noted overall response rate was 39.3% (13/33), 41.4% (12/29) for synovial sarcoma; 25.0% (1/4) for MRCLS. Next update due at CTOS meeting November 10-13, 2021
ADP-A2M4CD8 (SURPASS) Solid tumors Phase 1 Phase 1 data released September 16, 2021 - 4.5% of patients received CR, 31.8% received PR, 50% received SD, 13% received PD. Phase 2 trial, SURPASS-2, will start later 2021 for patients with esophageal and EGJ cancers.
ADP-A2M4CD8 (SURPASS-2) Esophageal and esophagogastric junction cancers Phase 2 Phase 2 trial to commence 3Q 2021.
ADCT ADC Therapeutics SA
$28.14
-0.11  -0.39%
78.3 million
$2.2 billion
09/21/2021
Tap to view 9 drugs
Drug Indication Stage News
Camidanlumab tesirine Hodgkin lymphoma (HL) Phase 2 Phase 2 interim data presented June 22, 2021. Overall response rate (ORR) was 66.3% (67/101 patients) with a complete response rate (CRR) of 27.7% and partial response rate (PRR) of 38.6%. Median duration of response has not been reached.
ZYNLONTA (Loncastuximab Tesirine) Diffuse Large B-Cell Lymphoma Approved FDA approval announced April 23, 2021.
Camidanlumab Tesirine and KEYTRUDA (pembrolizumab) Solid Tumors Phase 1b Phase 1b monotherapy data released at ASCO June 4, 2021.
ZYNLONTA (Loncastuximab Tesirine) B-cell non-Hodgkin lymphoma Phase 2 Trials to be initiated 2H 2021.
ZYNLONTA (loncastuximab tesirine) + IMBRUVICA (Ibrutinib) - (LOTIS-3) Diffuse Large B-Cell or Mantle Cell Lymphoma Phase 1/2 Phase 2 pivotal trial ongoing.
ZYNLONTA (Loncastuximab Tesirine) and RITUXAN (rituximab) - (LOTIS 5) Diffuse Large B-Cell Lymphoma Phase 3 Phase 3 safety lead-in to be completed 2H 2021.
ADCT-601 Solid tumors Phase 1b Phase 1b trial to be initiated 1H 2022.
ADCT-901 Phase 1 Phase 1 trial to be initiated 2H 2021.
ADCT-601 (mipasetamab uzoptirine) Solid tumors Phase 1b Phase 1b trial to be initiated 2H 2021.
ADGI Adagio Therapeutics Inc.
$47.86
+1.63  +3.53%
111.2 million
$5.3 billion
09/21/2021
Tap to view 2 drugs
Drug Indication Stage News
ADG20 (EVADE) COVID-19 (prevention) Phase 2/3 Phase 2/3 trial of ADG20 expanded following the independent data monitoring committee (IDMC) assessment to include adolescents 12 years and older and pregnant or nursing women, as well as a decrease in the protocol-specified, in-clinic post-injection monitoring time September 20, 2021.
ADG20 (STAMP) COVID-19 (treatment) Phase 2/3 Phase 2/3 new data supporting the potential for both the treatment and prevention of COVID-19 to be presented at IDWeek 2021 September 29 – October 3, 2021.
ADIL Adial Pharmaceuticals Inc
$4.24
+0.12  +2.91%
20.4 million
$86.7 million
09/21/2021
Tap to view 1 drug
Drug Indication Stage News
AD04 (ONWARD) Alcohol use disorder Phase 3 Phase 3 trial enrollment closed August 20, 2021 with data due 1Q 2022.
ADMA ADMA Biologics Inc
$1.25
  +0.00%
132.8 million
$166 million
09/21/2021
Tap to view 2 drugs
Drug Indication Stage News
ASCENIV (RI-002) Primary Immune Deficiency Diseases Approved FDA Approval announced April 1, 2019.
BIVIGAM Primary humoral immunodeficiency CRL FDA issued Complete Response Letter for PAS drug substance, but approved PAS for drug product.
ADMP Adamis Pharmaceuticals Corporation
$1.04
+0.01  +0.97%
148.9 million
$154.8 million
09/21/2021
Tap to view 6 drugs
Drug Indication Stage News
Epinephrine Pre-filled Syringe (PFS) Emergency treatment of anaphylaxis. Approved CRL issued March 27 2015. CRL issued again June 6, 2016. Approval announced June 15, 2017 following third submission.
APC-1000 Asthma/COPD Phase 2 Phase 3 development on hold - noted May 9, 2019.
Symjepi - low dose Anaphylaxis Approved FDA Approval announced September 27, 2018.
ZIMHI (naloxone HCI Injection) Opioid overdose PDUFA CRL announced November 16, 2020. NDA resubmitted with new PDUFA date November 12, 2021.
APC-8000 (sublingual tadalafil) Erectile dysfunction NDA Filing Refusal to file letter received February 26, 2019.
Tempol COVID-19 Phase 2/3 Phase 2/3 trial initiated dosing September 2, 2021.
ADMS Adamas Pharmaceuticals Inc.
$4.88
+0.08  +1.67%
45.6 million
$222.5 million
09/21/2021
Tap to view 3 drugs
Drug Indication Stage News
GOCOVRI (amantadine) Multiple sclerosis (MS) Phase 3 Phase 3 data met primary endpoint at one of two doses. Secondary endpoint in walking impairment not met. Second trial will not be initiated as a result of data - December 17, 2019. Findings were confirmed June 17, 2020.
Namzaric Moderate to severe dementia of the Alzheimer's type. Approved Approved December, 24 2014.
GOCOVRI (amantadine) Levodopa-Induced Dyskinesia + Parkinson's disease patients receiving levodopa and experiencing OFF episodes Approved FDA Approval announced August 24, 2017. Second approval to include treatment of OFF episodes in PD patients receiving levodopa announced February 1, 2021.
ADPT Adaptive Biotechnologies Corporation
$38.58
+0.87  +2.31%
140.8 million
$5.4 billion
09/21/2021
Drug Indication Stage News
ADTX Aditxt Inc.
$1.60
+0.06  +3.90%
20.3 million
$32.4 million
09/21/2021
Tap to view 1 drug
Drug Indication Stage News
ADi Psoriasis Phase 1/2 Phase 1/2 trial planned.
ADVM Adverum Biotechnologies Inc.
$2.25
+0.01  +0.45%
98.1 million
$220.8 million
09/21/2021
Tap to view 2 drugs
Drug Indication Stage News
ADVM-022 (OPTIC) Wet age-related macular degeneration (Wet-AMD) Phase 1 Phase 1 data to be presented in Fall 2021.
ADVM-022 - INFINITY Diabetic macular edema Phase 2 Phase 2 data to be presented 2H 2021, however intends not to further develop.
ADXS Advaxis Inc.
$0.50
+0.02  +5.12%
145.6 million
$73.5 million
09/21/2021
Tap to view 4 drugs
Drug Indication Stage News
ADXS-PSA and KEYTRUDA (pembrolizumab) - KEYNOTE-046 Castrate-resistant prostate cancer Phase 1/2 Phase 1 presentation at ASCO Genitourinary Cancers Symposium February 13, 2020 noted median overall survival (95% CI) of 33.7 months.
Axalimogene filolisbac - AIM2CERV Trial High-risk, locally advanced cervical cancer Phase 3 Phase 3 trial closed - noted June 27, 2019.
ADXS-503 Non-small cell lung cancer (NSCLC) Phase 1/2 Phase 1 Part B data presented at ASCO June 4, 2021. Abstract noted Disease Control Rate (DCR) was 44% (4/9).
ADXS-504 Prostate Cancer Phase 1 Phase 1 trial initiation announced July 15, 2021 with initial data due 1H 2022.
AERI Aerie Pharmaceuticals Inc.
$12.27
+0.68  +5.87%
47.2 million
$579.6 million
09/21/2021
Tap to view 6 drugs
Drug Indication Stage News
ROCLATAN (netarsudil/latanoprost ophthalmic solution) Glaucoma Approved FDA Approval announced March 12, 2019.
RHOPRESSA (netarsudil ophthalmic solution)) Glaucoma Approved Approved December 18, 2017.
AR-13503 Neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) Phase 1 Phase 1 dose escalation safety evaluation due 1Q 2022.
AR-1105 Macular edema due to RVO (retinal vein occlusion) Phase 2 Phase 2 top-line data July 27, 2020 noted treatment was well tolerated with no unexpected safety findings with sustained treatment effects.
ROCLATAN - (Mercury 3) Open Angle Glaucoma Phase 3 Phase 3 top-line data released September 24, 2020. Non-inferiority to Ganfort achieved.
AR-15512 (AVX-012) - COMET-1 Dry eye disease Phase 2b Phase 2b trial did not meet primary endpoints September 15, 2021. Phase 3 trial planned.
AEZS Aeterna Zentaris Inc.
$0.61
+0.02  +3.38%
121.3 million
$74.2 million
09/21/2021
Tap to view 3 drugs
Drug Indication Stage News
MACRILEN (Macimorelin Acetate) Adult Growth Deficiency Approved CRL issued November 2014. Approval announced following resubmission December 20, 2017.
Zoptrex Endometrial cancer Phase 3 Phase 3 trial did not meet primary endpoint - May 1, 2017.
MACRILEN (Macimorelin Acetate) - DETECT(Study P02) Paediatric patients with suspected growth hormone deficiency (GHD) Phase 3 Phase 3 trial initiation announced May 13, 2021. Trial to be completed 3Q 2022.
AFMD Affimed N.V.
$6.39
+0.09  +1.43%
119.7 million
$765.1 million
09/21/2021
Tap to view 7 drugs
Drug Indication Stage News
AFM13 with KEYTRUDA (pembrolizumab) Hodgkin Lymphoma - Cancer Phase 1b Phase 1b updated data at ICML June 22, 2019 noted ORR of 88% at highest dose, CR rates of 42%-46%.
AFM13 (REDIRECT) CD30-positive peripheral T cell lymphoma (PTCL) Phase 2 Phase 2 enrollment to be completed 1H 2022.
AFM24-101 EGFR-expressing solid tumors Phase 1/2 Phase 1/2a update on the dose escalation and initiation of the dose expansion cohorts due 2H 2021.
AFM13 + NK cells (AFM13-104) CD30-positive lymphomas Phase 1 Phase 1 early data released April 9, 2021 noted 100% response rate (2/4 partial responses and 2/4 complete responses). Trial is fully enrolled September 8, 2021. Data update expected 4Q 2021.
AFM13 T-Cell, Cutaneous Lymphoma Phase 1/2 Phase 1/2 data presented at ASH 2020. Objective Response Rate (ORR) of 42%(6/14).
AFM24-102 and TECENTRIQ (atezolizumab) EGFR Expressing Solid Tumors, Non-small cell lung cancer, and Gastric/gastroesophageal junction (GEJ) cancer Phase 1/2 Phase 1/2 trial planned for 2H 2021.
AFM24-103/SNK-01 EGFR-expressing tumors, Non-small cell lung cancer, and Squamous cell carcinoma of the head and neck Phase 1/2 Phase 1/2 trial planned for 2H 2021.
AGEN Agenus Inc.
$5.81
-0.01  -0.17%
233.1 million
$1.4 billion
09/21/2021
Tap to view 9 drugs
Drug Indication Stage News
Balstilimab (anti-PD-1) and Zalifrelimab - AGEN1884 (anti-CTLA-4) Cervical cancer Phase 2 Phase 2 data showed in 125 patients, the objective response rate (ORR) was 26%, with 9% of patients achieving a complete response (CR), and 17% of patients achieving a partial response (PR), noted September 17, 2021.
Zalifrelimab - AGEN1884 (anti-CTLA-4) Solid cancers Phase 1/2 Phase 3 expansion trial underway - noted August 6, 2020.
Balstilimab Cervical cancer PDUFA priority review PDUFA date under priority review December 16, 2021.
AGEN1181 and balstilimab (anti-CTLA-4) Various cancers Phase 1/2 Phase 1/2 data presented April 10, 2021, displayed 7 objective responses. Updated data due 2H 2021.
agenT-797 COVID-19 / Acute respiratory distress syndrome (ARDS) Phase 1/2 Phase 1 initial data released February 4, 2021. 3/4 patients were extubated and released after treatment. Phase 1/2 expansion trials underway.
MK-4830 Non-small cell lung cancer Phase 2 Phase 2 trial ongoing.
agenT-797 (iNKT) Multiple myeloma Phase 1 Phase 1 initiation of dosing announced April 14, 2021. Initial data due 4Q 2021.
AGEN2373 Solid tumors Phase 1 Phase 1 initial data presented at ASCO June 4, 2021. 5/22 patients showed stable disease.
AGEN1777 Solid tumors Phase 1 Phase 1 trial to be initiated 3Q 2021.
AGIO Agios Pharmaceuticals Inc.
$47.01
+0.9  +1.95%
59 million
$2.8 billion
09/21/2021
Tap to view 13 drugs
Drug Indication Stage News
Mitapivat (ENERGIZE ) Thalassemia Phase 3 Phase 3 trial to be initiated in 2021.
TIBSOVO (ivosidenib) IDH1m Relapsed/Refractory AML - cancer Approved FDA Approval announced July 20, 2018.
Mitapivat (AG-348) Pyruvate kinase deficiency PDUFA priority review PDUFA date under priority review February 17, 2022.
AG-120 and VIDAZA - AGILE Frontline Acute myeloid leukemia (AML) harboring an IDH1 mutation - cancer Phase 3 Phase 3 enrolment to be completed 2021.
IDHIFA (enasidenib) - AG-221 Advanced hematologic malignancies with an IDH2 mutation Approved Approval announced August 1, 2017.
TIBSOVO (ivosidenib) - (ClarIDHy) IDH1 mutant cholangiocarcinoma - cancer sNDA Filing sNDA filing announced March 1, 2021.
AG-270 Solid tumors Phase 1 Phase 1 enrolment has slowed due to COVID-19. A go/no-go decision is expected no later than 2022.
Vorasidenib (AG-881) Glioma Phase 3 Phase 3 enrolment has slowed as a result of COVID-19.
TIBSOVO (ivosidenib) Frontline AML with IDH1 mutation Approved FDA Approval announced May 2, 2019.
Vorasidenib (AG-881) IDHm low-grade glioma Phase 1 Phase 1 presentation at ASCO May 29, 2020. Median Progression-free Survival of 31.4 months.
Mitapivat (AG-348) - (ACTIVATE) Pyruvate Kinase Deficiency Phase 3 Phase 3 trial met primary endpoint - December 1, 2020. Data presented at EHA Virtual Congress, June 11, 2021. 40 percent (n=16) of patients randomized to mitapivat achieved a hemoglobin response, compared to 0 patients randomized to placebo (2-sided p<0.0001).
Mitapivat (AG-348) Sickle cell disease. Phase 2/3 Phase 2/3 trial to be initiated by end of 2021.
AG-946 Healthy volunteers Phase 1 Phase 1 data to be presented at ASH December 11-14, 2021.
AGLE Aeglea BioTherapeutics Inc.
$7.70
+0.09  +1.18%
49.1 million
$377.8 million
09/21/2021
Tap to view 2 drugs
Drug Indication Stage News
Pegzilarginase (AEB1102) - PEACE Arginase I deficiency Phase 3 Phase 3 data due 4Q 2021.
AGLE-177 Homocystinuria Phase 1/2 Phase 1/2 initiation of dosing announced June 24, 2021. Update by end of 2021.
AGRX Agile Therapeutics Inc.
$1.03
+0.02  +1.98%
93 million
$95.8 million
09/21/2021
Tap to view 1 drug
Drug Indication Stage News
TWIRLA Contraceptive patch Approved FDA Approval announced February 14, 2020.
AGTC Applied Genetic Technologies Corporation
$3.30
  +0.00%
42.8 million
$141.1 million
09/21/2021
Tap to view 3 drugs
Drug Indication Stage News
AAV Gene Therapy Achromatopsia Phase 1/2 Phase 1/2 12-month data presented June 24, 2021. Company noted at this time point consistent evidence not shown of biologic activity, patient-reported anecdotes continue to be encouraging.
rAAV-hRS1 X-linked retinoschisis (XLRS) Phase 1/2 Phase 1/2 interim data released December 12, 2018. No signs of clinical activity.
AGTC-501 X-linked Retinitis Pigmentosa (XLRP) Phase 1/2 Phase 1/2 12-month data due at the American Academy of Ophthalmology Annual Meeting in November 13-16, 2021; 3-month interim Skyline data due 4Q 2021. Phase 2/3 (VISTA) six-month interim analysis 4Q 2022.
AIM AIM ImmunoTech Inc.
$2.07
+0.09  +4.55%
39.7 million
$82.2 million
09/21/2021
Tap to view 6 drugs
Drug Indication Stage News
Ampligen CFS CRL CRL February 4, 2013.
Ampligen, Intron A, and celecoxib Colorectal cancer Phase 2 Phase 2 trial ongoing.
Ampligen, cisplatin and KEYTRUDA (pembrolizumab) Ovarian cancer Phase 2 Phase 2 trial is enrolling - noted August 2021.
Ampligen, Intron A Prostate Cancer Phase 2 Phase 2 trial has been initiated - noted August 2020.
Ampligen and interferon alpha-2b COVID-19 Phase 1/2 Phase 1/2a trial commencement of dosing announced November 25, 2020.
Ampligen human Rhinovirus hRV Phase 2a Phase 2a trial to commence 4Q 2021.
AKBA Akebia Therapeutics Inc.
$2.85
+0.05  +1.79%
174.5 million
$497.4 million
09/21/2021
Tap to view 4 drugs
Drug Indication Stage News
Auryxia Hyperphosphatemia Approved Approved Sept 5, 2014.
Vadadustat Anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis. PDUFA PDUFA date March 29, 2022.
Auryxia Iron deficiency anemia in non-dialysis dependent CKD patients Approved sNDA FDA Approval announced November 7, 2017.
Vadadustat COVID-19 Phase 3 Phase 3 initiation announced July 14, 2020.
AKRO Akero Therapeutics Inc.
$23.60
+0.36  +1.55%
34.9 million
$822.7 million
09/21/2021
Tap to view 2 drugs
Drug Indication Stage News
Efruxifermin Nonalcoholic steatohepatitis (NASH) Phase 2a Phase 2a Cohort C data announced March 22, 2021. 25% of EFX patients (3 of 12) showed NASH resolution. 4 of 12 patients (33%) achieved a one-stage improvement in fibrosis without worsening of NASH. Further data released at EASL meeting June 2021.
Efruxifermin (Harmony) Nonalcoholic Steatohepatitis Phase 2b Phase 2b initial data due 3Q 2022.
AKTX Akari Therapeutics Plc
$1.76
+0.02  +1.16%
47.6 million
$83.8 million
09/21/2021
Tap to view 5 drugs
Drug Indication Stage News
Nomacopan Paroxysmal nocturnal hemoglobinuria (PNH) Phase 3 Phase 3 interim data January 10, 2020 noted all patients achieved the primary endpoint of transfusion independence. Additional data from Phase 2 and 3 trials released December 11, 2020 - reduced transfusion dependence by 79% in the 14 formerly transfusion dependent patients.
Nomacopan Atopic keratoconjunctivitis Phase 1/2 Phase 1/2 trial saw patient numbers too small to show statistical significance on efficacy measures - December 11, 2020. Additional data to be collected.
Nomacopan Bullous Pemphigoid Phase 3 Phase 3 enrollment to commence 3Q 2021.
Nomacopan Hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) Phase 3 Phase 3 trial is enrolling.
Nomacopan COVID-19 Phase 2 Initiation of further COVID-19 randomized studies later in the year is subject to optimizing patient selection to align with the findings of a paper of the role of nomacopan in COVID-19 patients.
AKUS Akouos Inc.
$12.72
+0.43  +3.50%
34.5 million
$438.6 million
09/21/2021
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Drug Indication Stage News
AK-OTOF Hearing loss Phase 1/2 Phase 1/2 IND filing to be submitted 1H 2022.
ALBO Albireo Pharma Inc.
$31.59
+1.21  +3.98%
19.3 million
$608.3 million
09/21/2021
Tap to view 5 drugs
Drug Indication Stage News
BYLVAY (odevixibat) Progressive familial intrahepatic cholestasis (PFIC) Approved FDA approval announced July 20, 2021.
Elobixibat Nonalcoholic steatohepatitis (NASH) Phase 2 Phase 2 trial met primary endpoint. However, development in NASH will not continue - August 18, 2020.
BYLVAY (odevixibat) - (BOLD) Biliary atresia Phase 3 Phase 3 data due 2024.
BYLVAY (odevixibat) - (ASSERT) Alagille syndrome Phase 3 Phase 3 data due 2022.
A3907 Liver disease Phase 1 Phase 1 top-line data due 2H 2021.
ALDX Aldeyra Therapeutics Inc.
$7.94
-0.05  -0.63%
57.9 million
$459.4 million
09/21/2021
Tap to view 8 drugs
Drug Indication Stage News
Reproxalap (ADX-102) - (TRANQUILITY) Dry eye syndrome Phase 3 Phase 3 data due 4Q 2021.
Reproxalap (ADX-102) - (INVIGORATE) Allergic conjunctivitis Phase 3 Phase 3 trial met primary endpoint - April 27, 2021.
Reproxalap (ADX-102) Noninfectious anterior uveitis Phase 3 Phase 3 data did not meet endpoints - June 25, 2019.
Reproxalap (ADX-102) Sjögren-Larsson Syndrome (SLS) Phase 3 Development placed on hold - noted March 12, 2020.
Ganetespib (ADX-1612) Post-transplant lymphoproliferative disorder Phase 2 Development placed on hold - noted March 12, 2020.
ADX-2191 Proliferative vitreoretinopathy (PVR) Phase 3 Phase 3 (Part 1) completion of enrollment due 2021.
ADX-629 Psoriasis / atopic asthma / COVID-19 Phase 2 Phase 2 top-line data due by the end of 2021 or early-2022
Ganetespib (ADX-1612) Ovarian cancer Phase 2 Phase 2 trial ongoing.
ALEC Alector Inc.
$26.17
+0.4  +1.55%
80.9 million
$2.1 billion
09/21/2021
Tap to view 6 drugs
Drug Indication Stage News
AL001 (INFRONT-3) Frontotemporal Dementia Phase 3 Phase 3 commencement of dosing announced July 24, 2020.
AL002 (INVOKE-2) Alzheimer’s disease Phase 2 Phase 2 trial ongoing. Dosing commenced January 2021.
AL003 Alzheimer’s disease Phase 1 Phase 1b data due 2H 2021.
AL101 Healthy volunteers Phase 1a Phase 1a data due in 2021 / 2022.
AL001 (INFRONT-2) Frontotemporal Dementia Phase 2 Phase 2 open-label data presented at AAIC meeting July 29 2021 - slowed clinical progression by 47%.
AL001 Amyotrophic lateral sclerosis (ALS) Phase 2 Phase 2 trial initiated dosing, September 9, 2021.
ALGS Aligos Therapeutics Inc.
$15.50
+0.2  +1.31%
42.6 million
$660.4 million
09/21/2021
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Drug Indication Stage News
ALG-010133 Hepatitis B Phase 1 Phase 1 data from the three cohorts are due 1H 2022.
ALG-000184 Hepatitis B Phase 1 Phase 1 safety and antiviral data from the initial cohort(s) expected in 2H 2021.
ALG-020572 Hepatitis B Phase 1 Phase 1 trial to commence 4Q 2021.
ALG-055009 Nonalcoholic steatohepatitis (NASH) Phase 1 Phase 1 trial to commence 4Q 2021.
ALIM Alimera Sciences Inc.
$4.78
+0.19  +4.14%
6.9 million
$33.1 million
09/21/2021
Tap to view 1 drug
Drug Indication Stage News
Iluvien Diabetic macular edema Approved CRL Nov 2011. Second CRL Oct 17 2013. Approved Sept 26 2014
ALKS Alkermes plc
$30.29
+0.67  +2.26%
161.3 million
$4.9 billion
09/21/2021
Tap to view 10 drugs
Drug Indication Stage News
ARISTADA INITIO(aripiprazole lauroxil) Schizophrenia Approved FDA approval announced July 2, 2018.
LYBALVI (olanzapine/samidorphan) Schizophrenia, bipolar Approved FDA approval announced June 1, 2021.
ARISTADA (aripiprazole lauroxil) Schizophrenia Approved Approved October 5 2015. sNDA filed for 2-month option with approval announced June 6, 2017.
VUMERITY (Diroximel fumarate) Multiple sclerosis (MS) Approved FDA Approval announced October 30, 2019.
ALKS 5461 Major depressive disorder CRL CRL announced February 1, 2019.
Nemvaleukin (ALKS 4230) - ARTISTRY-1 Solid tumors Phase 1 Phase 1/2 data presented at ASCO June 4, 2021. 2/6 patients in melanoma monotherapy cohort showed partial responses.
Diroximel fumarate (BIIB098) - Head-to-head trial versus Tecfidera - Relapsing Remitting Multiple Sclerosis (RRMS) Phase 3 Phase 3 top-line data met primary endpoint - July 30, 2019.
Nemvaleukin (ALKS 4230) - (ARTISTRY-3) Solid Tumors Phase 3 Phase 2 trial initiation announced August 18, 2020.
Nemvaleukin (ALKS 4230) Ovarian cancer Phase 3 Phase 3 trial to commence 2H 2021.
Nemvaleukin (ALKS 4230) - (ARTISTRY-6) Melanoma Phase 2 Phase 2 trial initiation announced April 27, 2021. Phase 2 trial is ongoing.
ALLK Allakos Inc.
$108.00
+1.97  +1.86%
54 million
$5.8 billion
09/21/2021
Tap to view 5 drugs
Drug Indication Stage News
AK002 Severe Allergic Conjunctivitis Phase 1b Phase 1b presentation at ASCRS May 16, 2020.
Lirentelimab (ENIGMA 2) Eosinophilic Gastritis and/or eosinophilic duodenitis (EoD) Phase 3 Phase 3 top-line data due 4Q 2021.
Lirentelimab (KRYPTOS) Eosinophilic esophagitis Phase 2/3 Phase 2/3 top-line data due 4Q 2021.
Lirentelimab (subcutaneous) Eosinophilic gastritis (EG) / eosinophilic duodenitis (EoD) Phase 2/3 Phase 2/3 trial to be initiated 2H 2021.
Lirentelimab Non-eosinophilic gastrointestinal disease Phase 2 Phase 3 trial to be initiated 2H 2021.
ALLO Allogene Therapeutics Inc.
$25.32
+0.44  +1.77%
142.2 million
$3.6 billion
09/21/2021
Tap to view 8 drugs
Drug Indication Stage News
UCART19 (PALL) Acute lymphoblastic leukemia (ALL) Phase 1 Phase 1 trial ongoing.
UCART19 - CALM Refractory B-cell Acute Lymphoblastic Leukaemia Phase 1 Phase 1 trial ongoing.
ALLO-715 - UNIVERSAL Multiple myeloma Phase 1/2 Phase 1/2 updated data due 4Q 2021.
ALLO-501 - ALPHA Non-Hodgkin lymphoma (NHL) Phase 1 Phase 1 data at ASCO June 4, 2021. Overall Response Rate (ORR) of 75% and CR Rate of 50% across histologies in CAR T Naïve patients. Further data due late-2021.
ALLO-501A (ALPHA2) Large B-cell lymphoma Phase 1 Phase 1 data at ASCO June 4, 2021 noted overall response rate 56% (5/9). Pivotal trial to be initiated late-2021.
ALLO-316 - TRAVERSE Clear cell renal cell carcinoma (ccRCC) Phase 1 Phase 1 initial data due 2022.
AUTO8 Multiple Myeloma Phase 1 Phase 1 trial to commence mid-2021.
ALLO-605 (IGNITE) Multiple Myeloma Phase 1 Phase 1 trial to commence mid-2021.
ALNA Allena Pharmaceuticals Inc.
$0.90
  +-0.53%
80.1 million
$72.1 million
09/21/2021
Tap to view 4 drugs
Drug Indication Stage News
Reloxaliase ALLN-177 (URIROX-1) Enteric Hyperoxaluria Phase 3 Phase 3 trial met primary endpoint, key secondary endpoint missed - November 7, 2019.
Reloxaliase ALLN-177 (Study 206) Primary hyperoxaluria Phase 2 Phase 2 presentation at ASN November 8, 2019.
Reloxaliase (ALLN-177) - (URIROX-2) Enteric Hyperoxaluria Phase 3 Phase 3 interim analysis due 1Q 2022.
ALLN-346 Hyperuricemia Phase 2a Phase 1b initial data due 4Q 2021.
ALNY Alnylam Pharmaceuticals Inc.
$184.15
+0.69  +0.38%
118.8 million
$21.9 billion
09/21/2021
Tap to view 15 drugs
Drug Indication Stage News
GIVLAARI (givosiran) Acute hepatic porphyrias Approved FDA approval announced November 20, 2019.
Inclisiran Hypercholesterolemia PDUFA CRL received December 18, 2020. NDA refiled with new PDUFA date of January 1, 2022.
VIR-2218 with pegylated interferon-alpha Chronic hepatitis B virus (HBV) Phase 2 Phase 2 initial data presented at EASL meeting June 2021. Further data due 2H 2021.
OXLUMO (lumasiran) Primary Hyperoxaluria Type 1 (PH1) Approved FDA approval announced November 24, 2020.
ONPATTRO (patisiran) Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR Approved FDA Approval announced August 10, 2018.
Fitusiran (ATLAS) Hemophilia A/B Phase 3 Phase 3 top-line data due early-2022.
Vutrisiran ATTR amyloidosis PDUFA PDUFA date April 14, 2022.
ALN-AAT02 alpha-1 anti-trypsin deficiency-associated liver disease Phase 1/2 Phase 1/2 initial data released.
OXLUMO (lumasiran) - ILLUMINATE-B Primary Hyperoxaluria Type 1 Phase 3 Phase 3 top-line released September 30, 2020.
ONPATTRO (patisiran) - APOLLO-B Wild-type ATTR amyloidosis patients with cardiomyopathy Phase 3 Phase 3 completion of enrollment announced June 1, 2021. Top-line data due mid-2022.
OXLUMO (lumasiran) - ILLUMINATE-C Impaired renal function Phase 3 Phase 3 top-line data released July 29, 2021.
Vutrisiran - HELIOS-B ATTR amyloidosis with cardiomyopathy Phase 3 Phase 3 completion of enrollment announced August 9, 2021. Top-line data due early-2024.
VIR-2218 with pegylated interferon-alpha (PEG-IFN-α) Hepatitis B Phase 2 Phase 2 initial data released June 25, 2021. Of the 12 participants who received the 100 mg or 200 mg dose, four participants experienced sustained HBsAg reductions of >1 log10 IU/mL and absolute HBsAg levels below 100 IU/mL through Week 48.
Zilebesiran (ALN-AGT) - KARDIA-1 Hypertension Phase 2 Phase 2 initiation announced June 30, 2021.
Vutrisiran (HELIOS-A) ATTR Amyloidosis Phase 3 Positive results from subgroup analyses and exploratory endpoints compared with placebo at 9-month period. September 7, 2021
ALPN Alpine Immune Sciences Inc.
$9.80
+0.21  +2.19%
23.9 million
$234.4 million
09/21/2021
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Drug Indication Stage News
N91115 Cystic Fibrosis - one copy of the F508del mutation and a second mutation that results in a gating defect in the CFTR protein Phase 2 Phase 2 data released February 24, 2017 - primary endpoint not met.
ALPN-202 (NEON-1) Advanced Malignancies Phase 1 Phase 1 data presented at ASCO June 4, 2021. 61% (14 of 23) showed clinical benefit (stable disease or better).
ALPN-101 Graft Vs Host Disease Phase 1/2 Phase 1b/2 trial is open for enrolment - noted March 30, 2020.
ALPN-101 Systemic Lupus Erythematosus (SLE Phase 2 Phase 2 initiation of dosing announced June 24, 2021.
ALPN-202 KEYTRUDA (pembrolizumab) - NEON-2 Solid Tumors Phase 1 Phase 1 dosing has commenced - June 30, 2021.
ALRN Aileron Therapeutics Inc.
$1.07
-0.02  -1.83%
90.6 million
$96.9 million
09/21/2021
Tap to view 3 drugs
Drug Indication Stage News
ALRN-6924 Small Cell Lung Cancer (SCLC) Phase 1b Phase 1b final data showed a reduction of neutropenia, thrombocytopenia and anemia caused by chemotherapy, as well as a reduction of platelet and red blood cell transfusions, as compared to historical controls, noted September 16, 2021
ALRN-6924 Non-small cell lung cancer Phase 1b Phase 1b initiation announced July 1, 2021 with initial results due 4Q 2021 and full results mid-2022.
ALRN-6924 Healthy volunteers Phase 1 Phase 1 preliminary data showed a 0.3 mg/kg dose demonstrated favorable tolerability, with subjects experiencing only mild, transient adverse events, noted September 16, 2021
ALT Altimmune Inc.
$15.04
+0.47  +3.23%
39.7 million
$597.2 million
09/21/2021
Tap to view 6 drugs
Drug Indication Stage News
HepTCell Hepatitis B Phase 2 Phase 2 commencement of enrollment announced December 30, 2020. Data due 1H 2022.
NasoVAX Flu vaccine Phase 2 Phase 2 additional data released March 19, 2019 noted all patients remained seroprotected.
NASOSHIELD Anthrax Phase 1b Phase 1b data released April 1, 2021.
ALT-801 Non-alcoholic steatohepatitis (NASH) - Healthy Overweight and Obese Volunteers Phase 1 Phase 1 6-week MAD released June 16, 2021. Weight loss of 5.4% achieved at 6 weeks of treatment with 1.8 mg once weekly dose. 12-week data due September 2021. Phase 2 obesity and NASH trials expected to initiate in Q1 2022.
AdCOVID COVID-19 vaccine Phase 1 Phase 1 data released June 29, 2021 did not stimulate an adequate immune response. Development to be discontinued.
T-COVID COVID-19 Phase 1/2 Phase 1/2 enrollment to be terminated - June 29, 2021.
ALVR AlloVir Inc.
$23.48
+0.5  +2.18%
62.7 million
$1.5 billion
09/21/2021
Tap to view 5 drugs
Drug Indication Stage News
Viralym-M (ALVR105) Multi-virus prevention trial (following allo-HSCT) Phase 2 Phase 2 interim data due 4Q 2021.
ALVR109 COVID-19 Phase 1/2 Phase 1/2 trial is ongoing. However, no role seen to treat a broad patient population.
Viralym-M (ALVR105) BK viremia Phase 2 Phase 2 interim data due 4Q 2021.
Viralym-M (ALVR105) Virus-associated hemorrhagic cystitis Phase 3 Phase 3 trial has been initiated.
ALVR106 RSV, influenza Phase 1 Phase 1 trial to commence 2H 2021.
ALXO ALX Oncology Holdings Inc.
$76.00
+1.72  +2.32%
40.3 million
$3.1 billion
09/21/2021
Tap to view 7 drugs
Drug Indication Stage News
ALX148 and Vidaza (azacitidine) - (ASPEN-02) Myelodysplastic syndromes (MDS) Phase 1 Phase 1 final data and Phase 2 initiation due 4Q 2021.
ALX148 and KEYTRUDA (pembrolizumab) - (ASPEN-03) Head and neck squamous cell carcinoma (HNSCC) Phase 2 Phase 2 partial hold lifted - June 14, 2021.
ALX148 and HERCEPTIN (Trastuzumab) - (ASPEN-01) Solid Tumors and Lymphoma Phase 1 Phase 1 data presented at ESMO 23rd World Congress on Gastrointestinal Cancer, July 3, 2021 - objective response rate (ORR) of 72% and estimated overall survival (OS) at 12 months of 76%. Final data due 4Q 2021.
ALX148 in combination with VIDAZA (azacitidine) and VENCLEXTA (venetoclax) - (ASPEN-05) Acute myeloid leukemia (AML) Phase 1 Phase 1 trial to be initiated 2H 2021.
ALX148 + HERCEPTIN (Trastuzumab) + CYRAMZA (ramucirumab) and TAXOL (paclitaxel) - (ASPEN-06) 2nd line or greater gastric/gastroesophageal junction cancer Phase 2 Phase 2 trial to be initiated 2H 2021.
ALX148 and KEYTRUDA (pembrolizumab) - ASPEN-04 Head and Neck Squamous Cell Carcinoma Phase 2 Phase 2 initiation of dosing announced July 28, 2021.
ALX148 (evorpacept) + rituximab and lenalidomide non-Hodgkin lymphoma (NHL) Phase 1/2 Phase 1/2 trial commencement September 16, 2021
ALZN Alzamend Neuro Inc.
$2.34
-0.03  -1.27%
86.9 million
$203.3 million
09/21/2021
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Drug Indication Stage News
AL001 Alzheimer’s disease Phase 1 Phase 1 dosing initiated September 13, 2021.
AMAM Ambrx Biopharma Inc. American Depositary Shares (each representing seven)
$14.91
+0.91  +6.50%
37.7 million
$561.7 million
09/21/2021
Tap to view 4 drugs
Drug Indication Stage News
ARX788 (ACE-Breast-02) HER2-positive metastatic breast cancer Phase 2 Phase 2 trial ongoing in China. Top-line data due by end of 2022.
ARX517 (APEX-01) PSMA Expressing Tumors Phase 1 Phase 1 commencement of dosing announced August 3, 2021.
ARX788 (ACE-Breast-03) Breast cancer Phase 2 Phase 2 trial to commence 2H 2022.
ARX788 (ACE-Gastric-02) Gastric cancer Phase 2 Phase 2 trial to commence dosing 2H 2022.
AMGN Amgen Inc.
$215.36
+0.25  +0.12%
567.9 million
$122.3 billion
09/21/2021
Tap to view 49 drugs
Drug Indication Stage News
Bemarituzumab (FPA144) + chemo (FIGHT) Gastric and gastro-esophageal junction cancer Phase 2 Phase 2 data presented at ASCO June 4, 2021. Median OS of 19.2 months versus 13.5 months for chemotherapy alone. Phase 3 trial planned for 4Q 2021.
Tezepelumab Asthma PDUFA priority review PDUFA date under priority review estimated around January 8, 2022.
Prolia (denosumab) Glucocorticoid-induced osteoporosis (GIOP) Approved Approval announced May 21, 2018.
KYPROLIS (ASPIRE) Relapsed Multiple Myeloma Approved sNDA approval announced June 11, 2018.
Vectibix (Panitumumab) Wild-Type RAS Metastatic Colorectal Cancer Approved sBLA approval announced June 29, 2017.
MVASITM (bevacizumab-awwb) Biosimilar candidate to Avastin (bevacizumab) Approved Approved September 14, 2017.
CORLANOR (ivabradine) Chronic Heart Failure Approved Approved April 15, 2015.
AIMOVIG (Erenumab) Migraine Approved Approval announced May 17, 2018.
OTEZLA Scalp Psoriasis Approved FDA approval announced April 2020.
OTEZLA - PSA-006 Psoriatic Arthritis Phase 3 Phase 3 - primary endpoint met.
OTEZLA Behçet’s Disease Approved FDA Approval announced July 19, 2019.
REPATHA (evolocumab) Cardiovascular disease Approved Approval announced December 1, 2017.
XGEVA Multiple Myeloma Approved sBLA approval announced January 5, 2017.
KYPROLIS (ARROW) Multiple Myeloma Approved FDA approval announced October 1, 2018.
KYPROLIS (ENDEAVOR) Relapsed Multiple Myeloma Approved sNDA approved January 17, 2018.
BLINCYTO Ph+ R/R ALL Approved PDUFA date under priority review August 14, 2017. Approval announced July 11, 2017.
RIABNI (rituximab-arrx) RITUXAN biosimilar - non-Hodgkin lymphoma Approved FDA approval announced December 17, 2020.
ABP 980 (Kanjinti; trastuzumab-anns) Herceptin biosimilar Approved FDA approval announced June 13, 2019.
ABP 710 REMICADE biosimilar - rheumatoid arthritis Approved FDA Approval announced December 6, 2019.
Parsabiv Secondary hyperparathyroidism (SHPT) Approved Approved February 7, 2017.
EVENITY (Romosozumab) Osteoporosis Approved FDA Approval announced April 9, 2019.
Omecamtiv mecarbil GALACTIC-HF Acute heart failure Phase 3 Phase 3 trial data showed treatment in black patients is consistent with the overall population and white patients. Among black patients, treatment resulted in a trend towards reduction in the primary endpoint by 18%, corresponding to a reduction in the primary event rate of 7.7/100 patient-years with a number-needed-to-treat of 13 patients noted September 12, 2021.
Omecamtiv mecarbil METEORIC-HF Acute heart failure Phase 3 Phase 3 completion of enrollment announced June 15, 2021 with data due in early-2022.
FPT155 Solid tumors Phase 1 Phase 1 second cohort is open for enrollment.
NPLATE (Romiplostim) Immune Thrombocytopenia (Pediatric) Approved FDA approval announced December 14, 2018.
NPLATE (Romiplostim) Immune thrombocytopenia (ITP) Approved FDA Approval announced October 18, 2019.
AMG 714 / PRV-015 Celiac disease Phase 2b Phase 2b top-line data due 2022.
OTEZLA Plaque psoriasis PDUFA PDUFA date December 19, 2021. Additional Phase 3 data to be released September 29, 2021.
LUMAKRAS (Sotorasib) + Vectibix (panitumumab) - CodeBreak 101 KRAS G12C-mutated solid tumors Phase 3 Phase 1/2 data showed objective response rate (ORR) was 27% among 26 patients. The disease control rate (DCR) was 81%. In the expansion cohort of sotorasib-naïve patients with refractory CRC (18), 33% of patients experienced a response, noted September 16, 2021. Initated Phase 3 trial with Vectiblix September 16, 2021.
CNP520 Alzheimer’s Disease Phase 2/3 Phase 2/3 trial discontinued due to lack of efficacy.
BLINCYTO Acute lymphoblastic leukemia (ALL) - pediatric Phase 3 Phase 3 enrolment terminated due to treatment benefit over chemo. Primary endpoint of event-free survival met.
Rozibafusp alfa (AMG 570) Systemic Lupus Erythematosus (SLE) Phase 2 Phase 2 trial is enrolling.
Tezepelumab Chronic obstructive pulmonary disease (COPD) Phase 2 Phase 2 trial is enrolling.
LUMAKRAS (Sotorasib) Non-small cell lung cancer (NSCLC) Approved FDA approval announced May 28, 2021.
LUMAKRAS (Sotorasib) - CodeBreaK 200 Non-small cell lung cancer (NSCLC) Phase 3 Phase 3 data due 1H 2022.
Olpasiran (AMG 890) Cardiovascular disease / Elevated Lipoprotein Phase 2