Phase 3 Trial

Biohaven Pharmaceutical Holding Company Ltd (NYSE: BHVN) and Pfizer Inc (NYSE: PFE) reported topline results from an Asia-Pacific, Phase 3 trial of rimegepant in adults for the acute treatment of migraine.  The study met its co-primary endpoints of freedom from pain...

Scynexis Inc (NASDAQ: SCYX) has announced results from its Phase 3 CANDLE study of oral ibrexafungerp to prevent recurrent vulvovaginal candidiasis (rVVC), also known as vaginal yeast infection.  The Company plans to submit a supplemental marketing application to prevent rVVC in 1H of...

Alkermes plc's (NASDAQ: ALKS) ENLIGHTEN-Early Phase 3b study of Lybalvi (olanzapine & samidorphan) met its prespecified primary endpoint on body weight in young schizophrenia adult patients in the early stage of the disease.  Patients treated with Lybalvi experienced...

Cingulate Inc (NASDAQ: CING) plans to initiate Phase 3 studies for CTx-1301 for Attention Deficit/Hyperactivity Disorder (ADHD) in 2022. ADHD is a chronic neurobiological and developmental disorder. The planned studies include a fixed-dose pediatric & adolescent safety and...

Vanda Pharmaceuticals Inc (NASDAQ: VNDA) shares are plunging after the company announced Phase 3 trial data of tradipitant in treating the symptoms of gastroparesis.  Gastroparesis is a condition that reduces the ability of the stomach to empty its contents. It does not involve a...

Anavex Life Sciences Corp (NASDAQ: AVXL) reported topline data from the Phase 3 AVATAR trial of ANAVEX2-73 (blarcamesine) in adult female patients with Rett syndrome. The data demonstrated a statistically significant improvement over placebo for the primary efficacy endpoint and all the...

Valneva SE (NASDAQ: VALN) has initiated a Phase 3 trial in adolescents for its single-shot chikungunya vaccine candidate, VLA1553. The collaboration falls within the framework of the agreement signed between Coalition for Epidemic Preparedness Innovations and Valneva in July 2019,...

Madrigal Pharmaceuticals Inc (NASDAQ: MDGL) has announced topline data from Phase 3 MAESTRO-NAFLD-1 safety study of resmetirom.  The 52-week study demonstrated that resmetirom was safe and well-tolerated at 80 and 100 mg once a day dosing.  Additionally, resmetirom helped...

TYME Technologies Inc (NASDAQ: TYME) will discontinue SM-88 with MPS in the Precision Promise trial in metastatic pancreatic cancer (mPDAC). The trial's sponsor, Pancreatic Cancer Action Network (PanCAN), terminated the arm due to futility compared to the control of the standard...

Annovis Bio Inc (NYSE: ANVS) has completed a Type B meeting with the FDA regarding its planned Phase 3 studies of Buntanetap for the treatment of Parkinson's Disease (PD) as an offshoot of the Company's clinical program in Alzheimer's Disease (AD). Following the Company...

Achieve Life Sciences Inc (NASDAQ: ACHV) has initiated the screening in the ORCA-3 Phase 3 trial of cytisinicline for smoking cessation. The trial will evaluate the efficacy and safety of 3 mg cytisinicline dosed three times daily compared to placebo in 750 adult smokers. ORCA-3...

Sierra Oncology Inc (NASDAQ: SRRA) unveiled topline data for momelotinib in myelofibrosis patients who are symptomatic, anemic, and previously treated with an FDA-approved JAK inhibitor. With the new data in hand, Sierra now plans to submit a marketing application in Q2 FY22. In the...

Lyra Therapeutics Inc (NASDAQ: LYRA) has initiated its Phase 3 ENLIGHTEN I trial of LYR-210 in adult, surgically naïve chronic rhinosinusitis (CRS) patients. LYR-210 is designed to be administered in a brief, non-invasive, in-office procedure and deliver up to six months of...

SAB Biotherapeutics Inc (NASDAQ: SABS) has reported positive Phase 2 safety and efficacy data demonstrating that SAB-185 met the criteria required to move to Phase 3 in the National Institutes of Health (NIH) COVID-19 ACTIV-2 Trial. SAB-185 is a fully human, specifically targeted,...

The FDA has approved Gilead Sciences Inc's (NASDAQ: GILD) Veklury (remdesivir) for non-hospitalized adult and adolescent patients at high risk of progression to severe COVID-19.  This approval expands the role of Veklury, which is the antiviral standard of care for treating...