Biotech and pharmaceutical companies generally are involved in the lengthy process of getting their drug candidates to market through clinical trials. The amount of risk involved ranges from fair to great, should a study come back negative or a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be massive upside.
In simpler terms, these updates within the industry have the potential to make or break biopharma companies.
Here, 24/7 Wall St. has included a calendar of some of the biggest companies expecting clinical trial and U.S. Food and Drug Administration (FDA) updates in February and March.
It’s worth mentioning that these dates may be subject to change due to various internal and outside factors. Some of these changes are positive developments and some can be disasters if a company is deeply financed.
As a side note about the Prescription Drug User Fee Act (PDUFA): a Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
Bausch Health Companies Inc. (NYSE: BHC) has a PDUFA date scheduled for February 15 for its resubmitted New Drug Application (NDA) for Duobrii (halobetasol propionate and tazarotene) (IDP-118) lotion for the topical treatment of plaque psoriasis. If approved, Duobrii will be the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation for the treatment of plaque psoriasis in adult patients, allowing for a potentially expanded duration of use.
Aimmune Therapeutics Inc. (NASDAQ: AIMT) will present data on its Phase 3 study of AR101 for the treatment of peanut allergy at the 2019 American Academy of Asthma, Allergy and Immunology annual meeting, taking place February 22 to 25 in San Francisco. Specifically, this data will come out on the morning of February 24.
Rexahn Pharmaceuticals Inc. (NYSE: RNN) will present updated preliminary data from the Phase 2a trial of RX-3117 in advanced bladder cancer at the 2019 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium being held February 14 to 16 in San Francisco.
Sanofi (NASDAQ: SNY) has a PDUFA date scheduled for March 22 for Zynquista (sotagliflozin). This comes after the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted eight to eight on the question of whether the overall benefits of Zynquista outweighed the risks to support approval back in January. Sotagliflozin is an investigational oral dual SGLT1 and SGLT2 inhibitor under regulatory review as an adjunct to insulin for the treatment of adults with type 1 diabetes. Note that while the FDA is not required to follow the committee’s vote, the agency considers the committee’s recommendations when making its decision.
Axovant Sciences Ltd. (NASDAQ: AXON) is expecting data from its Sunrise-PD Phase 2 trial of AXO-Lenti-PD for Parkinson’s disease to be revealed in March. The patients in this trial were dosed with AXO-AAV-GM2.
Urovant Sciences Ltd. (NASDAQ: UROV) previously announced that it completed enrollment in its international Phase 3 clinical trial, Empowur, evaluating the safety and efficacy of vibegron as a treatment for adults with symptoms of overactive bladder back in November. The firm is expecting top-line efficacy and safety data from this Phase 3 trial by the end of March.
Axsome Therapeutics Inc. (NASDAQ: AXSM) is evaluating AXS-05 in its Stride-1 Phase 3 trial in treatment-resistant depression. Top-line results are expected by the end of March. Axsome previously received an FDA Fast Track designation for AXS-05.
Celldex Therapeutics Inc. (NASDAQ: CLDX) is expecting to reveal data from its Phase 2 study of CDX-3379 in advanced head and neck squamous cell cancer at some point in the first quarter of 2019. According to the study’s Simon two-stage design, if at least one patient achieves an objective response in the first stage, enrollment may progress to the second stage. While a confirmed partial response has been documented, Celldex will wait to review the full data set before making decisions on future development, as a number of patients are still undergoing treatment and are not yet eligible for response evaluation.
AstraZeneca PLC (NYSE: AZN) previously announced top-line results from its Tulip 1 Phase 3 trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus back in August 2018. Unfortunately, the trial did not meet the primary endpoint. However, data from the Tulip 2 Phase 3 trial (different dosing level) are expected to come out in the first quarter of 2019.