In addition to clinical trial data, there are also 20 biotech companies reporting earnings next week.
Below is a list of biotechnology companies that report earnings next week followed by companies with upcoming clinical trial data releases.
Biotech Stocks With Earnings Reports Next Week
Biotech Companies With Upcoming Clinical Trial Releases
DUR-928 for alcoholic hepatitis (AH). Phase 2 preliminary data is due May 7, 2019.
|Conference Call and Webcast with Slides|
|Wednesday, May 8th at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time|
A live audio webcast and data slide presentation will be available by accessing DURECT’s homepage at www.durect.com and clicking “Investors.” If you are unable to participate during the live webcast, the call and slide presentation will be archived on DURECT’s website under “Event Calendar – Past Events” in the “Investors” section.
During the webcast and conference call, DURECT management will provide a corporate business update, including a presentation of preliminary data from the ongoing Phase 2a open label, dose escalation, multi-center U.S. clinical trial investigating DUR-928 administered intravenously in patients with moderate and severe AH. The objectives of this study include assessment of safety, PK and pharmacodynamic signals, including liver biochemistry and biomarkers.
Back on February 7, 2019, Incyte announced that the FDA has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids. The new Prescription Drug User Fee Act (PDUFA) target action date is May 24, 2019.
The FDA extended the action date to allow time to review additional data submitted by Incyte in response to the FDA’s information requests. The submission of the additional information has been determined by the FDA to constitute a Major Amendment to the sNDA, resulting in an extension of the PDUFA goal date by three months.
“We remain confident in the data supporting our sNDA submission and look forward to continued dialogue with the FDA throughout the review process,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “We are committed to bringing ruxolitinib forward as a treatment option for patients with acute GVHD.”
The sNDA for ruxolitinib for the treatment of patients with acute GVHD was submitted in August 2018, and the FDA granted both Priority Review and Breakthrough Therapy Designation. The FDA grants Priority Review to medicines that have the potential to provide significant improvements in the treatment of a serious disease. The FDA’s Breakthrough Therapy Designation is designed to expedite the development and review of drugs for serious conditions that have shown encouraging early clinical results and may demonstrate substantial improvements over available medicines. Additionally, the FDA granted ruxolitinib Orphan Drug Designation for the treatment of GVHD, a designation granted to investigational compounds intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people.
GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor), where the donated cells initiate an immune response and attack the transplant recipients organs, leading to significant morbidity and mortality. There are two forms of GVHD, acute and chronic, which can affect multiple organ systems including the skin, gastrointestinal (digestive) tract and liver.
Inclisiran – ORION 3 for cardiovascular disease (ASCVD). Phase 2 open-label data to be presented at National Lipid Association Scientific Sessions on May 18, 2019.
The Medicines Company will present interim results on long-term safety and efficacy of inclisiran from the ongoing ORION-3 study during a late-breaking clinical trial session at the National Lipid Association Scientific Sessions in Miami, Florida on May 18, 2019.
ORION-3 is an open-label Phase 2, extension study (of ORION-1) to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran. The study also evaluates safety and efficacy of switching patients treated with evolocumab to inclisiran. Follow up for this latter group is still ongoing and will be presented at a later date.
Inclisiran is a small interfering RNA (siRNA) therapy being studied to evaluate its ability to lower low-density lipoprotein (LDL) cholesterol – also known as LDL-C or bad cholesterol. Inclisiran is designed to prevent the production of proprotein convertase subtilisin/kexin type 9 (PCSK9) at its source in the liver. Inclisiran is not yet approved for use by the FDA or any other regulatory authority. The Medicines Company obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals.
In the US alone, 67.5 million individuals are estimated to have sufficient cardiovascular risk to warrant lipid-lowering therapy. Approximately 27.5 million of these individuals are at a significantly elevated risk, either because of confirmed cardiovascular disease or LDL-C levels above 190 mg/dl. Of this higher-risk group, 15.1 million people are currently treated with lipid-lowering therapies, but only one out of five (or 2.4 million) is successfully reaching LDL-C targets with current therapies. This implies a population of at least 12.7 million Americans who could benefit from inclisiran, the first cholesterol-lowering siRNA with the potential to deliver potent, durable and consistent lowering of LDL-C levels via twice-a-year dosing.
RG7916 – FIREFISH for Spinal Muscular Atrophy (SMA) Type 1. Phase 2/3 data to be presented at AAN May 7, 2019. Source: https://www.roche.com/dam/jcr:f03df0f2-852c-47a5-9924-343bfb239c37/en/irp190417.pdf
Vicinium for non-muscle invasive bladder cancer (NMIBC). Phase 3 updated, preliminary data due May 13, 2019.
Back on April 29, 2019, Sesen Bio announced that Company management will host a conference call and webcast on Monday, May 13, 2019 at 8:00 a.m. EDT to review operating results for the first quarter ended March 31, 2019 and updated, preliminary primary and new secondary endpoint data from the Phase 3 VISTA trial of Vicinium® for patients with high-risk non-muscle invasive bladder cancer who have been previously treated with bacillus Calmette-Guérin.
To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 7176228. The webcast can be accessed in the Investor Relations section of the Company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the Company’s website at www.sesenbio.com for 60 days following the call.