BMY Awaits FDA Decision, LQDA On Watch, MNOV To Begin Clinical Trial In COVID-19

Today’s Daily Dose brings you news about Bristol Myers’ regulatory catalyst; Liquidia’s pulmonary arterial hypertension drug candidate; Moleculin Biotech joining the bandwagon of COVID-19 drug development; MediciNova initiating a clinical trial of MN-166 for acute respiratory distress syndrome (ARDS) caused by COVID-19 and FDA approval of Pfizer’s BRAFTOVI for yet another indication.

Read on…

Bristol Myers Squibb’s (BMY) supplemental Biologics License Application for Opdivo plus Yervoy, administered concomitantly with a limited course of chemotherapy, for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer is under priority review by the FDA – with a decision date set for August 6, 2020.

The Opdivo/Yervoy combo plus limited chemotherapy for the same indication is being reviewed by the European Medicines Agency also.

BMY closed Wednesday’s trading at $58.25, up 2.37%.

Liquidia Technologies Inc.’s (LQDA) New Drug Application seeking marketing approval for LIQ861 for the treatment of pulmonary arterial hypertension has been accepted for FDA review, with a decision expected on November 24, 2020.

LIQ861 is an investigational, inhaled dry powder formulation of Treprostinil designed using Liquidia’s novel PRINT technology and engineered with the goal of enhancing deep-lung delivery of Treprostinil in pulmonary arterial hypertension patients by means of a convenient, palm-sized dry powder inhaler.

Treprostinil is marketed under the trade names Remodulin for infusion, Orenitram for oral, and Tyvaso for inhalation by United Therapeutics Corp. (UTHR) for the treatment of pulmonary arterial hypertension.

In 2019, Remodulin generated annual sales of $587 million; Tyvaso $415.6 million and Orenitram had sales of $225.3 million.

The NDA for LIQ861 was submitted under the 505(b)(2) regulatory pathway.

LQDA closed Wednesday’s trading at $5.76, up 17.07%.

Shares of Moleculin Biotech Inc. (MBRX) jumped over 125 percent on Wednesday, following research findings that 2-deoxy-D-glucose reduces replication of SARS-CoV-2, the virus that causes COVID-19, by 100% in ‘in vitro’ testing.

The active compound in Moleculin’s drug candidate, WP1122, is also 2-deoxy-D-glucose.

Moleculin’s Chief Medical Officer – New Projects, Sandra Silberman noted, “The FDA has cleared the way for very rapid development of COVID-19 therapies, so we should be able to move WP1122 into the clinics on an expedited basis. Fortunately, it has a very good safety profile in mice. We are in the process of demonstrating safety in additional species before submitting our IND (Investigational New Drug application). Since it has better drug-like properties than 2-DG, WP1122 also actually works better in the animal tumor models we have been studying. We think this bodes well for its potential as a more potent drug than 2-DG as an antiviral agent against coronavirus.”

MBRX closed Wednesday’s trading at $1.27, up 125.70%.

MediciNova Inc. (MNOV) is all set to initiate a clinical trial of MN-166 (ibudilast) for acute respiratory distress syndrome (ARDS) caused by COVID-19.

The study will be conducted by Yale’s Advanced Therapies Group.

Geoffrey Chupp, Professor of Medicine (Pulmonology), Director of the Yale Center for Asthma and Airway Disease and Director of the Pulmonary Function Laboratory at Yale-New Haven Hospital, said, ” There approximately 200 COVID-19 patients at Yale with 34 on ventilators. We are hopeful that MN-166 will help patients with the most severe cases of COVID-19.”

MN-166 has successfully completed a Phase 2b clinical trial in relapsing multiple sclerosis while a phase III trial in the indication of amyotrophic lateral sclerosis is ongoing. Chemotherapy-Induced Peripheral Neuropathy, Degenerative Cervical Myelopathy, and Glioblastoma are the other indications for which MN-166 is being tested.

MNOV closed Wednesday’s trading at $4.41, up 37.81%. In after-hours, the stock gained another 9.52% to $4.83.

The FDA has approved Pfizer Inc.’s (PFE) BRAFTOVI in combination with Eli Lilly’s (LLY) ERBITUX for the treatment of adult patients with metastatic colorectal cancer with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.

BRAF mutations are estimated to occur in up to 15% of people with metastatic colorectal cancer and represent a poor prognosis for these patients. As the first-and-only targeted regimen for people with BRAFV600E-mutant metastatic colorectal cancer who have received prior therapy, BRAFTOVI in combination with ERBITUX is a much-needed new treatment option for these patients, according to Scott Kopetz, Associate Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center.

BRAFTOVI in combination with MEKTOVI is already approved for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.

PFE closed Wednesday’s trading at $34.60, up 2.95%.

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