Today’s Daily Dose brings you news about BioCryst Pharma’s upcoming regulatory event, Brickell Biotech clearing legal uncertainty related to its lead asset, Bellerophon’s phase IIb data of INOPulse, and progress on Lurbinectedin NDA.
The FDA decision on Baudax Bio Inc.’s (BXRX) New Drug Application for ANJESO for the management of moderate to severe pain is expected tomorrow – i.e., February 20, 2020.
ANJESO, the intravenous formulation of Meloxicam, has been twice rejected by the FDA – in May 2018 and in March 2019. Meloxicam belongs to the non-opioid class of drugs and oral formulations of the drug have been on the market since 2000.
Baudax Bio is a spinoff from Recro Pharma Inc (REPH) and began trading on the NASDAQ Capital Market on November 22, 2019.
BXRX closed Tuesday’s trading at $8.38, up 1.82%.
BioCryst Pharmaceuticals Inc.’s (BCRX) new drug application for the approval of oral, once-daily Berotralstat (BCX7353) for the prevention of hereditary angioedema attacks has been accepted for review by the FDA – with a decision date set for December 3, 2020.
Hereditary Angioedema, or HAE, is characterized by swelling in the hands, feet, face and larynx, and gastrointestinal attacks producing excruciating abdominal pain, nausea, vomiting, and diarrhea.
There are currently 7 FDA-approved products for preventing and treating hereditary angioedema attacks, according to the U.S. Hereditary Angioedema Association. The existing treatments for HAE are administered either intravenously (IV) or subcutaneously.
Commenting on the Berotralstat NDA acceptance by the FDA, Jon Stonehouse, chief executive officer of BioCryst, said, “HAE patients and their physicians tell us they have been waiting for a once-daily oral therapy to prevent attacks, and the acceptance of our submission, with a PDUFA date this year, means their wait is nearly over.”
Earlier in the month, the Company submitted its New Drug Application for oral, once-daily Berotralstat in Japan.
Torii Pharmaceutical Co. is BioCryst’s commercial partner in Japan for Berotralstat. If approved, Berotralstat would be the first approved chronic therapy for HAE patients in Japan.
BCRX closed Tuesday’s trading at $2.92, up 4.46%.
Brickell Biotech Inc. (BBI) soared as much as over 90% on Tuesday, following a settlement of a dispute with Bodor Laboratories Inc related to the Sofpironium bromide license agreement.
As part of the settlement and amended license agreement, Brickell agreed to make an upfront payment to Bodor of $1.0 million in cash and pay future amounts, up to $1.0 million in cash and $1.5 million in common stock, upon the achievement of specified milestones (with shares to be valued at the closing price on the day preceding each such issuance). Additionally, Brickell agreed to pay Bodor a low single-digit royalty related to a newly filed provisional patent application and modified the percentage of certain sub-licensing income that Bodor may receive in the future.
Now that a settlement has been reached, Brickell Biotech will continue its efforts to develop Sofpironium bromide for the treatment of hyperhidrosis, which is under phase III testing. The top-line results from the phase III long-term safety study of Sofpironium bromide in hyperhidrosis are expected in the second quarter of this year.
BBI closed Tuesday’s trading at $1.65, up 42.24%.
Shares of Bellerophon Therapeutics Inc. (BLPH) jumped as much as 100% on Tuesday, following positive top-line data from a phase IIb study of inhaled nitric oxide, or iNO, delivered using its INOpulse device, for the treatment of Pulmonary Hypertension associated with Pulmonary Fibrosis.
The phase IIb study, dubbed PHPF-002, evaluated the benefits of escalating iNO doses, say, iNO30, iNO45, and iNO75.
The top-line data demonstrated that pulmonary vascular resistance reduced by 21%, with increased benefit on dose escalation from iNO30 to iNO45. The mean pulmonary arterial pressure reduced by 12% and iNO was well-tolerated with no safety concerns across the doses.
A phase II/III placebo-controlled clinical study of inhaled nitric oxide, or iNO, delivered using its INOpulse device for the treatment of Pulmonary Hypertension associated with Interstitial Lung Disease is underway. Last December, the Company announced positive top-line results from Cohort 2 of that study. The Cohort 1 results were reported in January 2019. The phase III cohort initiation is expected in the first quarter of this year.
BLPH closed Tuesday’s trading at $9.20, up 168.37%.
A phase II trial testing the combination of Five Prime Therapeutics Inc.’s (FPRX) drug candidate Cabiralizumab with Bristol-Myers Squibb’s (BMY) Opdivo with and without chemotherapy in patients with advanced pancreatic cancer did not meet its primary endpoint.
Bristol-Myers Squibb noted that it will continue to support the evaluation of Cabiralizumab in select, ongoing investigator-sponsored trials and may continue to assess future development opportunities for that compound.
Five Prime inked an exclusive worldwide license and collaboration agreement with Bristol-Myers for the development and commercialization of Cabiralizumab, with an option to co-promote it in the United States, in 2015.
FPRX closed Wednesday’s trading at $4.42, down 2.43%. In after-hours, the stock fell another 0.45% at $4.40.
The New Drug Application seeking accelerated approval for Lurbinectedin for the treatment of patients with Small Cell Lung Cancer who have progressed after prior platinum-containing therapy has been accepted for priority review by the FDA, with a decision date set for August 16, 2020.
Lurbinectedin is developed by PharmaMar, which granted the U.S. commercialization rights to this compound to Jazz Pharmaceuticals plc (JAZZ) in January of this year.
JAZZ closed Tuesday’s trading at $136.83, down 2.85%.
Source: Read Full Article