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FDA Says "Not Now AVEO", HALO Axes 160 Jobs, RDHL Gets Nod For H.pylori Drug

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Today's Daily Dose brings you news about AVEO Pharma's regulatory update on its investigational drug Tivozanib in renal cell carcinoma; Halozyme's decision to cut 55% workforce following phase III trial failure; FDA approval of RedHill's drug for Helicobacter pylori; revised protocol of Tonix Pharma's RECOVERY phase III study and the new Commissioner of the FDA.

Read on…

Shares of AVEO Pharmaceuticals Inc. (AVEO) plunged more than 36%, following the regulatory update on its investigational drug Tivozanib in renal cell carcinoma.

The Company has completed a phase III trial of Tivozanib in renal cell carcinoma, dubbed TIVO-3, and was planning to proceed with a New Drug Application for the same.

However, the FDA has advised the Company not to submit an NDA at this time. The FDA stated that it remained concerned about the results of TIVO-3 in the context of the overall development of Tivozanib.

The FDA noted that the Company's current interim overall survival results of the TIVO-3 trial do not abrogate the FDA's concerns over detriment and that those results may worsen with final analysis at 263 events.

AVEO intends to submit to the FDA an update to the statistical analysis plan (SAP) for the final overall survival analysis, followed by an NDA submission in the first quarter of 2020.

AVEO closed Monday's trading at $0.56, down 36.68%.

FibroGen Inc. (FGEN) dropped 7.52% on Monday, following a short report issued by a former analyst at Kerrisdale Capital Management.

The report questions the safety of Roxadustat, and labels the Company as the next "biotech blow-up." It also alleges that the Company was being "mysteriously unforthcoming" and misleading investors with regards to the safety and efficacy of Roxadustat.

Roxadustat is currently approved in China for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and patients not on dialysis and approved in Japan for the treatment of anemia in CKD patients on dialysis.

The drug is in phase III clinical development in the U.S. and Europe and in phase II/III development in China for anemia associated with myelodysplastic syndromes (MDS), and in a phase II U.S. trial for the treatment of chemotherapy-induced anemia.

FGEN closed Monday's trading at $37.01, down 7.52%.

Halozyme Therapeutics Inc.'s (HALO) phase III study evaluating investigational drug PEGPH20 as a first-line therapy for the treatment of patients with metastatic pancreas cancer, dubbed HALO-301, has failed to reach the primary endpoint of overall survival.

The Company has decided to pull the plug on PEGPH20 and implement an organizational restructuring to focus its operations solely on its ENHANZE drug delivery technology.

As part of the organizational restructuring, the Company has decided to reduce its workforce by approximately 55%, or approximately 160 positions, with over 80% of the reduction completed in early January 2020.

The revamped company will comprise about 120 employees focused on driving the continued growth of ENHANZE, specifically in areas that are critical to supporting partners such as manufacturing, quality, regulatory and product development. An additional 12 employees will continue promoting the Company's commercial drug Hylenex.

HALO closed Monday's trading at $15.44, down 0.68%. In after-hours, the stock lost 1.20% and was at $15.26.

The FDA has approved RedHill Biopharma Ltd.'s (RDHL) Talicia delayed-release capsules for the treatment of Helicobacter pylori. The drug is expected to be launched in the U.S. in the first quarter of 2020.

Talicia is a novel and proprietary fixed-dose, all-in-one oral capsule combination of two antibiotics, Rifabutin, and Amoxicillin, and a proton pump inhibitor (PPI), Omeprazole.

The current standard-of-care therapies for H. pylori infection are the triple therapies based on a proton pump inhibitor, clarithromycin, and amoxicillin or metronidazole. Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies.

RDHL closed Monday's trading at $7.35, up 6.21%. In after-hours, the stock gained another 3.40% to $7.60.

Shares of Tonix Pharmaceuticals Holding Corp. (TNXP) took a hit, following a revised protocol of its phase III study of Tonmya for civilian and military-related posttraumatic stress disorder, dubbed RECOVERY.

As per the revised protocol, the primary endpoint, i.e., the mean change from baseline in the severity of PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), will be assessed at Week 12 instead of Week 4.

In addition, the RECOVERY study will include an unblinded interim analysis that allows for a potential sample size re-estimation. It will be conducted when 50 percent of the current target number of participants, i.e. 250, are randomized and have either completed or discontinued the 12-week course of treatment with bedtime Tonmya or placebo sublingual tablet. Results from the added interim analysis are expected in the first quarter of 2020.

The Company expects to report topline data from the RECOVERY study in the second quarter of 2020.

TNXP closed Monday's trading at $3.04, down 15.79%.

Stephen Hahn has been nominated to be the Commissioner of the FDA by President Donald Trump.

Hahn is the chief medical executive at the University of Texas MD Anderson Cancer Center. If Hahn's nomination is approved by the Senate, he replaces Ned Sharpless, who has been serving as Acting Commissioner of the U.S. regulatory agency, following the departure of Scott Gottlieb in April of this year.

Sharpless will be returning to his role as Director of the National Cancer Institute.

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