05/15/2019 | Press release | Distributed by Public on 05/15/2019 06:25
Here's a roundup of top developments in the biotech space over the last 24 hours.
(Biotech stocks hitting 52-week highs on May 14)
(Biotech stocks hitting 52-week lows on May 14)
'This is the first FDA approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC,' the companies said.
The approval was based on positive results from the Phase 3 JAVELIN Renal 101 study.
Biogen Inc (NASDAQ: BIIB) said U.K.'s National Institute for Health and Care Excellence, or NICE, has recommended funding for its spinal muscular dystrophy, or SMA, drug Spinraza on the National Health Service. The recommendation is for treating infants, children and adults with 5q SMA, including pre-symptomatic and symptomatic SMA Types 1, 2 and 3, the company said.
Dr.Reddy's Laboratories Ltd (NYSE: RDY) announced the U.S. launch of Daptomycin injection, 500mg/vial single-dose vial, a generic version of Merck & Co., Inc. (NYSE: MRK)'s Cubicin, which is indicated to treat complicated skin and skin structure infection.
Cubicin's branded and generic version fetched sales of $640.8 million in the U.S. in the 12-months ended March 2019, the company said, citing IQVIA.
DAIICHI SANKYO/S ADR (OTC: DSNKY) said the FDA's Oncologic Drugs Advisory Committee, which met Tuesday to discuss its NDA for quizartinib for treating adults with relapsed/refractory FLT3-ITD acute myeloid leukemia, or AML, voted 8 to 3 that safety risks outweigh benefits. The PDUFA date has been set for Aug. 5.
ENDRA Life Sciences Inc (NASDAQ: NDRA) reported no revenues for the first quarter of 2019 compared to revenues of $6,174 for the year-ago period. The net loss, however, narrowed from 72 cents to 37 cents. The loss was wider than the consensus loss estimate of 30 cents per share.
The stock fell 10.95 percent to $1.22 in after-hours trading.
Online abstracts of data to be presented at the American Society of Clinical Oncology Meeting (May 31-June 4) will be made available at 5 p.m. ET. Some of the key abstracts in focus will be:
Amgen, Inc. (NASDAQ: AMGN) - Phase 1 data for AMG 510 in solid tumors; Mirati Therapeutics Inc (NASDAQ: MRTX), which has a competing pipeline asset in MRTX849 will also be in focus, although Phase 1/2 data for it not expected until the second half of 2019.
Roche Holdings AG Basel ADR (OTC: RHHBY) - Entrectinib (central nervous system tumors with gene mutations)
• Vascular Biogenics Ltd (NASDAQ: VBLT) (before the market open)
• Rubius Therapeutics Inc (NASDAQ: RUBY) (before the market open)
• Achieve Life Sciences Inc (NASDAQ: ACHV) (after the close)
• Edap Tms SA (NASDAQ: EDAP) (after the close)
• Titan Pharmaceuticals, Inc. common stock (NASDAQ: TTNP) (after the close)
• Precision Therapeutics Inc (NASDAQ: AIPT) (after the close)
• Altimmune Inc (NASDAQ: ALT)