Here's a roundup of top developments in the biotech space over the last 24 hours:
(Biotech Stocks Hitting 52-week Highs Oct. 26)
(Biotech Stocks Hitting 52-week Lows Oct. 26)
Catabasis Pharmaceuticals Inc (NASDAQ:CATB) said the Phase 3 PolarisDMD trial of edasalonexent in Duchenne muscular dystrophy did not meet the primary endpoint, which was a change from baseline in the North Star Ambulatory Assessment over one year.
The secondary endpoint of timed function tests such as time to stand; 10-meter walk/run; and four-stair climb also did not show statistically significant improvements, the company said.
Consequently, the company said it is stopping activities related to the development of edasalonexent, including the ongoing GalaxyDMD open-label extension trial. Catabasis also said it plans to work with external advisors to explore and evaluate strategic options going forward.
The stock was down 64.18% at $1.92 premarket Tuesday.
DexCom, Inc. (NASDAQ:DXCM) preannounced third-quarter revenues of $500.9 million, representing 26% year-over-year growth. Analysts, on average, estimate revenues of $476.75 million.
The company also announced that longtime executive Rick Doubleday, who is serving as chief commercial officer, will retire at the end of 2020.
The stock was down 5.26% at $396 premarket.
Eli Lilly And Co's (NYSE:LLY) updated data from the NIAID-sponsored ACTIV-3 clinical trial evaluating the efficacy of its bamlanivimab in hospitalized COVID-19 patients suggests the antibody treatment candidate is unlikely to help them recover from this advanced stage of their disease, the company said in a statement.
No additional COVID-19 patients in this hospitalized setting will receive bamlanivimab, Lilly said.
All other studies are ongoing, including the NIH-sponsored ACTIV-2 trial testing bamlanivimab in recently diagnosed mild to moderate COVID-19 patients; the BLAZE-1 Phase 2 trial that is evaluating bamlanivimab monotherapy and in combination with etesevimab in recently-diagnosed COVID-19 patients in a non-hospitalized setting; and the BLAZE-2 Phase 3 trial that is evaluating bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities.
Lilly shares were down 4.57% premarket at $135.23.
Related Link: The Week Ahead In Biotech: Kala FDA Decision, Merck & Pfizer Earnings, Vaccine Updates And IPOs
Novartis AG's (NYSE:NVS) third-quarter net sales from continuing operations rose 1% to $12.26 billion, and its core operating income climbed 9% due to lower spending and improved gross margin. Core EPS came in at $1.52, ahead of the $1.45 consensus estimate.
The company raised its 2020 core operating income guidance from low double-digit growth to low double-digits-to-mid-teens percentage growth. The company expects net sales to grow by mid-single digits.
Exelixis, Inc. (NASDAQ:EXEL) said its Japanese partner Takeda Pharmaceutical Co Ltd (NYSE:TAK) and Ono Pharma have submitted a supplemental application to the Japanese Ministry of Health, Labour and Welfare for manufacturing and marketing approval of Cabometyx in combination with Bristol-Myers Squibb Co's (NYSE:BMY) Opdivo for the treatment of patients with unresectable, advanced or metastatic renal cell carcinoma.
Nantkwest Inc (NASDAQ:NK) announced the appointment of Richard Adcock as its CEO effective immediately. Adcock will replace Patrick Soon-Shiong, who will become executive chairman of the board.
The stock was up 0.89% at $9.11 premarket Tuesday.
Aerpio Pharmaceuticals Inc (NASDAQ:ARPO) said it has begun dosing of the first patient with razuprotafib in the military-sponsored Phase 2 trial targeting the prevention and treatment of acute respiratory distress syndrome in patients with moderate-to severe COVID-19.
The stock was down 0.78% premarket at $1.27.
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) said the FDA has approved an investigational new drug application to evaluate the cystic fibrosis transmembrane conductance regulator activator VSJ-110 for the treatment of allergic conjunctivitis.
Vanda said it plans to initiate enrollment in the Phase 2 study by the end of 2020 and anticipates results of this study in 2021.
The stock rose 2.59% to $10.70 in after-hours trading.
Mirati, which announced positive early-stage results for its KRAS G12C inhibitor MRTX849 in non-small cell lung cancer, said it intends to offer $700 million in shares of common stock in an underwritten public offering, and a selling stockholder intends to offer 375,000 shares in the offering.
The stock slid 2.89% to $191 in after-hours trading.
Galera Therapeutics Inc (NASDAQ:GRTX) is due to present at the ASTRO annual meeting data from its Phase 1b/2a clinical trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy for locally advanced pancreatic cancer. The presentation is scheduled between 3 p.m. and 4:15 p.m.
Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.