Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech Stocks Hitting 52-week highs on March 24)
BELLUS Health Inc (NASDAQ: BLU)
Global Cord Blood Corp (NYSE: CO)
Thermogenesis Holdings Inc (NASDAQ: THMO)(reacted to its fourth-quarter earnings)
Down In The Dumps
(Biotech Stocks Hitting 52-week lows on March 24)
Baudax Bio Inc (NASDAQ: BXRX) (reacted to announcement concerning common stock and warrant offerings)
Equillium Inc (NASDAQ: EQ)
IMMURON LTD/S ADR (NASDAQ: IMRN)
Neovasc Inc (NASDAQ: NVCN)
Oncternal Therapeutics Inc (NASDAQ: ONCT)
PLx Pharma Inc (NASDAQ: PLXP)
Salarius Pharmaceuticals Inc (NASDAQ: SLRX)(released its fourth-quarter results)
Viveve Medical Inc (NASDAQ: VIVE)
Stocks In Focus T2 Biosystems Licenses COVID-19 Test, Preannounces Q1 Revenue Shortfall, Suspends Guidance
T2 Biosystems Inc (NASDAQ: TTOO) said it has entered into a worldwide licensing agreement for a rapid COVID-19 test developed by Center of Discovery and Innovation at Hackensack Meridian Health.
Under the agreement, T2 Biosystems will adapt the test to run on its T2Dx Instrument, the same instrument used for the FDA-cleared T2Bacteria and T2Candida Panels.
Separately, the company preannounced a revenue shortfall for the first quarter, blaming the predicament on the COVID-19 pandemic, which has disrupted its commercial operations. The company also suspended its guidance for 2020.
In after-hours trading, the stock jumped 109.16% to 82 cents.
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PerkinElmer's New Coronavirus Test Gets FDA Emergency Use Authorization
PerkinElmer, Inc. (NYSE: PKI) said the FDA has issued Emergency Use Authorization for its new coronavirus RT-PCR test. This will allow clinical labs certified under Clinical Laboratory Improvement Amendments to immediately begin using the kit to detect SARS-CoV-2.
In after-hours trading, the stock rose 3.01% to $76.55.
Diffusion Pharma Announces Delay In Study of Lead Drug For Stroke Caused By Coronavirus
Diffusion Pharmaceuticals Inc (NASDAQ: DFFN) said it expects delays in enrollment in its ambulance-based PHAST-TSC Phase 2 trial in acute stroke due to coronavirus. The LA County Fire Department has suspended future training of first responders who had been scheduled to participate in the trial protocol, the company noted.
Immuron Announces Strategic Actions to Tide Over COVID-19 Impact; CEO Steps Down
Immuron announced measures to preserve capital, as it navigates through a tough environment amid the COVID-19 outbreak. As a first step, the company announced the resignation of Gary Jacob as CEO and member of the company's board. The company announced the appointment of Jerry Kanellos as CEO, with the move leading to day-to-day control of operations and executive strategy returning to Australia.
The company also plans to do away with or significantly reduce external consultant costs and also establish a remuneration model for directors, which will use payment of board fees other than by monetary recompense. These are expected to trim cash operating expense by over $2 million, effective April.
Immuron said it will also work toward increasing overall revenues to help mitigate an anticipated decrease in Travelan sales due to decreased travel by promoting Protectyn for gut benefits.
Immutep's Immuno-chemotherapy Combo Produces Positive Results In Midstage Breast Cancer Trial
Australian biotech IMMUTEP LTD/S ADR (NASDAQ: IMMP) announced data from the Phase 2b AIPAC study that evaluated its lead product candidate eftilagimod alpha in combination with paclitaxel, a taxane standard-of-care chemotherapy, in HER2-negative/HR+ metastatic breast cancer, which showed 63% of patients treated with the combo were progression-free at the 6-month landmark.
This compared to 54% for patients who received paclitaxel plus placebo. The company also noted the secondary endpoint of overall response rate increased from 38.4% in the placebo group to 48.3% in the efti group.
Allakos Reports Positive Results In Earlystage Study of Drug to Treat Mast Cell Gastrointestinal Disease
Allakos Inc (NASDAQ: ALLK) announced positive results from a Phase 1 study that evaluated the safety and efficacy of antolimab in treating patients with mast cell gastrointestinal disease. Six months of treatment resulted in a 64% mean reduction in total symptom score-8, which measures abdominal pain, nausea, vomiting, early satiety, loss of appetite, abdominal cramping, bloating, and diarrhea. Antolimab was also found generally well tolerated, with no drug-related serious adverse events occurring during the study.
Separately, the company also announced initiation of three clinical studies of antolimab – a Phase 3 study in eosinophilic gastritis and/or eosinophilic duodenitis, a Phase 2/3 study in eosinophilic esophagitis, and a Phase 1 study of subcutaneously administered antolimab in healthy volunteers.
The stock moved up 1.49% to $60 in after-hours trading.
Exelixis' Partner Takeda Gets Regulatory Nod For Cabometyx In Japan For Kidney Cancer
Exelixis, Inc. (NASDAQ: EXEL) said Takeda Pharmaceutical Co Ltd (NYSE: TAK), its partner responsible for the clinical development and commercialization of Cabometyx in Japan, received approval from the Japanese Ministry of Health, Labor and Welfare to manufacture and market the drug as a treatment for patients with curatively unresectable or metastatic renal cell carcinoma.
In pre-market trading, Takeda shares were adding 0.79% to $14.01 and Exelixis shares were moving up 1.01% to $16.01.
Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) reported a net loss of $2.86 per share for the fourth quarter of 2019 compared to a loss of $59.85 per share a year ago. Analysts estimated a loss of $1.49 per share for the quarter.
In after-hours trading, the stock slipped 11.62% to 88 cents.
Onconova Therapeutics Inc (NASDAQ: ONTX) reported full-year results that showed a loss of $1.49 per share for 2019 compared to a loss of $4.99 per share for 2018. Cash balance at the end of Feb. 2020 stood at $32.6 million. The company expects the cash and cash equivalents to be adequate to fund ongoing trials and operations into the third quarter of 2021.
The company also said it has completed the planned enrollment of 360 patients in the INSPIRE trial in higher-risk myelodysplastic syndrome, or MDS, patients. It expects to report topline survival data in the second half of 2020.
The stock advanced 14.48% to 42 cents in after-hours trading.
On The Radar PDUFA Dates
The FDA scheduled to announced its verdict on strong> Bristol-Myers Squibb Co (NYSE: BMY)'s NDA for ozanimod as a treatment option for patients with relapsing forms of multiple sclerosis.
Viela Bio Inc (NASDAQ: VIE) (after the close)
Biocept Inc (NASDAQ: BIOC) (after the close)
OncoCyte Corp (NYSE: OCX) (after the close)
HTG Molecular Diagnostics Inc (NASDAQ: HTGM) (after the close)
Eyenovia Inc (NASDAQ: EYEN) (after the close)
Exagen Inc (NASDAQ: XGN) (after the close)
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