The Daily Biotech Pulse: Liver Congress Underway, FDA Approves Companion Diagnostic Test For Clovis Cancer Drug, EUA For Abbott's $5, 15-Minute COVID-19 Test

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 26)

  • 10X Genomics Inc TXG
  • Abbott Laboratories ABT
  • Corbus Pharmaceuticals Holdings Inc CRBP
  • Fluidigm Corporation FLDM (announced emergency use authorization for its saliva-based COVID-19 test)
  • Generation Bio Co GBIO
  • Inari Medical Inc NARI
  • Kura Oncology Inc KURA
  • Lantern Pharma Inc. LTRN
  • Ocular Therapeutix Inc OCUL
  • PPD Inc PPD
  • Protagonist Therapeutics Inc PTGX
  • Revance Therapeutics Inc RVNC
  • Silk Road Medical Inc SILK

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 26)

  • Odonate Therapeutics Inc ODT
  • Polypid Ltd PYPD

Stocks In Focus

FDA Approves Companion Diagnostic Test For Clovis Oncology's Prostate Cancer Drug

Clovis Oncology Inc CLVS said the FDA approved FoundationOne Liquid CDx, Roche Holdings AG Basel ADR Common Stock RHHBY-owned Foundation Medicine's comprehensive liquid biopsy test for all solid tumors with multiple companion diagnostic indications, including for Rubraca tablets.

Rubraca was recently approved for the treatment of adult patients with a deleterious BRCA mutation-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

The liquid biopsy test is to be made commercially available by Aug. 28.

The stock was trading 15.73% higher at $5.74 at the time of publication Thursday.

Abbott Labs' Rapid COVID-19 Test Receives EUA

Abbott said the FDA has issued emergency use authorization for its BinaxNOW COVID-19 Ag Card rapid test for detection of COVID-19 infection. It is a highly portable test, priced at $5 and provides results in 15 minutes.

"With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others," Abbott said.

In premarket trading, Abbott shares were up 9.02% at $112.50.

Positive ISMC Recommendations For RedHill's US COVID-19 Phase 2 Study 

RedHill Biopharma Ltd RDHL said its U.S. Phase 2 study with opaganib 1 in patients hospitalized with severe COVID-19 pneumonia has successfully passed the first scheduled independent Safety Monitoring Committee following unblinded safety data from the first 12 patients treated for at least seven days.

The company also said it has received approval from the Italian Medicines Agency for the commencement of a global Phase 2/3 study evaluating opaganib in patients hospitalized with severe COVID-19 pneumonia. Enrollment in the study has already begun, the company said. 

Fast Track Designation For Rocket Pharma Infantile Osteoporosis Gene Therapy 

Rocket Pharmaceuticals Inc RCKT said the FDA granted fast track designation to RP-L401, its lentiviral vector-based gene therapy for the treatment of infantile malignant osteopetrosis, a rare, severe monogenic bone resorption disorder characterized by skeletal deformities, neurologic abnormalities and bone marrow failure.

See also: The Week Ahead In Biotech (Aug. 24-29): Lipocine Binary Event, Liver Congress In The Spotlight

Beigene In-Licenses Anti-COVID-19 Antibodies

Beigene Ltd BGNE announced an exclusive licensing agreement with Singlomics to develop, manufacture and commercialize Singlomics' investigational anti-COVID-19 antibodies globally outside of greater China.

They include DXP-593 and DXP-604, which have been recovered from patients with COVID-19.

Addex, SIB Win $66K Grant To Identify New ADX10061 Indications 

ADDEX THERAPEUT/ADR ADXN and the SIB Swiss Institute of Bioinformatics said they have been awarded a 600,000-franc ($66,1056) Innosuisse grant to apply computational approaches developed by the latter to identify new therapeutic indications for Addex's ADX10061, a selective dopamine D1 receptor antagonist.


Mesoblast limited MESO announced a 92% revenue increase in fiscal year 2020 to $16.7 million. The net loss after tax narrowed from $89.8 million to $77.9 million.

The stock rose 3.79% to $18.33 in premarket trading. 


Odonate Therapeutics said it has commenced an underwritten public offering of shares of its common stock. All the shares are being offered by the company.

Odonate said it intends to use the proceeds for development, regulatory and commercial preparation activities relating to tesetaxel, as well as for working capital and general corporate purposes.

The stock was down 4.36% at $16.68 premarket Thursday.

Cocrystal Pharma Inc COCP announced a public offering and purchase on a firm commitment basis of 14.29 million shares of common stock at $1.05 per share. The closing of the offering is expected to occur on or about Aug. 31.

In after-hours trading, the stock slipped 24.26% to $1.03. 

On The Radar

Clinical Readouts/Presentations

European Association For The Study Of The Liver, Digital International Liver Congress 2020 Presentations

Assembly Biosciences Inc ASMB: additional interim analysis from Study 211, a Phase 2, open-label extension study of ABI-H0731 in combination with standard of care therapy for hepatitis B virus, and data from multiple dose cohorts in the Phase 1b clinical of ABI-H2158-containing regimens for chronic hepatic B virus infection.

Mirum Pharmaceuticals IncMIRM: Phase 2 open-label data on five-year transplant-free survival for pediatric patients with progressive familial intrahepatic cholestasis type 2.

CymaBay Therapeutics Inc CBAY: final results on durability of treatment response after one year of therapy from an international Phase 2 study of seladelpar in patients with primary biliary cholangitis, or PBC.

Adaptimmune Therapeutics PLC – ADR ADAP: Updated data from the third dose cohort of an ongoing Phase 1 study of ADP A2AFP SPEAR T-cells in hepatocellular carcinoma.

Eiger Biopharmaceuticals Inc EIGR: Phase 2 LIFT study end-of-treatment data for peginterferon Lambda in hepatitis delta virus.

Genfit SA GNFT: oral presentation on its non-alcoholic steatohepatitis drug elafibranor in combination with semaglutide.


Ascendis Pharma A/S ASND (after the close)

Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates

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