The Daily Biotech Pulse: Fluidigm's Saliva-Based COVID Test Approved In Europe, China Backs Amarin's Vascepa

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 Jan. 21)

• Acasti Pharma Inc ACST
• Alimera Sciences IncALIM
• argenx SE – ADR ARGX
• Axonics Modulation Technologies Inc AXNX
• AzurRx BioPharma Inc AZRX
• Chimerix Inc CMRX
• Edap Tms SAEDAP
• Eli Lilly And Co LLY (announced positive results for its COVID-19 antibody treatment)
• ESSA Pharma Inc EPIX
• Idera Pharmaceuticals Inc IDRA
• Inari Medical Inc NARI
• INmune Bio Inc INMB (INSM)
• Integra Lifesciences Holdings Corp IART
• Inventiva ADR Representing Ord Shs IVA
• Jounce Therapeutics IncJNCE
• Krystal Biotech IncKRYS
• Laboratory Corp. of America Holdings LH
• Merus NV MRUS
• Neuronetics Inc STIM
• OncoSec Medical Inc ONCS (announced common stock offering)
• PRA Health Sciences Inc PRAH
• Precision BioSciences Inc DTIL
• Profound Medical CorpPROF
• Renalytix AI PLC RNLX
• Rhythm Pharmaceuticals IncRYTM
• Seelos Therapeutics Inc SEEL
• Surface Oncology Inc SURF
• Syneos Health Inc SYNH
• Synlogic Inc SYBX
• Twist Bioscience Corp TWST
• Vericel Corp VCEL
• Xencor IncXNCR

Down In The Dumps

None of the biotech/medical device/diagnostic stocks hit 52-week highs in the session.

Stocks In Focus

Fluidigm's Saliva-based COVID Diagnostic Test Gets CE Mark Certification

Fluidigm Corporation FLDM said it has received the CE-IVD mark for its Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus. The CE-IVD mark is in conformance with the European Union in ivitro diagnostic directive.

The Advanta Dx SARS-CoV-2 RT-PCR Assay does not require collection via invasive nasopharyngeal swab, and the company's clinical studies for submission demonstrated 100 percent agreement between saliva results from the Advanta Dx Assay and results from paired nasopharyngeal samples tested with authorized assays.

The stock rallied 26.62% to $7.80 in after-hours trading.

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

Exagen's Avise Testing For Autoimmune Disorders Offered By Tuft Medical Center

Exagen Inc XGN announced a partnership with Boston's Tufts Medical Center to offer its Avise testing as an in-network benefit for patients suffering from debilitating autoimmune diseases.

"Tufts Medical Center is recognized as one of the nation's leading centers for the treatment of arthritis and rheumatic disease. As one of Boston's premiere hospitals, the incorporation of AVISE testing will play an important part in enabling rheumatologists' ability to improve patient care through the differential diagnosis, prognosis, and monitoring of complex autoimmune diseases, including SLE," said Ron Rocca, CEO of Exagen.

In after-hours trading, the stock was up 12.29% to $18.

Amarin's Vascepa Recommended By China's Cardiology Society For Preventing Cardiovascular Disease

Amarin Corporation plc AMRN announced that the Chinese Society of Cardiology has included icosapent ethyl in its updated ‘Guidelines for Primary Prevention of Cardiovascular Diseases for 2021' as published in the Chinese Journal of Cardiovascular Diseases.

The guideline authors include icosapent ethyl 2 grams twice a day, as studied in Amarin's REDUCE-IT trial, as a treatment consideration to further lower atherosclerotic cardiovascular disease in the appropriate patient population.

The stock rose 5.39% to $6.65 in after-hours trading.

Viiv Healthcare's Long-acting, Injectable HIV Combo Therapy Approved by FDA

ViiV healthcare, a venture established by GlaxoSmithKline plc GSK and Pfizer Inc. PFE, said the FDA approved Cabenuva, the first long-acting regimen for the treatment of HIV-1 infection in adults. Cabenuva is provided as a co-pack with two injectable medicines — ViiV Healthcare's cabotegravir and Johnson & Johnson JNJ unit Janssen's rilpivirine — dosed once monthly.

This is as an option to replace the current antiretroviral regimen in those who are virologically suppressed on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.

Immutep Falls On Licensing Partner GlaxoSmithKline Halting Mid-stage Ulcerative Colitis Study

Immutep ADS Representing 10 Ord Shs IMMP said its licensing partner GlaxoSmithKline has discontinued its Phase 2 clinical trial evaluating an anti-LAG3 cell depleting monoclonal antibody, GSK2831781, which is derived from Immutep's IMP731 antibody, in patients with active ulcerative colitis.

The trial was stopped by GlaxoSmithKline based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial's Data Review Committee. The company is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program.

Under the terms of its ongoing collaboration agreement with GlaxoSmithKline, Immutep is eligible to receive up to a total of 54 million pounds ($74 million) in remaining developmental milestone payments as well as single-digit tiered royalties, if GSK2831781 is commercialized. Further milestone payments are subject to the continuation of the program, while GSK is responsible for all costs associated with the clinical development and commercialization of GSK2831781.

BioCryst Gets Japanese Regulatory Nod For Hereditary Angioedema Treatment

BioCryst Pharmaceuticals, Inc. (BCRX) said Japan's Ministry of Health, Labor and Welfare has granted marketing and manufacturing approval for oral, once-daily Orladeyo, 150 mg, for prophylactic treatment of hereditary angioedema in adults and pediatric patients 12 years and older.

The stock was advancing 3.99% to $9.51 in premarket trading Friday.

Offerings

Precigen Inc PGEN said it has commenced an underwritten public offering of shares of its common stock. In addition, Precigen intends to grant the underwriters a 30-day option to purchase additional shares of its common stock.

In after-hours trading, the stock slid 9.19% to $8.30.

On The Radar

The FDA is scheduled to rule on Aurinia Pharmaceuticals Inc's AUPH voclosporin as a treatment option for lupus nephritis.