The Daily Biotech Pulse: Bio-Rad's Coronavirus Test Gets EUA, Beat-And-Raise Quarter From GenMark, Adverum's Positive Gene Therapy Readout

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 May 5.)

• Arcturus Therapeutics Ltd ARCT (announced a partnership with Catalent Inc CTLT for manufacturing of a vaccine against the novel coronavirus)
• BIO-TECHNE Corp TECH
• Bio-Rad Laboratories, Inc. Class A Common Stock BIO
• ChemoCentryx Inc CCXI
• DexCom, Inc. DXCM (received Health Canada temporary authorization for its Dexcom G6 CGM for use in hospitals to monitor critically ill patients during COVID-19 pandemic)
• Halozyme Therapeutics, Inc. HALO (announced FDA approval for Johnson & Johnson JNJ Janssen unit's subcutaneous formulation of Darzalex, which uses Halozyme's Enhanze technology, in treating multiple myeloma)
• Imara Inc IMRA
• Immunomedics, Inc. IMMU (announced the commercial availability of its recently-approved breast cancer drug Trodelvy in the U.S.)
• Masimo Corporation MASI
• Minerva Neurosciences Inc NERV
• Vermillion, Inc. VRML
• Zynex Inc. ZYXI

None of the biotech/medical devices/diagnostics company hit 52-week lows Monday.

Stocks In Focus

Adverum's Gene Therapy Shows Robust Efficacy, Safety In Phase 1 Study For Wet Age-Related Macular Degeneration

Adverum Biotechnologies Inc ADVM announced new interim clinical data from Cohorts 1-3 of the OPTIC Phase 1 dose-ranging clinical study of single-dose of ADVM-022 intravitreal injection gene therapy in patients with wet age-related macular degeneration, which further demonstrated the transformative potential of ADVM-022 to greatly reduce anti-VEGF injection burden in wet AMD.

"It's impressive to see the long-term durability demonstrated at the higher dose of ADVM-022 in a patient population that previously required frequent injections to maintain their vision and are now beyond one year of follow-up with no rescue injections," Arshad Khanani, the study's principal investigator, said in a statement.

The company also offered a business update, reporting cash, cash equivalents and short-term investments of $297 million as of March 31. Adverum said it expects to submit a NDA for ADVM-022 in diabetic retinopathy in the first half of 2020 and present data from all four cohorts of the OPTIC trial in the second half.

Bio-Rad Droplet Digital PCR Test Kit For Coronavirus Receives EUA

Bio-Rad said its SARS-CoV-2 Droplet Digital PCR test kit has been granted Emergency Use Authorization by the FDA. The SARS-CoV-2 Droplet Digital PCR test runs on Bio-Rad's QX200 and QXDx ddPCR systems.

Chembio's Serological Test For Coronavirus Gets CE Marking

Chembio Diagnostics Inc CEMI said it has attained the CE Marking for its DPP COVID-19 System. The CE Marking allows the company commercialize the system within the member states of the European Union and the Caribbean region, except for Puerto Rico.

The DPP COVID-19 System is a serological test and analyzer that provides numerical readings for both IgM and IgG antibody levels within 15 minutes from a simple finger stick drop of blood. The test has received EUA in the U.S.

Separately, the company reported first-quarter results, showing a 20% decline in revenue to $6.9 million and a wider net loss of 29 cents per share.

In premarket trading Tuesday, the stock was gaining 17.47% to $14.39.

See also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Dates

Regeneron, Sanofi Say PD-1 Inhibitor Libtayo Found Effective In Skin Cancer In Pivotal Study

Regeneron Pharmaceuticals Inc REGN and Sanofi SA SNY announced top-line data from a pivotal, single-arm, open-label trial of PD-1 inhibitor Libtayo in patients with advanced basal cell carcinoma who had progressed on or were intolerant to prior hedgehog pathway inhibitor therapy. The data showed the investigational asset demonstrated clinically meaningful and durable responses in this group of patients for whom there are currently no approved treatments.

The companies said they plan regulatory submissions in 2020.

Libtayo was approved in September 2018 by the FDA to treat patients with metastatic cutaneous squamous cell carcinoma.

Insmed Announces Secondary Offering Of Common Stock

Insmed Incorporated INSM said it intends to offer and sell shares of its common stock in an underwritten public offering. All the shares are being offered by the company.

The stock was down 0.84% at $24.65 in Tuesday's premarket session.

Earnings

GenMark Diagnostics, Inc GNMK announced first-quarter revenue of $38.7 million, in line with the number it mentioned in its April 8 pre-announcement and representing an 80% year-over-year increase. The loss per share narrowed from 21 cents to 12 cents, while analysts estimated a loss of 14 cents per share.

The company raised its full-year revenue guidance to $120 million to $130 million, ahead of the $108.58-million consensus estimate, and it also increased its gross margin guidance to 38-40%.

Separately, GenMark announced the appointment of Scott Mendel as CEO. Mendel has been serving as CEO on an interim basis since February.

The stock was up 13.29% at $13.30 in the premarket session.

On The Radar

Earnings

• Oxford Immunotec Global PLC OXFD (before the market open)
• Karyopharm Therapeutics Inc KPTI (before the market open)
• Haemonetics Corporation HAE (before the market open)
• Antares Pharma Inc ATRS (before the market open)
• Harvard Bioscience, Inc. HBIO (before the market open)
• Vericel Corp VCEL (before the market open)
• Regeneron
• Neuronetics Inc STIM (before the market open)
• Mallinckrodt PLC MNK (before the market open)
• Akebia Therapeutics Inc AKBA (before the market open)
• Agile Therapeutics Inc AGRX (after the market close)
• Aquestive Therapeutics Inc AQST (after the market close)
• Akcea Therapeutics Inc AKCA (after the market close)
• Acorda Therapeutics Inc ACOR (after the market close)
• Axonics Modulation Technologies Inc AXNX (after the market close)
• Synthetic Biologics Inc SYN (after the market close)
• T2 Biosystems Inc TTOO (after the market close)
• Iovance Biotherapeutics Inc IOVA (after the market close)
• MacroGenics Inc MGNX (after the market close)
• Zogenix, Inc. ZGNX (after the market close)
• Jazz Pharmaceuticals PLC JAZZ (after the market close)
• Exelixis, Inc. EXEL (after the market close)
• Myriad Genetics, Inc. MYGN (after the market close)
• Inspire Medical Systems Inc INSP (after the market close)
• Rigel Pharmaceuticals, Inc. RIGL (after the market close)
• Supernus Pharmaceuticals Inc SUPN (after the market close)
• Nevro Corp NVRO (after the market close)
• Clovis Oncology Inc CLVS (after the market close)
• InVitae Corp NVTA (after the market close)
• Cytosorbents Corp CTSO (after the market close)
• Cardiovascular Systems Inc CSII (after the market close)
• Cerus Corporation CERS (after the market close)
• Deciphera Pharmaceuticals Inc DCPH (after the market close)
• Incyte Corporation INCY (after the market close)
• Orthopediatrics Corp KIDS (after the market close)

Related Link: The Week Ahead In Biotech: Smid-Cap Earnings News Flow Picks Up Pace