The Daily Biotech Pulse: GenMark Diagnostics Ships COVID-19 Test Kits, Karyopharm To Offer Shares, And More

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 2)

• Forty Seven Inc FTSV( announced a deal to be bought by Gilead Sciences, Inc. GILD)
• IGM Biosciences Inc IGMS
• Iovance Biotherapeutics Inc IOVA
• Karyopharm Therapeutics Inc KPTI(announced positive late-stage results for selinexor)
• Passage Bio Inc PASG(IPOed Friday)
• Syneos Health Inc SYNH
• Trillium Therapeutics Inc TRIL(moved in sympathy with Forty Seven, as it has a similar drug in the pipeline for solid tumor)
• Zynex Inc. ZYXI

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on March 2)

• Aerie Pharmaceuticals Inc AERI
• AEterna Zentaris Inc. AEZS
• Akorn, Inc. AKRX
• ANI Pharmaceuticals Inc ANIP(moved lower despite FDA nod for a generic version of Teva Pharmaceutical Industries Ltd's TEVA Alzheimer's related dementia drug)
• Autolus Therapeutics Ltd – ADR AUTL
• Axovant Gene Therapies Ltd AXGT
• Black Diamond Therapeutics Inc BDTX
• Eagle Pharmaceuticals Inc EGRX (reacted to its fourth-quarter results)
• Evolus Inc EOLS
• EXACT Sciences Corporation EXAS
• GenMark Diagnostics, Inc GNMK
• Imv Inc IMV
• Neurometrix Inc NURO
• Portola Pharmaceuticals Inc PTLA
• Precigen Inc PGEN
• Taro Pharmaceutical Industries Ltd. TARO
• Tetraphase Pharmaceuticals Inc TTPH
• TherapeuticsMD Inc TXMD
• Vanda Pharmaceuticals Inc. VNDA
• Viking Therapeutics Inc VKTX

Related Link: How The COVID-19 Outbreak Is Benefiting Biotech Investors

Stocks In Focus

GenMark Starts Shipping COVID-19 Test Kits

GenMark said it has begun shipping ePlex Research Use Only, or RUO, test kits to detect COVID-19 virus. The initial shipment will go to its Hong Kong distributor as well as several U.S. customers having access to clinical samples.

Separately, the company reported fourth-quarter results, showing 24% year-over-year revenue growth and a narrower loss of 17 cents per share, while analysts estimated a loss of 16 cents per share.

The stock jumped 21.65% to $4.27 in after-hours trading.

Novartis' Sandoz Unit Agrees For $195M Settlement In Generics Price Fixing Probe

Novartis AG's NVS Sandoz unit said it has reached a resolution with the U.S. DoJ in a 3-year-long antitrust investigation carried out by the agency into the U.S. generic drug industry. Sandoz said the settlement pertains to instances of misconduct by the company between 2013 and 2015 with certain generic drugs sold in the U.S. As part of the agreement, Sandoz will pay $195 million.

Unity Biotech Taps Former Biogen Executive as CEO

Unity Biotechnology Inc UBX announced the appointment of Anirvan Ghosh as CEO and member of the board, effective March 30. Ghosh was previously with as Biogen Inc BIIB as SVP, Head of Research and Early Development.

The company said current CEO Keith Leonard will step down from the role due to personal circumstances.

KemPharm Filed Regulatory Application For ADHD Drug

KemPharm Inc KMPH said it has submitted a NDA for KP415, its investigational asset to treat attention deficit hyperactivity disorder, or ADHD. KP415 contains serdexmethylphenidate and KemPharm's prodrug d-methylphenidate.

The stock jumped 37.61% to 45 cents in after-hours trading.

CanFite Submits Safety Report Showing Favorable Safety Snd Risk-Benefit Ratios

CAN FITE BIOPHARMA ADR REP 30 ORD CANF announced submission of annual Drug Safety Update Reports to health regulatory agencies concerning Piclidenoson and Namodenoson, which show both investigational-stage drugs have favorable safety profiles and risk-benefit ratios in more than 1,500 patients.

In premarket trading Tuesday, the shares were surging up 29.92% to $1.65.

Thermo Fisher To Buy Qiagen For $10B In Cash

Thermo Fisher Scientific Inc. TMO announced a deal to buy molecular diagnostics company Qiagen NV QGEN for 39 euros per share in cash or 9 billion euros ($10 billion).

In premarket trading Tuesday, Qiagen shares were rallying 16.06% to $41.92 and Thermo Fisher shares were moving up 3.26% to $314.90,

Alnylam Says Inherited Liver Enzyme Deficiency Drug Approved In Europe

Alnylam Pharmaceuticals, Inc. ALNY said the European Commission has granted marketing authorization for GIVLAARI, an injection for subcutaneous use targeting aminolevulinic acid synthase 1 for the treatment of acute hepatic porphyria in adults and adolescents aged 12 years and older

Lily Assuages COVID-19 Concerns

Eli Lilly And Co LLY issued an update alleviating any potential impact from COVID-19, stating that it does not anticipate shortages for any of its products, including all forms of insulin. It also said it does not source any of its approved medicines from China, and that its insulin manufacturing sites in the United States and Europe have not been impacted by coronavirus.

In pre-market trading Tuesday, the shares were adding 0.87% to $134 .

Earnings

Omeros Corporation's OMER fourth-quarter revenues rose 12% to $33.4 million and the net loss widened from 48 cents per share to 58 cents per share.

The stock added 17% to $14.73 in after-hours trading.

Zogenix, Inc. ZGNX reported fourth-quarter revenues of $1.95 million compared to no revenues a year ago. The net loss per share widened from 53 cents to $1.26. Analysts estimated a loss of $1.06 per share.

The stock slipped 6.93% to $23.50 in after-hours trading.

Precigen reported fourth-quarter revenues of $17 million, sharply lower than $41.19 million a year ago. The net loss, however, narrowed from $2.59 per share to $1.09 per share. Analysts expected a loss of 27 cents per share on 23.4 million.

The stock declined 7.93% to $3.60 in after-hours trading.

Offerings

Close on the heels of reporting positive late-stage data for selinexor, Karyopharm announced the commencement of a registered underwritten public offering of $150 million worth of its common shares.

The stock moved down 6.17% to $26.01 in after-hours trading.

On The Radar

Earnings

• Antares Pharma Inc ATRS (before the market open)
• Autolus Therapeutics Ltd – ADR AUTL (before the market open)
• Neuronetics Inc STIM (before the market open)
• TG Therapeutics Inc common stock TGTX (before the market open)
• Sierra Oncology Inc SRRA (before the market open)
• Infinity Pharmaceuticals Inc. INFI (after the close)
• Syndax Pharmaceuticals Inc SNDX (after the close)
• VIVUS, Inc. VVUS (after the close)
• Voyager Therapeutics Inc VYGR (after the close)
• DURECT Corporation DRRX (after the close)
• Cytokinetics, Inc. CYTK (after the close)