The Daily Biotech Pulse: FDA Blessings for Merck's HIV Drug Combo, Veracyte's Test Gets Medicare Coverage

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling the Peaks

(Stocks hitting 52-week highs on Aug. 30)

• Acceleron Pharma Inc XLRN
• Avid Bioservices Inc CDMO
• Becton Dickinson and Co BDX
• CareDx Inc CDNA
• Emergent Biosolutions Inc EBS
• Haemonetics Corporation HAE
• Illumina, Inc. ILMN
• Inogen Inc INGN
• Karyopharm Therapeutics Inc KPTI
• Medtronic PLC MDT
• Neogen Corporation NEOG
• Novocure Ltd NVCR
• Orthopediatrics Corp KIDS
• Reata Pharmaceuticals Inc RETA
• ResMed Inc. RMD
• Seattle Genetics, Inc. SGEN
• SurModics, Inc. SRDX
• Verastem Inc VSTM
• Xenon Pharmaceuticals Inc XENE(reported positive pharmacodynamic Phase 1b data for XEN1101)

Down In The Dumps

(Stocks hitting 52-week lows on Aug. 30)

• Endologix, Inc. ELGX

See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trial Results

Stocks In Focus

Merck's HIV Combo Drugs Wins FDA Nod

Merck & Co., Inc. MRK announced the FDA has approved two HIV-1 medicines, namely Delstrigo and Pifeltro to treat HIV-1 infection in adult patients with no prior antiretroviral treatment experience.

Delstrigo combines doravirine 100 mg, lamivudine 3TC, 300mg and tenofovir disoproxil fumarate, TDF, 300mg. Meanwhile, Pifeltro is a treatment regimen combining doravirine 100mg with other antiretroviral medicines.

FDA Approves Quidel's Sofia 2 Lyme FIA

Quidel Corporation QDEL said the FDA has granted 510(k) clearance and Clinical Laboratory Improvement Amendments waiver to market its Sofia 2 Lyme FIA to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from finger-stick whole blood specimens from patients suspected of B. burgdorferi infection.

Veracyte's Genomic Test Gets Medicare Coverage

Veracyte Inc VCYT said its Envisa Genomic Classifier received a draft Medicare local coverage determination.

"The Envisia classifier, which is built on next-generation RNA sequencing and machine learning technology, is the first test to achieve this significant Medicare coverage milestone for use in diagnosing idiopathic pulmonary fibrosis," Veracyte said.

The shares advanced 5.37 percent to $12.95 in after-hours trading.

Earnings

MEI Pharma Inc MEIP reported a fiscal-year 2018 loss of 97 cents per share compared to a profit of 7 cents per share in 2018. Revenues came in at $1.6 million.

As of June 30, 2018, the company had $102.7 million in cash, cash equivalents and short-term investments, with no outstanding debt.

Shares slipped 9.95 percent to $4.05 in after-hours trading.

Medigus Ltd. MDGS reversed to a loss in its Q2, while its revenues fell 34 percent to $54,000.

Biopharmx Corp BPMX reported a loss of 2 cents per share for its second quarter, in line with expectations.