The Daily Biotech Pulse: Roche's Flu Drug Aces Late-Stage Trial, Acura Outlicenses Pain Medication, Neuronetics Gets New Finance Chief

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 July 2)

• ANI Pharmaceuticals Inc Common Stock ANIP
• ArQule, Inc. ARQL
• Axsome Therapeutics Inc AXSM
• Coherus Biosciences Inc CHRS
• GALAPAGOS NV/S ADR GLPG
• MeiraGTx Holdings PLC MGTX
• ZEALAND PHARMA/S ADR ZEAL

Down In The Dumps

(Biotech stocks hitting 52-week lows on July 2)

• Adamis Pharmaceuticals Corp ADMP
• Aerie Pharmaceuticals Inc AERI
• Atreca Inc BCEL(IPOed June 20)
• Biopharmx Corp BPMX
• ContraVir Pharmaceuticals Inc CTRV
• Kaleido Biosciences Inc KLDO
• Nuvectra Corp NVTR
• Personalis Inc PSNL (IPOed June 20)
• Prevail Therapeutics Inc PRVL (IPOed June 20)
• Sienna Biopharmaceuticals Inc SNNA
• Surface Oncology Inc SURF
• Tetraphase Pharmaceuticals Inc TTPH
• TrovaGene Inc TROV

See Also: Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates

Stocks In Focus

Roche's Flu Medication Found Effective And Safe In Children

Roche Holdings AG Basel ADR Common Stock RHHBY's Genetech unit announced its Phase 3 study dubbed MNISTONE-2 met its primary endpoint of demonstrating that Xofluza was well tolerated in children with flu. The study also showed that Xofluza is comparable to oseltamivir, a proven effective treatment, for flu in children, in reducing the duration of flu symptoms, including fever.

Glaxo-owned ViiV's 2-Drug Regimen For HIV-1 Infection Receives EU Clearance

ViiV Healthcare, majority owned by GlaxoSmithKline plc GSK, with Pfizer Inc. PFE and SHIONOGI & CO L/ADR SGIOY also as shareholders, said the European Commission granted Marketing Authorization for Dovato for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg.

Dovato is once-daily, single pill combination of dolutegravir and lamivudine, as opposed to the current standard of care, which is a three-drug regimen.

Acura Outlicenses Abuse Deterrent Pain Medication For Up To $21.3M

Acura Pharmaceuticals, Inc. ACUR announced a licensing, development and commercialization agreement with Abuse Deterrent Pharma – a special purpose company representing a consortium of investors, which will finance the company's operations and completion of the development of LTX-03 immediate-release tablets using Acura's patented LIMITx technology.

The investigational drug addresses the consequences of excess oral administration of opioid tablets, the most prevalent route of opioid overdose and abuse.

The transaction is valued up to $21.3 million, not including royalties. The agreement also provides for Acura receiving royalties and potential sales-related milestones and AD Pharma retaining commercialization rights.

Neuronetics Appoints Furlong as Its CFO

Neuronetics Inc STIM announced the appointment of Stephen Furlong as its CFO and Secretary, effective July 22, replacing the incumbent Peter Donato, who will leave after a transition period.

Akero Doses First Patient In Mid-Stage NASH Study

Akero Therapeutics Inc AKRO said it has begun dosing the first patient in its Phase 2a study of AKR-001, a novel FGF21 analog for the treatment of non-alcoholic steatohepatitis. The company said it will report the results of the study in the first half of 2020.

Arbutus Sells Part Of Royalty Interest In Onpattro For $20M

Arbutus Biopharma Corp ABUS announced the sale of part of its royalty interest on future global net sales of Onpattro, an RNA interference therapeutic currently sold by Alnylam Pharmaceuticals, Inc. ALNY, to OMERS, the defined benefit pension plan for municipal employees based in the Province of Ontario, Canada, for $20 million in gross proceeds before advisory fees.