The Daily Biotech Pulse: FDA Nod For GlaxoSmithKline, Bristol-Myers Squibb Earnings, Acutus Medical IPO

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 5)

• ABIOMED, Inc. (NASDAQ:ABMD)
• Aerpio Pharmaceuticals Inc (NASDAQ:ARPO) (announced a U.S. government grant for a midstage COVID-19 treatment study)
• Allovir Inc (NASDAQ:ALVR) (went public Thursday)
• Annexon Inc (NASDAQ:ANNX)
• Axonics Modulation Technologies Inc (NASDAQ:AXNX)
• Biofrontera AG (NASDAQ:BFRA)
• Cardiff Oncology Inc (NASDAQ:CRDF)
• CareDx Inc (NASDAQ:CDNA) (reacted to second-quarter results)
• DarioHealth Corp (NASDAQ:DRIO)
• DexCom, Inc. (NASDAQ:DXCM)
• Emergent Biosolutions Inc (NYSE:EBS)
• Fulgent Genetics Inc (NASDAQ:FLGT) (reacted to second-quarter results)
• GenMark Diagnostics, Inc (NASDAQ:GNMK) (announced second-quarter results)
• Hologic, Inc. (NASDAQ:HOLX)
• Horizon Therapeutics PLC (NASDAQ:HZNP)
• Illumina, Inc. (NASDAQ:ILMN)
• Immunomedics, Inc. (NASDAQ:IMMU)
• Inari Medical Inc (NASDAQ:NARI)
• Inozyme Pharma Inc (NASDAQ:INZY)
• Inspire Medical Systems Inc (NYSE:INSP) (announced second-quarter results)
• iTeos Therapeutics Inc (NASDAQ:ITOS)
• Meridian Bioscience, Inc. (NASDAQ:VIVO)
• NeoGenomics, Inc. (NASDAQ:NEO)
• Novavax, Inc. (NASDAQ:NVAX) (reported positive Phase 1 data for coronavirus vaccine)
• OraSure Technologies, Inc. (NASDAQ:OSUR)
• PDL BioPharma Inc (NASDAQ:PDLI)
• Penumbra Inc (NYSE:PEN)
• Quidel Corporation (NASDAQ:QDEL)
• Renalytix AI PLC (NASDAQ:RNLX)
• Silk Road Medical Inc (NASDAQ:SILK)
• Shockwave Medical Inc (NASDAQ:SWAV)
• Sorrento Therapeutics Inc (NASDAQ:SRNE)
• Twist Bioscience Corp (NASDAQ:TWST)
• Unity Biotechnology Inc (NASDAQ:UBX)
• Zoetis Inc (NYSE:ZTS)

Down In The Dumps

• (Biotech Stocks Hitting 52-week Lows Aug. 5)
• Intec Pharma Ltd (NASDAQ:NTEC) (reacted to second-quarter results)
• Nkarta Inc (NASDAQ:NKTX)

Stocks In Focus

Aptinyx Finds Follow-Up Buying After R&D Event

Aptinyx Inc (NASDAQ:APTX) hosted a post-traumatic stress disorder R&D event, where a psychiatry and PTSD key opinion leader reviewed the PTSD treatment landscape, preclinical data supporting NYX-783 for PTSD indication and the clinical design and expectations for the ongoing Phase 2 PTSD study, which is now expected to read out in fourth quarter.

The company also announced plans to restart some of clinical trials that were paused due to COVID-19.

The stock was advancing 19.38% to $4.65 in premarket trading Thursday.

FDA Approves GlaxoSmithKline's Monotherapy Treatment of Multiple Myeloma In Second-Line+ Settings

GlaxoSmithKline plc (NYSE:GSK) said the FDA approved Blenrep as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.

The stock was slipping 0.83% to $40.87 in premarket trading Thursday.

See also: The Week Ahead In Biotech: Novavax Coronavirus Vaccine Readout, FDA Decisions And More Earnings

Novartis Announces Publication Of Positive Results For Multiple Sclerosis Study

Novartis AG (NYSE:NVS) said the New England Journal of Medicine published the positive results from the ASCLEPIOS I and II studies evaluating the safety and efficacy of ofatumumab 20mg monthly subcutaneous injections versus teriflunomide 14mg oral tablets taken once daily in adults with relapsing forms of multiple sclerosis.

Both studies met the primary endpoints where ofatumumab showed a significant reduction in the number of confirmed relapses, evaluated as the annualized relapse rate.

Anavex's Investigational Alzheimer's Drug Approved For Continued Use Under Special Access Scheme In Australia

Anavex Life Sciences Corp (NASDAQ:AVXL) said patients from the ANAVEX2-73-003 Phase 2a Alzheimer's disease trial will continue treatment with ANAVEX2-73 through the Australian Government Department of Health - Therapeutic Goods Administration compassionate use Special Access Scheme following completion of over five years of daily dosing of the investigational therapy and recommendation by their physicians.

The TGA compassionate use special access was issued based on the safety profile of ANAVEX2-73, as well as clinical evidence that it may benefit patients.

In premarket trading Thursday, the stock was advancing 18.68% to $5.40.

Anika Appoints Michael Levitz As CFO

Anika Therapeutics Inc (NASDAQ:ANIK) announced the appointment of Michael Levitz as EVP, CFO and treasurer beginning Aug. 10, replacing Sylvia Cheung, who will continue in an advisory capacity for a period.

Caladrius CFO To Depart

Caladrius Biosciences Inc (NASDAQ:CLBS) said CFO Joseph Talamo has tendered his resignation in order to explore opportunities outside of Caladrius. Talamo will continue to serve as CFO until Aug. 21, the company said. Caladrius said it has initiated a search to identify qualified candidates to fill the permanent CFO position.

The stock was slipping 8.46% to $2.38 in premarket trading Thursday.

Earnings

Orasure's second-quarter revenue fell 25% year-over-year to $29.3 million, and the company reversed from a profit of 7 cents per share to a loss of 16 cents per share. Analysts, on average, estimated a loss of 9 cents per share.

The stock was down 20.38% to $15.59 in after-hours trading.

ADMA Biologics Inc (NASDAQ:ADMA) said its second-quarter revenue jumped 19.4% to $7.79 million and its loss per share narrowed from 25 cents to 23 cents. Analysts expected a narrower loss of 16 cents per share.

The stock was moving down 14.33% to $3.05 in premarket trading Thursday.

MannKind Corporation (NASDAQ:MNKD) reported second-quarter revenue that was almost flat year-over-year at $15.1 million. The net loss per share narrowed from 7 cents to 5 cents, in line with the consensus estimate.

In premarket trading Thursday, the stock was plunging 8.6% to $1.70.

Offerings

Horizon Therapeutics said it plans to offer $700 million of its ordinary shares in an underwritten public offering. It intends to use the net proceeds to fund future acquisitions or licenses of, or investments.

The stock was sliding 4.08% to $73.26 in premarket trading Thursday.

DiaMedica Therapeutics Inc (NASDAQ:DMAC) said it intends to offer
its common shares in an underwritten public offering. All of the common shares will be offered by the company.
DiaMedica said it intends to use the net proceeds from the offering to continue its clinical and product development activities, and for other working capital and general corporate purposes.

On The Radar

Earnings

• Polarityte Inc (NASDAQ:PTE) (before the market open)
• Mylan NV (NASDAQ:MYL) (before the market open)
• Menlo Therapeutics Inc (NASDAQ:MNLO) (before the market open)
• Mediwound Ltd (NASDAQ:MDWD) (before the market open)
• Synlogic Inc (NASDAQ:SYBX) (before the market open)
• Zoetis Inc (NYSE:ZTS) (before the market open)
• TherapeuticsMD Inc (NASDAQ:TXMD) (before the market open)
• Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) (before the market open)
• Syneos Health Inc (NASDAQ:SYNH) (before the market open)
• Orthofix Medical Inc (NASDAQ:OFIX) (before the market open)
• Eloxx Pharmaceuticals Inc (NASDAQ:ELOX) (before the market open)
• Dicerna Pharmaceuticals Inc (NASDAQ:DRNA) (before the market open)
• Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) (before the market open)
• Athenex Inc (NASDAQ:ATNX) (before the market open)
• Amneal Pharmaceuticals Inc (NYSE:AMRX) (before the market open)
• Bristol-Myers Squibb Co (NYSE:BMY) (before the market open)
• Agenus Inc (NASDAQ:AGEN) (before the market open)
• ABIOMED, Inc. (NASDAQ:ABMD) (before the market open)
• BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) (before the market open)
• AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) (before the market open)
• Galmed Pharmaceuticals Ltd (NASDAQ:GLMD) (before the market open)
• PDL BioPharma Inc (NASDAQ:PDLI) (after the close)
• Syndax Pharmaceuticals Inc (NASDAQ:SNDX) (after the close)
• Regenxbio Inc (NASDAQ:RGNX) (after the close)
• Dynavax Technologies Corporation (NASDAQ:DVAX) (after the close)
• Accelerate Diagnostics Inc (NASDAQ:AXDX) (after the close)
• Adamas Pharmaceuticals Inc (NASDAQ:ADMS) (after the close)
• Achieve Life Sciences Inc (NASDAQ:ACHV) (after the close)
• Acceleron Pharma Inc (NASDAQ:XLRN) (after the close)
• Coherus Biosciences Inc (NASDAQ:CHRS) (after the close)
• Puma Biotechnology Inc (NASDAQ:PBYI) (after the close)
• Axonics Modulation Technologies Inc (NASDAQ:AXNX) (after the close)
• Theravance Biopharma Inc (NASDAQ:TBPH) (after the close)
• Iovance Biotherapeutics Inc (NASDAQ:IOVA) (after the close)
• Glaukos Corp (NYSE:GKOS) (after the close)
• CytomX Therapeutics Inc (NASDAQ:CTMX) (after the close)
• Cytokinetics, Inc. (NASDAQ:CYTK) (after the close)
• Insulet Corporation (NASDAQ:PODD) (after the close)
• Chembio Diagnostics Inc (NASDAQ:CEMI) (after the close)
• Exelixis, Inc. (NASDAQ:EXEL) (after the close)
• Editas Medicine Inc (NASDAQ:EDIT) (after the close)
• FibroGen, Inc. (NASDAQ:FGEN) (after the close)
• Guardant Health Inc (NASDAQ:GH) (after the close)
• GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) (after the close)
• PRA Health Sciences Inc (NASDAQ:PRAH) (after the close)
• Illumina, Inc. (NASDAQ:ILMN) (after the close)
• Insmed Incorporated (NASDAQ:INSM) (after the close)
• Pfenex Inc (NYSE:PFNX) (after the close)
• ZIOPHARM Oncology Inc. (NASDAQ:ZIOP) (after the close)
• Spero Therapeutics Inc (NASDAQ:SPRO) (after the close)
• NovaBay Pharmaceuticals, Inc. (NYSE:NBY) (after the close)
• Opiant Pharmaceuticals Inc (NASDAQ:OPNT) (after the close)
• Nektar Therapeutics (NASDAQ:NKTR) (after the close)

IPOs

Acutus Medical, Inc., an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, priced its initial public offering of 8.824 million shares at $18 per share, at the higher end of the estimated price range of $16-$18. The gross proceeds from the offering are expected to be about $158.8 million. The shares will begin trading on the Nasdaq under the symbol "AFIB."

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