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

Down In The Dumps

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

Stocks In Focus

Aptinyx Finds Follow-Up Buying After R&D Event

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

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