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The Daily Biotech Pulse: Sanofi's Dupixent Found Effective For Pediatric Itchy Skin, Novavax Gets Nod For Late-Stage Study, Allakos Offering

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The Daily Biotech Pulse: Sanofi's Dupixent Found Effective For Pediatric Itchy Skin, Novavax Gets Nod For Late-Stage Study, Allakos Offering

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

Scaling The Peaks

No biotech stocks hit 52-week highs Monday.

Down In The Dumps

(Biotech stocks hitting 52-week lows on Aug. 5)

  • Acer Therapeutics Inc (NASDAQ: ACER)
  • Aclaris Therapeutics Inc (NASDAQ: ACRS)
  • Actinium Pharmaceuticals Inc (NYSE: ATNM)
  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP)
  • Adaptive Biotechnologies Corp (NASDAQ: ADPT)
  • Agios Pharmaceuticals Inc (NASDAQ: AGIO)
  • Akcea Therapeutics Inc (NASDAQ: AKCA)(announced its subsidiary Keryx Biopharmaceuticals has reached a settlement agreement with Endo International PLC (NASDAQ: ENDP)'s Par Pharam related to Auryxia)
  • Akebia Therapeutics Inc (NASDAQ: AKBA)
  • Alder Biopharmaceuticals Inc (NASDAQ: ALDR)
  • Amneal Pharmaceuticals Inc (NYSE: AMRX)(reported below-consensus Q2 results and cut its 2019 guidance)
  • AnaptysBio Inc (NASDAQ: ANAB)
  • Arcus Biosciences Inc (NYSE: RCUS)
  • Assertio Therapeutics Inc (NASDAQ: ASRT)
  • Atara Biotherapeutics Inc (NASDAQ: ATRA)
  • Bellicum Pharmaceuticals Inc (NASDAQ: BLCM)
  • Atreca Inc (NASDAQ: BCEL)
  • Cellectis SA (NASDAQ: CLLS)
  • Champions Oncology Inc (NASDAQ: CSBR)
  • China SXT Pharmaceuticals Inc (NASDAQ: SXTC)
  • Crinetics Pharmaceuticals Inc (NASDAQ: CRNX)
  • Cyclerion Therapeutics Inc (NASDAQ: CYCN)
  • Eloxx Pharmaceuticals Inc (NASDAQ: ELOX)(commenced Phase 2 study of ELX-02 in cystinosis)
  • Endo International
  • Enochian Biosciences Inc (NASDAQ: ENOB)
  • ESSA Pharma Inc (NASDAQ: EPIX)
  • Galmed Pharmaceuticals Ltd (NASDAQ: GLMD)(reacted to Q2 results)
  • GENFIT S A/ADR (NASDAQ: GNFT)
  • GlycoMimetics Inc (NASDAQ: GLYC)(reported that Phase 3 trial evaluating sickle cell disease drug it is co-developing with Pfizer Inc. (NYSE: PFE) did not meet primary endpoint)
  • ContraVir Pharmaceuticals Inc (NASDAQ: HEPA)
  • Hemispherx BioPharma, Inc (NYSE: HEB)
  • IMMUTEP LTD/S ADR (NASDAQ: IMMP)
  • Inflarx NV (NASDAQ: IFRX)
  • Intercept Pharmaceuticals Inc (NASDAQ: ICPT)
  • Kaleido Biosciences Inc (NASDAQ: KLDO)
  • Kezar Life Sciences Inc (NASDAQ: KZR)
  • KITOV PHARMA LT/S ADR (NASDAQ: KTOV)
  • Ligand Pharmaceuticals Inc. (NASDAQ: LGND)
  • TapImmune Inc. common stock (NASDAQ: MRKR)
  • Menlo Therapeutics Inc (NASDAQ: MNLO)
  • Miragen Therapeutics Inc (NASDAQ: MGEN)
  • Moderna Inc (NASDAQ: MRNA)
  • Neon Therapeutics Inc (NASDAQ: NTGN)
  • Nuvectra Corp (NASDAQ: NVTR)
  • Oncolytics Biotech, Inc. (NASDAQ: ONCY)
  • OptiNose Inc (NASDAQ: OPTN)
  • Pfizer
  • Precision BioSciences Inc (NASDAQ: DTIL)
  • Proteon Therapeutics Inc (NASDAQ: PRTO)
  • Psychemedics Corp. (NASDAQ: PMD)
  • Puma Biotechnology Inc (NASDAQ: PBYI)
  • Rubius Therapeutics Inc (NASDAQ: RUBY)
  • Savara Inc (NASDAQ: SVRA)
  • Strongbridge Biopharma plc (NASDAQ: SBBP)
  • TherapeuticsMD Inc (NASDAQ: TXMD)
  • TRACON Pharmaceuticals Inc (NASDAQ: TCON)
  • Trevi Therapeutics Inc (NASDAQ: TRVI)

Related Link: The Week Ahead In Biotech: Focus On Earnings Deluge, Mid-Year Clinical Trial Readouts

Stocks In Focus

Sanofi's Dupixent Found Effective To Treat Itchy Skin In Children

Sanofi SA (NASDAQ: SNY) said a Phase 3 trial that evaluated its Dupixent to treat severe atopic dermatitis in children aged 6 to 11 years met the primary and secondary endpoints.

Topline results from the study showed that for children with severe atopic dermatitis, adding Dupixent to the standard-of-care topical corticosteroids, or TCS, significantly improved measures of overall disease severity, skin clearing, itching and health-related quality of life compared to TCS alone.

The company said it plans to submit sBLA for the indication in the fourth quarter.

The stock was rallying 1.49% to $40.94 in pre-market trading.

Evofem Says Late-Stage Study of Pregnancy Prevention Medication Meets Exploratory Endpoint

Evofem Biosciences Inc (NASDAQ: EVFM) released additional data from the Phase 3 trial dubbed AMPOWER, which is evaluating its Amphora for the prevention of pregnancy. The results showed that the use of Amphora may improve sexual satisfaction – an exploratory endpoint of the study - and have a positive impact on women's sex lives.

Allakos Plans $200M Common Stock Offering

Allakos Inc (NASDAQ: ALLK), which more than doubled Monday on positive trial results, said it plans to offer $200 million worth of its shares in an underwritten public offering

Novavax Given Greelight For Late-stage Study of Influenza Vaccine For Older Adults

Novavax, Inc. (NASDAQ: NVAX) said it has reached an agreement with the FDA regarding the Phase 3 trial design for NanoFlu following the inputs it received for its End-of-Phase 2 questions. Nanoflu is Novavax's adjuvanted recombinant quadrivalent seasonal influenza vaccine candidate for older adults aged 65 and over.

The company plans to initiate the Phase 3 trial in the fall of 2019.

The stock moved up 1.84% to $4.43 in after-hours trading.

Alnylam's RNAi Therapeutic For Porphyra Granted Priority Review

Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) said the FDA has accepted its NDA for givosiran, an investigational RNAi therapeutic, granting the application priority review status. Givosiran is being evaluated for the treatment of acute hepatic porphyra.

Earnings

Insulet Corporation (NASDAQ: PODD)'s second-quarter revenues jumped 43% year-over-year to $177 million. The bottom-line reversed from a loss of 3 cents per share to a profit of 2 cents per share, in line with estimates. The company raised its 2019 revenue guidance.

The stock rallied 10.23% to $130 in after-hours trading.

Shockwave Medical Inc (NASDAQ: SWAV) reported second-quarter revenues of $10 million, up 339% year-over-year. The loss per share narrowed from $5.79 to 38 cents. Analysts estimated a loss of 53 cents per share. The company issued above-consensus full-year revenue guidance.

The stock gained 9.38% to $50.50 in after-hours trading.

Fulgent Genetics Inc (NASDAQ: FLGT) reported 56% year-over-year revenue growth to $8.4 million and its bottom-line reversed from a loss of 6 cents per share to a profit of 2 cents per share.

The stock fell 5.84% to $8.52 in after-hours trading.

On The Radar

Clinical Trial Readouts

Leap Therapeutics Inc (NASDAQ: LPTX) is scheduled to provide an update on DKN-01 program in combination with Merck & Co., Inc. (NYSE: MRK)'s Keytruda in ornithine transcarbamylase deficiency.

Earnings

  • Avanos Medical Inc (NYSE: AVNS) (before the market open)
  • Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) (before the market open)
  • Antares Pharma Inc (NASDAQ: ATRS) (before the market open)
  • Evofem Biosciences Inc (NASDAQ: EVFM) (before the market open)
  • BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) (before the market open)
  • BioXcel Therapeutics Inc (NASDAQ: BTAI) (before the market open)
  • Haemonetics Corporation (NYSE: HAE) (before the market open)
  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN) (before the market open)
  • Mallinckrodt PLC (NYSE: MNK) (before the market open)
  • Dova Pharmaceuticals Inc (NASDAQ: DOVA) (before the market open)
  • Neuronetics Inc (NASDAQ: STIM) (before the market open)
  • Syneos Health Inc (NASDAQ: SYNH) (before the market open)
  • SAGE Therapeutics Inc (NASDAQ: SAGE) (before the market open)
  • Zoetis Inc (NYSE: ZTS) (before the market open)
  • Kala Pharmaceuticals Inc (NASDAQ: KALA) (before the market open)
  • Gamida Cell Ltd (NASDAQ: GMDA) (before the market open)
  • Karyopharm Therapeutics Inc (NASDAQ: KPTI) (before the market open)
  • GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) (after the close)
  • HTG Molecular Diagnostics Inc (NASDAQ: HTGM) (after the close)
  • Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) (after the close)
  • Akcea Therapeutics Inc (NASDAQ: AKCA) (after the close)
  • Alder Biopharmaceuticals (after the close)
  • Aileron Therapeutics Inc (NASDAQ: ALRN) (after the close)
  • Cellular Biomedicine Group Inc (NASDAQ: CBMG) (after the close)
  • SI-Bone Inc (NASDAQ: SIBN) (after the close)
  • Capricor Therapeutics Inc (NASDAQ: CAPR) (after the close)
  • Zogenix, Inc. (NASDAQ: ZGNX) (after the close)
  • Eton Pharmaceuticals Inc (NASDAQ: ETON) (after the close)
  • Enanta Pharmaceuticals Inc (NASDAQ: ENTA) (after the close)
  • Editas Medicine Inc (NASDAQ: EDIT) (after the close)
  • Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) (after the close)
  • Xencor Inc (NASDAQ: XNCR) (after the close)
  • Flexion Therapeutics Inc (NASDAQ: FLXN) (after the close)
  • Fate Therapeutics Inc (NASDAQ: FATE) (after the close)
  • Halozyme Therapeutics, Inc. (NASDAQ: HALO) (after the close)
  • Inspire Medical Systems Inc (NYSE: INSP) (after the close)
  • PTC Therapeutics, Inc. (NASDAQ: PTCT) (after the close)
  • TherapeuticsMD Inc (NASDAQ: TXMD) (after the close)
  • Retrophin Inc (NASDAQ: RTRX) (after the close)
  • Supernus Pharmaceuticals Inc (NASDAQ: SUPN) (after the close)
  • Paratek Pharmaceuticals Inc (NASDAQ: PRTK) (after the close)

Posted-In: Biotech Earnings News Offerings FDA Top Stories Pre-Market Outlook Trading Ideas Best of Benzinga

 

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