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 ACER
• Aclaris Therapeutics Inc ACRS
• Actinium Pharmaceuticals Inc ATNM
• Adaptimmune Therapeutics PLC – ADR ADAP
• Adaptive Biotechnologies Corp ADPT
• Agios Pharmaceuticals Inc AGIO
• Akcea Therapeutics Inc AKCAENDP's Par Pharam related to Auryxia)
• Akebia Therapeutics Inc AKBA
• Alder Biopharmaceuticals Inc ALDR
• Amneal Pharmaceuticals Inc AMRX(reported below-consensus Q2 results and cut its 2019 guidance)
• AnaptysBio Inc ANAB
• Arcus Biosciences Inc RCUS
• Assertio Therapeutics Inc ASRT
• Atara Biotherapeutics Inc ATRA
• Bellicum Pharmaceuticals Inc BLCM
• Atreca Inc BCEL
• Cellectis SA CLLS
• Champions Oncology Inc CSBR
• China SXT Pharmaceuticals Inc SXTC
• Crinetics Pharmaceuticals Inc CRNX
• Cyclerion Therapeutics Inc CYCN
• Eloxx Pharmaceuticals Inc ELOX(commenced Phase 2 study of ELX-02 in cystinosis)
• Endo International
• Enochian Biosciences Inc ENOB
• ESSA Pharma Inc EPIX
• Galmed Pharmaceuticals Ltd GLMD(reacted to Q2 results)
• GENFIT S A/ADR GNFT
• GlycoMimetics Inc GLYCPFE did not meet primary endpoint)
• ContraVir Pharmaceuticals Inc HEPA
• Hemispherx BioPharma, Inc HEB
• IMMUTEP LTD/S ADR IMMP
• Inflarx NV IFRX
• Intercept Pharmaceuticals Inc ICPT
• Kaleido Biosciences Inc KLDO
• Kezar Life Sciences Inc KZR
• KITOV PHARMA LT/S ADR KTOV
• Ligand Pharmaceuticals Inc. LGND
• TapImmune Inc. common stock MRKR
• Menlo Therapeutics Inc MNLO
• Miragen Therapeutics Inc MGEN
• Moderna Inc MRNA
• Neon Therapeutics Inc NTGN
• Nuvectra Corp NVTR
• Oncolytics Biotech, Inc. ONCY
• OptiNose Inc OPTN
• Pfizer
• Precision BioSciences Inc DTIL
• Proteon Therapeutics Inc PRTO
• Psychemedics Corp. PMD
• Puma Biotechnology Inc PBYI
• Rubius Therapeutics Inc RUBY
• Savara Inc SVRA
• Strongbridge Biopharma plc SBBP
• TherapeuticsMD Inc TXMD
• TRACON Pharmaceuticals Inc TCON
• Trevi Therapeutics Inc 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 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 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 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. 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. 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 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 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 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 LPTX is scheduled to provide an update on DKN-01 program in combination with Merck & Co., Inc. MRK's Keytruda in ornithine transcarbamylase deficiency.

Earnings

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