The Daily Biotech Pulse: D-Day For Clinuvel, Qiagen Warns Of Q3 Shortfall, Prevail Announces Gene Therapy Collaboration

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 Oct. 7)

• Alder Biopharmaceuticals Inc ALDR
• Celgene Corporation CELG
• Natera Inc NTRA

Down In The Dumps

(Biotech stocks hitting 52-week lows on Oct. 7)

• Adaptimmune Therapeutics PLC – ADR ADAP
• Aevi Genomic Medicine Inc GNMX
• Albireo Pharma Inc ALBO
• Arbutus Biopharma Corp ABUS
• Aridis Pharmaceuticals Inc ARDS
• ASLAN PHARMACEU/ADR ASLN
• Aurinia Pharmaceuticals Inc AUPH
• BIOLASE Inc BIOL
• Clovis Oncology Inc CLVS
• Corbus Pharmaceuticals Holdings Inc CRBP
• DarioHealth Corp DRIO
• DelMar Pharmaceuticals Inc DMPI
• Fulcrum Therapeutics Inc FULC
• Gemphire Therapeutics Inc GEMP
• GENFIT S A/ADR GNFT
• Heat Biologics Inc HTBX
• ImmuCell Corporation ICCC
• INmune Bio Inc INMB
• Intersect ENT Inc XENT( announced failed trial results for its drug coated balloon for reducing dilated sinus)
• Jaguar Health Inc JAGX
• Kalvista Pharmaceuticals Inc KALV
• Kiniksa Pharmaceuticals Ltd KNSA
• Mersana Therapeutics Inc MRSN
• Morphic Holding Inc MOR
• Myovant Sciences Ltd MYOV
• NGM Biopharmaceuticals Inc NGM(announced results of a mid-stage study of NASH drug that were below expectations)
• Novus Therapeutics Inc NVUS
• OncoSec Medical Inc ONCS
• PAVmed Inc PAVM
• Plus Therapeutics Inc PSTV
• Satsuma Pharmaceuticals Inc STSA
• Savara Inc SVRA
• Silk Road Medical Inc SILK
• Sorrento Therapeutics Inc SRNE
• Spring Bank Pharmaceuticals Inc SBPH
• TransMedics Group Inc TMDX
• Trinity Biotech plc TRIB
• Urogen Pharma Ltd URGN
• Viveve Medical Inc VIVE

See Also: Pfenex Gets FDA Seal of Approval For Amgen's Forteo Biosimilar

Stocks In Focus

Qiagen Lowers Q3 Sales Growth Guidance, Announces CEO Departure

Qiagen NV QGEN announced preliminary third-quarter sales, expecting sales growth of about 3% at constant exchange rates, lower than its earlier expectations for 4-5% growth, citing significantly weaker-than-expected developments in China. The company expects adjusted EPS within its outlook of 35-36 cents in constant exchange rate.

Separately, the company announced a 15-year partnership with Illumina, Inc. ILMN to broaden the availability and use of NGS-based in-vitro diagnostic kits, including companion diagnostics, for patient management.

The company also said its Chairman and CEO Peer Schatz has decided to resign from the positions, although he will serve as Special Advisor to the Supervisory Board. As the company scouts for a replacement, Thierry Bernard, SVP, Head of Molecular Diagnostics Business Area, will assume the CEO role on an interim basis.

The stock slipped 7.99% to $29.50 in after-hours trading.

Prevail, Lonza Stitch Up Gene Therapy Partnership

Prevail Therapeutics Inc PRVL and German biopharma LONZA GRP AG/ADR LZAGY announced a strategic collaboration focused on the baculovirus/Sf9 production system for gene therapies.

Under the agreement, Lonza will manufacture Prevail's pipeline of novel AAV-based gene therapy programs for patients with neurodegenerative diseases at its gene therapy center of excellence in Houston, Texas.

The companies will work together on the development and scaling up production of PR001, Prevail's gene therapy for Parkinson's disease with GBA1 mutations and neuronopathic Gaucher disease. Also, the companies plan to collaborate on PR006 gene therapy for patients with frontotemporal dementia with GRN mutations, and for future gene therapy programs.

Gilead Makes Japanese Regulatory Submission For Rheumatoid Arthritis Drug

Gilead Sciences, Inc. GILD has submitted to the Japanese Ministry of Health, Labor and Welfare an NDA for filgotinib, an investigational, oral selective JAK1 inhibitor for the treatment of adults with rheumatoid arthritis.

"This new drug application is an important milestone as we continue to expand Gilead's presence in Japan to now also include inflammation," the company said.

On The Radar

PDUFA Dates

FDA will issue its verdict on Clinuvel Pharmaceuticals Ltd CLVLY's NDA for Scenesse, which is being evaluated as a preventative treatment for phototoxicity and anaphylactoid reactions in adult patients with erythropoietic protoporphyria.