The Daily Biotech Pulse: Moderna Expands Into Switzerland, Tiziana To Spin Off Testing Unit, Metacrine IPO

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Sept. 15)

• Avidity Biosciences Inc RNA
• Beigene Ltd BGNE
• Bicycle Therapeutics PLC BCYC
• BioLife Solutions Inc BLFS
• Checkpoint Therapeutics Inc CKPT
• Denali Therapeutics Inc DNLI
• Fate Therapeutics Inc FATE
• Guardant Health Inc GH
• Horizon Therapeutics PLC HZNP
• Immunovant Inc IMVT
• InVitae Corp NVTA
• Jounce Therapeutics Inc JNCE
• Marinus Pharmaceuticals Inc MRNS ( announced a positive late-stage readout for ganaxolone)
• Mirati Therapeutics Inc MRTX
• Momenta Pharmaceuticals, Inc. MNTA
• Myokardia Inc MYOK
• Novocure Ltd NVCR
• Outset Medical Inc OM (more than doubled on its Wall Street debut)
• Repare Therapeutics Inc RPTX
• Revance Therapeutics Inc RVNC
• Shockwave Medical Inc SWAV
• SI-Bone Inc SIBN
• Silk Road Medical Inc SILK
• TRACON Pharmaceuticals Inc TCON

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 15)

• Histogen Inc HSTO
• PainReform Ltd PRFX
• Satsuma Pharmaceuticals Inc STSA
• SILENCE THERAPE/S ADR SLN

Stocks In Focus

Roche Gets Label Expansion For Cancer Screening Test

Roche Holdings AG Basel RHHBY announced FDA approval for the expanded use of CINtec PLUS Cytology, its first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus.

Aveo Publishes Positive Results For Late-stage Kidney Cancer Comparator Study

AVEO Pharmaceuticals, Inc. AVEO announced publication in the journal European Urology, positive final overall survival results from its Phase 3 TIVO-3 study comparing tivozanib, its next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor drug candidate, to sorafenib in third and fourth line renal cell carcinoma.

The stock climbed 16.32% to $6.70 in after-hours trading.

Tiziana to Spin Off Its Genomic Testing Company

TIZIANA LF SCIE/S ADR TLSA announced plans to spin-off its StemPrintER asset into a separate and independently listed public company, named Accustem Sciences Limited.

StemPrintER is a genomic signature-based assay for the prognosis of early and late recurrence of ER+/HER2 breast cancer in early stage breast cancer patients. The company said it will hold a shareholder meeting Oct. 2 to vet the proposed plan.
Tiziana expects to list StemPrintER on the LSE in late fourth quarter of 2020, and a potential dual listing on Nasdaq in 2021.

The stock was advancing 12.24% to $3.85 in pre-market trading Wednesday.

Moderna Sets Up Commercial Organization In Switzerland

Moderna Inc MRNA announced the appointment of Dan Staner as VP and General Manager, Switzerland, effective today. Switzerland is the first country outside of North America to host a Moderna regional hub and commercial organization, the company said.

NanoViricides Finalizes Vaccine Candidate For Advancing Into Human Trials

NanoViricides Inc NNVC said it has nominated a clinical drug candidate, codenamed NV-CoV-1-R, for the treatment of COVID-19. NV-CoV-1-R is made up of a nanoviricide that possesses broad-spectrum anti-coronavirus activity, and remdesivir encapsulated inside the core of NV-CoV-1, the company said.

The stock was gaining 6.59% to $4.85 in pre-market trading.

Takeda to Divest Bleeding Control Patch For About $415M

Takeda Pharmaceutical Co Ltd TAK said it has entered into an agreement to divest its TachoSil Fibrin Sealant Patch to Corza Health for about 350 million euros or $415.6 million in cash.

TachoSil is a surgical patch to deliver safe, fast and reliable bleeding control, and it fetched Takeda full-year net sales of $160 million in the fiscal year ended March 31, 2020.

Takeda said it intends to use the net proceeds to pay off debt.

Applied DNA to Initiate Study of Coronavirus Vaccine Candidate In Companion Animals

Applied DNA Sciences Inc APDN said it plans to initiate a veterinary clinical trial of one of its five LineaDNA vaccine candidates, upon approval of the clinical plan by the U.S. Department of Agriculture. The study done in collaboration with Evvivax, a spin-out of Takis Biotech, will evaluate the vaccine candidate as part of the strategy for the prevention of SARS-CoV-2 infections in companion felines of humans.

The stock was adding 8.58% to $8.86 in pre-market trading.

Offerings

Syneos Health Inc SYNH said it commenced an underwritten secondary offering by affiliates of Thomas H. Lee Partners, L.P. and Advent International Corporation of 7 million shares of its common stock. The company clarified that it will not receive any proceeds from the sale.

On The Radar

Clinical Readouts

Verastem Inc VSTM will present at the 2nd RAS- Targeted Drug Development Summit 2020 updated data from the LGSOC cohort of the investigator-initiated Phase 1/2 FRAME study evaluating VS-6766 and defactinib in KRAS mutant solid tumors, and new preclinical data from studies investigating VS-6766 and defactinib in combination with KRAS-G12C inhibitors.

IPOs

Metacrine, Inc., a clinical-stage biopharmaceutical company focused on developing differentiated therapies for patients with liver and gastrointestinal diseases, priced its 6.54-million shares initial public offering at $13 apiece, the midpoint of the estimated price range of $12-$14, for raising gross proceeds of about $85 million. The San Diego, California-based company's shares will be listed on the Nasdaq under the ticker symbol MTCR.