The Daily Biotech Pulse: Mixed Tidings From Novavax, Radius Health Out-licenses Breast Cancer Drug, 3 IPOs

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs July 23)

• Abbott Laboratories ABT
• ABIOMED, Inc. ABMD
• Acceleron Pharma Inc XLRN
• Aerpio Pharmaceuticals Inc ARPO
• Arbutus Biopharma Corp ABUS( won a patent challenge brought about by Moderna Inc MRNA)
• Bio-Rad Laboratories, Inc. BIO
• Brainstorm Cell Therapeutics Inc BCLI
• Champions Oncology Inc CSBR
• Fulgent Genetics Inc FLGT
• Genocea Biosciences Inc GNCA (reacted to its second-quarter results)
• Hologic, Inc. HOLX
• Intuitive Surgical, Inc. ISRG
• Ligand Pharmaceuticals Inc. LGND
• Medpace Holdings Inc MEDP
• NeoGenomics, Inc. NEO
• Penumbra Inc PEN
• Quest Diagnostics Inc DGX
• RENALYTIX AI ADR RNLX (IPOed Friday)
• ResMed Inc. RMD
• Silk Road Medical Inc SILK
• Tandem Diabetes Care Inc TNDM
• West Pharmaceutical Services Inc. WST(reacted to its second quarter results)
• Zoetis Inc ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 23)

• ALX Oncology Holdings Inc ALXO (IPOed last Friday)
• Forma Therapeutics Holdings Inc FMTX
• Fusion Pharmaceuticals Inc FUSN
• Nkarta Inc NKTX
• Chanticleer Holdings SONN

Related Link: 5 Coronavirus Stock Valuations Surging During The Pandemic

Stocks In Focus

Radius Health Out-licenses Breast Cancer Drug For Up To $350M

Radius Health Inc RDUS said it has entered into an exclusive global license agreement with the Menarini Group for the development and commercialization of elacestrant, an investigational asset that is currently being evaluated in a Phase 3 study as a hormonal treatment for postmenopausal women and men with advanced ER+/HER2- breast cancer.

Radius will receive an upfront payment of $30 million and up to $320 million in additional payments based on the successful achievement of future development and sales milestones. The company is also eligible for tiered, low to mid-teen percentage royalty payments on global net sales.

In pre-market trading Friday, Radius Health shares were rising 9.36% to $13.90.

BioMarin Makes Regulatory Submission For Bone Growth Disorder Drug In Europe

BioMarin Pharmaceutical Inc. BMRN announced the submission of a Marketing Authorization Application to the European Medicines Agency for vosoritide, an investigational, once-daily injection analog of C-type Natriuretic Peptide for children with achondroplasia, the most common form of disproportionate short stature in humans.

Subject to completion of EMA's validation check, BioMarin said it anticipates the start of the MAA review to commence in August.

Novavax Delays Phase 1 Data Readout, Strikes Coronavirus Manufacturing Deal

Novavax, Inc. NVAX said it will release the Phase 1 data, which will consist of preliminary immunogenicity and safety results, during the first week of August, as opposed to the earlier timeframe of July. The Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin shortly thereafter, it added.

Novavax also announced an agreement with FUJIFILM Diosynth Biotechnologies, a CDMO, to manufacture bulk drug substance for NVX-CoV2373, the former's COVID-19 vaccine candidate. Fujifilm's site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373, the companies said.

The stock was slipping 4% to $134 in pre-market trading.

Arcturus Announces Preliminary Deal to Supply Covid-19 Vaccine Candidate to Israel

Arcturus Therapeutics Holdings Inc ARCT announced a binding term sheet with the Israeli Ministry of Health to supply its COVID-19 vaccine candidate, LUNAR-COV19. The parties intend to finalize a comprehensive supply agreement within 30 days, the company said.

Earnings

LeMaitre Vascular Inc's LMAT second-quarter sales fell a smaller than expected 16% to $24.9 million and EPS fell from 23 cents to 17 cents. The company issued an upbeat guidance for the third quarter.

The stock was advancing 12.24% to $32.47 in pre-market trading Friday.

Edwards Lifesciences Corp's EW second-quarter sales fell 15% to $925 million, and adjusted EPS fell 26% to 34 cents. The bottom-line exceeded estimates. The company reiterated its full-year sales guidance of $4 billion to $4.5 billion, and increased its adjusted EPS guidance from $1.58 to $1.75 to $1.75 to $1.95. The sales guidance was in line and the bottom-line guidance exceeded estimates.

On The Radar

IPOs

iTeos Therapeutics, a clinical-stage biopharma engaged in the development of a new generation of highly differentiated immuno-oncology therapeutics for patients, priced its initial public offering, or IPO, of 10.586 million shares at $19.00 per share, above the estimated price range of $16-$18. The shares will begin trading on the Nasdaq under the ticker symbol ITOS. The offering is expected to generate gross proceeds of $201.1 million.

Nurix Therapeutics, Inc., a company developing targeted protein modulation drugs, priced its IPO of 11 million shares at $19 per share, for generating gross proceeds of $209 million. The company had earlier estimated a price range of $17-$18. The shares will commence trading on the Nasdaq under the ticker symbol NRIX.

Inozyme Pharma, Inc, a rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization, priced its upsized IPO of 7 million shares at $16 per share, for raising gross proceeds of $112 million. The shares are expected to commence trading on the Nasdaq under the ticker symbol INZY.