The Daily Biotech Pulse: FDA Vaccine Committee Meeting, Roche In $350M Deal for COVID-19 Treatment, Edwards Lifesciences Reports Q3 Beat

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 Oct. 21)

• Amicus Therapeutics, Inc. FOLD
• Athira Pharma Inc ATHA
• Bio-Rad Laboratories, Inc. Class B Common Stock BIO
• Forma Therapeutics Holdings Inc FMTX
• Immunomedics, Inc. IMMU
• Insmed Incorporated INSM
• Kalvista Pharmaceuticals Inc KALV
• Nevro Corp NVRO
• Tarsus Pharmaceuticals Inc TARS (listed on Nasdaq Friday)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 21)

• ADC Therapeutics SA ADCT
• Aerie Pharmaceuticals Inc AERI
• Alector Inc ALEC
• Artelo Biosciences Inc ARTL
• Avenue Therapeutics Inc ATXI
• Aziyo Biologics Inc AZYO
• Baudax Bio Inc BXRX
• Codiak BioSciences Inc CDAK (listed on Nasdaq Oct. 14)
• DBV Technologies ADR Representing 0.5 Ord Shs DBVT
• Intercept Pharmaceuticals Inc ICPT
• Invivo Therapeutics Holdings Corp NVIV
• Lexicon Pharmaceuticals, Inc. LXRX
• Oncternal Therapeutics Inc ONCT
• Rockwell Medical Inc RMTI
• Royalty Pharma plc RPRX

Stocks In Focus

Roche Announces Collaboration On COVID-19 Treatment

Roche Holdings AG Basel ADR Common Stock RHHBY announced a collaboration with Atea Pharmaceuticals to manufacture and distribute globally AT-527, Atea's investigational, oral, direct-acting antiviral.

AT-527 acts by blocking the viral RNA polymerase enzyme needed for viral replication. It's being studied in a Phase 2 clinical trial for hospitalized patients with moderate COVID-19.

A Phase 3 clinical trial, expected to start in the first quarter of 2021, will explore the potential use in patients outside of the hospital setting, Roche said. In addition, AT-527 may be developed for post-exposure prophylactic settings, the company said.

If approved, Atea will distribute AT-527 in the U.S., while Roche will be responsible for manufacturing and distribution outside of the U.S.

Under the terms of the agreement, Atea will receive an upfront payment of $350 million in cash from Roche, with the potential for future milestone payments and royalties.

NantKwest Doses First Patient In Coronavirus Vaccine Study

Nantkwest Inc NK and privately held ImmunityBio said the first patient has been dosed in the Phase 1 clinical trial of hAd5-COVID-19, a novel COVID-19 vaccine candidate that targets the inner nucleocapsid and the outer spike protein.

The Phase 1 trial, which is being conducted at the Hoag Hospital in Newport Beach, California, is enrolling healthy adult subjects up to age 55 with the goal of examining the safety and reactogenicity of two doses of the vaccine candidate.

In after-hours trading, the stock was up 3.94% to $7.91.

Genmab's Out-Licensed Blood Cancer Drug Produces Positive Study Results

Genmab 10 Sponsored ADR Ord Shs GMAB said the second part of the Phase 3 CASSIOPEIA study that was evaluating out-licensed investigational asset daratumumab monotherapy as a maintenance treatment for patients with newly diagnosed multiple myeloma eligible for autologous stem cell transplant produced positive results.

The study is being conducted by Johnson & Johnson's JNJ Janssen unit along with the French Intergroupe Francophone du Myelome and the Dutch-Belgian Cooperative Trial Group for Hematology Oncology.

The study met the primary endpoint of improving progression-free survival at a pre-planned interim analysis, resulting in a 47% reduction in the risk of progression or death in patients treated with daratumumab. No safety signals were observed, Genmab said.

Genmab shares were down 0.68% at $35.13 premarket Thursday.

Related Link: The Week Ahead In Biotech: Spectrum Pharma FDA Decision, Biogen And Abbott Earnings, Cancer Conference

Offerings

Helius Medical Technologies Inc HSDT announced a private placement with a select group of accredited investors, offering an aggregate of 6.64 million shares of Class A common stock, and warrants to purchase an aggregate of 3.33 million shares, at a purchase price of 52 cents per unit, consisting of one share of common stock and a warrant to purchase 0.5 shares of common stock. The private placement will raise total gross proceeds of approximately $3.4 million.

The stock was up 0.6% premarket at 45 cents.

Earnings

Edwards Lifesciences Corp EW reported third-quarter sales of $1.1 billion, up 4% year-over-year. The adjusted EPS rose 9% to 51 cents.

Analysts, on average, had estimated adjusted EPS of 44 cents on revenues of $1.09 billion.

The company raised the low end of its 2020 adjusted EPS guidance from $1.75 to $1.85, while maintaining the high end at $1.95. The consensus estimate calls for adjusted EPS of $1.84.

The stock slid 3.65% to $80.56 in after-hours trading.

On The Radar

Adcom Meetings

FDA's Vaccines and Related Biological Products Advisory Committee will meet to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19.

Clinical Readouts

Alnylam Pharmaceuticals, Inc. ALNY will present at the American Society of Nephrology Kidney Week 2020 annual meeting with results from the ILLUMINATE-B pediatric Phase 3 study of lumasiran in treating primary hyperoxaluria type 1.

Omeros Corporation OMER is due to present
final results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. The presentation in the form of a webcast is scheduled for Oct. 22 at 8:30 am.

Earnings

• Quest Diagnostics Inc DGX (Q3 revenues up 42.5% to $2.79 billion and EPS jumps 165% to $4.14; FY20 outlook raised)
• Neurometrix Inc NURO (before the market open)
• West Pharmaceutical Services Inc. WST (before the market open)
• Plus Therapeutics Inc PSTV (after the close)

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates