The Daily Biotech Pulse: FDA Nod For Roche, Arbutus Releases Positive Readout For HBV Therapy, Moderna Announces $1.34B Common Stock Offering

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 May 18)

ADC Therapeutics SA ADCT (went public May 15)
Allogene Therapeutics Inc ALLO
Arcturus Therapeutics Ltd ARCT
AtriCure Inc. ATRC
Biondvax Pharmaceuticals Ltd – ADR BVXV
Bio-Rad Laboratories, Inc. Class A Common Stock BIO
BioXcel Therapeutics Inc BTAI
Black Diamond Therapeutics Inc BDTX
Cytokinetics, Inc. CYTK
DexCom, Inc. DXCM
Evoke Pharma Inc EVOK
GENMAB A/S/S ADR GMAB
Geron Corporation GERN
Horizon Therapeutics PLC HZNP
I-Mab ADR IMAB
Immunomedics, Inc. IMMU
Intellia Therapeutics Inc NTLA
Kala Pharmaceuticals Inc KALA
Madrigal Pharmaceuticals Inc MDGL
Mersana Therapeutics Inc MRSN
Minerva Neurosciences Inc NERV
Moderna Inc MRNA (announced positive interim Phase 1 readout for coronavirus vaccine)
Myokardia Inc MYOK
Neurocrine Biosciences, Inc. NBIX
Novavax, Inc. NVAX (reacted to upward price target adjustment by B. Riley FBR)
PDL BioPharma Inc PDLI
Regeneron Pharmaceuticals Inc REGN
Repligen Corporation RGEN
Replimune Group Inc REPL
Sorrento Therapeutics Inc SRNE
Tandem Diabetes Care Inc TNDM
Translate Bio Inc TBIO
Twist Bioscience Corp TWST
Ultragenyx Pharmaceutical Inc RARE
United Therapeutics Corporation UTHR
Vermillion, Inc. VRML
Vertex Pharmaceuticals Incorporated VRTX
West Pharmaceutical Services Inc. WST
Y-mAbs Therapeutics, Inc YMAB
Zai Lab Ltd ZLAB
Zynex Inc. ZYXI (announced new line of products)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 18)

Genfit SA GNFT
Lyra Therapeutics Inc LYRA (went public May 1)

Stocks In Focus

Arbutus Reports Positive Early Stage Results For RNAi Therapy In Hepatitis B

Arbutus Biopharma Corp ABUS announced positive follow-up data from a Phase 1a/1b clinical trial in chronic HBV subjects on nucleos(t)ide therapy who received a single subcutaneous injection of 60 mg of AB-729, a proprietary GalNAc-delivered RNAi compound.

"These new data further demonstrate the robust activity of AB-729. At week 12, the 60 mg single-dose achieved equivalent reductions in HBsAg as the 180 mg single-dose," CEO William Collier said in a statement.

The company said it is dosing chronic HBV subjects in a multi-dose cohort with 60 mg at four-week intervals. It also intends to evaluate 60 mg at eight-week intervals while also exploring an additional 90 mg single-dose cohort. The company expects data from both 60-mg multi-dose cohorts in the second half of the year and the week 12, 90-mg single-dose in the second half of 2020.

The stock was up 36.9% at $2.56 in Tuesday's premarket session.

Roche's Tecentriq Approved As Initial Treatment For Some Lung Cancer Patients

Roche Holdings AG Basel ADR Common Stock RHHBY said the FDA approved Tecentriq as a first-line treatment for adults with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression.

"We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions," Levi Garraway, chief medical officer and head of global product development at Roche, said in a statement.

Novartis' Zolgensma Receives Conditional Approval In Europe

Novartis AG's NVS AveXis unit said the European Commission granted conditional approval for Zolgensma in the treatment of patients with spinal muscular atrophy and a clinical diagnosis of SMA Type 1, or SMA patients with up to three copies of the SMN2 gene.

The company said immediate access to Zolgensma, aligned to the label, is available in France through the ATU framework and is expected shortly in Germany. It is also in discussions with EU governments and reimbursement agencies to agree on terms of innovative "Day One" access program to enable rapid access in all EU countries given the urgent need to treat SMA.

Hepion To Advance NASH Candidate Into Phase 2 Trial

Hepion Pharmaceuticals Inc HEPA said it has completed the submission of a Phase 1 data memo and the Phase 2a protocol to the FDA, and intends to commence its Phase 2a clinical trial of CRV431 for the treatment of NASH fibrosis in June.

In premarket trading Tuesday, Hepion shares were rallying 18.34% to $2.

Quidel Obtains New EUA For COVID-19 Test

Quidel Corporation QDEL said it has received Emergency Use Authorization for the Lyra Direct SARS-CoV-2 Assay from FDA to allow direct sample processing.

The company said that under the new EUA, the assay no longer requires an upfront sample extraction, as it uses a reformulated buffer that replaces the extraction step with a simple 10-minute heat step, saving approximately 50 minutes in processing time.

Oxford Immunotech Releases Coronavirus Test Kit For Research Use

Oxford Immunotec Global PLC OXFD announced the release of the T-SPOT Discovery SARS-CoV-2 test kit. This kit is for research use only and launched under the T-SPOT Discovery brand.

The company said the T-SPOT technology goes further than simple serology by interrogating the immune system's T cell response and will enable research into the measurement of the strength of that response to SARS-CoV-2. The strength of this response may be linked to protection from reinfection.

Earnings

Adamis Pharmaceuticals Corp's ADMP first-quarter revenue fell from $4.9 million in 2019 to $4.7 million in 2020, trailing the $6.87-million consensus estimate. Cash and equivalents at the end of the first quarter totaled approximately $10.5 million.

The stock slipped 10.53% to 51 cents in after-hours trading.

Offerings

Moderna priced its underwritten public offering of 17.6 million shares at $76 per share for raising gross proceeds of about $1.34 billion. All the shares are being offered by the company. The offering is expected to close on or about May 21.

Moderna shares were down 6.37% to $74.90 in the premarket session Tuesday.

Gamida Cell Ltd GMDA priced its underwritten public offering of 13.33 million shares at $4.50 per share for aggregate gross proceeds of approximately $60 million. The offering is expected to close on or about May 21.

The stock was down 17.63% to $4.86 premarket.

Gossamer Bio Inc GOSS said it intends to offer, subject to market and other conditions, shares of common stock and convertible senior notes due 2027 in separate concurrent underwritten public offerings.

In after-hours trading, the stock shed 15.45% to $12.70.

Clovis Oncology Inc CLVS priced its common stock offering of 11.09 million shares at $8.05 per share. The offering is expected to close May 21.

The stock was down 7.59% at $8.28 premarket.

Krystal Biotech Inc KRYS priced its previously announced underwritten public offering of 2.275 million shares at $55 per share. The company said the offering is likely to raise gross proceeds of $125.1 million and close on or about May 21.

The stock was down 0.95% at $56.01 premarket.

bluebird bio Inc BLUE priced its underwritten public offering of 9.09 million shares at $55 per share. All of the shares in the offering are to be sold by the company. The company expects to raise gross proceeds of about $500 million.

The stock was down 3.48% at $55.15 premarket Tuesday.

Turning Point Therapeutics Inc TPTX priced its previously announced underwritten public offering of 5.42 million shares at $60 per share for raising gross proceeds of $325 million. The offering is expected to close on or about May 21.

Pfizer Inc. PFE announced pricing of a $4-billion debt offering, which consists of four tranches of notes. The company expects to use the net proceeds primarily for repaying debt. The offering is expected to close May 28.

The stock was down 0.32% at $37.95 premarket Tuesday.

Bellerophon Therapeutics Inc BLPH priced its offerings for an aggregate of 3.07 million shares of its common stock at $13 per share. The offerings consisted of an underwritten public offering of 1.923 million shares and a registered direct offering of 1.154 million shares to an institutional investor affiliated with a member of the company's board of directors.

The stock was falling 13.37% to $14 in Tuesday's premarket session.