The Daily Biotech Pulse: FDA Nod For UroGen, Novavax Coronavirus Vaccine To Enter Clinics, Soligenix Licenses Vaccine Adjuvant

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs April 15.)

Bio-Rad Laboratories, Inc. Class B Common Stock BIO
Calithera Biosciences Inc CALA (provided an update on the impact of COVID-19 on its ongoing clinical trials)
Eli Lilly And Co LLY
Keros Therapeutics Inc KROS (went public April 8)
Masimo Corporation MASI
Moderna Inc (NASDAQ: MRNA (analysts hiked price targets for the shares following the company's Virtual Vaccines Day)
Pluristem Therapeutics Inc. PSTI
Regeneron Pharmaceuticals Inc REGN

Down In The Dumps

(Biotech stocks that hit 52-week lows April 15.)

Akorn, Inc. AKRX
AxoGen, Inc Common Stock AXGN
TherapeuticsMD Inc TXMD
Vaccinex Inc VCNX
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Stocks In Focus

UroGen's Kidney Cancer Drug Gets FDA Approval

Urogen Pharma Ltd URGN said the FDA granted expedited approval for its Jelmyto for pyelocaliceal solution, indicated to treat adults with low-grade upper tract urothelial cancer. The company said the approval was granted based on positive results from a Phase 3 Olympus trial that demonstrated Jelmyto's effectiveness in this rare and difficult-to-treat cancer.

Jelmyto consists of mitomycin, an established chemotherapy and sterile hydrogel, using Urogen's proprietary sustained release RTGel technology.

The stock was trading more than 14% higher at $24 in Thursday's premarket session.

Accelerate Diagnostics Pre-Announces In-Line Q1 Revenue

Accelerate Diagnostics Inc AXDX said it expects first-quarter net sales of $2.3 million, higher than $1.8 million in the year-ago period and in line with the consensus estimate.

Citing the uncertainty surrounding the duration of the COVID-19 pandemic, the company withdrew its guidance.

The stock rallied 7.89% to $9.02 in after-hours trading.

Vanda To Study Impact Of Human Genetic Variations On Coronavirus Infection, Progression

Vanda Pharmaceuticals Inc. VNDA announced the initiation of the CALYPSO program to study the role that human genetic variations play in SARS-CoV-2 infection and disease progression. The company said it will collaborate with the University of Washington School of Medicine and its Virology Lab on a pharmacogenetics study in COVID-19 patients.

"The study will focus on the sequencing of the genome of individual patients, as well as the COVID-19 virus, and the identification of genetic factors that correlate with disease progression and outcomes," according to Vanda.

Separately, Vanda said it has enrolled the first patient in its ODYSSEY trial at Lenox Hill Hospital in New York City with Northwell Health's research arm. The ODYSSEY trial is a Phase 3 study investigating the efficacy and safety of tradipitant, a neurokinin-1 receptor antagonist, in the treatment of neurogenic inflammation of the lung secondary to SARS-CoV-2 infection.

The stock was trading 8.45% higher at $11.30 in Thursday's premarket session.

Vir Presents Positive Data For Hepatitis B Virus Drug

Vir Biotechnology Inc VIR announced additional interim data from the ongoing Phase 2 study and results from the Phase 1 trial in healthy volunteers of VIR-2218, an investigational small interfering ribonucleic acid that mediates RNA interference for the treatment of chronic hepatitis B virus infection.

The company said interim results from the Phase 2 study showed VIR-2218 resulted in a significant dose-dependent and durable reduction in hepatitis B surface antigen through week 24 in patients who received two doses ranging from 20 mg to 200 mg.

Vir had licensed the investigational asset from Alnylam Pharmaceuticals, Inc. ALNY. Vir said it will initiate combination trials of VIR-2218 with a shortened course of pegylated interferon, with dosing likely to begin in the second half of 2020.

Vir shares were trading 0.79% higher at $29.50 in the premarket session.

Co-Diagnostics Says COVID-19 Tests Validated For Use With Saliva Samples

Co-Diagnostics Inc CODX said OralDNA Labs, a CLIA-certified laboratory, recently validated a COVID-19 PCR test based on the its patented CoPrimer technology for use with saline oral rinse samples, and has notified the FDA of their intent to use the validated test in their CAP accredited high-complexity laboratory.

The stock was adding 7.16% to $10.18 in premarket trading.

Soligenix Licenses COVID-19 Vaccine Adjuvant From Boston Scientific Unit

Soligenix, Inc. Common Stock SNGX announced an agreement for exclusive worldwide licensing of CoVaccine HT, a novel vaccine adjuvant, from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation BSX, for SARS-CoV-2.

The stock was ripping higher by 60% to $2.24 in premarket trading.

Eagle Pharma Submits IND For Coronavirus Treatment Candidate

Eagle Pharmaceuticals Inc EGRX said its Ryanodex for injectable suspension inhibited the growth of SARS-CoV-2 in lab tests. The company said it submitted an IND to the FDA for a Phase 2 clinical trial in partnership with Hackensack University Medical Center to evaluate the efficacy of Ryanodex in patients infected with the virus.

Inovio Nets $6.9M In Funding To Initiate South Korean Clinical Trial Of Coronavirus Vaccine Candidate

Inovio Pharmaceuticals Inc INO has been granted $6.9 million in funding by the Coalition for Epidemic Preparedness Innovations to work with the International Vaccine Institute and the Korea National Institute of Health for a Phase 1/2 clinical trial of INOVIO's COVID-19 vaccine candidate INO-4800 in South Korea, according to the IVI.

The organization said it will conduct the trial in South Korea.

In premarket trading Thursday, Inovio shares were advancing 7.84% to $7.70.

Ascendis' Growth Hormone Deficiency Drug Granted Orphan Drug Designation

Ascendis Pharma A/S ASND said the FDA has granted Orphan Drug Designation to its TransCon hGH as a treatment for growth hormone deficiency.

AEterna Warned On Nasdaq Listing Standards, Has 180-Day Grace Period To Regain Compliance

AEterna Zentaris Inc. AEZS said it has received notice from Nasdaq indicating the company is not in compliance with the minimum $1-per-share bid price requirement, having closed below $1 per share for the prior 30 consecutive business days. The company said it has been provided a grace period of 180 calendar days through Oct. 5 to regain compliance.

Novavax Coronavirus Vaccine To Enter Clinics In Australia

Novavax, Inc.'s NVAX Australian development partner Nucleus Network said it is due to commence Phase 1 testing of the former's NVX-CoV2372, a SARS-CoV-2 recombinant spike protein nanoparticle vaccine, at its Melbourne and Brisbane clinics in the coming weeks.

In premarket trading Thursday, Novavax shares were adding 2.51% to $17.97.

Offerings

Calithera said it has priced its underwritten public offering of 5 million shares at $6.25 per share. The company expects to raise gross proceeds of $31.25 million from the offering. The offering is expected to close April 20.

The stock was down 1.18% to $7.51 in the premarket session.

Arcturus Therapeutics Ltd ARCT, which recently issued an update on its COVID-19 vaccine development program, said it intends to sell shares of its common stock in an underwritten public offering. All the shares are to be offered by the company.

The company said it intends to use the net proceeds for working capital and general corporate purposes, including capex and R&D expenses related to the advancement of its LUNAR-OTC, LUNAR-COV19 and its other product candidates and clinical trial expenditures.

The stock was down 3.06% at $17.45 in the premarket session.

Athersys Inc ATHX said it intends to offer $50 million of its common stock for sale in an underwritten public offering. The company said it will use the net proceeds for working capital and general corporate purposes, including funding its acute respiratory distress syndrome clinical program, which includes initiation of a Phase 2/3 pivotal study for COVID-19-induced ARDS patients, and its process development and manufacturing projects.

The stock was down 25.81% at $2.30 in the premarket session.

On The Radar

Clinical Readouts

Moleculin Biotech Inc MBRX is hosting a web-based investor conference call at 4:30 p.m. ET Thursday to explain the significance of the recent discovery that the active compound in its WP1122 drug candidate, which it has licensed to WPD Pharmaceuticals Inc WCOTF, has been shown to reduce replication of SARS-CoV-2 by 100%.

Earnings

Thursday

Abbott Laboratories ABT (before the market open)

Intuitive Surgical, Inc. ISRG (after the close)

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