The Daily Biotech Pulse: 2 IPOs, Nabriva Pneumonia Drug Gets Canadian Regulatory Nod, PhaseBio Doses First COVID-19 Trial Patient

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 July 16)

• AC Immune SA ACIU ( announced clinical trial update for its Alzheimer's vaccine candidate)
• argenx SE – ADR ARGX
• Bio-Rad Laboratories, Inc. Class A Common Stock BIO
• Castle Biosciences Inc CSTL
• Dynavax Technologies Corporation DVAX(announced a collaboration with Mt. Sinai to develop a universal influenza vaccine candidate with CpG1018 adjuvant)
• Heat Biologics Inc HTBX
• Novavax, Inc. NVAX
• Qiagen NV QGEN( Thermo Fisher Scientific Inc. TMO announced a sweetened offer to buy the company)
• Quest Diagnostics Inc DGX
• Otonomy Inc OTIC
• Principia Biopharma Inc PRNB(reacted to buyout rumors)
• Relay Therapeutics Inc RLAY (jumped 75.25% on its debut)
• Sanofi SA SNY (Bloomberg reported the French biotech is on a lookout to buy biotech companies, including Principia)
• TIZIANA LF SCIE/S ADR TLSA
• West Pharmaceutical Services Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 16)

• Avidity Biosciences Inc RNA
• Legend Biotech Corp LEGN
• Nkarta Inc NKTX (IPOed last Friday)
• Repare Therapeutics Inc RPTX
• Tricida Inc TCDA ( received a letter from FDA citing deficiencies in its NDA for the approval of metabolic acidosis treatment candidate)

Stocks In Focus

PhaseBio Doses First Patient In Potentially Pivotal Trial of PB1046 For COVID-19

PhaseBio Pharmaceuticals Inc PHAS said it has dosed the first patient in a potentially pivotal Phase 2 clinical trial, dubbed VANGARD, to evaluate PB1046 as a treatment for hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome, or ARDS.

PB1046 is a novel, once-weekly, subcutaneously-injected VIP receptor agonist that targets VPAC receptors in the cardiovascular, pulmonary and immune systems, having anti-inflammatory, antifibrotic and potent bronchodilatory and immunomodulatory effects in the respiratory system.

The stock advanced 10.21% to $5.18 in after-hours trading.

Applied DNA Reports Positive Preclinical Data For DNA Vaccine Candidates

Applied DNA Sciences Inc APDN announced linear-DNA forms of COVID-19 vaccine candidates under development by partner Takis Biotech and manufactured by it yielded strong antibody and T-cell responses even at very low doses of linear DNA, raising the potential of effective dosing empowering global utility.

In premarket trading Friday, Applied DNA shares were jumping 79.09% to $16.10.

Puma Biotech Announces Regulatory Nod For Breast Cancer Drug In Malaysia

Puma Biotechnology Inc PBYI said its licensing partner Specialised Therapeutics Asia has received marketing approval of Nerlynx in Malaysia from the Drug Control Agency, under Malaysia's Ministry of Health.

Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy.

In after-hours trading, the stock gained 3.89% to $10.15.

Nabriva's Community-acquired Pneumonia Drug Approved In Canada

Nabriva Therapeutics PLC – ADR NBRV said its partner, Sunovion Pharmaceuticals Canada Inc., has received approval from Health Canada to market oral and intravenous formulations of Xenleta for the treatment of community-acquired pneumonia in adults.

The stock jumped 29.76% to $1.09 in after-hours trading.

ASLAN to Transfer Primary Listing to Nasdaq

ASLAN PHARMACEU/ADR ASLN said it has made further progress toward a primary listing on the Nasdaq and the receipt of a Notice of Delisting from the Taipei Exchange, in an expected step in the TPEx delisting process.

The company also said it will retain its listing of ADSs on Nasdaq and existing holders of ADS do not need to take any action as a result of this announcement.

On The Radar

IPOs

Pandion Therapeutics, Inc., a clinical-stage biotech developing novel therapeutics designed to address the unmet needs of patients suffering from autoimmune disease, said it has priced its upsized initial public offering, or IPO, of 7.5 million shares at $18 per share to raise gross proceeds of $135 million. The company earlier estimated the pricing to be between $16 and $18. The shares will begin trading on the Nasdaq under the ticker symbol PAND.

LX Oncology Holdings Inc., a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, priced its IPO of 8.5 million shares at $19 per share compared to the estimated price range of $15-$17.The company expects to raise gross proceeds of $161.5 million from the offering. The shares will begin trading on the Nasdaq under the ticker symbol ALXO.

Renalytix AI plc, an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease, priced its global offering of an aggregate of 11 million shares. The offering is expected to raise gross proceeds of $74.3 million.