The Daily Biotech Pulse: Moderna Japanese Vaccine Deal Talk, Lipocine FDA Decision, Liver Congress Presentations

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 27)

• Abbott Laboratories ABT( announced emergency use authorization for an affordable rapid COVID-19 antigen test)
• Inari Medical Inc NARI
• Intuitive Surgical, Inc. ISRG
• Kura Oncology Inc KURA
• Merit Medical Systems, Inc. MMSI
• Silk Road Medical Inc SILK
• Shockwave Medical Inc SWAV
• Tandem Diabetes Care Inc TNDM
• TFF Pharmaceuticals Inc TFFP

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 27)

• Cyclacel Pharmaceuticals Inc CYCC
• Gritstone Oncology Inc GRTS
• Happiness Biotech Group Ltd HAPP
• Harmony Biosciences Holdings Inc HRMY
• Inhibrx Inc INBX
• Odonate Therapeutics Inc ODT (announced a common stock offering)
• Polypid Ltd PYPD
• Psychemedics Corp. (NASDAQ: PMD

Stocks In Focus

Moderna In Talks to Supply 40M Coronavirus Vaccine to Japan

Moderna Inc MRNA said it's in discussions with the Ministry of Health, Labour and Welfare of Japan to potentially purchase 40 million or more doses of mRNA-1273, its vaccine candidate against COVID-19, to support Japan's aim of providing vaccines to the public as soon as possible.

The agreement being negotiated calls for Moderna supplying the vaccine and Japanese drugmaker Takeda Pharmaceutical Co., Ltd. TAK distributing it, beginning in the first half of 2021, contingent on the vaccine getting the regulatory nod.

Surface Oncology Rallies On Bullish Sell-side Comments

Surface Oncology Inc SURF shares saw some strength in after-hours trading after Wedbush set a price target equivalent to the current Street-high target of $12 and assigned an Outperform rating.

The stock was up 4.14% to $5.53.

Offerings

Oncternal Therapeutics Inc ONCT priced its offering on a firm commitment basis of 2.143 million shares at $2.10 per share. The closing of the offering is expected to occur on or about Sept. 10.

The stock slipped 12.10% to $2.18 in after-hours trading.

On The Radar

PDUFA Dates

Lipocine Inc LPCN is knocking at FDA's doors for the fourth time with respect to its Tlando, an oral prodrug of testosterone containing testosterone undecanoate that is designed to help restore normal testosterone levels in hypogonadal men.

Clinical Readouts/Presentations

European Association for the Study of the Liver, Digital International Liver Congress 2020 Presentations

Arrowhead Pharmaceuticals Inc ARWR: an oral presentation showing short-term treatment with RNA interference therapy, JNJ-3989

Viking Therapeutics Inc VKTX: new data from the Phase 2 study of VK2809 in patients with non-alcoholic fatty liver disease, or NAFLD, and elevated LDL-cholesterol.

Axcella Health Inc AXLA: key data from AXA1125-003, assessing the impact of AXA1125 and AXA1957 in NAFLD.

Intercept Pharmaceuticals Inc ICPT: new interim analysis of data from the Phase 3 REGENERATE study of obeticholic acid in non-alcoholic steatohepatitis, or NASH, and additional long-term data of OCA through six years of open-label treatment in PBC.

Alnylam Pharmaceuticals, Inc. ALNY and Vir Biotechnology Inc VIR: results from an ongoing Phase 2 study of VIR-2218 in patients with chronic hepatitis B virus.