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

In this article:

Scaling The Peaks

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

  • Abbott Laboratories (NYSE: ABT)( announced emergency use authorization for an affordable rapid COVID-19 antigen test)

  • Inari Medical Inc (NASDAQ: NARI)

  • Intuitive Surgical, Inc. (NASDAQ: ISRG)

  • Kura Oncology Inc (NASDAQ: KURA)

  • Merit Medical Systems, Inc. (NASDAQ: MMSI)

  • Silk Road Medical Inc (NASDAQ: SILK)

  • Shockwave Medical Inc (NASDAQ: SWAV)

  • Tandem Diabetes Care Inc (NASDAQ: TNDM)

  • TFF Pharmaceuticals Inc (NASDAQ: TFFP)

Down In The Dumps

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

  • Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC)

  • Gritstone Oncology Inc (NASDAQ: GRTS)

  • Happiness Biotech Group Ltd (NASDAQ: HAPP)

  • Harmony Biosciences Holdings Inc (NASDAQ: HRMY)

  • Inhibrx Inc (NASDAQ: INBX)

  • Odonate Therapeutics Inc (NASDAQ: ODT) (announced a common stock offering)

  • Polypid Ltd (NASDAQ: PYPD)

  • Psychemedics Corp. (NASDAQ: PMD

Stocks In Focus Moderna In Talks to Supply 40M Coronavirus Vaccine to Japan

Moderna Inc (NASDAQ: 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. (NYSE: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: ARWR): an oral presentation showing short-term treatment with RNA interference therapy, JNJ-3989

Viking Therapeutics Inc (NASDAQ: 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 (NASDAQ: AXLA): key data from AXA1125-003, assessing the impact of AXA1125 and AXA1957 in NAFLD.

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

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