The Daily Biotech Pulse: Amarin's Vascepa Appeal Hearing, Avid Bioservices' Strong Q1, A Life Sciences Blank Check IPO

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Sept. 1)

• 10X Genomics Inc TXG
• Acutus Medical Inc AFIB
• Akouos Inc AKUS
• Catalent Inc CTLT
• Evogene Ltd EVGN (announced $10 million equity investment led by ARK Investment Management)
• I-Mab ADR IMAB
• Immunomedics, Inc. IMMU
• Intuitive Surgical, Inc. ISRG
• Pacific Biosciences of California Inc PACB
• PPD Inc PPD
• Shockwave Medical Inc SWAV
• Tandem Diabetes Care Inc TNDM
• TG Therapeutics Inc common stock TGTX
• Twist Bioscience Corp TWST
• West Pharmaceutical Services Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 1)

• Acasti Pharma Inc ACST
• ADiTx Therapeutics Inc ADTX
• China SXT Pharmaceuticals Inc SXTC
• Entera Bio Ltd ENTX
• Freeline Therapeutics Holdings PLC FRLN
• Happiness Biotech Group Ltd HAPP
• Histogen Inc HSTO
• Immatics NV IMTX
• NanoVibronix Inc NAOV
• Oncternal Therapeutics Inc ONCT
• Predictive Oncology Inc POAI
• Rockwell Medical Inc RMTI
• Sun BioPharma, Inc. SNBP

Stocks In Focus

Mesoblast Gets Ethics Approval For Using Stem Cell Therapy In COVID-19 Patients In Australia

Mesoblast MESO said it has received ethics approval to include Australian hospitals in the Phase 3 randomized controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with acute respiratory distress syndrome.

The company said an independent Data Safety Monitoring Board will complete an interim analysis this month in the trial's first 90 patients randomized in the US after they have completed 30 days of follow up.

The stock was up 2.16% to $19.36 in pre-market trading.

Castle Biosciences Announces Executive Promotions and Appointment of Medical Director

Castle Biosciences Inc CSTL announced the promotion of Toby Juvenal to the role of chief commercial officer. Juvenal has been with the company since Oct. 2008 and was most recently serving as SVP of sales. The company also announced the promotion of Kirsten Oelschlager as chief operations officer and Bob Cook as SVP, R&D.

Castle Biosciences also said Matthew Goldberg has joined the company as Medical Director in August.

Vir Biotech Appoints Former Arizona Governor Napolitano To Its Board

Vir Biotechnology Inc VIR announced the appointment of former Arizona Governor and former U.S. Secretary of Homeland Security Janet Napolitano to its board of directors, replacing Kristina Burow, who has resigned after four years as a founding director.

Earnings

Avid Bioservices Inc CDMO reported fiscal year 2021 first-quarter revenues of $25.4 million, up 66% year-over-year. The increase was attributed primarily to the number and scale of in-process and/or completed manufacturing runs. The company reversed from a loss of 8 cents per share to a profit of 6 cents per share. Analysts had estimated a loss of 7 cents per share.

The company confirmed its fiscal year guidance of $76 million to $81 million, surrounding the consensus estimate of $78.96 million.

The stock jumped 5.05% to $8.95 in after-hours trading.

In its first quarterly report as a public company, iTeos Therapeutics Inc ITOS said its second-quarter loss narrowed from $36.49 cents per share to $29.49 cents per share. The company had cash of $136.9 million as of June 30, 2020.

On The Radar

Federal Circuit appellate hearing related to Amarin Corporation plc's AMRN Vascepa patent is scheduled to be held. The hearing is to take place telephonically.

In late March, Amarin was handed down an adverse ruling in its patent challenge case against generic drug makers Dr.Reddy's Laboratories Ltd RDY and Hikma

"A reversal of the patent invalidation ruling, if it occurs, would likely secure exclusivity for branded Vascepa in the US for a significant period of time (until late in the decade, we think), and is an outcome which we believe is currently not priced-in to share," Aegis Capital's Nathan Weinstein said.

IPOs

CM Life Sciences, Inc. priced its initial public offering of 38.50 million units at $10 per unit. The units are to be listed on Nasdaq under the ticker symbol CMLFU, beginning Wednesday.

Each unit consists of one share of Class A common stock and one-third of one redeemable warrant, with each whole warrant exercisable to purchase one share of Class A common stock at a price of $11.50 per share. The company expects the offering to be consummated on Sept. 4.

The company, sponsored by affiliates of Casdin Capital, LLC and Corvex Management LP, is led by CEO Eli Casdin and Chairman Keith Meister. It said it intends to focus its search for business combination targets in three separate areas of the life sciences industry that are often fragmented – life sciences tools, synthetic biology and diagnostics.

Related Link: Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates