The Daily Biotech Pulse: Sanofi, Regeneron Drop COVID-19 Study, 2 Positive AstraZeneca Catalysts, Brickell Awarded Japanese Patent

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 31)

  • 10X Genomics Inc TXG
  • Acutus Medical Inc AFIB (reacted to sell-side initiations following expiry of IPO quiet period)
  • Cardiff Oncology Inc CRDF
  • Catalent Inc CTLT (reacted to fourth-quarter results)
  • Checkmate Pharmaceuticals Inc CMPI
  • Corbus Pharmaceuticals Holdings Inc CRBP
  • Edwards Lifesciences Corp EW
  • Evogene Ltd EVGN
  • Fortress Biotech FBIO
  • Generation Bio Co GBIO
  • I-Mab ADR IMAB
  • Inari Medical Inc NARI
  • Inspire Medical Systems Inc INSP
  • Intuitive Surgical, Inc. ISRG
  • Kura Oncology Inc KURA
  • Merit Medical Systems, Inc. MMSI
  • PPD Inc PPD
  • Protagonist Therapeutics Inc PTGX
  • Replimune Group Inc REPL
  • Revance Therapeutics Inc RVNC
  • Rhythm Pharmaceuticals Inc RYTM
  • Silk Road Medical Inc SILK
  • Shockwave Medical Inc SWAV
  • TFF Pharmaceuticals Inc TFFP
  • TG Therapeutics Inc common stock TGTX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 31)

  • Acasti Pharma Inc ACST (reacted to a negative readout for a second late-stage study of its hypertriglyceridemia candidate CaPre)
  • China SXT Pharmaceuticals Inc SXTC
  • Cyclacel Pharmaceuticals Inc CYCC
  • Happiness Biotech Group Ltd HAPP
  • Immatics NV IMTX
  • Predictive Oncology Inc POAI
  • Psychemedics Corp. PMD
  • Rockwell Medical Inc RMTI
  • Sun BioPharma, Inc. SNBP

Stocks In Focus

Sanofi's Kevzara Flunks Late-Stage COVID-19 Study 

Sanofi SA SNY said the global Phase 3 trial investigating intravenously administered Kevzara at doses of 200mg or 400mg in severely or critically ill hospitalized COVID-19 patients did not meet its primary endpoint and key secondary endpoint.

The 420-patient randomized trial was conducted outside the U.S. in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia and Spain.

Kevzara is being jointly developed by Sanofi and Regeneron Pharmaceuticals Inc REGN.

"At this time, Sanofi and Regeneron do not anticipate conducting further clinical studies for Kevzara in COVID-19," Sanofi said.

Sanofi stock was up 1.07% at $51.12 in premarket trading Tuesday, while Regeneron was lower by 0.26% at $618.33. 

Roche's Qualitative AIDS Test Approved In US

Roche Holdings AG Basel ADR Common Stock RHHBY announced FDA approval for the cobas HIV-1/HIV-2 qualitative test for use on the fully automated cobas 6800/8800 Systems in the U.S.

The test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, an important distinction needed to identify appropriate treatment options.

Vanda Issues Update On Tradipitant Development Program

Vanda Pharmaceuticals Inc. VNDA issued an update on the developmental plan for its tradipitant, with the pipeline asset now advancing in a late-stage study for the treatment of both diabetic and idiopathic gastroparesis. The company expects enrollment into the Phase 3 study in gastroparesis to be completed in the first half of 2021.

A robust package of preclinical program for tradipitant has been completed, including a two-year carcinogenicity study, the company said.

Vanda also said it is in disagreement with FDA's requirement to conduct a standard nine-month non-rodent chronic toxicity study, as it would necessitate the sacrifice of dozens of animals.

The company said it is currently recruiting patients in the Phase 3 ODYSSEY study that is evaluating tradipitant for acute respiratory distress associated with COVID-19, and is preparing to resume the motion sickness study, while the recruitment into an atopic dermatitis study remains on hold.

The stock slid 7.19% to $9.55 in after-hours trading.

See also: The Week Ahead In Biotech: Bristol-Myers Squibb FDA Decision, Adcom Review For Glaxo, Amarin Vascepa Hearing

MediciNova Preps Production Of Coronaviruus Vaccine Candidates For Human Trials

MediciNova, Inc. MNOV, which is working on an intranasal formulation of a coronavirus vaccine candidate, said it is in the process of analyzing neutralizing antibody titers through in-vivo testing.

It also said it would conduct tests such as induction of mucosal immunity and measurement of the antibody titer, analysis of cell-mediated immunity — CD4/CD8-positive T cells — and an in-vivo study to test the vaccine prototype's efficacy by nasal spray to prevent viral infection.

MediciNova said it is preparing to start production of vaccine candidates for safety toxicology tests and clinical trials.

In premarket trading Tuesday, the stock was adding 7.63% to $5.64.

AstraZeneca Begins Late-Stage US Study Of Coronavirus Vaccine Candidate, Announces EU Nod For Cancer Drug

AstraZeneca plc AZN said it has commenced a Phase 3 study of its coronavirus vaccine candidate AZZ1222 in the U.S. that would assess the safety and immunogenicity of the vaccine across all age groups.

The late-stage study in the U.S., funded by the BARDA and the NIAID, plans to recruit up to 30,000 adults ages 18 years and older from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus.

Separately, AstraZeneca said Imfinzi has been approved in the European Union for the first-line treatment of adults with extensive-stage small cell lung cancer in combination with a choice of chemotherapies: etoposide plus either carboplatin or cisplatin.

GlaxoSmithKline Begins Late-Stage Study Of 5-in-1 Meningococcal Vaccine Candidate

GlaxoSmithKline plc GSK said the first participant in the Phase 3 study of its 5-in-1 meningitis vaccine candidate compared to licensed meningococcal vaccines Bexsero and Menveo has been vaccinated. The trial is a global study that envisages to enroll 3,650 participants ages 10-25 in Canada, the U.S., Europe, Turkey and Australia.

In after-hours trading, the stock edged down 0.25% to $39.50.

Brickell Granted Japanese Patent Related To Hyperhidrosis Drug Candidate

Brickell Biotech Inc BBI said the company and its Japanese development partner Kaken Pharma were granted by the Japanese Patent Office a composition of matter patent with claims directed to the novel polymorphic, or crystalline, forms of sofpironium bromide.

The substance is a retrometabolically designed new chemical entity under development in the U.S. and Japan as a potential treatment for primary axillary hyperhidrosis.

The stock was trading 3.17% higher at 97 cents premarket Tuesday.

Unity Biotech Appoints Lynne Sullivan as CFO

Unity Biotechnology Inc UBX announced the appointment of pharma and biotech industry veteran Lynne Sullivan to the permanent role of chief financial officer effective Sept. 1.

T2 Biosystems COVID-19 Test Receives Emergency Use Authorization

T2 Biosystems Inc TTOO said the FDA has issued emergency use authorization for its COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel.

The test provides results in under two hours utilizing a nasopharyngeal swab sample and runs on the company's FDA-cleared and fully-automated T2Dx Instrument, which is capable of performing seven tests simultaneously, the company said.

Clinical testing on both positive and negative patient samples demonstrated a sensitivity of 95% and specificity of 100%, T2 Biosystems said.

The stock was trading 14.1% higher at $1.78 in the premarket session.

Lead Plus Therapeutics Drug Gets Orphan Designation In Recurrent Glioblastoma

Plus Therapeutics Inc PSTV said the FDA granted orphan drug designation for its lead investigational drug, Rhenium NanoLiposomes, for the treatment of patients with recurrent glioblastoma.

The stock was surging up 27.35% to $3.12 premarket Tuesday.


Zosano Pharma Corp ZSAN said it has commenced an underwritten public offering of shares of its common stock. All of the shares to be sold in the offering are to be issued by the company.

The stock was down 14.11% at $1.40 premarket.

On The Radar


Avid Bioservices Inc CDMO (Tuesday, after the close)

Related Link: 2 Moderna Analysts On Chances Of COVID-19 Vaccine Approval, Upcoming Catalysts

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