The Daily Biotech Pulse: Novavax Vaccine Data, Aerpio Gets $5.1M Funding For COVID Trial, Rigel Gains Big On Earnings

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 4)

  • ABIOMED, Inc. ABMD (FDA approved the emergency use of Abiomed's Impella heart pump in combination with an oxygen machine to treat Covid-19 patients who suffer heart and lung failure)
  • Allovir Inc ALVR (IPOed Thursday)
  • Alterity Therapeutics Ltd ATHE ( announced positive preclinical data for its lead drug in Multiple System Atrophy)
  • ALX Oncology Holdings Inc ALXO
  • Cardiff Oncology Inc CRDF
  • Cocrystal Pharma Inc COCP (announced the publication of positive preclinical animal studies of coronavirus antiviral compounds in a medical journal)
  • Dr.Reddy's Laboratories Ltd RDY
  • Fulgent Genetics Inc FLGT
  • Hologic, Inc. HOLX
  • Inari Medical Inc NARI
  • Inozyme Pharma Inc INZY
  • Quidel Corporation QDEL
  • Renalytix AI PLC RNLX
  • Sorrento Therapeutics Inc SRNE
  • Trevena Inc TRVN
  • Twist Bioscience Corp TWST
  • Varian Medical Systems, Inc. VAR
  • Zoetis Inc ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 4)

  • Pandion Therapeutics Holdco LLC PAND
  • Verrica Pharmaceuticals Inc VRCA

Stocks In Focus

Novavax Announces Positive Phase 1 Data For Coronavirus Vaccine

Novavax, Inc. NVAX announced Phase 1 data from its Phase 1/2 randomized, observer-blinded, placebo-controlled trial of its COVID 19 vaccine NVX CoV2373 with and without Matrix M adjuvant, which showed the investigational vaccine was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.

Overall, the investigational vaccine was well-tolerated and had a reassuring safety profile.

In after-hours trading, the stock rallied 12.62% to $177.

Genfit Announces Publication of Data On Technology to Identify At-risk NASH Patients

Genfit SA GNFT said pivotal data describing the derivation and validation of NIS4 has been accepted for publication by "The Lancet Gastroenterology and Hepatology." NIS4 is GENFIT's non-invasive, blood-based diagnostic technology to identify patients with non-alcoholic steatohepatitis and significant to advanced fibrosis, also referred to as at-risk NASH in the published study.

"The complexity of underlying chronic liver diseases, such as NASH, is that these conditions often do not present with obvious symptoms until the disease is in very advanced stages."

"Hence, we believe non-invasive testing will continue to gain importance within healthcare systems given the capability to identify those who may require more aggressive medical intervention with a simple blood draw while maintaining high diagnostic accuracy," said Suneil Hosmane, Head of Global Diagnostics at GENFIT."

In pre-market trading, the stock was gaining 5.71% to $5.55.

Roche Gets FDA Authorization For Quantitative Test to Detect Epstein-Barr Virus

Roche Holdings AG Basel ADR Common Stock RHHBY said the FDA has authorized the cobas EBV test, the first quantitative in vitro diagnostic test for Epstein-Barr virus (DNA in the United States.

"This authorization gives healthcare professionals a key tool in monitoring transplant patients at risk for complications from infections or reactivations of EBV, by providing the ability to run a large number of patient tests for this virus in a short period of time," the company said.

Aerpio Awarded $5.1M In Government Funding For A Mid-stage Study of COVID-19 Treatment

Aerpio Pharmaceuticals Inc ARPO announced an agreement with the U.S. government to evaluate its razuprotafib in a new investigational trial for the prevention and treatment of Acute Respiratory Distress Syndrome, or ARDS, in adult patients with moderate to severe COVID-19.

The Medical Technology Enterprise Consortium, on behalf of the government, will provide up to $5.1 million in funding toward the clinical trial, while Aerpio will support the trial with a spending of $2.8 million.

The partnership between Aerpio and MTEC will provide resources to support a second COVID-19 Phase 2 clinical trial, Aerpio said.

The stock was jumping 44.70% to $1.91 in pre-market trading.

BioNTech, Partner Fosun Begin Phase 1 Study of Coronavirus Vaccine Candidate In China

BioNTech SE – ADR BNTX and Fosun Pharma announced the first 72 participants have been dosed with BNT162b1 in a Phase 1 study in China following IND approval by the Chinese regulatory authority, National Medical Products Administration. The companies are jointly developing the COVID-19 vaccine candidate in China.

The Phase 1 study, according to the companies, will evaluate safety and immunogenicity in Chinese participants to support potential regulatory approval in China.

Earnings

Fulgent Genetics' second-quarter revenues jumped 105% year-over-year to $17.3 million, and the non-GAAP net income increased from 6 cents per share to 17 cents per share. The results were well ahead of consensus estimates.

In after-hours trading, the stock jumped 16.20% to $34.50.

Rigel Pharmaceuticals, Inc.'s RIGL second-quarter net loss per share narrowed from 12 cents in 2019 to 10 cents in 2020. Analysts, on average, had estimated a loss of 13 cents per share. Revenues increased year-over-year from $10.41 million to $16.02 million.

The stock advanced 12.20% to $2.76.

Vapotherm Inc VAPO said its second-quarter revenues climbed 193.3% to $35.2 million. The loss per share narrowed from 76 cent in 2019 to 35 cents in 2020, while analysts expected a loss of 39 cents per share.

For the third quarter, the company expects revenues of $24 million to $28 million, above the $18.65 million consensus estimate.

The stock was plunging 28.44% to $37.75.

On The Radar

Earnings

Constellation Pharmaceuticals Inc CNST (before the market open)
Vericel Corp VCEL (before the market open)
Eyepoint Pharmaceuticals Inc EYPT (before the market open)
PPD Inc PPD (before the market open)
Horizon Therapeutics PLC HZNP (before the market open)
Moderna Inc MRNA (before the market open)
Ionis Pharmaceuticals Inc IONS (before the market open)
Regeneron Pharmaceuticals Inc REGN (before the market open)
Harvard Bioscience, Inc. HBIO (before the market open)
IVERIC bio Inc ISEE (before the market open)
Brainstorm Cell Therapeutics Inc BCLI (before the market open)
BioDelivery Sciences International, Inc. BDSI (before the market open)
Allogene Therapeutics Inc ALLO
Arena Pharmaceuticals, Inc. ARNA
ADMA Biologics Inc ADMA (after the close)
ACADIA Pharmaceuticals Inc. ACAD (after the close)
AxoGen, Inc Common Stock AXGN (after the close)
Arrowhead Pharmaceuticals Inc ARWR (after the close)
Global Blood Therapeutics Inc GBT (after the close)
Transenterix Inc TRXC (after the close)
Kindred Biosciences Inc KIN (after the close)
ResMed Inc. RMD (after the close)
Silk Road Medical Inc SILK (after the close)
Tricida Inc TCDA (after the close)
SurModics, Inc. SRDX (after the close)
Varian Medical Systems, Inc. VAR (after the close)
Immunomedics, Inc. IMMU (after the close)
PTC Therapeutics, Inc. PTCT (after the close)
Sangamo Therapeutics Inc SGMO (after the close)
TRACON Pharmaceuticals Inc TCON (after the close)
Lyra Therapeutics Inc LYRA (after the close)
Miragen Therapeutics Inc MGEN (after the close)
Zogenix, Inc. ZGNX (after the close)
Sarepta Therapeutics Inc SRPT (after the close)
Natera Inc NTRA (after the close)
OraSure Technologies, Inc. OSUR (after the close)
Orthopediatrics Corp KIDS (after the close)
G1 Therapeutics Inc GTHX (after the close)
Globus Medical Inc GMED (after the close)
TransMedics Group Inc TMDX (after the close)
Nevro Corp NVRO (after the close)
Collegium Pharmaceutical Inc COLL (after the close)
Endo International PLC ENDP (after the close)

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