The Daily Biotech Pulse: Novavax Lands $1.6B For COVID-19 Vaccine, Amgen Prevails In Avastin Biosimilar Lawsuit, Cellectis Study Placed On Clinical Hold

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs July 6)

  • ACADIA Pharmaceuticals Inc. ACAD
  • Akero Therapeutics Inc AKRO
  • Amgen, Inc. AMGN
  • Biondvax Pharmaceuticals Ltd – ADR BVXV
  • Champions Oncology Inc CSBR
  • Crispr Therapeutics AG CRSP
  • Cytokinetics, Inc. CYTK
  • DexCom, Inc. DXCM
  • Eli Lilly And Co LLY
  • Fate Therapeutics Inc FATE
  • Halozyme Therapeutics, Inc. HALO
  • Hologic, Inc. HOLX
  • Horizon Therapeutics PLC HZNP
  • Illumina, Inc. ILMN
  • Immunomedics, Inc. IMMU (announced positive late-stage for its lead antibody-drug conjugate in breast cancer)
  • NeoGenomics, Inc. NEO
  • Quidel Corporation QDEL
  • ResMed Inc. RMD
  • Syros Pharmaceuticals Inc SYRS
  • Tandem Diabetes Care Inc TNDM
  • TFF Pharmaceuticals Inc TFFP
  • Trevi Therapeutics Inc TRVI
  • Trinity Biotech plc TRIB
  • Ultragenyx Pharmaceutical Inc RARE
  • West Pharmaceutical Services Inc. WST
  • Zynex Inc. ZYXI

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 6)

  • ADiTx Therapeutics Inc ADTX
  • BELLUS Health Inc BLU (reacted to a negative clinical readout)
  • Endologix, Inc. ELGX (announced voluntary Chapter 11 filing and an agreement to be taken private)
  • immatics biotechnologies GmbH IMTX (announced July 2 a business combination with blank check company Arya Sciences Acquisition and began trading on Nasdaq)
  • Lyra Therapeutics Inc LYRA
  • Polypid Ltd PYPD
  • Sonnet Biotherapeutics Holdings Inc SONN
  • VIVUS, Inc. VVUS

Stocks In Focus

Otonomy Reports Phase 1/2 Data For OTO-313 In Tinnitus, Revises Statistical Model For Late-Stage Otividex Program

Following submission of a revised statistical analysis plan to the FDA with respect to its Phase 3 clinical trial of Otividex in Ménière's disease, Otonomy Inc OTIC said the negative binomial model it has chosen to use — instead of the generalized Poisson model — allows it reduce the target patient enrollment in the ongoing trial from 160 to 142 patients while maintaining more than 90% power.

The company said it expects to complete enrollment into the trial in the third quarter and to announce results from the trial in the first quarter of 2021.

Separately, the company announced positive top-line results from the Phase 1/2 clinical trial of OTO-313 in patients with persistent tinnitus of at least moderate severity.

The stock was up 16.98% at $3.72 premarket Tuesday.

Evolus Raises $40M Through Convertible Note Offering 

Evolus Inc EOLS said its strategic partner, Daewoong Pharmaceutical Co. Ltd., will invest $40 million in a five-year, unsecured, subordinated, 3% convertible note issued by the company at a conversion price of $13, which represents a 144% premium to the July 6 closing price. The investment will be funded before July 31, the company said. 

"This investment signals our partner's long-term commitment to Evolus and the U.S. aesthetic neurotoxin market and confidence in the strength of our intellectual property," said CEO David Moatazedi. 

The stock was down 36.28% at $3.39 premarket.

FDA Approves Endo's Cellulite Treatment

Endo International PLC ENDP said the FDA approved its Qwo, or collagenase clostridium histolyticum-aaes, for the treatment of moderate to severe cellulite in the buttocks of adult women. QWO is the first FDA-approved injectable treatment for cellulite, Endo said. 

Endo expects to make Qwo available throughout the U.S. at aesthetic health care practitioner's offices starting in cpring 2021 compared to its earlier launch schedule of the first quarter of 2021. Endo has acquired the commercialization rights for Qwo from BioSpecifics Technologies Corp. BSTC.

Novavax Gets $1.6B In Coronavirus Funding From Operation Warp Speed

Novavax, Inc. NVAX said it has been selected to participate in Operation Warp Speed and has been awarded $1.6 billion by the federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX CoV2373, its COVID-19 vaccine candidate, as early as late 2020.

In premarket trading, the stock was surging up 36% to $108.04.

See also: The Week Ahead In Biotech: Endo, Eagle Pharma FDA Decisions, ObsEva Late-Stage Readouts In Focus

Appeals Court Rules In Favor of Amgen In Avastin Biosimilar Lawsuit

Amgen scored a legal victory as the U.S. Court of Appeals of the Federal Circuit upheld a ruling that denied Roche Holdings AG's Basel ADR Common Stock RHHBY request to stop Amgen from selling a biosimilar of its Genentech unit's cancer drug Avastin.

Cellectis Cancer Drug Study Placed On Clinical Hold Following Patient Death

Cellectis SA CLLS said its Phase 1 MELANI-01 study has been placed on clinical hold by the FDA following submission of a safety report regarding one patient at dose level two with relapsed and refractory multiple myeloma. This patient experienced a fatal treatment-emergent adverse event of cardiac arrest, the company said. 

MELANI-01 is evaluating UCARTCS1A, an allogeneic, off-the-shelf, gene-edited T-cell product candidate, for the treatment of patients with relapsed or refractory multiple myeloma.

The stock was down 16.01% at $16 premarket.

Quidel Expects Q2 Revenue To Exceed Estimates

Quidel pre-announced second-quarter of $201 million to $202 million, an 86%-87% year-over-year increase, with the company attributing the growth to demand for its COVID-19 Molecular Diagnostics and Rapid Immunoassay product. Analysts expect revenue of $178.91 million for the quarter.

The stock edged down 2.58% to $229.50 premarket Tuesday.

Novartis Asthma Maintenance Therapy Gets European Nod

Novartis NVS said the European Commission has approved Enerzair Breezhaler as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long acting beta2 agonist and a high-dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.

The EC decision is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein.

Chembio to Submit EUA For Revised COVID Test, Pre-Announces Q2 Revenue Shortfall

Chembio Diagnostics Inc CEMI said its plans to submit applications to the FDA for Emergency Use Authorization for a revised version of the DPP COVID-19 IgM/IgG System, a COVID-19 point-of-care serology system, and the DPP COVID-19 Antigen System, a new COVID-19 point-of-care antigen system. The company plans to apply for the revised test in the third quarter.

The FDA revoked the EUA for the DPP COVID-19 IgM/IgG System in mid-June.

Separately, the company pre-announced second-quarter revenue in the range of $4.5 million to $4.7 million, subject to increase by up to an additional $2.5 million of revenue with respect to products that were shipped outside the U.S. during the quarter. Analysts, on average, estimate revenues of $11.98 million.

The stock was up 3.72% at $4.18 premarket.

Tonix To Buy Facility In Massachusetts For Vaccine Development

Tonix Pharmaceuticals Holding Corp TNXP said it intends to purchase an approximately 40,000-square-foot facility in Massachusetts to use as laboratories to enable R&D functions associated with its expanding portfolio of immunology candidates, including vaccines for COVID-19 and biological products for other disorders.

The stock was gaining 2.88% to 61 cents premarket.

Corvus To Initiate Phase 1 Study Of Immunotherapy Treatment For COVID-19 

Corvus Pharmaceuticals Inc CRVS said it has initiated a Phase 1 study to investigate a novel immunotherapy approach for patients with COVID-19 following FDA approval of its IND.

The stock was soaring 98.91% to $5.45 premarket.

Pacira Pre-Announces Q2 Revenue, Will Offer $300M In Debt 

Pacira Biosciences Inc PCRX announced preliminary unaudited net revenue of $75.5 million for the second quarter of 2020, up from $102.6 million one year ago. The figure beat the consensus estimate of $57.83 million. 

Separately, the company said it intends to offer, subject to market and other conditions, a $300 million aggregate principal amount of convertible senior notes due 2025 in a private placement to qualified institutional buyers.

In after-hours trading, the stock slipped 2.32% to $53.

Unity Biotech Announces CFO Departure

Unity Biotechnology Inc UBX announced that CFO Bob Goeltz will leave the company at the end of July to pursue a new opportunity. The company said former Biogen Inc BIIB executive Lynne Sullivan will take over as interim CFO effective Aug 1.

The stock slid 1.01% to $8.78 in after-hours trading.


Trinity Biotech filed a shelf registration statement with the SEC for offering securities, including equity, warrants, debt, subscription rights and units, valued at $200 million.

The stock was trading 5.1% higher at $2.68 premarket. 

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

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