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The Daily Biotech Pulse: Vertex, Pfizer Earnings, Tiziana COVID-19 Vaccine Data, Decision Day For Mallinckrodt's Burn Treatment

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Shanthi Rexaline
·7 min read
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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 Feb. 1)

  • Abbott Laboratories (NYSE: ABT)

  • Adamas Pharmaceuticals Inc (NASDAQ: ADMS) (announced FDA approval for an expanded indication for its Parkinson's drug)

  • argenx SE – ADR (NASDAQ: ARGX) (announced decision to proceed with the enrollment into the study of subcutaneous efgartigimod in chronic inflammatory demyelinating polyneuropathy)

  • BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) (Reddit's r/WallStreetBets forum called it the most undervalued stock in the market)

  • Cellular Biomedicine Group Inc (NASDAQ: CBMG)

  • DarioHealth Corp (NASDAQ: DRIO)

  • Frequency Therapeutics Inc (NASDAQ: FREQ)

  • Fulgent Genetics Inc (NASDAQ: FLGT)

  • G1 Therapeutics Inc (NASDAQ: GTHX)

  • Harvard Bioscience, Inc. (NASDAQ: HBIO)

  • Hologic, Inc. (NASDAQ: HOLX)

  • I-Mab ADR (NASDAQ: IMAB)

  • Laboratory Corp. of America Holdings (NYSE: LH)

  • Maravai Lifesciences Holdings Inc (NASDAQ: MRVI)

  • Novavax, Inc.'s (NASDAQ: NVAX) (momentum buying following late-stage coronavirus vaccine readout and reports of commencing rolling regulatory submission for the vaccine candidate in Canada)

  • OncoSec Medical Inc (NASDAQ: ONCS)

  • Oramed Pharmaceuticals, Inc. (NASDAQ: ORMP)

  • Organogenesis Holdings Inc (NASDAQ: ORGO)

  • Qiagen NV (NYSE: QGEN)

  • Varian Medical Systems, Inc. (NYSE: VAR)

  • Vericel Corp (NASDAQ: VCEL)

  • Vincerx Pharma Inc (NASDAQ: VINC)

Down In The Dumps

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

  • Avidity Biosciences Inc (NASDAQ: RNA)

  • Imara Inc (NASDAQ: IMRA)

  • Kinnate Biopharma Inc (NASDAQ: KNTE)

  • NLS Pharmaceutics AG (NASDAQ: NLSP) (went public Friday)

  • Virios Therapeutics LLC (NASDAQ: VIRI)

Stocks In Focus Tiziana Reports Positive Clinical Data For Orally Administered COVID-19 Treatment

Tiziana Life Sciences ADR Representing 2 Ord Shs (NASDAQ: TLSA) announced positive data from the exploratory clinical study in Brazil that is investigating nasally administered Foralumab, its proprietary anti-CD3 human monoclonal antibody, either alone or in combination with orally administered dexamethasone, in COVID-19 patients.

In both the treatment cohorts, no grade 3 or 4 severe adverse events were observed and all treatments were well-tolerated, the company said. CT scans of lungs showed that improvement was double that shown in patients treated with Foralumab as compared to those in the control group.

The stock was jumping 40.31% to $5.36 premarket Tuesday.

Hologic Collaborates With Google Cloud For Enhancing Digital Diagnostic Capabilities In Cervical Cancer Screening

Hologic announced a multiyear strategic collaboration with Alphabet Inc's (NASDAQ: GOOGL) (NASDAQ: GOOG) Google Cloud that will feature the integration of Google Cloud's machine learning technologies with Hologic's Genius Digital Diagnostics System to transform screening and accelerate the eradication of cervical cancer across the globe.

Genius Digital Diagnostics is a digital cytology platform to combine artificial intelligence with advanced digital imaging to help identify precancerous lesions and cancer cells in women. With the Google Cloud collaboration, the system will derive even more actionable insights from cytology slides for cytotechnologists and pathologists. Google Cloud also provides a secure and reliable cloud data architecture to further extend the system's capabilities.

The stock was up 3.39% to $85.70 in after-hours trading.

Vertex Q4 EPS Trails Estimate

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) reported fourth-quarter revenue of $1.63 billion compared to $1.41 billion a year ago. The company's non-GAAP net income improved from $1.70 to $2.51, missing the consensus estimate of $2.59.

For the full year 2021, the company guided to product revenue of $6.7 billion to $6.9 billion, while analysts estimate total revenue of $6.95 billion.

The stock slipped 2.52% to $225.94 in after-hours trading.

Immunovant Voluntarily Pauses Enrollment Into IMVT-1401 Clinical Studies Following Elevated Cholesterol Levels In Treatment Arm

Immunovant Inc (NASDAQ: IMVT) announced a voluntary pause of dosing in its ongoing clinical trials for IMVT-1401. The decision follows the unearthing of a physiological signal consisting of elevated total cholesterol and LDL levels in IMVT-1401-treated patients in a Phase 2b trial in thyroid eye disease.

The shares were down 58.43% to $18 premarket Tuesday.

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

Travere Reports Positive Late-Stage Data For Kidney Disease Drug

Travere Therapeutics Inc (NASDAQ: TVTX) said the pivotal Phase 3 DUPLEX Study of sparsentan in focal segmental glomerulosclerosis achieved its pre-specified interim FSGS partial remission of proteinuria endpoint after 36 weeks of treatment.

Sparsentan, an investigational product candidate, demonstrated a statistically significant response on FPRE compared to the active control, irbesartan, the company said.

Bristol-Myers Squibb's Psoriasis Drug Aces Pivotal Late-Stage Study

Bristol-Myers Squibb Co (NYSE: BMY) announced positive results from POETYK PSO-2, the second pivotal Phase 3 trial evaluating deucravacitinib, a novel, oral, selective tyrosine kinase 2 inhibitor, for the treatment of patients with moderate to severe plaque psoriasis.

The stock was up 1.51% to $63.15 premarket Tuesday.

Nabriva CFO Gary Sender To Retire By Mid-March

Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV) announced the retirement of its chief financial officer Gary Sender, effective as of March 12. Sender has agreed to serve as a consultant for Nabriva on an ongoing basis following his retirement to ensure business continuity, the company said.

View more earnings on IBB

A search has been initiated to identify a new CFO, Nabriva said.

The stock was up 1.14% premarket at $2.67.

BioCryst Sees Follow-On Buying On r/WallStreetBets Prop

BioCryst shares are finding follow-on buying, extending the rally from Monday that was triggered by Reddit investing group r/WallStreetBets' warning of a "BioWar" against short sellers betting against the stock.

The stock, which jumped 39.08% to $11.85 in regular trading Monday, was gaining another 8.78% premarket to $12.89.

Vyne Therapeutics Rises On Fund Buying

Vyne Therapeutics Inc (NASDAQ: VYNE) shares are advancing after a Form 4 filing with the SEC showed Perceptive Advisors bought 4.22 million shares in the company at $2.37 per share.

After advancing 16.16% to $2.30 in Monday's regular session, the stock added an incremental 17.39% premarket to $2.70.

CoreMedix Transfers Listing of Shares to Nasdaq

CorMedix Inc. (NYSE: CRMD) announced that its shares have been approved for listing on the Nasdaq. The company's shares will continue to trade under its current symbol "CRMD" on the Nasdaq beginning Tuesday.

Offerings

Arcutis Biotherapeutics Inc (NASDAQ: ARQT) announced the commencement of an underwritten public offering of $150 million in shares of its common stock. All of the shares in the offering are being sold by the company.

The stock was down 4.44% premarket at $34.

Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) priced an underwritten public offering of 9.1 million shares of its common stock at a public offering price of $11 per share. The gross proceeds of the offering to the company are expected to be $100.1 million.

The stock was trading 5.84% higher premarket to $12.15.

argenx SE – ADR (NASDAQ: ARGX) said it has commenced a global offering of $750 million of its equity. The global offering will comprise an offering of ordinary shares represented by ADSs in the U.S. and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area and the U.K.

The U.S. offering and the European private placement are expected to close simultaneously.

The stock edged down 0.43% to $316.02 premarket.

On The Radar PDUFA Dates

The FDA will decide on Mallinckrodt PLC ‘s (OTC: MNKKQ) BLA for StrataGraft, an engineered, bilayer tissue, designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers. StrataGraft is being evaluated as a treatment option for deep partial-thickness thermal burns.

Clinical Readouts

Gregory Glenn, Novavax's president of R&D, is scheduled to present efficacy data updates from NVX-CoV2373, the company's protein-based vaccine candidate at a New York Academy of Science event, "The Quest for a COVID-19 Vaccine." The presentation is scheduled for 4 p.m. ET.

The stock was up 4.85% to $281.32 in premarket trading after jumping 21.44% to $268.30 in regular trading Monday.

Earnings:

  • BIO-TECHNE Corp (NASDAQ: TECH) (before the market open)

  • Catalent Inc (NYSE: CTLT) (before the market open)

  • Haemonetics Corporation (NYSE: HAE) (before the market open)

  • Pfizer Inc. (NYSE: PFE) (Q4 Revenues Climb 11% to $11.7 billion and adjusted EPS 42 cents Vs. Consensus Estimate of $11.43 billion and 48 cents per share; Raises FY21 adjusted EPS guidance to $3.10-$3.20 Vs. Consensus Estimate of $3.19)

  • Amgen, Inc. (NASDAQ: AMGN) (after the market close)

Related Link: The Week Ahead In Biotech: Merck, Pfizer In Earnings Mix, Plus Adamas, Mallinckrodt FDA Decisions, IPOs And More

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