The Daily Biotech Pulse: J&J Files For COVID-19 Vaccine Approval, Zimmer Biomet’s Spin-Off, IPO Deluge Hits Street

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. 4)

• 4D Molecular Therapeutics Inc (NASDAQ: FDMT)

• 9 Meters Biopharma Inc (NASDAQ: NMTR)

• Agenus Inc (NASDAQ: AGEN) (announced positive preliminary results from its Phase 1 trial of iNKT cell therapy in patients with moderate to severe symptoms of COVID-19)

• Anavex Life Sciences Corp (NASDAQ: AVXL)

• AngioDynamics, Inc. (NASDAQ: ANGO)

• Atea Pharmaceuticals Inc (NASDAQ: AVIR)

• BioVie Inc (NASDAQ: BIVI)

• Cassava Sciences Inc (NASDAQ: SAVA)

• Castle Biosciences Inc (NASDAQ: CSTL) (announced new data on validity and accuracy of skin cancer diagnostics test in patients with T1 cutaneous melanoma tumors)

• Celldex Therapeutics, Inc. (NASDAQ: CLDX)

• ChemoCentryx Inc (NASDAQ: CCXI)

• Cleveland BioLabs, Inc. (NASDAQ: CBLI)

• CorMedix Inc. Common Stock (NASDAQ: CRMD)

• DermTech Inc (NASDAQ: DMTK)

• Evogene Ltd (NASDAQ: EVGN)

• F-Star Therapeutics Inc (NASDAQ: FSTX)

• Glaukos Corp (NYSE: GKOS)

• Gracell Biotechnologies Inc (NASDAQ: GRCL)

• Halozyme Therapeutics, Inc. (NASDAQ: HALO)

• Inari Medical Inc (NASDAQ: NARI)

• Intra-Cellular Therapies Inc (NASDAQ: ITCI)

• Jounce Therapeutics Inc (NASDAQ: JNCE)

• MannKind Corporation (NASDAQ: MNKD)

• Mediwound Ltd (NASDAQ: MDWD)

• Morphic Holding Inc (NASDAQ: MORF)

• Nantkwest Inc (NASDAQ: NK)

• Oramed Pharmaceuticals, Inc. (NASDAQ: ORMP)

• Organogenesis Holdings Inc (NASDAQ: ORGO)

• Ortho Clinical Diagnostics Holdings PLC (NASDAQ: OCDX)

• Outlook Therapeutics Inc (NASDAQ: OTLK) (announced a clinical and operational update)

• Paratek Pharmaceuticals Inc (NASDAQ: PRTK)

• Pulse Biosciences Inc (NASDAQ: PLSE)

• Revolution Medicines Inc (NASDAQ: RVMD)

• Rocket Pharmaceuticals Inc (NASDAQ: RCKT)

• Sana Biotechnology Inc (NASDAQ: SANA) (went public Thursday)

• Sesen Bio Inc (NASDAQ: SESN)

• Summit Therapeutics Inc (NASDAQ: SMMT)

• Synlogic Inc (NASDAQ: SYBX)

• Veracyte Inc (NASDAQ: VCYT)

• Vericel Corp (NASDAQ: VCEL)

• Veru Inc (NASDAQ: VERU)

• Viking Therapeutics Inc (NASDAQ: VKTX)

Down In The Dumps

Story continues

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

Stocks In Focus J&J Applies For Emergency Use Authorization For COVID-19 Vaccine; Adcom Scheduled for Feb. 26

Johnson & Johnson (NYSE: JNJ) said it has submitted an application to the FDA requesting emergency use authorization for its investigational single-dose Janssen COVID-19 vaccine candidate. The company expects to have product available to ship immediately following authorization.

The company reported last week with positive Phase 3 data for the vaccine candidate.

The FDA later said a meeting of its Vaccines and Related Biological Products Advisory Committee is scheduled to meet Feb. 26 to discuss the EUA.

The stock was up 1.74% premarket to $164.81.

T2 Biosystems’ Molecular Diagnostic Test Capable of Detecting Brazilian Variant Of Novel Coronavirus

T2 Biosystems Inc (NASDAQ: TTOO) said its T2SARS-CoV-2 Panel, a molecular diagnostic test that detects SARS-CoV-2, is capable of detecting the Brazil variant of the virus, which was recently confirmed to be present in the U.S.

The stock climbed 47.92% premarket to $3.55.

Madrigal Shares Rally On Disclosure Of Institutional Stake

Madrigal Pharmaceuticals Inc (NASDAQ: MDGL) shares gained after a SEC filing revealed that hedge fund Wellington Management Group beneficially owned about 915,892 shares of the company, representing a 5.92% stake.

The stock rose 14.06% to $128 in after-hours trading.

Zimmer Biomet To Spin Off Spine, Dental Businesses

Zimmer Biomet Holdings Inc (NYSE: ZBH) announced its intention to spin off its Spine and Dental businesses to form a new and independent, publicly traded company.

The planned transaction will enhance the focus of both Zimmer Biomet and the new company to meet the needs of patients and customers and help achieve faster growth and deliver greater value for all stakeholders, the company said.

The shares were adding 2.03% to $164 in premarket trading Friday.

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

Novavax Confirms Initiation Of Rolling Review Of COVID-19 Vaccine Application By 4 Regulatory Agencies

Novavax, Inc. (NASDAQ: NVAX) announced the start of the rolling review process for authorization of NVX-CoV2373, its COVID-19 vaccine, by multiple regulatory agencies.

The company said it has begun the rolling review process with several regulatory agencies worldwide, including the European Medicines Agency, U.S. FDA, U.K. Medicines and Healthcare products Regulatory Agency and Health Canada.

The stock was edging up 0.46% to $28.20 in premarket trading Thursday.

Biolase Regains Compliance With Nasdaq Minimum Bid Price Requirement

BIOLASE Inc (NASDAQ: BIOL) said it has regained compliance with the minimum bid price requirement set forth by Nasdaq. Consequently, the company said the special meeting of shareholders convened to get shareholder approval for a reverse split has been cancelled.

The stock was up 15.45% premarket at $1.27.

Earnings

Sanofi SA (NASDAQ: SNY) said its sales rose 3.3% to 36.04 billion euros ($43.19 billion) in fiscal year 2020. Business EPS rose 3.9% on a reported basis and by 9.2% at constant exchange rate, exceeding the guidance for 7%-8% growth.

Fourth-quarter net sales fell 2.4% on a reported basis but rose 4.2% at CER to 9.38 billion euros and business EPS climbed 98% at CER.

For fiscal year 2021, Sanofi expects business EPS growth in the high single digits at CER, barring unforeseen major adverse events.

Twist Bioscience Corp’s (NASDAQ: TWST) fiscal-year 2021 first-quarter revenues climbed from $17.2 million to $28.2 million and the net loss per share narrowed from $1.69 to 72 cents, narrower the consensus estimate for a loss of 74 cents per share. The company maintained its fiscal year 2021 revenue guidance at $110 million to $118 million, in line with the $116.02 million consensus estimate.

View more earnings on IBB

The stock was down 15.51% premarket at $167.

Gilead Sciences, Inc. (NASDAQ: GILD) said its total revenue rose 26% year-over-year to $7.42 billion and non-GAAP net income nearly doubled from $1.10 to $2.19. Analysts, on average, estimated EPS of $2.15.

For fiscal year 2021, the company expects product sales of $23.7 billion to $25.1 billion and non-GAAP EPS of $6.75-$7.45, in line with the $7.09 per share consensus estimate.

The stock was up 3.3% premarket at $68.

Offerings

OncoCyte Corp (NYSE: OCX) said it has commenced an underwritten public offering of its common stock. All of the shares to be sold in the proposed offering will be sold by the company.

The stock was down 1.32% premarket at $5.24.

On The Radar Earnings:

Meridian Bioscience, Inc. (NASDAQ: VIVO) (before the market open)

Zimmer Biomet Holdings Inc (NYSE: ZBH) (before the market open)

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) (before the market open)

IPOs

Pharvaris, B.V., a clinical-stage biopharma developing treatments for hereditary angioedema and other bradykinin-B2-receptor-mediated indications, priced its upsized initial public offering of 8.27 million shares at $20 per share for total gross proceeds of about $165.4 million. The shares are expected to begin trading on the Nasdaq under the symbol “PHVS.”

Danish AI-immunology platform company Evaxion Biotech A/S priced its upsized IPO of 3 million ADSs in an IPO, with each ADS representing one ordinary share, at $10 per ADS.

The company had estimated a price range of $10-$12 for the offering. The shares will begin trading on the Nasdaq under the ticker symbol “EVAX.”

Clinical-stage immuno-oncology company Bolt Biotherapeutics, Inc. priced its upsized IPO of 11.5 million shares of its common stock at $20 per share, above the estimated $18-$19 price range. The shares are expected to begin trading on the Nasdaq under the symbol “BOLT.”

Terns Pharmaceuticals, Inc., a clinical-stage biopharma developing treatment for non-alcoholic steatohepatitis, priced its upsized IPO of 7.5 million shares of common stock at a $17 per share, for raising gross proceeds of $127.5 million. The company had estimated a per-share price range of $15-$17 for the offering. The shares will begin trading on the Nasdaq under the symbol “TERN.”

Lucira Health, Inc., a medical technology company focused on the development of infectious disease test kits, priced its upsized IPO of 9 million shares of common stock at $17 per share, for raising gross proceeds of $153 million. The shares will begin trading on the Nasdaq under the ticker symbol “LHDX.”

Immunocore Holdings Plc, a late-stage biotech developing T cell receptor bispecific immunotherapies designed to treat a broad range of diseases, priced its upsized IPO of 9.94 million ADSs, representing 9.94 million ordinary shares, at $26 per ADS, for total gross proceeds of approximately $258.3 million.

All ADSs sold in the offering were offered by Immunocore. The ADSs are expected to begin trading on Nasdaq under the ticker symbol “IMCR.”

Vor Biopharma, a cell therapy company developing engineered hematopoietic stem cell therapies combined with targeted therapies for the treatment of cancer, priced its IPO of 9.83 million shares at $18 per share. The gross proceeds to Vor from the offering are expected to be about $176.9 million. The shares will trade on the Nasdaq under the ticker symbol “VOR.”

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

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