The Daily Biotech Pulse: GSK, Vir To Start COVID-19 Antibody Study, Novartis In-Licenses BeiGene's Cancer Drug, Earnings Preannouncements Continue

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 Jan. 11)

  • 10X Genomics Inc TXG
  • AbbVie Inc (NYSE: (ABBV)
  • Aldeyra Therapeutics Inc ALDX
  • Atea Pharmaceuticals, Inc. AVIR
  • AtriCure Inc. ATRC (reacted to the company's preliminary fourth-quarter results)
  • Bioanalytical Systems, Inc. BASI
  • Biodesix Inc BDSX
  • C4 Therapeutics Inc CCCC
  • CareDx Inc CDNA (announced preliminary fourth-quarter results)
  • Celsius Holdings, Inc. CELH
  • Chimerix Inc CMRX
  • Curis, Inc. CRIS
  • Dyne Therapeutics Inc DYN (announced positive preclinical data from its myotonic dystrophy type 1 program)
  • Edap Tms SA EDAP
  • Eli Lilly And Co LLY (announced positive data from midphase study of its investigational asset in treating early symptomatic Alzheimer's)
  • ESSA Pharma Inc EPIX
  • EXACT Sciences Corporation EXAS (reacted to preliminary fourth-quarter results)
  • Eyenovia Inc EYEN
  • Guardant Health Inc GH
  • Johnson & Johnson JNJ
  • Kaleido Biosciences Inc KLDO
  • Oxford Immunotec Global PLC OXFD
  • Pacira Biosciences Inc PCRX
  • Supernus Pharmaceuticals Inc SUPN
  • Syneos Health Inc SYNH
  • Theratechnologies Inc THTX
  • Twist Bioscience Corp TWST
  • United Therapeutics Corporation UTHR
  • Vascular Biogenics Ltd VBLT
  • Xencor Inc XNCR

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Jan. 11)

  • AbCellera Biologics Inc ABCL

Stocks In Focus

T2 Biosystems' Molecular Diagnostic Test Capable Of Detecting Multiple Coronavirus Variants

T2 Biosystems Inc TTOO announced that its T2SARS-CoV-2 Panel, a molecular diagnostic test that detects SARS-CoV-2, is capable of detecting multiple variants of the SARS-CoV-2 virus most recently identified in the U.K., South Africa and the U.S.

"I'm proud that we can confidently say, after extensive analysis, that our T2SARS-CoV-2 Panel, which has demonstrated clinical sensitivity of 95 percent and specificity of 100 percent, can continue to help impact lives by detecting multiple variants of the SARS-CoV-2 virus," T2 Biosystems President and CEO John Sperzel said in a statement. 

The stock was up 39.38% premarket Tuesday to $2.23.

GSK, Vir To Begin COVID-19 Antibody Study In Patients With Mild-To-Moderate Infection

GlaxoSmithKline plc GSK and Vir Biotechnology Inc VIR announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild-to-moderate COVID-19 in a Phase 1b/2a clinical trial.

VIR-7832 is a neutralizing COVID-19 antibody that showed promising results in preclinical studies. It enhanced the ability to clear infected cells and possessed potential to enhance virus-specific T-cell function, which could help treat and/or prevent COVID-19 infection.

The trial is expected to begin in the first quarter at multiple sites across the U.K.

GlaxoSmithKline shares were down 0.53% premarket at $37.73. 

Roche To Present Positive Results For Late-Stage Kidney Cancer Combo Therapy

Roche Holdings AG Basel ADR Common Stock RHHBY announced updated overall survival data from the Phase 3 IMbrave150 study evaluating Tecentriq in combination with Avastin, compared with Bayer AG's BAYRY Nexavar, in people with unresectable hepatocellular carcinoma.

The data showed that after a median follow-up of 15.6 months, Roche's combo reduced the risk of death by 34%, with a median overall survival of 19.2 months compared with 13.4 months for Nexavar.

"These results show that Tecentriq in combination with Avastin provides the longest survival that we've ever seen in a front-line Phase III study in unresectable HCC," said Levi Garraway, Roche's chief medical officer.

Roche will present the data at the ASCO Gastrointestinal Cancers Symposium from 3:30-4:15 p.m. Sunday.

Novartis In-Licenses BeiGene's Cancer Drug For $650M

Novartis AG NVS and Beigene Ltd BGNE signed a strategic collaboration agreement to in-license BeiGene's tislelizumab in major markets outside of China. Tislelizumab is an anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages.

The agreement provides for Novartis obtaining the development and commercialization rights to tislelizumab in the U.S., Canada, Mexico, the EU, U.K., Norway, Switzerland, Iceland, Liechtenstein, Russia and Japan in exchange for an upfront payment of $650 million plus royalties and milestone payments. BeiGene will retain the rights to tislelizumab in China and other countries. The transaction has been approved by the boards of both companies.

BeiGene shares were up 2.12% premarket at $284.84. 

Amneal To Buy Specialty Pharms Company Kashiv 

Amneal Pharmaceuticals Inc AMRX announced an agreement to acquire a 98% interest in Kashiv Specialty Pharmaceuticals for a cash payment of $70 million at closing and a payment of $30 million at the one-year anniversary point of the deal. 

The company is engaged in the development of complex generics, innovative drug delivery platforms and novel 505(b)(2) drugs.

Kashiv is also eligible to receive up to an additional $8 million in contingent payments upon the achievement of certain regulatory milestones. In addition to the foregoing contingent payments, Amneal has agreed to pay Kashiv certain royalty payments equal to an escalating percentage of aggregate annual net sales for certain pharmaceutical products.

Related Link: The Week Ahead In Biotech (Jan 10-16): Expect Stocks To Move As J.P. Morgan Healthcare Conference Kicks Off

IGM In-Licenses Cancer Drug From Sweden's Medivir For Up To $352.5M

IGM Biosciences Inc IGMS announced that it has entered into an exclusive license agreement with Medivir AB through which IGM will receive global, exclusive development and commercialization rights for the cancer drug birinapant.

The combination of IGM-8444, an IgM antibody targeting death receptor 5 being developed by IGM, and birinapant has been shown to enhance anti-tumor activity preclinically.

IGM will pay $1 million upon signing the agreement, followed by an additional $1.5 million when birinapant is included by IGM in clinical Phase I studies. The terms of the agreement also entitle Medivir to receive development and regulatory milestone payments up to a total of approximately $350 million, plus tiered royalties from the mid-single digits up to mid-teens on net sales.

Adaptive Biotechnologies, AstraZeneca To Collaborate On Mapping Immune Response To Cancer Antigens

Adaptive Biotechnologies Corp ADPT announced a translational collaboration with AstraZeneca plc AZN to investigate the use of immunoSEQ T-MAP — a product that combines the sequencing and mapping capabilities of Adaptive's proprietary immune medicine platform to map T-cell receptors to antigens — across AstraZeneca's oncology portfolio.

Adaptive stands to receive quarterly payments plus sequencing and data mapping fees. In addition, AstraZeneca has an option to enter into a separate agreement with Adaptive for the development and commercialization of a companion diagnostic or therapeutic application based on T-MAP data.

La Jolla Licenses European Rights To 2 Drugs For Up To $122M

La Jolla Pharmaceutical Company LJPC announced an exclusive licensing agreement with PAION AG for Giapreza and Xerava in the European Economic Area, the U.K. and Switzerland for an upfront cash payment of $22.5 million and potential commercial milestone payments of up to $109.5 million. La Jolla will also receive double-digit tiered royalty payments based on net sales.

La Jolla shares were up 61.42% to $6.36 in premarket trading Tuesday.

Merck's Pneumococcal Conjugate Vaccine Accepted For Priority Review

Merck & Co., Inc. MRK said the FDA accepted for priority review a BLA for V114, its investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 and older. The FDA set a PDUFA goal date of July 18.

In premarket trading Tuesday, Merck shares were adding 0.12% to $85.10.


GenMark Diagnostics, Inc GNMK preannounced full-year 2020 revenues of about $171 million, up 95% year-over-year, with ePlex revenues climbing 155% to $152 million.

Fourth-quarter revenues are expected at $50 million, an 84% increase from a year-ago. Analysts, on average, estimate full-year revenues of $167.48 million and fourth-quarter revenues of $45.87 million.

The stock was up 5.3% premarket at $16.30. 

Orthopediatrics Corp KIDS announced preliminary fourth-quarter revenues of $21.7 million, up 14% year-over-year, and full-year revenues $73.8 million, representing annual growth of 2%. The consensus estimates call for revenues of $20.31 million for the quarter and $72.46 million for the full year.


RedHill Biopharma Ltd RDHL said it has entered into an underwriting agreement with H.C. Wainwright & Co. for the purchase on a firm commitment basis of 1.28 million ADSs at a price of $7.84 per ADS. The closing of the offering is expected to occur on or about Jan. 14, subject to satisfaction of customary closing conditions.

The stock was down 7.58% premarket at $8.05. 

Theratechnologies entered into an agreement with Mackie Research Capital as the lead underwriter and sole bookrunner, on behalf of a syndicate of underwriters, pursuant to which the underwriters have agreed to purchase, on a bought-deal basis, 14.55 million units of the company for aggregate gross proceeds of $40 million at a price of $2.75 per unit.

The stock was declining 5.66% premarket to $3. 

MediciNova, Inc. MNOV said it has entered into a securities purchase agreement pursuant to which MediciNova has agreed to issue $20 million in shares of its common stock to 3D Opportunity Master Fund, a fund managed by 3D Investment Partners, in a private placement transaction.

MediciNova intends to use the proceeds received from the private placement primarily for its clinical programs.

Polarityte Inc PTE said it has entered into a securities purchase agreement with a single, health care-dedicated institutional investor providing for the purchase and sale of 9.09 million shares of its common stock, or pre-funded warrants to purchase common stock in lieu thereof, and accompanying warrants to purchase up to 9.09 million shares of common stock.

The stock eased 5.62% to $1.18 in premarket trading Tuesday.

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

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