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Benzinga
Benzinga
Technology
Shanthi Rexaline

The Daily Biotech Pulse: Galapagos Appoints J&J Exec As CEO, Aridis Gets Funding For Antiviral Treatment, Moderna Starts Omicron-Specific Booster Study

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

Stocks In Focus

Atara To Sell Manufacturing Plant to Fuji's CDMO Unit For $100M

Atara Biotherapeutics, Inc. (NASDAQ:ATRA) announced that it has entered into a long-term strategic agreement with FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Holdings Corporation (OTC:FUJIY), under which Fujifilm will acquire Atara's T-Cell Operations and Manufacturing facility in Thousand Oaks, California for $100 million upfront, retaining current manufacturing and quality staff at the site.

Following completion of the transaction, FDB will provide Atara with access to the flexible capacity and specific capability needed to manufacture clinical and commercial-stage allogeneic cell therapies for its maturing pipeline.

Atara shares was adding 8.79% to $16.59 in premarket trading.

Galapagos Appoints Paul Stoffels As CEO

Galapagos NV (NASDAQ:GLPG) announced the appointment of Dr. Paul Stoffels as chief executive officer, effective April 1, 2022. Previously, Stoffels was vice chairman of the executive committee and chief scientific officer of Johnson & Johnson, Inc. (NYSE:JNJ), where he spearheaded the company's research and product pipeline.

The stock was climbing 12.08% to $59.76 in premarket trading.

Aridis Lands Gates Foundation Funding For Technology To Deliver Inhaled Formulation Of Monoclonal Antibodies Against COVID, Flu Viruses

Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS) said it received a grant award from the Bill & Melinda Gates Foundation to evaluate the application of its inhaled formulation technology to deliver cost-effective monoclonal antibodies against influenza and SARS-CoV2 to people in low- and middle-income countries.

The $1.9-million award will fund the preclinical development of stabilized liquid aerosols and room temperature stable inhalable dry powders containing anti-influenza and anti-SARS-CoV2 mAbs that are manufactured from spirulina algae. It also funds animal safety and efficacy testing in virus challenge animal models. Pending the outcome of preliminary results, the Gates Foundation has the option to continue funding through preclinical IND enabling activities and through a Phase 1/2a human clinical trial.

The stock was up 32.76% at $2.31 in premarket trading.

Atai Launches New Platform Company Focused On Mental Health Treatments

Atai Life Sciences N.V. (NASDAQ:ATAI) announced the launch of Invyxis, a new, wholly owned platform company committed to developing new chemical entities and to further pioneering next-generation mental health treatments. Invyxis will bring proven medicinal chemistry tools and comprehensive biological screening approaches to atai's growing enterprise of drug discovery and design, the company said. 

The stock was seen moving up 7.58% to $5.25 in premarket trading.

Related Link: The Week Ahead In Biotech (Jan. 23-29): Roche, Azurity FDA Decisions, J&J, Vertex Earnings, Samsara Vision IPO And More

Oncolytics' Chinese Partner Reports Positive Data From Dose-Escalation Study Of Immunotherpay-Chemo Combo In Breast Cancer

Oncolytics Biotech Inc. (NASDAQ:ONCY) announced that its partner Adlai Nortye has advanced to the second of three dose escalation cohorts in the bridging clinical trial evaluating the safety, tolerability and preliminary efficacy of pelareorep-paclitaxel combination therapy in Chinese patients with advanced or metastatic breast cancer.

Dosing in the trial's first dose escalation cohort is complete and no safety issues have been reported. The second dose escalation cohort is the equivalent dose that was administered in the IND-213 study, which reported a near doubling of survival in HR+/HER2- metastatic breast cancer patients.

Oncolytics shares were rising 8.74% to $1.99 in premarket trading.

Cue Biopharma Reports Early Stage Data From Monotherapy and Combo Study Of CUE-101 In Head And Neck Squamous Cell Carcinoma

Cue Biopharma, Inc. (NASDAQ:CUE) said early data from the Phase 1 combination study of CUE-101 and Merck & Co., Inc. (NYSE:MRK) supported synergistic activity, with two of the four patients treated in dose escalation in two cohosts showing partial responses. Two are manifesting reduction in target lesions, it added. The combo is being evaluated as a treatment option for third line and beyond HPV+ recurrent/metastatic head and neck squamous cell carcinoma.

The company also noted that updated CUE-101 monotherapy data further enhances confidence in potential as single agent therapeutic with 50% clinical benefit rate reported to date in RP2D (4mg/kg) expansion monotherapy trial and an emerging enhanced overall survival rate that supports the premise that CUE-101 selectively stimulates cancer-relevant CD8+ T cells.

The stock was slipping 2.83% to $10.30 in premarket trading.

Moderna Commences Phase 2 Study Of Omicron-Specific COVID Booster Vaccine Candidate

Moderna, Inc. (NASDAQ:MRNA) announced the first participant has been dosed in the Phase 2 study of its omicron-specific booster candidate.

The stock was gaining 3.25% to $160 in premarket trading.

Click here to access Benzinga's FDA Calendar.

Offerings

Zymeworks, Inc. (NASDAQ:ZYME) priced its underwritten public offering of 9.16 million common shares and, in lieu of common shares to certain investors, pre-funded warrants to purchase up to 3.34 million common shares. The common shares are being offered at a public offering price of $8 per common share and the pre-funded warrants are being offered at a public offering price of $7.9999 per pre-funded warrant. The gross proceeds to Zymeworks from the offering are expected to be approximately $100 million.

The stock was slipping 14.59% to $7.96 in premarket trading.

On The Radar

Earnings

ResMed Inc. (NYSE:RMD) (after the close)
Taro Pharmaceutical Industries Ltd. (NYSE:TARO) (after the close)

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

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