The Daily Biotech Pulse: Adcom Tryst For Pfizer/BioNTech Booster Shot, AbCellera's COVID Antibody Treatment Gets Expanded Use, Protagonist Slapped With 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 Sept. 16)

• Bicycle Therapeutics plc BCYC
• Cardiol Therapeutics Inc. CRDL
• Cytokinetics, Incorporated CYTK
• DexCom, Inc. DXCM
• DICE Therapeutics, Inc. Common Stock DICE (IPOed Wednesday)
• Itamar Medical Ltd. ITMR
• Opiant Pharmaceuticals, Inc. OPNT
• Pasithea Therapeutics Corp. Common Stock KTTA(IPOed Wednesday)
• Repligen Corporation RGEN (announced a definitive agreement to acquire privately-held Avitide Inc., for approximately $150 million)
• Tango Therapeutics, Inc. TNGX
• Vera Therapeutics, Inc. VERA

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 16)

• 4D pharma plc LBPS
• Absci Corporation ABSI
• Alzamend Neuro, Inc. ALZN
• Applied Molecular Transport Inc. AMTI
• Aytu Biopharma, Inc. AYTU
• AzurRx BioPharma, Inc. AZRX
• CVRx, Inc. CVRX
• Eiger BioPharmaceuticals, Inc. EIGR
• Forward Pharma A/S FWP
• Frequency Therapeutics, Inc. FREQ
• Harpoon Therapeutics, Inc. HARP
• Jazz Pharmaceuticals plc JAZZ
• Lyell Immunopharma, Inc. LYEL
• Madrigal Pharmaceuticals, Inc. MDGL
• Miromatrix Medical Inc. MIRO
• MorphoSys AG MOR
• Nanobiotix S.A. NBTX
• NeuroPace, Inc. NPCE
• Oyster Point Pharma, Inc. OYST
• Plus Therapeutics, Inc. PSTV
• Sangamo Therapeutics, Inc. SGMO
• Sight Sciences, Inc. SGHT
• Silverback Therapeutics, Inc. SBTX (reacted to ESMO presentation of Phase 1/1b solid tumor study data)
• Sonoma Pharmaceuticals, Inc. SNOA
• Spruce Biosciences, Inc. SPRB
• Teligent, Inc. TLGT
• TFF Pharmaceuticals, Inc. TFFP
• TherapeuticsMD, Inc. TXMD
• Titan Pharmaceuticals, Inc. TTNP
• TScan Therapeutics, Inc. TCRX
• Tyra Biosciences, Inc. TYRA (IPOed Tuesday)
• Unity Biotechnology, Inc. UBX
• Universe Pharmaceuticals INC UPC

Stocks In Focus

FDA Authorizes Expanded Use of AbCellera's COVID-19 Antibody Therapy to Include Post-exposure Prophylaxis

AbCellera Biologics Inc. ABCL announced the Food and Drug Administration has expanded the emergency use authorization for bamlanivimab, 700 mg, administered with etesevimab, 1400 mg, to include post-exposure prophylaxis to prevent SARS-CoV-2 infection or symptomatic COVID-19.
AbCellera is partnering with Eli Lilly and Company LLY for the combo antibody therapy.

The stock was advancing 17.17% to $23.20 in premarket trading.

Click here for accessing Benzinga's FDA Calendar

Kymera Announces Departure of Chief Scientific Officer

Kymera Therapeutics, Inc. KYMR announced that Richard Chesworth, its chief scientific officer, will be departing, effective Oct. 22.

The company said it has commenced a search for a new chief scientific officer.

Protagonist's Rusfertide Clinical Studies Placed On Hold Due to Skin Cancer Scare

Protagonist Therapeutics, Inc. PTGX announced the receipt of verbal communication from the FDA that Protagonist's clinical studies for rusfertide, an investigational product candidate currently in development, have been placed on a clinical hold.

The clinical hold follows Protagonist's notification to the FDA of a recent non-clinical finding in a 26-week rasH2 transgenic mouse model study. The rasH2 model is designed to detect signals related to tumorigenicity, and benign and malignant subcutaneous skin tumors were observed in this study.

Rusfertide, an investigational, injectable hepcidin mimetic, is being evaluated in a Phase 2 proof-of-concept clinical trial for polycythemia vera (PV), a Phase 2 study in PV subjects with high hematocrit levels, and a Phase 2 study for hereditary hemochromatosis.

The stock was slumping 59.90% to $18.50 in premarket trading.

Sight Sciences Files Lawsuit Against Ivantis For Infringing Patents Related to Devices For Reducing Interocular Pressure

Sight Sciences announced that it filed a lawsuit in the U.S. District Court in Delaware against Ivantis, Inc. for infringement of certain U.S. patents that describe and claim devices and methods for reducing intraocular pressure in the eye.

Sight Sciences' complaint seeks an injunction to prevent the infringing manufacture, use and sale of the Hydrus Microstent, along with money damages for past infringement.

Vascular Biogenics Announces Clearance From Independent DSMC For Proceeding With Late-stage Ovarian Cancer Study

Vascular Biogenics Ltd. VBLT announced the independent Data Safety Monitoring Committee of the ongoing OVAL Phase 3 registration-enabling study of VB-111 in ovarian cancer has conducted its fifth pre-planned review and has provided clearance to proceed with further clinical research as planned with no changes to the protocol.

The stock was advancing 4.60% to $2.50 in premarket trading.

Novavax' COVID-19 Vaccine to Be Part of Combo Vaccine Study Conducted by the Oxford University In U.K.

Novavax, Inc. NVAX announced its participation in a newly expanded Phase 2 clinical trial called Com-COV3, led by the University of Oxford and funded by the UK Vaccines Taskforce and the National Institute for Health Research.

Novavax's recombinant nanoparticle COVID-19 vaccine candidate, NVX-CoV2373, is one of the three COVID-19 vaccines that will be studied in adolescents to evaluate the potential for combined regimens that mix vaccines from different manufacturers to achieve immune protection against COVID-19.

Offerings

Gritstone bio, Inc. GRTS announced a $55 million private investment in public equity financing from the sale of 5 million shares of its common stock at a price per share of $11. The PIPE is being led by Frazier Life Sciences Public Fund, with additional participation from Redmile Group and Gilead Sciences, Inc. GILD.

The stock was moving down 1.18% to $13.38 in premarket trading.

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

On The Radar

PDUFA Dates

Biogen Inc. BIIB and Samsung Bioepis await FDA's verdict on their Biologic license application for SB11, a biosimilar to Roche Holding AG RHHBY's Lucentis indicated for a slew of retinal vascular disorders. The decision is likely to be announced by Friday, estimated based on the 10-month standard review period from the date of filing.

Adcom Calendar

FDA's Vaccines and Related Biological Products Advisory Committee is scheduled to meet between 8:30 am and 3:45 pm, to discuss Pfizer, Inc. PFE/BioNTech SE BNTX's COVID-19 vaccine, Comirnaty, for administration of a third dose, or "booster" dose in individuals 16 years of age and older.

Clinical Readouts/Presentations

TG Therapeutics, Inc. TGTX will present at the International Workshop On CLL data from the Phase 1/2 study of umbralisib + ublituximab + Merck's Keytruda in patients with relapsed/refractory chronic lymphocytic leukemia and Richter's transformation.

European Society for Medical Oncology 2021 Congress Presentations

Agenus Inc. AGEN presented in an abstract, final results from the Bal/Zal combination study in recurrent/metastatic cervical cancer, showing high response rates, durable clinical activity, and promising overall survival results.

In the 125 evaluable patients, the objective response rate in all patients was 26%, with 9% of patients achieving a complete response, and 17% of patients achieving a partial response. The median duration of response was not reached after a 19.4-month median follow-up.

The stock was up 4.85% at $5.84 in premarket trading.