The Daily Biotech Pulse: Illumina Announces Multiple Partnerships, Immunome Slides On Regulatory Setback For COVID Antibody Drug, Preannouncements Pour In

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

Stocks In Focus

BioAtla, Bristol-Myers Squibb Announce Collaboration To Evaluate ADC-Opdivo Combo In Solid Tumors

BioAtla, Inc. BCAB said it has entered into a clinical collaboration with Bristol-Myers Squibb Company BMY to investigate its two lead CAB-antibody-drug conjugate candidates, BA3011 and BA3021, in combination with the latter's cancer immunotherapy Opdivo.

BioAtla will serve as the study sponsor and will be responsible for costs associated with the trial execution. Bristol Myers Squibb will provide Opdivo with a clinical drug supply for the study.

BioAtla shares were up 3.04% at $16.25 in premarket trading.

Sana Biotech Obtains Non-Exclusive Commercial Rights To Fully Human CAR Construct To Be Used In Gene, Cell Therapy

Sana Biotechnology, Inc. SANA, IASO Biotherapeutics and Hong Kong-based Innovent Biologics jointly announced that the companies entered into an agreement pursuant to which Sana obtained from IASO Bio and Innovent non-exclusive commercial rights to a clinically validated fully human BCMA CAR construct for use in certain in vivo gene therapy and ex vivo hypoimmune cell therapy applications.

IASO Bio and Innovent will receive an upfront payment and are entitled to receive up to approximately $204 million in potential development and regulatory milestone payments across up to six products, as well as royalties.

Medtronic's Micra AV Pacemaker Receives Approval In Japan

Medtronic plc MDT said it has received approval from Japan's Ministry of Health, Labor and Welfare for the sale and reimbursement of the Micra AV Transcatheter Pacing System, the world's smallest pacemaker. The company expects to launch the product this month.

The stock was adding 0.91% to $106.58 in premarket trading.

Fusion Pharma Announces Selection Of First Candidate Under Oncology Collaboration With AstraZeneca

Fusion Pharmaceuticals Inc. FSUN announced the nomination of the first targeted alpha therapy candidate under its collaboration agreement with AstraZeneca AZN. Both companies will jointly develop through a Phase 1 study the candidate, which utilizes Fusion's Fast-Clear linker technology to radiolabel an AstraZeneca-owned bispecific antibody with the alpha-emitting isotope, actinium-225.

Fusion shares were adding 3.64% to $5.12 in premarket trading.

Immunome's COVID-19 Drug Investigational New Drug Application Slapped With Clinical Hold

Immunome, Inc. IMNM said it has received a clinical hold letter from the U.S. Food and Drug Administration in response to its recently submitted IND application for IMM-BCP-01, a three-antibody cocktail for the treatment of COVID-19. The regulator has requested further information related to the preparation and administration of IMM-BCP-01 at clinical sites.

The company submitted the application in late November.

The stock was slumping 13.72% to $10 in premarket trading.

Related Link: The Week Ahead In Biotech (Jan 10-15): JPMorgan Healthcare Conference Front And Center, Preannouncements Keep Coming

Black Diamond Gets Nod To Begin Clinical Study Of BDTX-1535 In Cancer With Certain Mutations

Black Diamond Therapeutics, Inc. BDTX announced that the FDA has cleared an investigational new drug application for its MasterKey inhibitor BDTX-1535 in glioblastoma multiforme non-small cell lung cancer, with certain mutations. The company expects to initiate the Phase 1 study of BDTX-1535 in the first quarter of 2022 and expects to provide a clinical update in the second half of 2023.

The stock was jumping 27.56% to $5.74 in premarket trading.

Illumina Announces Multiple Partnerships, Estimates Above-Consensus Q4 Revenue

Illumina, Inc. ILMN had a slew of news late Monday. Nashville Biosciences, a wholly owned subsidiary of Vanderbilt University Medical Center, announced an agreement with Illumina under which both companies will seek to establish an alliance with multiple pharmaceutical industry partners to perform whole genome sequencing on approximately 250,000 de-identified DNA samples collected under an Institutional Review Board -approved process over the last 15 years.

Illumina also announced a multiyear partnership with Agendia N.V., a precision oncology for breast cancer, to co-develop in vitro diagnostic tests for oncology testing.

Separately, the company announced a partnership with Boehringer Ingelheim to develop companion diagnostics for several programs in Boehringer Ingelheim's oncology pipeline.

At the JPMorgan Healthcare Conference, the company announced preliminary consolidated fourth quarter revenue of approximately $1.19 billion, up 25% year-over-year. This was ahead of the $1.1 billion consensus estimate.

The stock was advancing 4.06% to $371 in premarket trading.

NeuBase Gets New CFO

NeuBase Therapeutics, Inc. NBSE announced the appointment of Todd Branning as chief financial officer.

The stock was gaining 1.98% to $2.57 in premarket trading.

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Inari Medical, Inc. NARI announced preliminary revenue in the range of $82.8 million-$83.3 million for the fourth quarter, up 14% sequentially and 71% year-over-year at the midpoint of the range. Analysts, on average, estimate revenues of $73.16 million.

The stock was up 6.23% at $90.08 in premarket trading.

STRATA Skin Sciences, Inc. SSKN preannounced fourth-quarter revenues of $8.8 million to $9.2 million, compared to $6.7 million in the year-ago period. The consensus estimate calls for revenues of $8.19 million.

Natus Medical Incorporated NTUS said it expects to report revenue of approximately $127.5 million to $128.5 million for the fourth quarter, and $472.3 million to $473.3 million for the full year. Analysts, on average, estimate revenues of $123.5 million for the fourth quarter and $471 million for the year.

PacBio PACB announced preliminary revenue of approximately $36 million for its fourth quarter, below the consensus estimate of $36.58 million.

The stock was dropping 10.98% to $14.76 in premarket trading.

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

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