The Daily Biotech Pulse: Moderna Outlines Steps For mRNA Tech Advancement, Voyager-Novartis Strike Licensing Deal, Valneva Reports Positive Chikungunya Shot Readout

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

Stocks In Focus

Moderna Announces 4 Initiatives To Advance mRNA Vaccines As Preventative Options For Infectious Diseases

Moderna, Inc. MRNA announced four initiatives to advance mRNA vaccines to prevent infectious diseases. They include its global public health portfolio to 15 vaccine programs and setting up the mRNA Access to provide its mRNA technology to researchers to explore new vaccines against emerging or neglected infectious diseases. 

Additionally, the company said it has resolved not to enforce its COVID patents in the Gavi COVAX AMC for 92 low- and middle-income countries. The company also said, with the assistance of the U.S. government, it has entered into a memorandum of understanding with Kenya to establish Kenya as the location for its mRNA manufacturing facility.

Mallinckrodt Agrees To Pay $234M To Settle Lawsuit Alleging Underpayment Of Medicaid Drug Rebates

Mallinckrodt plc MNKKQ has agreed to pay $234 million to settle false claims act case brought by Whistleblower Law Collaborative regarding underpayment of Medicaid rebates for its drug Acthar. The settlement has been agreed between the company, the U.S. states, the District of Columbia and Puerto Rico, of which $123.64 million will be released to the U.S. and the remaining $110.066 million will go to the Medicaid participating case.

ADMA Announces FDA Nod For Georgia Plasma Collection Center

ADMA Biologics, Inc. ADMA said it has received U.S. Food and Drug Administration approval for its fifth ADMA BioCenters plasma collection facility located in Conyers, Georgia. With the approval, this facility is now FDA-approved to collect and introduce into interstate commerce human source plasma for further manufacturing in the U.S., the company said.

Axonics Gets FDA Greenlight For Recharge-Free Sacral Neuromodulation Implantable Neurostimulator

Axonics, Inc. AXNX said the FDA has approved its newly developed, long-lived, recharge-free sacral neuromodulation implantable neurostimulator. The Axonics F15 recharge-free SNM system, the company said, has small and thin INS with an expected life in the body of well over a decade that does not require any element of the system to be recharged — and sets a new standard for what is possible in this category. Shipments of Axonics F15 system will begin in April, the company added.

The stock was adding 1.57% to $55 in premarket trading.

Related Link: The Week Ahead In Biotech (March 6-12): Quiet Week On Tap With Earnings Season Reaching It Final Leg

Inventiva Gets Nod For Proceeding With Phase 2 Combo Study In Patients With Type 2 Diabetes And NASH

Inventiva IVA announced that the FDA has completed its safety review of the investigational new drug application and has concluded that the proof-of-concept Phase 2 combination trial with its lead drug candidate lanifibranor and empagliflozin in patients with Type 2 Diabetes and non-cirrhotic non-alcoholic steatohepatitis may proceed.

The initiation of the trial is planned for the first half of 2022 and the publication of top line results is expected for the second half of 2023.

Voyager Strikes Licensing Deal With Novartis For Tracer AAV Capsids For Gene Therapy Programs

Voyager Therapeutics, Inc. VYGR announced an agreement, which allows Novartis NVS to exercise options to license AAV capsids generated from Voyager's RNA-driven TRACER capsid discovery platform for potential use with three undisclosed CNS targets and options to access capsids for two additional targets to be agreed on in the future.

Voyager will receive $54 million upfront and is entitled to receive up to $37.5 million in exercise fees for options for three initial CNS targets. In addition, Novartis may elect to evaluate capsids for up to two additional targets to be agreed on in the future for $18 million upon selection of each target, and a $12.5-million exercise fee for selection of a capsid for each target.

Voyager is also eligible to earn up to $1.5 billion in potential development, regulatory, and commercial milestones for products utilizing Voyager licensed capsids, as well as mid- to high-single-digit tiered royalties based on net sales of Novartis products incorporating the licensed capsids.

Voyager shares were rising 13.99% to $4.48 in premarket trading.

Valneva Announces Positive Results From Pivotal Phase 3 Trial Of Single-Shot Chikungunya Vaccine

Valneva SE VALN announced the successful completion of the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. The positive final analysis included six-month follow-up data and confirmed the topline results reported in August 2021.

Valneva said it now expects to commence the pre-submission process with the FDA in the second quarter.

The stock was gaining 4.74% to $28.28 in premarket trading.

Click here to access Benzinga's FDA Calendar.

Offerings

Biodesix, Inc. BDSX said it has entered into a private placement agreement with Lincoln Park Capital Fund, a Chicago-based institutional investor, for the sale of its common stock worth up to $50 million.

Travere Therapeutics, Inc. TVTX announced its intention to offer, subject to market and other conditions, a $250-million aggregate principal amount of convertible senior notes due 2029 in an underwritten offering. The company said it intends to use a portion of the net proceeds from the offering to repurchase a portion of its outstanding convertible notes.

The stock was retreating 2.51% to $26 in premarket trading.

On The Radar

Earnings

• Neuronetics, Inc. STIM (before the market open)
• InspireMD, Inc. NSPR (before the market open)
• Matinas BioPharma Holdings, Inc. MTNB (before the market open)
• Harvard Bioscience, Inc. HBIO (before the market open)
• Aquestive Therapeutics, Inc. AQST (after the close)
• Accelerate Diagnostics, Inc. AXDX (after the close)
• Anika Therapeutics, Inc. ANIK (after the close)
• Cumberland Pharmaceuticals Inc. (CPIX) (after the close)
• Evoke Pharma, Inc. EVOK (after the close)

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