The Daily Biotech Pulse: Pfizer Begins Late-Stage Pediatric COVID Pill Study, Midatech And J&J Unit Expand R&D Collaboration, AbbVie-Alvotech Settle Humira Dispute

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

Stocks In Focus

AbbVie Settles With Alvotech On Humira Biosimilar Patent Dispute

AbbVie, Inc. ABBV and Alvotech announced a settlement agreement that gives Alvotech non-exclusive rights to market AVT01, a biosimilar to AbbVie's Humira, in the U.S. The settlement gives Alvotech a license entry date into the U.S. of July 1, 2023.

In February, the Food and Drug Administration accepted Alvotech's biologic license application for ATV02, with the application including new data supporting interchangeability between ATV02 and Humira.

AbbVie shares were adding 1.19% to $148.90 in premarket trading.

NRx Pharma Founder & CEO Jonathan Javitt Retires

NRx Pharmaceuticals, Inc. NRXP announced that Jonathan Javitt, the biopharma's founder, has retired as chief executive officer, effective immediately. The board appointed Robert Besthof, Head of Operations and chief commercial officer, as Interim CEO.

The stock was adding 5.75% to $2.76 in premarket trading.

Click here to access Benzinga's FDA Calendar

Midatech Announces Expansion to J&J R&D Collaboration To Include Second Molecule

Midatech Pharma PLC MTP announced an extension of its existing R&D collaboration with Johnson & Johnson's JNJ Janssen unit originally announced on 21 July 2020.

Following the initial program (MTX213), the collaboration has been extended to include another large molecule to the research performed by Midatech for Janssen. As with the MTX213 molecule, the work will concentrate on maximizing drug loading and optimizing in vitro duration of release for this undisclosed Janssen experimental molecule using Midatech's Q-Sphera technology.

Paratek Announces Publication Of Positive Data For Antibiotic In Treating Pulmonary Infection

Paratek Pharmaceuticals, Inc. PRTK announced publication in the Journal of Antimicrobial Chemotherapy, data from an investigator-initiated study evaluating the activity of Nuzyra in a dynamic hollow fiber model of Mycobacterium avium complex pulmonary infection.

The authors determined that Nuzyra demonstrated considerable efficacy and potency against MAC when tested in a hollow fiber system infection model at the standard clinical doses approved for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in adults.

Renalytix Jumps On Launch Of Provider Access Portal For Testing Of Kidney Disease Patients

Renalytix plc RNLX announced the launch of its new provider access portal, myIntelX, which will provide nationwide online access for physicians to order KidneyIntelX bioprognostic testing for more accurate identification of patients at greatest risk for rapid progression of kidney disease in type 2 diabetes.

The stock was soaring 14.50% to $8.45 in premarket trading.

Pfizer Commences Phase 2/3 Testing Of Oral COVID Pill In Pediatric Patients

Pfizer, Inc. PFE said it has initiated a Phase 2/3 study to evaluate the safety, pharmacokinetics, and efficacy of Pfizer's Palovid in non-hospitalized, symptomatic, pediatric participants with a confirmed diagnosis of COVID-19 who are at risk of progression to severe disease.

The stock was adding 0.86% to $47.85 in premarket trading.

Sanofi-Sobi Report Positive Phase 3 Data For Hemophilia A Treatment Candidate

Sanofi SNY and Swedish Orphan Biovitrum AB, known as Sobi, announced positive top-line results from the pivotal XTEND-1 phase 3 study evaluating efanesoctocog alfa in previously treated patients, ages 12 years and older, with severe haemophilia A.

The study met the primary endpoint, showing a clinically meaningful prevention of bleeds in people with severe haemophilia A receiving weekly prophylaxis with efanesoctocog alfa over a period of 52 weeks. The key secondary endpoint was also met, demonstrating once-weekly efanesoctocog alfa was superior to prior prophylactic factor VIII replacement therapy, showing a statistically significant reduction in ABR based on intra-patient comparison.

Offerings

Terns Pharmaceuticals, Inc. TERNS filed a registration statement with the SEC, regarding an offering of common stock, preferred stock, debt securities, warrants and/or units worth $250 million, and the sale of a maximum of $75 million shares in a private placement with Cowen.

The stock was 2.44% to $3.2 in premarket trading.

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

On The Radar

Earnings

TScan Therapeutics, Inc. TCRX (before the market open)
Amryt Pharma plc AMYT (before the market open)
Selecta Biosciences, Inc. SELB (before the market open)
Assertio Holdings, Inc. ASRT (before the market open)
Acorda Therapeutics, Inc. ACOR (after the close)
Histogen Inc. HSTO (after the close)
Mirum Pharmaceuticals, Inc. MIRM (after the close)