The Daily Biotech Pulse: Europe Approves Second Round Of Booster Doses of mRNA COVID-19 Vaccines, Perrigo Seeks Approval For First OTC Birth Control Pill, MacroGenics Closes Head & Cancer Study After Patient Death

The Daily Biotech Pulse: Europe Approves Second Round Of Booster Doses of mRNA COVID-19 Vaccines, Perrigo Seeks Approval For First OTC Birth Control Pill, MacroGenics Closes Head & Cancer Study After Patient Death

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

Stocks In Focus

European Regulator Recommend Additional Booster Doses of mRNA COVID-19 Vaccines

The European Centre for Disease Prevention & Control and the European Medicines Agency have recommended second booster doses of mRNA COVID-19 vaccines for people between 60 and 79.

In April 2022, the agencies recommended that people over 80 be considered for a second booster.

The move comes after a new wave is underway in Europe, with increasing hospital and intensive care unit rates.

Perrigo Files US Application For First OTC Birth Control Pill

Perrigo Company plc's PRGO HRA Pharma has submitted its application to the FDA for the first-ever over-the-counter (OTC) birth control pill.

The company has applied for an Rx-to-OTC switch for Opill, a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill).

Shares are up 2.31% at $42.05 during the premarket session.

Ionis Partner Licenses Rare Kidney Disease Treatment

Ionis Pharmaceuticals Inc IONS said that its long-standing partner, Roche Holdings AG RHHBY, will license and advance IONIS-FB-LRx, an investigational antisense medicine, into a Phase 3 study immunoglobulin A nephropathy. 

Roche's decision to advance the program comes after positive data from a Phase 2 study in which IONIS-FB-LRx met its primary endpoint of change in 24-hour urinary protein at 29 weeks compared to baseline. 

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Can-Fite to Submit FDA & EMA Registration Plans For Its Lead Candidate For Psoriasis

Can-Fite BioPharma Ltd CANF plans to submit its marketing application plan to the FDA and European Medicines Agency (EMA) for its lead drug candidate Piclidenoson for moderate to severe psoriasis.

Can-Fite recently reported topline results from its Phase 3 COMFORT study, which met its primary endpoint with statistically significant improvement over placebo in psoriasis patients and a favorable safety profile for Piclidenoson.

SOBI-Sanofi Partnered Hemophilia Therapy Shows Superior Bleed Protection Than Prior Prophylaxis

Swedish Orphan Biovitrum AB BIOVF and Sanofi SA SNY presented results from the XTEND-1 phase 3 study of efanesoctocog alfa (BIVV001) in previously treated hemophilia A patients.

The study met the primary efficacy endpoint, with once-weekly efanesoctocog alfa prophylaxis providing clinically meaningful bleed protection.

The study also demonstrated superior bleed protection over prior factor VIII prophylaxis.

Sanofi's Fitusiran Prophylaxis Cuts Bleeds By 61% In Hemophilia Patients

Sanofi SA SNY announced data from the Phase 3 ATLAS-PPX study of once-monthly fitusiran (80 mg) in severe hemophilia A or B patients.

The study met the primary endpoint and demonstrated fitusiran prophylaxis significantly reduced bleeding episodes compared to prior factor or bypassing agent (BPA) prophylaxis.

Fitusiran prophylaxis resulted in a statistically significant reduction in estimated ABR of 61.1% vs. factor or BPA prophylaxis.

63.1% of the patients treated with fitusiran experienced zero treated bleeds, compared to 16.9% with a prior factor or BPA prophylaxis.

Patient Death Prompts MacroGenics To Close Mid-Stage Head & Cancer Study

MacroGenics Inc MGNX closed the Phase 2 study (CP-MGA271-06) of enoblituzumab in the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

The decision to discontinue the study was based on an internal review of safety data, which included seven fatalities

The investigators said that one death event was possibly related to the study treatment.

Pliant Shares Surge After Positive Lung Disease Trial Data

Pliant Therapeutics Inc's PLRX Phase 2a trial of PLN-74809 in patients with idiopathic pulmonary fibrosis met its primary and secondary endpoints.

A pooled analysis of PLN-74809 treated patients showed an 80% reduction in forced vital capacity decline at 12 weeks versus placebo.

PLN-74809 was well tolerated at all three doses tested and exhibited dose-proportional increases in plasma concentrations, consistent with prior studies.

Shares are up 39.3% at $12.37 during the premarket session.

Innoviva Bolsters Its Infectious Disease, Hospital Portfolio With La Jolla Deal

Innoviva Inc INVA has agreed to acquire La Jolla Pharmaceutical Company LJPC for $5.95 per share, 

Innoviva will also pay an incremental $0.28 per share for additional cash proceeds received in connection with the divestiture of a non-core asset. 

The deal consideration of $6.23 per share in cash has an implied enterprise value of approximately $149 million.

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