Last week, the biotech sector was in focus, with regular pipeline and regulatory updates. While nothing much came from biotech majors, Amicus FOLD and Editas EDIT were in focus on updates.

Recap of the Week’s Most Important Stories:

Gilead, Merck Report Data

Gilead Sciences, Inc. GILD and partner Merck MRK announced new results from a mid-stage study evaluating the investigational combination of islatravir and lenacapavir for the treatment of HIV. The phase II study is evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class HIV-1 capsid inhibitor.

This open-label, active-controlled study enrolled virologically suppressed adults who were on Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF).

Data showed a treatment switch to an investigational oral once-weekly combination regimen of islatravir and lenacapavir maintained viral suppression in adults at week 48. The novel investigational combination maintained a high rate (n=49; 94.2%) of viral suppression in virologically suppressed adults, a secondary endpoint of the study at 48 weeks. None of the participants had a viral load of ≥50 copies/mL at week 48.

Based on the encouraging 48-week data for this once-weekly oral combination regimen, Gilead and Merck plan to advance the regimen to phase III studies.

FOLD Up on Settlement

Amicus announced that it has signed a licensing agreement with Teva Pharmaceuticals TEVA, resolving the patent lawsuit filed earlier by FOLD. The litigation arose after Teva submitted an abbreviated new drug application seeking approval to sell a generic version of Amicus' Galafold (migalastat) 123 mg capsules before the related patents expired. FOLD gained on the announcement of the settlement agreement.

Galafold, Amicus’s lead marketed drug, is approved for patients with amenable genetic variants who live with Fabry disease.

Under the terms of the agreement, Amicus will grant Teva a license to sell its generic version of Galafold in the United States starting Jan. 30, 2037. However, it is subject to FDA approval and the fulfillment of certain customary conditions. The agreement ends all ongoing litigation between Amicus and Teva concerning Galafold patents in the U.S. District Court for Delaware. However, the litigation will continue against Aurobindo Pharma as the remaining active party, and it will remain in place for Lupin.

Amicus currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Updates From Editas

Editas announced that it has entered into a collaboration and nonexclusive license agreement with Canada-based privately held company Genevant Sciences to develop in vivo gene editing medicines. The partnership is aimed at leveraging Editas’ CRISPR Cas12a genome editing systems with Genevant’s proprietary lipid nanoparticle (LNP) technology to develop novel mRNA-LNP gene editing therapies for two undisclosed targets in EDIT’s upregulation strategy.

Per the deal, Editas will pay up to $238 million in upfront and contingent milestone payments to Genevant, while the latter will also be eligible to receive tiered royalties on future net sales upon potential approval.

Editas also announced that it is seeking a global partner to advance its lead gene editing therapy, reni-cel, which is being developed for the treatment of sickle cell disease and beta thalassemia, or potentially out-license the candidate. As part of its strategic reprioritization efforts, Editas announced that it is set to focus resources on in vivo pipeline development.

Editas has successfully demonstrated in vivo preclinical proof of concept for editing hematopoietic stem and progenitor cells and inducing fetal hemoglobin in humanized mice. These mice were engrafted with human hematopoietic stem cells and lacked their hematopoietic cells. The company achieved high levels of editing of the HBG1/2 promoter using its clinically validated upregulation strategy and a proprietary targeted lipid nanoparticle formulation designed for delivery to extrahepatic (outside the liver) tissues.

Performance

The Nasdaq Biotechnology Index has lost 2.98% in the past five trading sessions and Moderna’s shares have lost 7.08%. In the past six months, shares of MRNA have lost 50.51%. (See the last biotech stock roundup here: Biotech Stock Roundup: VNDA, JAZZ Up on Updates, NVAX Suffers Setback & More)

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What's Next in Biotech?

Stay tuned for more pipeline updates.

 

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Merck & Co., Inc. (MRK) : Free Stock Analysis Report

Teva Pharmaceutical Industries Ltd. (TEVA) : Free Stock Analysis Report

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