The Daily Biotech Pulse: Kezar Life Surges On Positive Kidney Disease Trial Data, FDA Rejects Spero Therapeutics' Tebipenem, Graybug Reviews Strategic Alternatives

Zinger Key Points
  • Approval For Kite's Yescarta in follicular lymphoma marks third approval in Europe.
  • Kezar Life's Zetomipzomib appears to be immunomodulatory, well-tolerated and steroid-sparing.

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

Stocks In Focus

Kezar Life Sciences Shares Surge On Positive Data From Lupus Nephritis Trial

Kezar Life Sciences Inc KZR reported positive topline results from the MISSION Phase 2 trial of zetomipzomib in patients with active lupus nephritis (LN).

The results show a clinically meaningful overall renal response to zetomipzomib after six months without high-dose induction therapy.

Patients in the trial also experienced reductions in extra-renal manifestations of lupus.

Shares closed 103.6% higher at $11.77 during the after-hours session.

Centogene Names New CFO

Centogene N.V. CNTG has appointed Miguel Coego Rios as Managing Director and Chief Financial Officer of the Company, effective June 22.

Coego Rios joined Centogene as EVP Finance & Legal in February 2022 and served as Interim Chief Financial Officer as of April 1, 2022.

ESSA Pharma's EPI-7386 Monotherapy / Combo Therapy Show Early Activity Against Prostate Cancer

ESSA Pharma Inc EPIX presented clinical results from the Phase 1a dose-escalation study of EPI-7386 as a monotherapy for metastatic castration-resistant prostate cancer resistant to current standard-of-care therapies. 

The initial data from 36 patients demonstrate that EPI-7386 was well-tolerated, exhibited a favorable pharmacokinetic profile, and demonstrated initial anti-tumor activity in a heavily pretreated group of patients. 

ESSA expects to initiate the Phase 1b expansion study in Q3 2022.

Eliem Therapeutics Concludes Dosing In Radicular Pain Trial

Eliem Therapeutics Inc ELYM completed the dosing of the last patient in its Phase 2a trial of ETX-810 for chronic lumbosacral radicular pain, commonly known as sciatica. 

ETX-810 is an oral, non-opioid, new chemical entity prodrug of the bioactive lipid palmitoylethanolamide. 

Topline data are expected in the third quarter of 2022.

FDA Rejects Spero Therapeutics' Urinary Tract Infection Candidate

The FDA has issued a complete response letter (CRL) to Spero Therapeutics Inc's SPRO marketing application seeking approval for tebipenem HBr for complicated urinary tract infection, including pyelonephritis.

In the CRL, the FDA concluded that Spero's Phase 3 study was insufficient to support approval and that an additional clinical study would be required. 

Spero intends to request a Type A meeting with the FDA promptly.

Shares closed 8.12% lower at $0.86 during after-hours trading.

Also Read: Why Evofem Biosciences Stock Is Surging Today

Gilead Sciences Refiles FDA Application For Lenacapavir In Pretreated HIV Patients

Gilead Sciences Inc GILD resubmits a new marketing application to the FDA for lenacapavir for heavily pretreated people with multi-drug resistant HIV-1 infection.

Gilead resubmitted the NDA in response to the FDA complete response letter issued in February, which cited Chemistry Manufacturing and Controls issues relating to the compatibility of lenacapavir in borosilicate vials. 

If approved, lenacapavir would be the first and the only HIV-1 treatment option administered twice yearly.

Sutro Biopharma Stock Surges On Cancer Treatment Pact

Astellas Phara Inc ALPMF and Sutro Biopharma Inc STRO announced a strategic collaboration and licensing agreement focused on the discovery and development of immunostimulatory antibody-drug conjugates (iADC).

Sutro will engage in research and preclinical studies to identify candidate compounds, and then Astellas will pursue clinical development. 

Sutro will receive an upfront payment of $90 million to develop iADCs for three biological targets, and may be eligible to receive up to $422.5 million in milestone payments for each product candidate.

Kite Pharma's CAR T-Cell Therapy Approved In Europe For Pretreated Lymphoma Setting

The European Commission has approved Kite Pharma's, a Gilead Sciences Inc's GILD company, CAR T-cell therapy Yescarta (axicabtagene ciloleucel) for relapsed or refractory follicular lymphoma after three or more lines of systemic therapy.

The approval is supported by Phase 2 ZUMA-5 study data, demonstrating an overall response rate of 91% and a complete response rate of 77%.

Graybug Announces Review of Strategic Alternatives

Graybug Vision Inc's GRAY board of directors will conduct a comprehensive review of strategic alternatives focused on maximizing shareholder value.

As of March 31, the company's cash, cash equivalents, and short-term investments totaled $55.3 million. 

Graybug has retained Piper Sandler as its financial advisor to assist with this review process.

Shares are up 19.7% at 99 cents during the premarket session.

Soligenix Receives FDA Nod For Mid-Stage Psoriasis Study

The FDA has signed off Soligenix Inc's SNGX Phase 2a clinical trial of SGX302 (synthetic hypericin) for mild-to-moderate psoriasis. Patient enrollment is expected to start in Q4 of 2022.

The trial will enroll 32 patients. Efficacy endpoints will include the extent of lesion clearance and patient-reported quality of life indices.

Shares are up 9.89% at 61 cents during the premarket session.

On The Radar

Earnings

Roivant Sciences Ltd ROIV: Before the market open.

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