Spero Therapeutics, Inc.

Spero Therapeutics is initiated with a "Buy" rating, driven by its strategic pivot to immunology and strong non-dilutive financing. SPRO secured FDA approval for Utebzi and a $105M royalty deal, enabling funding for SP001 development without shareholder dilution. SP001, a third-generation anti-CD40L antibody, targets IgG4-RD and Sjögren's disease, with phase 2 trials planned for 2027 and a differentiated, B-cell-sparing MOA.

seekingalpha.com - 2026-07-14 13:40:33

CAMBRIDGE, Mass., July 14, 2026 (GLOBE NEWSWIRE) --  Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on advancing next-generation medicines in immunology and inflammation, today announced a $105 million non-recourse non-dilutive royalty financing transaction with affiliates of Healthcare Royalty, a business of KKR (HCRx). Under the agreement, HCRx will receive a portion of future milestone and royalty payments associated with sales of Utebzi™ (tebipenem pivoxil). The proceeds will primarily be used to support advancement of Spero's lead immunology drug candidate, SP001, a Phase 2-ready, Fc-silent, third-generation anti-CD40L monoclonal antibody with potential for development across a range of immune-mediated diseases.

globenewswire.com - 2026-07-14 06:02:00

Under the terms of the agreement, Spero will receive exclusive global rights, excluding Greater China, to develop, research, manufacture, and commercialize IBI355 (Spero R&D code: SP001) Innovent will receive an upfront payment, and is eligible to receive development, regulatory and commercial milestone payments, totaling approximately US$1.1 billion, as well as tiered royalties on net sales Spero plans to initiate a Phase 2 trial for IBI355 in Q2 2027 in IgG4-related disease (IgG4-RD), a serious, chronic fibroinflammatory condition with significant treatment burden and limited therapeutic options Innovent plans to initiate a Phase 2 trial in China by early 2027 for Sjögren's disease (SjD), a chronic autoimmune disorder with limited therapeutic options SAN FRANCISCO, CAMBRIDGE, Mass., and SUZHOU, China, July 14, 2026 /PRNewswire/ -- Innovent Biologics, Inc. (01801.HK) and Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced an exclusive license agreement for IBI355 (Spero R&D code: SP001), a third-generation Fc-silent anti-CD40L antibody.

prnewswire.com - 2026-07-14 06:00:00

CAMBRIDGE, Mass. and SAN FRANCISCO and SUZHOU, China, July 14, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) and Innovent Biologics, Inc. (01801.HK) today announced an exclusive license agreement for SP001 (Innovent R&D code: IBI355), a third-generation Fc-silent anti-CD40L antibody. Spero will receive exclusive rights to develop, research, manufacture, and commercialize SP001 worldwide, excluding Greater China, where Innovent retains rights. Spero currently expects to advance SP001 into a Phase 2 study in IgG4-RD patients in Q2 2027; Innovent expects to initiate a Phase 2 trial in China for SjD by early 2027.

globenewswire.com - 2026-07-14 06:00:00

LONDON and PHILADELPHIA, July 08, 2026 (GLOBE NEWSWIRE) -- Avacta Therapeutics (AIM: AVCT, "the Company", "Avacta"), a clinical stage biopharmaceutical company developing pre|CISION®, a tumor-activated oncology delivery platform, is pleased to announce the appointment of Dr. Patrick Vink, a seasoned healthcare executive, to its Board of Directors as Non-Executive Deputy Chairman and Senior Independent Director. Dr. Vink serves as Chairman at Arch Biopartners Inc (TSXV:ARCH, OTCQB:ACHFF) and on the board of Spero Therapeutics Inc. (NASDAQ:SPRO) as Nominating and Corporate Governance Chair.

globenewswire.com - 2026-07-08 02:00:00

Spero Therapeutics, Inc. and partner GSK receive FDA approval for Utebzi, the first oral carbapenem for complicated urinary tract infections, via partnership with GSK. SPRO stands to receive milestone payments and royalties from GSK, with potential annual earnings of ~$50m and upside if Utebzi achieves blockbuster status. Despite a volatile share price and limited pipeline, SPRO's low burn rate and funding runway into 2028 support a 'buy the dip' thesis for risk-tolerant investors.

seekingalpha.com - 2026-06-18 15:41:04

GSK wins FDA approval for Utebzi, the first oral carbapenem for complicated UTIs, further expanding its anti-infectives portfolio.

zacks.com - 2026-06-18 10:01:28

PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) and Spero Therapeutics (Nasdaq: SPRO) today announced that the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract infections (cUTIs) including pyelonephritisi, caused by certain susceptible pathogensii in adult patients who have limited or no alternative oral treatment options. This is the first and only oral carbapenem antibiotic approved for these patients. This app.

businesswire.com - 2026-06-17 16:21:00

CAMBRIDGE, Mass., June 17, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) and GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract infections (cUTIs) including pyelonephritis1, caused by certain susceptible pathogens2 in adult patients who have limited or no alternative oral treatment options. This is the first and only oral carbapenem antibiotic approved for these patients. This approval is a result of GSK's development and exclusive global licensing agreement (excluding select Asian territories) with Spero Therapeutics.iv

globenewswire.com - 2026-06-17 12:36:00

New Drug Application (NDA) for tebipenem HBr for complicated urinary tract infections (cUTI), including pyelonephritis, is under review at the FDA, with PDUFA date of June 18, 2026 Spero maintains its cash runway guidance into 2028 CAMBRIDGE, Mass., May 13, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need, today announced financial results for the first quarter ended March 31, 2026, and provided a business update.

globenewswire.com - 2026-05-13 16:05:00

CAMBRIDGE, Mass., May 05, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics , Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need, today announced that it will report its financial results for the first quarter ended March 31, 2026, and provide a business update on Wednesday, May 13, 2026, after market close.

globenewswire.com - 2026-05-05 16:05:00