Innoviva Specialty Therapeutics Announces Publication in The Lancet of Positive Zoliflodacin Phase 3 Data for the Treatment of Uncomplicated Urogenital Gonorrhea Innoviva Specialty Therapeutics (NASDAQ: INVA) announced publication in The Lancet of positive Phase 3 data showing single‑dose oral zoliflodacin was non‑inferior to ceftriaxone plus azithromycin for uncomplicated urogenital gonorrhea (difference 5.31%, 95% CI 1.38%–8.65%).The trial reported comparable extragenital microbiological cure and similar safety with no serious adverse events. Zoliflodacin has QIDP designation and the FDA accepted the NDA in June 2025 with a PDUFA target action date of December 15, 2025.

#INVA Innoviva Specialty Therapeutics Announces Publication in The Lancet of Positive Zoliflodacin Phase 3 Data for the Treatment of Uncomplicated Urogenital Gonorrhea

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#INVA Innoviva Reports Third Quarter 2025 Financial Results; Highlights Recent Company Progress

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Trump Readies Troops from California and Texas for Oregon and Illinois The moves followed a judge’s order on Saturday that blocked the Oregon Guard from deploying to Portland, Ore. Illinois’ governor called it “Trump’s Invasion.”. @cosmicmeta.ai #Inva

https://u2m.io/BP3BVsdf

Trump Readies Troops from California and Texas for Oregon and Illinois The moves followed a judge’s order on Saturday that blocked the Oregon Guard from deploying to Portland, Ore. Illinois’ governor called it “Trump’s Invasion.”. @cosmicmeta.ai #Inva

https://u2m.io/BP3BVsdf

Trump Readies Troops from California and Texas for Oregon and Illinois The moves followed a judge’s order on Saturday that blocked the Oregon Guard from deploying to Portland, Ore. Illinois’ governor called it “Trump’s Invasion.”. @cosmicmeta.ai #Inva

https://u2m.io/BP3BVsdf

Cuisine Fad Unleashes Invasive Threat Into The US Wilderness Golden oyster mushrooms, with their sunny yellow caps and nutty flavor, have become wildly popular for being healthy, delicious and easy to grow at home from mushroom kits.

Cuisine Fad Unleashes Invasive Threat Into The US Wilderness A rising trend in specialty cuisine has inadvertently led to the introduction of invasive species into U.S. wilderness areas, raising concerns among environmentalists... @cosmicmeta.io #Inva

https://u2m.io/G4VvmevG

'Humanity’s time is over!’ Apple TV+ drops release date and intense first teaser for 'Invasion' Season 3 Check out the amplified alien action in this alarming new preview for the hit sci-fi series.

'Humanity’s time is over!’ Apple TV+ drops release date and intense first teaser for 'Invasion' Season 3 Apple TV+ has officially announced the release date for the highly anticipated third season of "Invasion," accompanied by... @cosmicmeta.io #Inva

https://u2m.io/ogSDs35K

Apple’s alien thriller Invasion is back for season 3 in August It’s looking like another busy summer for streaming sci-fi.

Apple’s alien thriller Invasion is back for season 3 in August The alien invasion continues, as Apple just confirmed the next season of Invasion will be streaming this summer. The new season will premiere on Apple TV Plus on... @cosmicmeta.io #Inva

https://u2m.io/7PyHAO97

Breakthrough Gonorrhea Treatment Zoliflodacin Gets FDA Fast Track: First New Drug in Decades FDA expedites review of novel oral antibiotic zoliflodacin for gonorrhea treatment. PDUFA date set for December 2025. See development timeline and market potential.

#INVA FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025

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Innoviva Specialty Therapeutics Receives FDA New Drug Application Acceptance for Zoliflodacin, a First-in-Class Oral Antibiotic for Uncomplicated Gonorrhea in Adults The FDA has accepted Innoviva Specialty Therapeutics' New Drug Application for zoliflodacin, a groundbreaking oral antibiotic for treating uncomplicated gonorrhea in patients 12 years and older. If approved, zoliflodacin would be the first new gonorrhea antibiotic in decades, offering a single-dose oral treatment option against multidrug-resistant strains. The drug's Phase 3 trial demonstrated non-inferiority to current treatment (ceftriaxone injection plus oral azithromycin) and was well-tolerated. Zoliflodacin works by inhibiting type II topoisomerase enzyme and has shown effectiveness against resistant strains in laboratory studies. The FDA granted it Qualified Infectious Disease Product designation, enabling Priority Review and Extended Market Exclusivity. This development addresses a critical global health need, as gonorrhea affects 82 million people annually and has become increasingly resistant to existing treatments.

#INVA Innoviva Specialty Therapeutics Receives FDA New Drug Application Acceptance for Zoliflodacin, a First-in-Class Oral Antibiotic for Uncomplicated Gonorrhea in Adults

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ZEVTERA® (ceftobiprole), an Advanced-Generation Cephalosporin Antibiotic Now Commercially Available in the U.S. to Treat Three Types of Bacterial Infections Innoviva Specialty Therapeutics announces the U.S. commercial launch of ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic. ZEVTERA is the first and only FDA-approved cephalosporin for treating three types of bacterial infections, including Staphylococcus aureus bacteremia (SAB) with right-sided endocarditis caused by MRSA. The drug demonstrated non-inferiority to daptomycin in Phase 3 ERADICATE study, with success rates of 69.8% vs 68.7%. ZEVTERA received Priority Review, Fast Track, and Qualified Infectious Disease Product designations. This marks Innoviva's second novel therapy launch in two years targeting drug-resistant pathogens. The drug addresses a significant medical need, as over 100,000 people in the U.S. experience bacteremia annually, with nearly 20,000 deaths. Innoviva acquired exclusive U.S. marketing rights from Basilea Pharmaceutica in December 2024.

#INVA ZEVTERA® (ceftobiprole), an Advanced-Generation Cephalosporin Antibiotic Now Commercially Available in the U.S. to Treat Three Types of Bacterial Infections

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SmCpStr Technicals – Technical Indicators for Small-cap Stocks

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Innoviva Reports First Quarter 2025 Financial Results; Highlights Recent Company Progress Innoviva (NASDAQ: INVA) reported its Q1 2025 financial results, demonstrating mixed performance. The company's core royalty revenue from GSK remained strong at $61.3M, while Innoviva Specialty Therapeutics achieved $26.4M in U.S. net product sales, marking 52% YoY growth. Despite operational growth with income from operations increasing 61% to $41.4M, the company reported a net loss of $46.6M, primarily due to unfavorable changes in equity investments. Key developments include the upcoming NDA filing for zoliflodacin and planned U.S. launch of ZEVTERA® in mid-2025. The company maintains a strong balance sheet with $319.1M in cash and cash equivalents and continues strategic investments in healthcare assets, valued at $457.6M as of March 31, 2025.

#INVA Innoviva Reports First Quarter 2025 Financial Results; Highlights Recent Company Progress

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SmCpStr Technicals – Technical Indicators for Small-cap Stocks

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If You See This Creepy Fish, Cut Its Head Off The invasive northern snakehead, which has recently been appearing in Missouri and other states, must be eradicated, officials say.. @cosmicmeta.io #Inva

https://tinyurl.com/22r6lnwg

Armata Lands Critical $10M Funding to Push Revolutionary Phage Therapy Toward FDA Meeting Armata Pharmaceuticals secures strategic financing from Innoviva to advance late-stage bacteremia trials and prepare for crucial FDA discussions on phage therapy candidates.

#ARMP #INVA Armata Pharmaceuticals Announces $10 Million Secured Credit Agreement with Innoviva

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Innoviva Reports Fourth Quarter and Full Year 2024 Financial Results; Highlights Recent Company Progress Innoviva (NASDAQ: INVA) reported strong financial results for Q4 and full year 2024. GSK royalties reached $66.0M in Q4 and $255.6M for the full year. The company's Specialty Therapeutics division achieved significant growth with U.S. net product sales of $24.9M in Q4 and $80.9M for 2024, representing 47% year-over-year growth.Q4 net income was $20.3M ($0.32 per share), while full-year net income reached $23.4M ($0.37 per share). The company ended 2024 with $305.0M in cash and $86.4M in receivables.Key developments include acquiring U.S. rights to ZEVTERA®, planning for mid-2025 launch, and positive Phase 3 data for zoliflodacin. Product performance showed strong results: GIAPREZA® ($53.4M), XERAVA® ($12.8M), and XACDURO® ($14.7M) in annual U.S. sales. The company forecasts U.S. net product sales to exceed $100M in 2025.

#INVA Innoviva Reports Fourth Quarter and Full Year 2024 Financial Results; Highlights Recent Company Progress

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Innoviva Secures Exclusive Rights to Groundbreaking MRSA Antibiotic Zevtera in Major FDA-Approved Drug Deal Innoviva gains U.S. rights to Zevtera, the only FDA-approved MRSA cephalosporin for bloodstream infections, through a strategic $4M deal with Basilea Pharmaceutica.

#INVA Innoviva Specialty Therapeutics Signs Exclusive Distribution and Licensing Agreement to Acquire U.S. Marketing Rights for Zevtera® (ceftobiprole)

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#INVA Innoviva to Participate in the Citi 2024 Global Healthcare Conference

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