Pharmaceuticals & Biopharmaceuticals

QuVa Pharma Acquires CAPS' 503B Compounding Portfolio

Image
QuVa Pharma Acquires CAPS' 503B Compounding Portfolio

Sugar Land, Texas – September 11, 2026 -- QuVa Pharma, Inc. has acquired a portfolio of essential sterile compounded medications from Central Admixture Pharmacy Services, Inc. (CAPS) after CAPS decided to exit the 503B sterile compounding business, the companies announced.

QuVa to phase in acquired products starting later in 2026

QuVa expects to begin introducing selected products from the acquired portfolio in phases later in 2026, with plans to expand offerings over the following six months. The deal covers critical medication categories including Cardioplegia, Total Parenteral Nutrition and Heparin.

Harbour BioMed, Windward Bio Post Phase 2 Data for Twice-Yearly Asthma Antibody

Image
Harbour BioMed, Windward Bio Post Phase 2 Data for Twice-Yearly Asthma Antibody

Cambridge, Massachusetts – September 11, 2026 -- Harbour BioMed (HKEX: 02142) and partner Windward Bio reported positive Phase 2 interim results for HBM9378/WIN378, a twice-yearly TSLP-blocking antibody, from the 147-patient POLARIS-1 asthma trial, clearing the path for two Phase 3 studies.

Interim data show up to 174 mL lung-function gain after single dose

The Phase 2 interim analysis, conducted on the first 98 of 147 enrolled patients with uncontrolled moderate-to-severe asthma, found FEV1 increases of up to 174 mL, with a placebo-adjusted mean increase of 256 mL (p=0.033) at Week 24 after a single dose.

Biomarkers for airway inflammation drop sharply

FeNO fell by up to 24 ppb, a 43% reduction (p=0.006), while blood eosinophil counts dropped by up to 200 cells/μL, a 51% decline (p0.0001). Near-maximal effects appeared as early as Week 2 and were sustained through Week 24.

Bausch Health, YUN Expand Microbiome Skincare to Mexico, EMEA

Image
Bausch Health, YUN Expand Microbiome Skincare to Mexico, EMEA

Laval – September 11, 2026 -- Bausch Health Companies Inc. (NYSE: BHC)(TSX: BHC) and Belgian biotech YUN have expanded their strategic partnership to Mexico and additional EMEA markets, building on a 2025 launch in Poland.

Partnership adds five new markets across EMEA and Latin America

The collaboration has extended YUN's acne-prone and eczema-prone skincare lines into the Czech Republic, Slovakia, Ukraine and Bulgaria, alongside a fresh entry into Mexico. A further rollout in Kazakhstan is expected in October 2026.

Poland launch deepens into eczema care after 2025 acne debut

In Poland, Bausch Health broadened its dermatology portfolio with YUN's eczema-focused skincare, following last year's introduction of the company's probiotic-based acne-prone skin products.

Lakewood-Amedex CEO to Present at H.C. Wainwright Conference

Image
Lakewood-Amedex CEO to Present at H.C. Wainwright Conference

Sarasota, Fla. – September 11, 2026 -- Lakewood-Amedex Biotherapeutics Inc. (NASDAQ: LABT) will present at the H.C. Wainwright 28th Annual Global Investment Conference in New York City from September 14-16, 2026.

CEO Kelvin Cooper to hold one-on-one investor meetings during three-day conference

Kelvin Cooper, Ph.D., chief executive officer of the clinical-stage biotechnology company, will deliver a virtual presentation and conduct one-on-one meetings with registered investors and potential partners. The sessions will cover Lakewood-Amedex's business and clinical development strategy, recent corporate achievements, and anticipated milestones.

Alebund Wins FDA IND Clearance for AP308, First-in-Class IgAN Protease

Shanghai – September 11, 2026 -- Alebund Pharmaceuticals (Jiangsu) Limited (HKEX: 09637) has received U.S. FDA clearance of its Investigational New Drug application for AP308, a first-in-class engineered recombinant IgA protease targeting IgA Nephropathy (IgAN), moving the candidate from preclinical research into clinical development.

AP308 targets a disease affecting 9.5 million people worldwide

IgAN is the most common primary glomerulonephritis globally, with an estimated 9.5 million patients in 2025, including 5.1 million in China, more than half of the global total, according to China Insights Consultancy. Under current treatment strategies, median kidney survival is approximately 11 to 12 years, and roughly 60% of patients in a Chinese cohort progressed to end-stage renal disease within 15 years of diagnosis, per long-term studies in China and the UK.

Inhibrx's OX40 Drug Doubles Response Rate in Head and Neck Cancer Trial

Image
Inhibrx's OX40 Drug Doubles Response Rate in Head and Neck Cancer Trial

San Diego – September 11, 2026 -- Inhibrx Biosciences reported that its OX40 agonist INBRX-106, combined with pembrolizumab, produced a 48.3% confirmed objective response rate in first-line head and neck squamous cell carcinoma patients, nearly double the 26.5% seen with pembrolizumab alone.

Phase 2 data show the combination therapy nearly doubles response rates versus standard treatment

The randomized Phase 2 portion of the HexAgon study enrolled 68 patients across more than 80 sites in the United States, Europe and Asia, with 63 evaluable for the primary endpoint. Four patients (13.8%) on the combination arm achieved complete responses, compared with zero in the pembrolizumab-only control arm. Six-month progression-free survival reached 72.4% for the combination versus 42.8% for monotherapy, with median PFS of 9.6 months versus 4.9 months as of the August 19, 2026 data cutoff.

GCCL Expands Asia-Pacific Reach as Platinum Sponsor at ABP 2026

Image
GCCL Expands Asia-Pacific Reach as Platinum Sponsor at ABP 2026

Yongin, South Korea – September 11, 2026 -- GCCL (Global Clinical Central Lab), a South Korea-based clinical trial sample analysis provider, sponsored the Asia Bio Partnering Forum 2026 (ABP 2026) as a Platinum Sponsor, using the Singapore event to pursue expansion of its assay development and clinical sample analysis services across the Asia-Pacific region.

GCCL held partnering meetings with drug developers across mRNA, radiopharmaceutical and antibody therapy segments

The forum, held in Singapore from August 31 to September 2, drew approximately 650 pharmaceutical and biotechnology industry professionals, investors and life sciences stakeholders, generating roughly 2,500 one-on-one partnering meetings. GCCL engaged drug developers working across mRNA and nucleic acid therapeutics, radiopharmaceuticals and antibody-based therapies to assess evolving analytical requirements in global clinical development.

PeproMene's BAFF-R CAR-T Hits 80% Complete Remission in Lancet Study

Image
PeproMene's BAFF-R CAR-T Hits 80% Complete Remission in Lancet Study

Irvine, California – September 11, 2026 -- PeproMene Bio, Inc. reported that seven of nine patients (80%) treated with its BAFF-R-targeted CAR-T therapy PMB-CT01 achieved complete remission in a Phase 1 trial, with results now published in The Lancet.

All complete responses remained relapse-free at data cutoff, with the longest sustained remission reaching 35 months

Four of six patients who had previously progressed after conventional CD19-directed CAR-T therapy also achieved complete response under the new BAFF-R approach, described in the study as "CAR after CAR" treatment. No relapses were observed among any of the seven complete responders as of the data cutoff.

Capricor Sued Over Deramiocel Data After 64.5% Stock Collapse

Image
Capricor Sued Over Deramiocel Data After 64.5% Stock Collapse

New York – September 11, 2026 -- Capricor Therapeutics, Inc. (NASDAQ:CAPR) faces a securities fraud class action after its shares plunged 64.5% following disclosures about alleged undisclosed changes to clinical trial statistics underlying its Duchenne muscular dystrophy therapy application.

Epicyt Pharma's BAFA Cuts Urinary Calcium Loss in Bypass Patients

Gothenburg – – September 11, 2026 -- Epicyt Pharma AB reported positive topline results from a Phase 1/2a first-in-human study of its oral drug candidate BAFA, showing a statistically significant reduction in urinary calcium excretion in patients who underwent Roux-en-Y gastric bypass (RYGB) surgery. The Gothenburg-based clinical-stage biopharmaceutical company said the trial, completed in March 2026, also recorded improvements in key biomarkers of calcium homeostasis, consistent with enhanced intestinal calcium uptake.

BAFA targets a market of 3.5 million patients across the EU and US

Epicyt estimates that approximately 3.5 million people in the EU and US currently live with impaired calcium homeostasis following bariatric surgery, with roughly 250,000 new patients added annually. RYGB is widely used to treat severe obesity but frequently impairs calcium uptake, raising the risk of secondary hyperparathyroidism, reduced bone density and fractures.