Theratechnologies, Inc.

FDA Approves EGRIFTA WR™: New Weekly Reconstitution Formulation for HIV-Associated Lipodystrophy

2 months ago

• Theratechnologies has received FDA approval for EGRIFTA WR™ (tesamorelin F8), a new formulation that requires weekly rather than daily reconstitution for treating excess visceral abdominal fat in adults with HIV and lipodystrophy. • The improved formulation requires less than half the administration volume of the current EGRIFTA SV® version, offering a more convenient patient experience while maintaining bioequivalence to the original tesamorelin formulation. • Recent data presented at CROI 2025 highlights that BMI alone is insufficient for assessing cardiovascular risk in HIV patients, emphasizing the importance of measuring visceral adipose tissue in this population.

FDA Approves Blujepa, First New Class of Oral Antibiotic for UTIs in Nearly 30 Years

2 months ago

• GSK's Blujepa (gepotidacin) has received FDA approval for treating uncomplicated urinary tract infections, marking the first new class of oral antibiotics for UTIs in nearly three decades. • The novel triazaacenaphthylene antibiotic demonstrated non-inferiority or superiority to nitrofurantoin in clinical trials, offering a new treatment option amid rising antibiotic resistance concerns. • Blujepa works through a unique dual-enzyme inhibition mechanism that may reduce the potential for resistance development, with commercial availability expected in the second half of 2025.

Ionis and Ono Forge $940 Million Deal for Sapablursen in Polycythemia Vera Treatment

2 months ago

• Ionis Pharmaceuticals has licensed sapablursen, an RNA-targeted medicine for polycythemia vera, to Ono Pharmaceutical in a deal worth up to $940 million including $280 million upfront. • Sapablursen, currently in Phase 2 trials, has received FDA Fast Track and Orphan Drug designations and works by increasing hepcidin production to regulate iron homeostasis in PV patients. • Ono will gain exclusive global rights for development and commercialization, while Ionis will complete the ongoing IMPRSSION study before transferring responsibilities.

FDA Gears Up for Key Decisions on Vaccines and Novel Therapies in H1 2025

4 months ago

• The FDA is set to decide on Bavarian Nordic's CHIKV VLP vaccine for chikungunya, potentially the first VLP-based option in the U.S. • GSK's ABCWY vaccine, targeting multiple strains of Neisseria meningitidis, awaits FDA decision for primary care and pediatric use. • Innoviva Specialty Therapeutics' zoliflodacin, a novel antibiotic for gonorrhea, is under FDA review amid rising antimicrobial resistance. • Merck's clesrovimab, a monoclonal antibody for COVID-19, is being reviewed by the FDA for pediatric patients.

Sudocetaxel Zendusortide Shows Promise in Advanced Ovarian Cancer Phase 1b Trial

5 months ago

• Theratechnologies' sudocetaxel zendusortide demonstrates favorable tolerability and efficacy signals in heavily pre-treated ovarian cancer patients in a Phase 1b trial. • No dose-limiting toxicities were observed in patients receiving weekly doses of sudocetaxel zendusortide, indicating a manageable safety profile. • Preliminary efficacy data showed significant tumor shrinkage and complete resolution of a liver lesion in some patients at a 2.5-mg/kg/week dose. • The Medical Review Committee recommends further evaluation and exploration of higher doses based on the encouraging tolerability and efficacy data.

Theratechnologies Awaits FDA Decision on EGRIFTA SV® Manufacturing Change

6 months ago

• Theratechnologies has submitted a Prior Approval Supplement (PAS) to the FDA for changes in the manufacturing of EGRIFTA SV®. • The FDA's review is expected to take four months, with approval needed before new batches can be distributed, potentially impacting supply. • Current inventory of EGRIFTA SV® is projected to meet patient demand until mid-January 2025, creating a narrow window for approval. • The company is in talks with the FDA to expedite the review process and prevent potential shortages of EGRIFTA SV® in the US.

Senti Bio Announces Promising Early Phase 1 CAR-NK Data, Stock Surges

6 months ago

• Senti Bio reported encouraging early Phase 1 clinical trial data for its CAR-NK cell therapy in cancer patients, leading to a significant increase in the company's stock value. • The initial data showed that two out of three patients treated with Senti Bio's CAR-NK therapy exhibited positive responses, suggesting potential efficacy. • This early-stage trial marks a crucial step in evaluating the safety and potential of CAR-NK cell therapies as a novel approach to cancer treatment. • The company is continuing to enroll patients and further evaluate the therapy's efficacy and safety profile in this Phase 1 study.