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Clinical Trial News

Supernus Faces Generic Competition as Third Parties File ANDA Challenges for ADHD Drug Qelbree

  • Supernus Pharmaceuticals received Paragraph IV Notice Letters from third parties who submitted Abbreviated New Drug Applications (ANDAs) for generic versions of Qelbree (viloxazine extended-release capsules) in 100, 150, and 200 mg strengths.
  • The company plans to vigorously enforce its intellectual property rights, with six issued U.S. patents covering Qelbree that expire between September 2029 and April 2035.
  • This generic challenge represents a significant threat to Supernus's ADHD treatment franchise, as generic competition could substantially impact future revenue streams for the CNS-focused biopharmaceutical company.

Eisai and Merck Secure Patent Victory, Blocking Lenvima Generic Until 2036

  • Eisai and Merck successfully defended a key patent for cancer drug Lenvima against Shilpa Medicare's challenge, with a federal judge ruling the patent describes the invention clearly and in sufficient detail.
  • The patent victory covers purified lenvatinib mesylate and blocks Shilpa's generic version from FDA approval until the patent expires in February 2036.
  • Lenvima generated over $1 billion in alliance revenues for MSD last year and $1.51 billion in US sales for Eisai, making it a significant blockbuster cancer treatment.
  • The drug is widely used alongside Keytruda as first-line therapy for kidney cancer and second-line treatment for endometrial cancer, having treated over half a million patients worldwide.

FDA-Approved Menopause Drug Duavee Shows Promise for Breast Cancer Prevention in Phase 2 Trial

Oncology
  • A multi-center phase 2 clinical trial led by Northwestern Medicine found that Duavee significantly reduced cell growth in breast tissue among 141 postmenopausal women with ductal carcinoma in situ (DCIS).
  • The drug, already FDA-approved for menopausal symptoms, was well tolerated by participants and did not affect quality of life during the four-week treatment period.
  • Duavee may offer a promising alternative for women at elevated breast cancer risk who experience menopausal symptoms but are typically advised against standard hormone therapies.
  • Researchers will present findings at the American Society of Clinical Oncology Annual Meeting, though larger studies with longer follow-up are needed before considering the drug for breast cancer prevention.

The PROMISE Study: Duavee in Women With DCIS

NCT02694809CompletedPhase 2
Northwestern University
Posted 1/1/2017

AusperBio Secures $50 Million Series B+ Funding to Advance Hepatitis B Functional Cure Candidate AHB-137

  • AusperBio completed an oversubscribed $50 million Series B+ financing round led by existing investors with participation from major venture capital firms.
  • The funding will support ongoing clinical development of AHB-137, a novel antisense oligonucleotide targeting chronic hepatitis B, including planned Phase II trials outside mainland China.
  • AHB-137 has shown positive Phase IIb data presented at EASL Congress and has completed global Phase 1b trials while advancing through multiple Phase 2 studies in China.
  • The company's proprietary Med-Oligo™ ASO platform technology aims to deliver a functional cure for chronic hepatitis B and transform treatment paradigms for this serious chronic disease.

MAIA Biotechnology Raises $695,000 in Private Placement to Fund Phase II THIO-101 Cancer Trial

  • MAIA Biotechnology completed a $695,000 private placement offering 463,332 shares and warrants to fund its Phase II THIO-101 cancer trial.
  • The company will use proceeds to cover starting costs for Step 1 of Part C of the Phase II trial and working capital needs.
  • Investors received shares at $1.50 each with five-year warrants exercisable at $1.71, including participation from company director Stan Smith.
  • The securities were issued as restricted securities without registration rights, with closing expected on May 29, 2025.

CoreMap Receives FDA IDE Approval to Expand Novel Atrial Fibrillation Mapping Technology Study to U.S.

FDA Approval
  • CoreMap has received FDA Investigational Device Exemption approval to extend its INvENI clinical study to the U.S., evaluating its proprietary electrophysiology mapping system in persistent atrial fibrillation patients.
  • The company's ultra-high resolution mapping technology has demonstrated safety and acute effectiveness in over 50 patients, with the ability to identify AF driver regions not detectable by prior mapping methods.
  • The INvENI study is a multi-phase randomized controlled trial comparing CoreMap-guided ablation plus pulmonary vein isolation against standard-of-care treatment in persistent AF patients.
  • The technology features a dense array of micro-scale electrodes that can record hundreds of thousands of electrical activations during a single AF map, enabling patient-specific ablation strategies.

Eton Pharmaceuticals Receives FDA Approval for KHINDIVI, First Hydrocortisone Oral Solution for Pediatric Adrenal Insufficiency

Drug ApprovalRare Disease
  • Eton Pharmaceuticals announced FDA approval of KHINDIVI (hydrocortisone) oral solution, marking the first and only FDA-approved liquid hydrocortisone formulation for pediatric patients aged 5 and older with adrenocortical insufficiency.
  • The ready-to-use 1mg/ml oral solution eliminates the need to split or crush tablets, offering precise dosing for children who have difficulty swallowing pills or require gastric tube administration.
  • Commercial launch is expected the week of June 2nd, with Eton projecting combined peak sales of KHINDIVI and ALKINDI SPRINKLE to exceed $50 million annually.
  • The approval addresses a decades-long unmet need in pediatric endocrinology, providing accurate dosing capabilities critical for managing the more than 5,000 U.S. patients aged 5-17 with adrenal insufficiency.

FDA Approves First-in-Class TRPM8 Receptor Agonist Tryptyr for Dry Eye Disease Treatment

Drug Approval
  • The FDA approved Tryptyr (acoltremon ophthalmic solution) 0.003%, a first-in-class TRPM8 receptor agonist that stimulates corneal sensory nerves to rapidly increase natural tear production in dry eye disease patients.
  • In pivotal Phase 3 trials COMET-2 and COMET-3 involving over 930 patients, up to four times more Tryptyr patients experienced at least a 10mm increase in natural tear production at Day 14 compared to vehicle (42.6% vs 8.2% and 53.2% vs 14.4%, respectively).
  • The approval addresses a significant unmet need, as approximately 38 million individuals in the U.S. suffer from dry eye disease, yet only 13% of surveyed patients feel their condition is well-managed with current treatments.
  • Alcon expects to launch Tryptyr in the U.S. during the third quarter of 2025, marking the company's first prescription pharmaceutical approval since becoming an independent publicly traded eye care company.

Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)

NCT05360966CompletedPhase 3
Aerie Pharmaceuticals
Posted 7/18/2022

Study Evaluating the Safety and Efficacy of AR-15512

NCT05285644CompletedPhase 3
Aerie Pharmaceuticals
Posted 5/9/2022

IRA Biosimilar Incentives Drive Measurable Uptake in US Healthcare Facilities

  • The Inflation Reduction Act's 2% Medicare reimbursement boost for qualifying biosimilars has led to measurable increases in adoption, with 45% of surveyed facilities reporting slight increases and 14% reporting significant increases in utilization.
  • Healthcare facilities with higher awareness of IRA provisions use an average of eight biosimilars compared to 5.4 biosimilars at facilities with low awareness, demonstrating a clear correlation between policy knowledge and adoption rates.
  • Net price remains the primary driver of biosimilar adoption at 65% of facilities, while 32% cite the IRA's reimbursement incentives as a major factor in their decision-making process.
  • Despite progress, US biosimilar savings of $12.6 billion significantly lag behind Europe's €50 billion in savings since 2012, highlighting substantial untapped potential in the American market.

Cessatech Raises DKK 14.8 Million to Accelerate U.S. Commercial Launch of Pediatric Pain Treatment CT001

  • Cessatech completed a directed share issue raising approximately DKK 14.8 million through an accelerated bookbuilding process to strengthen its financial position ahead of the U.S. commercial launch of CT001.
  • The company announced positive top-line results from its final pediatric study 0202, meeting all primary endpoints with 55% of patients achieving pain relief after 15 minutes and 89% after 30 minutes.
  • CT001, an intranasal needle-free pain treatment for children, has received positive MDR assessment and completed the final study under the EMA approved PIP program, positioning the company for regulatory submissions.
  • The funding will support general corporate purposes and accelerate U.S. commercialization activities following approval of the manufacturing setup, with commercial launch anticipated during 2025.

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