Dec. 16, 2024 -- Atsena Therapeutics, a clinical-stage gene therapy company focused on bringing the life-changing power of genetic medicine to reverse or prevent blindness, today announced dosing has been completed in Part A of the LIGHTHOUSE study, a Phase I/II clinical trial evaluating subretinal injection of ATSN-201 for the treatment of X-linked retinoschisis (XLRS). ATSN-201, a best-in-class gene therapy product candidate, leverages AAV.SPR, the company’s novel spreading capsid, to achieve

December 16, 2024 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has entered into an exclusive distribution and license agreement with Innoviva Specialty Therapeutics, Inc., a wholly owned subsidiary of Innoviva Inc. (NASDAQ: INVA), for the commercialization of Basilea’s hospital anti-MRSA antibiotic Zevtera® (ceftobiprole) in the United

Company plans to meet with FDA regarding potential sNDA submission in 1H 2025 Call planned today at 8:30 a.m. (ET) to discuss company’s diabetes program progression Dec. 16, 2024 -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced six-month results from its Phase 3 INHALE-1 study of Afrezza (insulin human) Inhalation Powder in children

— First-in-class, oral small molecule to prevent weight regain, without need for significant lifestyle modifications — Breakthrough potential to treat obesity-related comorbidities by regulating underlying dysfunction in metabolic syndrome — Program is currently in IND-enabling studies and on track to enter the clinic in Q3 2025 Dec. 16, 2024 -- Verge Genomics, a clinical-stage biotechnology company pioneering the use of artificial intelligence (AI) and human data to transform drug discovery an

INX-315 was safe and well tolerated in monotherapy dose escalation INX-315 monotherapy demonstrated antitumor activity in heavily pretreated patients with ER+/HER2- breast cancer and CCNE1-amplified ovarian cancer Monotherapy and combination dose expansions are ongoing Dec. 13, 2024 -- Incyclix Bio, LLC, a next-generation cell cycle control company developing INX-315, a novel, potent and selective CDK2 inhibitor for the treatment of advanced and resistant cancer, announced interim clinical dat

The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of acoramidis in the EU based on positive results from the Phase 3 ATTRibute-CM study; final approval decision, typically consistent with the CHMP recommendation, is expected from the European Commission within the coming months Acoramidis, a near-complete (≥90%) stabilizer of transthyretin (TTR), was approved on November 22, 2024, by the U.S. Food and Drug Administration (FDA) as Attruby™ to reduce cardiovasc

Vabysmo PFS is the first and only prefilled syringe containing a bispecific antibody, offering a convenient alternative to currently available Vabysmo vials Vabysmo has demonstrated rapid and robust vision and anatomical improvements in neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and retinal vein occlusion (RVO) The ready-to-use Vabysmo PFS is co-packaged with the only CE-marked needle specifically designed for intravitreal injection 13 December 2024– Roche

Tolebrutinib designated Breakthrough Therapy by the FDA for non-relapsing secondary progressive multiple sclerosis Designation is based on positive results from the HERCULES study in adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS) Tolebrutinib is the first and only brain-penetrant BTK inhibitor in MS to be designated Breakthrough Therapy by the FDA December 13, 2024. The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutini

Dec. 12, 2024 -- Lumos Pharma, Inc. (NASDAQ:LUMO) (“Lumos Pharma” or the “Company”), a clinical stage biopharmaceutical company focused on therapeutics for rare diseases, and Double Point Ventures LLC (“DPV”) today announced the successful completion of the previously announced tender offer for Lumos Pharma’s shares at a purchase price of (i) $4.25 per share in cash at closing, without interest and less applicable tax withholding and (ii) one contingent value right (“CVR”) for each share of com

Dec. 11, 2024 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to the combination of ORPATHYS® (savolitinib) and TAGRISSO® (osimertinib) for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (“EGFR”) mutation‑positive non‑small cell lung cancer (“NSCLC”) with MET amplif