In 33 heavily pretreated NSCLC EGFR wild-type (EGFRwt) patients the combination of AFM24 and atezolizumab shows an overall response rate (ORR) of 21% (6 confirmed responses, 1 response awaiting confirmatory scan) and a disease control rate (DCR) of 76%; tumor shrinkage was observed in 48% of patients; preliminary median progression free survival (PFS) is 5.6 months and 36% of patients remain on treatment In 17 heavily pretreated NSCLC EGFR mutant (EGFRmut) patients the combination shows an ORR o

KYN-5356, an innovative, first-in-class small molecule inhibitor of KAT-II, a key enzyme in the kynurenine pathway implicated in schizophrenia, was shown to be safe and well-tolerated in the phase 1 study in healthy volunteers Initial data show clear evidence of target engagement and suggestive evidence of cognitive improvement, adding to body of evidence that supports further study of KYN-5356 in patients with cognitive impairment associated with schizophrenia (CIAS), which is among the most d

Preclinical studies with ACCG-2671 demonstrate potent target engagement, robust weight loss, favorable safety profile and PK properties supportive of once-daily dosing in humans ACCG-2671 is the most advanced oral small molecule amylin-based drug candidate, with Phase 1 study initiation expected by year end 2025 Company to host conference call today at 4:30 p.m. Eastern Time Dec. 17, 2024 -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developin

Dec. 16, 2024 -- Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the first patient has been dosed in the Company’s phase 2 trial evaluating petosemtamab monotherapy in heavily pretreated (3L+) metastatic colorectal cancer (mCRC). Petosemtamab is a Biclonics® targeting EGFR and LGR5. The phase 2, open-label trial will evaluate the safety and antitumor activity o

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