NEWS

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

Shots: The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy Approval was based on P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 75% (N=71: 6% CR & 69% PR)…

August 11, 2025

The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

Shots: The US FDA has granted FTD to Birelentinib (DZD8586) for the treatment of adults with r/r chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received ≥2L of therapy, incl. a BTK & a BCL-2 inhibitor Designation was based on pooled P-I/II data showing 84.2% ORR & DoR rate of 83.3% at 9mos.…

August 8, 2025

Genmab Reports P-III (EPCORE FL-1) Trial Data on Epcoritamab for R/R Follicular Lymphoma

Shots: Genmab has reported P-III (EPCORE FL-1) trial data assessing epcoritamab (SC) + rituximab & lenalidomide (R2) vs R2 alone for the treatment of adult patients with r/r follicular lymphoma The trial met dual primary endpoints with improved ORR and PFS, reducing risk of progression or death by 79%; interim data will be submitted to…

August 8, 2025

Syndicate of Global Investors to Acquire HistoSonics for $2.25B

Shots: A management-led syndicate, supported by global investors, will acquire a majority stake in HistoSonics for $2.25B The acquisition was led by K5 Global, Bezos Expeditions, Wellington Management, Alpha JWC Ventures, Venture Investors Health Fund, Lumira Ventures, & over 10 other private & public investors HistoSonics aims to expand its Edison histotripsy system beyond liver tumors…

August 8, 2025

Sebela Pharmaceuticals Reports P-III (TRIUMpH) Program Completion and Data on Tegoprazan for Gastroesophageal Reflux Disease (GERD)

Shots: TRIUMpH program consisted of 2 P-III trials assessing tegoprazan in US GERD pts with erosive esophagitis (EE; n=1250 incl. 463 with LA Grade C/D esophagitis) & non-erosive reflux disease (NERD; n=800); FDA’s NDA filing for both EE & NERD is planned in Q4’25 In EE pts, tegoprazan (100 & 50mg) met the 1EP, showing…

August 8, 2025

DoveTree Medicines Enters a ~$5.99B Deal with XtalPi to Discover Novel Therapeutics Across Various Indications

Shots: XtalPi has entered into a strategic collaboration with DoveTree Medicines to identify novel therapeutics across oncology, immunology, inflammation, neurology, & metabolic diseases, leveraging XtalPi's de novo drug discovery platform As per the deal, DoveTree will gain exclusive global rights to develop & commercialize multiple therapeutics from the collaboration, in exchange for a $51M upfront,…

August 8, 2025

Celltrion Secures the US FDA’s Approval for Avtozma IV (Biosimilar, Actemra) to Treat Cytokine Release Syndrome

Shots: The US FDA has approved Avtozma IV, a biosimilar to Actemra (tocilizumab), for treating cytokine release syndrome in pts (≥2yrs.), covering all Actemra IV-approved indications in the US; expected to be available in the US by Aug 31, 2025 In Jan 2025, the US FDA approved Avtozma IV to treat rheumatoid arthritis (RA), giant…

August 8, 2025

Flare Therapeutics Reports First Patient Dosing in P-Ib Trial of FX-909 for Urothelial Cancer

Shots: Flare Therapeutics has dosed its first patient with FX-909 in P-Ib trial for the treatment of locally-advanced or metastatic urothelial cancer The P-Ib trial will assess FX-909 (30 & 50mg; QD) in 40 pts, incl. a biomarker-defined population, building on clinical PoC achieved in P-Ia, with P-Ia data to be presented in 2025. Efficacy…

August 7, 2025

Fapon Biopharma Reports First Patient Enrolment in P-I Trial of FP008 for Solid Tumors

Shots: Fapon Biopharma has enrolled the first patient in China for its P-I trial of FP008 for advanced solid tumors, conducted at Zhejiang Cancer Hospital. The patient completed the DLT observation with a favorable safety profile. The trial focuses on evaluating FP008's safety and tolerability FP008 demonstrated favorable safety and PK in monkey studies and…

August 7, 2025

Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

Shots: The US FDA has granted 510(k) clearance to cobas Respiratory 4-flex, which utilizes TAGS technology for simplification of respiratory testing & improving diagnostic speed as well as accuracy The cobas Respiratory 4-flex integrates seamlessly with cobas 5800, 6800 & 8800 systems to allow qualitative detection & differentiation of SARS-CoV-2, influenza A/B, as well as…

August 7, 2025

NEWS

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for HER2-Mutant NSCLC

The US FDA Grants Fast Track Designation to Dizal’s Birelentinib for Treating R/R CLL/SLL

Genmab Reports P-III (EPCORE FL-1) Trial Data on Epcoritamab for R/R Follicular Lymphoma

Syndicate of Global Investors to Acquire HistoSonics for $2.25B

Sebela Pharmaceuticals Reports P-III (TRIUMpH) Program Completion and Data on Tegoprazan for Gastroesophageal Reflux Disease (GERD)

DoveTree Medicines Enters a ~$5.99B Deal with XtalPi to Discover Novel Therapeutics Across Various Indications

Celltrion Secures the US FDA’s Approval for Avtozma IV (Biosimilar, Actemra) to Treat Cytokine Release Syndrome

Flare Therapeutics Reports First Patient Dosing in P-Ib Trial of FX-909 for Urothelial Cancer

Fapon Biopharma Reports First Patient Enrolment in P-I Trial of FP008 for Solid Tumors

Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

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