NEWS

Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients

Shots: Memo Therapeutics has reported P-II (SAFE KIDNEY II) trial data assessing potravitug vs PBO for the treatment of BK polyomavirus (BKPyV) infection in kidney transplant recipients (n=95) Trial didn’t meet its 1EP of undetectable BKPyV DNAemia but showed superior viral response (≥1-log₁₀ reduction) & resolution of biopsy-proven BKPyVAN by Wk. 20, with histological improvement from…

July 28, 2025

Biogen’s Zurzuvae Receives the CHMP’s Positive Opinion to Treat Severe Postpartum Depression

Shots: The CHMP has recommended Zurzuvae (zuranolone) for the treatment of postpartum depression in adults; EC’s decision is expected in Q3’25 Opinion was based on P-III (SKYLARK) trial assessing Zurzuvae (50mg) vs PBO in pts with severe postpartum depression Trial met its 1EP with a significant mean reduction in HAMD-17 total score at Day 15,…

July 28, 2025

Gilead Reports the CHMP’s Positive Opinion on Lenacapavir for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: The CHMP has recommended approval of the MAA & EU-M4all application of lenacapavir as PrEP for individuals at risk of HIV across all 30 EEA states. It will be marketed in the EU as Yeytuo, if approved by the EC by late 2025 Opinion was based on P-III (PURPOSE 1 & PURPOSE 2) trials…

July 28, 2025

GSK Enters a ~$12.5B Deal with Hengrui Pharma to Develop up to 12 Novel Therapeutics Across Various Indications

Shots: GSK will obtain an exclusive global license to HRS-9821, an add-on maintenance therapy for COPD, along with exclusive option rights to develop & commercialize ~11 more programs in oncology, respiratory, immunology, & inflammation globally (excl. mainland China, Hong Kong, Macau, & Taiwan for both) Each of the ~11 additional programs will have its own…

July 28, 2025

KalVista Reports the CHMP’s Positive Opinion on Sebetralstat for Treating Hereditary Angioedema

Shots: The CHMP has recommended sebetralstat to treat acute attacks of hereditary angioedema (HAE) pts (≥12yrs.); EC’s decision expected by early Oct 2025. Application is under review in Japan & other regions Approval was based on P-III (KONFIDENT) study assessing sebetralstat (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries KONFIDENT data…

July 28, 2025

Minnesota Medical Technologies Receives the US FDA’s 510(k) Clearance for StaySure to Manage Fecal Incontinence

Shots: Minnesota Medical Technologies has reported the US FDA’s 510(k) clearance to StaySure for the management of fecal incontinence (FI) A completed clinical trial demonstrated the device’s safety & efficacy, with a reduction in fecal incontinence frequency & improved QoL; full results are expected later in 2025 StaySure, marketed as Navina Insert in the EU, is…

July 25, 2025

Elanco’s Zenrelia Secures the EC’s Approval to Treat Allergy and Atopic Dermatitis in Dogs

Shots: The EC has approved Zenrelia (ilunocitinib) for the treatment of pruritus linked to allergic dermatitis & clinical symptoms of atopic dermatitis in dogs (≥12mos.) As part of the EU approval process, Elanco conducted an H2H non-inferiority study in 338 dogs across 25 sites in 4 countries, which showed that Zenrelia (QD) is at least…

July 25, 2025

Exelixis and Ipsen Report the EC’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Shots: The EC has approved Cabometyx for inoperable, locally advanced or metastatic, well-differentiated pancreatic NET (pNET) & extra-pancreatic NET (epNET) pts, who progressed on ≥1 prior systemic therapy other than somatostatin analogues in all 30 EEA states Approval was based on P-III (CABINET) study assessing Cabometyx (60mg) vs PBO among 298 US pts, which were…

July 25, 2025

Eli Lilly Signs an ~$856M Deal with Gate Bioscience to Develop Molecular Gate Therapeutics

Shots: Eli Lilly has entered into a collaboration & license agreement with Gate Bioscience to identify, develop, & commercialize molecular gate drugs, leveraging Gate’s molecular gate drug discovery engine As per the deal, Gate will receive ~$856M in total, incl. an upfront payment, equity investment, & development, regulatory, & commercial milestones, along with tiered royalties…

July 25, 2025

Matchpoint Therapeutics Collaborates with Novartis to Develop Oral Covalent Inhibitors for Various Inflammatory Diseases

Shots: Matchpoint & Novartis have entered into an exclusive option & license agreement to develop & commercialize oral covalent inhibitors targeting a transcription factor in inflammatory diseases using Matchpoint’s ACE platform As per the deal, Matchpoint will lead all research activities through development candidate selection with funding from Novartis. Matchpoint will receive $60M in upfront & funding…

July 25, 2025

NEWS

Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients

Biogen’s Zurzuvae Receives the CHMP’s Positive Opinion to Treat Severe Postpartum Depression

Gilead Reports the CHMP’s Positive Opinion on Lenacapavir for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

GSK Enters a ~$12.5B Deal with Hengrui Pharma to Develop up to 12 Novel Therapeutics Across Various Indications

KalVista Reports the CHMP’s Positive Opinion on Sebetralstat for Treating Hereditary Angioedema

Minnesota Medical Technologies Receives the US FDA’s 510(k) Clearance for StaySure to Manage Fecal Incontinence

Elanco’s Zenrelia Secures the EC’s Approval to Treat Allergy and Atopic Dermatitis in Dogs

Exelixis and Ipsen Report the EC’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Eli Lilly Signs an ~$856M Deal with Gate Bioscience to Develop Molecular Gate Therapeutics

Matchpoint Therapeutics Collaborates with Novartis to Develop Oral Covalent Inhibitors for Various Inflammatory Diseases

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