Gilead Sciences to Acquire Arcellx for $7.8B

Shots: Gilead Sciences has entered into a definitive agreement to acquire Arcellx, incl. anito-cel from their 2022 collaboration & Arcellx’s D-Domain CAR technology platform, for the implied equity value of $7.8B As per the deal, Gilead, which owns ~11.5% of Arcellx, will launch a tender offer for $115/share, plus a non-transferable CVR of $5/CVR tied…

ByRidhi RastogiFebruary 23, 2026

NEWS

Gilead Highlights P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC) at ESMO 2025

Shots: The P-III (ASCENT-03) trial (n= 558) assessed Trodelvy (sacituzumab govitecan-hziy; 10mg/kg, IV, Day 1 & 8 of 21-day cycle) vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who were previously treated with a PD-L1 inhibitor Trial met its 1EP of improved PFS by 38% (mPFS:…

ByRidhi RastogiOctober 22, 2025

NEWS

Health Hope Pharma Collaborates with Gilead Sciences to Advance Encequidar in Virology

Shots: Health Hope Pharma (HHP) has entered into a global licensing & collaboration agreement with Gilead Sciences to advance encequidar in the field of virology As per the deal, Gilead will receive exclusive global virology rights to encequidar, while HHP & Hanmi Pharm will provide drug supply, technical support, project collaboration & receive an upfront…

ByRidhi RastogiSeptember 30, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in August 2025

Shots: The EMA’s CHMP has granted approvals to 1 Biologic and 3 new chemical entities in August 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Gilead’s Yeytuo has Secured the EC’s Approval for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV PharmaShots has compiled a list of 4…

ByDipanshu DixitSeptember 16, 2025

NEWS

Gilead Reports the EC’s Approval of Yeytuo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: Approval was based on P-III (PURPOSE 1 & PURPOSE 2) trials of Yeytuo vs Truvada, where PURPOSE 1 showed 0 infections & 100% risk reduction in 2134 women, while PURPOSE 2 depicted 99.9% non-infection rate in 2179 pts (2 acquired HIV), showing superiority to bHIV in both trials; published in The NEJM Approval is…

ByRidhi RastogiAugust 27, 2025

NEWS

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…

ByRidhi RastogiJuly 28, 2025

NEWS

Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: FDA has approved Yeztugo for PrEP in individuals (≥35kgs) at risk of HIV. MAA & EU-M4all filing are under EMA review, with ongoing reviews in Australia, Brazil, Canada, & South Africa; further filings are planned in Argentina, Mexico, & Peru Approval was based on P-III (PURPOSE 1 & 2) trials assessing Yeztugo (SC; twice…

ByRidhi RastogiJune 19, 2025

NEWS

Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC)

Shots: Gilead has reported topline P-III (ASCENT-03) trial data (n=~540) assessing Trodelvy vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who are previously treated with a PD-L1 inhibitor Trial met its 1EP of improved PFS in treatment-naïve mTNBC pts ineligible for PD-1/PD-L1 inhibitors; OS (2EP) data…

ByRidhi RastogiMay 26, 2025

NEWS

Gilead Reports Final P-III (MYR301) Trial Data of Bulevirtide for Patients Living with Chronic Hepatitis Delta Virus

Shots: Gilead has reported final P-III (MYR301) trial data assessing bulevirtide (QD) for 144wks. in 150 pts living with HDV, who were randomized to either bulevirtide (2mg, n=49 or 10mg, n=50) or no antiviral therapy arm (n=51); pts in no therapy arm were switched to 10mg after 48wks. In the trial, 36% adults (23/64) with…

ByRidhi RastogiMay 7, 2025

NEWS

Gilead Reports Topline P-III (ASCENT-04/KEYNOTE-D19) Trial Data of Trodelvy Regimen for Previously Untreated Triple-Negative Breast Cancer (TNBC)

Shots: The P-III (ASCENT-04/KEYNOTE-D19) trial assessed Trodelvy (10mg/kg, IV, Day 1 & 8 of 21-day cycle) + Keytruda (200mg, IV, Day 1 of 21-day cycle) vs Keytruda + CT in pts (n=443) with inoperable, locally advanced or metastatic TNBC expressing PD-L1 (CPS ≥ 10) Trial showed improved PFS (1EP); OS (2EP) was immature but showed…

ByRidhi RastogiApril 22, 2025

Gilead Sciences to Acquire Arcellx for $7.8B

Gilead Highlights P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC) at ESMO 2025

Health Hope Pharma Collaborates with Gilead Sciences to Advance Encequidar in Virology

EMA Marketing Authorization of New Drugs in August 2025

Gilead Reports the EC’s Approval of Yeytuo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

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

Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC)

Gilead Reports Final P-III (MYR301) Trial Data of Bulevirtide for Patients Living with Chronic Hepatitis Delta Virus

Gilead Reports Topline P-III (ASCENT-04/KEYNOTE-D19) Trial Data of Trodelvy Regimen for Previously Untreated Triple-Negative Breast Cancer (TNBC)

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