FDA grants Hepcludex accelerated approval, first US treatment for hepatitis delta
The FDA approved Gilead Sciences’ Hepcludex (bulevirtide-gmod) for Chronic hepatitis delta virus infection on May 22, 2026. The company can now sell it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Gilead Sciences, Inc. GILD
- Drug
- Hepcludex (bulevirtide-gmod)
- For
- Chronic hepatitis delta virus infection
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- May 22, 2026
- Source note
- Gilead announced accelerated approval of bulevirtide-gmod 8.5 mg for chronic HDV infection, based on HDV RNA reduction and ALT normalization from the pivotal Phase 3 MYR301 study.
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Gilead Sciences expects to report results from its Phase 3 study of Trodelvy (sacituzumab govitecan) for Advanced or recurrent endometrial cancer in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
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- Entry
- Trodelvy Phase 3 ASCENT-GYN update in advanced/recurrent endometrial cancer · Clinical trial results (readout / topline data)
- Drug
- Trodelvy (sacituzumab govitecan)
- For
- Advanced or recurrent endometrial cancer
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Gilead Q2 2026 earnings prepared remarks (Aug 4, 2026).
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Gilead Sciences expects to report results from its Phase 2 study of Emvistagrast (GS-1427); edecesertib for Inflammatory bowel disease; cutaneous lupus erythematosus in the second half of 2026 (no exact date yet). Phase 2 is the stage that tests whether the drug actually works.
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- Entry
- Phase 2 updates: emvistagrast (SWIFT, IBD) and edecesertib (COSMIC, cutaneous lupus) · Clinical trial results (readout / topline data)
- Drug
- Emvistagrast (GS-1427); edecesertib
- For
- Inflammatory bowel disease; cutaneous lupus erythematosus
- Stage
- Phase 2 · the stage that tests whether the drug actually works
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Gilead Q2 2026 prepared remarks (Aug 4, 2026).
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Gilead Sciences expects to report results from its Phase 1 study of GS-3242 injection for HIV treatment (long-acting) in the second half of 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.
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- Entry
- GS-3242 long-acting injectable INSTI higher-dose cohort Phase 1 data · Clinical trial results (readout / topline data)
- Drug
- GS-3242 injection
- For
- HIV treatment (long-acting)
- Stage
- Phase 1 · an early safety study in a small group of people
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Gilead Q2 2026 prepared remarks; Phase 2 of weekly oral lenacapavir + oral GS-3242 to start before end of 2026, GS-1720 combo in early 2027.
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The FDA is due to decide by Dec 23, 2026 whether to approve Gilead Sciences’ anitocabtagene autoleucel (anito-cel) for Fourth-line+ relapsed/refractory multiple myeloma. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
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- Entry
- PDUFA date for anito-cel in 4L+ relapsed/refractory multiple myeloma · FDA decision due (PDUFA date)
- Drug
- anitocabtagene autoleucel (anito-cel)
- For
- Fourth-line+ relapsed/refractory multiple myeloma
- Stage
- Phase 2 · the stage that tests whether the drug actually works
- When
- Dec 23, 2026
- Source note
- BLA accepted with PDUFA action date of December 23, 2026. Gilead is acquiring partner Arcellx ($7.8B deal announced Feb 23, 2026) and is preparing for a potential early-2027 launch.
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- Source: gilead.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
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- GILD headlines on this site
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The FDA is due to decide by Feb 2, 2027 whether to approve Gilead Sciences’ Yeztugo (lenacapavir) 300-mg once-weekly oral tablets for HIV pre-exposure prophylaxis (PrEP). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
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- Entry
- PDUFA date for once-weekly oral Yeztugo (lenacapavir) for HIV PrEP · FDA decision due (PDUFA date)
- Drug
- Yeztugo (lenacapavir) 300-mg once-weekly oral tablets
- For
- HIV pre-exposure prophylaxis (PrEP)
- Stage
- sNDA under FDA review
- When
- Feb 2, 2027
- Source note
- FDA accepted the supplemental NDA for a once-weekly oral formulation of lenacapavir for PrEP with a PDUFA target action date of February 2, 2027 (disclosed in Gilead's Q2 2026 earnings release).
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- Source: gilead.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- GILD headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Islatravir/lenacapavir once-weekly oral HIV regimen filings and potential launch, expected during 2027 (no exact date yet). A company milestone for Gilead Sciences (Islatravir + lenacapavir (ISL/LEN, with Merck) for HIV-1 treatment, virologically suppressed): a step in the program rather than a decision or a data readout.
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- Entry
- Islatravir/lenacapavir once-weekly oral HIV regimen filings and potential launch · Company milestone
- Drug
- Islatravir + lenacapavir (ISL/LEN, with Merck)
- For
- HIV-1 treatment, virologically suppressed
- Stage
- Phase 1/2 · an early study that checks safety and takes a first look at effect
- When
- 2027 · the company gave a window, not a day
- Source note
- Gilead Q2 2026 prepared remarks (Aug 4, 2026); ISLEND-1/2 data presented at IAS 2026 with NEJM publication.
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- Source: s29.q4cdn.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- GILD headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page