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Science & Health

Started Jun 4, 2026 ·Daily ·Active · Public

Today's briefing What changed

Science & Health Digest

TL;DR

The outbreaks all escalated at once: measles hit a 35-year high of 3,887 cases while Florida's dengue outbreak became the largest locally transmitted event in the continental US in decades and H5N1 reached Washington dairy herds. The DRC Ebola outbreak crossed 8,700 cases — the largest ever recorded in the country — with a dead imported case in Kenya and a medevaced responder in the Netherlands. On the regulatory side, the FDA approved atezolizumab for adjuvant dMMR colon cancer on a hazard ratio of 0.50, and told a federal court its mifepristone safety review lands by March 2027.

Measles: the federal posture is now openly two-faced

The federal response to measles has split into real money and real coordination on one side, continued public dispute of state death counts on the other. The national tally hit 3,887 cases as of October 1–2 — the highest since 1990/1991 and already exceeding all of 2025 — while Pennsylvania confirmed a fifth death on September 30, an unvaccinated Lancaster County resident (PA DOH, via the measles findingabcnews.comhealthline.comnytimes.compa.gov+1). The CDC still counts only two of Pennsylvania's five deaths.

The new development is the Hochul channel working. After New York's disaster emergency, HHS said RFK Jr. offered federal support during a Tuesday call and connected her with CDC Director Erica Schwartz. Hochul's spokesperson put it plainly:

"No state can address this on its own, which is why the governor will partner with anyone who can support our efforts to protect New Yorkers." — Reuters via Yahoo, via the measles findingabcnews.comhealthline.comnytimes.compa.gov+1

The contrast with Pennsylvania — which has resisted seeking CDC help after Kennedy disputed its death counts — is now the defining feature of the response. Meanwhile the NYT reports the CDC is offering states $100 million in measles support, so the machinery is funded even as the politics stay loaded. With three months of respiratory season left, losing elimination status at the November PAHO review is the default expectation.

What to watch: Whether the CDC tally absorbs Pennsylvania's five deaths before the November review — and whether Texas and Virginia's CDC-assistance requests, unlike Pennsylvania's, proceed without friction.

Dengue: Tampa Bay's outbreak is now bigger than any recent year, and the emergency orders came due

Florida's dengue event crossed a threshold this week: 296 locally acquired cases in 2026 against just 62 in all of 2025, with 44 new cases in the first week of October alone. The geography is brutally concentrated — "there have been 296 cases of locally acquired dengue fever in Florida in 2026, with nearly 88% of those cases reported in Hillsborough County" (WTSP, via the dengue findingpinellas.govwtsp.com).

The administrative clock is the story underneath the case count. Hillsborough and Pinellas had extended their local states of emergency until October 8 — today — and Pinellas has extended again (Pinellas County, via the dengue findingpinellas.govwtsp.com). Mosquito control has already cost Hillsborough roughly $6 million, 20 mosquito pools across eight counties have tested positive, and local health officials told commissioners the real numbers are higher because lab results are still processing. Pinellas is also flagging increased West Nile activity in sentinel chickens — a second mosquito-borne threat stacking onto the same counties.

What to watch: Whether weekly case growth bends as mosquito season winds down — or whether this becomes a permanent Florida transmission cycle requiring a state-level declaration.

H5N1: the fall surge reaches a state that had dodged cattle infections for 2.5 years

The avian flu fall surge is no longer a poultry story. USDA APHIS confirmed H5 clade 2.3.4.4b in two Washington dairy herds this week — "These are the first confirmed case detections of HPAI in livestock in the State of Washington" (USDA APHIS, via the H5N1 findingaphis.usda.gov). The uncomfortable detail: both herds had consistently tested negative under the National Milk Testing Strategy's routine surveillance before showing clinical signs. The screening net caught nothing until the cows got sick.

This lands on top of the September poultry surge — roughly 620,000 birds lost in 30 days — and Cambodia's sixth human case of the year. A new-state cattle detection in October widens the 2026 fall picture beyond business as usual, and sequencing results will determine which clade is circulating.

What to watch: Sequencing results, whether neighboring states report herds, and any human exposure cases tied to the Washington operations.

Ebola: the largest DRC outbreak ever, and the exports are arriving

The Bundibugyo outbreak hit 8,728 confirmed cases and 4,205 deaths as of October 6 — a 48.2% crude case-fatality rate — after adding 775 cases in under two weeks, and WHO now calls it "the largest Ebola disease outbreak ever recorded in the Democratic Republic of the Congo irrespective of virus species" (WHO DON 619, via the Ebola findingwho.int). The international footprint expanded this week: the Kenyan index patient died October 5 after flying Nairobi-ward from Kampala, and the Netherlands medevaced a positive healthcare worker on October 1.

The mortality math explains why this keeps growing — 264 of 372 recent deaths occurred in communities, not treatment centers, and contact tracing sits at 80.4% coverage against an 85% target. A dead imported case in Kenya and a treated responder in the EU are exactly the failure modes that expand an outbreak's map, even with WHO still rating global risk as low.

What to watch: EBO-PEP obeldesivir prophylaxis results (~1,000 contacts) — the only near-term countermeasure bet for a virus with no approved vaccine or specific treatment.

Drug approvals: ATOMIC delivers the biggest adjuvant number in colon cancer this year

The FDA's oncology desk moved on October 8 with an unusually strong result: atezolizumab (Tecentriq) plus chemo won approval for adjuvant Stage III dMMR colon cancer on ATOMIC data showing "The hazard ratio for the DFS comparison was 0.50 (95% CI: 0.35, 0.73; p-value 0.0001), and the median DFS was not reached (NR) in either arm" (FDA, via the Tecentriq findingfda.gov). Halving recurrence or death risk in the curative-intent, post-surgical setting is a large effect, and the label spans patients down to age 2 — rare for oncology. The review ran under Project Orbis with four international regulators.

Mifepristone: the FDA puts a date on the review that could roll back mail-order pills

In a late-Wednesday court filing in Louisiana, the administration committed to completing its mifepristone safety review by March 2027, with study results expected in December 2026. The design: "comparing a sample of 100,000 women who used mifepristone with a comparator group who received surgical abortions" (Reuters, via the mifepristone findingreuters.com). The FDA is also weighing petitions to reinstate the in-person dispensing requirement repealed in 2023 — the rule that enabled mail-order pills, which now account for 65% of US abortions. Louisiana's suit and a Texas/Florida challenge are paused pending the review.

What to watch: The December study results — the first hard signal of whether the review produces label changes, REMS restrictions, or an attempt at the 2000 approval itself.

What surprised us

  • The surveillance gap H5N1 just exposed. Two herds passed the National Milk Testing Strategy's routine screening repeatedly, then showed up sick anyway. The program built to close the surveillance blind spot missed its first real test in a new state.
  • The Hochul–Kennedy channel worked instantly while Pennsylvania's didn't. One emergency declaration bought a same-week call with the HHS Secretary and a direct line to the CDC Director; the other state's death counts are still publicly disputed. The variable isn't the outbreak — it's the politics.
  • Dengue's October growth. Case counts kept climbing into the month when mosquito season should be winding down, and the virus is now detectable in pools across eight counties. The Cuban DENV-2 strain looks entrenched, not transient.
  • ATOMIC's effect size. A hazard ratio of 0.50 in the adjuvant setting — halving recurrence risk after surgery — is the kind of number checkpoint inhibitors usually post in metastatic disease, not curative-intent colon cancer.

Open threads worth a vote

Science & Health Digest — what changed since last cycle

Since last time

  • New — three sections with no prior coverage: dengue in Tampa Bay, H5N1 reaching Washington dairy herds, and the FDA's mifepristone review timeline. The drug-approvals slot also carries entirely new substance (Tecentriq replacing last cycle's Tukysa/Rhapsido items).
  • Escalated — Measles: the outbreak hit a 35-year-high case count, Pennsylvania confirmed a fifth death, and the Hochul–Kennedy channel that opened last cycle actually delivered. Ebola: the DRC outbreak is now officially the largest ever recorded in that country, with exports landing in Kenya and the Netherlands.
  • Disappeared — the obesity/petrelintide section, the Nobel chemistry wrap-up, and both of last cycle's approval items (Tukysa, Rhapsido) are gone from this briefing. Also dropped: the $128M Ebola vaccine-trial funding gap, Kenya's 67-contact monitoring watch, and the "surprised us" items on petrelintide's discontinuation rate and the BTK class.
  • Demoted / Unchanged — nothing qualifies; every carried-over section grew.

Measles: the federal posture is now openly two-faced (Escalated)

The death-count gap you read about last cycle is still there — CDC counts 2 of Pennsylvania's now 5 deaths (the fifth confirmed September 30, an unvaccinated Lancaster County resident) — but the story has shifted from "will the CDC blink" to "the federal response is officially split." The national tally hit 3,887 cases as of October 1–2, the highest since 1990/1991 and already above all of 2025.

What's new is that the Hochul channel worked. After New York's disaster emergency, HHS says RFK Jr. offered support on a Tuesday call and connected her with CDC Director Erica Schwartz:

"No state can address this on its own, which is why the governor will partner with anyone who can support our efforts to protect New Yorkers." — Reuters via Yahoo, via the measles findingabcnews.comhealthline.comnytimes.compa.gov+1

The contrast with Pennsylvania — which has resisted seeking CDC help after Kennedy disputed its death counts — is now the defining feature. The NYT reports CDC is offering states $100 million in measles support, so the machinery is funded even as the politics stay loaded. Last cycle's PAHO watch item has hardened: losing elimination status at the November review is now the default expectation.

What to watch: Whether the CDC tally absorbs Pennsylvania's five deaths before November — and whether Texas and Virginia's CDC-assistance requests proceed without the friction Pennsylvania got.

Dengue: Tampa Bay's outbreak is now bigger than any recent year (New)

Not covered last cycle; this is the biggest new public-health story in the briefing. Florida has 296 locally acquired dengue cases in 2026 against 62 in all of 2025, with 44 new cases in the first week of October alone:

"there have been 296 cases of locally acquired dengue fever in Florida in 2026, with nearly 88% of those cases reported in Hillsborough County" — WTSP, via the dengue findingpinellas.govwtsp.com

The administrative clock matters as much as the count: Hillsborough and Pinellas's local emergencies ran to October 8, and Pinellas has extended again (Pinellas County, via the dengue findingpinellas.govwtsp.com). Mosquito control has cost Hillsborough roughly $6 million; 20 pools across eight counties are positive; officials say real numbers are higher pending lab processing. Pinellas is also flagging West Nile in sentinel chickens — a second mosquito-borne threat in the same counties.

What to watch: Whether weekly growth bends as mosquito season winds down — or whether this becomes a permanent Florida transmission cycle needing a state-level declaration.

H5N1: the fall surge reaches a state that had dodged cattle infections for 2.5 years (New)

New this cycle, and the surveillance failure is the point. USDA APHIS confirmed H5 clade 2.3.4.4b in two Washington dairy herds — "These are the first confirmed case detections of HPAI in livestock in the State of Washington" (USDA APHIS, via the H5N1 findingaphis.usda.gov). Both herds had repeatedly tested negative under the National Milk Testing Strategy before showing clinical signs — the screening net caught nothing until the cows got sick.

Context: ~620,000 poultry lost in 30 days in the September surge, and Cambodia's sixth human case of the year.

What to watch: Sequencing results, neighboring-state herds, and any human exposure cases tied to the Washington operations.

Ebola: the largest DRC outbreak ever, and the exports are arriving (Escalated)

Last cycle the story was Kenya's index patient dying and a "chaotic" response; both are now absorbed into a bigger fact. The Bundibugyo outbreak hit 8,728 confirmed cases and 4,205 deaths as of October 6 (48.2% CFR) after adding 775 cases in under two weeks, and WHO now calls it "the largest Ebola disease outbreak ever recorded in the Democratic Republic of the Congo irrespective of virus species" (WHO DON 619, via the Ebola findingwho.int).

The international footprint widened: the Kenyan patient died October 5 (flying Nairobi-ward from Kampala), and the Netherlands medevaced a positive healthcare worker October 1. The mortality math explains the growth — 264 of 372 recent deaths occurred in communities, and contact tracing sits at 80.4% coverage against an 85% target. WHO still rates global risk as low. Note: the $128M vaccine-trial funding gap from last cycle is no longer tracked here; the near-term bet is now framed entirely around obeldesivir.

What to watch: EBO-PEP obeldesivir prophylaxis results (~1,000 contacts) — the only near-term countermeasure test for a virus with no approved vaccine or specific treatment.

Drug approvals: ATOMIC delivers the biggest adjuvant number in colon cancer this year (New)

Entirely new substance — last cycle's Tukysa and Rhapsido approvals are not carried forward. The FDA approved atezolizumab (Tecentriq) plus chemo for adjuvant Stage III dMMR colon cancer on October 8:

"The hazard ratio for the DFS comparison was 0.50 (95% CI: 0.35, 0.73; p-value 0.0001), and the median DFS was not reached (NR) in either arm" — FDA, via the Tecentriq findingfda.gov

Halving recurrence or death risk in the curative-intent, post-surgical setting is a large effect; the label spans patients down to age 2, and the review ran under Project Orbis with four international regulators.

Mifepristone: the FDA puts a date on the review that could roll back mail-order pills (New)

New section, and the first hard timeline on a story that had been open-ended. In a late-Wednesday Louisiana court filing, the administration committed to completing its mifepristone safety review by March 2027, with study results expected December 2026:

"comparing a sample of 100,000 women who used mifepristone with a comparator group who received surgical abortions" — Reuters, via the mifepristone findingreuters.com

The FDA is also weighing petitions to reinstate the in-person dispensing requirement repealed in 2023 — the rule behind mail-order pills, now 65% of US abortions. Louisiana's suit and a Texas/Florida challenge are paused pending the review.

What to watch: The December study results — the first signal of whether this produces label changes, REMS restrictions, or an attempt at the 2000 approval itself.

What surprised us

  • The surveillance gap H5N1 just exposed. [NEW] Two herds passed the National Milk Testing Strategy's routine screening repeatedly, then showed up sick anyway. The program built to close the surveillance blind spot missed its first real test in a new state.
  • The Hochul–Kennedy channel worked instantly while Pennsylvania's didn't. [UPDATED — sharpens last cycle's observation about the inconsistent federal posture] One emergency declaration bought a same-week call with the HHS Secretary and a direct line to the CDC Director; the other state's death counts are still publicly disputed. The variable isn't the outbreak — it's the politics.
  • Dengue's October growth. [NEW] Case counts kept climbing into the month when mosquito season should be winding down, and the virus is now detectable in pools across eight counties. The Cuban DENV-2 strain looks entrenched, not transient.
  • ATOMIC's effect size. [NEW] A hazard ratio of 0.50 in the adjuvant setting — halving recurrence risk after surgery — is the kind of number checkpoint inhibitors usually post in metastatic disease, not curative-intent colon cancer.

Open threads

The previous briefing had no formal threads section — its watches lived in per-section "What to watch" lines. Status:

  • Closed/absorbed: the Nobel chemistry wrap (thread resolved last cycle, now dropped); Kenya's 67-contact monitoring watch (the Kenyan case is now covered via the Ebola exports narrative).
  • Still live, carried in the body: CDC tally vs. Pennsylvania's five deaths ahead of the November PAHO review (measles section).
  • Dropped without resolution: the $128M Bundibugyo vaccine-trial funding gap and the remibrutinib RemIND program watch.
  • New thread added:
129 total cycles · last run
Watch cycle →

Previous briefings

What to research next

Watch
FDA mifepristone safety review: December 2026 study results, report by March 2027

FDA's court filing (Louisiana case, Oct 8, 2026) commits to completing the mifepristone safety review by March 2027: study results (100,000 mifepristone users vs surgical-abortion comparator) expected December 2026, report after interpretation. Watch for the December study results, the report, and any resulting FDA action on the 2023 mail-order/remote-prescribing rule, in-person dispensing petitions, or the 2000 approval. Related litigation paused pending the review (Louisiana; Texas/Florida; Missouri).

one-shot Expected Mar 31, 2027 · Fires when the FDA issues its safety-report or takes formal action on mifepristone access; interim milestone is the December 2026 study results.
Watch
Ibogaine RFI comment period closes (Docket FDA-2026-N-10429)

FDA's Oct 5, 2026 RFI (Docket FDA-2026-N-10429) on early-phase ibogaine trial design closes Nov 20, 2026. Watch for the docket close and FDA's next move: docket summary, trial-design guidance, or first sponsor INDs under the stated parameters (starting dose ≤10 mg/kg, cardiac/neurologic monitoring, OUD and PTSD as priority populations).

one-shot Expected Nov 20, 2026 · Comment period closes Friday, Nov 20, 2026 per FDA press announcement; follow-on action expected after that.
Watch
EBO-PEP trial results: obeldesivir as post-exposure prophylaxis for Bundibugyo Ebola

AP (Oct 3, 2026) detailed the EBO-PEP trial: Gilead's obeldesivir pill given within 5 days of exposure to asymptomatic contacts of Bundibugyo cases (adults and children 12+), half placebo, 21 days daily monitoring + day-42 call. 250+ enrolled of ~1,000 target as of Oct 3; trial began July 2026 in Ituri. Coordinated by ALIMA with DRC's INRB and France's ANRS. Positive results would be the first efficacy evidence for any Bundibugyo-specific countermeasure (no approved vaccine or treatment exists); negative results would leave Ervebo cross-protection as the only prophylaxis option.

one-shot · Fires when ALIMA/Gilead or investigators report topline EBO-PEP results (infection rates in obeldesivir vs placebo arms among exposed contacts), or when enrollment completes / the trial is stopped.
Watch
US Title 42 Ebola travel restriction — expansion, lifting, or legal challenge

CDC's Title 42 order (interim final rule under 42 CFR 71.40, May 22, 2026) bars travelers — including U.S. citizens and lawful permanent residents — who have been in the DRC (originally also Uganda, South Sudan) within 21 days from boarding U.S.-bound flights. HHS disclosed Sept 28, 2026 that the U.S. has committed $1B+ to the response with 500+ CDC staff. Watch for expansion (additional countries, longer windows, new screening airports), lifting as transmission falls, or legal/congressional challenge.

ongoing · Fires on any formal change to the Title 42 Ebola entry restriction: expansion to more countries or longer exposure windows, formal lifting as the DRC outbreak recedes, or a court/congressional action against the order.
Watch
Revived political/OMB control of NIH grantmaking (EO revival, Uniform Guidance rule, or guidance workaround)

The Sept 2026 EO giving OMB veto power over NIH grants was dropped after bipartisan pushback (Collins, Murray, DeLauro), but the underlying May 2026 Uniform Guidance proposed rule — political-appointee review of discretionary grants, easier "for convenience" terminations — is only delayed by the CR funding the government through mid-December. Watch for: revival of the EO, movement on the Uniform Guidance rule at the December funding deadline, or equivalent political grant-review imposed via guidance.

ongoing · Fires on any formal action imposing political/OMB review of NIH or federal research grants: revived EO, Uniform Guidance rule implementation after the CR delay expires mid-December, or guidance-based workarounds.
Watch
Tampa Bay dengue outbreak escalation (emergency orders, spread, deaths)

Hillsborough, Pasco, and Pinellas counties declared local dengue emergencies Sept 23-24, 2026 (orders expire after 7 days unless extended). Hillsborough has 170 locally acquired cases (154 DENV-2) and Florida's first dengue death of 2026. Watch for: emergency-order extensions, declarations by additional counties or the state, sustained case growth (36 new cases in Hillsborough Sept 13-19), further deaths, or spread into new regions of Florida.

ongoing · Fires on material escalation: new county/state emergency declarations, further dengue deaths, or continued weekly case growth in Tampa Bay.
Watch
UNGA vote on PPPR Political Declaration (expected December 2026)

Follow-on to the Sept 25, 2026 HLM where US objection blocked consensus adoption. Health Policy Watch: the vote is "likely to occur just before the close of the Assembly's annual session in December." Watch whether the GA adopts the declaration by vote (with what language), further defers it, or the text collapses. PABS annex negotiations continue in parallel toward a May 2027 WHA target.

one-shot Expected Dec 31, 2026 · Fires when the UNGA takes the PPPR Political Declaration to a vote (expected just before the December session close) or when adoption is further deferred.
Watch
FDA final PMA decision on GRAIL's Galleri MCED test

Follow-on to the Sept 23, 2026 advisory panel endorsement (10-0 safety, 6-4 effectiveness, 7-2 benefit-risk). FDA is not bound by panel advice. Outside analysts (RBC) expect a decision late 2026-early 2027; approval would make Galleri the first FDA-authorized MCED screening test and open Medicare/insurer reimbursement.

one-shot · Fires when FDA issues its formal PMA decision on Galleri: approval, denial, or any further review action. No fixed PDUFA date; decision expected around H1 2027.
Watch
Telix shareholder vote (EGM) on ITM acquisition

Telix's acquisition of ITM ($1.65B upfront + up to $700M in ITM-11 milestones) is subject to Telix shareholder approval at an EGM expected November 2026, plus regulatory approvals, with closing expected by end of FY2026. Fires on the EGM vote outcome or any deal termination/regulatory block. The deal's $100M first milestone hinges on FDA approval of ITM-11 in G1-G2 GEP-NETs by Dec 31, 2027 — tracked via the separate ITM-11 NDA resubmission watch.

one-shot Expected Nov 30, 2026 · Fires when Telix shareholders vote on the ITM acquisition (EGM expected November 2026) or when the deal is terminated/blocked.
Question
Will CSTE's standardized measles-death definition and NCHS death-certificate reviews resolve the Pennsylvania death-count standoff?

CDC Director Schwartz said the agency asked the Council of State and Territorial Epidemiologists (CSTE) to develop a formal standardized definition of a measles-related death, and is waiting on NCHS reviews to confirm measles as underlying cause on PA death certificates. The outcome determines whether the CDC's national tally (currently zero deaths despite 3,471 cases) ever absorbs Pennsylvania's four measles-associated deaths — the core of the Kennedy–Shapiro standoff and an input to PAHO's November 2026 elimination-status review. Watch for CSTE definition adoption, NCHS review outcomes, or any CDC tally change.

Watch
FDA final decision on proposed withdrawal of Tavneos (avacopan) approval

FDA has proposed withdrawing Tavneos's U.S. approval (following NEJM's June 2026 retraction of ADVOCATE and the EC's August 2026 EU withdrawal), and FDA's March 2026 Drug Safety Communication counted 76 causally associated liver-injury cases including 8 deaths. Amgen stated Sept 19, 2026 (via Gastroenterology & Endoscopy News) that it plans to keep the drug on the market and contests withdrawal. Watch for the FDA's formal withdrawal decision, any Amgen hearing/appeal outcome, or a voluntary Amgen withdrawal.

one-shot · Fires on any formal FDA action concluding the withdrawal proposal: withdrawal effected, proposal dropped, or a hearing outcome.
Watch
LZ 700-day dark matter analysis — does the 2.6-sigma candidate event replicate?

LZ collaboration (LBNL/Bristol et al.) presented a 2.6-sigma candidate WIMP event (June 2023 recoil, 0.5% background probability) on Sept 1, 2026 at TeV Particle Astrophysics 2026, submitted to PRL. A 700-day dataset is now under blinded analysis with synthetic-event injection. Watch for the next LZ result release: additional high-energy recoils would push toward a 5-sigma dark matter claim; absence would kill the candidate. Independent cross-checks: XENONnT (Italy), PandaX-4T (China).

one-shot · Fires when the LZ collaboration publishes/presents its 700-day dataset analysis (submitted PRL paper pipeline; no fixed date).
Watch
CDC response to Pennsylvania's conditional measles Epi-Aid request

Pennsylvania Health Secretary Debra Bogen's Sept 16, 2026 letter conditions a CDC Epi-Aid request on the CDC publicly recognizing the state's four measles-associated deaths — which HHS instructed CDC to exclude from the national count. Watch for whether CDC grants the Epi-Aid, recognizes the deaths, or refuses (prompting PA to rescind). Related: PAHO's November 2026 elimination-status review is tracked separately.

one-shot · Fires when CDC formally responds to PA's conditional Epi-Aid request — either granting emergency support, publicly acknowledging the four measles deaths, or declining (which would trigger PA's stated rescission).
Watch
Novo files for Wegovy label expansion to ages 6–<12 (STEP Young)

Following positive Phase 3 STEP Young results (40.4% of children 6–<12 left the obesity range at 68 weeks vs 0% placebo), watch for Novo to announce a regulatory submission (sNDA/label extension) to the FDA for Wegovy in ages 6–<12, and any FDA action. Off-label prescribing in 8–11-year-olds already rose from 0.03% (2019) to 9.3% (2026), so a filing would formalize a rapidly growing practice.

one-shot · Fires when Novo formally announces filing for a pediatric (6–<12) obesity indication for Wegovy, or when FDA acts on such a filing.
Watch
Skyhawk FALCON-HD Phase 2/3 readout for SKY-0515 in Huntington's disease

The Phase 2/3 FALCON-HD pivotal program (NCT06873334 004-ANZ, fully enrolled with 144 participants in Australia/NZ; NCT07378644 004-WW, ~600 participants recruiting across 40+ sites) will test whether SKY-0515's Phase 1/2 signals (+1.59 cUHDRS vs external control at Month 15, >60% mHTT knockdown) hold in placebo-controlled pivotal testing. Fires when Skyhawk reports topline FALCON-HD results.

one-shot · No announced readout date; 004-WW enrollment (~600 participants) is the pacing item. Watch for enrollment completion announcements and interim data disclosures.
Watch
Vera Therapeutics sBLA submission for Trutakna full approval in IgAN

Following the positive ORIGIN 3 final efficacy analysis (eGFR stabilized, 76% composite progression risk reduction, HR 0.24) announced Sept 15, 2026, Vera plans to submit a supplemental BLA in Q4 2026 seeking conversion of Trutakna's accelerated approval to full approval in IgAN, with a potential FDA decision in 2027. Fires when the sBLA submission is formally announced.

one-shot Expected Dec 31, 2026 · Vera plans sBLA submission in Q4 2026 per CEO Marshall Fordyce's Sept 15, 2026 statement; full approval potentially 2027.
Watch
FDA selects first 8–10 Expedited IND Pilot sponsor-QRI pairs

Follow-on to the launched Expedited IND Pilot: applications close Oct 30, 2026; FDA expects to select 8–10 sponsor-QRI pairs for the initial cohort. Watch for the announcement of selected pairs and any early rolling-review outcomes.

one-shot Expected Dec 31, 2026 · Fires when the FDA announces the selected sponsor-QRI pairs (or any interim program action) for the Expedited IND Pilot's initial cohort.
Watch
FDA PDUFA decision on ivonescimab BLA (EGFR-mutated NSCLC)

FDA decision on Summit/Akeso's BLA for ivonescimab in EGFR-mutated NSCLC post-TKI, based on the HARMONi trial (updated OS HR 0.76, nominal p=0.0151). PDUFA date Nov 14, 2026 per Summit's 8-K. Approval would make ivonescimab the first PD-1/VEGF bispecific approved in the U.S.

one-shot Expected Nov 14, 2026 · Fires when the FDA grants approval, issues a CRL, or extends the review for the ivonescimab BLA on or around the Nov 14, 2026 PDUFA date.
Watch
Initiation of experimental H5N1 vaccine trials in Australian sea lions

Monitor whether South Australia or the Australian federal government initiates experimental H5N1 vaccination trials for endangered Australian sea lions at Seal Bay or other colonies.

one-shot · South Australian Government / Australian Federal Government
Watch
Full Phase 3 Lp(a)HORIZON trial data presentation

Monitor the presentation of the full Phase 3 Lp(a)HORIZON clinical trial results for pelacarsen at an upcoming medical congress to assess subpopulation and biomarker analyses.

one-shot · Novartis / Ionis
Watch
NMPA regulatory decision on Tam-Peli (tambotatug pelitecan) in SCLC

Monitor the Chinese National Medical Products Administration (NMPA) regulatory decision on the priority review New Drug Application (NDA) for Tam-Peli (tambotatug pelitecan; YL201) in recurrent small-cell lung cancer (SCLC).

one-shot Expected Jun 30, 2027 · Fires when the Chinese NMPA grants approval or issues a rejection for Tam-Peli in recurrent SCLC.
Watch
FDA priority review decision on Novartis's delpacibart zotadirsen (del-zota) in DMD44

Monitor the FDA's regulatory decision (accelerated approval or Complete Response Letter) on Novartis's Biologics License Application (BLA) for delpacibart zotadirsen (del-zota) for patients with Duchenne muscular dystrophy with mutations amenable to exon 44 skipping (DMD44), following its priority review acceptance.

one-shot Expected Feb 28, 2027 · Fires when the FDA issues its regulatory decision on the del-zota BLA in DMD44.
Watch
FDA regulatory filing and decision on Imdelltra + Imfinzi in first-line ES-SCLC

Monitor the regulatory filings and subsequent FDA approval decision for Amgen and AstraZeneca's Imdelltra (tarlatamab-dlle) in combination with Imfinzi (durvalumab) for first-line maintenance in extensive-stage small cell lung cancer (ES-SCLC) following the positive Phase 3 DeLLphi-305 trial.

one-shot Expected Jun 30, 2027 · Fires when the FDA grants approval or issues a CRL for the Imdelltra + Imfinzi combination as a first-line maintenance treatment in ES-SCLC.
Watch
FDA regulatory decision on Nanoscope's MOGENRY (MCO-010) BLA in retinitis pigmentosa

Monitor the FDA's final regulatory decision (approval or complete response letter) on Nanoscope Therapeutics' BLA for MOGENRY (sonpiretigene isteparvovec, MCO-010) for the treatment of retinitis pigmentosa.

one-shot Expected Jul 31, 2027 · Fires when the FDA grants approval or issues a CRL for MCO-010 in retinitis pigmentosa.
Watch
EMA regulatory decision on Takeda's rusfertide (Mimrylo) in polycythemia vera

Monitor the EMA's Committee for Medicinal Products for Human Use (CHMP) opinion and subsequent European Commission decision on rusfertide (Mimrylo) for the treatment of polycythemia vera.

one-shot Expected Jun 30, 2027 · Fires when the EMA issues its regulatory decision on the marketing authorization application for rusfertide in Europe.
Watch
EMA regulatory decision on Ionis' zilganersen (Zanvastro) in Alexander disease

Monitor the EMA's Committee for Medicinal Products for Human Use (CHMP) opinion and subsequent European Commission decision on zilganersen (Zanvastro) for the treatment of Alexander disease.

one-shot Expected Jun 30, 2027 · Fires when the EMA issues its regulatory decision on the marketing authorization application for zilganersen in Europe.
Watch
FDA traditional approval and confirmatory trial results for camizestrant in breast cancer

Monitor the FDA's traditional approval decision or subsequent clinical trial readouts (e.g. overall survival or other Phase III trials like SERENA-4) for camizestrant (Etcamah) in HR-positive, HER2-negative advanced breast cancer following its accelerated approval.

one-shot Expected Dec 31, 2027 · Fires when the FDA grants traditional approval or when AstraZeneca reports confirmatory overall survival data for camizestrant.
Watch
FDA regulatory decision on uniQure's AMT-130 BLA in Huntington's disease

Monitor the FDA's final regulatory decision (approval or complete response letter) on uniQure's Biologics License Application (BLA) for AMT-130 in Huntington's disease.

one-shot · Fires when the FDA grants accelerated approval or issues a Complete Response Letter (CRL) for AMT-130 in Huntington's disease.
Watch
Cytokinetics sNDA submission for aficamten in symptomatic nHCM

Monitor Cytokinetics' planned submission of a supplemental New Drug Application (sNDA) to the FDA for aficamten (MYQORZO) in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), targeted for Q4 2026.

one-shot Expected Dec 31, 2026 · Fires when Cytokinetics formally submits the sNDA for aficamten in symptomatic nHCM.
Watch
FDA regulatory decision on Capricor's deramiocel BLA in DMD

Monitor the FDA's final regulatory decision on Capricor's Biologics License Application (BLA) for deramiocel in Duchenne muscular dystrophy (DMD) on or before its new extended PDUFA date of November 22, 2026.

one-shot Expected Nov 22, 2026 · Fires when the FDA grants approval or issues a Complete Response Letter (CRL) for deramiocel on or before November 22, 2026.
Watch
RecovryAI De Novo submission for generative AI Virtual Care Assistant

Monitor RecovryAI's formal De Novo classification request submission to the FDA for its generative AI-based Virtual Care Assistant post-surgery recovery tool, planned for Q4 2026.

one-shot Expected Dec 31, 2026 · Fires when RecovryAI formally submits its De Novo request to the FDA.
Watch
EMA regulatory decision on Regeneron's garetosmab (Pasatru) in FOP

Monitor the EMA's Committee for Medicinal Products for Human Use (CHMP) opinion and subsequent European Commission decision on garetosmab (Pasatru) for the treatment of FOP following the regulatory submission in Q1 2026.

one-shot · Regeneron / EMA
Watch
Xspray Pharma NDA resubmission for Dasynoc

Monitor Xspray's formal resubmission of its NDA for Dasynoc to the FDA following the resolution of NerPharMa's manufacturing deficiencies and the generation of consecutive commercial-scale batch data.

one-shot · Xspray Pharma
Watch
argenx BLA submission for Vyvgart Hytrulo in autoimmune myositis

Monitor argenx's Biologics License Application (BLA) submission to the FDA for Vyvgart Hytrulo in autoimmune myositis following positive Phase III ALKIVIA results.

one-shot Expected Mar 31, 2027 · Fires when argenx formally submits its BLA to the FDA for Vyvgart Hytrulo in adults with autoimmune myositis.
Watch
BMS full Phase 3 EXCALIBER-RRMM data presentation

Monitor the presentation of the full Phase III EXCALIBER-RRMM clinical trial results for Zenbexus (iberdomide), including progression-free survival (PFS) data.

one-shot Expected Dec 31, 2026 · Fires when Bristol Myers Squibb presents full results, including PFS and overall survival, from the Phase III EXCALIBER-RRMM trial.
Watch
Regeneron Phase 3 OPTIMA 2 trial initiation of Pasatru in pediatric FOP

Monitor the initiation and enrollment of Regeneron's Phase III OPTIMA 2 clinical trial of Pasatru (garetosmab-grts) in pediatric and adolescent patients with fibrodysplasia ossificans progressiva (FOP).

one-shot Expected Dec 31, 2026 · Fires when Regeneron formally initiates clinical trial sites or starts enrolling pediatric patients for the Phase III OPTIMA 2 trial.
Watch
Launch of JAXA's Martian Moons eXploration (MMX) mission

Monitor the launch of JAXA's MMX spacecraft aboard H3 Launch Vehicle flight No. 10 from Tanegashima Space Center to collect samples from Phobos.

one-shot Expected Oct 20, 2026 · JAXA
Watch
Merck and Moderna BLA submission for intismeran autogene mRNA cancer vaccine in melanoma

Monitor the formal regulatory submission (BLA) of the Merck/Moderna mRNA cancer vaccine (intismeran autogene / V940) in combination with Keytruda for completely resected Stage IIB-IV melanoma to the FDA.

one-shot Expected Dec 31, 2026 · Fires when Merck and Moderna formally submit their BLA to the FDA for intismeran autogene in resected melanoma.
Watch
PAHO decision on U.S. measles elimination status

Monitor the official announcement by the Pan American Health Organization (PAHO) in November 2026 on whether the United States will lose its measles elimination status due to ongoing domestic transmission chains.

one-shot Expected Nov 30, 2026 · PAHO / CDC
Watch
Summit/Akeso Phase III HARMONi-3 trial results of ivonescimab in first-line NSCLC

Monitor the topline Phase III HARMONi-3 trial results for ivonescimab in first-line NSCLC, expected in H2 2026, to assess if global PFS benefits are replicated or show similar degradation as seen in China's HARMONi-6.

one-shot Expected Dec 31, 2026 · Fires when Summit reports topline Phase III HARMONi-3 results.
Watch
FDA regulatory decision on BMS's mezigdomide NDA in multiple myeloma

Monitor the FDA's regulatory decision on BMS's second CELMoD therapy, mezigdomide, in combination with carfilzomib and dexamethasone, on or before its PDUFA date of May 13, 2027.

one-shot Expected May 13, 2027 · Bristol Myers Squibb / FDA
Watch
ITM NDA resubmission for ITM-11 in GEP-NETs

Monitor ITM's resubmission of its NDA for ITM-11 to the FDA following the resolution of the CMC and third-party commercial facility deficiencies cited in the August 2026 CRL.

one-shot · ITM Isotope Technologies Munich
Watch
FDA regulatory decision on Belite Bio's tinlarebant NDA in Stargardt disease

Monitor the FDA's regulatory decision (approval or complete response letter) on Belite Bio's NDA for tinlarebant in Stargardt disease type 1, with a PDUFA target action date of February 12, 2027.

one-shot Expected Feb 12, 2027 · Fires when the FDA issues its regulatory decision on the tinlarebant NDA for STGD1 on or before the PDUFA target action date of February 12, 2027.
Watch
Tarsus/Alkeus Phase 3 NORTHSTAR trial results of gildeuretinol in Stargardt disease

Monitor the Phase 3 NORTHSTAR trial results for Tarsus/Alkeus's oral gildeuretinol in Stargardt disease, expected in the second half of 2029.

one-shot Expected Dec 31, 2029 · Fires when Tarsus reports topline Phase 3 NORTHSTAR data for gildeuretinol in Stargardt disease.
Watch
Replimune Phase 3 IGNYTE-3 confirmatory trial results for Tudriqev in melanoma

Monitor the Phase 3 IGNYTE-3 randomized confirmatory trial results for Replimune's Tudriqev in advanced melanoma (expected by late 2027), which is required to support its accelerated approval.

one-shot Expected Dec 31, 2027 · Fires when Replimune reports topline Phase 3 IGNYTE-3 confirmatory trial data for Tudriqev + nivolumab in advanced melanoma.
Watch
FDA final regulatory decision on Saol's SL1009 (DCA) in PDCD

Monitor the FDA's final regulatory decision (approval or complete response letter) on Saol Therapeutics' resubmitted NDA for SL1009 (sodium dichloroacetate) in pyruvate dehydrogenase complex deficiency (PDCD) on or before the PDUFA target action date of December 30, 2026.

one-shot Expected Dec 30, 2026 · Fires when the FDA grants approval or issues a CRL for SL1009 (DCA) in PDCD on its PDUFA date of December 30, 2026.
Watch
FDA final decision on compounding peptides 503A list addition

Monitor the FDA's formal administrative decision and rulemaking on whether to adopt the Pharmacy Compounding Advisory Committee's (PCAC) July 2026 recommendations to add BPC-157, KPV, TB-500, MOTS-c, epitalon, and semax to the 503A bulk drug substances list.

one-shot Expected Jun 30, 2027 · Fires when the FDA publishes a final rule, guidance, or administrative decision regarding the addition of the six recommended peptides to the 503A bulk compounding list.
Watch
FDA response to CRL public disclosure citizen petition (Docket FDA-2026-P-4369)

Monitor the FDA's formal administrative response to the citizen petition (Docket No. FDA-2026-P-4369-0001) filed by an unnamed pharmaceutical company seeking to halt the proactive publication of Complete Response Letters.

one-shot Expected Oct 17, 2026 · Fires when the FDA issues its formal response to the citizen petition seeking to halt the proactive publication of Complete Response Letters.
Watch
New Zealand H5N1 transmission to poultry or wildlife sanctuaries

Monitor whether the newly arrived H5N1 bird flu strain spreads to New Zealand's commercial poultry flocks, native wildlife sanctuaries (like Pūkaha Mount Bruce), or causes mass mortality in native wild bird colonies or marine mammals.

ongoing · Fires when New Zealand confirms H5N1 transmission to commercial poultry operations, wildlife sanctuaries, or local marine mammal colonies.
Watch
FDA final rule on Complete Response Letter public disclosure (RIN 0910-AJ16)

Monitor the FDA's proposed rule (RIN 0910-AJ16) to formalize the Complete Response Letter (CRL) transparency policy and eliminate the presumption of commercial confidentiality for unapproved marketing applications.

one-shot Expected Mar 31, 2027 · Fires when the FDA publishes its final rule (RIN 0910-AJ16) or takes further formal administrative action to permanently codify the CRL public disclosure policy.
Watch
Australia H5N1 transmission to poultry or local wildlife

Monitor whether the newly arrived H5N1 avian influenza strain jumps from migratory seabirds to local Australian wildlife, marine mammals (e.g. fur seals), or commercial poultry farms.

ongoing · Fires when Australia confirms the transmission of H5N1 to commercial poultry flocks, native land birds, or local marine mammal colonies.
Watch
Sobi BLA resubmission for NASP in uncontrolled gout

Monitor Sobi's resubmission of the BLA for NASP (nanoencapsulated sirolimus plus pegadricase) in uncontrolled gout following the resolution of CMC and contract manufacturing facility deficiencies.

one-shot · Fires when Sobi formally resubmits its BLA for NASP to the FDA after addressing the manufacturing deficiencies cited in the June 2026 CRL.
Watch
Achieve Life Sciences NDA resubmission for cytisinicline in smoking cessation

Monitor Achieve Life Sciences' planned NDA resubmission in Q4 2026 for cytisinicline in smoking cessation, naming Adare Pharma Solutions as its primary manufacturer.

one-shot Expected Dec 31, 2026 · Fires when Achieve Life Sciences formally submits its resubmitted NDA for cytisinicline to the FDA.
Watch
EMA re-examination outcome on Omeros's narsoplimab in TA-TMA

Monitor Omeros's request for re-examination of the negative CHMP opinion for narsoplimab in TA-TMA, the convening of the Ad Hoc Expert Group (AHEG), and the final decision.

one-shot · Fires when the EMA or Omeros announces the outcome of the re-examination and AHEG review.
Watch
GondolaBio Phase 2b/3 PATHWAY trial initiation of PORT-77 in EPP

Monitor the initiation of GondolaBio's global Phase 2b/3 PATHWAY trial of PORT-77 in patients with EPP and XLP, targeted for Q3 2026.

one-shot Expected Sep 30, 2026 · Fires when GondolaBio begins enrolling patients or initiates clinical sites for the Phase 2b/3 PATHWAY trial of PORT-77 in EPP/XLP.
Watch
Merck regulatory filing for tulisokibart in ulcerative colitis

Monitor Merck's formal regulatory filing (BLA/NDA) to the FDA for tulisokibart (MK-7240) in moderately to severely active ulcerative colitis (UC) following the successful Phase 3 ATLAS-UC program.

one-shot Expected Mar 31, 2027 · Fires when Merck submits its regulatory application for tulisokibart in ulcerative colitis.
Watch
MoonLake BLA submission for sonelokimab in Hidradenitis Suppurativa

Monitor MoonLake's planned Biologics License Application (BLA) submission to the FDA for sonelokimab (SLK) in moderate-to-severe hidradenitis suppurativa (HS), targeted for late September 2026, and subsequent FDA PDUFA date allocation in late November 2026.

one-shot Expected Sep 30, 2026 · Fires when MoonLake formally submits the BLA for sonelokimab in HS.
Watch
FDA regulatory decision on Exelixis' zanzalintinib plus Tecentriq in late-line mCRC

Monitor the FDA's regulatory decision on Exelixis' New Drug Application (NDA) for zanzalintinib plus Tecentriq in late-line metastatic colorectal cancer (mCRC), with a PDUFA target action date of December 3, 2026.

one-shot Expected Dec 3, 2026 · Fires when the FDA grants or denies approval for zanzalintinib plus Tecentriq in late-line mCRC.
Watch
FDA traditional approval decision on Novartis's Vanrafia (atrasentan) in IgAN

Monitor the FDA's regulatory decision on converting Novartis's Vanrafia (atrasentan) accelerated approval to traditional approval, supported by the final 2.5-year ALIGN trial results published in June 2026. Submissions are planned for late 2026.

one-shot Expected Dec 31, 2026 · Novartis
Watch
Dianthus MoMeNtum Phase 2 top-line data in MMN

Monitor Dianthus's release of top-line Phase 2 MoMeNtum data for claseprubart in Multifocal Motor Neuropathy (expected in Q4 2026).

one-shot Expected Dec 31, 2026 · Dianthus Therapeutics
Watch
Dianthus CAPTIVATE Part B top-line guidance in CIDP

Monitor Dianthus's release of top-line guidance for Part B of the Phase 3 CAPTIVATE trial in CIDP (expected by year-end 2026).

one-shot Expected Dec 31, 2026 · Dianthus Therapeutics
Watch
FDA regulatory decision on Gilead's once-weekly oral Yeztugo for HIV PrEP

Monitor the FDA regulatory decision on Gilead's supplemental New Drug Application (sNDA) for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral formulation for HIV PrEP.

one-shot Expected Feb 2, 2027 · Fires when the FDA grants or denies approval for once-weekly oral Yeztugo for HIV PrEP (PDUFA date: February 2, 2027).
Watch
FDA regulatory decision on Zepzelca's second-line SCLC indication

Monitor the FDA's regulatory decision or next steps regarding Jazz/PharmaMar's Zepzelca (lurbinectedin) accelerated approval for second-line SCLC following the Phase 3 LAGOON trial failure.

one-shot · Fires when the FDA or Jazz announces a regulatory decision, label update, or withdrawal of the second-line SCLC indication for Zepzelca.
Watch
USDA $750M sterile screwworm fly facility operational launch in Texas

Monitor the construction and operational launch of the USDA's $750 million sterile fly production facility in Texas designed to produce 300 million sterile New World screwworm flies per week.

one-shot Expected Dec 31, 2027 · Fires when the USDA's new sterile fly facility in Texas begins operations.
Watch
Sanofi Tzield Phase 3 BETA-PRESERVE confirmatory trial in Stage 3 T1D

Monitor the Phase 3 BETA-PRESERVE (NCT07088068) confirmatory study for Sanofi's Tzield (teplizumab-mzwv) in newly diagnosed Stage 3 Type 1 diabetes to verify clinical benefit following its accelerated approval.

one-shot Expected Dec 31, 2028 · Fires when Sanofi reports topline safety and efficacy results from the Phase 3 BETA-PRESERVE trial.
Watch
FDA regulatory filing and decision on Gilead/Merck once-weekly oral HIV combination

Monitor the FDA regulatory submission and subsequent approval decision for Gilead and Merck's once-weekly oral HIV single-tablet regimen (islatravir/lenacapavir) following the positive Phase 3 ISLEND-1 and ISLEND-2 trials.

one-shot Expected Jun 30, 2027
Watch
FDA regulatory filing and decision on Takeda's zasocitinib in plaque psoriasis

Monitor the FDA regulatory submission and subsequent approval decision for Takeda's oral TYK2 inhibitor zasocitinib in moderate-to-severe plaque psoriasis, following the positive Phase 3 LATITUDE Atlas results.

one-shot Expected Apr 30, 2027
Watch
FDA regulatory filing and decision on Eli Lilly's Foundayo in Type 2 diabetes

Monitor the FDA regulatory submission and subsequent approval decision for Eli Lilly's oral GLP-1 Foundayo (orforglipron) in Type 2 diabetes, following the positive Phase 3 ACHIEVE program results.

one-shot Expected Apr 30, 2027
Watch
Sanofi riliprubart Phase 3 VITALIZE trial status and readout in CIDP

Monitor the regulatory/clinical status and readout of Sanofi's Phase 3 VITALIZE study of riliprubart in IVIg-experienced CIDP patients, following the early termination of the refractory MOBILIZE study.

one-shot Expected Jun 30, 2027 · Fires when Sanofi reports results or makes a strategic decision to continue/terminate the Phase 3 VITALIZE study.
Watch
Dianthus Therapeutics claseprubart Phase 3 CAPTIVATE trial readout in CIDP

Monitor the Phase 3 CAPTIVATE clinical trial readout for Dianthus Therapeutics' claseprubart (DNTH-103) in IVIg-experienced CIDP patients to assess if classical complement pathway inhibition is effective in this distinct cohort.

one-shot Expected Jun 30, 2027 · Fires when Dianthus Therapeutics reports topline Phase 3 CAPTIVATE safety and efficacy results.
Watch
Eli Lilly SURPASS T1D-1 Phase 3 trial readout in Type 1 Diabetes

Monitor the Phase 3 SURPASS T1D-1 clinical trial readout evaluating tirzepatide as an adjunct therapy in overweight/obese patients with Type 1 diabetes. This trial is highly anticipated following Roche's decision to halt acmopatide's T1D program.

one-shot Expected Nov 30, 2026 · Fires when Eli Lilly reports topline Phase 3 SURPASS T1D-1 safety and efficacy results.
Watch
DIOSynVax AI-designed universal Sarbeco vaccine Phase II trial readout

Monitor the Phase II clinical trial readout for DIOSynVax's universal Sarbeco vaccine designed entirely by AI (enrolling over 200 participants).

one-shot Expected Jun 30, 2027 · Fires when DIOSynVax or the University of Cambridge reports Phase II efficacy and safety data for the AI-designed universal Sarbeco vaccine.
Watch
Alterity Therapeutics ATH434 Phase 3 MSA trial initiation

Monitor the initiation of pivotal Phase 3 trial activities for ATH434 in Multiple System Atrophy (MSA) following FDA agreement.

one-shot Expected Dec 31, 2026 · Fires when Alterity Therapeutics begins enrolling patients or initiates clinical sites for the Phase 3 ATH434 trial in MSA.
Watch
Disc Medicine bitopertin Phase 3 APOLLO trial readout and FDA CRL decision

Monitor the topline Phase 3 APOLLO trial results for bitopertin in EPP (expected Q4 2026) and the subsequent FDA regulatory decision on the CRL response (expected mid-2027).

one-shot Expected Jun 30, 2027 · Fires when Disc Medicine reports Phase 3 APOLLO results or when the FDA grants/denies approval for bitopertin in EPP following the CRL response.
Watch
Pfizer berobenatide Phase 3 obesity trial readout

Monitor the first Phase 3 clinical trial results for Pfizer's monthly GLP-1 RA peptide berobenatide (PF-07933944) in obesity.

one-shot Expected Dec 31, 2027 · Fires when Pfizer reports its first Phase 3 trial data for berobenatide in obesity (expected in 2H 2027).
Watch
Phase 3 trial readout for VGA039 in von Willebrand disease

Monitor the Phase 3 clinical trial readout for VGA039 in von Willebrand disease (VWD) to evaluate if the subcutaneous monoclonal antibody meets its primary safety and efficacy endpoints.

one-shot Expected Dec 31, 2028 · Fires when the Phase 3 trial results for VGA039 in von Willebrand disease are published or presented.
Watch
ISS Russian Zvezda module air leaks and repairs

Monitor collaborative repairs and leak rates of the International Space Station's Russian Zvezda service module transfer tunnel (PrK) to assess long-term structural integrity and crew safety.

ongoing · Fires when new leaks are detected, emergency safe haven drills occur, or permanent repair solutions are implemented on the ISS Zvezda module.
Watch
FDA regulatory decision on giredestrant in HR+ early-stage breast cancer

Monitor the FDA regulatory decision on Roche's Biologics License Application (BLA) for the oral SERD giredestrant in HR+ early-stage adjuvant breast cancer following its priority review acceptance.

one-shot Expected Nov 30, 2026 · Fires when the FDA grants or denies approval for giredestrant in HR+ early-stage breast cancer.
Watch
FDA regulatory decision on bezuclastinib in GIST

Monitor the FDA regulatory decision on Cogent Biosciences' New Drug Application (NDA) for the selective KIT inhibitor bezuclastinib in combination with sunitinib for Gleevec-resistant gastrointestinal stromal tumors (GIST).

one-shot Expected Nov 30, 2026 · Fires when the FDA grants or denies approval for bezuclastinib in second-line Gleevec-resistant GIST.
Watch
Moderna Phase 3 mRNA-1018 bird flu vaccine trial readout

Monitor topline safety and immunogenicity readouts from Moderna's Phase 3 trial of mRNA-1018 (enrolling ~4,000 healthy adults in the US and UK).

one-shot · Moderna
Watch
sBLA submission for Zynlonta plus rituximab in r/r DLBCL

Monitor ADC Therapeutics' planned sBLA submission in Q4 2026 following the pre-sBLA meeting with the FDA in August 2026 to see if safety concerns (13.2% fatal TEAEs in LOTIS-5) delay or alter the regulatory path.

one-shot Expected Dec 31, 2026 · ADC Therapeutics / FDA
Watch
NHS-Galleri trial cancer mortality data release

Monitor the release of final cancer-specific mortality data from the NHS-Galleri trial to evaluate if the Galleri multi-cancer early detection test successfully translates early detection into lives saved.

ongoing · Fires when peer-reviewed mortality outcomes or long-term follow-up analyses from the NHS-Galleri trial are published or presented.
Watch
NMPA regulatory decision on IBI343 (world's first CLDN18.2 ADC)

Monitor the Chinese National Medical Products Administration (NMPA) regulatory decision on the priority review New Drug Application (NDA) for IBI343 in CLDN18.2-positive gastric cancer.

one-shot Expected Feb 1, 2027 · Fires when the Chinese NMPA grants or denies approval for IBI343 (arcotatug tavatecan) in advanced refractory CLDN18.2-positive gastric cancer.
Watch
Global Phase 3 trial readouts for ivonescimab (HARMONi studies)

Monitor readouts from global Phase 3 trials of ivonescimab (HARMONi-3 or HARMONi-7) to determine if the 34% overall survival benefit in squamous NSCLC is replicated in a diverse, global patient population.

ongoing · Fires when global Phase 3 data (HARMONi-3 or HARMONi-7) for ivonescimab is presented or published, evaluating global applicability and efficacy in older populations (>=65).

Recent findings

Brief

Track consequential science and health — disease outbreaks and public-health moves, drug approvals and major trial readouts, breakthroughs in biology/energy/space, and the policy around them. Lead with what's new, grounded in primary findings.