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Biohaven (BHVN) pipeline and stated timing

Pipeline at a glance

ProgramEventStageStated timingFiling
BHV-1530/data readoutStage not statedOctober 20268-K ·
Opakalim (BHV-7000)Topline/data readoutOtherthe second half of 20268-K ·
Taldefgrobep alfaTopline/data readoutStage not stated 20268-K ·

Source: ORION, orionbiotechai.com/company/BHVN, data as of Oct 13, 2026
https://www.orionbiotechai.com/company/BHVN

Nearest upcoming stated timing: BHV-1530 · Topline/data readout · October 2026

SEC sources last checked .

Programs and stated timing

○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.

BHV-1530

Matched

Topline/data readoutOctober 2026

Stage: Not stated

Public float: $1,044,000,000 · as of · SEC filing

New clinical data with BHV-1530, an FGFR3-directed ADC using a novel TopoIx payload, being presented at ESMO in October 2026

8-K · Filed · Last checked

Source details

Accession 0001935979-26-000067

Opakalim (BHV-7000)

Matched

Topline/data readoutthe second half of 2026

Stage: OtherSEC filing · “Phase 2/3”

Public float: $1,044,000,000 · as of · SEC filing

Dosing remains ongoing in BHV7000-303 and topline data continues to be on timelines for the second half of 2026.

8-K · Filed · Last checked

Source details

Accession 0001935979-26-000077

How this date was described over time

Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .

Program / eventStated period and SEC wordingDisclosure in stated period
Opakalim (BHV-7000)Clinical resultsthe second half of 2026
“Dosing remains ongoing in BHV7000-303 and topline data continues to be on timelines for the second half of 2026.”

Filed · 8-K

Still within period

As of Oct 19, 2026

Opakalim (BHV-7000)Clinical results2H 2026
“with topline results from the RISE3 trial expected in 2H 2026.”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

Opakalim (BHV-7000)Clinical results2H 2026
“with RISE3 trial topline results expected in 2H 2026.”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

BHV-1530Clinical resultsOctober 2026
“New clinical data with BHV-1530, an FGFR3-directed ADC using a novel TopoIx payload, being presented at ESMO in October 2026”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

Opakalim (BHV-7000)Clinical results2H 2026
“pivotal readout on track for 2H 2026”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

Opakalim (BHV-7000)Clinical results2H 2026
“Topline results from the Phase 2/3 RISE3 trial in focal epilepsy remain on track for 2H 2026.”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

Opakalim (BHV-7000)Clinical results2H 2026
“Topline results from the Phase 2/3 RISE3 trial in focal epilepsy are expected during 2H 2026.”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

Opakalim (BHV-7000)Clinical results2H 2026
“study expected in 2H 2026.”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

Opakalim (BHV-7000)Clinical resultsthe second half of 2026
“We expect to report topline results from RISE 3 in the second half of 2026.”

Filed · 10-Q

Still within period

As of Oct 19, 2026

Taldefgrobep alfaClinical results2H 2026
“Topline data expected during 2H 2026.”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

Opakalim (BHV-7000)Clinical results2H 2026
“On track to receive top-line results in 2H 2026”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

Opakalim (BHV-7000)Clinical results2H 2026
“Biohaven is on track to announce in 2H 2026 top-line results”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

Opakalim (BHV-7000)Clinical resultsthe second half of 2026
“We expect to report topline results from RISE 3 in the second half of 2026.”

Filed · 10-Q

Still within period

As of Oct 19, 2026

Opakalim (BHV-7000)Clinical results2H 2026
“Pivotal epilepsy program with selective Kv7 ion channel activator, opakalim, with expected topline results in 2H 2026.”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

Opakalim (BHV-7000)Clinical resultsthe second half of 2026
“In the second half of 2026, we expect to report pivotal data from our epilepsy program and topline results from our obesity program”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

Opakalim (BHV-7000)Clinical results2H 2026
“study expected in 2H 2026.”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

Taldefgrobep alfaClinical resultsthe second half of 2026
“Topline results for the Phase 2 proof-of-concept study are expected in the second half of 2026.”

Filed · 10-Q

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

Taldefgrobep alfaClinical results2H 2026
“taldefgrobep alfa, completed enrollment and topline data expected in 2H 2026.”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

Taldefgrobep alfaClinical resultsthe second half of 2026
“In the second half of 2026, we expect to report pivotal data from our epilepsy program and topline results from our obesity program”

Filed · EX-99.1

Not compared

ORION has no confirmed start and end dates for this wording, so it is not compared with filings.

Taldefgrobep alfaClinical results2H 2026
“Topline data from the study are expected in 2H 2026.”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

Taldefgrobep alfaClinical results2H 2026
“topline results expected in 2H 2026.”

Filed · EX-99.1

Still within period

As of Oct 19, 2026

“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.

Retained founder-checked records

These dated records retain their original scope and check dates.

opakalim / RISE3 focal epilepsy · Topline results

Record BHVN-P4 · Clinical results disclosure · Window open

Last checked: .

First stated window
“in the second half of 2026”SEC Form , filed
Disclosure date
None foundLast checked:

Initial statement

· Checked by founder · SEC Form 10-Q

Stated period: in the second half of 2026

We expect to report topline results from RISE 3 in the second half of 2026.

Statement retained

· Checked by founder · SEC Exhibit 99.1

Stated period: for 2H 2026

Topline results from the Phase 2/3 RISE3 trial in focal epilepsy remain on track for 2H 2026.

Statement retained

· Checked by founder · Company press release

Stated period: 2H 2026

with RISE3 trial topline results expected in 2H 2026.

Statement retained

· Checked by founder · SEC Exhibit 99.1

Stated period: 2H 2026

with RISE3 trial topline results expected in 2H 2026.

Statement retained

· Checked by founder · SEC Form 8-K

Stated period: for the second half of 2026

topline data readout remains on timeline for the second half of 2026

Statement retained

· Checked by founder · SEC Form 8-K

Stated period: for the second half of 2026

Dosing continues in BHV7000-303 and topline data remain on track for the second half of 2026.

Context disclosure

· Checked by founder · SEC Form 8-K

FDA partial clinical hold letter:

partial clinical hold letter on September 4, 2026
new patient enrollment only
Dosing continues
topline data remain on track
second half of 2026

Item 8.01: paragraph beginning Thus, FDA and paragraph beginning BHV7000-303, one of two pivotal studies

Sources and scope

Scope source

· Biohaven sponsor-submitted ClinicalTrials.gov record

Company release: · Company original

Company release: · Company original

Company press release listing · checked

The initial entry means the earliest wording located within the sources checked; an exhaustive history is not asserted.

Company timing wording is retained. A newer corporate release about another program does not establish a results announcement for this trial.

Additional source review: 2026-10-10. Earlier retained sources were reviewed on 2026-10-09; their original source-check dates and scopes are retained.

ClinicalTrials.gov NCT06309966: acronym RISE 3; organization study ID BHV7000-303.

SEC filings searched through : 10-Q 5/4, 8/10, 8-K 8/26 quotes checked against originals. Later SEC filings not searched. Supplement reviewed 2026-10-10: selected 2026-09-10 SEC Form 8-K timing occurrences. This is not an exhaustive later-filing search.

Company press releases checked : Company press releases page 1 checked on 10/9; Oct 8 release is BHV-1300, not RISE3.

Checked by founder: .

Corrections

· Display rule corrected — equivalent timing phrases (e.g., 'H2 2026' / 'second half of 2026') are now shown as Statement retained. Source quotes and status unchanged. · Equivalent timing notation is compared after normalization. · Founder approved the normalization correction and this exact public line in this chat on 2026-10-09.

· Added source-context excerpts from 2026-09-10 SEC Form 8-K. · Founder-requested context retained from the checked original filing. · https://www.sec.gov/Archives/edgar/data/1935979/000193597926000077/bhvn-20260904.htm

· Added previously omitted 2026-09-10 SEC Form 8-K timing source. · Selected-source supplement following founder review; prior rows retained. · https://www.sec.gov/Archives/edgar/data/1935979/000193597926000077/bhvn-20260904.htm

Biohaven (BHVN) — opakalim / RISE3 focal epilepsy · Topline results: “in the second half of 2026” (SEC Form 10-Q 2026-05-04); statement retained “for 2H 2026” (2026-08-10); statement retained “2H 2026” (2026-08-26); statement retained “2H 2026” (2026-08-26); statement retained “for the second half of 2026” (2026-09-10); statement retained “for the second half of 2026” (2026-09-10). Status Window open, checked 2026-10-10. Sources: https://www.sec.gov/Archives/edgar/data/1935979/000193597926000045/bhvn-20260331.htm | https://www.sec.gov/Archives/edgar/data/1935979/000193597926000067/a2026q2bhvnearningsprex991.htm | https://ir.biohaven.com/news-releases/news-release-details/biohaven-and-sk-biopharmaceuticals-enter-strategic-global | https://www.sec.gov/Archives/edgar/data/1935979/000193597926000072/exhibit991-biohavenandskbi.htm | https://www.sec.gov/Archives/edgar/data/1935979/000193597926000077/bhvn-20260904.htm | https://www.sec.gov/Archives/edgar/data/1935979/000193597926000077/bhvn-20260904.htm

Retained program pages

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Reading these records

First stated window
The timing wording in the earliest company statement located within the sources checked, quoted as written (for example “2H 2026”). An earlier statement may exist outside those sources.
Disclosure date
The date of the filing or company release that disclosed the readout. “None found” means no such disclosure was located in the sources checked. SEC filings were searched through the “SEC filings searched through” date shown.
1H, 2H, 1Q–4Q
First or second half, or first to fourth quarter, of the year named, as the company wrote it. Equivalent notations are compared together; the original wording stays visible.
SEC original
The filing as published on the SEC EDGAR system. “Company original” is the release on the company's own investor site.
Status
One of seven labels set by founder review of the original filings. Definitions: Methodology.

See BHVN in the calendar · Review labels and methodology

Topline results are the main summary results of a clinical trial, released before the full data.1H means January–June and 2H means July–December of the stated year, unless the company uses a different fiscal year.A Form 10-Q is a company’s quarterly report to the SEC, with unaudited financial statements.A Form 8-K is a report a company files with the SEC to announce a significant event between its regular reports.