Akebia Therapeut Stock Price, News & Analysis

Akebia (Nasdaq: AKBA) announced the establishment of a rare kidney disease pipeline on Dec 1, 2025, centered on two candidates: AKB-097 (a tissue-targeted C3d‑Factor H fusion protein complement inhibitor acquired from Q32 Bio) and praliciguat (an sGC stimulator).

Akebia acquired all rights to AKB-097 and says it targets complement activation sites without expected systemic complement inhibition. A Phase 2 trial of praliciguat in FSGS has been initiated, and both Phase 2 programs are planned to begin treating subjects in 2026. Akebia expects AKB-097 Phase 2 basket trial data beginning in 2027.

Q32 Bio (NASDAQ:QTTB) sold its Phase 2 complement inhibitor ADX-097 to Akebia Therapeutics (NASDAQ:AKBA) for $12 million in upfront and near-term payments and is eligible for up to $592 million in total milestone payments plus tiered royalties.

Q32 received $7M at signing, $3M at six months, and $2M by end of 2026 or upon an earlier milestone. The company says proceeds and existing cash are expected to extend its runway into the second half of 2027 while it advances bempikibart and SIGNAL-AA Part B topline data is on track for mid-2026. Q32 retains its tissue-targeted complement platform, including ADX-096, and is evaluating strategic options for remaining programs.

Akebia Therapeutics (Nasdaq: AKBA) said its executive team will participate in a Fireside Chat at the Piper Sandler 37th Annual Healthcare Conference on Tuesday, December 2, 2025 at 4:30 PM ET in New York City.

The company said a webcast of the presentation will be available after the conference via the Investors section at https://ir.akebia.com. The Piper Sandler conference runs December 2–4, 2025.

Akebia (Nasdaq: AKBA) reported Q3 2025 results and operational updates for Vafseo (vadadustat). Total revenues were $58.8 million in Q3 2025 versus $37.4 million in Q3 2024. Vafseo net product revenue was $14.3 million in Q3 2025; Auryxia net product revenue was $42.5 million.

Prescribing access across the customer base reached 60,000 patients by end of Q3 and is expected to grow to 275,000 patients by year-end. A DaVita operational pilot at >100 clinics is expected to complete in November 2025. A post-hoc INNO2VATE analysis presented at ASN Kidney Week showed a statistically more favorable composite of all-cause mortality and hospitalization for vadadustat versus ESA.

Q3 net income was $0.5 million versus a $20.0 million loss year-ago; cash and cash equivalents were $166.4 million as of September 30, 2025.

Akebia Therapeutics (Nasdaq: AKBA) presented a post-hoc win-odds analysis from the Phase 3 INNO2VATE dialysis trials at ASN Kidney Week on Nov 6, 2025 showing a statistically more favorable composite of all-cause mortality and hospitalization for patients receiving Vafseo (vadadustat) versus darbepoetin alfa. The analysis reported an inverted win-odds of 0.93 (95% CI 0.87–0.99; P=0.03) on study and 0.86 (95% CI 0.81–0.95; P<0.0001) on treatment plus 28 days. Vafseo is approved for dialysis-dependent CKD anemia and available in the U.S. since January 2025. The company noted ongoing real-world trials including VOICE to further measure mortality and hospitalizations.

Akebia Therapeutics (Nasdaq: AKBA) announced that CEO John P. Butler and Chief Financial and Chief Business Officer Erik Ostrowski will present at two investor conferences in November 2025. They will appear at the Guggenheim 2nd Annual Healthcare Innovation Conference in Boston on November 10, 2025 with a fireside chat at 3:00 PM EST, and at the Jefferies Global Healthcare Conference in London on November 17, 2025 with a fireside chat at 12:00 PM GMT.

A webcast of each presentation will be available through the Investors section of Akebia’s website at https://ir.akebia.com following the conferences.

Akebia Therapeutics (Nasdaq: AKBA) granted stock options to three newly hired employees on October 31, 2025 as inducement awards under Nasdaq Listing Rule 5635(c)(4). An aggregate of 51,825 options were issued with an exercise price of $2.21 per share, equal to the closing price on the grant date.

The options vest over four years (25% at the first anniversary, then quarterly for the remaining 75%), have a 10-year term, and are subject to Akebia’s inducement award program and stock option agreement, and to continued service requirements.

Akebia Therapeutics (Nasdaq: AKBA) will release its third quarter 2025 financial results for the period ended September 30, 2025 on Monday, November 10, 2025 prior to market open.

The company will host a conference call on November 10, 2025 at 8:00 a.m. EST to discuss results and recent business highlights. Investors are asked to register for dial‑in details and to dial in 15 minutes early to avoid delays. A live webcast and an online archive will be available in the Investors section at https://ir.akebia.com/.

Akebia Therapeutics (Nasdaq: AKBA) announced it does not expect to initiate the VALOR clinical trial for vadadustat in late-stage chronic kidney disease patients not on dialysis after a Type C meeting with the U.S. FDA on Oct. 28, 2025. Akebia said it did not reach alignment with the FDA on trial design and believes a regulatory pathway would require a significantly larger patient population than proposed, adding materially more time and cost.

The company does not expect to pursue a broad non-dialysis CKD label for Vafseo, but said FDA feedback indicated potential alignment on smaller CKD subgroups. Vafseo is approved in the U.S. for adults on dialysis; U.S. nephrologists began prescribing in January 2025.