FDA approves TAUKLARIFY, new molecular entity from Cerveau Lantheus
The intravenous imaging agent received standard approval under NDA220496, with submission status recorded as of August 13, 2026.
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Thursday, August 13
AbCellera completes pricing of $200 million offering, files final prospectus supplement
The company detailed final offering economics and closing terms, with the deal expected to close August 14, 2026.
SEC filing (3)
Instil Bio reports Q2 2026 results, says it is weighing acquisitions and in-licensing deals
The Dallas biotech reported $69.9 million in cash as of June 30, 2026 and said it is exploring outside opportunities to add new therapeutic candidates.
SEC filing
Edesa reports fiscal Q3 2026 results, readies EB06 vitiligo trial and ARDS data
Company says site activation for its Phase 2 EB06 vitiligo study is underway with enrollment expected in coming weeks, while new ARDS/AKI analyses show mortality benefit for paridiprubart.
SEC filing
Equillium reports Q2 2026 results, plans Australia dossier filing for EQ504
The company said it expects to start a Phase 1 study of EQ504 in the fourth quarter of 2026, with topline data about six months later, while cash on hand is projected to fund operations into 2029.
SEC filing
Olema Oncology names Jason O'Byrne as chief financial officer
The appointment, effective August 11, 2026, comes as the company approaches pivotal data from its OPERA-01 trial and prepares for a potential first commercial launch.
SEC filing
Pelthos posts second quarter 2026 results as Zelsuvmi revenue climbs
Net product revenue for the molluscum treatment rose 45% quarter over quarter to $15.4 million, while the company disclosed a restatement of its first-quarter 2026 financials.
SEC filing
PDS Biotech refocuses pipeline on PDS0301, halts PDS0101 phase 3 trial
The company will stop internally funding PDS0101 and seek a partner for it while making PDS0301 its lead program, alongside new colorectal cancer data.
SEC filing
Omeros adds Joseph Schocken to board of directors
Omeros Corporation expanded its board to nine members and appointed the investor and Broadmark Capital founder effective August 12, 2026.
SEC filing
Dare Bioscience reports Q2 2026 results as first direct product launches
The company began selling Flora Sync LF5 in July and reported positive interim Phase 3 data for Ovaprene while starting a Phase 2 study of DARE-HPV.
SEC filing
Cabaletta reports Q2 2026 results, reaffirms mid-2027 myositis data and 2H27 BLA plan
The company also plans to start a registrational systemic sclerosis-ILD study in 4Q26 and said cash on hand funds operations into mid-2027.
SEC filing
Elutia lines up new financing for NXT-41x, backs FDA timelines
The company said fresh credit and divestiture proceeds fund it through NXT-41x's expected clearance and 2028 launch year, alongside second-quarter results.
SEC filing
Yarrow Bioscience files amended 8-K with Pre-Merger Yarrow financials after VYNE merger
The filing adds recast financial statements, pro forma results, and an August 13, 2026 quarterly release, covering the entity now known as Yarrow Bioscience Operating Company Corp.
SEC filing
Cingulate reports Q2 2026 results, updates CTx-1301 CMC and NDA resubmission plans
Cingulate said it is finishing manufacturing work with its CDMO and plans to resubmit the CTx-1301 NDA to the FDA as promptly as practicable, with cash extending into mid-2027.
SEC filing
Silexion prices $2.5 million public offering, closes it days later
The clinical-stage RNAi cancer company sold shares, pre-funded warrants and new warrants at $0.65, with proceeds earmarked for its SIL204 pancreatic cancer trial.
SEC filing (3)
Ensysce completes Cy Biopharma acquisition, adds CRPS candidate CY200
The San Diego biotech folded in Cy Biopharma on August 6, 2026, gaining an Orphan Drug-designated pain therapy and up to $77 million in new funding.
SEC filing
Akari Therapeutics reports Q2 2026 results, keeps AKTX-101 Phase 1 on track for mid-2027
The oncology biotech said it raised $8.6 million in gross proceeds during the quarter while advancing its lead ADC candidate through IND-enabling work.
SEC filing
Serina completes Cohort 1 dosing in SER-252 Parkinson's trial ahead of schedule
The company reported Cohort 1 enrollment finished early, with single-ascending-dose top-line data still targeted for the first half of 2027.
SEC filing
Rockwell Medical reports second quarter 2026 results and reiterates full-year guidance
The company posted 11% sales growth and expanding margins while pointing to new supply deals and a completed reverse stock split.
SEC filing
Eton Pharmaceuticals posts 99% revenue growth, raises 2026 guidance to over $145 million
The rare disease drugmaker reported Q2 2026 product sales of $37.6 million, added a hemangioma pipeline asset, and pushed guidance higher for the full year.
SEC filing
Candel targets Q4 2026 BLA for prostate cancer therapy, opens NSCLC phase 3 trial
Candel reported second-quarter 2026 results with $201.6 million in cash, said to fund operations into the first quarter of 2028, alongside progress on its lead program.
SEC filing
Grace Therapeutics details GTx-104 resubmission plan after CRL, sets cash runway to 2028
Grace Therapeutics said its FDA rejection cited manufacturing and non-clinical issues, not safety or efficacy, as it pursues a two-site production strategy.
SEC filing
Pulmatrix reports Q2 2026 results, cites progress on Eos SENOLYTIX merger
Cipla's Phase 3 plan for PUR1900 in India advances as Pulmatrix works toward closing its merger with Eos SENOLYTIX, expected in Q3 2026.
SEC filing
VolitionRx reports Q2 2026 results, cites licensing talks and Sysmex collaboration
Volition said it is in discussions with more than a dozen diagnostic and liquid biopsy companies on potential licensing deals as it reported second-quarter 2026 results.
SEC filing
Nektar reports Q2 2026 results, details Phase 3 rezpegaldesleukin timeline
Nektar says its first Phase 3 atopic dermatitis trials began in July, with a BLA path targeted for 2029 and cash into the third quarter of 2028.
SEC filing
MiNK reports early Phase 2 data for agenT-797 in acute lung injury, Q2 2026 results
Initial patients in Ukraine trial showed Day 28 survival and improved oxygenation as MiNK also launched a paid named-patient access program in Brazil.
SEC filing
Aktis Oncology reports Q2 2026 results, three Phase 1b trials now underway or cleared
The company disclosed new clinical imaging data for AKY-2519 and reported $517.3 million in cash expected to fund operations into 2029.
SEC filing
Aethlon Medical dosed first patient in final cohort of Australia oncology trial
The company reported fiscal first quarter results and said early biomarker signals from its Hemopurifier oncology study support continued evaluation, while cash stood at about $4.9 million as of June 30, 2026.
SEC filing
Karyopharm says myelofibrosis sNDA submission remains on track for August
The company reported second-quarter 2026 results and flagged a September debt payment that could trigger default without new financing.
SEC filing
MacroGenics reports Q2, streamlines model, updates ADC and bispecific pipeline
MacroGenics paired second-quarter results with a completed manufacturing divestiture and fresh pipeline updates, including a Gilead option exercise and ESMO data plans.
SEC filing
Caribou reports Q2 2026 results, updates vispa-cel and CB-011 data
Caribou cites durable ANTLER and CaMMouflage phase 1 results as it plans a pivotal ANTLER-3 trial, with cash seen lasting into late 2027.
SEC filing
ImmuCell reports Q2 2026 results, presses ahead with capacity expansion
The animal health company posted second-quarter net income of $1.8 million as it moves through a multi-phase plan to expand First Defense production.
SEC filing
Zenas BioPharma reports Q2 2026 results, obexelimab BLA now accepted by FDA
FDA accepted the IgG4-RD application with a target decision date in May 2027, while the company posted a wider quarterly net loss and $673.9 million in cash.
SEC filing
RenovoRx completes Phase III enrollment, raises 2026 revenue guidance
RenovoRx reported record quarterly revenue, full enrollment in its TIGeR-PaC trial, and a first sarcoma treatment with RenovoCath.
SEC filing
Tempest reports Q2 2026 results, in vivo CAR-T collaboration with Senlang Biotechnology
Tempest ended the quarter with $0.8 million in cash and outlined plans for TPST-4003 dosing in China in the fourth quarter of 2026.
SEC filing
Eledon reports Q2 2026 results, confirms Phase 3 kidney transplant trial on track for late 2026
Eledon said an End-of-Phase 2 FDA meeting cleared the path for a global Phase 3 trial of tegoprubart in kidney transplantation, while cash fell to $88.8 million.
SEC filing
Abeona reports second-quarter ZEVASKYN growth, expanded treatment center network
Abeona said ZEVASKYN net revenue rose 31% quarter-over-quarter to $11.4 million as it added new qualified treatment centers and secured a Medicare payment designation.
SEC filing
Indaptus halts Decoy20 enrollment, pivots to strategic review after Q2 2026
Indaptus Therapeutics reported no active clinical programs and a new sleep-related research collaboration as it evaluates strategic alternatives following a $12.0 million private placement.
SEC filing
Calidi gets FDA pre-IND feedback on CLD-401, still targets Q1 2027 first dose
The company said the FDA agreed with its development strategy for the RedTail program's lead candidate, keeping the first-in-human study on track for early 2027.
SEC filing
Kyntra Bio reports Q2 2026 results, reaffirms fourth-quarter trial milestones
Company says roxadustat Phase 3 protocol is finalized and FG-3246 interim analysis remains on track, both targeted for the fourth quarter of 2026.
SEC filing
Cadrenal reports Q2 2026 results, launches partnering process for cardiac pipeline
The company presented late-breaking Phase 2 CAD-1005 data at ISTH and said cash on hand should fund operations into early 2027.
SEC filing
NextCure's NC410-pembrolizumab trial ends after Phase 1b; Part 2 never launched
Eikon Therapeutics reports Q2 2026 results with seven ESMO abstracts and melanoma trial progress
Eikon disclosed a completed interim analysis of its Phase 2/3 melanoma trial and $531.2 million in cash as of June 30, 2026, expected to fund operations into the second half of 2027.
SEC filing
ProMIS reports interim PRECISE-AD data showing no ARIA-E, ends Q2 with $53.4 million
Blinded six-month safety and biomarker results from the Phase 1b Alzheimer's trial of PMN310 show zero ARIA-E cases, with topline data due in Q1 2027.
SEC filing
CAMP4 clears regulatory hurdles in Australia, Argentina for SYNGAP1 trial
CAMP4 plans to launch its first-in-human Phase 1/2 trial of CMP-002 in the fourth quarter of 2026 after clearing regulators in two countries, with cash extended into 2028.
SEC filing
Gossamer reports Q2 2026 results, reacquires seralutinib rights from Chiesi
Gossamer says it remains on track to file its seralutinib NDA in PAH in September 2026 after a Pre-NDA meeting with the FDA, while reporting $57.0 million in cash as of June 30, 2026.
SEC filing
Elicio reports Q2 2026 results, plans new Phase 1 combination trial after complete responses
Elicio said it will start a Phase 1 study combining ELI-002 7P with a RAS inhibitor in metastatic pancreatic cancer in Q4 2026 after seeing complete responses, while its Phase 2 trial missed its main goal.
SEC filing
Kodiak reports Q2 2026 results, confirms three Phase 3 readouts by year-end
Kodiak said it remains on track for September DAYBREAK and December PEAK topline data, while cash fell to $125.9 million.
SEC filing
Fortress Biotech reports Q2 2026 results as partnered pipeline advances on multiple fronts
Crystalys raised $130 million for dotinurad's Phase 3 program while AstraZeneca reported positive subgroup data for anselamimab, as Fortress's cash balance grew to $196.6 million.
SEC filing
Alumis reports long-term ONWARD3 data, keeps NDA and LUMUS timelines on track
Alumis said 54% of psoriasis patients reached complete skin clearance at 48 weeks in ONWARD3 and reaffirmed a Q4 2026 NDA filing and Q3 2026 SLE readout for envudeucitinib.
SEC filing