Kyverna reports one-year data for miv-cel in stiff person syndrome and myasthenia gravis
The company said 12-month results from its SPS trial and longer-term follow-up in gMG support a BLA submission on track for completion in Q4 2026.
SEC filing
Latest
Thursday, September 24
Black Hawk Acquisition and Vesicor sign financing deals with Meteora ahead of merger
The agreements, dated September 22, 2026, add a forward purchase deal, a non-redemption agreement, a subscription agreement, and a $200 million standby equity facility tied to the planned business combination.
SEC filing
FDA approves supplement 35 for Eisai's Lenvima
The efficacy-related application update for the oral cancer drug lenvatinib mesylate was approved with a standard review priority.
Drugs@FDA
Acadia's remlifanserin narrowly misses primary endpoint in Phase 2 Alzheimer's psychosis study
The company will proceed to Phase 3 with the 60 mg dose and drop the 30 mg arm after mixed Phase 2 RADIANT results.
SEC filing
Nanobiotix updates on JNJ-1900 (NBTXR3) trials, FDA-cleared protocol change, and cash into 2029
New Phase 1 lung cancer data, early CONVERGE efficacy signals, and a NANORAY-312 protocol amendment accompanied a first half 2026 financial report showing €110.9 million in cash.
SEC filing
Novartis updates Scemblix label; registers PV real-world study and CAD trial
Trial registered testing Jornay PM for ADHD with cannabis use disorder in young people
SciSparc's NeuroThera expands US patent filings on psychedelic-PEA combinations with Clearmind
Three new US patent applications cover LSD, ketamine and ibogaine paired with NeuroThera's PEA technology for conditions including depression, PTSD and substance use disorders.
SEC filing
Alveus registers Phase 2 trial of ALV-100 for weight-loss maintenance after semaglutide
Okyo registers Phase 3 trial of urcosimod for neuropathic corneal pain
HCW Biologics prices $1.5 million private placement with existing investor
The company will use proceeds to fund clinical work on HCW9302 and early-stage development of two other pipeline candidates.
SEC filing
Hemab Therapeutics adds Keli Walbert to board and audit committee
The company disclosed in an 8-K that Walbert joined the board effective September 24, 2026, with a standard option grant and cash compensation package.
SEC filing
Ligand agrees to fund AvenCell's CAR-T pipeline for up to $47 million
The royalty aggregator will back AvenCell's switchable CAR-T programs AVC-201 and AVC-203 through a tranched financing tied to clinical milestones.
SEC filing
New Phase Ib myeloma study registered; GSK-linked FTD trial terminated, BRCA study posted
Tvardi's TTI-101 breast cancer trial posts results after early termination
Legend Biotech shareholders back directors, auditor, and share plan increase at 2026 AGM
At its September 24, 2026 annual meeting, Legend Biotech investors re-elected four directors and approved adding 19.1 million shares to its restricted share plan.
SEC filing
Rezolute updates on ersodetug trials, FDA review, fiscal 2026 results
The company reported interim upLIFT progress, an ongoing FDA review of the sunRIZE congenital HI data, and $107.8 million in cash and investments as of June 30, 2026.
SEC filing
Merck posts two Phase 3 trials, sotatercept in HFpEF and sac-TMT in bladder cancer
Glucotrack prices $3 million public offering of stock and pre-funded warrants
The Nasdaq-listed company will sell shares and warrants at $2.04 to raise gross proceeds of about $3.1 million, with closing expected September 25, 2026.
SEC filing (4)
Kaiser Permanente registers COVID vaccine choice messaging trial with Sanofi as collaborator
Senti Biosciences board member Brenda Cooperstone resigns effective immediately
The company disclosed in a September 24, 2026 filing that Cooperstone stepped down from the board and her committee post on September 23, citing no dispute with the company.
SEC filing
TuHURA draws two more tranches on Parkview credit line, each for $650,000
TuHURA Biosciences tapped its revolving credit facility with Parkview Holdings One on both September 14 and September 21, 2026, pulling $650,000 each time.
SEC filing (2)
Unbuzzd Wellness names Michael Zapolin as CEO ahead of planned stock listing
Quantum BioPharma said Unbuzzd Wellness appointed Zapolin, who takes on financing and listing the company while overseeing a national U.S. commercial rollout.
SEC filing
Pfizer recalls dopamine injection lot; two Phase 3 trials remain not yet recruiting
Jaguar Health confirms 2025 note fully retired, updates outstanding share count to 1,463,958
A second 8-K from Jaguar Health confirms the 2025 Streeterville note was fully paid and cancelled and reports 1,463,958 shares outstanding as of September 24, 2026.
SEC filing (2)
Novlead registers post-market study of INOwill N200 nitric oxide device for neonatal PPHN
Satellos gets FDA clearance for forazapadin IND in FSHD
The FDA cleared Satellos Bioscience's IND for forazapadin in facioscapulohumeral muscular dystrophy, with the FSHD Canada Foundation providing up to $5 million in non-dilutive funding for a planned Phase 2 study.
SEC filing
Viking Therapeutics registers Phase 1 study of VK2735 in obese adults without comorbidities
Genmab grants employees restricted stock units and warrants
The Copenhagen-based biotech disclosed the awards in a September 24, 2026 filing tied to its equity compensation programs.
SEC filing
FDA clears two Welireg supplements for Merck's belzutifan, both approved September 24, 2026
HUTCHMED details ESMO 2026 slots for SAFFRON, SANOVO Phase III lung cancer data
Wednesday, September 23
Zymeworks-Theravance merger CVR agreement details milestone and royalty terms
A contingent value rights agreement filed by Theravance Biopharma sets payment terms tied to licensing, sales, and a first commercial sale milestone for ampreloxetine, dated September 22, 2026.
SEC filing
Mesoblast gets FDA nod for new potency assay to release Ryoncil batches
The company said the assay, called TIBA, will work alongside existing tests to help confirm product consistency as manufacturing evolves.
SEC filing
Optimi Health finishes psilocybin batch for Canadian MDD trial and Australian TRD supply
The company said one cGMP-manufactured batch of 5mg psilocybin capsules will serve both its Health Canada-approved Phase 2 depression trial and existing commercial clinics in Australia.
SEC filing
Vitruvias Therapeutics recalls thyroid tablets as Class I, FDA says
The FDA classified an August recall of Thyroid Tablets, USP, 1/2 Grain as Class I on September 22, 2026, citing superpotency.
FDA recall
FDA approves Eli Lilly's Onswik, a new insulin efsitora alfa-gobe injection
The agency's drug database lists the original biologics license application as approved with a status date of September 23, 2026.
Drugs@FDA
Evommune to present Phase 2a EVO301 atopic dermatitis data at EADV 2026
The late-breaker presentation on October 1 in Vienna will detail topline results from the IL-18 binding protein trial, with a Phase 2b study planned for mid-2027.
SEC filing
AC Immune reports positive week-100 safety and immunogenicity data for ACI-7104 in Parkinson's trial
All primary endpoints of Part 1 of the VacSYn Phase 2 trial were met, with the company planning FDA discussions on next steps in early 2027.
SEC filing
IQVIA Inc. completes $2 billion senior notes offering due 2034
The notes carry a 6.375% coupon and will fund redemption of existing 2026 notes and partial paydown of revolving credit debt.
SEC filing
Anteris Aus Operations amends supply agreement with Harvey Industries
The amendment extends the companies' existing supply and quality pact through year-end 2026 or until a new agreement replaces it.
SEC filing
Decoy Therapeutics closes $3.85 million warrant inducement transaction
The Houston biotech got holders to exercise Series B milestone warrants at a reduced price and issued new warrants for double the shares in exchange.
SEC filing
Glucotrack director resigns citing conflict of interest, CEO details LT-100 plans
Board member Paul Goode stepped down September 14, 2026, and the company's CEO issued a strategic update on its therapeutics pipeline days later.
SEC filing (2)
QuidelOrtho amends credit agreement, resets financial covenants through 2029
The company's Amendment No. 1, signed September 23, 2026, adjusts leverage and interest coverage requirements and interim borrowing rates.
SEC filing
Odense University Hospital registers OPTICARE cardiorenal clinic trial for CKD and heart disease
Gossamer Bio submits first NDA, for seralutinib in pulmonary arterial hypertension
The company filed its application with the FDA in September 2026, backed by Phase 3 PROSERA and Phase 2 TORREY data.
SEC filing
BeOne registers Phase 3 trial of BGB-B2033 for pretreated hepatocellular carcinoma
Decoy Therapeutics closes $3.85 million warrant inducement transaction
The company induced exercise of Series B warrants at a reduced price and issued new warrants for up to 2,368,868 shares, closing September 23, 2026.
SEC filing
Sarepta settles patent litigation with REGENXBIO, UPenn, Catalent over gene therapy capsid
Sarepta will pay REGENXBIO $39.0 million to resolve patent infringement suits tied to the AAVrh74 capsid used in ELEVIDYS.
SEC filing