Longeveron's ELPIS II trial misses primary endpoint in HLHS study
The Phase 2b trial of laromestrocel failed to improve right ventricular ejection fraction, and Longeveron said it will review all options to maximize shareholder value.
SEC filing
Latest
Wednesday, September 23
Ionis and Roche report positive Phase 3 interim data for sefaxersen in IgA nephropathy
The IMAgINATION study hit its primary endpoint at 37 weeks, with the trial continuing blinded to assess kidney function through week 105.
SEC filing
IB Acquisition Corp. amends GNQ Insilico deal terms, discloses $50M equity facility
A September 23 filing details a commitment note, PIPE notes up to $90 million, and an amendment removing the merger's minimum cash condition ahead of the GNQ Insilico combination.
SEC filing (2)
AstraZeneca's Trixeo approved in EU for asthma maintenance treatment
The triple-combination inhaler becomes the first of its kind cleared in the EU for asthma patients 12 and older regardless of exacerbation history.
SEC filing
Zymeworks closes acquisition of Theravance Biopharma
The Nasdaq-listed biotech finalized the merger on September 23, 2026, paying Theravance shareholders $17.00 in cash plus contingent value rights tied to ampreloxetine.
SEC filing
Cardiol hits MAVERIC enrollment target early, expands trial to 150 patients
Company pushes topline data to mid-2027 from Q1 2027 after blinded review shows fewer recurrences than expected in the Phase III pericarditis trial.
SEC filing (2)
Bio-Techne shareholders approve Merck KGaA acquisition
Shareholders voted at a September 23 special meeting to back the merger, clearing a major step toward closing.
SEC filing
MeiraGTx adds Alan M. Sebulsky, former Adage Capital manager, to board
The genetic medicines company named Sebulsky a Class I director effective September 23, 2026, with a term running until the 2028 annual meeting.
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
Jazz Pharmaceuticals reprices and extends term loan B facility
Jazz Lux amended its credit agreement on September 23, 2026, cutting the interest margin by 50 basis points and pushing the maturity date out five years to 2033.
SEC filing
OneMedNet stockholders back equity plan increase and possible reverse stock split
At its September 18, 2026 annual meeting, OneMedNet shareholders approved director elections, an auditor ratification, an expanded equity incentive plan, and authority for a reverse stock split of between 1-for-5.
SEC filing
ProQR names Chris Hart as Chief Data and AI Officer, adds Thomas Wolf to board
The moves are meant to expand AI use across ProQR's Axiomer RNA editing programs, with an early readout for lead AI-discovered candidate AX-0811 expected in January 2027.
SEC filing
Eledon registers Phase 3 trial comparing tegoprubart with tacrolimus in kidney transplant
Corcept names Justin Gunn to succeed retiring endocrinology president Sean Maduck
Sean Maduck steps down as President of Corcept's Endocrinology division effective October 1, 2026, with Justin Gunn taking over the role.
SEC filing
FDA approves label update for TEPEZZA; Amgen registers MariTide bioavailability study
Valion Bio names Dean Zikria interim CEO, shifts board leadership
The company also elevated Thomas Jensen to board chair and named Jared Malbin audit committee chair as Sheryle Bolton departed the board.
SEC filing
REGENXBIO, UPenn settle patent suit with Sarepta over ELEVIDYS
Sarepta will pay REGENXBIO $39.0 million and both sides drop patent litigation tied to ELEVIDYS manufacturing.
SEC filing
Tuesday, September 22
FDA lifts clinical hold on Filana's simufilam, clearing path for TSC epilepsy study
Filana Therapeutics said patient screening for a Phase 2a trial in TSC-related epilepsy is expected to begin by the first quarter of 2027.
SEC filing
Biomea Fusion pushes BMF-650 Phase I data to October 2026
The company filed an 8-K revising its expected timeline for topline results from the Phase I GLP-131 study of obesity candidate BMF-650.
SEC filing
Rocket One agrees to acquire Tracer Drone Technologies
The definitive agreement, signed September 18, 2026, would give Rocket One full ownership of the New Jersey drone services provider.
SEC filing
Celldex says barzolvolimab hit all primary and secondary goals in two Phase 3 CSU trials
Celldex reported that EMBARQ-CSU1 and EMBARQ-CSU2 met their primary endpoint and all key secondary endpoints at 12 weeks, with a BLA submission planned for 2027.
SEC filing
FDA tells Compass Therapeutics to run survival trial before BLA for tovecimig
Compass disclosed on September 22, 2026 that the FDA wants a trial showing survival benefit before it accepts a BLA filing for tovecimig in biliary tract cancer, but the company disputes that a new study is needed.
SEC filing
Adagene gets NMPA clearance for HER2xCD3 bispecific ADG138
China's drug regulator cleared the IND for the double-masked T-cell engager, with a first-in-human Phase 1 study expected to start in China in the fourth quarter of 2026.
SEC filing
Vistagen reports preliminary open-label data from PALISADE-4 extension for fasedienol
The company said as-needed use of the nasal spray for up to a year showed no new safety concerns and improvement on anxiety scales over four months.
SEC filing
Viking reports positive maintenance data for obesity drug VK2735
Less frequent dosing after weekly induction preserved most weight loss, with tolerability similar to placebo, Viking said September 22, 2026.
SEC filing
PDS Biotech publishes VERSATILE-002 Phase 2 results for PDS0101 in JAMA Oncology
The head and neck cancer trial combining PDS0101 with pembrolizumab reported 39.3-month median overall survival in checkpoint-inhibitor-naive patients, as the company pursues a partner for further development.
SEC filing
Ligand pays $23 million for royalty rights on Santen's myopia drug Ryjunea
Ligand acquired the royalty and milestone interest in Ryjunea from Sydnexis, gaining tiered royalties on Santen's sales across Europe, the Middle East, and Africa.
SEC filing
Optimi Health names Michael Blough to lead clinical development for psychedelic trials
The appointment supports Optimi's planned Phase 2 psilocybin trial for major depression and Phase 3 MDMA trial for PTSD, both expected to start enrolling in 2027.
SEC filing (3)
Enlivex terminates RAIN token financing deal with Rain Foundation
The company ended a July 2026 stock purchase agreement that would have paid it in RAIN tokens, canceling plans for a shareholder vote.
SEC filing
Cypherpunk Technologies names Amanda Fabiano to board of directors
The privacy technology company disclosed the appointment in an 8-K filed September 22, 2026, alongside details on its Zcash mining operation and treasury.
SEC filing
Neurocrine registers Phase 2a trial of NBI-1117567 in mild to moderate Alzheimer's disease
Halozyme completes $1.5 billion convertible notes offering due 2033
The company plans to use part of the proceeds to fund capped calls and buy back existing 2027 and 2028 convertible notes.
SEC filing
Biomea Fusion files preliminary prospectus for stock and pre-funded warrant offering
The company filed a shelf take-down on September 22, 2026, with Konik Capital Partners underwriting, to fund diabetes and obesity drug development.
SEC filing
Aytu reports first full launch quarter for EXXUA, fiscal 2026 results
EXXUA brought in $3.9 million in fourth-quarter net revenue and $6.6 million for the fiscal year, while legacy ADHD and pediatric brands declined amid generic competition.
SEC filing
Regeneron registers two new trials: prion disease gene therapy and HS/obesity combo drug
Calidi Biotherapeutics closes $1.2 million registered direct stock offering
The San Diego biotech sold about 1 million shares at $1.17 apiece, with no underwriter involved, closing September 21, 2026.
SEC filing
Vogenx appoints Ken Toombs to board of directors
The clinical-stage company named the former PA Consulting chief executive as an independent director and audit committee chair, effective September 21, 2026.
SEC filing
SCYNEXIS names Steven K. Burke to board as ADPKD program advances
The clinical-stage biotech added a kidney disease drug development veteran to its board as it works toward a Phase 2 study of SCY-770.
SEC filing
Quoin gets FDA Fast Track for QRX003 in peeling skin syndrome
The designation, Quoin's second for the topical drug, follows July 2026 clearance of the first-ever IND filed for the rare skin disease.
SEC filing
Attovia registers Phase 2 trial of ATTO-1310 for chronic pruritus of unknown origin
Sinovac registers two new not-yet-recruiting trials for PCV13 and Anflu
Harrow registers Phase 3 trial of TRIESENCE for pain and inflammation after eye surgery
Sovargen doses first patient in paxalisib epilepsy trial, triggers $2M payment to Kazia
The Phase 1b/2a study targets rare seizure disorders linked to mTOR pathway overactivation, expanding paxalisib beyond its oncology roots.
SEC filing
LeonaBio's Series A warrants become exercisable, could raise $146.2 million
The warrants, issued in a December 2025 private placement, became exercisable September 18, 2026 and expire a month later.
SEC filing
Alaunos closes registered direct offering, gross proceeds about $1.12 million
Alaunos Therapeutics closed the offering on September 21, 2026, receiving net proceeds of about $915,400.50 after fees and expenses.
SEC filing
Monday, September 21
Insight Molecular Diagnostics amends Chronix merger royalty terms again
The September 15, 2026 amendment narrows the equity holders' royalty to CNI Monitor sales specifically and adds a final payment tied to any future sale of the test.
SEC filing
EC approves NewAmsterdam's obicetrapib drugs Ubeslo and Evlarco with Menarini
The European Commission authorized both obicetrapib products for cholesterol-lowering use, the first regulatory clearance for the drug worldwide.
SEC filing
Tiziana completes last patient visit in Phase 2a INFORM-MS foralumab trial
The company said database lock is expected within the week, with topline 12-week data from the intranasal foralumab study due in October 2026.
SEC filing