Jaguar Health to complete 1-for-15 reverse stock split on September 17, 2026
The gastrointestinal drug developer said the split is meant to help it meet Nasdaq listing requirements, with split-adjusted trading starting Thursday.
SEC filing
Latest
Tuesday, September 15
BlossomHill reports 45% response rate for BH-30643 in EGFR C797S lung cancer
The company presented updated Phase 1/2 SOLARA trial data at the IASLC 2026 World Conference on Lung Cancer, following recent FDA Fast Track designation for the drug.
SEC filing
Vera's TRUTAKNA hits all endpoints in ORIGIN 3 final analysis for IgA nephropathy
Vera Therapeutics plans to file a supplemental BLA in Q4 2026 seeking full approval after two-year data showed stabilized kidney function and reduced disease progression.
SEC filing
GSK to acquire trispecific T cell engager for multiple myeloma from Chimagen
GSK will pay up to $750 million for a Chimagen asset expected to begin phase I trials in 2027, targeting multiple myeloma.
SEC filing
Jazz Pharmaceuticals completes acquisition of Actio Biosciences
The $820 million deal brings Jazz an oral KCNT1 inhibitor for KCNT1-related epilepsy that has shown seizure reductions in an early pediatric trial.
SEC filing
Rocket Pharmaceuticals says FDA aligns on Danon disease pivotal trial path
The FDA confirmed a 12-patient pivotal population, a recalibrated dose, and 12-month co-primary endpoints for RP-A501 in Danon disease.
SEC filing
FibroBiologics raises $0.5 million from CSO Hamid Khoja in private placement
The Houston biotech sold stock and warrants to its Chief Scientific Officer at $1.675 per unit, expecting to close the deal the same day.
SEC filing
Indivior and Reckitt Benckiser move up end date of Suboxone/Subutex supply deal
The companies agreed to end their manufacturing arrangement early, on January 15, 2027, as Indivior transitions to a new supplier.
SEC filing
Shuttle Pharmaceuticals converts preferred shares, issues warrants after stockholder vote
The company issued nearly 3.7 million common shares from preferred stock conversions and warrants covering over 17.8 million shares following a September 9, 2026 special meeting.
SEC filing
BioNTech posts results for mpox vaccine BNT166a Phase I/II trial NCT05988203
VolitionRx issues shares to Lind on convertible note conversions
Two conversions in September 2026 covered $465,000 of obligations under senior secured convertible notes tied to a 2025 purchase agreement.
SEC filing
LB Pharmaceuticals names Susan Kozauer as chief medical officer
The neuromedicines company said the hire comes as it heads toward Phase 3 NOVA-2 schizophrenia trial results in the first half of 2027.
SEC filing
Repligen board member Karen Dawes to retire after over 20 years
Dawes notified the company on September 10, 2026 that she will step down effective September 30, 2026, following the completion of a CEO transition.
SEC filing
Attovia registers Phase 1 trial of ATTO-1091 for ulcerative colitis
Legend Biotech names Ingrid Zhang CEO, effective September 15, 2026
Zhang, formerly Novartis International's Chief Commercial Officer, succeeds interim CEO Alan Bash, who returns to lead the CARVYKTI business.
SEC filing
Monday, September 14
AstraZeneca's SERENA-4 trial misses main goal for Etcamah in first-line breast cancer
The Phase III study of Etcamah plus palbociclib showed a numerical but not statistically significant PFS benefit in untreated advanced ER-positive breast cancer.
SEC filing
FDA approves Telix's Pixclara for glioma imaging
The agency cleared the first FET-PET imaging drug for brain cancer, allowing use in adults and pediatric patients as young as 1 month old.
SEC filing
Contineum's MOONLIGHT-1 Phase 2 trial fails to hit primary endpoint in depression
JNJ-5120/PIPE-307, licensed to Johnson & Johnson, missed its primary efficacy measure in major depressive disorder, though the company reported no new safety signals.
SEC filing
Agomab reports positive Phase 1 data for inhaled IPF drug AGMB-447, plans Phase 2
The company submitted a clinical trial application for a 120-patient Phase 2 study called INSPIRIA and expects to start it in the second half of 2026.
SEC filing
Quince Therapeutics sells Italian unit and A-T drug technology to Ayma for $450,000
The September 8, 2026 asset sale offloads Quince's eDSP program and its Italian subsidiary while the company's president departs the same day.
SEC filing
60 Degrees Pharmaceuticals seeks FDA priority voucher for babesiosis drug
The company asked for a Commissioner's National Priority Voucher to speed review of tafenoquine for babesiosis, with a DSMB analysis due October 1, 2026.
SEC filing
Sionna to advance SION-451 plus SION-2222 into Phase 2a after PreciSION CF post hoc analysis
The company also cut its workforce by about 46% and now projects cash runway into the second half of 2029.
SEC filing
FDA approves two Tagrisso supplements for AstraZeneca
The agency cleared an efficacy supplement and a related labeling update for the lung cancer drug osimertinib on the same day.
Drugs@FDA (2)
PDS Biotech closes first tranche of PIPE, adds Soon-Shiong to board
The company raised $11.3 million in an initial closing led by Nant Capital and redeemed a $6 million Yorkville note.
SEC filing (2)
Emergent BioSolutions cuts full-year 2026 revenue and EBITDA guidance
In a September 14 investor presentation, the company lowered its 2026 financial outlook and set third-quarter revenue guidance of $110 million to $130 million.
SEC filing
Arrowhead's ARO-MUC5AC trial marked terminated for business reasons; results posted to registry
Recursion registers Phase 1/2 trial of REC-7735 in PIK3CA-H1047R solid tumors
Benitec reports fiscal 2026 results, updates BB-301 trial progress and FDA meeting
All six low-dose patients finished 12-month follow-up, high-dose cohort is fully enrolled and treated, and Benitec plans a pivotal trial start in mid-2027.
SEC filing
Moonwalk Biosciences discloses $70.2 million equity offering in SEC Form D
The South San Francisco biotech has sold nearly $60 million of a planned $70.2 million round to seven investors, according to a filing dated September 14, 2026.
SEC filing
MindWalk reports 21% revenue growth, gross margin expands to 58.6% in fiscal Q1 2027
The company launched its ReefIQ platform and secured a $30 million unsecured credit facility commitment as it shifts toward recurring revenue.
SEC filing
AIM ImmunoTech converts third Streeterville note tranche, adding $400,000 in stock swaps
A new filing shows AIM issued 1,749,434 shares to Streeterville Capital in September 2026, adding to two earlier rounds of note-to-equity exchanges disclosed the same month.
SEC filing (3)
INmune Bio adds two directors with rare-disease and business-development backgrounds
The company appointed R. Duane Clark II and James Sapirstein to its board on September 8, 2026, as Ebstrocel nears potential commercialization.
SEC filing
Cabaletta Bio warrants from 2025 offering fully exercised by expiration
Investors exercised common stock warrants tied to a June 2025 offering through their September 12, 2026 expiration, generating total gross proceeds of about $128.2 million.
SEC filing
Yarrow Bioscience prices $161.8M stock offering, expected to close Sept 14
The company sold 5,769,231 shares at $26.00 each after underwriters fully exercised their option, with closing expected September 14, 2026.
SEC filing
COPD Foundation registers DELIVERY trial with Viatris, PARI, Theravance as collaborators
Glucotrack stockholders approve Nasdaq-required share issuances at special meeting
Shareholders backed two proposals tied to the company's ELOC and bridge financing deals, clearing a Nasdaq rule hurdle, according to an 8-K dated September 14, 2026.
SEC filing (2)
Tyra Biosciences prices $400 million stock offering
The company priced 9,079,000 shares plus pre-funded warrants at $22.03, expecting to close September 15, 2026 and net about $373.9 million for its FGFR3 programs.
SEC filing (2)
Bio-Techne adds proxy disclosures ahead of Merck KGaA merger vote amid shareholder suit
Amneal's itraconazole ANDA gets labeling supplement approved by FDA
Friday, September 11
FDA approves supplement 6 for Pharming's Joenja tablets
The efficacy supplement for leniolisib phosphate, reviewed under priority status, was approved with an application letter and label dated September 15, 2026.
Drugs@FDA
Sunshine Biopharma discloses lower exercise price on Series B warrants
The company said stock sales under its at-the-market offering triggered an anti-dilution adjustment, cutting the Series B Warrant exercise price to $1.2046.
SEC filing
Louisiana biotech Therapeutic Neuromodulation Systems files Form D for equity offering
The Metairie-based company reported $969,500 sold toward a $5 million exempt offering, with 33 total investors as of the September 11, 2026 filing.
SEC filing
Tempo Therapeutics discloses $14 million raised in debt offering
The San Diego biotechnology company reported 43 investors in a Form D filing tied to a Rule 506(b) exemption.
SEC filing