Inhibrx reports Phase 2 HNSCC data showing INBRX-106 combo nearly doubles response rate
The company's OX40 agonist plus pembrolizumab hit 48.3% response rate versus 26.5% for pembrolizumab alone, with benefit strongest in HPV+ patients.
SEC filing
Latest
Tuesday, September 8
Pharvaris reports positive CHAPTER-3 Phase 3 data for deucrictibant XR in HAE prophylaxis
The trial met its primary endpoint with an 83% reduction in attack rate versus placebo, and all secondary endpoints reached statistical significance.
SEC filing
FDA approves AstraZeneca's Etcamah for HR-positive breast cancer
The approval covers Etcamah combined with a CDK4/6 inhibitor for first-line advanced HR-positive, HER2-negative breast cancer patients who develop an ESR1 mutation.
SEC filing
Spyre reports positive Phase 2 SPY003 data, completing proof-of-concept for IBD trio
SPY003 hit its primary endpoint in SKYLINE Part A, joining SPY001 and SPY002 with positive monotherapy results ahead of combination-arm data expected in 2027.
SEC filing
Clearmind gets Yale IRB clearance to expand CMND-100 trial recruitment
The approval opens Yale School of Medicine's Department of Psychiatry as a new recruitment site for Parts B and C of the Phase I/II study, following positive Part A safety data.
SEC filing
Novartis starts Phase 2 trial of Monte Rosa's MRT-6160 in Sjögren's disease
Novartis initiated a Phase 2a/b study of the VAV1-directed molecular glue degrader, triggering a $50 million milestone payment to Monte Rosa under their license agreement.
SEC filing
FDA accepts Intellia's BLA for lonvo-z in hereditary angioedema, grants priority review
The agency set a PDUFA date of March 10, 2027, and does not currently plan an advisory committee meeting.
SEC filing
United Therapeutics discloses share count for $477.6 million ASR deal with Citi
A new 8-K specifies United Therapeutics will get an initial delivery of about 719,376 shares under its accelerated buyback with Citibank.
SEC filing
Structure Therapeutics reports new data on oral amylin and GLP-1 obesity drugs
The company disclosed Phase 1/2a data on ACCG-2671 and 72-week extension results for aleniglipron, an oral GLP-1 candidate now in Phase 3.
SEC filing
Friday, September 4
Novartis's pelacarsen fails cardiovascular outcomes trial in Phase 3 study
Lp(a)HORIZON did not reduce cardiovascular events despite lowering Lp(a) levels, Ionis and partner Novartis reported.
SEC filing
Senti Biosciences completes NSG note sale, updates form of note to reflect new party
The closing follows Nasdaq's disclosure of bid price and equity deficiencies as Senti moves toward its planned merger with a Celadon Partners affiliate.
SEC filing (2)
iSpecimen agrees to buy AI assets from Foldlab for $4.5 million
The deal covers two AI products and requires iSpecimen shareholder approval before it can close.
SEC filing
FDA drug application records confirm Etcamah approval details, dosage form
New NDA filing data shows Etcamah is a 75 mg film-coated tablet, approved September 4, 2026, alongside FDA's public announcement.
FDA press release, Drugs@FDA (2)
FDA approves Ionis's ZANVASTRO for Alexander disease
The agency cleared zilganersen as the first disease-modifying therapy for the ultra-rare neurological disorder and awarded Ionis a Rare Pediatric Disease Priority Review Voucher.
SEC filing
Clearmind Medicine agrees to acquire 51% stake in Israeli wireless EV charging firm
The clinical-stage biotech will pay $2.5 million for majority control of Charging Robotics and extend a separate $1.5 million loan.
SEC filing
Johns Hopkins registers Phase 2 HEROIC caregiver trial in advanced heart failure
Insmed registers Phase 3 trial of inhaled TPIP for progressive pulmonary fibrosis
Novartis roundup: ITP real-world data completed; three trials registered; Utah study terminated
Virax Biolabs caps at-the-market share sales at about $2.07 million
The company filed an updated prospectus supplement on September 4, 2026 recalculating how much stock it can still sell under its existing Nasdaq offering agreement with H.C. Wainwright.
SEC filing
Veraxa Biotech names Raju Willener as new CFO
The Zurich-based cancer therapy developer announced the leadership change effective September 4, 2026, in a filing that also details Willener's prior finance roles.
SEC filing
Gossamer Bio files Form D for $150 million offering of rights to acquire securities
The San Diego biotechnology company reported $25 million sold so far to 38 investors, with $125 million remaining under the notice.
SEC filing
AbbVie posts IMGN632 BPDCN results; opens NOA LIFT filler trial vs VOLIFT
IDEAYA registers Phase 3 adjuvant trial of darovasertib plus crizotinib in uveal melanoma
Arcturus posts Phase 1/2 results for ARCT-2304 self-amplifying mRNA flu vaccine
CRISPR Therapeutics registers Phase 1/2 trial of CTX112 in neurologic autoimmune disease
Jupiter Neurosciences files Form D for $774,787 private offering
The Palm Beach Gardens company reported selling all of a $774,787 exempt securities offering to a single investor, per an SEC Form D filed September 4, 2026.
SEC filing
TuHURA Biosciences draws $1.5 million more from Parkview credit line
The Nasdaq-listed company borrowed an additional $1.5 million under its existing revolving credit facility on September 2, 2026.
SEC filing
Indaptus Therapeutics board member Tim Ruan resigns effective immediately
Indaptus disclosed in an SEC filing that director Tim Ruan stepped down from its board on September 2, 2026, with no stated dispute behind the move.
SEC filing
Indaptus corrects dilution math in $100M at-the-market offering prospectus
An amendment filed September 4, 2026 fixes a clerical error in dilution figures tied to Indaptus's up-to-$100 million stock offering with H.C. Wainwright.
SEC filing (2)
ADARx Pharmaceuticals files S-1 for Nasdaq IPO under ticker ADRX
The San Diego siRNA drugmaker seeks to list its three clinical-stage and two preclinical programs, backed by a $335 million AbbVie upfront payment.
SEC filing
Intellia secures up to $400 million credit facility from OrbiMed
The gene-editing company drew $75 million upfront and can access further tranches tied to lonvo-z regulatory and revenue milestones.
SEC filing
Harrow's Pollard steps down as chief accounting officer, Boll adds the role
Harrow, Inc. named CFO Andrew R. Boll as principal accounting officer after Randall E. Pollard's exit from that post, effective September 4, 2026.
SEC filing
Pluri prices $1.50 registered offering, plans concurrent private placement warrants
Pluri Inc. priced a registered direct offering and a concurrent private placement of warrants on August 26, 2026, with delivery expected August 28.
SEC filing (2)
PDS Biotechnology amends promissory note with YA II PN
The August 31, 2026 amendment reshapes repayment terms on a $6 million note, tying weekly ATM proceeds to note payments and extending a Nasdaq compliance cure period.
SEC filing
GSK registers Phase 3 trials for mRNA flu vaccine and prostate cancer ADC Ris-Rez
Amgen registers Phase 4 trial testing Repatha's effect on coronary plaque burden
Lilly posts Phase 3 orforglipron results; two more programs report terminated-trial data
CDT Equity amends Sarborg purchase pact, issues and repays convertible note
CDT Equity Inc. modified payment terms for its Sarborg Limited stake and briefly took on, then retired, a J.J. Astor & Co. secured note.
SEC filing
Thursday, September 3
Latigo reports Q2 2026 results, NEJM publication for onzotrigine, and completed IPO
Latigo said its Phase 3 program for onzotrigine will start in the second half of 2026, with cash it says funds operations into 2029.
SEC filing
UCSD registers Phase 2 study of low-dose dexamethasone to prevent Immunocore's tebentafusp CRS
bioAffinity Technologies to present at H.C. Wainwright investment conference
The company disclosed in a September 3, 2026 filing that CEO Maria Zannes will meet with investors during the September 14-16 conference, alongside details on its share count and market value.
SEC filing
CervoMed/EIP Pharma trial posts results for neflamapimod in Lewy body dementia
LB Pharmaceuticals names Joseph Miller as chief financial officer
The neuromedicines company said Miller starts as CFO effective September 2, 2026, ahead of pivotal NOVA-2 trial results for LB-102 in schizophrenia.
SEC filing
HUTCHMED licenses HMPL-A830 to GSK; source cites both $1.295B and $1.185B totals
HUTCHMED will get $110 million upfront as GSK takes global rights outside Greater China to the KRAS-EGFR conjugate HMPL-A830, with milestone figures stated differently across the filing.
SEC filing
AstraZeneca week: Imfinzi label update, ASSURE CLL results posted, four trials registered
Medicus Pharma subsidiary signs co-development deal with Pfizer for antibody-drug conjugate
Medicus Pharma Inc. licensed rights to Pfizer's early clinical-stage asset CD228V, agreeing to pay up to $27 million in near-term fees plus potential milestones exceeding $1 billion.
SEC filing
Jaguar Health cuts ATM offering size after triggering Form S-3 share-value limit
Jaguar Health filed a September 3, 2026 supplement showing its at-the-market program reduced to about $4.78 million after hitting a threshold under General Instruction I.B.6 of Form S-3.
SEC filing
Aptevo files prospectus for resale of over 6.4 million warrant shares
The Seattle biotech registered shares tied to an August 12, 2026 private placement and warrant inducement, as its stock traded at $2.60 on Nasdaq.
SEC filing
BNB Plus Corp. board turns over, adds three directors tied to GlobalStake
Three directors resigned effective September 3, 2026, and the board filled the seats with new members, one of whom leads a paid advisory review of the company through GlobalStake Infrastructure.
SEC filing