NeOnc reports positive Phase 2a data for NEO100 in recurrent IDH1-mutant glioma
NeOnc Technologies plans to seek an FDA Type B meeting after intranasal NEO100 met its primary endpoint in a 24-patient study of recurrent high-grade glioma.
SEC filing
Latest
Wednesday, August 12
Zipalertinib combo hits PFS endpoint in Phase 3 lung cancer trial
Taiho and Cullinan Therapeutics report the REZILIENT3 trial met its primary endpoint at a planned interim analysis, with plans to pursue FDA approval.
SEC filing
Humacyte reports ATEV outperformed AV fistula in Phase 3 dialysis trial
The company plans to file an sBLA in the second half of 2026 and start a Phase 2a coronary study in the third quarter, per its second-quarter 2026 update.
SEC filing
Scilex extends $20 million credit line to related company Vivasor
The uncommitted revolving facility, disclosed in an August 2026 8-K, is led by a borrower whose CEO also runs Scilex.
SEC filing
Madrigal adds J&J R&D executive John C. Reed to board of directors
The company grew its board to nine seats and named Reed, who oversees Johnson & Johnson's innovative medicine research and development, to a Class II director term.
SEC filing
Adagene reports mid-2026 results, muzastotug data across CRC and HCC trials
The company reported $127.9 million in cash and updated Phase 1b/2 data for its lead antibody muzastotug in colorectal and liver cancer.
SEC filing
Alkermes amends credit facility, cuts interest rate spreads
Alkermes signed an amendment on August 12, 2026 to its February 2026 credit agreement, lowering the interest rate spreads on its term loan A and term loan B facilities.
SEC filing
Xilio gets FDA clearance for XTX501 IND, reports Q2 2026 results
The bispecific PD-1/masked IL-2 candidate is set to begin Phase 1 dosing in the second half of 2026 as Xilio's cash runway extends into early 2028.
SEC filing
Armata reports new FDA milestones for AP-SA02 ahead of planned Phase 3 start
Armata Pharmaceuticals disclosed Fast Track designation and an agreed pediatric study plan for AP-SA02 while confirming plans to begin a pivotal Phase 3 trial in the second half of 2026.
SEC filing
Bio-Techne posts Q4 FY2026 results as Merck KGaA acquisition proceeds
Bio-Techne reported fourth quarter and full-year fiscal 2026 results while confirming progress toward its previously disclosed acquisition by Merck KGaA, Darmstadt, Germany.
SEC filing
Alto Neuroscience adds third Phase 3 trial for ALTO-207, cites Nature Medicine data
Company now plans a monotherapy trial alongside its adjunctive Phase 3 study in treatment-resistant depression, backed by roughly $338 million in pro forma cash.
SEC filing
Liquidia reports YUTREPIA sales growth, begins enrollment in L606 pivotal study
Second-quarter 2026 results show continued YUTREPIA uptake and the start of the Re-Spire pivotal study for L606, alongside a fourth straight profitable quarter.
SEC filing
Agenus grants CEO Garo Armen a special performance stock option award
Agenus's Compensation Committee approved a one-time award of nearly 2 million performance-based options for Chairman and CEO Garo Armen, priced above market to match his team's terms.
SEC filing (2)
Milestone activates sites for Phase 3 AFib-RVR trial, reports $170.6M cash
Milestone said its ReVeRA-301 trial for etripamil in AFib-RVR is open with sites activated, while first patient enrollment remains targeted for the second half of 2026.
SEC filing
Belite Bio posts Q2 2026 results as FDA reviews tinlarebant NDA under priority review
The FDA accepted Belite Bio's NDA for tinlarebant in Stargardt disease type 1 with a PDUFA date of February 12, 2027, as the company reported wider losses and new Phase 3 data.
SEC filing (2)
Entera Bio reports $274.99 million offering completed under Form D
The Israel-based biotechnology company sold ordinary shares and pre-funded warrants to 53 investors in a private placement relying on Rule 506(b).
SEC filing
BioCardia gets positive regulator signals in Japan and US for CardiAMP and Helix
PMDA and FDA feedback support advancing both a Japan filing this year and the ongoing US pivotal trial, while cash stood at $4.1 million with runway into 2027.
SEC filing
ArriVent reports Q2 2026 results, licenses ARR-002 to Allist in Greater China
FURVENT Phase 3 topline data for firmonertinib still expected in second half of 2026 as ArriVent posts $373.1 million in cash and investments.
SEC filing
Sutro Biopharma posts early STRO-004 responses, updates Q2 2026 financials
The company reported partial responses in its Phase 1 STRO-004 trial and said cash on hand should fund operations into at least Q2 2028.
SEC filing
Pharvaris reports Q2 2026 results, expects CHAPTER-3 data in third quarter
The company said cash reached €318 million as it awaits pivotal HAE data and an April 2027 FDA decision on deucrictibant IR.
SEC filing
Vogenx prices $81.25 million IPO ahead of Nasdaq listing under VOGX
The clinical-stage metabolic disease company set terms for its initial public offering, with shares expected to price at $13.00 each.
SEC filing
OnKure reprices underwater stock options for CEO and other executives
The board approved a repricing that cut the exercise price on eligible options to $4.14 per share, with a retention condition tied to continued service.
SEC filing
Omeros reports Q2 2026 results as YARTEMLEA sales climb and CHMP issues negative opinion
Omeros posted strong U.S. launch revenue for YARTEMLEA while the EMA's CHMP gave a negative opinion on the drug's European application, triggering a re-examination.
SEC filing
Lexeo starts pivotal LX2006 trial, wins RMAT for LX2020
The company reported $234.2 million in cash as of June 30, 2026, and said it expects that to fund operations into 2028.
SEC filing
OS Therapies details Leonite settlement and $10 million August note financing
Company disclosed terms of a July 31 Leonite settlement and an August 10 securities purchase agreement for senior secured convertible notes.
SEC filing (2)
Citius Oncology adds Jonathan Peri to board, expanding to nine members
The oncology-focused company, majority owned by Citius Pharmaceuticals, named the higher education and legal executive an independent director effective August 10, 2026.
SEC filing
Acumen reports Q2 2026 results, reaffirms ALTITUDE-AD readout for late 2026
Acumen ended June with $110.2 million in cash and said its Phase 2 sabirnetug trial data are still expected this year, with two new brain-delivery candidates moving toward a 2027 IND.
SEC filing
MaxCyte posts Q2 2026 revenue, reiterates full-year guidance
The cell-engineering company reported second quarter revenue of $7.3 million and said its Strategic Platform License pipeline continues to advance through the clinic.
SEC filing
Arbutus reaches FDA alignment on imdusiran Phase 2b design, advances Pfizer/BioNTech LNP suits
The company also began collecting on its $950 million Moderna settlement and outlined a plan to return up to $230 million to shareholders, though timing remains unconfirmed.
SEC filing
Regeneron registers Phase 1b trial of Factor XI/XII antibodies in dialysis patients
Roche posts results for satralizumab TED trial; completes Ocrelizumab SC vs IV MS study
Onconetix files S-1 to register 100 million shares tied to Series F preferred stock
The Cincinnati-based oncology company registered shares for resale after a $30.25 million private placement, disclosing a going concern warning and a pending Realbotix share exchange.
SEC filing
Talphera reports NEPHRO CRRT trial 75% enrolled, KDIGO 2026 draft guideline backs nafamostat
The company said site activation is complete and enrollment completion is expected by year-end, while cash and investments stood at $17.1 million as of June 30, 2026.
SEC filing
Longeveron reports Q2 2026 results, keeps September readout for HLHS heart trial
Longeveron said its Phase 2b HLHS trial for laromestrocel remains on track for September top-line data, with cash on hand extending only into the fourth quarter of 2026.
SEC filing
Aprea reports Q2 2026 results, faster enrollment in APR-1051 trial
Aprea Therapeutics said patient enrollment in its Phase 1 WEE1 inhibitor study is picking up as it ended the quarter with $41.2 million in cash.
SEC filing
Lakefront reports H1 2026 results after closing Ouro Medicines deal with Gilead
The company said it expects at least €1.6 billion in cash to remain after funding its lead program, gamgertamig, to first approval.
SEC filing
Novartis: TOUR006 Phase 2 results posted in CKD; eltrombopag pediatric PK study also reports out
Can-Fite recaps FDA, EMA regulatory status for two Phase III drugs
The company said Namodenoson and Piclidenoson each hold defined regulatory pathways toward possible marketing approval in the US and Europe.
SEC filing
TScan doses first patient in Phase 3 heme trial, cites Cohort C manufacturing data
TScan Therapeutics reports first patient dosed in the ALLOHA-2 Phase 3 trial and shares Cohort C data supporting its commercial-ready manufacturing process, with cash into Q2 2027.
SEC filing
Kailera reports Q2 2026 results, oral IND active, Phase 2b fully enrolled
Kailera says its oral ribupatide IND is active with the FDA and its high-dose Phase 2b injection trial has completed enrollment, with cash runway now guided into mid-2028.
SEC filing
Century Therapeutics reports Q2 2026 results, FDA pre-IND meeting for T1D program
Century says CNTY-813's IND submission is on track for the fourth quarter of 2026 after aligning with FDA on trial design, while cash on hand grew to $197.2 million.
SEC filing
Protalix reports Q2 2026 results, reaffirms PRX-115 gout trial timeline and 2026 revenue guidance
Enrollment continues in the Phase 2 RELEASE study of PRX-115 with top-line data still expected in the second half of 2027, as the company reiterated full-year revenue guidance of $78.0 million to $83.0 million.
SEC filing
Tuesday, August 11
Agenus posts results for zalifrelimab plus balstilimab trial in advanced cervical cancer
Intensity moves to resume INVINCIBLE-3 sites, restarts TNBC treatment, reports $9.5M cash
The company targets a limited U.S. site restart for its Phase 3 sarcoma trial by Q3 2026 while presurgical TNBC dosing has resumed under a revised protocol.
SEC filing
BridgeBio Oncology reports Q2 2026 results, starts two KRAS inhibitor combination trials
BBOT dosed BBO-11818 with BBO-10203 after the quarter closed and said cash covers operations into 2028.
SEC filing