Radiopharm reports positive Phase 1 imaging data for RAD301 in pancreatic cancer
The company said all evaluable patients showed significant tumor uptake, supporting plans to move RAD301 into Phase 2 testing.
SEC filing
Latest
Wednesday, September 9
Aspire-Lakewood Holdings authorizes $10 million stock buyback, completes name change
The company, formerly Aspire Biopharma Holdings, cited automotive subsidiary DCSC's revenue as support for the expanded repurchase program effective September 9, 2026.
SEC filing
Evotec's Just biologics unit starts Phase 1 trial of antibody cocktail against orthopoxviruses
JST-018, developed for the U.S. Department of War's Accelerated Antibodies Program, moves into first-in-human testing after manufacturing at Evotec's Redmond facility.
SEC filing
Pyxis Oncology reports updated Phase 1 data for MICVO in head and neck cancer
Updated results show a 36% response rate and 79% one-year survival probability, supporting plans for a Phase 3 trial starting mid-2027.
SEC filing
Cocrystal Pharma completes dosing in norovirus challenge study of CDI-988
The company reported no serious adverse events so far, with preliminary efficacy data expected late 2026 or early 2027.
SEC filing
Incannex updates on IHL-42X dosing, new patent, and $70 million cash position
Incannex Healthcare confirmed dosing has begun in its DReAMzz sleep apnea trial and disclosed a new U.S. patent and roughly $70 million in cash with no debt.
SEC filing
Arcutis posts results for roflumilast psoriasis extension trial, NCT04286607
Rallybio CFO Jonathan Lieber shifts to part-time role ahead of Avenzo merger
Lieber will keep his title and duties on a part-time basis starting September 15, 2026, with employment ending when the Avenzo merger closes.
SEC filing
BioLineRx files Form D for $3.75 million warrant-related offering
The Israeli biotech reported total proceeds sold of $3,750,000 tied to a registered direct offering and accompanying warrants, according to a Form D filed with the SEC.
SEC filing
OS Therapies stockholders back director slate, pay plan changes at 2026 annual meeting
Shareholders holding a majority of votes present approved all six director nominees, an updated incentive compensation plan, and the auditor's reappointment at the September 9 meeting.
SEC filing
Trinity Biotech's Trinovium unit signs cooling deal with Red Team Investments
The contract covers a U.S. pilot supplying liquid cooling fluids and analytical systems for AI and high-performance computing data centers.
SEC filing
MapLight Therapeutics registers 13.2 million shares for resale after $150 million private placement
The S-1, filed September 9, 2026, covers shares and pre-funded warrants sold to institutional investors in an August 2026 private placement.
SEC filing
ProQR doses first participant in Phase 1 trial of AX-0811
The clinical-stage RNA editing company also set a September 30, 2026 investor event to discuss NTCP modulation in biliary atresia.
SEC filing
Century Therapeutics adds Joseph Truitt to board of directors
The iPSC-derived cell therapy company appointed the iECURE CEO effective September 9, 2026, expanding its board to seven members.
SEC filing
Indaptus Therapeutics raises $24 million in private placement, revamps ATM agreement
The company sold over 20 million shares in a private placement and separately entered an amended $100 million at-the-market sales agreement with H.C. Wainwright.
SEC filing (3)
Opus Genetics reports Cohort 1 data for OPGx-BEST1, aligns with FDA on pivotal endpoint
All five patients in the low-dose cohort showed visual function improvement, and Opus plans Phase 3 dosing in 2027 after an August FDA meeting.
SEC filing
IQVIA subsidiary to sell $2 billion in senior notes due 2034
IQVIA Inc. priced the notes at 6.375% interest to redeem 2026 debt and pay down revolving credit, with closing expected September 23, 2026.
SEC filing
Xeris details Phase 3 plan for weekly hypothyroidism therapy XP-8121
Xeris Biopharma Holdings hosted a program overview outlining its Cornerstone trial design and a targeted 2030 approval timeline for XP-8121.
SEC filing
Regeneron registers two new cemiplimab trials in skin cancer and early lung cancer
Lexaria raises about $5.9 million through warrant exercise inducement deal
Holders agreed to immediately exercise existing warrants at a reduced price, with H.C. Wainwright acting as placement agent for the September 9, 2026 closing.
SEC filing
Okyo Pharma to present at two European ophthalmology industry events in September 2026
Tuesday, September 8
Veru advances oral sabizabulin toward Phase 2 in daraxonrasib-resistant pancreatic cancer
New preclinical data show sabizabulin overcomes resistance to Revolution Medicines' daraxonrasib, prompting Veru to drop a cardiovascular indication and pursue an FDA preIND meeting in Q4 2026.
SEC filing
Roivant details Phase 2 PHocus data for mosliciguat, unveils ongoing Phase 3 PHrontier trial
Roivant presented full PHocus results at ERS 2026 and confirmed its Phase 3 PHrontier study in PH-ILD is now enrolling patients.
SEC filing
Pharvaris reports positive Phase 3 CHAPTER-3 results for deucrictibant XR in HAE prophylaxis
The company said the trial met its primary and secondary endpoints, with plans to file for marketing authorization starting in the first half of 2027.
SEC filing
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
Evommune's EVO756 fails Phase 2b atopic dermatitis trial, shifts focus to EVO301
The company will stop developing EVO756 for atopic dermatitis but continue testing it for migraine, while advancing its IL-18BP candidate EVO301.
SEC filing
Bicara Therapeutics updates registry record NCT07807163: recruiting
Annexon registers Phase 3 extension study of vonaprument for geographic atrophy
enGene reports Q3 2026 results, keeps 4Q BLA-related timelines for detalimogene
The company said it remains on track for a pre-BLA meeting and to start a BLA submission for detalimogene in the fourth quarter of 2026, with $266 million in cash.
SEC filing
Mirum names Rob Myers as CMO, succeeding Joanne Quan
Mirum Pharmaceuticals disclosed a Chief Medical Officer transition, with Myers' start and Quan's separation both described as expected rather than final.
SEC filing
Aardvark posts Phase 2 results for ARD-101 in Prader-Willi Syndrome
Kura Oncology names Jennifer Fulk as chief financial officer
Fulk takes over principal financial and accounting officer duties effective September 8, 2026, under an employment agreement with severance terms tied to a change of control.
SEC filing
Kiora Pharmaceuticals names Keith Lane as EVP of Clinical Development and Regulatory Affairs
The ophthalmology-focused hire, effective September 8, 2026, comes with a $350,000 base salary and a stock option grant of up to 55,000 shares.
SEC filing
Qiagen names Jonathan Pratt as next CEO, effective September 1, 2026
Pratt, formerly head of Filtration Group, succeeds Thierry Bernard as Qiagen reaffirms its 2026 outlook and continues its strategic review.
SEC filing
HCW Biologics signs exclusive distribution deal with Akron Biotech for HCW11-006
The agreement covers a five-year, worldwide (excluding China) distribution arrangement for HCW11-006 as a CAR-T manufacturing reagent, with closing set for no later than November 30, 2026.
SEC filing
Amylyx signs two manufacturing deals to secure avexitide drug substance supply
The company reached a manufacturing agreement with Bachem Americas and a term sheet with Polypeptide Group to lock in long-term commercial supply of avexitide starting in 2028.
SEC filing
Pyxis Oncology names Thomas Civik permanent CEO and Chairman
The board also named co-founder John Flavin Lead Independent Director as the company nears key MICVO clinical data readouts.
SEC filing
CDT Equity registers resale of 16.8 million shares tied to notes and Sarborg deal
The S-1, dated September 8, 2026, covers shares issuable from J.J. Astor convertible notes, warrants, consulting stock grants, and a Sarborg equity acquisition.
SEC filing (2)
Braveheart Bio starts Phase 3 oHCM trial, reports Q2 2026 results
The company began its LIONHEART-HCM Phase 3 study in obstructive hypertrophic cardiomyopathy and reported $122.8 million in cash as of June 30, 2026, rising to $527.3 million after its August IPO.
SEC filing
Apnimed's OSA drug NDA accepted by FDA, PDUFA date set for February 2027
Apnimed reported second-quarter 2026 results alongside FDA acceptance of the NDA for AD109, proposed name Oxnimbi, and completion of its upsized IPO.
SEC filing
Sutro Biopharma registers Phase 1 first-in-human trial of ADC STRO-006 in solid tumors
Mayo Clinic registers Phase 3 trial of DEKA TWIIST insulin pump in pregnant T1D patients
Anteris names Brent Moen as new CFO, shifts McDonnell to Australia role
Anteris Technologies Global Corp said Moen will take over as Chief Financial Officer on September 11, 2026, while Matthew McDonnell moves into a new Head of Australia position.
SEC filing
Belite Bio files Japan NDA for tinlarebant in Stargardt disease type 1
The filing, made under Japan's Sakigake accelerated review system, arrives alongside a similar U.S. application already accepted by the FDA.
SEC filing
NovaBridge names Martin Dewhurst as independent director
The Nasdaq-listed biotech added the veteran healthcare executive to its board and to the Audit and Compensation Committees effective September 8, 2026.
SEC filing
X4 Pharmaceuticals gets FDA agreement to cut 4WARD trial size to 126 patients
The FDA agreed the smaller sample preserves statistical power for the Phase 3 chronic neutropenia trial, with enrollment completion targeted for year-end 2026 and topline data expected in the first half of 2028.
SEC filing
Revolution Medicines registers Phase 3 RASolute 309 in KRAS G12D pancreatic cancer
Teva prices multi-tranche notes offering to fund redemption of five outstanding bond series
Teva's Dutch finance subsidiaries plan euro and dollar notes due 2032 through 2037, with proceeds earmarked to redeem called notes and repay debt.
SEC filing
Acurx files S-1 to register 1.5 million more shares for Lincoln Park sale facility
The Staten Island biopharma seeks to add to its equity line with Lincoln Park Capital, which has already bought $9.2 million of stock under the deal.
SEC filing
Scinai ends PC111 arrangements, shifts focus to NanoAb and CDMO business
The Israeli biopharma will not extend its option and license deal with PinCell on preclinical candidate PC111, redirecting capital toward its NanoAb platform and CDMO operations.
SEC filing