Tuesday, August 11
The company said it will stop internal funding of the VERSATILE-003 Phase 3 trial and pursue partners for PDS0101 while advancing PDS0301 based on Phase 2 mCRC data.
SEC filing
Sentynl gets an option for U.S. rights to Mereo's alvelestat, with milestone payments up to $435 million if the option is exercised.
SEC filing
The IND clearance lets the ongoing Phase 2 VacSYn trial add U.S. sites, with full Part 1 week-100 results still due in the second half of 2026.
SEC filing
Absci says its hair-loss antibody was well tolerated in early dosing, adds $40 million from Eli Lilly, and now expects cash to last into second half of 2028.
SEC filing
The company finished enrollment ahead of target in both mid-stage tibulizumab studies and plans a third trial in polymyalgia rheumatica by year-end 2026.
SEC filing
The company reported 108 patients enrolled in its choroidal melanoma trial, deprioritized its bladder cancer program, and named three new executives while its CFO and legal chief depart.
SEC filing
The FDA's target decision date for lorundrostat is December 22, 2026, and Mineralys says commercial launch preparations remain on schedule.
SEC filing
The company reiterated its $257.6 million cash position and confirmed plans for a Phase 3 acne trial of denifanstat in the second half of 2026, alongside a new investor slide deck.
SEC filing
Monday, August 10
Olema Oncology also struck a Bayer collaboration testing its KAT6 inhibitor with darolutamide in prostate cancer and ended the quarter with $461.1 million in cash.
SEC filing
The August 7, 2026 amendment changes how commitment shares are calculated and adds a true-up payment provision tied to share pricing.
SEC filing
The company said it expects to present initial data from its Ntrust-1 and Ntrust-2 trials at a medical conference in 2026, with cash it says can fund operations into 2029.
SEC filing
Two prospectuses filed August 10, 2026 cover warrant exercise shares, insider resale shares, and a $50 million Lincoln Park equity line following the company's Nasdaq debut.
SEC filing (2)
BridgeBio said BBP-418 and encaleret now carry Priority Review PDUFA dates in November 2026 and May 2027, while infigratinib's achondroplasia NDA awaits a PDUFA date and a mid-2027 launch.
SEC filing
The company said it is on track for potential approvals in GIST and non-advanced systemic mastocytosis this year, with a third NDA for advanced disease submitted in June.
SEC filing
The company detailed its TRUTAKNA launch, an aligned earlier ORIGIN 3 efficacy analysis, and a planned sBLA filing, alongside a $109.5 million quarterly net loss.
SEC filing
The former Intra-Cellular Therapies president takes over as topline data from the first pivotal study of HLP003 in major depressive disorder are expected in the fourth quarter of 2026.
SEC filing (2)
The British Columbia biotechnology company reported selling all of the offered securities to two investors, per a Form D filed with the SEC.
SEC filing
All three initial Danon disease patients cleared safety observation under Rocket's modified Phase 2 protocol, as the company sits on $283.7 million in cash after monetizing its priority review voucher.
SEC filing
The ophthalmic disease company posted $70.7 million in quarterly revenue and pointed to several clinical and regulatory milestones expected through 2027.
SEC filing
Company confirms 4Q 2026 IND submission plan for MGX-001, with clinical trials expected to start in 2027 pending clearance, and reports $120.7 million in cash.
SEC filing
The company cited an adverse Delaware court decision on CINVANTI patents and a paused sales force expansion as reasons it can no longer forecast the year.
SEC filing
The company's CFO Alan Musso takes on the added role effective August 7, 2026, following the planned departure of Greg Tourangeau.
SEC filing
The company said its Phase 1 SEP-479 trial data support once-daily dosing, with full SAD/MAD results expected in the first quarter of 2027.
SEC filing
The Encinitas, California biotech disclosed a completed private placement to the SEC, with the offering already fully sold as of the filing.
SEC filing
The Princeton biopharma will use the proceeds for manufacturing and regulatory work on its nimodipine infusion candidate, with a Form D confirming nine investors participated.
SEC filing (2)
Company reports Q2 2026 results and says it finished the regulatory and operational groundwork needed to start the Phase 2 ASCENTRA-UC trial in the second half of 2026.
SEC filing
Theravance Biopharma said its previously announced acquisition by Zymeworks is expected to close in the second half of 2026, as YUPELRI revenue and cost cuts advanced.
SEC filing
The company amended its Guggenheim Securities sales agreement to sell up to $400 million in common stock as its bezuclastinib program awaits three FDA decisions.
SEC filing
The oncologist and former Genentech/Roche executive joined the biotech effective August 10, 2026, with an equity package including 1,300,000 stock options.
SEC filing
Biohaven started a pivotal Phase 3 trial for BHV-1300 in Graves' disease and reported new biomarker data across its degrader and epilepsy programs, with cash of $270.5 million as of June 30, 2026.
SEC filing
The biopharmaceutical company named Blumenkranz a Class II director on August 10, 2026, while longtime director Satter resigned effective immediately before the appointment.
SEC filing
Jade highlighted interim IgA nephropathy results, new dosing in two other programs, and cash reaching $461 million as of June 30, 2026.
SEC filing
Belgium-based Agomab Therapeutics plans to add the two as non-executive directors, pending a shareholder vote in September 2026.
SEC filing
Veru said the enobosarm-semaglutide combination trial exceeded its enrollment target as the company reported fiscal Q3 2026 results and a pending key patent allowance.
SEC filing
Oruka says EVERLAST-B is fully enrolled ahead of schedule and lays out a string of upcoming data readouts as it holds $1.1 billion in cash.
SEC filing
Tonix Pharmaceuticals said TONMYA net sales grew as it enrolled its first HORIZON trial patient and prepared to expand its sales force and Lyme disease study.
SEC filing
FDA accepted the AXS-12 narcolepsy NDA with a May 1, 2027 PDUFA date as two solriamfetol ADHD trials began.
SEC filing
Terms match the August 10 pricing announcement, with details on the underwriting agreement and Advisory Committee vote behind TUDRIQEV's approval now on file.
SEC filing (2)