Tuesday, August 11
Tango is moving toward late-stage development of vopimetostat with daraxonrasib in pancreatic cancer after early combination data, while holding $1.0 billion in cash.
SEC filing
The company plans to start a Phase 2b Alport syndrome trial in Q3 2026 and holds $62 million in cash it says will fund operations into mid-2028.
SEC filing
The company said end-of-Phase 2 talks with the FDA remain on schedule as it prepares Phase 3 trials in severe asthma and CRSwNP for verekitug.
SEC filing
Ryan Cohlhepp will succeed Claire Mazumdar as CEO in January 2027 as Bicara nears full enrollment in its head and neck cancer trial and reports $497.3 million in cash.
SEC filing
Dermata Therapeutics said its first direct-to-consumer skincare product, Tome Foundational Treatment, is set to launch on August 25, 2026, as it reported second-quarter financials.
SEC filing
The company ended its HERO and OLE trials in June 2026 and is reviewing unblinded data while working with the FDA to resolve a hold on ARD-101's IND.
SEC filing
Autolus reported second-quarter net product revenue growth of 119% year over year and increased full-year revenue guidance to $140-150 million, while advancing obe-cel trials in lupus nephritis, pediatric ALL.
SEC filing
The retinal disease company said patient dosing is underway in its Phase 1b/2 study of TH103, with cash of $93.5 million expected to fund operations into the fourth quarter of 2027.
SEC filing
The company secured Medicare reimbursement for its pivotal heart valve trial and began enrolling U.S. patients, while reporting $20.8 million in quarterly operating cash outflows.
SEC filing
The company is broadening its polycythemia vera trial to new sites after an FDA meeting, pushing enrollment into the fourth quarter, while enrollment continues in an M.
SEC filing
The company's board approved stock-based pay programs for its CEO, executive chairman, and chief medical officer, with terms detailed in an August 11 filing.
SEC filing
Achieve plans to resubmit its cytisinicline NDA in the fourth quarter of 2026 after a June Complete Response Letter tied to manufacturing and labeling issues, not efficacy or safety.
SEC filing
Study '306' enrollment is complete with topline data due in the first half of 2027, while the company reported $819.9 million in cash as of June 30, 2026.
SEC filing
The company also unveiled a new bleeding-disorder candidate, HMB-003, and posted early HMB-002 data in Von Willebrand disease.
SEC filing
The royalty-focused company reported $869 thousand in license revenue and said it keeps weighing an acquisition, merger, or other transaction, with no timetable set.
SEC filing
The company said Phase 1 results support advancing SL-325 into a Crohn's disease Phase 2b trial while it also unveiled a second DR3-targeting candidate, SL-846.
SEC filing
The Lincoln, Nebraska company disclosed the departure in an August 11, 2026 filing and said it has begun a search for his replacement.
SEC filing
The company reported second-quarter 2026 results and said the FDA has completed review of rexaceract's IND application, clearing the way for Phase 2 testing in Parkinson's disease.
SEC filing
Following positive Phase 2 data and an End-of-Phase 2 meeting with FDA, Cardiff plans to start a registrational trial of onvansertib in first quarter 2027, subject to financing.
SEC filing
BBOT dosed BBO-11818 with BBO-10203 after the quarter closed and said cash covers operations into 2028.
SEC filing
Protara now plans an exploratory, multi-cohort ADVANCED-3 study and expects to complete BCG-Unresponsive cohort enrollment in the fourth quarter of 2026, with cash extending into 2028.
SEC filing
The company reported cash of $11.3 million as of June 30, 2026, with runway into the first quarter of 2027, alongside clinical progress in its lead oncolytic virus program.
SEC filing
The company said its IMPROVE-PAH study has cleared regulatory review in 26 countries and started dosing at 43 sites, while cash and the July $50 million raise are meant to fund the trial through Part B data.
SEC filing
The company finished the human factors and pharmacokinetic studies tied to January's FDA rejection and reaffirmed plans to resubmit the epinephrine film's application in the third quarter.
SEC filing
PLN-101095 trial enrollment is running ahead of schedule ahead of 2027 interim data, while the company outlines new board additions and cash into second half of 2028.
SEC filing
Maze says enrollment continues in its Phase 2 HORIZON and CIPheR trials, with cash runway extended into 2029.
SEC filing
The prospectus supplement, dated August 11, 2026, replaces a prior $100 million program and discloses fresh PDAC combination data for vopimetostat.
SEC filing
The company also detailed the separation terms for former CEO Daniel Vitt as he transitions to a consulting and advisory role.
SEC filing
In an August 11, 2026 8-K, AIM ImmunoTech furnished an article by CEO Thomas K. Equels arguing broad-spectrum antivirals like Ampligen should be evaluated before future outbreaks emerge.
SEC filing
The company said enrollment in its Phase 3 ovarian cancer trial is running ahead of plan, with cash of $6.9 million as of June 30, 2026.
SEC filing
The company also detailed plans to expand LB-102 into new neuropsychiatric indications and reported $327.8 million in cash as of June 30, 2026.
SEC filing
All 10 patients in Neurogene's Phase 1/2 trial of NGN-401 showed improvement as of a June 16, 2026 cutoff, while a $144 million offering pushed runway into early 2029.
SEC filing
The company started Phase 3 enrollment for danicamtiv in DCM and reported cash of $660.7 million as of June 30, 2026, following its June IPO.
SEC filing
The Doylestown, Pennsylvania biotech's Form D shows a small debt raise sold to two investors, signed August 11, 2026.
SEC filing
The company said topline results from a six-month interim analysis and FDA feedback on the BLA path for TSHA-102 are expected in the first half of 2027.
SEC filing
Bolt said its Phase 1/2 trial of BDC-4182 in gastric and gastroesophageal cancer continues to enroll, with initial clinical data due alongside third-quarter results.
SEC filing
Prelude says it expects to initiate a Phase 1 study of PRT13722 in HR+ breast cancer in the fourth quarter, pending IND clearance, while enrollment continues for PRT12396 in PV and MF.
SEC filing
Company points to a June private placement of up to $49 million, an FDA-aligned Phase 2b design in acute pancreatitis, and mid-2027 targets for PAH data and a CM5480 IND.
SEC filing
The company said its Phase 2 MOMENTUM trial and a Phase 1b combination study of cemsidomide remain on track, with cash extending runway to the end of 2028.
SEC filing
Immunome said the FDA accepted its NDA for varegacestat in desmoid tumors with an April 28, 2027 PDUFA date, while two more programs began dosing patients.
SEC filing
LENZ posted $5.5 million in Q2 2026 revenue and launched telehealth prescribing for VIZZ, while regulatory submissions advanced in the UK, Canada and Saudi Arabia.
SEC filing
Kyverna added a third RMAT designation for its CAR T therapy while keeping its stiff person syndrome and myasthenia gravis timelines on track.
SEC filing
Coya said its first ALSTARS cohort has moved into a blinded extension phase and it still expects topline ALS data in early 2027, with cash reaching $43.2 million.
SEC filing
New AURORAS-1 data showed 57% response rate in pancreatic cancer patients, as Erasca advances toward three potentially registration-enabling trials backed by a $632.5 million offering.
SEC filing
Mereo said cash of $30.1 million should fund operations into late-2027 as it advances option deals for alvelestat and continues regulatory talks on setrusumab.
SEC filing
Sellas said it is approaching the 80th event needed for final analysis of the Phase 3 REGAL trial in AML, while its SLS009 frontline trial keeps enrolling.
SEC filing