HUTCHMED wins NMPA approval for ATLED in FGFR2-altered bile duct cancer
China's regulator granted conditional approval for fanregratinib in pretreated intrahepatic cholangiocarcinoma patients with FGFR2 fusion or rearrangement.
SEC filing
Latest
Friday, August 28
Oragenics gets NYSE American deficiency notice, updates trial and FDA progress
Oragenics disclosed a stockholders' equity shortfall triggering a listing compliance deadline, alongside continued Phase IIa dosing for ONP-002 and an ongoing FDA review of its Type B meeting package.
SEC filing
Cytokinetics reports positive ACACIA-HCM results for aficamten in non-obstructive HCM
The Phase 3 trial hit both primary endpoints, and Cytokinetics plans an FDA supplemental filing in the fourth quarter of 2026.
SEC filing
Alterity Therapeutics discloses governance practices in August 2026 filing
The company's corporate governance statement details board composition, committee structures, and diversity metrics, with a note that the source document contains an apparent date typo for the Chair's start date.
SEC filing
BioNTech ends Phase 2 trial of autogene cevumeran in colorectal cancer
The company halted the BNT122-01 study after a safety board found an overall survival imbalance and said further follow-up would not change the efficacy outcome.
SEC filing
Amgen posts results for rocatinlimab AD trial, daxdilimab myositis study; mCRPC trial terminated
AbbVie registers Phase 3 trial of etentamig vs Dara-CyBorD in AL amyloidosis
Pfizer posts MET097 obesity results; registers new Phase 3 obesity and dermatitis trials
Thursday, August 27
FDA approves updated Pfizer-BioNTech COVID-19 vaccine targeting XFG variant
The 2026-2027 formula gained approval for older adults and higher-risk younger people, with shipping starting immediately.
SEC filing
Mesoblast reports FY2026 revenue of $120.3 million, driven by Ryoncil launch
The company said gross profit reached $103.6 million as reported, or $109.7 million excluding amortization, while completing patient treatment in its Phase 3 back pain trial.
SEC filing
Tezspire meets primary endpoints in Phase III EoE trial CROSSING
AstraZeneca and Amgen said the drug showed durable, statistically significant benefits over placebo in eosinophilic esophagitis through week 52.
SEC filing
argenx completes acquisition of Forte Biosciences
The deal brings the anti-CD122 antibody FB102 into argenx's immunology pipeline after a cash tender offer at $77.00 per share.
SEC filing
ABVC completes partial spinoff of BioKey (Cayman) subsidiary
ABVC BioPharma distributed roughly 15% of BioKey Cayman shares to its stockholders on August 21, 2026, while keeping majority control.
SEC filing
FDA approves two efficacy supplements for Eli Lilly's Mounjaro
The agency cleared supplement numbers 44 and 45 for tirzepatide's NDA on the same status date, with labeling updated in early September 2026.
Drugs@FDA (2)
Outlook Therapeutics names Kevin Lundquist as new CFO
Lawrence Kenyon steps down as CFO effective September 1, 2026, with Kevin Lundquist taking over the role and other financial officer duties.
SEC filing
BMS registers new deucravacitinib continuation study; prior week's trial results still stand
Quince Therapeutics discloses departure of President Charles Ryan
The company reported the leadership change in an 8-K with an event date of August 23, 2026, and a signature date of August 27, 2026.
SEC filing
Boehringer Ingelheim registers Phase 3 VERANDA-IIM trial of nerandomilast in myositis
Jupiter Neurosciences executives forgive $875,315 in accrued pay
Four officers and directors waived unpaid compensation in agreements signed August 26, 2026, with no shares or cash exchanged in return.
SEC filing
Platform Therapeutics files Form D for $4 million equity offering
The Andover, Massachusetts biotech reported $1.75 million raised from one investor as of a August 12, 2026 first sale date.
SEC filing
Lilly registers four new trials: Alzheimer's, cardiovascular, obesity, Crohn's programs
FluidForm Bio reports Form D offering with $1.7 million raised so far
The Waltham, Massachusetts biotechnology company disclosed a $3 million equity offering, of which $1,703,371 has been sold to 20 investors as of the filing.
SEC filing
Alto Neuroscience elevates CFO Nicholas Smith to president role
The company also put in place a two-year retention package worth $6 million tied to Smith staying through August 2028.
SEC filing
Rocket Pharmaceuticals adopts new severance program, signs executive employment deals
The board approved a severance and change-in-control program for U.S. employees and entered new employment agreements with CEO Gaurav Shah and General Counsel Martin Wilson.
SEC filing
AstraZeneca posts MITCHELL asthma results; registers AZD6234 Phase 3 SELENE 2
LifeVantage reports fourth-quarter and fiscal 2026 revenue decline, skips 2027 guidance
The company posted a 23.1% drop in fourth-quarter revenue and said it will not issue formal fiscal 2027 guidance because of a recent CEO transition.
SEC filing
Novartis-linked melanoma trial posts results; new ITP preference survey and LASIK study active
MBX Biosciences doses first patient in Phase 3 trial of canvuparatide for hypoparathyroidism
The trial, called oPTimize, will enroll about 160 adults and test the once-weekly PTH replacement therapy against placebo over 26 weeks.
SEC filing
GSK posts results for 2021 COVID-19 SAM vaccine trial; advances four Phase 3 respiratory studies
Jazz posts results for XYWAV sleep study; registers new zanidatamab real-world study
Wednesday, August 26
Radiopharm advances three programs across RAD202, RAD101, and BetaBart
In August 2026 filings, Radiopharm Theranostics reported dose escalation clearances for two radiotherapeutics and a scheduled FDA meeting for a diagnostic imaging agent.
SEC filing (3)
Summit's partner Akeso reports positive Phase III data for ivonescimab in bile duct cancer
Akeso's HARMONi-GI1 trial in China showed ivonescimab plus chemotherapy beat durvalumab plus chemotherapy on overall survival in advanced biliary tract cancer.
SEC filing
Black Hawk Acquisition Corp secures up to $300,000 convertible note from sponsor
The SPAC disclosed a new sponsor note for working capital and extension fees, with repayment tied to a future business combination or liquidation.
SEC filing
FDA approves Sun Pharma's Vobrig, a leuprolide acetate injection
The new drug application for Vobrig, a subcutaneous leuprolide acetate solution, received FDA approval with a status date of August 26, 2026.
Drugs@FDA
Aptevo Therapeutics discloses $3.47 million private placement, registers warrant shares for resale
An August 12 warrant inducement and private placement raised about $4.5 million for Aptevo, which is now registering up to 6.4 million shares for resale.
SEC filing (2)
Phibro reports record fiscal 2026 sales, plans Chicago Heights plant closure, issues FY27 guidance
Phibro posted $1,518.1 million in fiscal 2026 net sales and said it will close its Chicago Heights manufacturing site by summer 2027, affecting about 100 employees.
SEC filing
Tevogen holders reelect two directors, back KPMG and charter changes at annual meeting
Tevogen Inc. shareholders approved an equity plan expansion and a governance change allowing action by written consent, per an 8-K filed for the August 24, 2026 meeting.
SEC filing
Ubivac files Form D for equity offering, discloses $80,000 raised so far
The Portland, Oregon biotechnology company reported two investors in an ongoing offering under Rule 506(b) exemption.
SEC filing
Turn Therapeutics discloses $1.65 million equity raise in Form D filing
The Westlake Village biotechnology company reported sales to eight investors under a Rule 506(b) exemption, with first sale dated August 14, 2026.
SEC filing
Dare Bioscience files resale registration for shares tied to August warrants
The S-1 covers up to 8,934,345 shares issuable from warrants tied to Dare's August 14 private placement and registered direct offering.
SEC filing (4)
Biomerica completes $2.23 million private placement of common stock
Biomerica sold 1,393,705 shares at $1.60 per share to institutional and individual investors, including B. Riley Principal Capital, LLC and company insiders.
SEC filing
Biohaven files license and assignment agreements for SK Biopharmaceuticals Kv7 deal
New SEC filing details royalty terms, termination rights, and a separate $245 million Knopp Biosciences obligation tied to the opakalim licensing deal.
SEC filing
Jasper Therapeutics receives Nasdaq notice over stockholders' equity shortfall
The company has until October 5, 2026 to submit a plan addressing the deficiency, and is counting on a preferred stock conversion vote to fix it.
SEC filing
NIAID-led IMPAACT 2026 pharmacokinetic study terminated early, results posted
BeOne Medicines files STAR Market interim report, discloses R&D spend by product under US GAAP
The August 26, 2026 8-K reconciles PRC GAAP and US GAAP accounting differences and breaks out research and development spending for key pipeline products for the first half of 2026.
SEC filing
UNC registers Phase 4 trial testing Phathom's vonoprazan in Barrett's Esophagus
Addex raises $2.8 million via ATM offering, extends cash runway to Q4 2027
Geneva-based Addex Therapeutics sold ADSs to H.C. Wainwright & Co. under its at-the-market agreement, pushing its projected cash runway into the fourth quarter of 2027.
SEC filing
Two new registry studies posted: obesity-linked heart failure and long-term glaucoma surgery outcome
Prenetics CEO and CFO buy $1 million in shares after Q2 results
Danny Yeung and Brian Rosin purchased shares between August 20 and 25, 2026, bringing leadership's cumulative investment since November 2025 to about $3.75 million.
SEC filing
Serina Therapeutics signs $25 million equity purchase deal with Roth Principal Investments
The Alabama biotech gained discretionary access to sell newly issued shares over 36 months under an agreement dated August 21, 2026.
SEC filing