Sol-Gel completes patient follow-up in Gorlin syndrome Phase 3 trial
The last enrolled patient finished the final study visit for SGT-610 in Gorlin syndrome, with top-line data still expected late November 2026.
SEC filing
Latest
Thursday, September 17
Lisata acquires Marea Therapeutics, raises $225 million in private placement
The merger, announced September 17, 2026, pairs Lisata's clinical-stage pipeline with Marea's cardioendocrine candidates and is expected to fund operations into 2028.
SEC filing
Fennec reports Phase 2 PEDMARK data from Japan met primary endpoint at SIOP 2026
Investigator-led STS-J01 study showed lower hearing loss than a historical benchmark, with tumor responses seen in nearly all evaluable patients.
SEC filing
NeOnc CEO buys more stock after positive NEO100 Phase 2a data
Amir Heshmatpour purchased 35,000 additional NeOnc shares on September 15, 2026, bringing his and CMO Thomas Chen's combined open-market purchases to about $629,000 since August's trial results.
SEC filing
UVA registers Phase 1b/2 trial of Verastem's avutometinib/defactinib in pancreatic cancer
Faeth Therapeutics expands board, adds co-founder Karen Vousden
The cancer biologist and Faeth co-founder joins as a sixth director, seated on the Compensation Committee, per a September 17 8-K.
SEC filing
Sanofi and Cheplapharm announce mature medicines partnership
Sanofi plans to transfer 20 mature medicines and three manufacturing sites to Cheplapharm in exchange for a 26.4% equity stake in the German company.
SEC filing
CardioVision registers heart-failure pathway trial; unrelated ACP and Pilates studies also post
GeoVax files S-1 for resale of 11.4 million warrant shares tied to August inducement
The clinical-stage biotech registered shares for a selling stockholder while flagging going-concern doubts and cash runway into October 2026.
SEC filing
Innate Pharma reports H1 2026 net loss of €19.6 million amid cash decline
Cash and financial assets fell to €21.4 million as of June 30, 2026, but the company points to a post-period Sobi deal and share placement to fund operations into 2028.
SEC filing
Innate Pharma reports H1 2026 results, confirms Sobi deal launch and cash runway into 2028
Sobi partnership closed and TELLOMAK-3 is starting as Innate reports €21.4 million in cash and a runway extended to the end of Q1 2028.
SEC filing (2)
AstraZeneca registers Phase 3 ovarian cancer ADC trial and Phase 1 hMPV antibody study
Wednesday, September 16
FDA approves supplement for NUVATION's Ibtrozi (NDA219713)
A new efficacy supplement for the taletrectinib adipate capsule was approved, with the label updated in September 2026.
Drugs@FDA
FDA approves supplemental efficacy application for AstraZeneca's Truqap
The regulator cleared a sixth supplement to Truqap's original approval, with an updated label issued the following day.
Drugs@FDA
Impact Biomedical says Zoar Limited filed Form F-4 for merger with Impact
Zoar Limited filed the registration statement on September 10, 2026, a step Impact called a major milestone toward closing its planned combination.
SEC filing (2)
Alkermes announces Anne C. Whitaker's appointment to board via press release
The company confirmed the September 14 board appointment in a September 16 statement that included executive comments and details on Whitaker's background.
SEC filing
Adial Pharmaceuticals amends PIPE and note exchange agreements ahead of annual meeting
The September 16, 2026 amendments reclassify milestone warrant liabilities as equity, addressing a Nasdaq stockholders' equity shortfall tied to the Azora merger financing.
SEC filing
Merck's Phase 3 enlicitide trial for hyperlipidemia recruiting in India
Pfizer wins Xeljanz label update; registers four new trials across RSV, eczema, sleep apnea
Oncobiomix files Form D for $2.5 million offering
The San Antonio biotech reported one investor and $100,000 raised toward a $2.5 million exempt securities offering, according to a Form D filed with the SEC.
SEC filing
Novartis updates Zortress label; advances Fanconi anemia and IgAN trials
Novo Nordisk registers Phase 3 obesity trial in Japan; new CagriSema switch study
Teva subsidiaries price $3.2 billion and €1.5 billion in new senior notes
Teva Pharmaceutical Finance units issued five tranches of notes on September 16, 2026, with proceeds set to fund redemptions of existing debt.
SEC filing
Myriad Genetics names Vishal Sikri as EVP of Commercial, effective September 16, 2026
Sikri steps up from SVP of Product to succeed Brian Donnelly, who is leaving the company on September 21, 2026.
SEC filing
Lipocine registers Phase 3 study of oral LPCN 1154A for postpartum depression
Kymera registers Phase 1 crossover trial testing oral formulations of KT-621
MacroGenics registers Phase 1 first-in-human trial of ADC MGC030 in solid tumors
Xenetic Biosciences and Santersus agree to all-stock combination targeting NETs
The companies signed a definitive share exchange agreement expected to close in Q4 2026, creating a Nasdaq-listed firm renamed Santersus Bio, Inc.
SEC filing
Avalyn Pharma adds Robert Meyer, M.D. to board of directors
The former FDA official and regulatory consultant joins as a Class II director effective September 15, 2026.
SEC filing
Tevogen grants performance-based restricted stock to CEO and CFO tied to $1 billion revenue goal
The awards to Ryan Saadi and Kirti Desai vest only if Tevogen hits $1.0 billion in aggregate revenue by September 30, 2031.
SEC filing
Clene prices $4 million registered direct offering with insider participation
Clene said the September 15, 2026 raise, backed by its chairman, CEO and other existing holders, is expected to fund operations into mid-first quarter 2027.
SEC filing
Gossamer Bio adds Greg Ciongoli to board and audit committee
The seralutinib developer named the Adiumentum Capital founder as a Class III director effective September 16, 2026.
SEC filing
Ernexa Therapeutics appoints Robert J. Spiegel to board of directors
The Cambridge biotech named Spiegel a director effective September 14, 2026, following a recommendation from its Nominating and Corporate Governance Committee.
SEC filing
AbbVie registers Phase 3 trial of telisotuzumab adizutecan in NSCLC
Clene sells $4 million in stock directly to insiders and existing holders
The Nasdaq-listed biotech priced 1,219,513 shares at $3.28 apiece in a direct offering, with directors and officers committing about $2.1 million as the company flags going-concern doubt.
SEC filing
argenx registers Phase 2 trial of empasiprubart for Guillain-Barré syndrome
Mirum registers Phase 2 trial of maralixibat for cholestasis of pregnancy
Incyte registers Phase 2 trial of INCA33890 in MRD-positive colorectal cancer
ImprimisRx NJ recalls ophthalmic solution for subpotency, Class III
Tuesday, September 15
Connect Biopharma reports Phase 2 asthma data for rademikibart
The company said rademikibart cut treatment failures by 66% versus placebo, though the result missed statistical significance, while lung function improved significantly at Day 7.
SEC filing
Coya Therapeutics reaches 100-patient mark in ALS Phase 2/3 trial
The company said full enrollment of 120 subjects is on track to support topline data in early Q2 2027.
SEC filing
BioMarin halts VOXZOGO development for Noonan syndrome in children
BioMarin disclosed on September 15, 2026 that it is discontinuing the pediatric Noonan syndrome program for VOXZOGO, citing study feasibility and treatment landscape factors rather than safety or efficacy concerns.
SEC filing
Summit reports updated HARMONi overall survival data at WCLC 2026
Longer follow-up in western patients on ivonescimab plus chemotherapy matched survival gains seen earlier in Asian patients, with no new safety signals.
SEC filing
Scholar Rock corrects statement on FDA conditions for ISEMBYLD approval
The company said it misspoke on an investor call about post-marketing safety requirements tied to its spinal muscular atrophy drug's FDA approval.
SEC filing
Parabilis Medicines to present zolucatetide desmoid tumor data at ESMO Congress 2026
The company disclosed plans for an oral presentation of updated Phase 1/2 trial results in Madrid on October 24, 2026.
SEC filing
Shuttle Pharmaceuticals converts preferred shares, issues warrants after stockholder vote
The company issued nearly 3.7 million common shares from preferred stock conversions and warrants covering over 17.8 million shares following a September 9, 2026 special meeting.
SEC filing
BeOne Medicines registers Phase 1 drug interaction trial for CDK4 inhibitor BGB-43395
Aethlon Medical amends executive employment agreements ahead of change-in-control scenarios
The company revised severance terms for its CEO/CFO and Chief Medical Officer so that qualifying post-merger terminations trigger lump-sum, not installment, payments.
SEC filing
Jaguar Health exchanges debt and preferred stock for common stock, closes Napo Therapeutics deal
Filing covers a note exchange with Lincoln Alternative Strategies, three preferred stock exchanges with Streeterville Capital, and completion of a stock purchase to acquire remaining Napo Therapeutics shares.
SEC filing