Strategic Signals Weekly

Capricor Therapeutics announced that the FDA's Cellular, Tissue and Gene Therapies Advisory Committee voted against the effectiveness of Deramiocel for cardiomyopathy in Duchenne muscular dystrophy patients (3 for, 9 against). Despite the non-binding negative recommendation, the FDA's PDUFA target action date for the Biologics License Application remains August 22, 2026.

Drug: Deramiocel · Indication: cardiomyopathy in patients with Duchenne muscular dystrophy

Karyopharm Therapeutics is exploring strategic alternatives and potential financing transactions with Centerview Partners to extend its cash runway and maximize stakeholder value. This corporate update follows mixed clinical news, including the failure of its Phase 3 XPORT-EC-042 trial for selinexor in endometrial cancer to meet its primary endpoint, and plans for an August 2026 sNDA submission for accelerated approval of selinexor in myelofibrosis, which is subject to further FDA discussions regarding data for traditional approval conversion.

Werewolf Therapeutics, Inc. announced its financial results for the quarter ended June 30, 2026. Concurrently, the company is exploring strategic alternatives, including potential partnerships, to enhance stockholder value, while also evaluating its cash runway and clinical development timelines.

AnaptysBio, Inc. provided an update on its ongoing litigation against TESARO, Inc. and its parent GlaxoSmithKline. AnaptysBio is seeking a court declaration that Tesaro materially breached their Collaboration and Exclusive License Agreement and that GlaxoSmithKline tortiously interfered with the agreement. Following a trial held in July 2026, the parties submitted a joint stipulation for a post-trial briefing schedule, with post-trial arguments set for October 20, 2026.

Partner: TESARO, Inc., GlaxoSmithKline

Keros Therapeutics, Inc. announced it will receive a $20 million development milestone payment from partner Takeda Pharmaceuticals U.S.A., Inc. This payment follows the dosing of the first patient in the Phase 3 ELRiSE MDS clinical trial. The trial is evaluating elritercept for the treatment of anemia in patients with myelodysplastic syndromes.

Drug: elritercept · Indication: myelodysplastic syndromes · Partner: Takeda Pharmaceuticals U.S.A., Inc.

Standard BioTools Inc. received approximately $30 million in cash from Illumina, Inc. to terminate existing royalty and license agreements. This agreement waives Standard BioTools' rights to a 2026 earnout and ends royalty streams related to SOMAmer-based next-generation sequencing library preparation kits and Single SOMAmers.

Drug: SOMAmer-based next-generation sequencing library preparation kits, Single SOMAmers · Partner: Illumina, Inc.

SELLAS Life Sciences Group, Inc. lost an arbitration case against 3D Medicines, Inc. concerning disputed milestone payments. Despite the ruling, 3D Medicines will continue the development and commercialization of galinpepimut-S (GPS) in Greater China under their exclusive license agreement, with $191.5 million in potential future milestone payments still outstanding, including the previously disputed $13.0 million. SELLAS also reported an estimated $138.3 million in cash and cash equivalents as of June 30, 2026.

Drug: galinpepimut-S (GPS) · Partner: 3D Medicines, Inc.

Gossamer Bio and Chiesi terminated their Collaboration and License Agreement, leading to Gossamer reacquiring worldwide development and commercial rights for seralutinib, including for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Chiesi will pay Gossamer $5 million as reimbursement for development costs, while Gossamer will make success-based milestone and royalty payments to Chiesi. Separately, Gossamer plans to submit a New Drug Application (NDA) for seralutinib for PAH in September 2026, following a positive Pre-NDA meeting with the FDA, with a potential approval decision in Q3 2027.

Drug: seralutinib · Indication: pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD) · Partner: Chiesi

Inovio Pharmaceuticals, Inc. entered into an underwriting agreement with Piper Sandler & Co. for a public offering of 21,052,632 shares of common stock and accompanying warrants to purchase up to 42,105,264 shares. The company also granted the underwriter an option for additional shares and warrants, which was exercised for warrants to purchase up to 6,315,788 shares. The offering is expected to generate approximately $18.3 million in net proceeds for Inovio.

LB Pharmaceuticals Inc. announced a private placement generating approximately $150.0 million in gross proceeds through the sale of common stock and pre-funded warrants to certain investors. The company plans to use the net proceeds to expand its pipeline for LB-102 into new indications, including negative symptoms of schizophrenia and Alzheimer’s disease agitation/psychosis. Trial initiation for schizophrenia is potentially targeted for the second half of 2027.

Processa Pharmaceuticals, Inc. completed a private placement, entering into a Securities Purchase Agreement to sell Series A Preferred Stock for approximately $200.0 million. The company plans to use these proceeds to fund operations into the second half of 2029 and through key clinical milestones. These milestones include top-line data from Phase 2 proof-of-concept studies for food allergy, chronic spontaneous urticaria (CSU), and relapsing multiple sclerosis (RMS).

HCW Biologics Inc. entered into a private placement with accredited investors, agreeing to issue and sell units consisting of common stock or pre-funded warrants, and rights to receive common stock purchase warrants. The company expects to raise approximately $1.6 million in gross proceeds from this offering. The net proceeds will be used for working capital and general corporate purposes, including continuing clinical development activities.

Entera Bio Ltd. completed a private placement, raising $275.0 million from institutional investors, including BVF Partners L.P. The proceeds will fund the initiation of a Phase 3 registrational study for EB613 in postmenopausal women with osteoporosis, as well as general corporate purposes. As part of the agreement, BVF Partners L.P. gained the right to designate two directors to Entera Bio's board.