Strategic Signals Weekly

The company announced it was released from a postmarketing requirement for Afrezza related to pulmonary malignancy risk in type 2 diabetes. The FDA accepted a supplemental BLA for Afrezza in pediatric patients (4-17 with type 1 or type 2 diabetes) with a PDUFA target action date of May 29, 2026. Additionally, enrollment is ongoing for the INHALE-1st study, evaluating Afrezza plus basal insulin for youth aged 10-17 with newly-diagnosed type 1 diabetes, with data expected in late 2027.

Drug: Afrezza · Indication: pediatric type 1 and type 2 diabetes

Genprex announced positive clinical data from its Acclaim trials for Reqorsa® Gene Therapy (quaratusugene ozeplasmid) in lung cancer, presented at the 2026 ASCO Annual Meeting. The data showed that high Trop-2 levels and low PTEN levels correlated with prolonged Progression Free Survival (PFS) in Non-Small Cell Lung Cancer (NSCLC) patients treated with Reqorsa. These identified biomarkers may help predict patient response and enable targeted patient selection for precision medicine.

Ionis Pharmaceuticals announced positive pivotal Phase 3 data for bepirovirsen, partnered with GSK, for chronic hepatitis B (CHB). The drug achieved a statistically significant 19% functional cure rate in the overall study population, meeting primary endpoints, with results published in the New England Journal of Medicine. Bepirovirsen is currently under priority review by the FDA with Breakthrough and Fast Track Designations, with initial regulatory decisions expected in Q3 2026.

Drug: bepirovirsen · Indication: chronic hepatitis B · Partner: GSK

Passage Bio, Inc. terminated its research, collaboration, and license agreement with Gemma Biotherapeutics, Inc., effective May 21, 2026. Under this agreement, Gemma conducted preclinical and IND-enabling work for Passage Bio's active Huntington's disease program and a paused Temporal Lobe Epilepsy program. The termination also impacts options for mutually-agreed research programs in four new central nervous system indications.

Indication: Huntington's disease, Temporal Lobe Epilepsy · Partner: Gemma Biotherapeutics, Inc.

Solana Company entered into an Amended and Restated Sales Agreement for its existing at-the-market (ATM) offering with Clear Street LLC and Maxim Group LLC. This amendment increases the aggregate gross sales price of Class A common stock that may be offered and sold from $92.8 million to $250 million. The company has already sold approximately $24.7 million under the prior agreement and will pay the agents up to 3.00% commission on gross proceeds.

Rani Therapeutics Holdings, Inc. has entered into a securities purchase agreement with institutional investors for a private placement. The company will issue Class A common stock and pre-funded warrants, expecting to raise approximately $20.0 million in gross proceeds. The closing of the offering is anticipated around May 27, 2026, subject to customary conditions.

Aptevo Therapeutics, through its subsidiary, has entered into a collaboration agreement with Niowave, Inc. to develop a therapeutic product combining Aptevo’s APVO455 and Niowave’s Actinium-225, commencing with a proof of concept study. Concurrently, Aptevo completed an initial private placement with Niowave, selling shares and warrants for approximately $0.5 million, with potential for additional investments. This financing supports the strategic partnership aimed at advancing a novel radioisotope-based therapeutic.

Assembly Biosciences, Inc. completed an underwritten public offering of common stock and pre-funded warrants, including the full exercise of the underwriters' option. The company received net proceeds of approximately $107.4 million from the offering. Executive officers and directors are subject to a 90-day lock-up period.

Editas Medicine completed an underwritten public offering of common stock and warrants, generating approximately $117.0 million in net proceeds. This financing is projected to extend the company's cash runway into the second half of 2028. The warrants' exercise is tied to the public announcement of Phase 1 clinical data for EDIT-401, specifically demonstrating a significant reduction in LDL-cholesterol.