Strategic Signals Weekly

Aquestive Therapeutics announced that the FDA has accepted its resubmitted New Drug Application for Anaphylm™ (dibutepinephrine) sublingual film. The NDA, targeting Type I allergic reactions including anaphylaxis, has been deemed complete, and the FDA has set a PDUFA goal date of March 16, 2027. This update provides clarity on the regulatory timeline for the potential approval of Anaphylm™.

Drug: Anaphylm™ (dibutepinephrine) · Indication: Type I allergic reactions, including anaphylaxis

Ocugen, Inc. entered into an exclusive, royalty-bearing license agreement with Roots Pharmaceutical Company WLL for OCU400, a novel modifier gene therapy for retinitis pigmentosa (RP), in the Middle East and North Africa. Under the agreement, Ocugen will receive an upfront license fee, up to $4 million in regulatory and development milestones, up to $255 million in sales milestones, and a 22% royalty on net sales. Roots will be responsible for regulatory submissions and commercialization in the territory.

Drug: OCU400 · Indication: retinitis pigmentosa · Partner: Roots Pharmaceutical Company WLL

Biohaven Ltd. entered into a Collaboration and License Agreement with Ono Pharmaceutical Co., Ltd., granting Ono exclusive rights to develop and commercialize Biohaven's MoDE™ pan IgG degrader portfolio, including BHV-1300, BHV-1310, and BHV-1320, in Japan and select Asian regions. Biohaven will receive an $80 million upfront payment, an additional $20 million milestone payment upon Ono's election to continue development, and approximately 20% royalties on net sales. Biohaven retains all rights outside the licensed territory.

Drug: BHV-1300, BHV-1310, BHV-1320 · Indication: Graves' Disease · Partner: Ono Pharmaceutical Co., Ltd.

Vir Biotechnology and Gilead Sciences have formed a global strategic collaboration to discover and engineer three novel PRO-XTEN® dual-masked T-cell engager development candidates targeting solid tumor-associated antigens. Concurrently, Gilead made an equity investment of approximately $25 million in Vir Bio by purchasing shares of common stock, supporting the early-stage oncology programs.

Drug: PRO-XTEN® dual-masked T-cell engager · Indication: solid tumor-associated antigens · Partner: Gilead Sciences, Inc.

Eton Pharmaceuticals acquired exclusive U.S. commercialization rights for LIBERVANT (diazepam) buccal film from Aquestive Therapeutics for the acute treatment of seizure clusters in epilepsy patients. The product has received tentative FDA approval for specific age groups. Eton paid an upfront license fee of $10.0 million and is responsible for potential regulatory and commercial milestones up to $47.5 million, plus mid-teens percentage royalties on net sales.

Drug: LIBERVANT (diazepam) buccal film · Indication: acute treatment of seizure clusters in patients with epilepsy · Partner: Aquestive Therapeutics, Inc.

Aquestive Therapeutics entered into a license agreement with Eton Pharmaceuticals, granting Eton exclusive U.S. commercialization rights for LIBERVANT (diazepam) buccal film, which has received tentative FDA approval for the acute treatment of seizure clusters in epilepsy patients. Aquestive received an upfront payment of $10.0 million and is eligible for up to $47.5 million in regulatory and commercial milestones, plus mid-teens percentage royalties on net sales. Aquestive will also serve as the exclusive manufacturer and supplier of the product.

Drug: LIBERVANT (diazepam) buccal film · Indication: acute treatment of seizure clusters in patients with epilepsy · Partner: Eton Pharmaceuticals, Inc.

Alector, Inc. entered into an underwriting agreement with Morgan Stanley & Co. LLC and BTIG, LLC for a public equity offering. The company will issue and sell 36,600,000 shares of common stock at $2.05 per share, expecting gross proceeds of $75.03 million. The offering is anticipated to close on October 19, 2026, subject to customary closing conditions.

Recursion Pharmaceuticals announced the pricing of a public offering of 61,540,000 shares of Class A common stock at $3.25 per share, expecting gross proceeds of approximately $200 million. This offering, along with $86 million from a prior ATM program, is expected to extend the company's cash runway into 2029.

Verastem, Inc. entered into an underwriting agreement for a public offering of 30,937,500 shares of common stock and pre-funded warrants to purchase up to 312,503 shares. The company anticipates receiving net proceeds of approximately $234.7 million from this offering. The closing of the offering is expected around October 15, 2026.

ADC Therapeutics SA entered into an $86.6 million private placement with institutional investors, selling common shares and pre-funded warrants, with the closing anticipated on October 22, 2026. This financing is accompanied by amendments to existing debt and royalty agreements, including a $70.0 million prepayment on a loan with Blue Owl and a revised royalty purchase agreement with Healthcare Royalty Management, LLC. The company also disclosed preliminary Q3 2026 net product revenues for ZYNLONTA.

Tessera Defense and Homeland Security Inc. reported raising over $6 million in net proceeds through its at-the-market (ATM) offering program as of October 12, 2026. Additionally, the company issued restricted shares of common stock to Mayers Ventures LLC for an acquisition and to Mandragola Ltd. upon cashless exercises of warrants related to a prior acquisition. Management is continuously evaluating capital needs and may halt ATM sales.