Astellas Pharma Inc. and Vir Biotechnology Inc. have signed a global co-development pact to advance VIR-5500, Vir’s PRO-XTEN dual-masked CD3 T-cell engager targeting prostate-specific membrane antigen for treating prostate cancer. Under the deal terms, Vir will receive $335 million in up-front and near-term payments, including $240 million in cash, $75 million in equity investment and a $20 million near-term milestone. Vir is also eligible to receive up to $1.37 billion in development, regulatory and sales-based milestones plus royalties on ex-U.S. sales.

Immedica wins US nod for Loargys to treat ARG1-D

Targeting an ultrarare disease affecting about 250 U.S. residents, Immedica Pharma AB’s Loargys (pegzilarginase) won accelerated FDA approval to treat hyperargininemia in those ages 2 and older with arginase 1 deficiency (ARG1-D). The approval comes about two and a half years after Immedica acquired the arginine-specific enzyme developed by Aeglea Biotherapeutics Inc., now Spyre Therapeutics Inc. The inability to properly break down arginine results in neurological symptoms that include seizures, developmental delays, walking difficulties and stiff muscles. ARG1-D is a urea cycle and recessive genetic disorder typically found before age 3.

Palvella wins in LMs phase III; Protara shares sink on phase II NMIBC data

Almost three months to the day after Protara Therapeutics Inc. disclosed positive interim data from the phase II trial testing cell-based therapy TARA-002 in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs), Palvella Therapeutics Inc. scored positive top-line results from the phase III Selva study evaluating Qtorin 3.9% rapamycin anhydrous gel for microcystic LMs. Protara had more data with TARA-002 as well. The company rolled out updated interim findings from the closely watched phase II, open-label experiment called Advanced-2, gauging the merit of its intravesical drug – an inactivated Streptococcus pyogenes (Su strain) immunotherapy – in high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ or CIS (±Ta/T1) who are Bacillus Calmette-Guérin (BCG)-unresponsive or BCG-naïve. Shares of Palvella (NASDAQ:PVLA) were trading at $118.34, up $30.51, or 34%, while Protara’s stock (NASDAQ:TARA) was selling for $6.03, down $1.40, or 18%. LMs are benign fluid-filled growths that can cause various health problems, depending on their location. NMIBC represents a seriously problematic tumor type and a hotly competitive space.

US Fed Circuit protects 101 passage for some gene therapy patents

In handing a win to Regenxbio Inc. Friday, the U.S. Court of Appeals for the Federal Circuit also cleared some leaves from the 101 patentability threshold after years of Supreme Court decisions cluttering the passageway. The Federal Circuit opinion in Regenxbio vs. Sarepta Therapeutics Inc. overturned a lower court, which, applying its take on Supreme Court rulings, had invalidated the disputed patent, saying the claims, related to genetically engineered host cells, were directed to natural phenomenon. “The cultured host cells required by the claims are undisputedly human made. They do not exist in nature,” the appellate court said.

Innovacell’s $91M Tokyo IPO to fund incontinence cell therapies

Innovacell Inc. launched a ¥14.16 billion (US$91.2 million) stock sale on the Tokyo Stock Exchange Feb. 24, ending a near two-year lull of biotech listings in Japan while signaling a dynamic year ahead for cell-based therapeutics. Innovacell’s shares began trading under the ticker 504A and closed at ¥1,050 each, about 22.22% below the listing price. J-Pharma Co. Ltd., an oncology-focused biotech, also received clearance from TSE regulators for a March listing on Jan. 19, indicating a potential rebound of biotech IPOs in Japan.

Medtronic’s diabetes unit Minimed seeks $784M in IPO

Minimed Group Inc., Medtronic plc’s diabetes business, is looking to raise up to $784 million in its initial public offering (IPO). Medtronic last May revealed plans to spin off the unit as an independent public company and expected to complete the separation within 18 months.

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