Astellas Pharma Inc. announced it plans to acquire Iveric Bio Inc. in an all-cash deal in which it will pay $40 per Iveric share for a total equity value of roughly $5.9 billion. “Iveric Bio has promising programs including avacincaptad pegol (Zimura), an important program for geographic atrophy secondary to age-related macular degeneration, and capabilities across the entire value chain in the ophthalmology field,” said Naoki Okamura, Astellas’ president and CEO. The price is a 64% premium to Iveric’s closing price of $24.33 on March 31, 2023, and a 75% premium to its 30-day weighted average. Both boards have unanimously approved the merger, which should close in the third quarter. At midday on May 1, Iveric’s shares (NASDAQ:ISEE) were trading at $37.91, up more than 15%. Astellas’ buyout offer for Iveric represents the fourth largest M&A, pending or completed, for 2023.

Sanofi taps Maze in potential $750M Pompe deal focused on GYS1 blocker 

Maze Therapeutics Inc. signed a deal with Sanofi SA for the former’s oral glycogen synthase (GYS1) inhibitor MZE-001, a substrate reduction therapy to treat Pompe disease. The terms bring South San Francisco-based Maze $150 million consisting of up-front cash and a future equity investment for the rights to develop and commercialize the compound, along with an exclusive license to backup programs related to GYS1-targeting, as well as intellectual property. Privately held Maze could bank about $600 million more in development, regulatory and sales milestone payments from Sanofi, of Paris, with royalties described as “meaningful” also part of the arrangement. Maze has advanced MZE-001 through the phase I stage.

Pliant data yield good results but a droopy stock

Despite posting some early but positive phase IIa data, Pliant Therapeutics Inc.’s stock (NASDAQ:PLRX) was struggling mightily at midday, with shares down 23% at about $21.75 each since the opening bell. Still, the stock has surged in the past 12 months as shares went for about $5 each this time last year. The good news came from 24-week data from the 320-mg dose group of INTEGRIS-IPF, a randomized, dose-ranging, double-blind, placebo-controlled phase IIa study of PLN-74809 (bexotegrast) for treating idiopathic pulmonary fibrosis. The dosage group hit its primary and secondary endpoints as the oral, once-daily, dual-selective αvß6/αvß1 integrin inhibitor was well tolerated up to 40 weeks and with no drug-related serious adverse events. 

US lawmakers to CMS: Lengthy NCD coverage process ‘not acceptable’

The U.S. Centers for Medicare and Medicaid Services’ (CMS) years-long musing over a coverage policy specifically for breakthrough medical devices is now taking a toll on breakthrough medications that could provide a cure or arrest the progression of debilitating diseases. “That’s not acceptable,” Rep. Anna Eshoo (D-Calif.) said at last week’s hearing before the House Energy and Commerce Subcommittee on Health. She noted that after a device has been cleared by the FDA, CMS can take up to 17 months to make a nationwide coverage decision (NCD) for that device. Now CMS is using that same process to determine its reimbursement for drugs such as Eisai Co. Ltd.’s Alzheimer’s drug, Leqembi (lecanemab).

Ascendis gets CRL, but also clarity, for Transcon PTH NDA

Ascendis Pharma A/S reported a complete response letter from the U.S. FDA for its once-daily hormone replacement therapy, Transcon PTH, for hypoparathyroidism. But the rejection of the NDA offered some much-needed clarity, with the agency citing concerns related to the manufacturing control strategy for variability of delivered dose of the drug/device combination product. No concerns were raised regarding safety or efficacy data, and Ascendis hopes to be able to provide a timeline for resubmission following a type A meeting with the FDA. Shares of Ascendis (NASDAQ:ASND), which had fallen a month ago on news of unspecified deficiencies in the NDA, were trading up 20% May 1 at midday.

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