After spending three years battling the U.S. FDA for approval of Xphozah (tenapanor) for treating hyperphosphatemia in adults with chronic kidney disease (CKD), Ardelyx Inc. is wasting no time getting to market, aiming to have the NHE3 inhibitor available to patients next month. The approval restricts use to CKD patients on dialysis who have an inadequate response or are intolerant to phosphate binder therapy, a label that had been widely anticipated and one that’s not expected to put a damper on Xphozah’s commercial potential.

Drug prices, deals shadow hearing of US NIH nominee

A week before the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee is scheduled to vote on the confirmation of Monica Bertagnolli as the next NIH director, she faced a committee grilling today, Oct. 18, fueled by drug pricing agendas and deals the Biden administration made with certain lawmakers to advance her nomination. In opening the hearing, HELP Chair Bernie Sanders (I-Vt.) focused on drug prices, blaming them for a health care system he called broken and failing. Sanders had refused to hold the hearing on Bertagnolli, who was nominated in May, until the Biden administration delivered what the senator considered a satisfactory plan to lower drug prices beyond the provisions in the Inflation Reduction Act. Noting the deals reportedly cut to advance the nomination, Ranking Member Bill Cassidy (R-La.) said he was concerned that the administration would jeopardize the long-term enterprise for the short-term goal of Bertagnolli’s confirmation.

Nkarta charts a new course that includes autoimmune disease 

Nkarta Inc. is looking to return to the heady heights it hit three years ago when its shares were going for nearly $70 each. As part of the company’s reinvention from cancer fighter into an autoimmune specialist, it will collaborate with Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance. They plan to develop Nkarta’s natural killer cell therapy NKX-019 – already in the clinic for treating relapsed or refractory acute myeloid leukemia – to treat lupus. The company also cut back its headcount by 10% to extend its cash runway. Nkarta’s stock (NASDAQ:NKTX) was down 4.5% to $3 per share at midday Oct. 18, but that was in the wake of the previous day’s 112% surge. Still, that’s far below the $69 shares fetched in December 2020.

GI Innovation inks second GI-301 licensing deal with Japan’s Maruho for $220M 

Korean bioventure GI Innovation Inc. inched closer to achieving its goal of “five tech transfer deals in five years” with another licensing deal for its allergy drug, GI-301, with Japan-based Maruho Co. Ltd. for ₩298 billion (US$220.7 million), although share prices still dropped on the news. Under the terms announced on Oct. 16, the Seoul, South Korea-based immunotherapy and allergy drug developer will receive an undisclosed amount from Osaka-based dermatology firm Maruho, including undisclosed up-front and milestone payments for GI-301's clinical development and commercialization, along with sales royalties. In turn, Maruho will lead GI-301's clinical development and commercialization in Japan.

Q3 boasts solid biopharma mega-deals, more mergers, but 2023 falls behind other years

While biopharma dealmaking remains active, a strong third quarter (Q3) was not enough to bring it to the same level seen during each of the last three years, although values are coming close. At the same time, M&As appear to be rising above 2022, but even with the increase, they still lag behind other years. If the Pfizer Inc./Seagen Inc. merger, worth $43 billion, closes before the end of 2023, for example, M&As will still not come close to the overall value seen in 2019 and 2020. The biopharma industry completed a total of 333 deals, including licensings, collaborations and joint ventures in Q3, valued at $42.47 billion. As for M&As, there were 36 completed in Q3 worth a combined $25.35 billion, making the third quarter the best for the year.

USITC releases report on COVID-19 diagnostics and therapeutics

The United States International Trade Commission (USITC) issued its public report titled “COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities,” on Oct. 17 in response to concerns about global inequity in access to diagnostics and medicines. In a letter to the USITC dated Dec. 16, 2022, U.S. Trade Representative Katherine Tai discussed this concern, and noted the varied and divergent opinions on whether the intellectual property protections that support the development of new medicines may also act as a barrier to access, particularly in developing countries. Tai’s request letter asked the USITC to provide information on a number of issues and factors concerning COVID-19 diagnostics and therapeutics, as well as to identify where significant data and information gaps exist.

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