Tvardi Therapeutics Inc. had lost more than 80% of its value at midday as investors took in poor preliminary results of the phase II study of its lead candidate for treating idiopathic pulmonary fibrosis. The study of the oral STAT3 inhibitor missed its safety and efficacy data goals, along with having a high dropout rate in the rare lung disease marked by scarring of the lungs. The company said it was digging deeper into the data to understand the results and decide what to do next. The company’s shares (NASDAQ:TVRD) were going for $6.84 at midday.

Rx tariff a stick and a carrot for US price, onshoring deals

Although U.S. President Donald Trump’s Oct. 1 start date for a hefty biopharma sector tariff has come and gone, the threat remains in place, serving as both a stick and a carrot to get drug companies to come to the table with their best deals. Astrazeneca plc is the second biopharma manufacturer to accept the invite to sit down with the administration over most-favored nation (MFN) pricing and an onshoring commitment. Like Pfizer Inc. before it, Astrazeneca was rewarded with a three-year delay from the tariff, giving it time to fully onshore its drug manufacturing so that all its medicines sold in the U.S. are made in the U.S. But tariffs and MFN aren’t the only threats overshadowing the sector. On the eve of Astrazeneca’s Friday announcement with the White House, the Senate, with a 77-20 bipartisan vote, passed the National Defense Authorization Act, complete with a provision reformulating last year’s Biosecure legislation.

Drug resistance rising: one in six infections show no response

One in six common bacterial infections diagnosed worldwide in 2023 were resistant to treatment with antibiotics, according to the latest surveillance data gathered by the World Health Organization (WHO). Drug-resistant gram-negative bacteria are an increasing threat globally, with more than 55% of cases of Klebsiella pneumoniae and more than 40% of cases of Escherichia coli now resistant to third-generation cephalosporins, the first choice treatment. These two bacteria are leading causes of bloodstream infections that can lead to sepsis, organ failure and death.

Excellergy launches with $70M for a new class of allergy drugs

With $70 million in hand, Excellergy Inc. is ready to advance its lead candidate for allergic diseases into clinical trials. The new class of drugs, which the company has coined effector cell response inhibitors (ECRIs), are involved in disrupting the binding of IgE to its receptor. By removing IgE bound to mast cells and basophils, ECRIs have the potential to work quicker and more efficiently than drugs that bind free IgE.

Inhalation drug developer CF Pharmtech raises $78M in Hong Kong IPO

CF Pharmtech Inc. raised HK$607.67 million (US$78.12 million) through the sale of 41.19 million H shares on the Hong Kong Stock Exchange (HKEX) Oct. 8. The proceeds will be used to advance the Suzhou, China-based drug developer’s portfolio of inhalation candidates for respiratory diseases. CF Pharmtech’s stock surged on its trading debut, closing at HK$38.50 per share – a 161% increase from its offering price of HK$14.75. As of Oct. 13, shares had settled at HK$30.92 per share, reflecting a 19.7% decline from the debut close.

US federal shutdown takes another bite out of CDC, FDA staffing

The budget impasse between Democrats and Republicans on Capitol Hill has implications for a wide range of federal government operations, but the Trump administration is exploiting the stand-off to further reduce staffing levels at the FDA and the Centers for Disease Control and Prevention. While some of the recently announced reductions in force have been reversed in the past three days, the FDA said in an Oct. 1 statement that it would not accept new applications that require user fees, putting a wide range of life science premarket applications in a state of limbo.

Also in the news

Annovis, Askbio, Assembly Biosciences, Bioaffinity, Biogen, Cabaletta Bio, Celltrion, Evommune, Ferrer, Genethon, Idorsia, Mandos, Minapharm, Molecule.ai, Mundipharma, OS Therapies, Prilenia, Probiogen, Quoin, Renalys, Renovorx, Shuttle, Stoke Therapeutics, Tela Bio, Vividion