Despite the U.S. FDA’s tentative approval of Liquidia Corp.’s Yutrepia (treprostinil) for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, the company is stuck in the starting gate. Liquidia said it disagrees with the agency’s stance of simultaneously granting regulatory exclusivity in both indications to United Therapeutics Corp.’s powdered formulation of treprostinil, branded Tyvaso, until May 2025. Continuing the long-running litigation between the two companies, Liquidia said it plans to “take quick action to challenge” the FDA’s decision on exclusivity. Liquidia’s stock (NASDAQ:LQDA) had sunk 29.7% at midday to $9.91 per share, while United’s stock (NASDAQ:UTHR) slowly rose after the market opened to $345.42 per share, a 7.5% increase at midday.

PTSD phase II plan sends Alzamend stock skyrocketing

Shares of Alzamend Neuro Inc. (NASDQ:ALZN) soared to 10.64, up $8.60, or 421%, after the Atlanta-based firm disclosed a partnership with Massachusetts General Hospital in Boston as its contract research organization to launch a phase II study with the next-generation lithium compound AL-001 for patients with post-traumatic stress disorder (PTSD). Lithium was the first mood stabilizer approved by the U.S. FDA and is considered the gold standard for bipolar disorder (BD). Though marketed for more than 35 years, lithium has yet to gain clearance from the FDA in PTSD. AL-001 is a patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline, and salicylate, and is in the mid-stage works for Alzheimer’s disease, BD, and major depressive disorder, as well as PTSD.

Pfizer urges Australia to establish clear vision for life sciences

Pfizer Inc. is calling on the Australian government to establish priorities for the life sciences sector to attract more investment into research, clinical trials and manufacturing in Australia. The new report recommends that the government issue a life sciences vision akin to the one issued by the U.K. in 2021 to make the country more competitive to attract investment. The U.K. vision was a response to the COVID-19 pandemic and served as a blueprint for developing treatments for a range of other diseases and the basis for a new 10-year strategy for life sciences. “Australia’s high quality research institutions and strong public hospital system make it a good candidate for further investment,” the report says.

Stocks rise along with concerns of global mpox outbreak

Following the World Health Organization’s escalation of mpox to a public health emergency of international concern and the emergence of what appears to be a more severe strain of the orthopoxvirus, the spotlight has focused on a handful of companies working on vaccines and antivirals. Shares of Geovax Labs Inc., Emergent Biosolutions Inc. and Tonix Pharmaceuticals Inc. were all trading up Aug. 19.

Huadong gets China rights to Imbiologics’ Oxtima program for ₩430B

Imbiologics Inc. scored a potential ₩430 billion (US$315.5 million) deal with China’s Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd. for Oxtima, an autoimmune disease program with two assets co-developed by Seoul, South Korea-based HK Inno.N Corp. An HK Inno.N official confirmed to BioWorld that the deal announced Aug. 16 grants Zhongmei Huadong development and commercialization rights to both IMB-101 and IMB-102 in Asia, excluding South Korea, North Korea and Japan. In turn, Suwon, South Korea-based Imbiologics will receive ₩10.9 billion in an up-front payment. Undisclosed milestone payments could push up the deal’s total to ₩430 billion, along with royalty payments.

Scientists discover gene associated with recovery responses in severe respiratory viral infections

Researchers have identified a gene associated with whether patients hospitalized with respiratory viral infections recover rapidly or face life-threatening complications. In a study led by the Peter Doherty Institute for Infection and Immunity in Melbourne, Australia, researchers uncovered the critical role of a gene called OLAH in determining disease severity. Their findings show that highly elevated expression levels of the gene were strongly associated with severe respiratory viral infections, while minimal OLAH expression was found in recovery and milder disease.

Also in the news

Adicet, Astellas, Astrazeneca, Bavarian Nordic, Biontech, BITT, Deciphera, Eli Lilly, Fulcrum, Incyte, Lobe Sciences, Lykos, Mediwound, Moleculin, Moonwalk, Otsuka, Pfizer, Silexion, Theramex, Tiziana