A joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee is taking up the NDA for Alkermes plc’s ALKS-3831 to treat schizophrenia and bipolar I disorder. The drug consists of new molecular entity samidorphan – an opioid antagonist – formulated in a two-layer tablet with the antipsychotic agent olanzapine. Dublin-based Alkermes designed ALKS-3831 to provide olanzapine’s efficacy while mitigating weight gain. The FDA approved olanzapine as Zyprexa/Zyprexa Zydis in 1996. It’s marketed in the U.S. by Eli Lilly & Co., of Indianapolis. Trading in Alkermes shares has been halted as panelists debate the relevance of the weight improvements shown by ALKS-3831, while sorting through safety concerns with regard to patients on opioids. The session ends this afternoon with three voting questions.

Sobi drug falls short in phase III chemotherapy-induced thrombocytopenia trial

A phase III failure of Swedish Orphan Biovitrum (Sobi) AB's avatrombopag to effectively outperform a placebo in treating chemotherapy-induced thrombocytopenia sent company shares (STO:SOBI) down 17.9% on Friday, another day without an approved therapy for the condition. Sobi CEO Guido Oelkers said peak sales estimates for the product, branded Doptelet in two indications already, remain unchanged. Sobi acquired the product last year, when it paid about $915 million for Dova Pharmaceuticals Inc.

FDA guidance roils Saniona’s stock

Pre-IND feedback from the FDA regarding Saniona AB’s submission for Tesomet in Prader-Willi syndrome and hypothalamic obesity sent the stock tumbling. Saniona, which had asked if its planned phase IIb study could be a single pivotal trial, was told by the FDA to consider a supportive phase IIb prior to beginning a phase III to ensure safety and efficacy in Prader-Willi. The FDA also recommended Saniona evaluate Tesomet in patients younger than age 12 and recommended a supportive phase IIb plus a phase III for Tesomet in hypothalamic obesity. Tesomet is a fixed-dose combination of a triple monoamine reuptake inhibitor and a beta-1 selective blocker. The Ballerup, Denmark-based company’s stock (STOCKHOLM:SANION) took a 10.5% dive before closing Oct. 9.

After a slow summer, clinical trial reports pick up in September

As clinical trials, halted due to the COVID-19 pandemic, begin to resume and biopharma companies find workarounds to keep the research going, activity in phase I, II and III studies picked up by more than 40% in September.

Galmed partners with Gannex to develop NASH cure

HONG KONG – Galmed Pharmaceuticals Ltd. has struck an agreement with Ascletis Pharma Inc.’s Gannex arm to develop a combination therapy comprising Ascletis’ ASC-41 and Galmed’s Aramchol (arachidyl amido cholanoic acid) for non-alcoholic steatohepatitis (NASH). Although neither company provided details on the partnership’s financial aspects, Allen Baharaff, CEO at Tel-Aviv, Israel-based Galmed, told BioWorld that “the two companies will be equally sharing all rights and profits” arising from the combination.

Exciting toxicity study implicates TRMP4 in NMDA-mediated cell death

Investigators at the University of Heidelberg have identified a previously unknown mechanism for excitotoxicity and used their insight to identify “unconventional neuroprotectant” compounds that could prevent cell death and reduce brain damage in a mouse model of stroke.

Everest makes strong debut in Hong Kong with $451M IPO

BEIJING – Three-year-old start-up Everest Medicines Ltd. (1952.HK) placed its 63 million shares at HK$55 apiece to raise HK$3.49 billion (US$451 million) on the Hong Kong Stock Exchange on Oct 9. Shares were oversubscribed by 654 times in Hong Kong. The company also gained 33% in its share price on the first trading day, closing at HK$72.75.

Also in the news

Allarity, Apellis, Artelo, Ascentage, Axovant Gene Therapies, Bold, Caladrius, Eli Lilly, Emergent Biosolutions, Foresee, Grifols, Igan, Innovent, Inova, Inspyr, Italfarmaco, Kronos, Kymera, Merck KGaA, Pfizer, Praxis Precision Medicines, Precigen, Rezolute, Rigel, Saniona, Selecta, Shattuck Labs, Sobi, Spruce, Sumitomo Dainippon, Vir