Sage Therapeutics Inc. shares (NASDAQ:SAGE) were trading at $12.52, down $3.11, or almost 20%, after the Cambridge, Mass.-based firm rolled out top-line data from Precedent, a double-blind, placebo-controlled phase II study of the investigational oral medicine dalzanemdor, also known as SAGE-718, in mild cognitive impairment related to Parkinson’s disease (PD). The study fell short of its primary endpoint of statistically significant difference from baseline in subjects given the NMDA receptor-positive allosteric modulator once daily vs. placebo on the Wechsler Adult Intelligence Scale Fourth Edition-IV Coding Test score at day 42. Dalzanemdor was generally well-tolerated, with no new safety signals turning up. Development in PD will stop but top-line data readouts are due later this year from the phase II studies in Huntington’s and Alzheimer’s diseases.

Lilly’s GLP-1/GIP tirzepatide clears sleep apnea phase III hurdle

Eli Lilly and Co. plans to submit for U.S. FDA approval later this year for use of tirzepatide in treating obstructive sleep apnea (OSA) after the GLP-1/GIP dual receptor agonist met all primary and key secondary endpoints in two phase III trials. An OSA nod would make tirzepatide the first drug approved specifically for the indication, a sleep-related breathing disorder that is associated with increased cardiovascular risk, while also providing potential entry access for Medicare Part D coverage, which had been denied tirzepatide, branded Zepbound, as a strictly anti-obesity medication.

Alvotech-Teva biosimilar approved, impact of negotiations looms

Having addressed the manufacturing issues that resulted in a few complete response letters, Alvotech Holdings SA and Teva Pharmaceutical Industries Ltd.’s biosimilars partnership is on a roll now with the U.S. FDA approving the team’s second biosimilar, Selarsdi, less than two months after approving the first one. Greenlighted on its April 16 BsUFA date, Selarsdi is the second biosimilar to Johnson & Johnson’s immunology drug Stelara (ustekinumab). The first follow-on, Amgen Inc.’s Wezlana, was approved as an interchangeable in October, about two months after Stelara was selected for the first round of Medicare price negotiations. Together, Wezlana and Selarsdi could become a case study for how the mandatory negotiations of a reference biologic impact biosimilar competition. 

Theolytics hauls in $23.7M for oncolytic virus therapy THEO-260

Oncolytic virus specialist Theolytics Ltd. has raised £19 million (US$23.7 million) in its latest financing round, as it prepares to start phase I development of the lead product, THEO-260, later this year. THEO-260, for treating platinum-resistant ovarian cancer, is designed to have a dual mode of action, lysing cancer cells and also destroying cancer associated fibroblasts (CAFs) that support tumor growth. The destruction of CAFs both differentiates THEO-260 from other oncolytic viruses and means it has potential for use in other stromal rich tumors, such as breast and pancreatic cancer, where CAFs are a barrier to the effectiveness of therapies.

Neurotech’s NTI-164 meets endpoints in pediatric autism trial

Neurotech International Ltd.’s cannabinoid NTI-164 met the primary and secondary endpoints in a phase II/III trial in children with autism spectrum disorder (ASD). The company also reported positive top-line data for Rett syndrome in a phase I/II trial. NTI-164 is a proprietary drug formulation derived from a unique cannabis strain with low THC (less than 3%) and a combination of cannabinoids for neurological applications. Children with ASD treated with NTI-164 achieved the primary endpoint of exhibiting a statistically significant improvement in Clinical Global Impression - Severity of Illness (CGI-S) scores at eight weeks compared to placebo.

BNC Korea nabs commercial deal, 4.5% stake in Denmark’s Kariya

BNC Korea Inc. is picking up exclusive commercial rights to Kariya Pharmaceuticals ApS’ dual GLP-1/GIP agonists for Parkinson’s and Alzheimer’s disease (PD/AD) in five countries – a move that comes shortly after BNC Korea dropped $1.5 million into the Danish pharma for a 4.5% stake. The deal would grant exclusive commercial rights to Kariya’s KP-405 and KP-404 in South Korea, Singapore, Thailand, Indonesia and Malaysia. Specific terms were not disclosed. Kariya, supported by funding from Novo Nordisk Foundation’s Bioinnovation Institute and Innovation Fund Denmark, is developing the two assets as disease-modifying therapies for central nervous system disorders, including AD and PD. 

EMA workshop signals support for psychedelics

“The development of psychedelic medicines should adhere to the current European regulatory framework, at both the pan-European and member state level. It is imperative that developers understand and thoroughly apply the regulatory guidance and requirements that are in place.” That was the somewhat discouraging opening statement at the stakeholder workshop convened by the EMA to discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health. But despite signaling the agency would be standing by the letter of the regulations, Pavel Balabanov, head of the EMA office for therapies for neurological and psychiatric disorders, assured attendees that the EMA appreciates the unique challenges around developing psychedelics as approved drugs.

Yuhan-Sorrento’s cancer-focused Immuneoncia targets Kosdaq IPO

Immuneoncia Therapeutics Inc., a joint venture between South Korea’s Yuhan Corp. and San Diego-based Sorrento Therapeutics Inc., is looking to list on the Korea Exchange (KRX), having recently passed local technology evaluation. Dongjak-gu-Seoul-based Yuhan said on April 17 that Yongin-si, Gyeonggi-do’s Immuneoncia received A and BBB ratings from two external evaluation bodies appointed by the KRX, helping confirm its technological competitiveness and business feasibility. The qualification also paves the way forward for a pre-IPO round and eligibility review to list on the KRX.

US House hearing includes calls for federal cybersecurity support

With the recent hack of Change Healthcare back in the news, a committee of the U.S. House of Representatives took up the subject of cybersecurity, which included only a couple of mentions of medical devices. However, witnesses at the hearing emphasized the role of the federal government in thwarting foreign cybersecurity threats against health care facilities, with John Riggi of the American Hospital Association (AHA) stating, “we need the [federal] government to go after bad actors overseas.”

BioWorld Insider Podcast: Biopharma execs seek to avoid pain points in AI integration

Because artificial intelligence is such a new technology it comes with a mountain of unknowns. Integrating it into a pharmaceutical company presents a unique series of challenges, as a new survey from Verix shows. The report is based on responses from directors, vice presidents and C-suite executives in sales, marketing and brand management at pharmaceutical companies in the U.S. that have more than $100 million in annual revenue. Doron Aspitz, the CEO of Verix, talked about the new findings with the BioWorld Insider podcast and the profound shift that executives face as the new technology takes over an entire industry.

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