Neumora Therapeutics Inc., a neuroscience startup aiming to launch precision medicines for brain diseases, said Thursday it has raised more than $500 million, including a $100 million equity investment from Amgen Inc. and a series A financing led by Arch Venture Partners. The company launches with a portfolio of eight clinical, preclinical and discovery-stage programs from internal discovery efforts, the acquisitions of multiple private companies and license agreements with Amgen. Arch’s managing director, Paul Berns, who co-founded the company, is its initial CEO and chairman.

Intergalactic Therapeutics hits engage with $75M for DNA gene therapy tech

Intergalactic Therapeutics Inc. is aiming for the stars with a nonviral gene therapy platform, backed with $75 million in series A financing from life sciences venture capital firm Apple Tree Partners (ATP). While management are tongue in cheek about the name of the company, they are serious about their mission to produce a next generation of gene therapies that overcome the issues associated with marketed adeno-associated virus-based products. Founder and CEO Michael Ehlers, who is also chief scientific officer and venture partner at ATP, told BioWorld that the company’s name reflects the idea that the technology is light years away from the therapies that are already on the market.

FDA adcom: No question that maribavir addresses unmet need

While advances in prophylactic and preemptive treatments have reduced cytomegalovirus (CMV) infections following transplant from 30% down to 5% in recent years, there’s a significant need for treatments for the patients who develop what can be life-threatening infections, Camille Kotton, clinical director of transplant and immunocompromised host infectious diseases at Massachusetts General Hospital, said as she highlighted the need for Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, before the FDA’s Antimicrobial Drugs Advisory Committee Oct. 7. If maribavir gets a thumbs up from the FDA, it would be the first treatment approved in the U.S. for post-transplant refractory/resistant CMV infections. The four antivirals currently used off-label share the same mechanism of action and toxicities, with no alternative for refractory or resistant infections.

Phase III trials positive with Brickell’s hyperhidrosis therapy; NDA next year

Brickell Biotech Inc. disclosed positive top-line data from the phase III pivotal Cardigan I and Cardigan II studies testing sofpironium bromide gel 15% as a once-daily topical formulation in patients with primary axillary hyperhidrosis (excessive underarm sweating). The company expects to submit an NDA in mid-2022 for the product, already approved for the same indication under the brand name Ecclock in Japan, where it was launched by development partner Kaken Pharmaceutical Co. Ltd., of Tokyo. Shares of Boulder, Colo.-based Brickell (NASDAQ:BBI) were trading midday at 68 cents, up 2 cents.

M&As recovering as biopharma deals slide past 2020

With a growing number of deals worth $1 billion or more, 2021 values are slowly inching past 2020’s record year, as mergers and acquisitions also move higher, indicating a potentially stronger second half of the year. So far, the third quarter (Q3) is the best quarter this year, with deal values reaching $62.7 billion, the highest amount recorded for a Q3 within the past six years. In fact, it is the best quarter of any quarter in all recent years going back to 2016, and the 19 deals with projected values above $1 billion – again, the most ever for any quarter – has certainly helped. M&A values, which settled around $12 billion in Q1 and $20 billion in Q2, have reached $57.49 billion in Q3, mostly due to the $39 billion buyout of Alexion Pharmaceuticals Inc. by Astrazeneca plc in July, as well as the $8 billion join-up between Grail Inc. and Illumina Inc. in August.

AACR: Prelude helps open virtual conference with phase I results

Data from two phase I studies presented by Prelude Therapeutics Inc. helped open the American Association for Cancer Research virtual International Conference on Molecular Targets and Cancer Therapeutics but tugged the company’s stock down at midday. Results from the dose-escalation portion of Prelude’s study of protein arginine methyltransferase 5 (PRMT5) inhibitor PRT-543 in treating advanced solid tumors and lymphoma showed a favorable safety profile and evidence of preliminary clinical activity, including durable responses and high levels of target inhibition. Another phase I dose-escalation study, of PRMT5 brain-penetrant inhibitor PRT-811 for treating advanced solid tumors, also showed a favorable safety profile, dose-dependent increases in pharmacokinetic parameters and target engagement. Prelude’s stock (NASDAQ:PRLD) was sagging about 30% at midday. The conference runs until Oct. 10.

Newco news: Sapreme hatches endosomal escape plans with $17M series A round

DUBLIN – The extraordinary inefficiency of intracellular delivery of macromolecular drugs is one of those issues that the pharmaceutical industry does not like to make too much noise about. In many cases, only a tiny fraction of a particular drug dose – for which patients and payers pay dearly – actually gets to do its work. Most of it remains trapped within endosomes, the membrane-bound organelles that form around large molecules that enter the cell through receptor-mediated endocytosis. Sapreme Technologies BV is taking a novel approach to addressing that problem by developing a series of compounds that can dramatically improve the rate with which drugs such as proteins and oligonucleotides can escape the endosome. It has just closed a €15 million (US$17.3 million) series A round to move the technology through preclinical proof of concept and manufacturing scale-up.

FDA preemption of state law for product labeling at risk in Mississippi court ruling

FDA preemption of state liability law has proved controversial on a number of occasions, a fact of life resurrected by a case arising out of the Supreme Court of the State of Mississippi. The court declared that the FDA must invoke the rulemaking process for its regulation of medical product labels, a determination which a number of former FDA employees – including former commissioner Andrew von Eschenbach – are pushing back against in an appeal to the U.S. Supreme Court.

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