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Home » Newsletters » BioWorld

BioWorld

March 12, 2024

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Collaboration illustration

Recoded organisms pioneer Pearl Bio signs $1B Merck deal

Technology of genomically recoded organisms borne out of Yale and Stanford university laboratories and housed at Khosla Ventures-backed Pearl Bio received validation on March 12 through a $1 billion deal signed with Merck & Co. Inc. Cambridge, Mass.-based Pearl, which emerged from stealth last year, is eligible for the funds through up-front, option and milestone payments, plus potential royalties on sales of deal-related products that gain approval. The synthetic biology company aims to create a new class of multi-functionalized therapeutics with tunable properties. The deal with Rahway, N.J.-based Merck will focus on new cancer biologics. Read More

US FDA’s briefing doc sends Geron tumbling

Although Geron Corp.’s imetelstat met its primary and key secondary endpoints in a phase III study, the U.S. FDA is questioning the magnitude and durability of the effect of the first-in-class telomerase inhibitor as a second-line treatment of transfusion-dependent anemia in adults with low- to intermediate-1 risk myelodysplastic syndromes. The agency’s concerns resulted in more than an 12% stock tumble March 12 after the FDA released its briefing document two days ahead of an Oncology Drugs Advisory Committee meeting, in which the panel will be asked to vote on whether imetelstat’s benefits outweigh its risks. Read More
Psychiatric disorders illustration

Acadia halts pimavanserin development after a phase III fail

It’s the end of the development line for Acadia Pharmaceuticals Inc.’s main asset, pimavanserin. The company said it won’t conduct any more clinical studies on the selective serotonin inverse agonist and antagonist targeting 5-HT2A receptors after a phase III fail in schizophrenia. Read More

‘Second’ language speaks well of Regulus phase Ib kidney bid

With a second batch of phase Ib data from the trial testing RGLS-8429 in hand from Regulus Therapeutics Inc., Wall Street is looking forward to results from the third cohort in midyear and weighing prospects with the compound in autosomal dominant polycystic kidney disease. Screening of the fourth cohort will start during the second quarter. Meanwhile, the company has begun to mull a pivotal phase II trial that would launch in the middle of next year, and may help with accelerated approval by the U.S. FDA. Read More
Kidneys

Dimerix raises AU$20M on positive phase III kidney disease data

Dimerix Ltd. announced a AU$20 million ($US13.22 million) capital raise following the news that its lead candidate, DMX-200, was successful in a prespecified interim analysis of the efficacy endpoint in its pivotal phase III trial in focal segmental glomerulosclerosis, a rare kidney disease. Read More
HIV virus cells

CROI 2024: New options, and concerns, on HIV drug resistance

One topic at the 31st Conference on Retroviruses and Opportunistic Infections (CROI 2024) held in Denver this month was that resistance to antiretroviral therapy (ART) has become a public health problem for people living with HIV. Without a vaccine or a cure, these patients depend on treatments that suppress viremia by preventing the virus from replicating. They are lifelong treatments and, until new advances succeed in eradicating the virus from reservoirs, the only option available. Read More

Cognition adding $11.5M in public offering for Alzheimer’s drug

With early phase II trial data from Cognition Therapeutics Inc.’s lead candidate, CT-1812, for Alzheimer’s disease expected in mid-2024, the firm is hoping to raise $11.5 million from an underwritten public offering of about 6.6 million shares, priced at $1.75 each. Read More

US DOJ sets more aggressive course for qui tam activity

U.S. deputy attorney general Lisa Monaco recently outlined some new programs related to federal enforcement across the economy, including some novel elements related to artificial intelligence. However, the more important take-away, according to Preston Pugh of Crowell & Moring LLP, is that the Department of Justice (DOJ) continues to work to make the legal environment more friendly to would-be whistleblowers, thus increasing the risk for companies inside and outside the life sciences. Read More

Appointments and advancements for March 12, 2024

New hires and promotions in the biopharma industry, including: Capsida, Gossamer, Idrx, Quotient, Rigel, Telix, Veru. Read More

Financings for March 12, 2024

Biopharmas raising money in public or private financings, including: Eupraxia, Lirum, Recce, Siolta. Read More

In the clinic for March 12, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelyrin, Allyx, Alumis, Arcutis, Bioarctic, Dermavant, Eisai, Eli Lilly, Galderma, Immunabs, Immuneering, Incyte, Leo, Moonlake, Remegen, Replay, Sanofi, Sensorion, Synnovation, Timber, Tonix, UCB, Ventyx. Read More

Other news to note for March 12, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: BMS, Cytomx. Read More

Regulatory actions for March 12, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adma, Aprea, Astellas, Celltrion, Delta-Fly, Formycon, Lexicon, Mesoblast, Novo Nordisk, Pfizer, Regeneron, Transthera, Travere, Viatris. Read More

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