It’s been a rough year at Macrogenics Inc., but times may be changing. Having terminated a phase II study due to fatalities, dropped 15% of its workforce and closed research and manufacturing sites in the past year, the company has taken the helping hand of Gilead Sciences Inc. The pair have agreed to develop the bispecific MGD-024, which has a CD3 component for minimizing cytokine release syndrome, as an oncology candidate along with two additional bispecific research programs. Macrogenics will receive an up-front payment of $60 million from Gilead and could bring in up to $1.7 billion in target nomination, option fees, and development, regulatory and commercial milestones. Tiered, double-digit royalties on worldwide net sales of MGD-024 and a flat royalty on worldwide net sales of products under the two research programs could also come Macrogenics’ way. Macrogenics stock (NASDAQ:MGNX) climbed 13% by midday to $4 per share.

NGM plummets on phase II top-line miss in geographic atrophy

Shares of NGM Biopharmaceuticals Inc. (NASDAQ:NGM) were trading down 72% at midday on disappointing data from its phase II Catalina study testing complement 3 inhibitor NGM-621 in patients with geographic atrophy secondary to age-related macular degeneration. Company execs, however, pointed to secondary analysis data and “unexpected baseline characteristics” in the sham arm of the trial that warrant further exploration before deciding on next steps. NGM also will be talking with partner Merck & Co. Inc., which currently retains an option to NGM-621 under the companies’ amended 2021 collaboration agreement.

No punches held as CDER opens hearing on Makena withdrawal

The U.S. FDA’s Center for Drug Evaluation and Research (CDER) came out punching this morning at the start of a three-day hearing before the Obstetrics, Reproductive and Urologic Drugs Advisory Committee on whether Covis Pharma BV’s Makena (17-hydroxyprogesterone caproate), a branded version of a drug that’s been used since 1956 to prevent preterm births, should be withdrawn from the market. Granted accelerated approval in 2011 based on a single trial, Makena failed to demonstrate clinical benefit in the confirmatory trial that took nearly a decade to complete. Leaving Makena on the market “hinders development of other treatments,” CDER’s Peter Stein said, and it undermines the accelerated approval pathway.

CSL unveils strategy for integrating $11.7B Vifor acquisition

Nearly one year after CSL Ltd. announced its $11.7 billion acquisition of Vifor Pharma Ltd., the company outlined for the first time the synergies of the two companies and its long-term growth strategy aimed at the nephrology market.

Milestone plots 2023 FDA filing after etripamil hits marks in heart rhythm trial 

Milestone Pharmaceuticals Inc. saw a premarket surge in its share price value after a phase III trial of the company’s self-administered, heart rhythm restoring nasal spray, etripamil, hit its target in a phase III trial, setting up a potential filing with the U.S. FDA in mid-2023.

Genetic factors shown to influence COVID vaccine responses

Differences in individual responses to COVID-19 vaccines have been linked directly to different human leukocyte antigen (HLA) alleles and it has been shown that people carrying one specific variant, HLA-DQB1*06, generate higher antibody responses and are better protected from SARS-CoV-2 infection. 

ECNP 2022: Epilepsy is much more than seizures, studies suggest

“Epilepsy is really a classical neurological disorder,” Lars Pinborg told the audience at the European College of Neuropsychopharmacology (ECNP) annual conference on Sunday. “Or is it?” Pinborg, of Rigshospitalet's The Neuroscience Center in Denmark, was chairing a session dedicated to an alternative hypothesis, summed up in the session title: “Is epilepsy a psychiatric disorder?”

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