Everything from regulatory approvals, clinical readouts and big money buyout offers can boost the stocks of biopharma companies. But restructurings, diminishing cash and safety issues can also push the prices down. Either way, since the end of July, BioWorld’s Drug Developers Index (BDDI) has shown minimal movement. It is still down by 21.95% for the year, but that is its highest point since the end of March. In comparison with the broader markets, it is following closely the path of both the Nasdaq Biotechnology Index, down 17.16% for the year, and the Dow Jones Industrial Average, down 13.09%.

Regeneron sees market strength in new Eylea data

Success in two pivotal studies of high-dose Eylea (aflibercept) has significantly strengthened Regeneron Pharmaceuticals Inc.’s market position. After struggling for much of the year, the Tarrytown, N.Y.-based company’s stock (NASDAQ: REGN) has risen about 26% to about $739 per share this week. Analyst reaction has been strong, too, as Regeneron’s price target was raised from $735 to $815, about 11%, by Barclays on Sept. 9. SVB Securities took it further, with analysts raising the price target 20%, from $630 to $756. Driving the stock was meeting the primary endpoints in the two studies testing 8-mg doses of aflibercept in treating diabetic macular edema and wet age-related macular degeneration. About 90% of patients with diabetic macular edema and about 80% of patients with wet age-related macular degeneration maintained a 16-week dosing regimen, improving participants’ vision with fewer injections.

ESMO 2022: Genexine’s therapeutic DNA vaccine could extend survival in late-stage cervical cancer

Genexine Co. Ltd.’s DNA vaccine, GX-188E, showed potential in extending overall survival in patients with advanced cervical cancer in a phase II study when given in combination with Merck & Co. Inc.’s anti-PD-1 therapy, Keytruda (pembrolizumab). Top-line results showed a best overall response rate of 31.7% (19 of 60 patients). Six patients (10%) had a complete response and 13 patients (21.7%) had a partial response. Median duration of response was 12.3 months and overall survival was 17.2 months. The top-line results are being presented at the European Society for Medical Oncology conference on Sept. 10.

HPT stars rising as Takeda struggles to revive Natpara

An uncertain future for Takeda Pharmaceutical Co. Ltd.’s withdrawn-from-the-market Natpara, the recombinant human parathyroid hormone for hypoparathyroidism (HPT), created a gap that other developers are seeking to fill. Approved in January 2015, injectable Natpara was taken off shelves in September 2019 because of safety concerns related to rubber particulates leaking into the cartridge. Among HPT contenders is Entera Bio Ltd., with a phase II-stage oral compound delivering the same active ingredient as Natpara.

Cellectis gears up for solid tumor research as ‘game-changing’ allogeneic CAR T cells edge toward market

It’s been five years since the first CAR T-cell therapy was approved, marking the beginning of a new era in cancer therapy, but it’s been a huge effort from pharma to turn them into commercial therapies. The first generation of cell therapies such as Novartis AG’s Kymriah (tisagenlecleucel) and Gilead Science Inc.’s Yescarta (axicabtagene ciloleucel) have undoubtedly bought benefits to patients but have failed to reach the blockbuster sales predicted before their launch. Although they are effective, it was always going to be a difficult task to set up the manufacturing and logistics network for the products, which require a patient’s T cells to be harvested, genetically modified and then injected back into the patient to fight cancer.

The BioWorld Insider Podcast: $1B+ biopharma deals keep values afloat, even amid muted volume 

BioWorld writers bring you the details of new R&D alliances, financings, IPOs and M&A every day. These stories are the heartbeat of the relationships between industry giants and their smaller, more innovative peers. But what's the top-line read for dealmaking these days? With nearly 1,000 biopharma deals completed through early August amid a volatile economic climate, there's a lot to talk about. Join the BioWorld Insider podcast as we talk with Senior Analyst Karen Carey, whose data-driven research delivers a detailed picture of the ups and downs.

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Almirall, Alnylam, Amgen, Amylyx, Anthos, Biogen, Cara, Cytomx, Edesa, Elevar, Eli Lilly, EMD Serono, Erasca, Exelixis, Gatehouse, Genexine, Gilead, Hutchmed, Inflarx, Innervace, Innovent, Inxmed, Leo, Lianbio, Lobe, Lyra, Mindmed, Muvon, Nanobiotix, Neuroplast, Ocuphire, Oncxerna, Palatin, Regeneron, Revance, Scynexis, Silence, Teva, Trethera, Vanda, Veru, Vistagen, Yishengbio, Zynerba