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Marc de Garidel, CinCor Pharma CEO (Eric Piermont/AFP via Getty Images)

Fol­low­ing the re­cent play­book, Cin­Cor rais­es $225M on back of pos­i­tive PhII read­out

On Monday, CinCor Pharma drummed up positive Phase II data for its hypertension drug baxdrostat, following it later that day with a public offering — as many other public biotechs with positive readouts have done with astounding frequency in the lukewarm market conditions.

The size of that raise? $225 million, CinCor said today in a press release. The biotech had originally proposed its public offering at six million shares, but said it was upsized to 7.5 million.

George Scangos, Vir CEO (BIO via YouTube)

Af­ter FDA re­vokes EUA for GSK-part­nered mAb, Vir changes its plans on Covid-19 treat­ments

Vir Biotechnology is moving away from some of its Covid-19 ambitions.

Months after the FDA revoked the emergency use authorization on Vir and GSK’s monoclonal antibody sotrovimab, Vir announced Tuesday that it no longer plans to submit a Biologics License Application for the therapy.

Additionally, Vir announced it does not plan to pursue the Phase III COMET-STAR prophylaxis trial. The trial aimed to administer sotrovimab to uninfected adults at high risk of Covid-19 to prevent symptomatic infection.

Samantha Du, Zai Lab CEO

Up­dat­ed: Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added.

David Zaccardelli, Verona Pharma CEO

Verona’s COPD drug shines in PhI­II study, po­ten­tial­ly clear­ing path to FDA — shares jump

UK-based Verona Pharma’s COPD drug, ensifentrine, has succeeded in its Phase III trial, paving the way for a possible FDA approval.

In Verona’s Phase III ENHANCE-2 study, roughly 800 patients with moderate to severe COPD received ensifentrine or placebo through a nebulizer twice a day for 24 weeks. At 12 hours post-treatment on week 12, the placebo-corrected change in forced expiratory volume (FEV1) — a standard measure of lung function that tests how much breath one can forcefully exhale in one second — was 94 mL, leading the trial to meet its primary endpoint.

John Oyler, BeiGene CEO (Paul Yeung/Bloomberg via Getty Images)

BeiGene touts pos­i­tive PhI­II da­ta on tislelizum­ab in af­ter­math of set­backs at FDA

After the FDA indefinitely delayed its decision on BeiGene’s Novartis-partnered PD-1 drug candidate tislelizumab as a monotherapy for esophageal cancer, Novartis announced that it was scrapping a second application for non-small cell lung cancer. However, BeiGene is holding out hope that there’s yet another way to expand the drug’s market outside of China.

BeiGene put out word Tuesday morning that a Phase III open-label global study, named RATIONALE 301, met its primary endpoint of non-inferior overall survival (OS) versus sorafenib as a first-line treatment in adults with unresectable hepatocellular carcinoma (HCC). The company claimed that the trial, which enrolled more than 600 patients from the US, Europe and Asia, showed a consistent safety profile from previous studies involving tislelizumab and reported no new safety signals.

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Warren Huff, Reata Pharmaceuticals CEO

Rea­ta’s ‘reg­u­la­to­ry con­cerns’ turn in­to three-month de­lay on FDA de­ci­sion for Friedre­ich’s atax­ia drug

In its Q2 report Monday, Reata Pharmaceuticals said that the FDA continues to have concerns about its Friedreich’s ataxia drug.

On Tuesday, those concerns manifested in a three-month delay on an FDA approval decision. Reata’s new FDA decision deadline for its Friedreich’s ataxia drug, omaveloxolone, is the end of February 2023, it announced this morning.

In the Q2 report, Reata noted that the FDA was concerned about the efficacy of omaveloxolone. The Plano, TX-based biotech said that in response to those concerns, it submitted additional data from its clinical trial. But in order to review that new data, the FDA needs more time, hence the three-month delay, Reata said Tuesday morning.

Victor Perlroth, Kodiak Sciences CEO

Ko­di­ak man­ages to score a win for its Eylea ri­val — but the ma­jor test is still ahead

Kodiak Sciences may have failed to show that its anti-VEGF drug is just as good as Regeneron’s Eylea for wet AMD, but the biotech is keeping the pressure on.

In a new Phase III study involving patients with retinal vein occlusion (RVO) — a blinding condition that stems from vein blockage in the eye — KSI-301, which is dosed every two months, proved non-inferior in visual acuity gains to a monthly regimen of Eylea.

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Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Matt Kapusta, uniQure CEO

UniQure halts high-dose treat­ments of Hunt­ing­ton's drug af­ter 3 pa­tients hos­pi­tal­ized — shares tank

UniQure has been working on a gene therapy for Huntington’s disease for some time, and as the field has suffered through multiple failures, the company’s program has been set back.

The biotech announced Monday morning that back in July, it had observed “suspected, unexpected severe adverse reactions”, or SUSARs, in two patients after they were treated with the “higher dose” of a gene therapy candidate, AMT-130, in a European Phase Ib/II clinical trial. A third patient, who was treated back in March in the US, had their side effect deemed not related to the candidate, but it then was reclassified as a severe adverse reaction after review.

Warren Huff, Reata CEO

Rea­ta con­tin­ues to hit FDA road­blocks with its Friedre­ich’s atax­ia can­di­date, not­ing reg­u­la­tor 'con­cern­s'

Reata Pharmaceuticals is facing an FDA wall on its small molecule candidate to treat Friedreich’s ataxia, omaveloxolone. According to the company’s Q2 report, the FDA might still not be sold on the drug.

“[The FDA] continues to have concerns regarding the strength of the efficacy evidence. The FDA did not identify any significant clinical safety issues. The FDA stated that the safety review is ongoing, and they are continuing to evaluate the cardiac safety of omaveloxolone in patients with Friedreich’s ataxia. They have not identified any other major safety concerns at this stage of their review,” the Q2 report said.