Illumina and Qiagen in long-term IVD diagnostics partnership

Illumina (NASDAQ:ILMN) and QIAGEN N.V. (NYSE:QGEN) have entered into a 15-year agreement aimed at developing and commercializing next-gen sequencing-based in vitro diagnostic (IVD) test kits.

Under the terms of the partnership, QGEN will have non-exclusive rights to develop and commercialize IVD kits that can be used with ILMN’s MiSeq Dx and NextSeq 550Dx Systems, including the rights to expand the deal into future ILMN diagnostic systems.

The parties will also commercialize a lineup of clinically validated workflows that combine QGEN’s proprietary content and bioinformatics solutions.

Financial terms are not disclosed.

https://seekingalpha.com/news/3504316-illumina-qiagen-ink-long-term-ivd-diagnostics-partnership

Qiagen prelim Q3 top line less than expected

On a preliminary basis, Q3 sales growth for QIAGEN N.V. (NYSE:QGEN) will be ~3% on a constant exchange rate basis versus guidance of 4 – 5%, due mainly from softer sales in China.

Non-GAAP EPS should be within its guided range of $0.35 – 0.36.

Complete results will be released on October 30.

On another note, Chairman and CEO Peer Schatz has decided to step down in the coming weeks, continuing as a Special Advisor to assist in the transition to new leadership. A search for a permanent CEO has been initiated. In the interim, CFO Roland Sackers will take the reins.

Shares up 1% after hours.

https://seekingalpha.com/news/3504319-qiagen-q3-top-line-less-expected

Intersect ENT down on failed study of drug-coated sinus balloon

Intersect ENT (NASDAQ:XENT) slumps 26% premarket on light volume in reaction to unsuccessful results from the randomized ASCEND study evaluating its drug-coated sinus balloon for dilating the frontal sinus ostium to reduce post-balloon dilation edema via the localized delivery of steroid directly to dilated tissue.

The drug-coated sinus balloon failed to beat an uncoated balloon control as measured by sinus patency grade at day 30, the primary endpoint. Several secondary endpoints were met, including reductions in inflammation and polypoid edema.

No safety signals were observed.

The company will further analyze the results before deciding on next steps.

https://seekingalpha.com/news/3504148-intersect-ent-26-percent-premarket-failed-study-drug-coated-sinus-balloon

Akcea out-licenses antisense candidate to Pfizer for up to $1.5B

Ionis Pharmaceuticals (NASDAQ:IONS) affiliate Akcea Therapeutics (NASDAQ:AKCA) inks an agreement with Pfizer (NYSE:PFE) for global rights to antisense drug AKCEA-ANGPTL3-Lrx for certain cardiovascular and metabolic diseases.

Under the terms of the deal, Akcea and Ionis will receive $250M upfront, divided equally, up to $1.3B in milestones and tiered double-digit royalties on net sales. Akcea will settle its $125M obligation to Ionis via common stock instead of cash.

Pfizer will be responsible for all development and regulatory activities beyond the ongoing Phase 2 trial.

Akcea has the right to participate in certain commercialization activities in the U.S. and selected other markets based on predefined terms and criteria.

AKCEA-ANGPTL3-Lrx is designed to reduce the production of a protein called angiopoietin-like 3, a key regulator of a range of lipid and metabolic pathways. The absence of the protein is associated with reduced risk of insulin resistance and diabetes.

https://seekingalpha.com/news/3504157-akcea-licenses-antisense-candidate-pfizer-1_5b

Mereo Bio’s navicixizumab Fast Track’d for ovarian cancer

Thinly traded nano cap Mereo BioPharma Group (NASDAQ:MREO) is up 6% premarket on increased volume, albeit on turnover of only 29K shares, in reaction to Fast Track designation in the U.S. for Phase 1-stage bispecific antibody navicixizumab for heavily pretreated patients with high grade ovarian, primary peritoneal or fallopian tube cancer who have received at least three prior lines of therapy and/or prior treatment with Roche’s Avastin (bevacizumab).

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

Celgene was investigating the candidate but declined to exercise its license option about a year ago.

https://seekingalpha.com/news/3504171-mereo-bios-navicixizumab-fast-trackd-ovarian-cancer-shares-6-percent-premarket

Brainstorm up on U.S. patent covering NurOwn

Thinly traded nano cap BrainStorm Cell Therapeutics (BCLI +1.4%) is up on below-average volume in reaction to the issuance of a new U.S. patent covering its NurOwn cell therapy.

The patent, entitled “Method of Qualifying Cells,” covers a pharmaceutical composition for MSC-NTF cells secreting neurotrophic factors (NurOwn) consisting of a culture medium as a carrier and an isolated population of differentiated bone marrow-derived mesenchymal stem cells (MSCs) that secrete neurotrophic factors.

https://seekingalpha.com/news/3504271-brainstorm-1-percent-u-s-patent-covering-nurown

NGM Bio down on underwhelming data on NASH candidate

Thinly traded NGM Biopharmaceuticals (NASDAQ:NGM) is down 17% premarket on light volume in apparent reaction to preliminary 24-week data from Cohort 4 in a Phase 2 clinical trial evaluating daily 1 mg doses of aldafermin in NASH patients.

Absolute liver fat content dropped 7.9% in treated patients compared to a reduction of 2.0% in the placebo arm (p<0.05). The relative reduction was -39.6% versus -5.9% for control (p<0.05).

The results appear to be shy of Viking Therapeutics’ (NASDAQ:VKTX) VK2809 and similar to Madrigal Pharmaceuticals’ (NASDAQ:MDGL) MGL-3196.

On the safety front, the most common treatment-related adverse events (mostly mild/moderate) were diarrhea, headache, nausea and joint pain.

Topline data should be available in Q1 2020.

https://seekingalpha.com/news/3504182-ngm-bio-17-percent-premarket-underwhelming-data-nash-candidate