Mereo BioPharma up 27% on license deal

Thinly traded nano cap Mereo BioPharma Group (MREO +27.1%) is up more than double normal volume, albeit on turnover of only 465K shares, on the heels of its out-licensing agreement with Oncologie for exclusive global rights to ovarian cancer candidate navicixizumab, one of two assets Merel acquired via its reverse merger with OncoMed Pharmaceuticals last year.

Under the terms of the deal, Mereo will receive $4M upfront, a $2M CMC-related milestone, up to $300M in other milestones and tiered mid-single-digit-to-sub-teen royalties on net sales. It will also be eligible to receive a percentage of revenues from certain sublicenses.

Navicixizumab is bispecific antibody that induces an anti-tumor response via the inhibition of vascular endothelial growth factor (VEGF) and a cancer stem cell pathway called DLL4 (Delta-like ligand 4).

https://seekingalpha.com/news/3531372-mereo-biopharma-up-27-on-license-deal

AtriCure provides Q4, FY19 outlook

AtriCure (NASDAQ:ATRC) expects $61.3M in Q4 revenue (+16% Y/Y) with U.S. revenue of $49.5M and $11.8M in international sales.

For FY19, AtriCure sees $230.8M in revenue (consensus: $228.7M) with an adjusted EBITDA loss of $7-9M.

AtriCure projects 2020 revenue of $254-261M (up 10-13%; consensus: $257.5M) with an adjusted EBITDA loss of about $10M.

https://seekingalpha.com/news/3531282-atricure-provides-q4-fy19-outlook

Horizon up on bullish views of two meds

Based on encouraging sales to date, Horizon Therapeutics (NASDAQ:HZNP) boosts its peak sales expectation for Krystexxa (pegloticase injection) to more than $1B from more than $750M. Sales growth in 2019 should be more than 25%.

Results from an open-label pilot study, MIRROR OL, evaluating the combination of Krystexxa and methotrexate in gout patients showed a 79% (n=11/14) complete response rate (patients achieving serum uric acid below 6 mg/dL at month 6). By comparison, the response rate was 42% in the Phase 3 program assessing Krystexxa alone.

A separate 135-subject study, MIRROR RCT, evaluating the combination in gout patients is in process with an estimated primary completion date in February 2021. The data will support a label update.

It is planning to evaluate a significantly shorter infusion duration (currently at least two hours) in a proof-of-concept study that should launch mid-year.

The company is also boosting its U.S. peak sales outlook for teprotumumab to more than a $1B from more than $750M. Its marketing application for thyroid eye disease is currently under FDA review with an action date of March 8. It plans to evaluate the IGF-1R inhibitor in diffuse cutaneous scleroderma.

https://seekingalpha.com/news/3531287-horizon-up-7-premarket-on-bullish-views-of-two-meds

Amicus Therapeutics provides FY 2020 strategic and financial outlook

Amicus Therapeutics (NASDAQ:FOLD) provides FY 2020 strategic outlook and financial guidance.

For FY 2020, the Company anticipates total Galafold revenue of $250M to $260M.

To complete Pompe Phase 3 PROPEL study, enroll pediatric studies and advance manufacturing to support 2021 BLA and MAA, data expected  H1 2021.

Advance clinical development, manufacturing and regulatory discussions for CLN6 and CLN3 Batten programs.

Progress Pompe gene therapy towards IND and disclose up to two additional IND candidates.

Biologics manufacturing with WuXi Biologics on track with PPQ runs at commercial Scale.

#JPM20

https://seekingalpha.com/news/3531288-amicus-therapeutics-provides-fy-2020-strategic-and-financial-outlook

CareDx reports preliminary Q4 and FY 2019 results

CareDx (NASDAQ:CDNA) reports preliminary Q4 and FY 2019.

Q4 Preliminary revenue is expected to be between $35.7M and $36M.

Q4 Testing revenue between $29M to $29.3M.

Total AlloSure Kidney and AlloMap Heart patient results provided in the quarter were 14,055.

Q4 Product revenue of $5.1M.

FY 2019 Preliminary revenue is expected to be between $127M and $127.3M.

FY 2019 Testing revenue is expected to be between $104.4M to $104.7M.

Product revenue for FY 2019 is $18.3M.

Effective January 1, 2020, the Board of Directors elected Peter Maag as Chairman of the Board. Dr. Maag will also continue his current role as CEO.

CareDx will report Q4 and FY 2019 financial results in February.

https://seekingalpha.com/news/3531292-caredx-reports-preliminary-q4-and-fy-2019-results

Editas teams up with Sandhill Therapeutics on cancer

Editas Medicine (NASDAQ:EDIT) perks up 2% premarket on light volume in reaction to its agreement with Sandhill Therapeutics aimed at discovering, developing and manufacturing allogeneic engineered natural killer (NK) cells and non-alpha beta T cell medicines for the treatment of cancer.

The partnership will leverage EDIT’s genome editing technology with Sandhill’s Binate product process, a novel universal donor technology to extract, isolate, and expand NK cells and non-alpha beta T cells.

Under the terms of the deal, EDIT will secure an exclusive license to Sandhill’s technology for solid tumors originating within a given area of the body and an option to expand the license into two additional areas. In exchange, Sandhill will receive an upfront payment, milestones and royalties on net sales. Specific financial terms remain confidential.

https://seekingalpha.com/news/3531295-editas-teams-up-sandhill-therapeutics-in-cancer-shares-up-2-premarket

Daré Biosciences higher on Bayer licensing deal

Daré Bioscience (NASDAQ:DARE) +117.2% pre-market after saying it has signed a licensing agreement in which Bayer (OTCPK:BAYRY) may commercialize Daré’s Ovaprene investigational contraceptive product in the U.S. upon approval by the U.S. Food and Drug Administration.

Daré says the deal will entitle it to receive commercial milestone payments potentially totaling $310M, in addition to double digit tiered royalties on sales.

If Bayer makes payment to Daré of $20M, which Daré says it would apply to reimbursement of clinical study costs, then the exclusive license to commercialize Ovaprene in the U.S. will become effective.

Bayer says it would receive the right to obtain exclusive rights to commercialize the product in the U.S. following completion of a pivotal clinical trial being undertaken by Daré.

https://seekingalpha.com/news/3531298-dar-biosciences-blasts-higher-on-bayer-licensing-deal