Merck teams up with Taiho Pharma and Astex Pharma in cancer

Merck (NYSE:MRK) inks an exclusive global research collaboration and license agreement with Taiho Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Co. (OTCPK:OTSKF) unit Astex Pharmaceuticals aimed at developing small molecule inhibitors against several drug targets in cancer, including the KRAS oncogene.

Under the terms of the deal, the three companies will combine their preclinical candidates and know-how. Merck will have an exclusive global license to the programs and will pay Taiho and Astex $50M upfront, up to $2.5B in milestones and tiered royalties on net sales. Merck will fund R&D and will be responsible for worldwide commercialization. Taiho retains co-commercialization rights in Japan with an option to promote in certain areas of Southeast Asia.

https://seekingalpha.com/news/3529706-merck-teams-up-taiho-pharma-and-astex-pharma-in-cancer

Pfizer-Merck KGaA’s Bavencio extends survival in urothelial cancer study

Results from a Phase 3 clinical trial, JAVELIN Bladder 100, evaluating Pfizer (NYSE:PFE) and alliance partner Merck KGaA’s (OTCPK:MKGAY) Bavencio (avelumab) for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial cancer (UC) whose disease did not progress in induction chemo met the primary endpoint of overall survival (OS).

The data will be submitted for presentation at a future medical conference and will be shared with regulatory authorities.

https://seekingalpha.com/news/3529724-pfizer-and-merck-kgaas-bavencio-extends-survival-in-urothelial-cancer-study

BridgeBio nabs accelerated review in U.S. for infigratinib for bile duct cancer

BridgeBio Pharma (NASDAQ:BBIO) is up 7% premarket on light volume in reaction to the FDA’s Fast Track and Orphan Drug designations for infigratinib for the first-line treatment of advanced/metastatic cholangiocarcinoma (bile duct cancer) with FGFR2 gene fusions or translocations.

Dosing is underway in a 384-subject Phase 3 clinical trial, PROOF, with an estimated primary completion date in October 2021. The primary endpoint is progression-free survival (PFS) at month 12 compared to chemo.

https://seekingalpha.com/news/3529744-bridgebio-nabs-accelerated-review-in-u-s-for-infigratinib-for-bile-duct-cancer

Plus Therapeutics up on shareholder update

Plus Therapeutics (NASDAQ:PSTV) is up 12% premarket on issuing shareholders update.

The Company has achieved a long-term viability in a rapid burst of financial milestones, adding ~$26M to the balance sheet through a series of transactions including the sale of non-core assets, a $4.6M reimbursement from BARDA contract, and a $15M public offering.

Further, PSTV is looking to divest another pipeline product candidate, DoxoPLUS, PEGylated liposomal doxorubicin, a generic version of CAELYX, used for the treatment of ovarian and breast cancers.

In 2019, the Company received positive pre-IND feedback for DocePLUS product candidate. PSTV expects to finalize Phase 2 clinical protocol in H1 2020 and treat the first patients in H2 2020.

https://seekingalpha.com/news/3529750-plus-therapeuticsplus-12-premarket-on-shareholder-update

ATyr Pharma up 57% premarket on Kyorin Pharma deal

Thinly traded nano cap aTyr Pharma (NASDAQ:LIFE) jumps 57% premarket on increased volume in reaction to its collaboration and license agreement with Kyorin Holdings (OTC:KYRNF) unit Kyorin Pharmaceutical Co., Ltd. for the development and commercialization of lead candidate ATYR1923 in Japan for the treatment of interstitial lung diseases.

Under the terms of the deal, it will receive $8M upfront, up to $167M in milestones and tiered royalties on net sales in Japan. In exchange, Kyorin will receive exclusive in-country rights to the NRP2-modulating fusion protein for the indication.

Kyorin will fund all R&D, regulatory and commercialization activities while aTyr will supply product and support development efforts.

https://seekingalpha.com/news/3529753-atyr-pharma-up-57-premarket-on-kyorin-pharma-deal

Cellectar Bio up on Orphan Drug tag for CLR 131 in LPL

Thinly traded nano cap Cellectar Biosciences (NASDAQ:CLRB) perks up 11% premarket on average volume in reaction to Orphan Drug designation in the U.S. for CLR 131 for a slow-growing type of non-Hodgkin lymphoma called lymphoplasmacytic lymphoma (LPL).

A Phase 2 study, CLOVER-1, evaluating the phospholipid ether-drug conjugate in a range of blood cancers, including LPL, is in process.

Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.

https://seekingalpha.com/news/3529761-cellectar-bio-up-11-premarket-on-orphan-drug-tag-for-clr-131-in-lpl

FDA OKs Novo’s Fiasp for diabetic children

The FDA approves Novo Nordisk’s (NVO -0.2%) Fiasp (insulin aspart) 100 U/mL as a mealtime insulin option for children with type 1 diabetes (T1D).

The FDA approved the fast-acting prandial insulin in adults with T1D or T2D in September 2017 followed by approval to use it in insulin pumps for this population in October 2019.

https://seekingalpha.com/news/3529789-fda-oks-novos-fiasp-for-diabetic-children