RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
Elanco Animal Health’s (NYSE:ELAN) planned acquisition of Bayer’s (OTCPK:BAYRY) animal health unit is advancing. It received a second request for information from the U.S. Federal Trade Commission, a standard part of the regulatory review process.
Elanco announced its $5.32B cash-and-stock bid in August.
Bolstering its immuno-oncology pipeline, Sanofi (NASDAQ:SNY) will acquire all of the outstanding shares of Synthorx (NASDAQ:THOR) for $68 per share in cash, representing a 172% premium to the latter’s closing price on Dec. 6.
“This acquisition fits perfectly with our strategy to build a portfolio of high-quality assets and to lead with innovation, as you will hear at our Capital Markets Day tomorrow,” said CEO Paul Hudson.
“Additionally, it is aligned with our goal to build our oncology franchise with potentially practice-changing medicines and novel combinations.”
Agios Pharmaceuticals (NASDAQ:AGIO) is up 13% premarket on light volume in reaction to data on the combination of Tibsovo (ivosidenib) and chemo agent azacitidine (Celgene’s Vidaza) in IDH1 mutation-positive AML patients. The results were presented at ASH in Orlando.
Results from 23 newly diagnosed participants in a Phase 1/2 study showed a 61% (n=14) complete response (CR) rate, increasing to 70% (n=16) if CRs with partial hematologic recovery were included. Median duration of CR had not been reached at data cutoff.
Abeona Therapeutics (ABEO +2.7%) is up out of the gate this morning in response to the FDA’s sign-off on a Phase 3 clinical trial, VIITAL, evaluating gene therapy EB-101 in patients with a rare inherited skin-blistering disorder called recessive dystrophic epidermolysis bullosa (RDEB).
The company is on go to start the late-stage study after the agency removed the clinical hold on the program subsequent to the submission of additional transport stability data on EB-101 to clinical sites.
VIITAL’s primary endpoint will be the proportion of wounds showing at least 50% healing at month 3 compared to untreated wounds on the same patient.
EB-101 has Breakthrough Therapy, Orphan Drug, Rare Pediatric designation and Regenerative Medicine Advanced Therapy status for the indication.
Merck’s $2.7B bid for ArQule is yet another example of Big Biopharma’s high regard for oral kinase inhibitors for treating cancer. ArQule’s lead drug is ARQ 531, an oral inhibitor of Bruton’s tyrosine kinase (BTK).
Previous deals include Pfizer’s (PFE -0.1%) $10.4B takeout of Array BioPharma and its lineup of tyrosine kinase inhibitors (TKIs), finalized in July, and Eli Lilly’s (LLY -0.2%) $8B acquisition of Loxo Oncology in February and its portfolio of RET, TRK and BTK inhibitor candidates and TRK inhibitor Vitrakvi (larotrectinib), approved in the U.S. in November 2018 for TRK fusion cancers.
AbbVie (ABBV -0.1%) bought Pharmacyclics for $21B in 2015 in order to secure the rights to BTK inhibitor Imbruvica (ibrutinib), sharing profits with Johnson & Johnson (JNJ +0.1%).
AstraZeneca (AZN +0.2%) acquired a majority stake in Acerta Pharma for $4B late 2015 for access to its kinase inhibitor lineup. Its first win was BTK inhibitor Calquence (acalabrutinib), approved in the U.S. in October 2017 for mantle cell lymphoma and last month for CLL.
Kinase inhibitor-related tickers: BeiGene (BGNE +0.6%), Principia Biopharma (PRNB +3.5%), Merck KGaA (OTCPK:MKGAY), TG Therapeutics (TGTX +30.3%), Aptose Biosciences (APTO +37.9%), Exelixis (EXEL -1%), Deciphera Pharmaceuticals (DCPH +3.8%), Curis (CRIS -0.6%), Pulmatrix (PULM +1.1%), Verastem (VSTM +8.3%), BioCryst Pharmaceuticals (BCRX +0.2%), Aclaris Therapeutics (ACRS +6.6%), IDEAYA Biosciences (IDYA +1.8%), Rigel Pharmaceuticals (RIGL +1.4%), Astellas Pharma (OTCPK:ALPMY), Blueprint Medicines (BPMC -7.4%), Seattle Genetics (SGEN -2.7%), Spectrum Pharmaceuticals (SPPI +0.3%), Puma Biotechnology (PBYI -1%), Galapagos NV (GLPG +1.6%)
