Tokai raises $92.7M in upsized IPO
Tokai Pharmaceuticals Inc. (NASDAQ:TKAI) was up $8.76 (58%) to $23.76 on its first day of trading Wednesday after raising $97.2 million through the sale of 6.5 million shares at $15 in an IPO. The IPO price valued the company at $327.6 million. BMO Capital Markets Corp; Stifel; William Blair; and Janney Montgomery Scott are underwriters.
Gilead's simtuzumab misses in pancreatic cancer
Gilead Sciences Inc. (NASDAQ:GILD) said simtuzumab (GS-6624) missed the primary endpoint of progression-free survival (PFS) in a Phase II trial to treat patients with advanced pancreatic cancer.
Flexion falls on FX006 trial hold
Flexion Therapeutics Inc. (NASDAQ:FLXN) fell $4.38 (23%) to $15.00 in early after-hours trading on Wednesday on post-market news that FDA placed a clinical hold on an ongoing Phase IIb trial of FX006 to treat osteoarthritis (OA) knee pain.
CVS reports on Sovaldi discontinuation rates
Discontinuation rates for HCV drug Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) were nearly four times higher in a real-world setting than in clinical trials, according to an analysis of 1,965 patients from pharmacy benefits manager CVS Caremark Corp. (NYSE:CVS).
Sutro, Merck KGaA in ADC deal
Sutro Biopharma Inc. (South San Francisco, Calif.) and the EMD Serono division of Merck KGaA (Xetra:MRK) partnered to use Sutro's Xpress CF and Xpress CF+ cell-free protein synthesis technologies to discover and develop antibody-drug conjugates (ADCs) against undisclosed cancer targets.
Sun licenses Merck's tildrakizumab
Merck & Co. Inc. (NYSE:MRK) granted Sun Pharmaceutical Industries Ltd. (BSE:524715; NSE:SUNPHARMA) exclusive, worldwide rights to tildrakizumab (MK-3222). The anti-IL-23 antibody is in two Phase III trials to treat chronic plaque psoriasis, with data expected in June 2015.
Sanofi, MyoKardia in cardiomyopathy deal
Sanofi (Euronext:SAN; NYSE:SNY) and MyoKardia Inc. (San Francisco, Calif.) partnered to develop targeted therapeutics for hypertrophic cardiomyopathy (HCM) and dilated cardiomyopathy (DCM).
Auxilium jumps on Endo bid
Auxilium jumped $9.66 (45%) to $31.18 on Wednesday after Endo International plc (NASDAQ:ENDP; TSX:ENL) made an unsolicited bid to acquire the specialty pharma postmarket on Tuesday (see BioCentury Extra, Sept. 16).
NICE draft recommends Olysio for some HCV patients
The U.K.'s NICE issued draft guidance recommending Olysio simeprevir from Medivir AB (SSE:MVIR B) and Johnson & Johnson (NYSE:JNJ) in combination with peginterferon alfa and ribavirin to treat HCV genotype 1 infection.
NICE backs Tafinlar
The U.K.'s NICE issued a final appraisal determination (FAD) recommending Tafinlar dabrafenib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat adults with unresectable or metastatic melanoma with a BRAF V600 mutation, its approved indication.
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NICE still mulling changes
The U.K.'s NICE said it is undecided on how to amend its medicine and technology appraisal methods. Moreover, NICE said any changes to its appraisal methods will not sufficiently address concerns about how the NHS accesses new treatments.
FDA awards C-Path $2.1M
FDA awarded the first $2.1 million of a potential $10.5 million five-year grant to the not-for-profit Critical Path Institute (Tucson, Ariz.). C-Path creates public-private partnerships to speed up drug development and approval.