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3:11 PM, Jun 22, 2018  |  BC Extra | Financial News

Crinetics proposes $86.3M IPO

Endocrine disease company Crinetics Pharmaceuticals Inc. (San Diego, Calif.) proposed to raise up to $86.3 million in an IPO on NASDAQ underwritten by J.P. Morgan, Leerink and Piper Jaffray. In March, Crinetics raised a $63.5 million...
2:22 PM, Jun 22, 2018  |  BC Extra | Politics & Policy

China accelerates drug review timelines for rare, life-threatening diseases

The China State Council set new policies to speed drug approvals, accelerate price cuts and market access for cancer drugs, and monitor and increase drug supplies. The changes include setting a review timeline of three months...
1:59 PM, Jun 22, 2018  |  BioCentury | Finance

Bountiful, not bubbly

A compressed calendar, rather than investor overexuberance, accounts for one of the busiest weeks for IPO pricings in the sector’s history. Seven NASDAQ IPOs were completed during the week ending June 22, raising a total of...
1:58 PM, Jun 22, 2018  |  BioCentury | Finance

Direct from UCB Ventures

UCB Ventures’ recent investment in Durham, N.C.-based gene therapy play StrideBio Inc. marks the next phase in how the strategic investor plans to deploy its €150 million ($174 million) fund. After backing multiple healthcare VC...
1:44 PM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Alexion submits BLA for long-acting C5 inhibitor for PNH

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) submitted a BLA to FDA for ALXN1210 to treat paroxysmal nocturnal hemoglobinuria (PNH) using a rare disease Priority Review voucher. The submission is based on data from the Phase III ALXN1210-PNH-301 and...
1:44 PM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves Suboxone generics from Mylan, Dr. Reddy

FDA approved two generic buprenorphine/naloxone sublingual film products from Mylan N.V. (NASDAQ:MYL) and Dr. Reddy's Laboratories Ltd. (NYSE:RDY), respectively, to treat opioid dependence. FDA said they are the first approved generic versions of Suboxone sublingual...
1:44 PM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

ObsEva's linzagolix meets in Phase IIb for endometriosis-associated pain

ObsEva S.A. (NASDAQ:OBSV) said three of four doses of linzagolix (OBE2109, KLH-2109) met the primary endpoint in the Phase IIb EDELWEISS trial to treat moderate to severe endometriosis-associated pain. The company plans to present additional...
1:43 PM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Nanobiotix’s NBTXR3 meets in Phase II/III for STS

Nanobiotix S.A. (Euronext:NANO) said NBTXR3 (PEP503) met the primary and secondary endpoints in the Phase II/III act.in.sarc trial to treat locally advanced soft tissue sarcoma. The compound comprises crystalline nanoparticles of hafnium oxide activated in...
12:48 PM, Jun 22, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

PTC's oral SMA candidate improves motor development scores in pivotal trial

PTC Therapeutics Inc. (NASDAQ:PTCT) reported updated interim data from part 1 of the pivotal Phase II/III FIREFISH trial showing that oral risdiplam (RG7916) improved motor development scores in infants with spinal muscular atrophy (SMA) type...
12:20 PM, Jun 22, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

Eidos raises $106M in IPO priced at top of range

Eidos Therapeutics Inc. (NASDAQ:EIDX) added $6.12 (36%) to $23.12 June 20 after raising $106.3 million through the sale of 6.3 million shares at $17 in an IPO underwritten by J.P. Morgan, BofA Merrill Lynch and...

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