BioCentury | Jan 12, 2019
Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
BC Week In Review | Dec 7, 2018
Clinical News

FDA approves Ocular's Dextenza for post-surgery pain

FDA approved Dextenza sustained-release dexamethasone insert from Ocular Therapeutix Inc. (NASDAQ:OCUL) for intracanalicular use to treat ocular pain following ophthalmic surgery. Ocular had received two complete response letters from FDA for Dextenza, the first in...
BioCentury | Oct 6, 2018
Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
BC Week In Review | Jul 20, 2018
Clinical News

FDA reviewing Ocular's Dextenza for third time

Ocular Therapeutix Inc. (NASDAQ:OCUL) said FDA accepted for review a resubmitted NDA for Dextenza dexamethasone insert (sustained-release dexamethasone, OTX-DP) to treat ocular pain following ophthalmic surgery. The PDUFA data is Dec. 28. Ocular has received...
BC Extra | Jan 25, 2018
Financial News

Follow-on roundup: Audentes, Iovance

At least six companies have priced follow-ons since Wednesday’s market close, raising more than $600 million. Gene therapy company Audentes Therapeutics Inc. (NASDAQ:BOLD) raised $201.3 million after hours on Wednesday through the sale of 5.8...
BC Week In Review | Nov 30, 2017
Clinical News

Otonomy's Meniere’s disease candidate meets in Phase III

Otonomy Inc. (NASDAQ:OTIC) reported top-line data from the double-blind, European Phase III AVERTS-2 trial in 174 patients with unilateral Meniere’s disease showing that a single 12 mg intratympanic injection of Otividex dexamethasone (OTO-104) met the...
BioCentury | Oct 6, 2017
Finance

Bargain shopping

With all companies valued over $1 billion increasing a median of at least 16.8% in 1H17, investors went bargain shopping in the $500-$999 million tier in 3Q17. The group outperformed all other market cap bands,...
BC Week In Review | Sep 1, 2017
Clinical News

Otonomy's Meniere’s disease candidate misses in Phase III

Otonomy Inc. (NASDAQ:OTIC) reported data from the double-blind, U.S. Phase III AVERTS-1 trial in 165 patients with unilateral Meniere’s disease who were experiencing 4 to 22 days with definitive vertigo episodes of >20 minutes showing...
BC Extra | Aug 30, 2017
Clinical News

Otonomy falls after Phase III Meniere’s disease failure

Otonomy Inc. (NASDAQ:OTIC) plummeted $17.22 (83%) to $3.58 after it said Otividex dexamethasone (OTO-104) missed the primary endpoint in the U.S. Phase III AVERTS-1 study to treat unilateral Meniere’s disease. The company, which lost $521.8...
BC Week In Review | Jul 14, 2017
Clinical News

Ocular receives second CRL for Dextenza

Ocular Therapeutix Inc. (NASDAQ:OCUL) said it received a second complete response letter from FDA for an NDA for Dextenza dexamethasone insert (sustained-release dexamethasone, OTX-DP) to treat ocular pain following ophthalmic surgery. Ocular said the letter...
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