Search This Blog

Monday, December 2, 2019

Merck’s Keytruda nabs accelerated review in U.S. for bladder cancer

The FDA grants Priority Review status to Merck’s (NYSE:MRK) supplemental marketing application seeking approval to use Keytruda (pembrolizumab) to treat patients with high-risk non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy (removal of bladder) and who have failed to respond to standard-of-care Bacillus Calmette-Guerin therapy.
The agency’s action date should be next month.
Shares up 1% premarket on light volume.
Posted by at No comments:

EMA accepts Orchard’s marketing application for OTL-200 for MLD

The  European Medicines Agency (EMA) has validated Orchard Therapeutics’ (NASDAQ:ORTX) Marketing Authorization Application for OTL-200, an ex vivo, autologous, hematopoietic stem cell-based gene therapy that has been developed in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy, for the treatment of metachromatic leukodystrophy (MLD).
Validation confirms that the submission is sufficiently complete to begin the formal review process.
Shares are up 2% premarket.
Posted by at No comments:

Lexicon loses appeal of sotagliflozin CRL; shares down 10% premarket

The FDA has denied Lexicon Pharmaceuticals’ (NASDAQ:LXRX) appeal of the CRL it received in March related to its marketing application for type 1 diabetes med sotagliflozin. Undeterred, it now plans to appeal the decision to the Center for Drug Evaluation and Research (CDER).
The company will host a conference call this morning at 8:00 am ET to discuss the matter.
Shares down 10% premarket on light volume.
Posted by at No comments:

Xenon Pharma up 23% premarket on Neurocrine Bio partnership in epilepsy

Thinly traded micro cap Xenon Pharmaceuticals (NASDAQ:XENE) is up 23% premarket on light volume in response to its license and collaboration deal with Neurocrine Biosciences (NASDAQ:NBIX) to develop treatments for epilepsy.
Under the terms of the agreement, NBIX will have an exclusive license to XEN901 and certain preclinical candidates. The partnership also includes a multiyear research collaboration aimed at discovering and developing additional assets.
XENE will receive $30M upfront, a $20M equity investment from NBIX based on a share price of $14.196, a $25M milestone payment triggered by the FDA acceptance of the XEN901 IND (expected to be filed in mid-2020), up to $1.7B in additional milestones, low double-digit-to-mid-teen royalties on U.S. sales of XEN901 and slightly lower royalties on ex-U.S. sales of XEN901.
XENE will be eligible to receive tiered mid-single-digit-to-low double-digit royalties on U.S. sales of other products (slightly lower rates ex-U.S.).
The company will host a conference call this morning at 8:30 am ET to discuss the collaboration.
Posted by at No comments:

Aquestive +8% premarket on completing NDA submission for libervant buccal film

Aquestive Therapeutics (NASDAQ:AQST) completes the rolling submission of a NDA to the FDA for its therapeutic candidate Libervant (diazepam) Buccal Film for the management of seizure clusters.
The company plans to share the results from the single dose crossover study at the upcoming American Epilepsy Society 2019 Annual Meeting.
Shares are up 8% premarket.
Posted by at No comments:

Baxter to acquire Seprafilm from Sanofi for $350M

Baxter International (NYSE:BAX) has agreed to acquire Sanofi’s (NASDAQ:SNY) Seprafilm Adhesion Barrier device and related assets for $350M in cash. The transaction should close no later than next quarter.
The assets should generate $100M in sales in the first year following the close.
SNY is down 1% premarket on light volume.
Posted by at No comments:

Premarket analyst action, Dec. 3

Bausch Health Companies (NYSE:BHC) initiated with Neutral rating and C$40 (7% upside) price target at Goldman Sachs. Shares up 2% premarket.
Centogene N.V. (NASDAQ:CNTG) initiated with Buy rating and $18 (38% upside) price target at BTIG Research. Initiated with Outperform rating and $17 target at Evercore ISI.
Galapagos N.V. (NASDAQ:GLPG) initiated with Neutral rating and €199 (11% upside) price target at BofA Merrill Lynch.
Galera Therapeutics (NASDAQ:GRTX) initiated with Buy rating and $15 (20% upside) price target at BofAML. Initiated with Buy rating and $20 target at Citigroup. Shares up 1% premarket.
Galmed Pharmaceuticals (NASDAQ:GLMD) initiated with Buy rating and $29 (544% upside) price target at Canaccord Genuity. Shares up 16% premarket.
GlaxoSmithKline (NYSE:GSK) initiated with Outperform rating and $53 (17% upside) price target at SVB Leerink. Shares down 1% premarket.
Intercept Pharmaceuticals (NASDAQ:ICPT) initiated with Buy rating and $165 (52% upside) price target at Canaccord.
Revance Therapeutics (NASDAQ:RVNC) initiated with Buy rating and $25 (40% upside) price target at Goldman.
TherapeuticsMD (NASDAQ:TXMD) initiated with Buy rating and $5 (99% upside) price target at Guggenheim. Shares up 3% premarket.
Theratechnologies (NASDAQ:THTX) initiated with Buy rating and $12 (280% upside) price target at Canaccord.
Trulieve Cannabis (TRUL CN)(OTCPK:TCNNF) upgraded to Buy with a C$22.60 (33% upside) price target at Compass Point.
Biogen (NASDAQ:BIIB) downgraded to Underperform with a $250 (17% downside risk) price target at Baird.
Teladoc (NYSE:TDOC) downgraded to Hold with an $80 (4% downside risk) price target at SunTrust. Shares down 3% premarket.
Posted by at No comments:
Subscribe to: Posts (Atom)