BioPharma Update: TODAYS UPDATE CONTAINS INFORMATI
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Posted On: 07/19/2017 10:08:52 PM
BioPharma Update: TODAYS UPDATE CONTAINS INFORMATION ON: AEZS; RGLS; CYCC and CERU,,,ALL OF WHICH HAVE BEEN DISCUSSED AT ONE TIME OR ANOTHER ON THIS BOARD.
Sarepta Therapeutics Inc (NASDAQ:SRPT) shares are trading up 14% in the after-hours session to $38.70 following better than expected sales data reported in its 2Q earnings release. Sales from Exondys 51, approved by the FDA in 2016 for the treatment of Duchenne muscular dystrophy, were $35m in 2Q 2017, above market estimates of around $22m. Guidance was also raised for 2017 to between $125m and $130m, above previous consensus of $105m.
Shares of Aeterna Zentaris Inc. (NASDAQ: AEZS) surged to close up 129% to $2.34. The company announced Tuesday that its New Drug Application (NDA) seeking approval of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD) has been granted a PDUFA date of December 30, 2017. The resubmission follows the Complete Response Letter (CRL) issued in November 2014 and its failed Phase 3 trial in January 2017. At the time of its release of data from the Phase 3 trial, the company’s Chief Scientific Officer noted;
We are, of course, very disappointed about the outcome of the trial. Based on an analysis of top-line data, macimorelin did not achieve equivalence to the ITT (insulin tolerance test) as a means of diagnosing AGHD.
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) shares closed up 21% to $159.69 following its announcement Tuesday of overwhelming positive data from its Phase 1 and Phase 2 trials of three different triple combination regimens in people with cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation (F508del/Min).
Regulus Therapeutics Inc. (NASDAQ: RGLS) announced that it has commenced an underwritten public offering to issue and sell shares of its common stock. Shares are currently trading down 6% in the after-hours session to $0.90.
Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) shares tumbled 40% to $1.75 following its underwritten public offering of shares and warrants for gross proceeds of $13.2 million.
ContraFect Corporation (NASDAQ: CFRX) also announced that it has commenced an underwritten public offering. Shares are trading down 10% to $1.30 in the after-hours session.
Cerulean Pharma Inc. (NASDAQ:CERU) announced that it is changing its name to "Daré Bioscience, Inc" in a reverse merger under the new ticker "DARE", to be effected concurrent with a one-for-ten reverse stock split on July 20, 2017.
Sarepta Therapeutics Inc (NASDAQ:SRPT) shares are trading up 14% in the after-hours session to $38.70 following better than expected sales data reported in its 2Q earnings release. Sales from Exondys 51, approved by the FDA in 2016 for the treatment of Duchenne muscular dystrophy, were $35m in 2Q 2017, above market estimates of around $22m. Guidance was also raised for 2017 to between $125m and $130m, above previous consensus of $105m.
Shares of Aeterna Zentaris Inc. (NASDAQ: AEZS) surged to close up 129% to $2.34. The company announced Tuesday that its New Drug Application (NDA) seeking approval of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults (AGHD) has been granted a PDUFA date of December 30, 2017. The resubmission follows the Complete Response Letter (CRL) issued in November 2014 and its failed Phase 3 trial in January 2017. At the time of its release of data from the Phase 3 trial, the company’s Chief Scientific Officer noted;
We are, of course, very disappointed about the outcome of the trial. Based on an analysis of top-line data, macimorelin did not achieve equivalence to the ITT (insulin tolerance test) as a means of diagnosing AGHD.
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) shares closed up 21% to $159.69 following its announcement Tuesday of overwhelming positive data from its Phase 1 and Phase 2 trials of three different triple combination regimens in people with cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation (F508del/Min).
Regulus Therapeutics Inc. (NASDAQ: RGLS) announced that it has commenced an underwritten public offering to issue and sell shares of its common stock. Shares are currently trading down 6% in the after-hours session to $0.90.
Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) shares tumbled 40% to $1.75 following its underwritten public offering of shares and warrants for gross proceeds of $13.2 million.
ContraFect Corporation (NASDAQ: CFRX) also announced that it has commenced an underwritten public offering. Shares are trading down 10% to $1.30 in the after-hours session.
Cerulean Pharma Inc. (NASDAQ:CERU) announced that it is changing its name to "Daré Bioscience, Inc" in a reverse merger under the new ticker "DARE", to be effected concurrent with a one-for-ten reverse stock split on July 20, 2017.
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'Everything works out in the end,,,If it hasn't worked out,,it's not the end'
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