Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech stocks hitting 52-week highs on March 19)
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Abbott Laboratories (NYSE: ABT)
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AstraZeneca plc (NYSE: AZN)
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Axsome Therapeutics Inc (NASDAQ: AXSM)
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CYCLERION THERA/SH (NASDAQ: CYCNV)
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Glaukos Corp (NYSE: GKOS)
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Millendo Therapeutics Inc (NASDAQ: MLND)(initiates Phase 2b/3 study for its investigational candidate livoletide
for treating Prader-Willi syndrome)
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Orthopediatrics Corp (NASDAQ: KIDS)
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Zoetis Inc (NYSE: ZTS)
Down In The Dumps
(Biotech stocks hitting 52-week lows on March 19)
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Aerpio Pharmaceuticals Inc (NASDAQ: ARPO)
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resTORbio, Inc. (NASDAQ: TORC)
(announced a common stock offering)
See Also: Attention
Biotech Investors: Mark Your Calendar For These March PDUFA Dates
Stock In Focus
Sage Gets FDA Approval For Postpartum Depression Drug
SAGE Therapeutics Inc (NASDAQ: SAGE)
said the FDA has approved its Zulresso, chemically brexanolone, injection for the treatment of postpartum depression. With the
approval, Zulresso becomes the first and only medicine, specifically approved for treating postpartum depression.
The company said the drug will be available in late June following scheduling by the U.S. Drug Enforcement Administration, which
is expected to occur within 90 days.
Sage shares rallied 5.57 percent to $164.80 in after-hours trading.
Pfizer Picks Up Stake in Gene Therapy Company Vivet
Pfizer Inc. (NYSE: PFE) said it acquired a
15-percent equity interest in privately-held gene therapy company Vivet, and secured an exclusive option to acquire all outstanding
shares of Vivet, Pfizer also said it will collaborate with Vivet on the development of VTX-801, Vivet's proprietary treatment for
Wilson disease, a life-threatening liver disorder.
Tiziana Files IND For NASH/NAFLD Candidate
TIZIANA LF SCIE/S ADR (NASDAQ: TLSA)
announced the submission of IND to the FDA to initiate Phase 1 trial of enteric-coated capsules of Foralumab in healthy volunteers.
The company said Foralumab is a fully human anti-CD3 monoclonal antibody that is being evaluated for autoimmune and inflammatory
diseases such as NASH and
NAFLD.
Motif Bio Says FDA Agrees For Type A Meeting Related to Antibacterial Candidate
MOTIF BIO PLC/S ADR (NASDAQ: MTFB) said
the FDA has granted it, its request for a Type A meeting to discuss the points raised in the complete response letter for the NDA
for iclaprim for the treatment of acute bacterial skin and skin structure infections.
The company said the meeting is scheduled for May 3.
A Type A meeting is a meeting that is immediately necessary for an otherwise stalled drug development program to proceed.
The stock was soaring 27.33 percent to $2.05 in pre-market trading.
Nevro Announces CEO Transition and Board Reshuffle
Nevro Corp (NYSE: NVRO) announced the
appointment of Keith Grossman as CEO and a member of its board, effective Tuesday, replacing Rami Elghandour. The company also said
it has appointed two new independent directors Elizabeth Weatherman and Kevin O'Boyle, effective immediately, while accepting the
resignation of Ali Behbahani as a director.
The changes at the helm and to the board comes in the wake of pressure from Broadfin Capital, which holds a significant stake in
the company.
The stock was climbing 9.34 percent to $48.95 in pre-market trading.
Offerings
resTORbio priced its previously announced public offering of 7.2 million shares at $6.95 per share.
The stock fell 1.29 percent to $6.89 in pre-market trading, adding to the 22.87 percent slide Tuesday in the wake of the
announcement of the offering.
Dermira Inc (NASDAQ: DERM), which on
Monday spiked higher on positive
mid-stage trial results for its atopic dermatitis drug candidate lebrikizumab, priced its previously announced public offering
of 9.811 million shares at $13.25 per share.
The company said it expects to mobilize gross proceeds of $130 million from the offering.
The stock was seen slipping 2.69 percent to $13.75 in pre-market trading.
Earnings
Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) reported a fourth-quarter net loss of 76 cents per share compared to a net
loss of 92 cents per share last year. Revenues fell from $30,000 to $29,000.
The stock was seen rising 3.58 percent to $6.65 in premarket trading.
Principia Biopharma Inc (NASDAQ: PRNB)
reported revenues of $26.1 million and a profit of 37 cents per share in the fourth quarter of 2018. In comparison, the company
reported revenues of $3.38 million and a loss of $4.55 per share a year ago. Analysts estimated a loss of 31 cents per share for
the recent fourth quarter.
The stock was slipping 1.15 percent to $36.67 in pre-market trading.
On The Radar
PDUFA Date
The FDA will rule on Jazz Pharmaceuticals PLC (NASDAQ: JAZZ)'s NDA for JZP-110, its treatment candidate for excessive sleepiness in adult
patients with narcolepsy or obstructive sleep apnea.
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