The Daily Biotech Pulse: FDA Nod For Sage's Postpartum Depression Drug, Pfizer Invests In Gene Therapy Company

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)

• Abbott Laboratories ABT
• AstraZeneca plc AZN
• Axsome Therapeutics Inc AXSM
• CYCLERION THERA/SH CYCNV
• Glaukos Corp GKOS
• Millendo Therapeutics Inc MLND(initiates Phase 2b/3 study for its investigational candidate livoletide for treating Prader-Willi syndrome)
• Orthopediatrics Corp KIDS
• Zoetis Inc ZTS

Down In The Dumps

(Biotech stocks hitting 52-week lows on March 19)

• Aerpio Pharmaceuticals Inc ARPO
• resTORbio, Inc. 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 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. 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 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 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 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 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 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 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 JAZZ's NDA for JZP-110, its treatment candidate for excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea.